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SIGYN THERAPEUTICS, INC.

Date Filed : Jun 23, 2022

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ASFILED WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION ON JUNE 22, 2022

 

RegistrationNo. 333-

 

 

 

UNITEDSTATES

SECURITIESAND EXCHANGE COMMISSION

WASHINGTON,D.C. 20549

 

FORMS-1

 

REGISTRATIONSTATEMENT UNDER THE SECURITIES ACT OF 1933

 

SIGYN THERAPEUTICS, INC.
(Exact name of Registrant as specified in its charter)

 

Delaware   3841   47-2573116
(State or other jurisdiction of
incorporation or organization)
 

(Primary Standard Industrial

Classification Code)

 

(I.R.S. Employer

Identification No.)

 

2468Historic Decatur Road

Suite140

SanDiego, California 92106

Telephone:(619) 353-0800

(Addressand Telephone Number of Registrant’s Principal
Executive Offices and Principal Place of Business)

 

VCorpServices

18Lafayette Place

Woodmere,NY 11598

Telephone:(845) 425-0077

(Name,Address, and Telephone Number for Agent of Service)

 

Copiesto:

 

Jolie Kahn, Esq.

12 E. 49th Street, 11th Floor

New York, NY 10017

Telephone: (516) 217-6379

Fax: (866) 705-3071

 

 

Patrick J. Egan, Esq.

Leslie Marlow, Esq.
Hank Gracin, Esq.

Blank Rome LLP

1271 Avenue of the Americas

New York, NY 10020

Phone: (212) 885-5000

Fax: (212) 885-5001

 

Approximatedate of commencement of proposed sale to the public: As soon as practicable on or after the effective date of this registration statement.

 

Ifany of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under theSecurities Act of 1933, please check the following box: ☒

 

Ifthis form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the followingbox and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.☐

 

Ifthis form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list theSecurities Act registration statement number of the earlier effective registration statement for the same offering. ☐

 

Ifthis form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list theSecurities Act registration statement number of the earlier effective registration statement for the same offering. ☐

 

Indicateby check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company,or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smallerreporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer Accelerated Filer
Non-accelerated filer Smaller reporting company
    Emerging growth company

 

Ifan emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complyingwith any new or revised financial accounting standards provided to Section 7(a)(2)(B) of the Securities Act.

 

TheRegistrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until theRegistrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effectivein accordance with Section 8(a) of the Securities Act of 1933, as amended, or until this Registration Statement shall become effectiveon such date as the Commission acting pursuant to said Section 8(a) may determine.

 

 

 

 
 

 

Theinformation in this prospectus is not complete and may be changed. We may not sell these securities until the Securities and ExchangeCommission declares our registration statement effective. This prospectus is not an offer to sell these securities and is not solicitingan offer to buy these securities in any state where the offer or sale is not permitted.

 

PRELIMINARYPROSPECTUS SUBJECT TO COMPLETION DATED JUNE 22, 2022

 

SigynTherapeutics, Inc.

 


 

Class A Units

Each Class A Unit Consisting of

One Shareof Common Stock and

One Series A Warrant to Purchase One Share ofCommon Stock

Class B Units

Each Class B Unit Consistingof __ Shares of Series B Preferred Stock and One Series A Warrant to

Purchase One Share ofCommon Stock

 

This is a firm commitmentpublic offering of ____ Class A Units (“Class A Units”), with each Class A Unit consisting of one share of our commonstock, par value $0.001 per share, and one Series A Warrant to purchase one share our common stock (and the shares issuable from timeto time upon exercise of the Series A Warrants) pursuant to this prospectus based on an assumed offer price of $____ for each Class AUnit. Each Series A Warrant will have an exercise price of $____ (assumed) per share, will be exercisable upon issuance and will expirefive years from issuance. We expect the public offering price will be $______ per Class A Unit.

 

The Class A Units have nostand-alone rights, will not be certificated or issued as stand-alone securities and there will be no trading market for the Class AUnits. The shares of common stock and the Series A Warrants comprising the Class A Units will separate immediately upon completion ofthis offering and prior to any trading of the common stock and Series A Warrants.

 

We are also offering to those purchasers, whosepurchase of Class A Units in this offering would result in the purchaser, together with its affiliates and certain related parties, beneficiallyowning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock following the consummation of thisoffering, the opportunity to purchase, in lieu of the number of Class A Units that would result in ownership in excess of 4.99% (or,at the election of the purchaser, 9.99%) of our outstanding common stock, a unit consisting of one share of Series B convertible preferredstock, par value $.001 per share, convertible at any time at the holder’s option into a number of shares of common stock equalto $5,000 divided by $_____, the public offering price per Class A Unit (the “Conversion Price”), and warrants to purchasea number of shares of common stock equal to the number of shares of common stock issuable upon conversion of one share of Series B convertiblepreferred stock (“Class B Unit”) at a public offering price of $5,000 per Class B unit. The warrants included in the ClassB Units will have the same terms as the warrants included in the Class A Units. For each Class B Unit we sell, the number of Class A Units we are offeringwill be decreased on a dollar-for-dollar basis. Because we will issue a Series A Warrant as part of the Class A Unit or Class BUnit, the number of Series A Warrants sold in this offering will not change as a result of the change in the mix of Class A Units andClass B Units.

 

Our common stock is quoted on the OTC MarketsPink Sheets trading system under the symbol “SIGY”. On June 21 , 2022, the last report sale price of our common stockon the OTC Markets Pink Sheets was $0.249. Prior to this offering, there has been no public market for our Class A Units or ourSeries A Warrants. We plan to apply to have our shares of common stock listed on the Nasdaq Capital Market under the symbol“SIGY”. No assurance can be given that our application will be approved or that the trading price of our common stockon the OTC Markets Pink Sheets will be indicative of the prices of our common stock if our common stock were traded on the NasdaqCapital Market.  If, for whatever reason, Nasdaq does not confirm the listing of our common stock on Nasdaq prior to thepricing of the offering, we will not be able to consummate and will terminate this offering. There is no established trading marketfor the warrants or the Series B convertible preferred stock. In addition, we do not intend to apply for the listing of the Series AWarrants or the Series B Preferred on any national securities exchange or other trading market. Without an active trading market,the liquidity of the Series A Warrants and the Series B Preferred will be limited.

 

The number of Class A Units and Class B Unit offeredin this prospectus and all other applicable information has been determined based on an assumed public offering price of $ perClass A Unit and $___ per Class B Unit, which is based on the last reported sales price of our common stock of $ on             , 2022 . The actualpublic offering price of the Class A Units and Class B Units will be determined between the underwriters and us at the time of pricing,considering our historical performance and capital structure, prevailing market conditions, and overall assessment of our business, andmay be at a discount to the current market price. Therefore, the assumed public offering price per Class A Unit and Class B Unit usedthroughout this prospectus may not be indicative of the actual public offering price for the Class A Units and Class B Units. See “Determinationof Offering Price” for additional information.

 

Investingin our securities involves a high degree of risk. See “Risk Factors” beginning on page 5 of this prospectus for adiscussion of information that should be considered in connection with an investment in our securities.

 

Weare an “emerging growth company” under the federal securities laws and may elect to comply with certain reduced public companyreporting requirements for future filings.

 

Weintend to apply to have our common stock listed on The Nasdaq Capital Market under the symbol “SIGY”.

 

Neitherthe Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determinedif this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

 

    Class A Unit   Class B Unit   Total  
Public offering price   $         $        $       
Underwriting discounts and commissions(1)   $     $     $    
Proceeds to us, before expenses (2)   $     $     $    

 

(1)We have also agreed to issue warrants to purchase shares of our common stock to the representative of underwriters and to reimburse the representative of the underwriters for certain expenses. See “Underwriting” for additional information regarding total underwriter compensation.
(2)The amount of offering proceeds to us presented in this table does not give effect to any exercise of the: (i) over-allotment option (if any) we have granted to the representative of the underwriters as described below and (ii) warrants being issued to the representative of the underwriters in this offering. The public offering price and underwriting discount corresponds to (i) in respect of the Class A Units (a) a public offering price per share of common stock of $__ and (b) a public offering price per Series A Warrant of $__, and (ii) in respect of the Class B Units (a) a public offering price per share of Series B preferred stock of $__ and (ii) a public offering price per Series A Warrant of $_____.

 

We have granted a 45-day option to the underwriters,exercisable one or more times in whole or in part, to purchase up to an additional ____ shares of common stock and/or __ shares of SeriesB preferred stock and/or  additional Series A Warrants (having the same terms as the Series A Warrants included in the Class A Unitsin the offering) from us in any combination thereof at the public offering price per share of common stock equal to the public offeringprice per Class A Unit minus $0.01 per share and $0.01 per Series A Warrant, respectively, less the underwriting discounts payable byus, solely to cover over-allotments, if any.

 

Theunderwriters expect to deliver the securities to purchasers in the offering on or about               ,2022.

 

 

Thedate of this prospectus is           , 2022

 

 
 

 

Tableof Contents

 

  Page
   
Prospectus Summary 1
The Offering 3
Summary Financial Data 4
Risk Factors 5
Cautionary Note Regarding Forward-Looking-Statements 17
Use of Proceeds 19
Determination of Offering Price 20
Market for our Common Stock and Related Stockholder Matters 20
Dividend Policy 20
Capitalization 21
Dilution 22
Management’s Discussion and Analysis of Financial Condition and Results of Operation 23
Description of Business 34
Description of Property 40
Directors, Executive Officers, Promoters, and Control Persons 40
Executive Compensation 44
Security Ownership of Certain Beneficial Owners and Management 46
Underwriting 47
Certain Relationships and Related Transactions 52
Description of Securities 53
Shares Eligible for Future Sales 55
Legal Matters 55
Experts 56
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 56
Where You Can Find More Information 56
Financial Statements F-1
Other Expenses of Issuance and Distribution II-1
Recent Sale of Unregistered Securities II-2
Exhibits II-6
Undertakings II-8
Signatures II-9

 

Youshould rely only on the information contained in this prospectus. We have not authorized anyone to provide you with different information.We are not making an offer of these securities in any state where the offer is not permitted. You should not assume that the informationcontained in this prospectus is accurate as of any date other than the date on the front of this prospectus.

 

 
 

 

PROSPECTUSSUMMARY

 

Exceptas otherwise indicated, as used in this prospectus, references to the “Company,” “we,” “us,” or “our”refer to Sigyn Therapeutics, Inc.

 

Thefollowing summary highlights selected information contained in this prospectus, and it may not contain all of the information that isimportant to you. Before making an investment decision, you should read the entire prospectus carefully, including “Risk Factors”and our financial statements and related notes, included elsewhere in, or incorporated by reference into, this prospectus.

 

OurCompany

 

SigynTherapeutics, Inc. (“Sigyn” or the “Company”) is a medical technology company headquartered in San Diego, California.Our focus is on the treatment of pathogen-associated conditions that precipitate sepsis, the leading cause of hospital deaths worldwide1.Sigyn Therapy™ is a multi-function blood purification technology designed to extract pathogen   sources of life-threateninginflammation in concert with the broad-spectrum elimination of inflammatory mediators from human blood plasma.

 

Beyondthe treatment of sepsis, Sigyn Therapy establishes a novel strategy to address emerging pandemic threats, hepatic encephalopathy, bridge-to-livertransplant, and community acquired pneumonia, which is a leading cause of death among infectious diseases2, the leading causeof death in children under five years of age2, and a catalyst for approximately 50% of sepsis and septic shock cases2.

 

1Global,regional and national sepsis incidence and mortality The Journal Lancet, January 2020  

 

2TheAmerican Thoracic Society – Pneumonia Facts 2019

 

Risksand Challenges That We Face

 

Aninvestment in our securities involves a high degree of risk. You should carefully consider the risks summarized below and the other risksthat are discussed more fully in the “Risk Factors” section of this prospectus immediately following this prospectus summary.These risks include, but are not limited to, the following:

 

  Demand and market acceptance of our product offerings may be considerably less than what we currently anticipate.
     
  We may be unable to increase revenues in the manner in which we anticipate and generate profitability.
     
  We may face challenges in successfully completing U.S. Food and Drug Administration (“FDA”) testing requirements.
     
  We may not be able to meet increased and changing regulatory requirements.
     
  Our systems are not commercially tested.
     
  We will need to raise additional capital to fully commercialize our products.
     
  Some of our target products may face an uncertain regulatory environment.
     
  We may be unable to expand operations and manage growth.
     
  We may be unable to retain key members of our management and development teams and to recruit additional qualified personnel.
     
 

We face competition from companies that have greater resources than we do and we may not be able to effectively compete against these companies.

     
  We face risks as a result of the ongoing COVID-19 pandemic.
     
  We may not be able to continue as a going concern.

 

1
 

 

Implicationsof Being an Emerging Growth Company

 

Weare an “emerging growth company,” as defined in Section 2(a) of the Securities Act of 1933, or the Securities Act, as modifiedby the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. As such, we are eligible to take advantage of certain exemptionsfrom various reporting requirements applicable to other public companies that are not “emerging growth companies” including,but not limited to:

 

  being permitted to present only two years of audited financialstatements and only two years of related disclosure in “Management’s Discussion and Analysis of Financial Condition and Resultsof Operations” in this prospectus;
     
  being permitted to provide less extensive narrative disclosurethan other public companies including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-OxleyAct of 2002 and reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registrationstatements;
     
  being permitted to utilize exemptions from the requirementsof holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previouslyapproved;
     
  being permitted to defer complying with certain changes inaccounting standards; and
     
  being permitted to use test-the-waters communications withqualified institutional buyers and institutional accredited investors.

 

Weintend to take advantage of these and other exemptions available to “emerging growth companies.” We could remain an “emerginggrowth company” until the earliest of (a) the last day of our fiscal year following the fifth anniversary of the closing of thisoffering, (b) the last day of the first fiscal year in which our annual gross revenues exceed $1.07 billion, (c) the last day of ourfiscal year in which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Securities ExchangeAct of 1934, or Exchange Act (which would occur if the market value of our equity securities that is held by non-affiliates exceeds $700million as of the last business day of our most recently completed second fiscal quarter), or (d) the date on which we have issued morethan $1 billion in nonconvertible debt during the preceding three-year period.

 

TheJOBS Act permits an “emerging growth company” like us to take advantage of an extended transition period to comply with newor revised accounting standards applicable to public companies. This means that an “emerging growth company” can delay theadoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to delay suchadoption of new or revised accounting standards.

 

AvailableInformation

 

Wefile various reports with the SEC, including Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form8-K, which are available through the SEC’s electronic data gathering, analysis and retrieval system (“EDGAR”) by accessingthe SEC’s home page (http://www.sec.gov).

 

CorporateInformation

 

OnOctober 19, 2020, Sigyn Therapeutics, Inc, a Delaware corporation (the “Registrant”) formerly known as Reign ResourcesCorporation, completed a Share Exchange Agreement (the “Agreement”) with Sigyn Therapeutics, Inc., a private entityincorporated in the State of Delaware on October 19, 2019. Our mailing address is currently 2468 Historic Decatur Road., Suite 140,San Diego, California, 92106. Our telephone number is (619) 353-0800.

 

2
 

 

THEOFFERING

 

Class A Units offered by us:

 

We are offering Class A Units. Each Class A Unit consists of one share of our common stock and a Series A Warrant to purchase one share of our common stock (together with the shares of common stock underlying such warrants). The Class A Units will not be certificated or issued in stand-alone form. The shares of our common stock and the Series A Warrants comprising the Class A Units are immediately separable upon issuance and will be issued separately in this offering.

     
Assumed Offering price:   $[__] per Class A Unit
     
Class B Units offered by us:   We are also offering to those purchasers, whose purchase of Class A Units in this offering would result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock following the consummation of this offering, the opportunity to purchase, in lieu of the number of Class A Units that would result in ownership in excess of 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock, Class B Units. Each Class B Unit will consist of one share of Series B preferred stock, par value $0.001 per share, convertible into a number of shares of common stock equal to $5,000 divided by $____, the public offering price per Class A Unit (the “Conversion Price”), and warrants to purchase a number of shares of common stock equal to the number of shares of common stock issuable upon conversion of one share of Series B convertible preferred stock (together with the shares of common stock underlying such shares of Series B convertible preferred stock and such warrants). The Class B Units are immediately separable into their components upon closing of the offering contemplated hereby. For each Class B Unit we sell, the number of Class A Units we are offeringwill be decreased on a dollar-for-dollar basis. Because we will issue a warrant as part of each Unit, the number of warrants sold in thisoffering will not change as a result of a change in the mix of the Units sold.
     
Offering price per Class B Unit:   $
     
Description of Series B Preferred Stock:  

Each share of Series B preferred stock is convertible at any time at the holder’s option into a number of shares of common stock equal to $5,000 divided by the Conversion Price. Notwithstanding the foregoing, we shall not effect any conversion of Series B preferred stock, with certain exceptions, to the extent that, after giving effect to an attempted conversion, the holder of shares of Series B preferred stock (together with such holder’s affiliates, and any persons acting as a group together with such holder or any of such holder’s affiliates) would beneficially own a number of shares of our common stock in excess of 4.99% (or, at the election of the purchaser, 9.99%)  of the shares of our common stock then outstanding after giving effect to such exercise. The Series B Preferred Stock does not generally have any voting rights. For additional information, see “Description of Securities—Series B Preferred Stock” in this prospectus.

     
Number of shares of common stock outstanding after the offering:(1)   _______ shares of common stock
     
Market for the common stock:   Our common stock is quoted on the OTC Markets Pink Sheets trading system under the symbol “SIGY”. On June 21, 2022, the last reported sale price for our common stock was $0.249 per share. Prior to this offering, there has been a limited market for our common stock. While our common stock is quoted on the OTC Markets Pink Sheets, there has been negligible trading volume.
     
    There is no assurance that an active trading market will develop, or, if developed, that it will be sustained. Consequently, purchasers of our common stock may find it difficult to resell the securities offered herein should the purchasers desire to do so when eligible for public resale.
     
    Our officers and directors are not purchasing securities in this offering.
     
Use of proceeds:  

We estimate that we will receive approximately $___________ in gross proceeds if we sell all of the Class A Units in the offering (based on an assumed offering price of $[__] per Class A Unit, which was the last reported sales price of our common stock as quoted on the OTC Markets Pink Sheets on , 2022), and we will receive estimated net proceeds (after deducting underwriting discounts and estimated offering expenses) (assuming no exercise of the underwriter’s over-allotment option, the Series A Warrants included in the Class A Units and Class B Units or the Representatives’ Warrants offered hereby).

 
We currently intend to use the net proceeds from this offering, together with our existing cash and cash equivalents, to fund our research and development activities, clinical trials and the regulatory review process, and the remainder for working capital and other general corporate purposes. See “Use of Proceeds” for a more detailed explanation of how the proceeds from the Offering will be used.

     
Over-allotment option:   We have granted a 45-day option to the representative of the underwriters to purchase up to additional shares of common stock and/or additional Series A Warrants, based on an assumed public offering price of $ per Class A Unit or $__ per Class B Unit, which was the last reported sales price of our common stock on the OTC Markets Pink Sheets on , 2022 (having the same terms as the Series A Warrants included in the Class A Units and Class B Units in the offering) from us in any combination thereof at a price per share of common stock equal to the public offering price per Class A Unit and Class B Unit minus $0.01 and a price per warrant of $0.01, respectively, in each case, less the underwriting discounts payable by us, solely to cover over-allotments, if any.
     
Representative’s Warrants   The registration statement of which this prospectus is a part also registers for sale warrants (the “Representative’s Warrants”) to purchase shares of our common stock (based on an assumed offering price of $ per share, which was the last reported sales price of our common stock as quoted on the OTC Markets Pink Sheets on , 2022) to Univest Securities, LLC (the “representative”), as the representative of the several underwriters, as a portion of the underwriting compensation payable to the representative in connection with this offering. The representative’s warrants will be exercisable at any time, and from time to time, in whole or in part, during the four and one half period commencing 180 days following the commencement of sales of the securities in this offering at an exercise price of $[__] (110% of the assumed public offering price of the Class A Units). Please see “Underwriting—Representative’s Warrants” for a description of these warrants.
     
Risk Factors:   See “Risk Factors‚” and the other information in this prospectus for a discussion of the factors you should consider before deciding to invest in shares of our securities.
     
Trading symbol:  

Ourcommon stock is currently quoted on the OTC Markets Pink Sheets trading system under the symbol “SIGY”. We plan to applyto have our shares of common stock listed on the Nasdaq Capital Market under the symbol “SIGY”. No assurance can be giventhat our application will be approved or that the trading prices of our common stock on the OTC Markets Pink Sheets trading system willbe indicative of the prices of our common stock if our common stock were traded on the Nasdaq Capital Market. If, for whatever reason,Nasdaq does not confirm the listing of our common stock on Nasdaq prior to the pricing of the offering, we will not be able to consummateand will terminate this offering.

 

There is no established trading market for theSeries B Preferred Stock or the Series A Warrants and we do not expect a market to develop. In addition, we do not intend to apply forthe listing of the Series B Preferred Stock or the Series A Warrants on any national securities exchange or other trading market. Withoutan active trading market, the liquidity of the Series B Preferred Stock and the Series A Warrants will be limited.

 

Series A Warrants   The exercise price of the Series A Warrants shall be 110% of the offering price of the Class A Units. The Series A Warrants have a five-year term. The Series A Warrants are exercisable at any time after their original issuance and at any time up to the date that is five years after their original issuance. The Series A Warrants will be exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed exercise notice and, at any time a registration statement registering the issuance of the shares of common stock underlying the Series A Warrants under the Securities Act is effective and available for the issuance of such shares, or an exemption from registration under the Securities Act is available for the issuance of such shares, by payment in full in immediately available funds for the number of shares of common stock purchased upon such exercise. If a registration statement registering the issuance of the shares of common stock underlying the Series A Warrants under the Securities Act is not effective or available and an exemption from registration under the Securities Act is not available for the issuance of such shares, the holder may, in its sole discretion, elect to exercise the Series A Warrant through a cashless exercise, in which case the holder would receive upon such exercise the net number of shares of common stock determined according to the formula set forth in the Series A Warrant. No fractional shares of common stock will be issued in connection with the exercise of a Series A Warrant. In lieu of fractional shares, we will pay the holder an amount in cash equal to the fractional amount multiplied by the exercise price.

 

(1) The number of shares of our common stock to be outstanding after this offering is based on shares of our common stock outstanding as June 22, 2022.
   
Unless we indicate otherwise or the context otherwise requires, all information in this prospectus:

 

  assumes no exercise by the underwriters of their option to purchase up to                  additional shares of our common stock and/or Series A Warrants from us to cover over-allotments, if any;
 

no exercise of the Series A Warrants included in the Class A Units and Class B Units;

  assumes no exercise of the Representative’s Warrants to be issued upon consummation of this offering at an exercise price equal to 110% of the initial offering price of the Class A Units;
 

assumes no shares of Series B Preferred Stock are sold in this offering;

  assumes no exercise of outstanding warrants to purchase              shares of our common stock at an exercise price of $[__]; and
  excludes shares of common stock to be reserved for future issuance under our equity incentive plan, which will be effective upon the completion of this offering.

 

Tothe extent we sell any Class B Units in this offering, the same aggregate number of common stock equivalents resulting from this offeringwould be convertible under the Series B Preferred issued as part of the Class B Units.

 

3
 

 

SUMMARYFINANCIAL DATA

 

Thefollowing tables set forth a summary of our historical financial data as of, and for the periods ended on, the dates indicated. The statementsof operations data for the years ended December 31, 2021, and 2020 and the three months ended March 31, 2022 and March 31, 2021,and balance sheet data as of December 31, 2021, and December 31, 2020 and March 31, 2022 and March 31, 2021 are derived fromour audited financial statements included elsewhere in this prospectus.

 

Thefollowing summary financial information should be read in connection with, and is qualified by reference to, our financial statementsrelated notes thereto and the section titled “Management’s Discussion and Analysis of Financial Condition and Results ofOperations” included elsewhere in this prospectus. Our historical results are not necessarily indicative of results to be expectedin any future period.

 

Statementof Operations Data:

 

   Year ended   Year ended 
   December 31,   December 31, 
   2021   2020 
         
Operating costs and expenses          
General and administrative  $1,274,203   $497,072 
Research and development   734,014    419,362 
Total operating Expenses   2,008,217    916,434 
Loss from operations   (2,008,217)   (916,434)
           
Other expense          
Impairment of assets   536,047    - 
Interest expense   460,355    343,156 
Total other income   996,402    343,156 
Net loss   (3,004,619)   (1,259,590)
           
Net loss per share, basic and diluted  $(0.08)  $(0.17)
           
Weighted average number of shares of common stock outstanding, basic and diluted   36,396,585    7,351,272 

 

BalanceSheet Data

 

   December 31,   December 31, 
   2021   2020 
Cash   $340,956   $84,402 
Working capital  $52,075   $586,047 
Total assets  $710,259   $694,082 
Total liabilities  $974,843   $594,903 
Preferred stock  $-   $- 
Common stock  $3,730   $3,520 
Additional paid-in-capital  $3,997,445   $1,356,799 
Accumulated deficit  $(4,265,759)  $(1,261,140)
Total stockholders’ equity  $(264,584)  $694,082 

 

Statementof Operations Data:

 

   Three Months Ended   Three Months Ended 
   March 31,   March 31, 
   2022   2021 
         
Operating costs and expenses          
Marketing expenses  $250   $82,250 
General and administrative   228,342   $116,516 
Research and development   380,644    203,330 
Total operating Expenses   609,236    402,096 
Loss from operations   (609,236)   (402,096)
           
Other expense          
Interest expense   31    - 
Interest expense - debt discount   52,257    50,860 
Interest expense - original issuance costs   16,522    8,726 
Total other income   68,810    59,586 
Net loss   (678,046)   (461,682)
           
Net loss per share, basic and diluted  $(0.02)  $(0.01)
           
Weighted average number of shares of common stock outstanding, basic and diluted   37,295,803    35,266,601 

 

Balance Sheet Data

 

   Three Months Ended   Three Months Ended 
   March 31,   March 31, 
   2022   2021 
Cash     $81,385   $340,956 
Working capital   $62,245   $52,075 
Total assets   $447,414   $710,259 
Total liabilities   $1,178,983   $974,843 
Preferred stock   $-   $- 
Common stock   $3,730   $3,730 
Additional paid-in-capital   $4,208,506   $3,997,445 
Accumulated deficit   $(4,943,805)  $(4,265,759)
Total stockholders’ equity   $(731,569)  $(264,584)

  

4
 

 

RISKFACTORS

 

Youshould carefully consider the risks described below before investing in our securities. Additional risks not presently known to us orthat our management currently deems immaterial also may impair our business operations. If any of the risks described below were to occur,our business, financial condition, operating results, and cash flows could be materially adversely affected. In such an event, the tradingprice of our common stock could decline, and you could lose all or part of your investment. In assessing these risks, you should alsorefer to the other information contained in this Prospectus, including our consolidated financial statements and related notes. The risksdiscussed below include forward-looking statements, and our actual results may differ substantially from those discussed in these forward-lookingstatements.

 

RisksRelated to Financial Condition

 

Weare a development-stage therapeutic organization whose primary focus in the foreseeable future will be the clinical progression of SigynTherapy toward market clearance.

 

Todate, we have devoted substantially all of our resources to support the development of Sigyn Therapy. This includes the completion invitro blood purification validation studies, animal studies, the establishment of initial manufacturing protocols, staffing our organization,establishing our intellectual property portfolio, drafting regulatory documents and raising capital to support these activities. However,there is no assurance that we will obtain the capital resources necessary to continue to advance Sigyn Therapy or other product candidatestoward market approval.

 

Wehave incurred significant net losses since inception and do not anticipate that we will generate revenue in the near future. It is expectedthat we will continue to incur substantial net losses in the foreseeable future and we may never achieve profitability.

 

Weare a development-stage medical technology company. Investment in development-stage therapeutic organizations is highly speculative basedon the need for substantial capital resources and the risk that therapeutic candidates will not receive regulatory approval or becomecommercially viable if market cleared. We have incurred losses in each year since inception. Our net losses were $3.0 million and $1.3million for the years ended December 31, 2021 and 2020 , respectively As of December 31, 2021 and March 31, 2022, we had an accumulateddeficit of $4.3 million and $4.9 million respectively. We expect to continue to spend significant resources to fund the clinical progressionof Sigyn Therapy and other potential product candidates.

 

GoingConcern Risk Factor.

 

Asdescribed in our audited financial statements for the year ended December 31, 2021 contained in our Annual Report on Form 10-K for thatsame time period, our independent registered public accounting firm included an explanatory paragraph indicating that our current liquidityposition raises substantial doubt about our ability to continue as a going concern. It is anticipated that we will continue to operateas a going concern until the completion of this offering; however, there are no assurances that we will be continue to operate if thisoffering is delayed.

 

Uponthe completion of this offering, we may require additional capital in the future to fund the continuance of our operations. If we areunable to raise additional capital when needed, we could be forced to delay, reduce or terminate our clinical development programs.

 

Webelieve that the net proceeds from this offering will be approximately $____ million, based on an assumed public offering price of $[__]per Class A Unit and Class B Unit, after deducting the estimated underwriting discounts and commissions and estimated offeringexpenses payable by us. We believe that such proceeds will fund our operations plan for up to 24 months after the completion of the offering.Accordingly, we acknowledge that there will be a need to raise additional capital to fund future operations, which may include the continuedclinical progression of Sigyn Therapy and other potential product candidates. However, our business or operations plan may change asa result of factors currently unknown to us, and we may need to seek additional funds sooner than planned. However, there is no assurancethat we will be able to secure funding when we need it or on favourable terms. Additionally, our ability to raise additional capitalcould be adversely impacted by market conditions or a worsening global economic climate.

 

5
 

 

Purchasersof our stock will experience dilution.

 

AtMarch 31, 2022 and December 31, 2021, we had a net tangible book value of approximately $0.005 and $0.012 per share of our commonstock, respectively. If you purchase our common stock from us in our Offering, you will experience immediate and substantial dilutionto the extent of the difference between the public offering price per share of our common stock (assuming a $ per share public offeringprice, which is the assumed public offering price set forth on the cover page of this prospectus) and the as adjusted net tangiblebook value per share of our common stock immediately after the offering of $xxx per share (assuming all xxx,000 shares in the Offeringare sold at $xxx per share, which is the assumed public offering price set forth on the cover page of this prospectus).

 

Asmall group of Company officers and directors hold a majority of the control of the Company.

 

Asof June 10, 2022, 2022, the Company’s executive officers and directors beneficially owned approximately 68.9% of the Company’soutstanding common stock. By virtue of such stock ownership, the principal shareholders are able to control the electionof the members of the Company’s Board of Directors and to generally exercise control over the affairs of the Company. Such concentrationof ownership could also have the effect of delaying, deterring or preventing a change in control of the Company that might otherwisebe beneficial to stockholders. There can be no assurance that conflicts of interest will not arise with respect to such directors orthat such conflicts will be resolved in a manner favorable to the Company.

 

IntellectualProperty Risk Factors

 

Wecurrently own the rights to U.S. and foreign patents pending and patent applications and endeavor to continually improve our intellectualproperty position. We consider the protection of our technology to be vital to our business. While we intend to focus primarily on patentabletechnology, we may also rely on trade secrets, unpatented property, know-how, regulatory exclusivity, patent extensions and continuingtechnological innovation to develop our competitive position. We also own rights to the trademarks Sigyn Therapeutics™ and SigynTherapy™.

 

Oursuccess will depend in large part on our ability to protect our proprietary technologies, including Sigyn Therapy, and to operate withoutinfringing the proprietary rights of third parties. We rely on a combination of patent, trade secret, copyright and trademark laws, aswell as confidentiality agreements, and other agreements to establish and protect our proprietary rights. Our success also depends, inpart, on our ability to avoid infringing patents issued to others. If we were judicially determined to be infringing on any third-partypatent, we could be required to pay damages, alter our products or processes, obtain licenses, or cease sales of products or certainactivities.

 

Itis possible that our pending patent applications may not result in issued patents, and that we will not develop additional proprietaryproducts that are patentable, that any patents issued to us may not provide us with competitive advantages or will be challenged by thirdparties and that the patents of others may prevent the commercialization of products incorporating our technology. Furthermore, othersmay independently develop similar products, duplicate our products or design around our patents. U.S. patent applications are not immediatelymade public, so it is possible that a third party may obtain a patent on a technology we are actively using. Additionally, there is arisk that any patent applications that we file or later obtain could be challenged by third parties and declared invalid or unenforceable.

 

Patentlaw outside the United States is uncertain and currently undergoing review and revisions in many countries. The laws of some countriesmay not protect our proprietary rights to the same extent as the laws of the United States. Third parties may attempt to oppose the issuanceof patents to us in foreign countries by initiating opposition proceedings. Opposition proceedings against any of our patent filingsin a foreign country could have an adverse effect on our corresponding patents that may be issued or pending in the United States. Inaddition to patent protection, we rely on unpatented trade secrets and proprietary technological expertise. It is possible that otherscould independently develop or otherwise acquire substantially equivalent technology or somehow gain access to our trade secrets andproprietary technological expertise.

 

WeFace Industry & Competition Risks

 

Basedon the size of the market opportunity, the industry to treat sepsis and other life-threatening inflammatory conditions is expected tobecome extremely competitive. As a development-stage device, Sigyn Therapy faces the challenge of establishing medical industry support,which will be driven by treatment data resulting from human clinical studies. Should Sigyn Therapy become market cleared, we are likelyto face significant competition. Additionally, we will need to establish large-scale production of Sigyn Therapy in order to be competitivein the marketplace.

 

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Inthe absence of approved drug agents to treat sepsis and other life-threatening disorders, our competition is likely to come from organizationsthat develop extracorporeal blood purification therapies. Among these therapies are a cytokine adsorption technology (CytoSorb from CytosorbentsCorporation); a technology that removes circulating endotoxin (Toraymyxn from Toray Industries); and two devices that target the removalof pathogens from the bloodstream (the Hemopurifier from Aethlon Medical) and (the Seraph-100 Microbind Affinity Filter from ExtheraMedical).

 

CytoSorbis a clinical-stage therapeutic candidate in the United States and market cleared in more than 40 countries outside the U.S. CytoSorbwas recently cleared to treat severe COVID-19 infections under FDA Emergency-Use Authorization (EUA) based on its ability to adsorb inflammatorycytokines from the bloodstream.

 

Toraymyxnis a clinical-stage therapeutic candidate in the United States and broadly market cleared outside the U.S. Toraymyxn houses an immobilizedantibiotic agent with a high specificity to bind circulating endotoxin, a potent activator of sepsis resulting from gram-negative bacterialinfections. In North America, exclusive rights to Toraymyxin are licensed to Spectral Medical, who is conducting FDA approved studiesto treat sepsis.

 

TheAethlon Hemopurifier is a clinical-stage therapeutic candidate in the United States. The Hemopurifier has been cleared to treat severeCOVID-19 infections through an FDA IDE supplement and was previously cleared under FDA Emergency-Use Authorization (EUA) to treat Ebolavirus. Immobilized within the Hemopurifier is an affinity lectin that has a high specificity to bind a broad-spectrum of viral pathogensfrom the bloodstream.

 

TheExthera Seraph-100 Microbind Affinity Filter is a clinical-stage therapeutic candidate in the United States and market cleared outsidethe U.S. for the removal of bloodstream pathogens. The Seraph-100 was recently cleared and broadly deployed to treat severe COVID-19infections under FDA Emergency-Use Authorization (EUA). The Seraph-100 incorporates heparin-coated polyethylene beads that bind bothviral and bacterial pathogens in the bloodstream.

 

Whilein vitro studies have validated the ability of Sigyn Therapy to address inflammatory cytokines, bacterial toxins (including endotoxin),hepatic toxins, and infectious viruses, there is no assurance that we will receive market clearance and be able to establish scalablemanufacturing that would allow us to compete with these and other emerging therapies.

 

GovernmentRegulation May Cause Us Delays in Ability to Obtain Approval

 

SigynTherapy is subject to regulation by numerous regulatory bodies, including the United States Food and Drug Administration (FDA) and comparableinternational regulatory agencies. These agencies will require that we comply with applicable laws and regulations governing the development,testing, manufacturing, labeling, marketing, storage, distribution, advertising and promotion, and post-marketing surveillance of SigynTherapy. As a medical device, the FDA’s Center for Devices and Radiological Health (CDRH) will have primary jurisdiction over thepremarket development, review, and approval of Sigyn Therapy. Failure to comply with applicable requirements could subject us to a varietyof administrative sanctions, such as issuance of warning letters, import detentions, civil monetary penalties and/or judicial sanctions,such as product seizures, injunctions, and criminal prosecution.

 

FDA’sPre-market Approval Pathway May Take a Long Time for Approval of our Product

 

Medicaldevices are classified into one of three categories—Class I, Class II or Class III—depending on the degree of risk associatedwith each medical device and the extent of controls needed to provide reasonable assurance of safety and effectiveness. We anticipateSigyn Therapy to be a Class III device, which is subject to a Pre-market Approval (PMA) submission and approval.

 

Apre-market approval application must be supported by extensive data, including but not limited to technical, preclinical, clinical trials,manufacturing and labelling to demonstrate to the FDA’s satisfaction reasonable evidence of safety and effectiveness of the device.

 

Aftera pre-market approval application is submitted, the FDA has 45 days to determine whether the application is sufficiently complete topermit a substantive review and thus whether the FDA will file the application for review. The FDA has 180 days to review a filed pre-marketapproval application, although the review of an application generally occurs over a significantly longer period of time and can takeup to several years. During this review period, the FDA may request additional information or clarification of the information alreadyprovided. Also, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and providerecommendations to the FDA as to the approvability of the device.

 

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Althoughthe FDA is not bound by the advisory panel decision, the panel’s recommendations are important to the FDA’s overall decision-makingprocess. In addition, the FDA may conduct a preapproval inspection of the manufacturing facility to ensure compliance with the QualitySystem Regulation, or QSR. The agency also may inspect one or more clinical sites to assure compliance with FDA’s regulations.

 

Uponcompletion of the PMA review, the FDA may: (i) approve the PMA which authorizes commercial marketing with specific prescribing informationfor one or more indications, which can be more limited than those originally sought; (ii) issue an approvable letter which indicatesthe FDA’s belief that the PMA is approvable and states what additional information the FDA requires, or the post-approval commitmentsthat must be agreed to prior to approval; (iii) issue a not approvable letter which outlines steps required for approval, but which aretypically more onerous than those in an approvable letter, and may require additional clinical trials that are often expensive and timeconsuming and can delay approval for months or even years; or (iv) deny the application. If the FDA issues an approvable or not approvableletter, the applicant has 180 days to respond, after which the FDA’s review clock is reset.

 

ClinicalTrial Requirements Pose Risk to Obtaining Approval

 

Humanclinical trials are required to support pre-market approval. In the United States, human clinal studies require the submission of anInvestigational Device Exemption (IDE) to FDA. The IDE application must be supported by appropriate data, such as animal and laboratorytesting results, showing it is safe to test the device in humans and that the testing protocol is scientifically sound. At present, weare preparing an IDE to submit to FDA. Prior to initiating human studies, our IDE will need to be approved in advance by the FDA fora specific number of patients at specified study sites. During the trial, we must comply with the FDA’s IDE requirements for investigatorselection, trial monitoring, reporting and recordkeeping. Our clinical trial investigators must obtain patient informed consent, rigorouslyfollow the investigational plan and study protocol, control the disposition of investigational devices and comply with all reportingand recordkeeping requirements. Clinical trials of Sigyn Therapy will not be allowed to begin until our IDE application has been approvedby the FDA and the appropriate institutional review boards, or IRBs, at the clinical trial sites. An IRB is an appropriately constitutedgroup that has been formally designated to review and monitor medical research involving subjects and which has the authority to approve,require modifications in, or disapprove research to protect the rights, safety and welfare of human research subjects. The FDA or theIRB at each site at which a clinical trial is being performed may withdraw approval of a clinical trial at any time for various reasons,including a belief that the risks to study subjects outweigh the benefits or a failure to comply with FDA or IRB requirements. Even ifa trial is completed, the results of clinical testing may not demonstrate the safety and effectiveness of Sigyn Therapy or other productcandidates.

 

Thesuccess of Sigyn Therapy and other product candidates will depend on several factors, which include:

 

●the completion of clinical studies that demonstrate the safety and efficacy of our products; the receipt of market approval fromapplicable regulatory authorities, and the completion of post-market studies that may be required by applicable regulatoryauthorities;

 

the establishment of commercial manufacturing capabilities and launch of product marketing and commercial sales;

 

●the acceptance of Sigyn Therapy or other product candidates by patients, the medical community and third-party payors;

 

obtaining and maintaining healthcare coverage and adequate reimbursement for Sigyn Therapy and other product candidates.

 

Manyof these factors may be beyond our control, including the time that will be required to complete clinical testing, the regulatory submissionprocess, and a change in the competitive landscape. It is possible that none of our product candidates will ever obtain regulatory approval,even if we expend substantial time and resources seeking such approval. If we do not achieve one or more of these factors in a timelymanner or at all, we could experience significant delays or an inability to successfully complete clinical trials, obtain regulatoryapproval or, if approved, commercialize our product candidates, which would materially harm our business, financial condition and theresults of our operations.

 

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OurPre-clinical Outcomes May Not Be Predictive of Clinical Trial Success

 

Theresults of our pre-clinical in vitro validations and animal studies may not be predictive of human clinical study outcomes. Historically,therapeutic candidates that perform satisfactorily in pre-clinical and animal studies may nonetheless fail to obtain marketing approval.If the results of our clinical studies are inconclusive or if there are safety concerns or adverse events associated with our productcandidates, we may:

 

be delayed in obtaining marketing approval for our product candidates, if approved at all;

 

obtain approval for indications or patient populations that are not as broad as intended or desired;

 

be required to change the way our product is administered;

 

●be required to perform additional clinical studies to support approval or be subject to additional post-marketing testing requirements;

 

●have regulatory authorities withdraw their approval of a product or impose restrictions on its distribution in the form of a modifiedrisk evaluation and mitigation strategy.

 

Additionally,our product candidates could potentially cause adverse events that have not yet been predicted. The inclusion of ill patients in ourclinical studies may result in deaths or other adverse medical events due to other therapies or medications that such patients may beusing. As described above, any of these events could prevent us from achieving or maintaining market acceptance of our product candidatesand impair our ability to commercialize our products.

 

Wewill depend on enrollment and retention of patients in our clinical trials for our product candidates. Delays or difficulties enrollingor retaining patients in our clinical trials could adversely impact our business operations.

 

Thesuccessful and timely completion of clinical trials will require that we enroll and retain a sufficient number of patient candidates.Any clinical trials that we conduct could be subject to delays for a variety of reasons, including as a result of patient enrollmenttaking longer than anticipated, patient withdrawal, or adverse events. These types of developments could cause us to delay a clinicaltrial or halt further development. Patient enrollment depends on many factors, including:

 

the size and nature of the patient population;

 

theseverity of the disease, condition or infection under investigation;

 

●eligibility criteria for the trial;

 

the proximity of patients to clinical sites;

 

●the design of the clinical protocol;

 

●the ability to obtain and maintain patient consents;

 

perceived risks and benefits of the product candidate under evaluation;

 

the ability to recruit clinical trial investigators with the appropriate competencies and experience;

 

●the risk that patients enrolled in clinical trials will drop out of the trials before the administration of our product candidates ortrial completion;

 

the availability of competing clinical trials;

 

●the availability of candidate patients during pandemic outbreaks, such as COVID-19; and

 

the availability of new therapies that are approved for the indication the clinical trial is investigating.

 

Thesefactors may make it difficult for us to enroll enough patients to complete our clinical trials in a timely and cost-effective manner.Delays in the completion of our clinical trials may jeopardize our ability to commence product sales and generate revenue. Additionally,factors that delay the commencement or completion of clinical trials may establish a basis for FDA to deny the approval of our therapeuticcandidates.

 

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RisksRelated to our Business and Industry

 

Weare highly dependent on our Chief Executive Officer.

 

Weare highly dependent on our Chief Executive Officer, James A. Joyce, who is integral to our business operations and the development ofour product candidates. The loss of Mr. Joyce’s services could have a material adverse effect on our business operations.

 

Wehave a limited number of employees

 

Weare a small organization that maintains a staff of five full-time employees. The departure of any employee could have a material adverseeffect on our business operations.

 

Wemay be adversely affected by current and future pandemic outbreaks  .

 

Thecurrent COVID-19 (“COVID-19”) outbreak and the emergence of future pandemics could have a deleterious impact on our businessoperations. As demonstrated by COVID-19, pandemic outbreaks can significantly delay or interrupt crucial business operations. Pandemicoutbreaks may also reduce the availability of human resources or critical supplies that will be required to carry out our clinical andmanufacturing programs. Additionally, stay-at-home and other pandemic outbreak policies could restrict critical personnel from conductingthe core activities necessary to advance Sigyn Therapy and other potential product candidates.

 

Economicuncertainty may adversely affect our access to capital, cost of capital and ability to execute our business plan as scheduled.

 

Generally,worldwide economic conditions remain uncertain. Access to capital markets is critical to our ability to operate. Traditionally, medicaltechnology companies have funded their research and development expenditures through raising capital in the equity markets. Declinesand uncertainties in these markets in the past have severely restricted raising new capital and have affected companies’ abilityto continue to expand or fund clinical development efforts. There is no certainty that the capital markets will be conducive to raisingcapital on favorable terms. If economic conditions become worse, our future cost of equity or debt capital and access to the capitalmarkets could be adversely affected. In addition, if we are unable to access the capital markets on favorable terms, our ability to executeour clinical progression plan would be compromised. Moreover, we rely and intend to rely on third-party vendors, including clinical researchorganizations, contract manufacturing organizations and consultants. Global economic conditions may result in a disruption or delay inthe performance of our third-party contractors and suppliers. If such third-parties are unable to adequately satisfy their contractualcommitments to us in a timely manner, our business could be adversely affected.

 

Ourreliance on third-party vendors heightens the risks faced by our business.

 

Werely on third-party vendors for certain key aspects of our business, including support for information technology systems and certainhuman resource functions. We do not control these partners, but we depend on them in ways that may be significant to us. If these partiesfail to meet our expectations or fulfill their obligations to us, we may fail to receive the expected benefits. In addition, if any ofthese third parties fails to comply with applicable laws and regulations in the course of its performance of services for us, there isa risk that we may be held responsible for such violations as well, which could adversely affect our business, reputation, financialcondition or results of operations.

 

Werely on third party organizations to conduct our pre-clinical testing, research and clinical trials.

 

Werely on third-party organizations to conduct preclinical studies, and we expect to continue to rely on third parties, such as CROs, contractmanufacturers of clinical supplies, clinical data management organizations, medical institutions and clinical investigators, to conductour clinical trials and to conduct some aspects of our research and pre-clinical testing. These third parties may terminate their engagementswith us at any time. If these third parties do not successfully carry out their duties, meet expected deadlines or conduct our studiesin accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketingapprovals for our product candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our productcandidates. Furthermore, these third parties may also have relationships with other entities, some of which may be our competitors. Ifwe are required to enter into alternative arrangements, it could delay our product development activities.

 

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Uponcommercialization of our products, we may be dependent on third parties to market, distribute and sell our products.

 

Ourability to generate revenues may be dependent upon the sales and marketing efforts of any future co-marketing partners and third-partydistributors. At this time, we have not entered into an agreement with any commercialization partner and only plan to do so prior tocommercialization. If we fail to reach an agreement with any commercialization partner, or upon reaching such an agreement that partnerfails to sell a large volume of our products, it may have a negative impact on our business, financial condition and results of operations  .

 

Wewill be dependent on third parties for the manufacture of our product candidates. If we experience problems with any of these third parties,they could delay clinical development or marketing approval of our product candidates or our ability to sell any approved products.

 

Wedo not have any manufacturing facilities. We expect to rely on third-party manufacturers for the manufacture of our product candidatesfor clinical trials and for commercial supply of any product candidate for which we obtain marketing approval.

 

Wemay be unable to establish agreements with third-party manufacturers for clinical or commercial supply on terms favorable to us, or atall. Even if we are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additionalrisks, including:

 

reliance on the third party for regulatory compliance and quality assurance;
   
the possible breach of the manufacturing agreement by the third party, including the inability to supply sufficient quantities or to meet quality standards or timelines; and
   
the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.

 

Third-partymanufacturers may not be able to comply with U.S. cGMPs or similar regulatory requirements outside the United States. Our failure, orthe failure of our third-party manufacturers, to comply with cGMPs or other applicable regulations, even if such failures do not relatespecifically to our product candidates or approved products, could result in sanctions being imposed on us or the manufacturers, includingfines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of productcandidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidatesand harm our business and results of operations.

 

Anyproduct that we develop may compete with other product candidates and products for access to these manufacturing facilities. There area limited number of manufacturers that operate under cGMPs and that might be capable of manufacturing for us.

 

Anyperformance failure on the part of our manufacturers, including a failure that may not relate specifically to our product candidatesor approved products, could delay clinical development or marketing approval or adversely impact our ability to generate commercial sales.If our contract manufacturers cannot perform as agreed, we may be required to replace that manufacturer.

 

Ouranticipated future dependence upon others for the manufacture of our current and future product candidates or products may adverselyaffect our future profit margins and our ability to commercialize any product candidates that receive marketing approval on a timelyand competitive basis.

 

Ourbusiness could be adversely affected by reliance on sole suppliers.

 

Notwithstandingour current multiple supplier approach, certain essential product components may be supplied in the future by sole, or a limited groupof, suppliers. Most of our products and components are purchased through purchase orders rather than through long term supply agreementsand large volumes of inventory may not be maintained. There may be shortages and delays in obtaining certain product components. Disruptionof the supply or inventory of components could result in a significant increase in the costs of these components or could result in aninability to meet the demand for our products. In addition, if a change in the manufacturer of a key component is required, qualificationof a new supplier may result in delays and additional expenses in meeting customer demand for products. These factors could adverselyaffect our revenues and ability to retain our experienced sales force.

 

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Changesin financial accounting standards or practices may cause adverse, unexpected financial reporting fluctuations and affect our reportedresults of operations.

 

Weare required to prepare our financial statements in accordance with generally accepted accounting principles in the United States ofAmerica (“GAAP”), which is periodically revised and/or expanded. From time to time, we are required to adopt new or revisedaccounting standards issued by recognized authoritative bodies, including the FASB and the SEC. It is possible that future accountingstandards we are required to adopt may require additional changes to the current accounting treatment that we apply to our financialstatements and may require us to make significant changes to our reporting systems. Such changes could result in a material adverse impacton our business, results of operations and financial condition.

 

Wehave a limited operating history, which may make it difficult to evaluate our business and prospects.

 

Weface the risks associated with businesses in their early stages, with limited operating histories and whose prospects are hard to evaluate.Any evaluation of our business and our prospects must be considered in light of the uncertainties, delays, difficulties and expensescommonly experienced by companies at this stage, which generally include unanticipated problems and additional costs relating to thedevelopment and testing of products, product approval or clearance, regulatory compliance, production, product introduction and marketing,and competition. Many of these factors are beyond the control of our management. In addition, our performance will be subject to otherfactors beyond our control, including general economic conditions and conditions in the healthcare industry.

 

Marketacceptance of Sigyn Therapy and other product candidates will be vital to our future success.

 

Thecommercial success of our products is dependent upon their acceptance by the intended markets. Our product candidates may not gain ormaintain any significant degree of market acceptance among consumers, surgeons or healthcare providers, or acceptance by third-partypayors, such as health insurance companies, Medicaid and Medicare. We cannot be certain that our products will be used by the medicalcommunity, even upon market approval of our product candidates.

 

Marketacceptance will be dependent on numerous factors, many of which are not under our control, including:

 

  the safety and efficacy of our products and product candidates, as demonstrated in clinical trials and after commercialization;
  favorable regulatory approval and product labeling;
  the ease of use of our product and any related instrumentation that accompany our product;
  our ability to educate and train doctors on the advantages of our product;
  the price of any approved product relative to alternative technologies; and
  the availability of third-party reimbursement.

 

Ifour products and product candidates do not achieve significant market acceptance, our potential for revenues and profitability wouldbe adversely affected.

 

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Ouremployees, independent contractors, principal investigators, consultants, vendors and clinical research organizations, or CROs, couldengage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

 

Weare exposed to the risk that our employees, independent contractors, principal investigators, consultants, vendors and CROs may engagein fraudulent or other illegal activity. Misconduct by these persons could include intentional, reckless or negligent conduct or unauthorizedactivity that violates: laws or regulations, including those laws requiring the reporting of true, complete and accurate informationto the FDA or foreign regulatory authorities; manufacturing standards; federal, state and foreign healthcare fraud and abuse laws anddata privacy; or laws that require the true, complete and accurate reporting of financial information or data. In particular, sales,marketing and other business arrangements in the healthcare industry are subject to extensive laws intended to prevent fraud, kickbacks,self-dealing and other abusive practices. These laws may restrict or prohibit a wide range of business activities, including research,manufacturing, distribution, pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other businessarrangements. Activities subject to these laws also involve the improper use of information obtained in the course of clinical trials,which could result in regulatory sanctions or other actions stemming from a failure to comply with such laws or regulations, and seriousharm to our reputation. In addition, federal procurement laws impose substantial penalties for misconduct in connection with governmentcontracts and require certain contractors to maintain a code of business ethics and conduct. If any such actions are instituted againstus, we may have to terminate employees or others involved and the impact of such termination can result in our experiencing delays andadditional costs associated with replacing the services being provided. If we are not successful in defending ourselves or assertingour rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrativepenalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs,FDA debarment, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, anyof which could adversely affect our ability to operate our business and our operating results.

 

U.S.legislative or FDA regulatory reforms may make it more difficult and costly for us to obtain regulatory approval of future product candidatesand to manufacture, market and distribute our products after approval is obtained.

 

Fromtime to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions governing theregulatory approval, manufacture and marketing of regulated products or the reimbursement thereof. In addition, FDA regulations and guidanceare often revised or reinterpreted by the FDA in ways that may significantly affect our business and our products. Any new regulationsor revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of future products. Inaddition, FDA regulations and guidance are often revised or reinterpreted by the agency in ways that may significantly affect our businessand our products. It is impossible to predict whether legislative changes will be enacted or FDA regulations, guidance or interpretationschanged, and what the impact of such changes, if any, may be.

 

InformationTechnology Risks

 

Ourinternal information technology (IT) systems could be compromised, damaged, breached or destroyed. IT risks include hardware and softwarefailure, human error, spam, viruses, malicious attacks, industrial espionage, as well as natural disasters such as fires, earthquakes,hurricanes or floods. IT system failures may affect our ability to run our operations. Operational impact of IT failures or breachesmay result in loss of productivity and a reduced ability to advance our clinical programs. Failures or breaches of our IT systems couldalso result in the loss or corruption of confidential data or in the theft of data or critical information.

 

Additionally,the increased sophistication and activities of perpetrators of cyber-attacks have resulted in an increase in information security risksin recent years. Hackers develop and deploy viruses, worms, and other malicious software programs that attack products and services andgain access to networks and data centers. If we experience difficulties maintaining existing systems or implementing new systems, wecould incur significant losses due to disruptions in our operations. Additionally, these systems may contain valuable proprietary andconfidential information and may contain personal data of employees, third-party vendors, and collaborators. A security breach couldresult in disruptions of our internal systems and business applications, harm to our competitive position from the compromise of confidentialbusiness information, or subject us to liability under laws that protect personal data. As cyber threats continue to evolve, we may berequired to expend additional resources to continue to enhance our information security measures and/or to investigate and remediateany information security vulnerabilities. Any of these consequences could adversely affect business.

 

RiskFactors Related to Our Common Stock

 

Theprice of our common stock may be volatile, and a shareholder’s investment in our common stock could suffer a decline in value.

 

Therehas been significant volatility in the volume and market price of our common stock, and such volatility may continue in the future. Inaddition, factors such as quarterly variations in our operating results, actions by governmental agencies, national economic and stockmarket considerations as well as other events and circumstances beyond our control, including the effects of pandemic outbreaks, couldhave a significant impact on the future market price of our common stock and the relative volatility of such market price.

 

Aprolonged decline in the price of our common stock could result in a reduction in the liquidity of our common stock and a reduction inour ability to raise capital. If we are unable to raise the funds required for all of our planned operations and key initiatives, wemay be forced to allocate funds from other planned uses, which may negatively impact our business and operations, including our abilityto develop new products and continue our current operations.

 

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Ourcommon stock is currently traded on the OTC Markets Pink Sheets, which may have an unfavorable impact on our stock price and liquidity.

 

Whilewe plan to submit an application to list our securities on the Nasdaq stock exchange, our stock is currently listed on the OTC MarketsPink Sheets. The OTC Markets Pink Sheets is significantly more limited market than the national securities exchanges such as the NewYork Stock Exchange, or Nasdaq stock exchange, and there are lower financial or qualitative standards that a company must meet to haveits stock quoted on the OTC Markets Pink Sheets. OTC Markets Pink Sheets is an inter-dealer quotation system much less regulated thanthe major exchanges, and trading in our common stock may be subject to abuses, volatility and shorting, which may have little to do withour operations or business prospects. This volatility could depress the market price of our common stock for reasons unrelated to operatingperformance. The Financial Industry Regulatory Authority (“FINRA”) has adopted rules that require a broker-dealer to havereasonable grounds for believing an investment is suitable for that customer when recommending an investment to a customer. FINRA believesthat there is a high probability that speculative low-priced securities will not be suitable for some customers and may make it moredifficult for broker-dealers to recommend that their customers buy our common stock, which may result in a limited ability to buy andsell our stock.

 

Ourcommon shares are currently subject to the “Penny Stock” rules of the SEC, and the trading market in our securities willlikely be limited, which makes transactions in our stock cumbersome and may reduce the value of an investment in our stock.

 

TheSecurities and Exchange Commission has adopted Rule 15g-9 which establishes the definition of a “penny stock,” for the purposesrelevant to us, as any equity security that has a market price of less than $5.00 per share or with an exercise price of less than $5.00per share, subject to certain exceptions. For any transaction involving a penny stock, unless exempt, the rules require:

 

  That a broker or dealer approve a person’s account for transactions in penny stocks; and
  The broker or dealer receive from the investor a written agreement to the transaction, setting forth the identity and quality of the penny stock to be purchased.

 

Inorder to approve a person’s account for transactions in penny stocks, the broker or dealer must:

 

  Obtain financial information and investment experience objectives of the person; and
  Make a reasonable determination that the transactions in penny stocks are suitable for that person and the person has sufficient knowledge and experience in financial matters to be capable of evaluating the risks of transactions in penny stocks.

 

Thebroker or dealer must also deliver, prior to any transaction in a penny stock, a disclosure schedule prescribed by the Commission relatingto the penny stock market, which, in highlight form:

 

  Sets forth the basis on which the broker or dealer made the suitability determination; and
  That the broker or dealer received a signed, written agreement from the investor prior to the transaction.

 

Generally,brokers may be less willing to execute transactions in securities subject to the “penny stock” rules. This may make it moredifficult for investors to dispose of our common stock and cause a decline in the market value of our stock.

 

Disclosurealso has to be made about the risks of investing in penny stocks in both public offerings and in secondary trading and about the commission’spayable to both the broker-dealer and the registered representative, current quotations for the securities and the rights and remediesavailable to an investor in cases of fraud in penny stock transactions. Finally, monthly statements have to be sent disclosing recentprice information for the penny stock held in the account and information on the limited market in penny stocks.

 

Wedo not intend to pay any cash dividends on our shares of common stock in the near future, so our shareholders will not be able to receivea return on their shares unless they sell their shares.

 

Wedo not anticipate paying any cash dividends on our common stock in the foreseeable future. There is no assurance that future dividendswill be paid, and if dividends are paid, there is no assurance with respect to the amount of any such dividend. Unless we pay dividends,our shareholders will not be able to receive a return on their shares unless they sell such shares.

 

14
 

 

Raisingadditional capital may cause dilution to our existing stockholders and investors in this offering, restrict our operations or requireus to relinquish rights to our product candidates on unfavorable terms to us.

 

Wemay seek additional capital through a variety of means, including through private and public equity offerings and debt financings, collaborations,strategic alliances and marketing, distribution or licensing arrangements. To the extent that we raise additional capital through thesale of equity or convertible debt securities, or through the issuance of shares under other types of contracts, or upon the exerciseor conversion of outstanding options, warrants, convertible debt or other similar securities, the ownership interests of our stockholderswill be diluted, and the terms of such financings may include liquidation or other preferences, antidilution rights, conversion and exerciseprice adjustments and other provisions that adversely affect the rights of our stockholders, including rights, preferences and privilegesthat are senior to those of our holders of common stock in terms of the payment of dividends or in the event of a liquidation. In addition,debt financing, if available, could include covenants limiting or restricting our ability to take certain actions, such as incurringadditional debt, making capital expenditures, entering into licensing arrangements, or declaring dividends and may require us to grantsecurity interests in our assets. If we raise additional funds through collaborations, strategic alliances, or marketing, distributionor licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams,product or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional fundsthrough equity or debt financings when needed, we may need to curtail or cease our operations.

 

There is no established market for the SeriesB Preferred Stock or Series A Warrants being offered in this offering.

 

There is no established trading market for theSeries B Preferred Stock or Series A Warrants and we do not expect a market to develop. In addition, we do not intend to apply for thelisting of the Series B Preferred Stock or Series A Warrants on any national securities exchange or other trading market. Without anactive trading market, the liquidity of the Series B Preferred Stock or Warrants will be limited.

 

Holders of Series B Preferred Stock willhave limited voting rights.

 

Except with respect to certain material changesin the terms of the Series B Preferred Stock and certain other matters and except as may be required by Delaware law, holders of SeriesB Preferred Stock will have no voting rights. Holders of Series B Preferred Stock will have no right to vote for any members of our boardof directors.

 

The Series A Warrants are speculative.

 

The Series A Warrants offered in this offeringdo not confer any rights of common stock ownership on their holders, such as voting rights or the right to receive dividends, but rathermerely represent the right to acquire shares of our common stock at a fixed price for a limited period of time. Specifically, commencingon the date of issuance, holders of the Series A Warrants may exercise their right to acquire the common stock and pay an exercise priceof $____ per share (110% of the public offering price of our Class A Units in this offering), prior to five years from the date of issuance,after which date any unexercised warrants will expire and have no further value. Moreover, following this offering, the market valueof the Series A Warrants is uncertain and there can be no assurance that the market value of the Series A Warrants will equal or exceedtheir public offering price. There can be no assurance that the market price of the common stock will ever equal or exceed the exerciseprice of the Series A Warrants, and consequently, whether it will ever be profitable for holders of the warrants to exercise the SeriesA Warrants.

 

The Series A Warrants may not have anyvalue and if an active, liquid trading market for the Series A Warrants does not develop, you may not be able to sell your warrants quicklyor at or above the price you paid for them.

 

The Series A Warrants issued in this offeringwill be immediately exercisable and expire five years after their issuance. The Series A Warrants will have an initial exercise priceequal to $            . In the event that our common stock price does not exceedthe exercise price of the warrants during the period when the warrants are exercisable, the warrants may not have any value.

 

Prior to this offering, there has been no publicmarket for any of our warrants and we do not intend to list the Warrants on the Nasdaq Capital Market or any other exchange. As a result,an active trading market may not develop for the Series A Warrants to be sold in this offering or, if developed, may not be sustained,and the market for the Series A Warrants may be highly volatile or may decline regardless of our operating performance. The lack of anactive market may impair your ability to sell your Series A Warrants at the time you wish to sell them or at a price that you considerreasonable.

 

The exercise price of the Series A Warrantsoffered by this prospectus will not be adjusted for certain dilutive events.

 

The exercise price of the Series A Warrants offeredby this prospectus are subject to adjustment for certain events, including, but not limited to, the payment of a stock dividend, stocksplits, certain issuances of capital stock, options, convertible securities and other securities. However, the exercise prices will notbe adjusted for dilutive issuances of securities and there may be transactions or occurrences that may adversely affect the market priceof our common stock or the market value of such warrants without resulting in an adjustment of the exercise prices of such warrants.

 

Thereis no assurance that we will fulfill or maintain the listing requirements of the NASDAQ.

 

Weare applying to list our common stock on the Nasdaq Capital Market, a national securities exchange. An approval of ourlisting application by NASDAQ will be subject to, among other things, our ability to fulfill all of the listing requirements of NASDAQ.There is no assurance that our securities will become NASDAQ listed and even if our shares become NASDAQ listed, there is no assurancethat an active trading market for our securities will develop or be sustained after this offering is completed.

 

Inaddition, NASDAQ has rules for continued listing, including, without limitation, minimum market capitalization and other requirements.Failure to maintain our listing, or de-listing from NASDAQ, would make it more difficult for shareholders to dispose of our securitiesand more difficult to obtain accurate price quotations on our securities. This could have an adverse effect on the price of our commonshares. Our ability to issue additional securities for financing or other purposes, or otherwise to arrange for any financing we mayneed in the future, may also be materially and adversely affected if our common shares and/or other securities are not traded on a nationalsecurities exchange.

 

Ifwe are unable to meet the NASDAQ listing criteria, our common shares may continue to trade on the OTC Pink Sheets.

 

Weare applying for our common stock to be listed on NASDAQ, a national securities exchange. The NASDAQ requires companies desiringto list their common stock to meet certain listing criteria including total number of shareholders: minimum stock price (whichwill necessitate that we effect a reverse split of our issued and outstanding common stock before listing), total value of public float,and in some cases total shareholders’ equity and market capitalization. Our failure to meet such applicable listing criteria couldprevent us from listing our common stock on NASDAQ. In the event we are unable to have our shares traded on NASDAQ, our commonstock may continue to trade on the OTC Pink Sheets, which is less liquid and more volatile than the NASDAQ. Our failure to haveour shares traded on NASDAQ could make it more difficult for you to trade our shares, could prevent our common stock trading ona frequent and liquid basis and could result in the value of our common stock being less than it would be if we were able to listour shares on NASDAQ.

 

Wewill have broad discretion in the use of the net proceeds to us from this offering and may not use them effectively.

 

Wewill have broad discretion in the application of the net proceeds to us from this offering, including for any of the purposes describedin the section titled “Use of Proceeds,” and you will not have the opportunity as part of your investment decision to assesswhether the net proceeds are being used appropriately. Because of the number and variability of factors that will determine our use ofthe net proceeds from this offering, our ultimate use may vary substantially from our currently intended use. Investors will need torely upon the judgment of our management with respect to the use of proceeds. Pending use, we may invest the net proceeds from this offeringin investment-grade, interest-bearing securities, such as money market accounts, certificates of deposit, commercial paper and guaranteedobligations of the U.S. government that may not generate a high yield for our stockholders. If we do not use the net proceeds that wereceive in this offering effectively, our business, financial condition, results of operations and prospects could be harmed, and themarket price of our common stock could decline.

 

15
 

 

Weare an “emerging growth company,” and we cannot be certain if the reduced reporting and disclosure requirements applicableto emerging growth companies will make our common stock less attractive to investors.

 

Weare an “emerging-growth company,” as defined in the JOBS Act, and we have elected to take advantage of certain exemptionsfrom various reporting requirements that are applicable to other public companies that are not “emerging growth companies,”including the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, or Section 404, reduced disclosure obligationsregarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbindingadvisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. Pursuant toSection 107 of the JOBS Act, as an emerging growth company, we have elected to use the extended transition period for complying withnew or revised accounting standards until those standards would otherwise apply to private companies. As a result, our financial statementswill not be comparable to the financial statements of issuers who are required to comply with the effective dates for new or revisedaccounting standards that are applicable to public companies, which may make our common stock less attractive to investors. In addition,if we cease to be an emerging growth company, we will no longer be able to use the extended transition period for complying with newor revised accounting standards.

 

Wewill remain an emerging-growth company until the earliest of: (1) the last day of the fiscal year following the fifth anniversary ofthis offering; (2) the last day of the first fiscal year in which our annual gross revenue is $1.07 billion or more; (3) the date onwhich we have, during the previous rolling three-year period, issued more than $1 billion in non-convertible debt securities; and (4)the date we qualify as a “large accelerated filer,” with at least $700 million of equity securities held by non-affiliates.

 

Wecannot predict if investors will find our common stock less attractive as a result of choosing to rely on these exemptions. For example,if we do not adopt a new or revised accounting standard, our future results of operations will not be as comparable to the results ofoperations of certain other companies in our industry that adopted such standards. If some investors find our common stock less attractiveas a result, there may be a less active trading market for our common stock, and our stock price may be more volatile.

 

16
 

 

SPECIALNOTE REGARDING FORWARD-LOOKING STATEMENTS

 

Thisprospectus contains forward-looking statements concerning our business, operations and financial performance and condition, as well asour plans, objectives and expectations for our business operations and financial performance and condition. Any statements containedherein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-lookingstatements by terminology such as “aim”, “anticipate”, “assume”, “believe”, “contemplate”,“continue”, “could”, “due”, “estimate”, “expect”, “goal”, “intend”,“may”, “objective”, “plan”, “predict”, “potential”, “positioned”,“pioneer”, “seek”, “should”, “target”, “will”, “would” and othersimilar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparableterminology.

 

Theseforward-looking statements include, but are not limited to, statements about:

 

our use of net proceeds from this offering;
   
the continued development and growth of the demand and markets for our products;
   
our ability to raise future capital through debt or equity financing transactions;
   
our ability to attract and retain key employees;
   
our ability to manage growth in our business; and
   
our ability to identify and successfully execute strategic partnerships.

 

Althoughwe base the forward-looking statements contained in this prospectus on assumptions that we believe are reasonable, we caution you thatactual results and developments (including our results of operations, financial condition and liquidity, and the development of the industryin which we operate) may differ materially from those made in or suggested by the forward-looking statements contained in this prospectus.In addition, even if results and developments are consistent with the forward-looking statements contained in this prospectus, thoseresults and developments may not be indicative of results or developments in subsequent periods. Certain assumptions made in preparingthe forward-looking statements contained in this prospectus include:

 

our ability to implement our business strategies;
   
our ability to complete the development of products on time and on budget;
   
our competitive advantages;
   
our ability to obtain and maintain financing on acceptable terms;
   
the impact of competition;
   
the changes and trends in the life sciences industry;
   
changes in laws, rules and regulations;
   
our ability to maintain good business relationships with our exclusive independent operators and strategic partners;
   
our ability to keep pace with changing consumer preferences;
   
our ability to protect our intellectual property;
   
our ability to identify, manage and integrate acquisitions;
   
our ability to retain key personnel; and
   
the absence of material adverse changes in our industry or the global economy, including as a result of the COVID-19 pandemic.

 

17
 

 

Theseforward-looking statements are based on our current expectations, estimates, forecasts and projections about our business and the industryin which we operate and management’s beliefs and assumptions, and are not guarantees of future performance or development and involveknown and unknown risks, uncertainties and other factors that are in some cases beyond our control. As a result, any or all of our forward-lookingstatements in this prospectus may turn out to be inaccurate. Factors that may cause actual results to differ materially from currentexpectations include, among other things, those listed under “Risk Factors” and elsewhere in this prospectus. Potential investorsare urged to consider these factors carefully in evaluating the forward-looking statements. These forward-looking statements speak onlyas of the date of this prospectus. Except as required by law, we assume no obligation to update or revise these forward-looking statementsfor any reason, even if new information becomes available in the future. You should, however, review the factors and risks we describein the reports we will file from time to time with the SEC, after the date of this prospectus. See “Where You Can Find More Information”.

 

Thisprospectus contains estimates, projections and other information concerning our industry, our business, and the markets for our products.Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties,and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwiseexpressly stated, we obtained this industry, business, market and other data from our own internal estimates and research as well asfrom reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medicaland general publications, government data and similar sources.

 

Inaddition, assumptions and estimates of our and our industry’s future performance are necessarily subject to a high degree of uncertaintyand risk due to a variety of factors, including those described in “Risk Factors”. These and other factors could cause ourfuture performance to differ materially from our assumptions and estimates.

 

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USEOF PROCEEDS

 

We estimate that the net proceeds from the sale of_____Class A Units (assuming no purchase of Class B Units) will be approximately $____ million, or approximately $____million if the underwriter exercises in full its option to purchase additional shares of our common stock and/or Series A Warrants,based on an assumed public offering price of $ per Class A Unit, after deducting the estimated underwriting discounts and commissionsand estimated offering expenses payable by us. Each $1.00 increase (decrease) in the assumed public offering price of $____ per ClassA Units would increase (decrease) the net proceeds to us from this offering by approximately $___ million, or approximately $___million if the underwriter exercises its over-allotment option in full, assuming the number of Class A Units offered by us, asset forth on the cover page of this prospectus, remain the same and after deducting estimated underwriting discounts and commissionsand estimated offering expenses payable by us.

 

Theexpected use of net proceeds of this offering represents our current intentions based upon our present plan and business conditions.As of the date of this prospectus, we cannot specify with certainty all of the particular uses for the net proceeds to be received uponthe completion of this offering. The amounts and timing of our actual use of net proceeds will vary depending on numerous factors. Asa result, management will have broad discretion in the application of the net proceeds, and investors will be relying on our judgmentregarding the application of the net proceeds of this offering. We currently estimate that we will use the net proceeds from this offeringas follows: ______________________ We have presumed that we will receive aggregate gross proceeds of $____ million and deducted $___million payable in offering costs, commissions and fees.

 

Weintend to use the net proceeds from this offering as follows:

 

Approximately 70% to fund research and the continued development of Sigyn Therapy; and
   

Approximately 30% for working capital and other general corporate purposes, including the additional costs with being a public company.

 

Theuse of the proceeds represents management’s estimates based upon current business and economic conditions. We reserve the rightto use of the net proceeds we receive in the offering in any manner we consider to be appropriate. Although our Company does not contemplatechanges in the proposed use of proceeds, to the extent we find that adjustment is required for other uses by reason of existing businessconditions, the use of proceeds may be adjusted. The actual use of the proceeds of this offering could differ materially from those outlinedabove as a result of several factors including those set forth under “Risk Factors” and elsewhere in this prospectus.

 

19
 

 

DETERMINATIONOF OFFERING PRICE

 

Theoffering price of the Class A Units and Class B Units will be negotiated between the underwriters and us considering our historicalperformance and capital structure, prevailing market conditions, and overall assessment of our business. Our common stock is currentlyquoted on the OTC Markets Pink Sheets trading system under the symbol “SIGY.” On June 22, 2022, the last reportedsale price of our common stock was $[__] per share.

 

MARKETFOR OUR COMMON STOCK AND RELATED STOCKHOLDER MATTERS

 

Ourcommon stock is currently quoted on the OTC Markets Pink Sheets trading system.

 

Asof June 22, 2022, we had _______ shareholders of record of our shares of common stock.

 

Weintend to apply to list our common stock on the Nasdaq Capital Market under the symbol “SIGY.” No assurance can be giventhat such application will be approved or that a trading market will develop. If, for whatever reason, Nasdaq does not confirmthe listing of our common stock on Nasdaq prior to the pricing of the offering, we will not be able to consummate and will terminatethis offering.

 

DIVIDENDPOLICY

 

Wehave never paid any cash dividends on our common shares. We anticipate that we will retain funds and future earnings to support operationsand to finance the growth and development of our business. Therefore, we do not expect to pay cash dividends in the foreseeable futurefollowing this offering. Any future determination to pay dividends will be at the discretion of our Board of Directors and will dependon our financial condition, results of operations, capital requirements and other factors that our Board of Directors deems relevant.In addition, the terms of any future debt or credit financings may preclude us from paying dividends.

 

20
 

 

CAPITALIZATION

 

Thefollowing table sets forth our capitalization and cash as of March 31, 2022:

 

  on an actual basis; and
     
 

on a pro forma as adjusted basis to reflect the sale by us of ______ Class A Units (assuming no Class B Units are purchased) at the assumed public offering price of $____ per Class A Unit, after deducting the underwriting discounts and commissions and estimated offering costs payable by us; and

     

 

on a proforma basis to reflect the conversion of senior secured debentures.

 

Thepro forma as adjusted information below is illustrative only and our capitalization following the completion of this offering will beadjusted based on the actual public offering price and other terms of this offering determined at pricing.

 

Youshould read this table together with the section in this prospectus entitled “Management’s Discussion and Analysis of FinancialCondition and Results of Operations” and our financial statements and related notes included elsewhere in this prospectus. Numbersare expressed in thousands (U.S. dollars) except share and per share data.

 

   March 31, 2022 
Capitalization in U.S. Dollars in thousands (except share data)  Actual  

Pro Forma As

Adjusted

 
Cash   $81   $ 
Notes payable and senior secured debentures    705      
Warrant liability    -      
Common stock, $0.0001 par value per share, 1,000,000,000 shares authorized; 37,295,803 shares issued and outstanding; _____ shares issued and outstanding pro forma as adjusted   $4   $    
Additional paid in capital    4,209      
Obligation to issue shares    -      
Accumulated deficit    (4,944)     
Accumulated other comprehensive income    -    - 
Total stockholders’ equity    (732)   - 
Total Capitalization   $(26)  $- 

 

Thenumber of common shares that will be outstanding after this offering set forth above is based on 37,295,803 common shares outstandingas of March 31, 2022.

 

Unlessspecifically stated otherwise, all information in this prospectus assumes:

 

  assumes no exercise by the underwriters of their option to purchase up to additional shares of our common stock and/or Series A Warrants from us to cover over-allotments, if any;
  assumes no exercise of the representative’s warrants or Series A Warrants to be issued upon consummation of this offering at an exercise price equal to 110% of the initial offering price of the common stock;
  assumes no shares of Series B Preferred Stock are sold in this offering;
  assumes no exercise of outstanding warrants to purchase shares of the Company’s common stock at an exercise price of $[__]; and
  excludes shares of common stock to be reserved for future issuanceunder our equity incentive plan, which will be effective upon the completion of this offering.

  

To the extent we sell any Class B Units in thisoffering, the same aggregate number of common stock equivalents resulting from this offering would be convertible under the Series BPreferred Stock issued as part of the Class B Units.

 

(1) A $1.00 increase or decrease in the assumed public offering price per Class A Units would increase or decrease our pro forma as adjusted cash and cash equivalents, additional paid-in capital, total shareholders’ equity and total capitalization by approximately $___ million assuming the number of Class A Units offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the underwriting discount and estimated offering expenses payable by us.

 

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DILUTION

 

Ifyou invest in our shares in this offering, your ownership interest will be diluted to the extent of the difference between the initialpublic offering price per common share of in this offering and the as adjusted net tangible book value per share immediately after thisoffering. We calculate net tangible book value per share by dividing our net tangible book value, which is tangible assets less totalliabilities less debt discounts, by the number of our outstanding common shares as of March 31, 2022. Our historical net tangible bookvalue (deficit) as of March 31, 2022, was approximately $0.012 million or $0.005 per common share.

 

Aftergiving effect to the sale of a _____ Class A Units at an assumed shares at $ per share (and assuming no sale of Class B Units),after deducting the underwriting discounts and commissions and estimated offering costs payable by us, our as adjusted net tangiblebook value (deficit) as of December 31, 2021, would have been approximately $ million, or per common share. This represents an immediateincrease in as adjusted net tangible book value of $ per share to existing shareholders and an immediate dilution of $ per share to investorspurchasing our common shares in this offering at the assumed public offering price.

 

Thefollowing table illustrates per share dilution as of March 31, 2022:

 

Assumed public offering price per common share      $ - 
Net tangible book value (deficit) per share as of March 31, 2022  $-      
Increase in net tangible book value (deficit) per share attributable to this offering  $-      
Net tangible book value (deficit) per share after this offering       $- 
Dilution per share to investors participating in this offering       $- 

 

Each$1.00 increase (decrease) in the assumed public offering price per Class A Unit would increase (decrease) our as adjusted nettangible book value (deficit) after this offering by approximately $___ million, or approximately $____ per share, and the dilution pershare to new investors by approximately $____ per share, assuming that the number of shares offered by us, as set forth on the coverpage of this prospectus, remain the same and after deducting the estimated underwriting discounts and commissions and estimated offeringexpenses payable by us. We may also increase or decrease the number of Class A Units we are offering. An increase of 500,000 ClassA Units in the number of Class A Units offered by us would increase our as adjusted net tangible book value (deficit) afterthis offering by approximately $____, or $____ per common share, and decrease the dilution per share to new investors by $____ per commonshare, assuming that the assumed initial public offering price remains the same, and after deducting the estimated underwriting discountsand commissions and estimated offering expenses payable by us. Similarly, a decrease of 500,000 Class A Units offered by us woulddecrease our as adjusted net tangible book value (deficit) after this offering by approximately $___ million, or $____ per common share,and increase the dilution per share to new investors by $____ per common share, assuming that the assumed initial public offering priceremains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable byus. The information discussed above is illustrative only and will adjust based on the actual initial public offering price and otherterms of this offering determined at pricing. This table does not take into account further dilution to new investors that could occurupon the exercise of outstanding options and warrants having a per share exercise price less than the public offering price per sharein this offering.

 

Ifthe underwriters exercise in full their option to purchase up to ____ additional shares of common stock and Series A Warrantsat the assumed initial public offering price of $____ per share, the as adjusted net tangible book value (deficit) after this offeringwould be $____ per share, representing an increase in net tangible book value (deficit) of $____ per share to existing shareholders andimmediate dilution in net tangible book value (deficit) of $____ per share to investors purchasing our common shares in this offeringat the assumed public offering price.

 

22
 

 

MANAGEMENT’SDISCUSSION AND ANALYSIS OF FISCAL CONDITION AND RESULTS OF OPERATION

 

Thefollowing discussion of our plan of operation should be read in conjunction with the financial statements and related notes that appearelsewhere in this prospectus. This discussion contains forward-looking statements that involve risks and uncertainties. Our actual resultscould differ materially from those anticipated in these forward-looking statements as a result of various factors, including those discussedin “Risk Factors” beginning on page 5 of this prospectus. All forward-looking statements speak only as of the date on whichthey are made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after thedate on which they are made.

 

Weare an emerging growth company as defined in Section 2(a) (19) of the Securities Act. Pursuant to Section 107 of the Jumpstart Our BusinessStartups Act, we may take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complyingwith new or revised accounting standards, meaning that we can delay the adoption of certain accounting standards until those standardswould otherwise apply to private companies. We have chosen to take advantage of the extended transition period for complying with newor revised accounting standards applicable to public companies to delay adoption of such standards until such standards are made applicableto private companies. Accordingly, our consolidated financial statements may not be comparable to the financial statements of publiccompanies that comply with such new or revised accounting standards.

 

OurCompany

 

SigynTherapeutics, Inc. (“Sigyn” or the “Company”) is a medical technology company headquartered in San Diego, California.Our focus is the treatment of pathogen-associated conditions that precipitate sepsis, the leading cause of hospital deaths worldwide1.Sigyn Therapy™ is a multi-function blood purification technology that extracts pathogen sources of life-threatening inflammationin concert with the broad-spectrum elimination of inflammatory mediators from human blood plasma.

 

Beyondthe treatment of sepsis, Sigyn Therapy establishes a novel strategy to address emerging pandemic threats, hepatic encephalopathy, bridge-to-livertransplant, and community acquired pneumonia, which is a leading cause of death among infectious diseases2, the leading causeof death in children under five years of age2, and a catalyst for approximately 50% of sepsis and septic shock cases2.

 

1Global,regional and national sepsis incidence and mortality The Journal Lancet, January 2020

2TheAmerican Thoracic Society – Pneumonia Facts 2019

 

FinancingTransactions   

 

PreferredStock

 

TheCompany has 10,000,000 shares of par value $0.0001 preferred stock authorized, of which no preferred shares are issued and outstandingat May 5, 2022.

 

CommonStock

 

TheCompany has authorized 1,000,000,000 shares of par value $0.0001 common stock, of which 37,238,656   shares are outstandingat May 5, 2022.

 

OnOctober 28, 2021, an investor elected to convert $16,714 of the aggregate principal amount of the Note of $199,650,into 42,857 common shares.

 

OnOctober 25, 2021, an investor elected to convert the aggregate principal amount of the Note, $110,000, into 157,143 common shares.

 

OnOctober 20, 2021, the Company entered into a securities purchase agreement with an accredited investor that resulted in the issuanceof 320,000 shares of common stock and warrants to purchase an aggregate of 320,000 shares of the Company’s common stock for totalproceeds totaling $400,000. The offering allowed for qualified investors to purchase one share of the Company’s common stock at$1.25. For each share purchased, the investor received a five-year warrant to purchase one share of common stock at $1.25 per share.No commissions were paid in the offering. This issuance was pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, ina transaction exempt from registration.

 

23
 

 

OnOctober 14, 2021, the Company issued a total of 47,000 shares of its common stock valued at $37,600 (based on the stock price of theCompany’s common stock on the date of issuance) to a third party, for communications to the financial industry.

 

OnJuly 14, 2021, the Company issued a total of 47,000 shares of its common stock valued at $47,000 (based on the stock price of the Company’scommon stock on the date of issuance) to a third party, for communications to the financial industry.

 

OnMay 10, 2021, Brio Capital elected to convert the aggregate principal amount of a $110,000 convertible note issued on February 10, 2021into 157,143 shares of the Company’s common stock.

 

InApril 2021, the Company initiated an offering of up to $1.5 million of the Company’s restricted common shares. The offering allowedfor qualified investors to purchase one share of the Company’s common stock $1.25. For each share purchased, the investor receiveda five-year warrant to purchase one share of common stock at $1.75 per share. On May 10, 2021, the Company closed the offering to investorsand subsequently disclosed that it had entered into securities purchase agreements with accredited investors that resulted in the issuanceof 1,172,000 shares of common stock and warrants to purchase an aggregate of 1,172,000 shares of the Company’s common stock fortotal proceeds totalling $1,465,000. No commissions were paid in the offering. This issuance was pursuant to Section 4(a)(2) of the SecuritiesAct of 1933, as amended, in a transaction exempt from registration.

 

OnApril 14, 2021, the Company issued a total of 47,000 shares of its restricted common stock valued at $82,250 (based on the stock priceof the Company’s common stock on the date of issuance) to a third party, for communications to the financial industry. This issuancewas pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transaction exempt from registration.

 

OnFebruary 19, 2021, a previous noteholder exercised the warrants pursuant to the cashless exercise provision of the warrant agreementinto 57,147 common shares. The common shares have not been issued as of March 14, 2022.

 

OnJanuary 14, 2021, the Company issued a total of 47,000 shares of its restricted common stock valued at $82,250 (based on the stock priceof the Company’s common stock on the date of issuance) to a third party, for communications to the financial industry. This issuancewas pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transaction exempt from registration.

 

Duringthe year ended December 31, 2020, the Company issued 1,015,344 common shares to third parties in conjunction with the exchange of convertiblepromissory debentures.

 

OnOctober 19, 2020, the Company issued 33,686,169 common shares in conjunction with acquisition.

 

Warrants

 

OnOctober 22, 2021, the Company and Osher amended convertible debt agreements for the maturity date from October 20, 2021 to October 20,2022. In exchange for the extension of the Note, the Company issued Osher 450,000 warrants to purchase an aggregate of 450,000 sharesof the Company’s common stock, valued at $197,501 (based on the Black Scholes valuation model on the date of grant) (see Note 6).The warrants are exercisable for a period of five years at $1.00 per share in whole or in part, as either a cash exercise or as a cashlessexercise, and fully vest at grant date. The Company is amortizing the value of the warrants ratably through October 20, 2022. The Companyrecorded $40,041 and $0 for the years ended December 31, 2021 and 2020, respectively, and is classified in other expenses in the consolidatedStatements of Operations.

 

CurrentNoteholders

 

Osher– $457,380

 

OnJanuary 28, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “PurchaseAgreement”) with respect to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”) of(i) $385,000 aggregate principal amount of Original Issue Discount Senior Convertible Debenture due January 26, 2021, based on $1.00for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants to purchase up to an aggregate of 80,209 shares ofthe Company’s Common Stock at an exercise price of $7.00 per share. The aggregate cash subscription amount received by the Companyfrom Osher for the issuance of the note and warrants was $350,005 which was issued at a $34,995 original issue discount from the facevalue of the Note. The conversion price for the principal in connection with voluntary conversions by a holder of the convertible notesis $0.094 per share, as amended on October 20, 2020, subject to adjustment as provided therein, such as stock splits and stock dividends.

 

24
 

 

TheCompany and Osher amended the convertible debt agreement as follow-on October 20, 2020:

 

The parties amended the Warrants dated January 28, 2020, for the number of warrant shares from 80,209 warrant shares to 4,113,083 warrant shares at an exercise price of $0.14 per share.
The parties amended the Note for the maturity date from June 23,2021 to October 20, 2021.

 

OnOctober 22, 2021, the Company and Osher amended convertible debt agreements as follows:

 

The parties amended the October 20,2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
The parties amended the October 20,2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
In exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of the Company’s common stock at an exercise price of $1.00 per share.

 

Osher– $60,500

 

OnJune 23, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “PurchaseAgreement”) with respect to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”) of(i) $50,000 aggregate principal amount of Original Issue Discount Senior Convertible Debenture (the “Note”) due June 23,2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants (“Warrants”) to purchaseup to an aggregate of 10,000 shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cashsubscription amount received by the Company from Osher for the issuance of the Note and Warrants was $50,005 which was issued at a $0original issue discount from the face value of the Note. The conversion price for the principal in connection with voluntary conversionsby a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment as provided therein, suchas stock splits and stock dividends.

 

TheCompany and Osher amended the convertible debt agreement as follow-on October 20, 2020:

 

The parties amended the Note for the aggregate principal amount from $50,000 to $55,000. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants was $50,005 which was issued at an amended $4,995 original issue discount from the face value of the Note.
The parties amended the Warrants dated June 23, 2020, for the number of warrant shares from 10,000 warrant shares to 141,020 warrant shares at an exercise price of $0.59 per share.
The parties amended the Note for the maturity date from June 23, 2021 to October 20, 2021.

 

OnOctober 22, 2021, the Company and Osher amended convertible debt agreements as follows:

 

The parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
The parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
In exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of the Company’s common stock at an exercise price of $1.00 per share.

 

Osher– $199,650

 

OnSeptember 17, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “PurchaseAgreement”) with respect to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”) of(i) $181,500 aggregate principal amount of Original Issue Discount Senior Convertible Debenture (the “Note”) due September30, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants (“Warrants’) topurchase up to an aggregate of 8,250 shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregatecash subscription amount received by the Company from Osher for the issuance of the Note and Warrants was $165,000 which was issued ata $16,500 original issue discount from the face value of the Note. The conversion price for the principal in connection with voluntaryconversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment as providedtherein, such as stock splits and stock dividends.

 

25
 

 

TheCompany and Osher amended the convertible debt agreement as follow-on October 20, 2020:

 

The parties amended the Warrants dated September 17, 2020, for the number of warrant shares from 8,250 warrant shares to 465,366 warrant shares at an exercise price of $0.59 per share.
The parties amended the Note for the maturity date from September 30, 2021 to October 20, 2021.

 

OnOctober 22, 2021, the Company and Osher amended convertible debt agreements as follows:

 

The parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
The parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
In exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of the Company’s common stock at an exercise price of $1.00 per share.

 

OnOctober 28, 2021, Osher elected to convert $16,714 of the aggregate principal amount of the Note of $199,650, into 42,857 common shares.

 

Osher– $110,000

 

OnMarch 23, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respectto the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”) of (i) $110,000 aggregate principalamount of Note due March 23, 2023 based on $1.00 for each $0.90909 paid by the previous noteholder and (ii) five-year Common Stock PurchaseWarrants (“Warrants’) to purchase up to an aggregate of 220,000 shares of the Company’s Common Stock at an exerciseprice of $0.50 per share. The aggregate cash subscription amount received by the Company from the previous noteholder for the issuanceof the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The conversionprice for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.50 per share, subject toadjustment as provided therein, such as stock splits and stock dividends.

 

Brio– $110,000

 

OnMarch 23, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respectto the sale and issuance to institutional investor Brio Capital Master Fund Ltd. (“Brio”) of (i) $110,000 aggregate principalamount of Note due March 23, 2023 based on $1.00 for each $0.90909 paid by the previous noteholder and (ii) five-year Common Stock PurchaseWarrants (“Warrants’) to purchase up to an aggregate of 220,000 shares of the Company’s Common Stock at an exerciseprice of $0.50 per share. The aggregate cash subscription amount received by the Company from the previous noteholder for the issuanceof the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The conversionprice for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.50 per share, subject toadjustment as provided therein, such as stock splits and stock dividends.

 

Osher– $110,000

 

OnApril 28, 2022, the Company entered into an Original Issue Discount Senior Convertible Debentures (the “Note”) totaling (i)$220,000 aggregate principal amount of Note due April 28, 2023 based on $1.00 for each $0.90909 paid by the previous noteholder and (ii)five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 440,000 shares of the Company’sCommon Stock at an exercise price of $0.50 per share. The conversion price for the principal in connection with voluntary conversionsby the holders of the convertible notes is $0.50 per share.

 

Brio- $110,000

 

OnMay 10, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “May 2022 Note”) totaling(i) $110,000 aggregate principal amount of Note due May 10, 2023 based on $1.00 for each $0.90909 paid by the previous noteholder and(ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 220,000 shares of the Company’sCommon Stock at an exercise price of $0.50 per share. The conversion price for the principal in connection with voluntary conversionsby the holders of the convertible notes is $0.50 per share.

 

26
 

 

 Impairmentof Inventory

 

Basedon the significant advancement of Sigyn Therapy, the Company decided in the 4th quarter of 2021 to assess the value of retailbusiness operations that were a focus of the Company prior to the merger transaction consummated on October 19, 2020.

 

Relatedto this assessment, management determined the wholesale liquidation value of its sapphire gem inventory to be 5-10% of the previouslyreported retail value, based on communications with certified gemologists, the variance between retail and wholesale valuations, andcurrent market conditions. As a result, the Company has valued the inventory at $50,000 and recorded an impairment of assets of $536,047in the year ended December 31, 2021 and is classified in other expenses in the consolidated Statements of Operations.

 

LimitedOperating History; Need for Additional Capital

 

Thereis limited historical financial information about us on which to base an evaluation of our performance. We cannot guarantee we will besuccessful in our business operations. Our business is subject to risks inherent in the establishment of a new business enterprise, includinglimited capital resources, and possible cost overruns due to increases in the cost of services. To become profitable and competitive,we must receive additional capital. We have no assurance that future financing will materialize. If that financing is not available,we may be unable to continue operations.

 

Resultsof Operations - Year Ended December 31, 2021 Compared to Year Ended December 31, 2020

 

Thefollowing discussion represents a comparison of our results of operations for the years ended December 31, 2021 and 2020. The resultsof operations for the periods shown in our audited consolidated financial statements are not necessarily indicative of operating resultsfor the entire period. In the opinion of management, the audited consolidated financial statements recognize all adjustments of a normalrecurring nature considered necessary to fairly state our financial position, results of operations and cash flows for the periods presented.

 

   Year Ended December 31, 2021   Year Ended December 31, 2020 
         
Net revenues   $-   $ -   
Cost of sales    -    - 
Gross Profit    -    - 
Operating expenses    2,008,217    916,434 
Other expense    996,402    343,156 
Net loss before income taxes   $(3,004,619)  $(1,259,590)

 

NetRevenues

 

Forthe years ended December 31, 2021 and 2020, we had no revenues.

 

Costof Sales

 

Forthe years ended December 31, 2021 and 2020, we had no cost of sales.

 

Operatingexpenses

 

Operatingexpenses increased by $1,091,783, or 119.1%, to $2,008,217 for the year ended December 31, 2021 from $916,434 for the year ended December31, 2020 primarily due to increases in professional fees of $36,211, compensation costs of $259,154, consulting costs of $112,919, researchand development costs of $314,652, depreciation and amortization costs of $7,851, investor relations costs of $306,487, rent expensesof $45,154, and general and administration costs of $9,355, as a result of adding administrative infrastructure for our anticipated businessdevelopment.

 

Forthe year ended December 31, 2021, we had research and development costs of $734,014, and general and administrative expenses of $1,274,203primarily due to professional fees of $123,293, compensation costs of $451,734, consulting costs of $286,194, rent of $46,663, depreciationand amortization costs of $19,151, investor relations costs of $329,006, and general and administration costs of $18,162, as a resultof adding administrative infrastructure for our anticipated business development.

 

27
 

 

Forthe year ended December 31, 2020, we had marketing expenses of $705, research and development costs of $419,362, and general and administrativeexpenses of $496,367 primarily due to professional fees of $260,356, compensation costs of $192,580, rent of $1,509, depreciation andamortization costs of $11,300, investor relations costs of $22,519, and general and administration costs of $8,103, as a result of addingadministrative infrastructure for our anticipated business development.

 

OtherExpense

 

Otherexpense for the year ended December 31, 2021 totaled $996,402 primarily due to impairment of assets of $536,047, interest expense of$429,488 in conjunction with accretion of debt discount and original issuance discount, and interest expense of $30,867, compared toother expense of $343,156 primarily due to interest expense of $343,156 in conjunction with accretion of debt discount and original issuancediscount for the year ended December 31, 2020.

 

Netloss before income taxes

 

Netloss before income taxes for the year ended December 31, 2021 totaled $3,004,619 primarily due to (increases/decreases) in compensationcosts, professional fees, consulting costs, research and development costs, investor relations costs, and general and administrationcosts compared to a loss of $1,259,590 primarily due to (increases/decreases) in compensation costs, professional fees, marketing costs,research and development costs, investor relations costs, and general and administration costs for the year ended December 31, 2020 primarilydue to professional fees.

 

Assetsand Liabilities

 

Assetswere $710,259 as of December 31, 2021. Assets consisted primarily of cash of $340,956, inventories of $50,000, equipment of $28,046,intangible assets of $5,700, and operating lease right-of-use assets of $262,771. Liabilities were $974,843 as of December 31, 2021.Liabilities consisted primarily accounts payable of $39,674, accrued payroll and payroll taxes of $1,072, convertible notes of $647,202,net of $53,614 of unamortized debt discount, operating lease liabilities of $286,716, and other current liabilities of $179.

 

Liquidityand Capital Resources

 

General– Overall, we had an increase in cash flows for the year ended December 31, 2021 of $256,554 resulting from cash providedby financing activities of $2,060,000, offset partially by cash used in operating activities of $1,774,182 and cash used in investingactivities of $29,264.

 

Thefollowing is a summary of our cash flows provided by (used in) operating, investing, and financing activities during the periods indicated:

 

   Year Ended December 31, 2021   Year Ended December 31, 2020 
         
Net cash provided by (used in):          
Operating activities  $(1,774,182)  $(829,809)
Investing activities   (29,264)   (10,799)
Financing activities   2,060,000    925,010 
   $256,554   $84,402 

 

CashFlows from Operating Activities – For the year ended December 31, 2021, net cash used in operations was $1,774,182 comparedto net cash used in operations of $829,809 for the year ended December 31, 2020. Net cash used in operations was primarily due to a netloss of $3,004,619 for year ended December 31, 2021 and the changes in operating assets and liabilities of $34,149, primarily due tothe increases in other current assets of $2,075 and other assets of $20,711, and a decrease in accrued payroll and payroll taxes of $58,635,offset primarily by increases in accounts payable of $23,669 and other current liabilities of $23,603. In addition, net cash used inoperating activities includes adjustments to reconcile net profit from depreciation expense of $2,946, amortization expense of $16,205,accretion of original issuance costs of $61,283, accretion of debt discount of $368,205, stock issued for services of $249,100, interestexpense converted to notes payable of $30,800, and impairment of assets of $536,047.

 

28
 

 

Netcash used in operations was primarily due to a net loss of $1,259,590 for year ended December 31, 2020 and the changes in operating assetsand liabilities of $75,325, primarily due to the increase in accounts payable of $15,095, accrued payroll and payroll taxes of $59,707,and other current liabilities of $523. In addition, net cash used in operating activities includes adjustments to reconcile net profitfrom depreciation expense of $346, amortization expense of $10,954, accretion of original issuance costs of $67,823, and accretion ofdebt discount of $275,333.

 

CashFlows from Investing Activities – For the year ended December 31, 2021, net cash used in investing was $29,264 due to thepurchase of property and equipment compared to cash flows from investing activities of $10,799 due to the purchase of intangible assetsfor the year ended December 31, 2020.

 

CashFlows from Financing Activities – For the year ended December 31, 2021, net cash provided by financing was $2,060,000 dueto proceeds from short term convertible notes of $250,000, repayments of short-term convertible notes of $55,000, and common stock andwarrants issued for cash of $1,865,000. For the year ended December 31, 2020, net cash provided by financing was $925,010 due to proceedsfrom short term convertible notes.

 

Financing– We expect that our current working capital position, together with our expected future cash flows from operations willbe insufficient to fund our operations in the ordinary course of business, anticipated capital expenditures, debt payment requirementsand other contractual obligations for at least the next twelve months. However, this belief is based upon many assumptions and is subjectto numerous risks, and there can be no assurance that we will not require additional funding in the future.

 

Wehave no present agreements or commitments with respect to any material acquisitions of other businesses, products, product rights ortechnologies or any other material capital expenditures. However, we will continue to evaluate acquisitions of and/or investments inproducts, technologies, capital equipment or improvements or companies that complement our business and may make such acquisitions and/orinvestments in the future. Accordingly, we may need to obtain additional sources of capital in the future to finance any such acquisitionsand/or investments. We may not be able to obtain such financing on commercially reasonable terms, if at all. Due to the ongoing globaleconomic crisis, we believe it may be difficult to obtain additional financing if needed. Even if we are able to obtain additional financing,it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our shareholders,in the case of equity financing .

 

GoingConcern

 

Theaccompanying financial statements have been prepared assuming the Company will continue as a going concern, which contemplates, amongother things, the realization of assets and satisfaction of liabilities in the normal course of business. The Company had an accumulateddeficit of approximately $4,266,000 at December 31, 2021, had a working capital deficit of approximately $341,000 at December 31, 2021,had net losses of approximately $3,005,000 and $1,260,000 for the years ended December 31, 2021 and 2020, respectively, and net cashused in operating activities of approximately $1,774,000 and $830,000 for the years ended December 31, 2021 and 2020, respectively, withno revenue earned since inception, and a lack of operational history. These matters raise substantial doubt about the Company’sability to continue as a going concern.

 

Whilethe Company is attempting to expand operations and increase revenues, the Company’s cash position may not be significant enoughto support the Company’s daily operations. Management intends to raise additional funds by way of a private offering or an assetsale transaction. Management believes that the actions presently being taken to further implement its business plan and generate revenuesprovide the opportunity for the Company to continue as a going concern. While management believes in the viability of its strategy togenerate revenues and in its ability to raise additional funds or transact an asset sale, there can be no assurances to that effect oron terms acceptable to the Company. The ability of the Company to continue as a going concern is dependent upon the Company’s abilityto further implement its business plan and generate revenues.

 

Theconsolidated financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.

 

CriticalAccounting Policies

 

Referto Note 3 in the accompanying notes to the unaudited condensed consolidated financial statements for critical accounting policies.

 

RecentAccounting Pronouncements

 

Referto Note 3 in the accompanying notes to the unaudited condensed consolidated financial statements.

 

29
 

 

Off-BalanceSheet Arrangements

 

Asof December 31, 2021, we have not entered into any transaction, agreement or other contractual arrangement with an entity unconsolidatedunder which it has:

 

  a retained or contingent interest in assets transferred to the unconsolidated entity or similar arrangement that serves as credit;
  liquidity or market risk support to such entity for such assets;
  an obligation, including a contingent obligation, under a contract that would be accounted for as a derivative instrument; or
 

anobligation, including a contingent obligation, arising out of a variable interest in an unconsolidated entity that is held by, and materialto us, where such entity provides financing, liquidity, market risk or credit risk support to or engages in leasing, hedging, or researchand development services with us.

 

Resultsof Operations - Three Months Ended March 31, 2022 Compared to Three Months Ended March 31, 2021

 

Thefollowing discussion represents a comparison of our results of operations for the three months ended March 31, 2022 and 2021. The resultsof operations for the periods shown in our audited condensed consolidated financial statements are not necessarily indicative of operatingresults for the entire period. In the opinion of management, the audited condensed consolidated financial statements recognize all adjustmentsof a normal recurring nature considered necessary to fairly state our financial position, results of operations and cash flows for theperiods presented.

 

  

Three Months Ended

March 31,

 
   2022   2021 
         
Net revenues   $ -  $ - 
Cost of sales    -    - 
Gross Profit    -    - 
Operating expenses    609,236    402,096 
Other expense    68,810    59,586 
Net loss before income taxes and discontinued operations   $(678,046)  $(461,682)

 

NetRevenues

 

Forthe three months ended March 31, 2022 and 2021, we had no revenues.

 

Costof Sales

 

Forthe three months ended March 31, 2022 and 2021, we had no cost of sales.

 

Operatingexpenses

 

Operatingexpenses increased by $207,140, or 51.5%, to $609,236 for three months ended March 31, 2022 from $402,096 for the three months endedMarch 31, 2021 primarily due to increases in professional fees of $35,610, compensation costs of $40,209, research and development costsof $111,826, depreciation costs of $1,360, rent expenses of $17,469, consulting fees of $76,642, and general and administration costsof $41,874, offset primarily by a decrease in investor relations costs of $26,395, marketing costs of $82,000, and amortization costsof $9,454, as a result of adding administrative infrastructure for our anticipated business development.

 

Forthe three months ended March 31, 2022, we had marketing expenses of $250, research and development costs of $228,342, and general andadministrative expenses of $380,644 primarily due to professional fees of $53,494, compensation costs of $144,894, rent of $17,919, depreciationcosts of $1,704, amortization costs of $900, investor relations costs of $10,105, consulting fees of $107,252, and general and administrationcosts of $44,377, as a result of adding administrative infrastructure for our anticipated business development.

 

30
 

 

Forthe three months ended March 31, 2021, we had marketing expenses of $82,250, research and development costs of $116,516, and generaland administrative expenses of $203,330 primarily due to professional fees of $17,884, compensation costs of $104,685, rent of $450,depreciation and amortization costs of $10,698, investor relations costs of $36,500, consulting fees of $30,610, and general and administrationcosts of $2,503, as a result of adding administrative infrastructure for our anticipated business development.

 

OtherExpense

 

Otherexpense for the three months ended March 31, 2022 totaled $68,810 primarily due to interest expense of $52,257 in conjunction with accretionof debt discount and interest expense of $16,522 in conjunction with accretion of original issuance discount, compared to other expenseof $59,586 for the three months ended March 31, 2021 primarily due to interest expense of $50,860 in conjunction with accretion of debtdiscount and interest expense of $8,726 in conjunction with accretion of original issuance discount.

 

Netloss before income taxes

 

Netloss before income taxes and discontinued operations for the three months ended March 31, 2022 totaled $678,046 primarily due to (increases/decreases)in compensation costs, professional fees, marketing costs, investor relations costs, consulting fees, and general and administrationcosts compared to a loss of $461,682 for the three months ended March 31, 2021 primarily due to (increases/decreases) in compensationcosts, professional fees, marketing costs, investor relations, consulting fees, and general and administration costs.

 

Assetsand Liabilities

 

Assetswere $447,414 as of March 31, 2022. Assets consisted primarily of cash of $81,385, inventories of $50,000, other current assets of $12,245,equipment of $26,342, intangible assets of $4,800, operating lease right-of-use assets of $251,931, and other assets of $20,711. Liabilitieswere $1,178,983 as of March 31, 2022. Liabilities consisted primarily accounts payable of $196,147, convertible notes of $704,920, netof $215,896 of unamortized debt discount and debt issuance costs, operating lease liabilities of $275,929, and other current liabilitiesof $1,987.

 

Liquidityand Capital Resources

 

GoingConcern

 

Theaccompanying financial statements have been prepared assuming the Company will continue as a going concern, which contemplates, amongother things, the realization of assets and satisfaction of liabilities in the normal course of business. The Company had an accumulateddeficit of $4,943,805 at March 31, 2022, had a working capital deficit of $807,218 and $341,187 at March 31, 2022 and December 31, 2020,respectively, had a net loss of $678,046 and $461,682 for the three months ended March 31, 2022 and 2021, respectively, and net cashused in operating activities of $459,571 and $274,424 for the three months ended March 31, 2022 and 2021, respectively, with no revenueearned since inception, and a lack of operational history. These matters raise substantial doubt about the Company’s ability tocontinue as a going concern.

 

Whilethe Company is attempting to expand operations and increase revenues, the Company’s cash position may not be significant enoughto support the Company’s daily operations. Management intends to raise additional funds by way of a private offering or an assetsale transaction. Management believes that the actions presently being taken to further implement its business plan and generate revenuesprovide the opportunity for the Company to continue as a going concern. While management believes in the viability of its strategy togenerate revenues and in its ability to raise additional funds or transact an asset sale, there can be no assurances to that effect oron terms acceptable to the Company. The ability of the Company to continue as a going concern is dependent upon the Company’s abilityto further implement its business plan and generate revenues.

 

Thecondensed consolidated financial statements do not include any adjustments that might be necessary if we are unable to continue as agoing concern.

 

General– Overall, we had a decrease in cash flows for the three months ended March 31, 2022 of $259,571 resulting from cash usedin operating activities of $459,571, offset partially by cash provided by financing activities of $200,000.

 

31
 

 

Thefollowing is a summary of our cash flows provided by (used in) operating, investing, and financing activities during the periods indicated:

 

   Three Months Ended March 31, 
   2022   2021 
         
Net cash provided by (used in):          
Operating activities  $(459,571)  $(274,424)
Investing activities   -    (2,871)
Financing activities   200,000    200,000 
   $(259,571)  $(77,295)

 

CashFlows from Operating Activities – For the three months ended March 31, 2022, net cash used in operations was $459,571 comparedto net cash used in operations of $274,424 for the three months ended March 31, 2021. Net cash used in operations was primarily due toa net loss of $678,046 for three months ended March 31, 2022 and the changes in operating assets and liabilities of $147,092, primarilydue to the increase in accounts payable of $156,473, other current liabilities of $789, and other current assets of $10,170. In addition,net cash used in operating activities includes adjustments to reconcile net profit from depreciation expense of $1,704, amortizationexpense of $900, accretion of original issuance costs of $16,522, and accretion of debt discount of $52,257.

 

Forthe three months ended March 31, 2021, net cash used in operations was $274,424. Net cash used in operations was primarily due to a netloss of $461,682 for three months ended March 31, 2021 and the changes in operating assets and liabilities of $34,724, primarily dueto the increase in accounts payable of $28,055, accrued payroll and payroll taxes of $5,007, and other current liabilities of $1,662.In addition, net cash used in operating activities includes adjustments to reconcile net profit from depreciation expense of $344, amortizationexpense of $10,354, stock issued for services of $82,250, accretion of original issuance costs of $8,726, and accretion of debt discountof $50,860.

 

CashFlows from Investing Activities – For the three months ended March 31, 2022, net cash used in investing was none comparedto cash flows from investing activities of $2,871 for the three months ended March 31, 2020 due to the purchase of property and equipment.

 

CashFlows from Financing Activities – For the three months ended March 31, 2022 and 2021, net cash provided by financing was$200,000 and $200,000, respectively, due to proceeds from short term convertible notes.

 

Financing– We expect that our current working capital position, together with our expected future cash flows from operations willbe insufficient to fund our operations in the ordinary course of business, anticipated capital expenditures, debt payment requirementsand other contractual obligations for at least the next twelve months. However, this belief is based upon many assumptions and is subjectto numerous risks, and there can be no assurance that we will not require additional funding in the future.

 

Wehave no present agreements or commitments with respect to any material acquisitions of other businesses, products, product rights ortechnologies or any other material capital expenditures. However, we will continue to evaluate acquisitions of and/or investments inproducts, technologies, capital equipment or improvements or companies that complement our business and may make such acquisitions and/orinvestments in the future. Accordingly, we may need to obtain additional sources of capital in the future to finance any such acquisitionsand/or investments. We may not be able to obtain such financing on commercially reasonable terms, if at all. Due to the ongoing globaleconomic crisis, we believe it may be difficult to obtain additional financing if needed. Even if we are able to obtain additional financing,it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our stockholders,in the case of equity financing.

 

CapitalExpenditures

 

Weexpect to purchase approximately $30,000 of equipment in connection with the expansion of our business during the next twelve months.

 

Fiscalyear end

 

Ourfiscal year end is December 31.

 

CriticalAccounting Policies

 

Referto Note 3 in the accompanying notes to the unaudited condensed consolidated financial statements for critical accounting policies.

 

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RecentAccounting Pronouncements

 

Referto Note 3 in the accompanying notes to the condensed consolidated financial statements.

 

Off-BalanceSheet Arrangements

 

Asof March 31, 2022, we have not entered into any transaction, agreement or other contractual arrangement with an entity unconsolidatedunder which it has:

 

  a retained or contingent interest in assets transferred to the unconsolidated entity or similar arrangement that serves as credit;
     
  liquidity or market risk support to such entity for such assets;
     
  an obligation, including a contingent obligation, under a contract that would be accounted for as a derivative instrument; or
     
  an obligation, including a contingent obligation, arising out of a variable interest in an unconsolidated entity that is held by, and material to us, where such entity provides financing, liquidity, market risk or credit risk support to or engages in leasing, hedging, or research and development services with us.

 

Inflation

 

Wedo not believe that inflation has had a material effect on our results of operations.

 

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DESCRIPTIONOF BUSINESS

 

SigynTherapeutics, Inc. (“Sigyn” or the “Company”) is a development-stage therapeutic technology company headquarteredin San Diego, California USA. Our business focus is the clinical advancement of Sigyn Therapy, a multi-function blood purification technologydesigned to overcome the limitations of previous drugs and devices to treat life-threatening inflammatory disorders, including sepsis,the leading cause of hospital deaths worldwide.

 

AboutSigyn Therapy

 

Weare advancing Sigyn Therapy to treat pathogen-associated conditions that precipitate sepsis and other high-mortality disorders that arenot addressed with approved drug therapies. To address these unmet therapeutic needs, we designed Sigyn Therapy to extract pathogen sourcesof life-threating inflammation from the bloodstream in concert with the depletion of pro-inflammatory cytokines, whose dysregulated production(the cytokine storm) plays a prominent role in each of our therapeutic indication opportunities.

 

Inaddition to sepsis, our candidate treatment indications include, but are not limited to; emerging pandemic threats, drug resistant pathogens,hepatic encephalopathy, bridge to liver transplant, and community-acquired pneumonia (“CAP”), which is a leading cause ofdeath among infectious diseases, the leading cause of death in children under five years of age, and a catalyst for approximately 50%of sepsis and septic shock cases.

 

MergerTransaction

 

OnOctober 19, 2020, Reign Resources Corporation, completed a Share Exchange Agreement (the “Agreement”) with Sigyn Therapeutics,Inc., a private entity incorporated in the State of Delaware on October 19, 2019. Pursuant to the Share Exchange Agreement, we acquired100% of the issued and outstanding shares of privately held Sigyn Therapeutics common stock in exchange for 75% of the fully paid andnonassessable shares of our common stock outstanding (the “Acquisition”). In conjunction with the transaction, we changedour name from Reign Resources Corporation to Sigyn Therapeutics, Inc. pursuant to an amendment to our articles of incorporation thatwas filed with the State of Delaware. Subsequently, our trading symbol was changed to SIGY. The Acquisition was treated as a “tax-freeexchange” under Section 368 of the Internal Revenue Code of 1986 and resulted in the private Sigyn Therapeutics corporate entitybecoming a wholly owned subsidiary known as Sigyn Medical Corporation. Upon the closing of the Acquisition, we appointed James A. Joyceand Craig P. Roberts to serve as members of our Board of Directors.

 

Asof May 5, 2022, we have a total 37,238,656 shares issued and outstanding, of which 11,655,803 shares are held by non-affiliate shareholders.

 

Post-MergerDevelopments

 

Sincethe consummation of our public merger on October 19, 2020, we have advanced Sigyn Therapy from conceptual design to clinical application.We initiated and completed a series of in vitro blood plasma studies that validated the ability of Sigyn Therapy to address abroad-spectrum of relevant therapeutic targets, including endotoxin (gram-negative bacterial toxin); peptidoglycan and lipoteichoic acid(gram-positive bacterial toxins); viral pathogens (including SARS-CoV-2); hepatic toxins (ammonia, bile acid, and bilirubin); CytoVesicles(extracellular vesicles that transport inflammatory cytokine cargos); and tumor necrosis factor alpha (TNF alpha), interleukin-1 beta(IL-1b), and interleukin 6 (IL-6), which are pro-inflammatory cytokines whose dysregulated production (the cytokine storm) precipitatesepsis and play a prominent role in each of our therapeutic opportunities.

 

Subsequentto these milestone achievements, we announced the completion of in vivo animal studies on February 23, 2022, that demonstratedSigyn Therapy to be safe and well tolerated.

 

Inthe studies, Sigyn Therapy was administered via standard dialysis machines utilizing conventional blood-tubing sets, for periods of upto six hours in eight (8) porcine (pig) subjects, each weighing approximately 40-45 kilograms. The studies were comprised of a pilotphase (two subjects), which evaluated the feasibility of the study protocol in the first-in-mammal use of Sigyn Therapy; and an expansionphase (six subjects) to further assess treatment safety and refine pre-treatment set-up and operating procedures. Sigyn Therapy was welltolerated by all eight animal subjects and no serious adverse events were reported in any treated animal subject. Important criteriafor treatment safety – including hemodynamic parameters, serum chemistries and hematologic measurements – were stable acrossall subjects.

 

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Thestudies were conducted by a clinical team at Innovative BioTherapies, Inc. (“IBT”), under a contract with the Universityof Michigan to utilize animal care, associated institutional review oversight, as well as surgical suite facilities located within theNorth Campus Research Complex. IBT is uniquely experienced in providing development services that support the clinical advancement ofextracorporeal devices. The treatment protocol of the study was reviewed and approved by the University of Michigan Institutional AnimalCare and Use Committee (IACUC).

 

Weplan to incorporate the data resulting from our in vivo and invitro studies into an Investigational Device Exemption (IDE) thatwe are drafting for submission to the U.S. Food and Drug Administration (“FDA”) to support the potential initiation of humanclinical studies.

 

SigynTherapy Mechanism of Action

 

Toovercome the limitations of previous drug and device therapies, we created Sigyn Therapy with a novel multi-function mechanism of action.Based on the results of studies conducted to date, our expansive mechanism establishes Sigyn Therapy as an emerging candidate to treata wide-range of pathogen-associated conditions that precipitate sepsis and other life-threatening disorders.

 

Tosupport widespread implementation, we designed Sigyn Therapy to be a single-use disposable device that is deployable on the global infrastructureof hemodialysis and continuous renal replacement therapy (CRRT) machines already located in hospitals and clinics.

 

Incorporatedwith Sigyn Therapy is a “cocktail” of adsorbent components formulated to optimize the broad-spectrum extraction of therapeutictargets from the bloodstream. In the medical field, the term “cocktail” is a reference to the simultaneous administrationof multiple drugs (a drug cocktail) with differing mechanisms of actions. While drug cocktails are emerging as potential mechanisms totreat cancer, they are proven life-saving countermeasures to treat HIV and Hepatitis-C viral infections. However, dosing of multi-drugagent cocktails is limited by toxicity and adverse events that can result from deleterious drug interactions.

 

SigynTherapy is not constrained by such limitations as our adsorbent components are not introduced into the body. As a result, we are ableto incorporate a substantial dose of multiple adsorbents, each with differing mechanisms and capabilities to optimize Sigyn Therapy’sability to address a broad-spectrum of pathogenic and inflammatory targets that precipitate the cytokine storm that underlies sepsisand other acute life-threatening disorders.

 

Theadsorbent components that we incorporate in Sigyn Therapy provide more than 200,000 square meters (~50 acres) of surface area on whichto adsorb and remove circulating pathogens, toxins, inflammatory mediators, and other relevant targets below 200nm in diameter. Beyondan immense capacity to remove therapeutic targets, Sigyn Therapy is also highly efficient. Based on blood flow rates of 350ml/min, apatient’s entire bloodstream can pass through Sigyn Therapy up to seventeen (17) times during a single four-hour treatment period.

 

Overviewof Candidate Treatment Indications

 

Basedon data resulting from in vitro blood purification studies, our candidate treatment indications include, but are not limited to;sepsis, community-acquired pneumonia, emerging pandemic threats, hepatic encephalopathy, bridge to liver transplant, and drug resistantpathogens. However, there is no assurance that controlled human studies will demonstrate Sigyn Therapy to be an efficacious treatmentfor any of these indications.

 

Sepsis

 

Sepsisis defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. In January of 2020, a reportentitled; “Global, Regional, and National Sepsis Incidence and Mortality, 1990-2017: Analysis for the Global Burden of DiseaseStudy,” was published in the Journal Lancet. The publication reported 48.9 million cases of sepsis and 11 million deaths in2017. In that same year, an estimated 20.3 million sepsis cases and 2.9 million deaths were among children younger than 5-years old.The report included a reference that sepsis kills more people around the world than all forms of cancer combined. In the United States,sepsis was reported to be the most common cause of hospital deaths with an annual financial burden that exceeds $24 billion.

 

Todate, more than 100 human studies have been conducted to evaluate the safety and efficacy of candidate drugs to treat sepsis. With onebrief exception (Xigris, Eli Lilly), none of these studies resulted in a market cleared therapy.

 

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Assepsis remains beyond the reach of single-target drugs, there is an emerging interest in multi-mechanism therapies that can target bothinflammatory and pathogen associated targets. Sigyn Therapy addresses a broad-spectrum of pathogen sources and the resulting dysregulatedcytokine production (the cytokine storm) that is the hallmark of sepsis. Additionally, we believe that inflammatory cytokine cargos transportedby CytoVesicles may represent a novel, yet important therapeutic target.

 

Community-acquiredPneumonia

 

CAPrepresents a significant opportunity for Sigyn Therapy to reduce the occurrence of sepsis. CAP is a leading cause of death among infectiousdiseases, the leading cause of death in children under five years of age, and a catalyst for approximately 50% of sepsis and septic shockcases.

 

Inthe United States, more than 1.5 million individuals are hospitalized with CAP each year, resulting in an annual financial burden thatexceeds $10 billion.

 

Statistically,a therapeutic strategy that reduced the incidence of CAP related sepsis and septic shock would save thousands of lives each year. Ina study of 4,222 patients, the all-cause mortality for adult patients with CAP was reported to be 6.5% during hospitalization. However,the mortality of patients with CAP related sepsis and septic shock rose to 51% during hospitalization.

 

CAPis further complicated by the fact that the pathogen sources of CAP are identified in only 38% of patients, based on a study of 2,259subjects whose pneumonia diagnosis was confirmed by chest x-ray. Of the source pathogens identified in the study, ninety seven percent(97%) were either viral or bacterial in origin.

 

Toreduce the occurrence of CAP related sepsis and septic shock, Sigyn Therapy offers a broad-spectrum mechanism to reduce the circulatingpresence of viral pathogens and bacterial toxins before and if they are identified as the CAP pathogen source. Additionally, Sigyn Therapymay help to control the excess production of inflammatory cytokines (the cytokine storm) that precipitate sepsis and septic shock.

 

EmergingPandemic Threats

 

Covid-19affirmed the important role of extracorporeal blood purification technologies as first-line countermeasures to treat a newly emergingpandemic threat not addressed with a drug or vaccine at the outset of an outbreak. The confluence of global warming, urban crowding,and intercontinental travel is expected to fuel a continuance of future pandemic threats.

 

Additionally,as a majority of known human viruses are not addressed with a corresponding drug or vaccine, there will be an ongoing need for bloodpurification technologies that reduce the severity of infection and mitigate the excess production of inflammatory cytokines (the cytokinestorm) associated with high mortality in non-pandemic viral infections. In this regard, we believe that Sigyn Therapy aligns with U.S.Government initiatives that support the development of broad-spectrum medical countermeasures that can mitigate the impact of emergingpandemic threats, yet also have viability in established disease indications.

 

HepaticEncephalopathy

 

Basedon the results of invitro blood purification studies conducted to date, we consider Sigyn Therapy to be a compelling strategyto reverse the length and severity of Hepatic Encephalopathy (“HE”), a frequent and serious complication of both chronicliver disease and acute liver failure. A hallmark characteristic of HE is the accumulation of neurotoxic substances in the bloodstreamthat translocate through the blood-brain barrier, which can result in a hepatic coma in severe cases and ultimately cause death.

 

Thethree-year survival rate following the first episode of HE is approximately 15%. The clinical and economic burden of HE is considerableas it contributes to an impaired quality of life, morbidity, and mortality. In the United States, HE is a significant public health concernthat results in 100,000–115,000 yearly hospital admissions.

 

Theseverity of Hepatic Encephalopathy is often correlated with elevated concentrations of hepatic toxins, pro-inflammatory cytokines, andbacterial toxins in the bloodstream. In vitro blood plasma studies have validated the ability of Sigyn Therapy to address hepatictoxins (ammonia, bile acid, and bilirubin), relevant pro-inflammatory cytokines (TNF-a, IL-1b, and IL-6), gram-negative bacterial toxin(endotoxin), and gram-positive bacterial toxins (peptidoglycan and lipoteichoic acid).

 

HEis often a common occurrence in cirrhosis patients awaiting a donor liver for transplant. As the reduced duration of an HE episode correlateswith higher rates of survival to transplant, Sigyn Therapy may have potential utility as a bridge-to-liver transplant device.

 

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Bridge-To-LiverTransplant

 

Thereis an urgent need for a medical intervention that could reduce the circulating presence of hepatic toxins, pro-inflammatory cytokines,and pathogenic factors as a means to assist in extending the lives to those awaiting a liver transplant. Based on these requirements,there may be an opportunity for Sigyn Therapy to stabilize or extend the life of a patient prior to the identification of a matched liverfor transplantation - otherwise known as a bridge-to-liver transplant. In 2017, 8,082 U.S. patients received a liver transplant, and13,885 patients were on the waiting list for a liver transplant. In that year, the average cost associated with a liver transplant wasreported to be $577,100 USD.

 

RecentCorporate Developments

 

December 2020 – Reported the first in vitro study results of Sigyn Therapy. The study demonstrated the simultaneous reduction of endotoxin, a gram-negative bacterial toxin, and relevant pro-inflammatory cytokines from human blood plasma. Included among validated cytokines were Interleukin-1 Beta (IL-1B), Interleukin-6 (IL-6) and Tumor Necrosis Factor alpha (TNF-a).
   
January 2021 - Announced the results of an in vitro pilot study that successfully modeled the ability of Sigyn Therapy to address CytoVesicles (extracellular vesicles that transport inflammatory cargos in the bloodstream).
   
January 2021 - Appointed industry veteran Eric Lynam as Head of Clinical Affairs, with a mandate to oversee clinical studies of Sigyn Therapy.
   
April 2021 - Disclosed in vitro study observations that demonstrated the ability of Sigyn Therapy to adsorb viral pathogens, including SARS-CoV-2 (COVID-19).
   
April 2021 - Appointed former Aethlon Medical executive Charlene Owen as Director of Operations.
   
July 2021 - Announced the completion of in vitro blood purification studies that demonstrated the broad-spectrum ability of Sigyn Therapy to eliminate hepatic toxins (ammonia, bile acid & bilirubin) associated with Hepatic Encephalopathy.
   
July 2021 - Disclosed the completion of a first-in-mammal pilot animal study that validated the feasibility of a clinical protocol that resulted in the safe administration of Sigyn Therapy during six-hour treatment exposures.
   
December 2021 - Announced the completion of in vitro studies that validated the ability of Sigyn Therapy to deplete gram-positive bacterial toxins from human blood plasma.
   
February 2022 - Reported the successful completion of an in vivo animal study conducted at the University of Michigan, which demonstrated Sigyn Therapy to be safe and well tolerated.
   
March 2022 - Appointed accomplished financial executive, Jeremy Ferrell, CPA, MBA as Chief Financial Officer, with overall responsibility for operational finance, budgeting, and financial reporting, as well as helping to manage the Company’s relationships and interactions with the investment community.
   
March 2022 - Announced the appointments of two internationally recognized clinician researchers, Alexander S. Yevzlin, MD, FASN and H. David Humes, MD, to Sigyn Therapeutics’ Scientific Advisory Board.
   
March 2022 - Ajay Verma, MD, PhD, a recognized thought leader in the field of neurology joins the Science Advisory Board.
   
April 2022 - Donald J. Hillebrand, M.D., a recognized thought leader in the field of Hepatology and Liver Transplantation joins the Science Advisory Board.

 

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Marketingand Sales

 

Atpresent, our primary focus is the clinical and regulatory advancement of Sigyn Therapy. As such, we do not market or sell any therapeuticproducts at this time. However, we plan to forge relationships with organizations that have established distribution channels into marketsthat may have a demand for Sigyn Therapy should it receive market clearance from FDA or other foreign regulatory agencies.

 

IntellectualProperty

 

Weown the intellectual property rights to pending royalty-free patents that have been assigned to us by our co-founders, James A. Joyceand Craig P. Roberts. We have also received a “Notice of Allowance” from the United States Patent and Trademark Office (USPTO)related to the use of Sigyn Therapeutics, Sigyn Therapy, and the protection of our corporate logo. We plan to continually expand ourintellectual property portfolio and protect trade secrets that are not the subject of patent submissions. However, there is no assurancethat the claims of current pending and future patent applications will result in issued patents.

 

Atpresent, we own the rights to the following patents pending.

 

DEVICES,SYSTEMS AND METHODS FOR THE BROAD-SPECTRUM REDUCTION OF PRO-INFLAMMATORY CYTOKINES IN BLOOD - U.S. Application No.: 62/881,740; FilingDate: 2019-08-01 - Inventors: Joyce and Roberts

 

DEVICES,SYSTEMS AND METHODS FOR THE BROAD-SPECTRUM REDUCTION OF PRO-INFLAMMATORY CYTOKINES IN BLOOD - International Patent Application No.: PCT/US2020/044223;Filing Date: 2020-07-30 - Inventors: Joyce and Roberts

 

DEVICES,SYSTEMS AND METHODS FOR THE BROAD-SPECTRUM REDUCTION OF PRO-INFLAMMATORY CYTOKINES IN BLOOD - U.S. Patent Application No.: 16/943,436;Filing Date: 2020-07-30 - Inventors: Joyce and Roberts

 

DEVICES,SYSTEMS AND METHODS FOR THE BROAD-SPECTRUM REDUCTION OF PRO-INFLAMMATORY CYTOKINES IN BLOOD - EP No.: 20757445; Filing Date: 2022-01-24- Inventors: Joyce and Roberts

 

DEVICES,SYSTEMS AND METHODS FOR THE BROAD-SPECTRUM REDUCTION OF PRO-INFLAMMATORY CYTOKINES IN BLOOD - CA No.: 3148773; Filing Date: 2022-01-25- Inventors: Joyce and Roberts

 

DEVICES,SYSTEMS AND METHODS FOR THE BROAD-SPECTRUM REDUCTION OF PRO-INFLAMMATORY CYTOKINES IN BLOOD - JP No.: 2022-506670; Filing Date: 2022-01-31- Inventors: Joyce and Roberts

 

EXTRA-LUMENADSORPTION OF VIRAL PATHOGENS FROM BLOOD

U.S.Patent Application No.: 63/177,520; Filing Date: 2021-04-21

Inventor:James A. Joyce

 

GovernmentRegulation

 

Inthe United States, Sigyn Therapy is subject to regulation by the FDA. Should we seek to commercialize Sigyn Therapy outside the UnitedStates, we expect to face comparable international regulatory oversight. Based on published guidance by FDA, Sigyn Therapy is a ClassIII medical device whose regulatory jurisdiction is the Center for Devices and Radiological Health (“CDRH”), the FDA branchthat oversees the market approval of medical devices. As a Class III device, we are subject to a Pre-Market Approval (“PMA”)submission pathway with CDRH. The approval of a PMA application to support market clearance of Sigyn Therapy will require extensive data,which includes but is not limited to technical documents, preclinical studies, animal studies, human clinical trials, the establishmentof Good Manufacturing Practice (“GMP”) standards and labeling that fulfills FDA’s requirement to demonstrate reasonableevidence of safety and effectiveness of a medical device product. In this regard, there is no assurance that Sigyn Therapy will be demonstratedto be a safe and effective product for any therapeutic indication that we pursue.

 

ShouldSigyn Therapy receive market clearance, we will need to comply with applicable laws and regulations that govern the development, testing,manufacturing, labeling, marketing, storage, distribution, advertising and promotion, and post-marketing surveillance reporting for medicaldevices. Failure to comply with these applicable requirements may subject a device and/or its manufacturer to a variety of administrativesanctions, such as issuance of warning letters, import detentions, civil monetary penalties and/or judicial sanctions, such as productseizures, injunctions and criminal prosecution. Our failure to comply with any of these laws and regulations could have a material adverseeffect on our operations.

 

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Weare subject to regulations by federal, state, local and foreign regulators. The implementation, modification, interpretation and enforcementof these laws and regulations vary and can limit our ability to provide many of our services. Our ability to compete in our target marketsdepends, in part, upon favorable regulatory conditions and the favorable interpretations of existing laws and regulations.

 

Manufacturingand Procurement

 

Weare advancing a manufacturing relationship with an FDA registered Contract Manufacturing Organization (CMO) to establish GMP compliantmanufacturing to support human clinical studies and potential commercialization should we receive clearance to market Sigyn Therapy.We plan to establish manufacturing procedure specifications that define each stage of our manufacturing, inspection and testing processesand the control parameters or acceptance criteria that apply to each activity that result in the production of our technology.

 

Wehave also established relationships with industry vendors that provide components necessary to manufacture our device. Should the relationshipwith an industry vendor be interrupted or discontinued, we believe that alternate component suppliers can be identified to support thecontinued manufacturing of our product. However, delays related to interrupted or discontinued vendor relationships could adversely impactour business.

 

Researchand Product Development

 

Todate, we have outsourced our research and product development activities, which include the performance of in vitro blood plasmavalidation studies, animal studies, pre-GMP product assembly and manufacturing through third party organizations with extensive experiencein advancing extracorporeal blood purification technologies. At present, we do not have plans to build and staff our own research andproduct development facility.

 

Employees

 

Asof the date of this prospectus, the Company had 5 full time employees and believes its relationships with its employees are good.

 

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DESCRIPTIONOF PROPERTY

 

OperatingLease

 

Ourcorporate address 2468 Historic Decatur Road, Suite 140, San Diego, California, 92106

 

OnMay 27, 2021, the Company entered into a sixty-three month lease for its corporate office at $5,955 per month commencing June 15, 2021maturing September 30, 2026.

 

Webelieve that our existing facilities are adequate for our current needs and that we will be able to lease suitable additional or alternativespace on commercially reasonable terms if and when we need it.

 

DIRECTORS,EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS

 

Directorsand Executive Officers  

 

Thefollowing table sets forth the names, ages, and biographical information of each of our current directors and executive officers andthe positions with the Company held by each person. Our executive officers are elected annually by the board of directors. The directorsserve one-year terms until their successors are elected. The executive officers serve terms of one year or until their death, resignationor removal by the board of directors. Unless described below, there are no family relationships among any of the directors and officers.

 

Name   Age   Title
Jim Joyce   60   Chief Executive Officer and Chairman of the Board of Directors (“CEO”)
Craig Roberts   69   Chief Technology Officer and Director
Jeremy Ferrell (1)   52   Chief Financial Officer

 

(1)Mr. Ferrell was hired as the Company’s Chief Financial Officer effective March 9, 2022.

 

Mr.Joyce is the Co-founder, Chairman and CEO of Sigyn Therapeutics, Inc. He has 30+ years of diverse public market experience, which includestwo decades of public company CEO and Corporate Board leadership roles.

 

Mr.Joyce  was previously the founder, Chairman and CEO of Aethlon Medical, a therapeutic device company that he navigated from a singleshareholder start-up to Nasdaq-traded Company with 8000+ shareholders. During his tenure, Mr. Joyce oversaw the development of the AethlonHemopurifier, the first and only therapeutic candidate to receive two “Breakthrough Device” awards from the United StatesFood and Drug Administration (FDA). Under his leadership, the Hemopurifier received FDA “Emergency Use Authorization” (EAU)approval to treat Ebola virus and was cleared to treat Ebola by the German Government and Health Canada as well. In response, Time Magazinenamed the Hemopurifier one of the “11 Most Remarkable Advances in Healthcare” and designated the device to its “Top25 Best Inventions” award list. Mr. Joyce is well suited to sit on the Board due to his extensive public company background.

 

DuringMr. Joyce’s tenure, Aethlon won two Department of Defense (DOD) contract awards, a National Cancer Institute (NCI) contract awardand a grant from the National Institutes of Health (NIH). He also led the completion of approximately $100 million of equity financingsand originated preclinical and clinical collaborations with more than twenty government and non-government institutes and organizations.Mr. Joyce is also the former Executive Chairman of Exosome Sciences, Inc., a company he founded to advance the discovery of exosomalbiomarkers to diagnose and monitor cancer and neurological disorders.

 

Mr.Roberts is an inventor of therapeutic device technologies, which includes a Percutaneous Adult Extracorporeal Membrane Oxygenation (ECMO)system that was licensed and subsequently sold to C.R. Bard. During the ongoing pandemic, ECMO has been broadly deployed to treat criticallyill COVID-19 patients. Additionally, Mr. Roberts is the inventor of the IMPACT System, which received CE Mark clearance in the EuropeanUnion and was subsequently registered in 32 countries and successfully deployed to treat cytokine storm related conditions, includingsepsis, acute respiratory distress syndrome (ARDS), acute liver failure, severe pneumonia and H5N1 bird flu virus infection. Mr. Robertsis suited to sit on the Board due to his strong medical device background.

 

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Mr.Ferrell has more than 25 years of finance and operations leadership experience, with expertise in venture capital; mergers and acquisitions;due diligence; initial public offerings; strategic alliance negotiation; and financial planning and reporting. He was most recently CFOat Miku, Inc, a privately held consumer hardware and tele-health company, where he managed a successful seed financing round and ledMiku’s transition from its parent to an independent company. Previously, he founded a Fractional CFO Services firm, where he servedas CFO for various life sciences and technology companies, including Singular Genomics, Inc., Aspen Neuroscience, Inc., and Hyduro, Inc.Before that, he served as Corporate Controller for ecoATM, Inc., which was acquired by Outerwall, Inc. in 2013. Earlier in his career,Mr. Ferrell practiced as a certified public accountant. Mr. Ferrell received his Bachelor of Science degree in Accountancy from LibertyUniversity and his Master of Business Administration degree in International Finance from the Thunderbird School of Global Management.

 

Conflictsof Interest

 

Certainpotential conflicts of interest are inherent in the relationships between our officers and directors and us.

 

Fromtime to time, one or more of our affiliates may form or hold an ownership interest in and/or manage other businesses both related andunrelated to the type of business that we own and operate. These persons expect to continue to form, hold an ownership interest in and/ormanage additional other businesses which may compete with our business with respect to operations, including financing and marketing,management time and services and potential customers. These activities may give rise to conflicts between or among the interests of usand other businesses with which our affiliates are associated. Our affiliates are in no way prohibited from undertaking such activities,and neither we nor our shareholders will have any right to require participation in such other activities.

 

Wemay transact business with some of our officers, directors and affiliates, as well as with firms in which some of our officers, directorsor affiliates have a material interest, potential conflicts may arise between the respective interests of us and these related personsor entities. We believe that such transactions will be effected on terms at least as favorable to us as those available from unrelatedthird parties. As of this filing, we have not transacted business with any officer, director, or affiliate.

 

Withrespect to transactions involving real or apparent conflicts of interest, we have adopted policies and procedures which require that:(I) the fact of the relationship or interest giving rise to the potential conflict be disclosed or known to the directors who authorizeor approve the transaction prior to such authorization or approval, (ii) the transaction be approved by a majority of our disinterestedoutside directors, and (iii) the transaction be fair and reasonable to us at the time it is authorized or approved by our directors.

 

Ourpolicies and procedures regarding transactions involving potential conflicts of interest are not in writing. We understand that it willbe difficult to enforce our policies and procedures and will rely and trust our officers and directors to follow our policies and procedures.We will implement our policies and procedures by requiring the officer or director who is not in compliance with our policies and proceduresto remove himself and the other officers and directors will decide how to implement the policies and procedures, accordingly.

 

CorporateGovernance

 

TheCompany promotes accountability for adherence to honest and ethical conduct; endeavors to provide full, fair, accurate, timely and understandabledisclosure in reports and documents that the Company files with the Securities and Exchange Commission (the “SEC”) and inother public communications made by the Company; and strives to be compliant with applicable governmental laws, rules and regulations.

 

DirectorIndependence

 

Wedo not have any independent directors. The Company will be appointing independent directors in accordance with NASDAQ listing rule 5605(a)(2) before we uplist via an amendment to this registration statement of which this prospectus is a part. Because our common stockis not currently listed on a national securities exchange, we have used the definition of “independence” of The NASDAQ StockMarket to make this determination. NASDAQ Listing Rule 5605(a)(2) provides that an “independent director” is a person otherthan an officer or employee of the company or any other individual having a relationship which, in the opinion of the company’sboard of directors, would interfere with the exercise of independent judgment in carrying out the responsibilities of a director. TheNASDAQ listing rules provide that a director cannot be considered independent if:

 

  the director is, or at any time during the past three years was, an employee of the company;
 

the director or a family member of the director accepted any compensation from the company in excess of $120,000 during any period of 12 consecutive months within the three years preceding the independence determination (subject to certain exclusions, including, among other things, compensation for board or board committee service);

 

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  a family member of the director is, or at any time during the past three years was, an executive officer of the company;
  the director or a family member of the director is a partner in, controlling stockholder of, or an executive officer of an entity to which the company made, or from which the company received, payments in the current or any of the past three fiscal years that exceed 5% of the recipient’s consolidated gross revenue for that year or $200,000, whichever is greater (subject to certain exclusions);
  the director or a family member of the director is employed as an executive officer of an entity where, at any time during the past three years, any of the executive officers of the company served on the compensation committee of such other entity; or
  the director or a family member of the director is a current partner of the company’s outside auditor, or at any time during the past three years was a partner or employee of the company’s outside auditor, and who worked on the company’s audit.

 

BoardComposition

 

Ourbusiness and affairs are managed under the direction of our board of directors, which upon the consummation of this offering is expectedto consist of five members. Directors serve for a term of one year and until their successors have been duly elected and qualified.

 

Committeesof the Board

 

OurCompany currently does not have nominating, compensation, or audit committees or committees performing similar functions nor does ourCompany have a written nominating, compensation or audit committee charter. The Company plans to update its board committees to meetNASDAQ requirements via an amendment to this registration statement of which this prospectus is a part.

 

Inlieu of an audit committee, the Company’s board of directors is responsible for reviewing and making recommendations concerningthe selection of outside auditors, reviewing the scope, results and effectiveness of the annual audit of the Company’s consolidatedfinancial statements and other services provided by the Company’s independent public accountants. The board of directors, the ChiefExecutive Officer and the Chief Financial Officer of the Company review the Company’s internal accounting controls, practices andpolicies.

 

TheCompany maintains a Scientific Advisory Board (“SAB”) to assist the Board of Directors by reviewing and evaluating our researchand development programs. Members of the SAB receive per meeting fees and may also be eligible to receive stock options upon approvalof the Company’s board of directors.

 

AuditCommittee Financial Expert

 

Priorto the completion of this offering, we plan to appoint a board member that qualifies as an “audit committee financial expert”as defined in Item 407(D)(5) of Regulation S-K, nor do we have a board member that qualifies as “independent” as the termis used in Item 7(d)(3)(iv)(B) of Schedule 14A under the Securities Exchange Act of 1934, as amended, and as defined by Rule 4200(a)(14)of the FINRA Rules.

 

Webelieve that our directors are capable of analyzing and evaluating our consolidated financial statements and understanding internal controlsand procedures for financial reporting. The directors of our Company do not believe that it is necessary to have an audit committee becausemanagement believes that the board of directors can adequately perform the functions of an audit committee. In addition, we believe thatretaining an independent director who would qualify as an “audit committee financial expert” would be overly costly and burdensomeand is not warranted in our circumstances given the stage of our development and the fact that we have not generated any positive cashflows from operations to date.

 

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Involvementin Certain Legal Proceedings

 

Ourdirectors and our executive officers have not been involved in or a party in any of the following events or actions during the past tenyears:

 

  1. any bankruptcy petition filed by or against any business of which such person was a general partner or executive officer either at the time of the bankruptcy or within two years prior to that time;
  2. any conviction in a criminal proceeding or being subject to a pending criminal proceeding (excluding traffic violations and other minor offenses);
  3. being subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction, permanently or temporarily enjoining, barring, suspending or otherwise limiting his involvement in any type of business, securities or banking activities; or
  4. being found by a court of competent jurisdiction (in a civil action), the Commission or the Commodity Futures Trading Commission to have violated a federal or state securities or commodities law, and the judgment has not been reversed, suspended, or vacated.
  5. Such person was found by a court of competent jurisdiction in a civil action or by the Commission to have violated any Federal or State securities law, and the judgment in such civil action or finding by the Commission has not been subsequently reversed, suspended, or vacated;
  6. Such person was found by a court of competent jurisdiction in a civil action or by the Commodity Futures Trading Commission to have violated any Federal commodities law, and the judgment in such civil action or finding by the Commodity Futures Trading Commission has not been subsequently reversed, suspended or vacated;
  7. Such person was the subject of, or a party to, any Federal or State judicial or administrative order, judgment, decree, or finding, not subsequently reversed, suspended or vacated, relating to an alleged violation of: (I) Any Federal or State securities or commodities law or regulation; or (ii) Any law or regulation respecting financial institutions or insurance companies including, but not limited to, a temporary or permanent injunction, order of disgorgement or restitution, civil money penalty or temporary or permanent cease-and-desist order, or removal or prohibition order; or (iii) Any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity; or
  8. Such person was the subject of, or a party to, any sanction or order, not subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the Exchange Act (15 U.S.C. 78c(a)(26))), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act (7 U.S.C. 1(a)(29))), or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons associated with a member.

 

Codeof Ethics

 

TheCompany has not formally adopted a written Code of Ethics that governs the Company’s employees, officers and directors as the Companyis not required to do so. The board of directors evaluated the business of the Company and the number of employees and determined thatsince the business is operated by a small number of persons, general rules of fiduciary duty and federal and state criminal, businessconduct and securities laws are adequate ethical guidelines. In the event our operations, employees and/or directors expand in the future,we may take actions to adopt a formal Code of Ethics.

 

Roleof Board of Directors in Risk Oversight

 

Ourboard of directors oversees an enterprise-wide approach to risk management, designed to support the achievement of business objectives,including organizational and strategic objectives, to improve long-term organizational performance and enhance stockholder value. Theinvolvement of our board of directors in setting our business strategy is a key part of its assessment of management’s plans forrisk management and its determination of what constitutes an appropriate level of risk for our company. The participation of our boardof directors in our risk oversight process includes receiving regular reports from members of senior management on areas of materialrisk to our company, including operational, financial, legal and regulatory, and strategic and reputational risks.

 

Whileour board of directors has the ultimate responsibility for the risk management process, senior management and various committees of ourboard of directors, when formed, will also have responsibility for certain areas of risk management. Our senior management team is responsiblefor day-to-day risk management and regularly reports on risks to our full board of directors or a relevant committee. Our finance andregulatory personnel serve as the primary monitoring and evaluation function for company-wide policies and procedures, and manage theday-to-day oversight of the risk management strategy for our ongoing business. This oversight includes identifying, evaluating, and addressingpotential risks that may exist at the enterprise, strategic, financial, operational, compliance and reporting levels.

 

DirectorCompensation

 

Allof the Company’s directors are employees of the Company and such persons have not been separately compensated for their servicesto the Company as a director.

 

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Limitationon Liability and Indemnification Matters

 

OurCertificate of Incorporation and bylaws provide that we will indemnify our directors and officers, and may indemnify our employees andother agents, to the fullest extent permitted by the Delaware General Corporation Law, which prohibits our Certificate of Incorporationfrom limiting the liability of our directors for the following:

 

any breach of the director’s duty of loyalty to the corporation or its shareholders;
   
any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;
   
unlawful payments of dividends or unlawful stock repurchases or redemptions; or
   
any transaction from which the director derived an improper personal benefit.

 

IfDelaware law is amended to authorize corporate action further eliminating or limiting the personal liability of a director, then theliability of our directors will be eliminated or limited to the fullest extent permitted by Delaware law, as so amended. Our Articlesof Incorporation does not eliminate a director’s duty of care and in appropriate circumstances, equitable remedies, such as injunctiveor other forms of non-monetary relief, remain available under Delaware law. This provision also does not affect a director’s responsibilitiesunder any other laws, such as the federal securities laws or other state or federal laws. Under our bylaws, we will also be empoweredto purchase insurance on behalf of any person whom we are required or permitted to indemnify.

 

Inaddition to the indemnification required in our Certificate of Incorporation and bylaws, we have entered or will enter into indemnificationagreements with each of our directors and officers. These agreements provide indemnification for certain expenses and liabilities incurredin connection with any action, suit, proceeding, or alternative dispute resolution mechanism, or hearing, inquiry, or investigation thatmay lead to the foregoing, to which they are a party, or are threatened to be made a party, by reason of the fact that they are or werea director, officer, employee, agent, or fiduciary of our company, or any of our subsidiaries, by reason of any action or inaction bythem while serving as an officer, director, agent, or fiduciary, or by reason of the fact that they were serving at our request as adirector, officer, employee, agent, or fiduciary of another entity. In the case of an action or proceeding by, or in the right of, ourcompany or any of our subsidiaries, no indemnification will be provided for any claim where a court determines that the indemnified partyis prohibited from receiving indemnification. We believe that these bylaw provisions and indemnification agreements are necessary toattract and retain qualified persons as directors and officers. We also maintain directors’ and officers’ liability insurance.

 

Thelimitation of liability and indemnification provisions in our Certificate of Incorporation and bylaws may discourage shareholders frombringing a lawsuit against directors for breach of their fiduciary duties. They may also reduce the likelihood of derivative litigationagainst directors and officers, even though an action, if successful, might benefit us and our shareholders. A shareholder’s investmentmay be harmed to the extent we pay the costs of settlement and damage awards against directors and officers pursuant to these indemnificationprovisions. Insofar as we may provide indemnification for liabilities arising under the Securities Act to our directors, officers, andcontrolling persons pursuant to the foregoing provisions, or otherwise, we have been advised that, in the opinion of the SEC, such indemnificationis against public policy as expressed in the Securities Act, and is, therefore, unenforceable. There is no pending litigation or proceedingnaming any of our directors or officers as to which indemnification is being sought, nor are we aware of any pending or threatened litigationthat may result in claims for indemnification by any director or officer.

 

EXECUTIVECOMPENSATION

 

Thefollowing is a discussion and analysis of compensation arrangements of our named executive officers, or NEOs. This discussion containsforward looking statements that are based on our current plans, considerations, expectations and determinations regarding future compensationprograms. Actual compensation programs that we adopt may differ materially from currently planned programs as summarized in this discussion.As an “emerging growth company” as defined in the JOBS Act, we are not required to include a Compensation Discussion andAnalysis section and have elected to comply with the scaled disclosure requirements applicable to emerging growth companies.

 

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SummaryCompensation Table

 

Theparticulars of the compensation paid to the following persons: (1) our principal executive officer; and (2) each of our two most highlycompensated executive officers who were serving as executive officers at the end of the fiscal year ended December 31, 2021, who we willcollectively refer to as the “named executive officers” of the Company, are set out in the following summary compensationtable:

 

SUMMARY COMPENSATION TABLE
Name and Principal Position  Year   Salary
($)
   Bonus
($)
   Stock
Awards
($)
   Option
Awards
($)
   Non-Equity
Incentive Plan
Compensation
($)
   Change in
Pension
Value and
Nonqualified
Deferred
Compensation Earnings ($)
   All Other
Compensation
($) (1)
   Total
($)
 
Jim Joyce   2021    496,125    -    -    -    -    -   $31,126   $527,251 
Chief Executive Officer   2020    418,842    -    -    -    -    -   $22,516   $440,866 
                                              
Craig Roberts   2021    259,000    -    -    -    -    -   $21,704   $280,704 
Chief Technology Officer   2020    233,981    -    -    -    -    -   $22,024   $256,497 
    2019    -    -    -    -    -    -    -    - 
                                              
Jeremy Ferrell   2021    -    -    -    -    -    -   $-   $- 
Chief Financial Officer (2)   2020    -    -    -    -    -    -   $-   $- 

 

(1)amounts include health insurance and employer matched 401(k) costs.
(2)Mr. Ferrell was hired as the Company’s Chief Financial Officer effective March 9, 2022.

 

Otherthan as disclosed below, there are no compensatory plans or arrangements with respect to our executive officers resulting from theirresignation, retirement or other termination of employment or from a change of control.

 

Grantsof Plan-Based Awards Table

 

Noneof our named executive officers received any grants of stock, option awards or other plan-based awards during the years ended December31, 2021 and 2020, except as described below in “Equity Compensation Plans and Other Benefit Plans” below.

 

OptionsExercised and Stock Vested Table

 

Noneof our named executive officers exercised any stock options or restricted stock units during the years ended December 31, 2021 and 2020.

 

OutstandingEquity Awards at 2021 Year End

 

Exceptas described below in “Equity Compensation Plans and Other Benefit Plans”, the Company has not issued any awards to its namedexecutive officers. The Company and its board of directors may grant awards as it sees fit to its employees as well as key consultants.See the discussion of “Equity Compensation Plans and Other Benefit Plans” below.

 

Agreementswith Executive Officers

 

JimJoyce

 

Mr.Joyce receives an annual base salary of $455,000, plus bonus compensation not to exceed 50% of salary. Mr. Joyce’s employment alsoprovides for medical insurance, disability benefits and one year of severance pay if his employment is terminated without cause or dueto a change in control. Additionally, the Company has agreed to maintain a beneficial ownership target of 9% for Mr. Joyce. Mr. Joyce’scompensation was approved by the Reign Resources Corporation Board of Directors on October 6, 2020 and was among conditions of the ShareExchange Agreement that was completed with Sigyn Therapeutics, Inc. on October 19, 2020.

 

JeremyFerrell

 

Mr.Ferrell was hired on March 9, 2022 as the Company’s Chief Financial Officer. Mr. Ferrell receives an annual base salary of $250,000,plus discretionary bonus compensation not to exceed 40% of salary. Mr. Ferrell’s employment also provides for medical insurance,disability benefits and three months of severance pay if his employment is terminated without cause or due to a change in control. Additionally,Mr. Ferrell will be granted up to 600,000 options to purchase 600,000 of the Company’s common shares upon the implementation ofa Company employee option plan.

 

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CraigRoberts

 

Mr.Roberts, the Company’s Chief Technology Officer (CTO) receives an annual base salary of $240,000 as well as medical insurance andrelated benefits. Mr. Roberts is eligible to receive bonus compensation at the discretion of the Sigyn Therapeutics, Inc. Board of Directors.

 

EquityCompensation Plans and Other Benefit Plans

 

TheCompany does not currently have any equity compensation plans and there are no arrangements or plans in which we provide pension, retirementor similar benefits for directors or executive officers. We have no material bonus or profit-sharing plans.

 

Indebtednessof Directors, Senior Officers, Executive Officers and Other Management

 

Noneof our directors or executive officers or any associate or affiliate of the Company during the last two fiscal years, is or has beenindebted to the Company by way of guarantee, support agreement, letter of credit or other similar agreement or understanding currentlyoutstanding.

 

OutstandingEquity Awards at Fiscal Year-End Table

 

Thefollowing table sets forth certain information concerning outstanding stock awards held by the Named Executive Officers for our yearended December 31, 2021:

 

    Option Awards   Stock Awards  
Name  

Number of Securities Underlying Unexercised Options

(#)

Exercisable

   

Number of Securities Underlying Unexercised Options

(#)

Unexercisable

   

Equity Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Options

(#)

   

Option Exercise Price

($)

    Option Expiration Date  

Number of Shares or Units of Stock That Have Not Vested

(#)

   

Market Value of Shares or Units of Stock That Have Not Vested

($)

   

Equity Incentive Plan Awards: Number of Unearned Shares, Units or Other Rights That Have Not Vested

(#)

   

Equity Incentive Plan Awards: Market or Payout Value of Unearned Shares, Units or Other Rights That Have Not Vested

($)

 
                                                     
None.     -0-       -0-       -0-       -0-     -0-     -0-       -0-       -0-       -0-  

 

SECURITYOWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

 

Thefollowing table sets forth information relating to the beneficial ownership our common stock as of June 22, 2022 by (i) each personknown to be the beneficial owner of more than 5% of the outstanding shares of common stock and (ii) each of our directors and executiveofficers. Unless otherwise noted below, we believe that all persons named in the table have sole voting and investment power with respectto all shares of common stock beneficially owned by them. For purposes hereof, a person is deemed to be the beneficial owner of securitiesthat can be acquired by such person within 60 days from the date hereof upon the exercise of warrants or options or the conversion ofconvertible securities. Each beneficial owner’s percentage ownership is determined by assuming that any warrants, options or convertiblesecurities that are held by such person (but not those held by any other person) and which are exercisable within 60 days from the datehereof, have been exercised.

 

Name and Address (2)  Amount of Beneficial Ownership  

Percentof Class (1)

 
         
Jim Joyce (3)    12,820,000    34.4%
Craig Roberts (4)    12,820,000    34.4%
           
All Officers and Directors as a Group (2 Persons)   25,640,000   68.8%
           
Brio Capital Master Fund Ltd.      3,725,850    9.9%
           
Osher Capital Partners LLC (5)   3,050,658    8.2%

 

 

(1) Based on 37,238,656 shares of common stock issued and outstanding.
(2) Unless otherwise noted, the address of each beneficial owner is c/o Sigyn Therapeutics, Inc., 2468 Historic Decatur Road, Suite 140, San Diego, CA 92106.
(3) Mr. Joyce is the Company’s CEO.
(4) Mr. Roberts is the Company’s CTO.
(5) Consists of 3,050,658 common shares as of the date of this filing. Osher Capital Partners LLC (“Osher”) is contractually limited to beneficial ownership of our common shares not to exceed 9.99%.

 

Weare not aware of any person who owns of record, or is known to own beneficially, five percent or more of our outstanding securities ofany class, other than as set forth above. We do not have an investment advisor. There are no current arrangements which will result ina change in control.

 

EquityCompensation Plans

 

Thefollowing represents a summary of the Equity Compensation grants and options awards outstanding at December 31, 2021 and 2020 and changesduring the years then ended:

 

2021 and 2020
Plan category  Number of securities to be issued upon exercise of outstanding options, warrants and rights   Weighted-average exercise price of outstanding options, warrants and rights   Number of securities remaining available for future issuance under equity compensation plan (excluding securities reflected in column (a)) 
   (a)   (b)   (c) 
Equity compensation plans approved by security holders   -0-   $-0-    -0- 
Equity compensation plans not approved by security holders   -0-   $-0-    -0- 
Total   -0-   $-0-    -0- 

 

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UNDERWRITING

 

UnivestSecurities, LLC is acting as representative of the underwriters. Subject to the terms and conditions of an underwriting agreement betweenus and the representative, we have agreed to sell to each underwriter named below, and each underwriter named below has severally agreedto purchase, at the public offering price less the underwriting discounts set forth on the cover page of this prospectus, the numberof Class A Units listed next to its name in the following table:

 

Underwriter  Number of
Class A Units
  

Number of

Class B Units

 
Univest Securities, LLC        
Total          

 

The underwriting agreement provides that the obligationsof the underwriters to pay for and accept delivery of the securities offered by this prospectus are subject to various conditionsand representations and warranties, including the approval of certain legal matters by their counsel and other conditions specified inthe underwriting agreement. The securities are offered by the underwriters, subject to prior sale, when, as and if issued to andaccepted by them. The underwriters reserve the right to withdraw, cancel or modify the offer to the public and to reject orders in wholeor in part. The underwriters are obligated to take and pay for all of the Class A Units and Class B Units offered by this prospectusif any such Class A Units and/or Class B Units are taken, other than those shares of common stock and/or Series A Warrantscovered by the over-allotment option described below.

 

Wehave agreed to indemnify the underwriters against specified liabilities, including liabilities under the Securities Act, and to contributeto payments the underwriters may be required to make in respect thereof.

 

Over-AllotmentOption

 

We have granted to the representative an option,exercisable one or more times in whole or in part, not later than 45 days after the date of this prospectus, to purchase from us up toan (i) additional            shares of our common stock at a price of $       per share and/or (ii) additional Series A Warrants to purchase         shares of commonstock at a price of $0.01 per warrant (15% of the shares of common stock and warrants included in the Class A Units and Class B Unitssold in this offering), in each case, less the underwriting discounts and commissions set forth on the cover of this prospectus in anycombination thereof to cover over-allotments, if any. To the extent that the representative exercises this option, each of the underwriterswill become obligated, subject to conditions, to purchase approximately the same percentage of these additional shares of common stockand/or Series A Warrants as the number of Class A Units and Class B Units to be purchased by it in the above table bears to the totalnumber of Class A Units and Class B Units offered by this prospectus. We will be obligated, pursuant to the option, to sell these additionalshares of common stock and/or Series A Warrants to the underwriters to the extent the option is exercised. If any additional shares ofcommon stock and/or Series A Warrants are purchased, the underwriters will offer the additional shares of common stock and/or SeriesA Warrants on the same terms as those on which the other Class A Units and Class B Units are being offered hereunder. If this optionis exercised in full, the total offering price to the public will be $        and the total net proceeds,before expenses and after the credit to the underwriting commissions described below, to us will be $           .

 

Discountsand Commissions

 

The underwriters propose initially to offer the ClassA Units and Class B Units to the public at the public offering price set forth on the cover page of this prospectus and to dealersat those prices less a concession not in excess of $         per Class A Unit and $____ perClass B Units. If all of the Class A Units offered by us are not sold at the public offering price, the underwriters may changethe offering price and other selling terms by means of a supplement to this prospectus.

 

The following table shows the public offering price,underwriting discounts and commissions and proceeds before expenses to us. The information assumes either no exercise or full exerciseof the over-allotment option we granted to the representative of the underwriters.

 

   Per Class A Unit   Per Class B Unit   Total Without Over-allotment Option   Total With Over-allotment Option 
Public offering price  $           $           $          $       
Underwriting discount (7.0%)  $   $   $   $ 
Proceeds, before expenses, to us  $   $   $   $ 
Non-accountable expense allowance (1.0%)  $   $   $   $ 

 

(1)The non-accountable expense allowance will not payable with respect to representative’s exercise of the over-allotment option.

 

Wehave agreed to pay a non-accountable expense allowance to the representative of the underwriters equal to 1.0% of the gross proceedsreceived at the closing of the offering. The non-accountable expense allowance of 1.0% is not payable with respect to any Class AUnits and Class B Units sold upon exercise of the underwriters’ over-allotment option. In addition, wehave agreed to reimburse the representative up to a maximum of $150,000 for out-of-pocket accountable expenses, including,but not limited to, travel, due diligence expenses, reasonable fees and expenses of its legal counsel, accountable roadshowexpenses, and background checks on our principal shareholders, directors and officers.

 

Ourtotal estimated expenses of the offering, including registration, filing and listing fees, printing fees and legal and accounting expenses,but excluding underwriting discounts and commissions, are approximately $         .

 

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Representative’sWarrants

 

Upon completion of this offering, we have agreedto issue to the representative as compensation warrants to purchase up to         shares of commonstock (6.0% of the aggregate number of shares of common stock sold in this offering inclusive of the over-allotment option (the“representative’s warrants”). The representative’s warrants will be exercisable at a per share exercise priceequal to 110% of the public offering price per Class A Unit and Class B Unit in this offering. The representative’s warrantsare exercisable at any time and from time to time, in whole or in part, during the four and one half year period commencing 180 daysfollowing the commencement of sales of the securities issued in this offering.

 

Therepresentative’s warrants have been deemed compensation by FINRA and are therefore subject to a 180-day lock-up pursuant to Rule5110(e)(1)(A) of FINRA. The representative (or permitted assignees under Rule 5110(e)(2)) will not sell, transfer, assign, pledge, orhypothecate these warrants or the securities underlying these warrants, nor will they engage in any hedging, short sale, derivative,put, or call transaction that would result in the effective economic disposition of the warrants or the underlying securities for a periodof 180 days following the commencement of sales of the securities issued in this offering. In addition, the representative’s warrantsprovide for registration rights upon request, in certain cases. The sole demand registration right provided will not be greater thanfive years from the commencement of sales of the securities issued in this offering in compliance with FINRA Rule 5110(g)(8)(C). Thepiggyback registration rights provided will not be greater than seven years from the commencement of sales of the securities issued inthis offering in compliance with FINRA Rule 5110(g)(8)(D). We will bear all fees and expenses attendant to registering the securitiesissuable on exercise of the warrants other than underwriting commissions incurred and payable by the holders. The exercise price andnumber of shares issuable upon exercise of the warrants may be adjusted in certain circumstances including in the event of a stock dividendor our recapitalization, reorganization, merger or consolidation. However, the warrant exercise price or underlying shares will not beadjusted for issuances of shares of common stock at a price below the warrant exercise price.

 

Rightof First Refusal

 

Wehave agreed to grant the representative, for the 9-month period following the closing of this offering, a right of first refusal to provideinvestment banking services to us on an exclusive basis in all matters for which investment banking services are sought by us (the “Rightof First Refusal”), which right is exercisable in the representative’s sole discretion. In accordance FINRA Rule 5110(g)(6)(A),such Right of First Refusal does not have a duration of more than three years from the commencement of sales of the publicoffering or the termination date of the engagement between the us and the underwriters.

 

Lock-UpAgreements

 

Pursuantto “lock-up” agreements, we, our executive officers and directors, and certain stockholders, have agreed, without the priorwritten consent of the representative not to directly or indirectly, offer to sell, sell, pledge or otherwise transfer or dispose ofany of shares of (or enter into any transaction or device that is designed to, or could be expected to, result in the transfer or dispositionby any person at any time in the future of) our common stock, enter into any swap or other derivatives transaction that transfers toanother, in whole or in part, any of the economic benefits or risks of ownership of shares of our common stock, make any demand for orexercise any right or cause to be filed a registration statement, including any amendments thereto, with respect to the registrationof any shares of common stock or securities convertible into or exercisable or exchangeable for common stock or any other securitiesof ours or publicly disclose the intention to do any of the foregoing, subject to customary exceptions, for a period of six monthsafter the date of this prospectus in the case of our directors, executive officers, the Company and any successor of the Company andcertain stockholders.

 

DiscretionaryAccounts

 

Theunderwriters do not intend to confirm sales of the shares of common stock offered hereby to any accounts over which they have discretionaryauthority.

 

NasdaqCapital Market Listing

 

Weintend to apply to have our common stock listed on the Nasdaq Capital Market under the symbol “SIGY”. No assurance canbe given that our application will be approved by Nasdaq.

 

Determinationof Offering Price

 

The public offering price of the Class A Unitsand Class B Units that we are offering was negotiated between us and the underwriters. Factors considered in determining the publicoffering price of the Class A Units and Class B Units include the history and prospects of the Company, the stage of developmentof our business, our business plans for the future and the extent to which they have been implemented, an assessment of our management,general conditions of the securities markets at the time of the offering and such other factors as were deemed relevant.

 

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PriceStabilization, Short Positions and Penalty Bids

 

Inconnection with this offering, the underwriters may engage in transactions that stabilize, maintain or otherwise affect the price ofour common stock and Series A Warrants. Specifically, the underwriters may over-allot in connection with this offering by sellingmore shares of common stock and/or Series A Warrants than are set forth on the cover page of this prospectus. This creates a shortposition in our common stock or Series A Warrants for its own account. The short position may be either a covered short positionor a naked short position. In a covered short position, the number of shares of common stock and/or Series A Warrants over-allottedby the underwriters is not greater than the number of shares of common stock and/or Series A Warrants that they may purchase inthe over-allotment option. In a naked short position, the number of shares of common stock and/or Series A Warrants involved isgreater than the number of shares common stock in the over-allotment option. To close out a short position, the underwriters may electto exercise all or part of the over-allotment option. The underwriters may also elect to stabilize the price of our common stock and/orSeries A Warrants or reduce any short position by bidding for, and purchasing, common stock and/or Series A Warrants in theopen market.

 

Theunderwriters may also impose a penalty bid. This occurs when a particular underwriter or dealer repays selling concessions allowed toit for distributing securities in this offering because the underwriter repurchases the securities in stabilizing or shortcovering transactions.

 

Finally,the underwriters may bid for, and purchase, securities in market making transactions, including “passive” market makingtransactions as described below.

 

Theseactivities may stabilize or maintain the market price of our common stock and/or Series A Warrants at a price that is higher thanthe price that might otherwise exist in the absence of these activities. The underwriters are not required to engage in these activities,and may discontinue any of these activities at any time without notice. These transactions may be effected on the national securitiesexchange on which our shares of common stock are traded, in the over-the-counter market, or otherwise.

 

Indemnification

 

Wehave agreed to indemnify the underwriters against liabilities relating to this offering arising under the Securities Act and the ExchangeAct, liabilities arising from breaches of some or all of the representations and warranties contained in the underwriting agreement,and to contribute to payments that the underwriters may be required to make for these liabilities.

 

Affiliations

 

Theunderwriters and their respective affiliates are full service financial institutions engaged in various activities, which may includesecurities trading, commercial and investment banking, financial advisory, investment management, investment research, principal investment,hedging, financing and brokerage activities. The underwriters and their affiliates may from time to time in the future engage with usand perform services for us or in the ordinary course of their business for which they will receive customary fees and expenses. In theordinary course of their various business activities, the underwriters and their respective affiliates may make or hold a broad arrayof investments and actively trade debt and equity securities (or related derivative securities) and financial instruments (includingbank loans) for their own account and for the accounts of their customers, and such investment and securities activities may involvesecurities and/or instruments of us. The underwriters and their respective affiliates may also make investment recommendations and/orpublish or express independent research views in respect of these securities or instruments and may at any time hold, or recommend toclients that they acquire, long and/or short positions in these securities and instruments.

 

Conflictsof Interest

 

Weare not under any contractual obligation to engage any of the underwriters to provide any services for us after this offering and haveno present intent to do so. However, any of the underwriters may introduce us to potential target businesses or assist us in raisingadditional capital in the future. If any of the underwriters provide services to us after this offering, we may pay such underwriterfair and reasonable fees that would be determined at that time in an arm’s length negotiation; provided that no agreement willbe entered into with any of the underwriters and no fees for such services will be paid to any of the underwriters prior to the datethat is 90 days from the date of this prospectus, unless FINRA determines that such payment would not be deemed underwriter’s compensationin connection with this offering and we may pay the underwriters of this offering or any entity with which they are affiliated a finder’sfee or other compensation for services rendered to us in connection with the completion of a business combination.

 

ElectronicDistribution

 

Thisprospectus in electronic format may be made available on websites or through other online services maintained by one or more of the underwriters,or by their affiliates. Other than this prospectus in electronic format, the information on any underwriter’s website and any informationcontained in any other website maintained by an underwriter is not part of this prospectus or the registration statement of which thisprospectus forms a part, has not been approved and/or endorsed by us or any underwriter in its capacity as underwriter, and should notbe relied upon by investors.

 

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SellingRestrictions

 

Noaction has been taken in any jurisdiction (except in the United States) that would permit a public offering of our securities,or the possession, circulation or distribution of this prospectus or any other material relating to us or our securities in anyjurisdiction where action for that purpose is required. Accordingly, our securities may not be offered or sold, directly or indirectly,and this prospectus or any other offering material or advertisements in connection with our securities may be distributed or published,in or from any country or jurisdiction, except in compliance with any applicable rules and regulations of any such country or jurisdiction.

 

EuropeanEconomic Area and United Kingdom

 

Inrelation to each Member State of the European Economic Area and the United Kingdom (each a “Relevant State”), no securitieshave been offered or will be offered pursuant to the offering to the public in that Relevant State prior to the publication ofa prospectus in relation to the securities which have been approved by the competent authority in that Relevant State or,where appropriate, approved in another Relevant State and notified to the competent authority in that Relevant State, all in accordancewith the Prospectus Regulation, except that offers of shares may be made to the public in that Relevant State at any time under the followingexemptions under the Prospectus Regulation:

 

to legal entities which are qualified investors as defined under the Prospectus Regulation;
   
by the underwriters to fewer than 150 natural or legal persons (other than qualified investors as defined in the Prospectus Regulation), subject to obtaining the prior consent of the representatives of the underwriters for any such offer; or
   
in any other circumstances falling within Article 1(4) of the Prospectus Regulation,

 

providedthat no such offer of securities shall result in a requirement for us or any underwriter to publish a prospectus pursuant to Article3 of the Prospectus Regulation or supplement a prospectus pursuant to Article 23 of the Prospectus Regulation.

 

Forthe purposes of this provision, the expression an “offer of securities to the public” in relation to any securitiesin any Relevant State means the communication in any form and by any means of sufficient information on the terms of the offer andany securities to be offered so as to enable an investor to decide to purchase or subscribe for our securities, and theexpression “Prospectus Regulation” means Regulation (EU) 2017/1129.

 

UnitedKingdom

 

Thisprospectus has only been communicated or caused to have been communicated and will only be communicated or caused to be communicatedas an invitation or inducement to engage in investment activity (within the meaning of Section 21 of the Financial Services and MarketsAct of 2000, or the FSMA) as received in connection with the issue or sale of our securities in circumstances in which Section21(1) of the FSMA does not apply to us. All applicable provisions of the FSMA will be complied with in respect to anything done in relationto our securities in, from or otherwise involving the United Kingdom.

 

Canada

 

Thesecurities may be sold only to purchasers purchasing, or deemed to be purchasing, as principal that are accredited investors,as defined in National Instrument 45-106 Prospectus Exemptions or subsection 73.3(1) of the Securities Act (Ontario), and are permittedclients, as defined in National Instrument 31-103 Registration Requirements, Exemptions and Ongoing Registrant Obligations. Any resaleof the securities must be made in accordance with an exemption from, or in a transaction not subject to, the prospectus requirementsof applicable securities laws.

 

Securitieslegislation in certain provinces or territories of Canada may provide a purchaser with remedies for rescission or damages if this prospectus(including any amendment thereto) contains a misrepresentation, provided that the remedies for rescission or damages are exercised bythe purchaser within the time limit prescribed by the securities legislation of the purchaser’s province or territory. The purchasershould refer to any applicable provisions of the securities legislation of the purchaser’s province or territory for particularsof these rights or consult with a legal advisor.

 

Pursuantto section 3A.3 of National Instrument 33-105 Underwriting Conflicts, or NI 33-105, the underwriters are not required to comply withthe disclosure requirements of NI 33-105 regarding underwriter conflicts of interest in connection with this offering.

 

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HongKong

 

Thesecurities may not be offered or sold by means of this document or any other document other than (i) in circumstances that donot constitute an offer or invitation to the public within the meaning of the Companies Ordinance (Cap.32, Laws of Hong Kong) or theSecurities and Futures Ordinance (Cap.571, Laws of Hong Kong), or (ii) to “professional investors” within the meaning ofthe Securities and Futures Ordinance (Cap.571, Laws of Hong Kong) and any rules made thereunder, or (iii) in other circumstances thatdo not result in the document being a “prospectus” within the meaning of the Companies Ordinance (Cap.32, Laws of Hong Kong),and no advertisement, invitation or document relating to the shares may be issued or may be in the possession of any person for the purposeof issue (in each case whether in Hong Kong or elsewhere), that is directed at, or the contents of which are likely to be accessed orread by, the public in Hong Kong (except if permitted to do so under the laws of Hong Kong) other than with respect to the shares whichare or are intended to be disposed of only to persons outside Hong Kong or only to “professional investors” within the meaningof the Securities and Futures Ordinance (Cap.571, Laws of Hong Kong) and any rules made thereunder.

 

People’sRepublic of China

 

Thisprospectus has not been and will not be circulated or distributed in the PRC, and the securities may not be offered or sold, andwill not be offered or sold to any person for re-offering or resale, directly or indirectly, to any resident of the PRC except pursuantto applicable laws and regulations of the PRC.

 

Singapore

 

Thisprospectus has not been registered as a prospectus with the Monetary Authority of Singapore. Accordingly, this prospectus and any otherdocument or material in connection with the offer or sale, or invitation for subscription or purchase, of the securities may notbe circulated or distributed, nor may the securities be offered or sold, or be made the subject of an invitation for subscriptionor purchase, whether directly or indirectly, to persons in Singapore other than (i) to an institutional investor under Section 274 ofthe Securities and Futures Act, Chapter 289 of Singapore, or the SFA, (ii) to a relevant person, or any person pursuant to Section 275(1A),and in accordance with the conditions, specified in Section 275 of the SFA, or (iii) otherwise pursuant to, and in accordance with theconditions of, any other applicable provision of the SFA.

 

SouthKorea

 

Thesecurities may not be offered, sold and delivered directly or indirectly, or offered or sold to any person for re-offering orresale, directly or indirectly, in South Korea or to any resident of South Korea except pursuant to the applicable laws and regulationsof South Korea, including the Financial Investment Services and Capital Markets Act and the Foreign Exchange Transaction Law and thedecrees and regulations thereunder. The securities have not been registered with the Financial Services Commission of South Koreafor public offering in South Korea. Furthermore, the securities may not be re-sold to South Korean residents unless the purchaserof the securities complies with all applicable regulatory requirements (including but not limited to government approval requirementsunder the Foreign Exchange Transaction Law and its subordinate decrees and regulations) in connection with their purchase.

 

Taiwan

 

Thesecurities have not been and will not be registered or filed with, or approved by, the Financial Supervisory Commission of Taiwanpursuant to relevant securities laws and regulations and may not be offered or sold in Taiwan through a public offering or in circumstanceswhich constitute an offer within the meaning of the Securities and Exchange Act of Taiwan or relevant laws and regulations that requirea registration, filing or approval of the Financial Supervisory Commission of Taiwan. No person or entity in Taiwan has been authorizedto offer or sell the securities in Taiwan.

 

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CERTAINRELATIONSHIPS AND RELATED TRANSACTIONS

 

Otherthan compensation arrangements, we have not entered into any related party transaction with a member of the immediate family or the foregoingpersons of any director, executive officer, or holder of more than 5% of our capital stock during the last two completed fiscal years.Compensation arrangements, including employment agreements, for our directors and named executive officers are described elsewhere in“Executive Compensation—Agreements with Executive Officers.”

 

IndemnificationAgreements

 

Wehave entered or intend to enter into indemnification agreements with each of our directors and executive officers. These agreements,among other things, will require us to indemnify each individual to the fullest extent permitted by Delaware law, including indemnificationof expenses such as attorneys’ fees, judgments, fines and settlement amounts incurred by the individual in any action or proceeding,including any action or proceeding by or in right of us, arising out of the person’s services as a director, officer or other employee.

 

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DESCRIPTIONOF SECURITIES

 

Thefollowing description of our capital stock is a summary and is qualified in its entirety by the provisions of our Certificateof Incorporation, which has been filed as an exhibit to our registration statement of which this prospectus is a part.

 

CommonStock

 

Weare authorized to issue 1,000,000,000 shares of common stock, par value $0.0001, of which 37,238,656 shares are issued and outstandingas of June 22, 2022. Each holder of shares of our common stock is entitled to one vote for each share held of record on all matters submittedto the vote of stockholders, including the election of Directors. The holders of shares of common stock have no pre-emptive, conversion,subscription or cumulative voting rights. There is no provision in our Articles of Incorporation or By-laws that would delay, defer,or prevent a change in control of our Company.

 

Securities Offered in this Offering

 

Weare offering ______ Class A Units, each unit consisting of one share of our common stock and one Series A Warrant to purchase one shareof our common stock and Class B Units, each consisting of Series C preferred stock and one Series A Warrant. The share of common stockand accompanying Series A Warrants included in each Class A Unit will be issued separately and the share of Series B Preferred Stockand accompanying Series A Warrant will be issued separately. Class A Units and Class B Unitswill not be issued or certificated. We arealso registering the shares of common stock included in the Class A Units and the shares of common stock issuable from time to time uponexercise of the Series A Warrants included in the Class A Units and Class B Units and Series B preferred stock offered hereby. The descriptionof our common stock is set forth above under the heading “—Common Stock.”

 

SeriesB Preferred Stock Issued in this Offering

 

Ourboard of directors shall have designated _____ shares of our preferred stock as Series B convertible preferred stock (“Series Bpreferred stock”), none of which are currently issued and outstanding. The preferences and rights of the Series B preferred stockwill be as set forth in a Certificate of Designation (the “Series B Certificate of Designation”) filed as an exhibit to theregistration statement of which this prospectus is a part.

 

Pursuantto a transfer agency agreement between us and Equity Stock Transfer, as transfer agent, the Series B preferred stock will be issued inbook-entry form and shall initially be represented only by one or more global certificates deposited with The Depository Trust Company,or DTC, and registered in the name of Cede & Co., a nominee of DTC, or as otherwise directed by DTC.

 

Inthe event of a liquidation, the holders of Series B preferred stock are entitled to participate on an as-converted-to-Common Stock basiswith holders of the Common Stock in any distribution of assets of the Company to the holders of the Common Stock. The Series B Certificateof Designation provides, among other things, that we shall not pay any dividends on shares of Common Stock (other than dividends in theform of Common Stock) unless and until such time as we pay dividends on each Series B preferred share on an as-converted basis. Otherthan as set forth in the previous sentence, the Series B Certificate of Designation provides that no other dividends shall be paid onSeries B preferred stock.

 

Withcertain exceptions, as described in the Series B Certificate of Designation, the Series B preferred stock have no voting rights. However,as long as any shares of Series B preferred stock remain outstanding, the Series B Certificate of Designation provides that we shallnot, without the affirmative vote of holders of a majority of the then-outstanding Series B preferred stock, (a) alter or change adverselythe powers, preferences or rights given to the Series B preferred stock or alter or amend the Series B Certificate of Designation, (b)increase the number of authorized shares of Series B preferred stock or (c) amend our certificate of incorporation in any manner thatadversely affects the rights of holders of Series B preferred stock.

 

EachSeries B preferred share is convertible at any time at the holder’s option into a number of shares of common stock equal to $5,000divided by the Series B Conversion Price. The “Series B Conversion Price” is initially $ and is subject to adjustment forstock splits, stock dividends, distributions, subdivisions and combinations. Notwithstanding the foregoing, the Series B Certificateof Designation further provides that we shall not effect any conversion of Series B preferred stock, with certain exceptions, to theextent that, after giving effect to an attempted conversion, the holder of Series B preferred stock (together with such holder’saffiliates, and any persons acting as a group together with such holder or any of such holder’s affiliates) would beneficiallyown a number of shares of Common Stock in excess of 4.99% (or, at the election of the holder, 9.99%) of the shares of our Common Stockthen outstanding after giving effect to such exercise (the “preferred stock Beneficial Ownership Limitation”); provided,however, that upon notice to the Company, the holder may increase or decrease the preferred stock Beneficial Ownership Limitation, providedthat in no event shall the preferred stock Beneficial Ownership Limitation exceed 9.99% and any increase in the preferred stock BeneficialOwnership Limitation will not be effective until 61 days following notice of such increase from the holder to us.

 

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Wedo not intend to apply for listing of the Series B preferred stock on any securities exchange or other trading system.

 

The following summary of certain terms andprovisions of the Series A Warrants offered hereby is not complete and is subject to, and qualified in its entirety by theprovisions of the form of Series A Warrant, which is filed as an exhibit to the registration statement of which this prospectus is apart. Prospective investors should carefully review the terms and provisions set forth in the form of Series A Warrant. We do nothave a price as of yet so we cannot disclose the amounts of warrants outstanding following the offering, and none were availablepre-offering. The exercise price is 110% of the offering price per Class A Unit for the Series A Warrants.

 

Exercisability. The Series A Warrants are exercisableat any time after their original issuance and at any time up to the date that is five years after their original issuance. The Series A Warrants will be exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed exercisenotice and, at any time a registration statement registering the issuance of the shares of common stock underlying the Series A Warrants underthe Securities Act is effective and available for the issuance of such shares, or an exemption from registration under the SecuritiesAct is available for the issuance of such shares, by payment in full in immediately available funds for the number of shares of commonstock purchased upon such exercise. If a registration statement registering the issuance of the shares of common stock underlying theSeries A Warrants under the Securities Act is not effective or available and an exemption from registration under the Securities Act is not availablefor the issuance of such shares, the holder may, in its sole discretion, elect to exercise the warrant through a cashless exercise, inwhich case the holder would receive upon such exercise the net number of shares of common stock determined according to the formula setforth in the Series A Warrant. No fractional shares of common stock will be issued in connection with the exercise of a Series A Warrant. In lieu of fractionalshares, we will pay the holder an amount in cash equal to the fractional amount multiplied by the exercise price.

 

Exercise Limitation. A holder will not have theright to exercise any portion of the Series A Warrant if the holder (together with its affiliates) would beneficially own in excess of 9.99% ofthe number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage ownership isdetermined in accordance with the terms of the Series A Warrants.

 

Exercise Price. The exercise priceper whole share of common stock purchasable upon exercise of the Series A Warrants is $___ per share or 110% of the public offering price of theClass A Units. The exercise price is subject to appropriate adjustment in the event of certain stock dividends and distributions,stock splits, stock combinations, reclassifications or similar events affecting our common stock and also upon any distributions of assets,including cash, stock or other property to our stockholders.

 

Transferability. Subject to applicablelaws, the Series A Warrants may be offered for sale, sold, transferred or assigned without our consent.

 

Exchange Listing. There is no established trading market for the Series A Warrants and we do not expect a market to develop. In addition,we do not intend to apply for the listing of the Series A Warrants on any national securities exchange or other trading market. Withoutan active trading market, the liquidity of the Series A Warrants will be limited.

 

Warrant Agent. The Series A Warrants will be issued inregistered form under a warrant agency agreement between VStock Transfer, LLC, as warrant agent, and us. The Series A Warrants shall initiallybe represented only by one or more global warrants deposited with the warrant agent, as custodian on behalf of The Depository Trust Company(DTC) and registered in the name of Cede & Co., a nominee of DTC, or as otherwise directed by DTC.

 

Fundamental Transactions. In the eventof a fundamental transaction, as described in the Series A Warrants and generally including any reorganization, recapitalization or reclassificationof our common stock, the sale, transfer or other disposition of all or substantially all of our properties or assets, our consolidationor merger with or into another person, the acquisition of more than 50% of our outstanding common stock, or any person or group becomingthe beneficial owner of 50% of the voting power represented by our outstanding common stock, the holders of the warrants will be entitledto receive upon exercise of the Series A Warrants the kind and amount of securities, cash or other property that the holders would have receivedhad they exercised the warrants immediately prior to such fundamental transaction.

 

Rights as a Stockholder. Except asotherwise provided in the warrants or by virtue of such holder’s ownership of shares of our common stock, the holder of a Series A Warrantdoes not have the rights or privileges of a holder of our common stock, including any voting rights, until the holder exercises the Series A Warrant.

 

Governing Law. The Series A Warrants and the warrant agencyagreement are governed by New York law.

 

Warrantsand Options

 

During2020, in conjunction with the sale and issuance of Original Issue Discount Senior Convertible Debentures (“Notes”), the Companyissued warrants to purchase an aggregate of 1,621,730 shares of the Company’s common stock with an exercise price of $0.59 andvest over a period of five years. On February 19, 2021, a noteholder exercised 70,510 warrants pursuant to the cashless exercise provisionof the warrant agreement into 57,147 common shares. In addition, the Company issued warrants to purchase an aggregate of 4,113,083 sharesof the Company’s common stock with an exercise price of $0.14 and vest over a period of five years.

 

InFebruary and April 2021, in conjunction with the sale and issuance of Notes, the Company issued warrants to purchase an aggregate of386,255 shares of the Company’s common stock with an exercise price of $1.20 and vest over a period of five years.

 

OnMay 10, 2021, the Company closed a private placement to accredited investors that resulted in the issuance of 1,172,000 warrants to purchasean aggregate of 1,172,000 shares of the Company’s common stock with an exercise price of $1.75 and vest over a period of five years.

 

OnOctober 20, 2021, the Company entered into a securities purchase agreement with an accredited investor that resulted in the issuanceof 320,000 shares of common stock and warrants to purchase an aggregate of 320,000 shares of the Company’s common stock for totalproceeds totaling $400,000. For each share purchased, the investor received a five-year warrant to purchase one share of common stockat $1.25 per share.

 

OnOctober 22, 2021, in exchange for the extension of Notes, the Company issued a noteholder five-year warrants to purchase an aggregateof 450,000 shares of the Company’s common stock at an exercise price of $1.00 per share

 

SecurityHolders

 

Asof May 5, 2022, there were 37,238,656   common shares issued and outstanding, which were held by approximately 72 stockholdersof record. We do not know the number of our beneficial shareholders or shareholders holding shares through their broker(s) in “streetname.”

 

Non-cumulativeVoting

 

Holdersof shares of our common stock do not have cumulative voting rights, which means that the holders of more than 50% of the outstandingshares, voting for the election of directors, can elect all of the directors to be elected, if they so choose, and, in such event, theholders of the remaining shares will not be able to elect any of our directors.

 

TransferAgent

 

Wehave engaged VStock Transfer, LLC as the Company’s transfer agent to serve as agent for shares of our common stock. Our transferagent’s contact information is as follows:

 

VStockTransfer, LLC

18Lafayette Place

Woodmere,NY 11598

Phone:(212) 828-8436

 

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SHARESELIGIBLE FOR FUTURE SALE

 

Priorto this offering, there was no public market for our common stock. We cannot predict the effect, if any, that market sales of sharesof our common stock or the availability of shares of our common stock for sale will have on the market price of our common stock. Salesof substantial amounts of our common stock in the public market could adversely affect the market prices of our common stock and couldimpair our future ability to raise capital through the sale of our equity securities.

 

Wehave an aggregate of 37,295,803 shares of our common stock outstanding as of December 31, 2021 (prior to the Offering). All of the xx,000shares to be registered in this Offering will be freely tradable without restriction or further registration under the Securities Act,unless those shares are purchased by our affiliates, as that term is defined in Rule 144 under the Securities Act.

 

Rule144

 

Rule144 allows for the public resale of restricted and control securities if a number of conditions are met. Meeting the conditions includesholding the shares for a certain period of time, having adequate current information, looking into a trading volume formula, and filinga notice of the proposed sale with the SEC.

 

Ingeneral, a person who has beneficially owned restricted shares of our common stock for at least six months would be entitled to selltheir securities provided that (I) such person is not deemed to have been one of our affiliates at the time of, or at any time duringthe 90 days preceding, a sale, (ii) we are subject to the Exchange Act periodic reporting requirements and have filed all required reportsfor a least 90 days before the sale, and (iii) we are not and have never been a shell company (a company having no or nominal operationsand either (1) no or nominal assets, (2) assets consisting solely of cash and cash equivalents, or (3) assets consisting of any amountof cash and cash equivalents and nominal other assets). If we ever become a shell company, Rule 144 would be unavailable until one yearfollowing the date we cease to be a shell company and file Form 10 information with the SEC ceasing to be a shell company, provided thatwe are then subject to the reporting requirements of section 13 or 15(d) of the Exchange Act and have filed all reports and other materialsrequired to be filed by section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period that we wererequired to file such reports and materials), other than Form 8-K reports.

 

Personswho have beneficially owned restricted shares of our common stock for at least six months but who are our affiliates at the time of,or any time during the 90 days preceding, a sale, would be subject to additional restrictions, by which such person would be entitledto sell within any three-month period only a number of securities that does not exceed the greater of either of the following:

 

  1% of the number of shares of our common stock then outstanding, which would equal approximately 388,000 shares, based on the number of shares of our common stock outstanding as of December 31, 2021 (37,295,803), and assuming the 1,500,000 shares being registered in the Offering are issued and sold; or
  The average weekly trading volume of our common stock during the four calendar weeks preceding the filing of a notice on Form 144 with respect to the sale.

 

Atthe expiration of the one-year holding period, a person who was not one of our affiliates at any time during the three months precedinga sale would be entitled to sell an unlimited number of shares of our common stock without restriction. A person who was one of our affiliatesat any time during the three months preceding a sale would remain subject to the volume restrictions described above.

 

Salesunder the Rule 144 by our affiliates or persons selling shares on behalf of our affiliates are also subject to certain manner of saleprovisions and notice requirements and to the availability of current public information about us.

 

LEGALMATTERS

 

Thevalidity of the securities offered by this prospectus will be passed upon by Jolie Kahn, Esq., New York, New York. Blank Rome LLP, NewYork, New York is acting as counsel for the underwriters in this offering.

 

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EXPERTS

 

Exceptas disclosed herein, no expert or counsel named in this prospectus as having prepared or certified any part of this prospectus or havinggiven an opinion upon the validity of the securities being registered or upon other legal matters in connection with the registrationor offering of the common stock was employed on a contingency basis or had, or is to receive, in connection with the offering, a substantialinterest, directly or indirectly, in the registrant or its subsidiary. Nor was any such person connected with the Company or any of itsparents, or subsidiaries, as a promoter, managing or principal underwriter, voting trustee, director, officer or employee.

 

Thefinancial statements of Sigyn Therapeutics, Inc. as of December 31, 2021 and 2020, have been included herein in reliance on the reportsof Paris Kreit & Chiu, an independent registered public accounting firm, given on the authority of that firm as experts in auditingand accounting.

 

CHANGESIN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

 

Duringthe two most recent fiscal years ended December 31, 2021 and 2020, there have been no changes in or disagreements with our independentregistered public accounting firm on any matter of accounting principles or practices, financial statement disclosure, or auditing scopeor procedure, which disagreements if not resolved to the satisfaction of the Former Accounting Firm would have caused them to make referencethereto in their report on the financial statements.

 

WHEREYOU CAN FIND MORE INFORMATION

 

Wehave filed a registration statement on Form S-1 under the Securities Act with the SEC for the securities offered hereby. This prospectus,which constitutes a part of the registration statement, does not contain all of the information set forth in the registration statementor the exhibits and schedules which are part of the registration statement. For additional information about our securities, and us werefer you to the registration statement and the accompanying exhibits and schedules. Statements contained in this prospectus regardingthe contents of any contract or any other documents to which we refer are not necessarily complete. In each instance, reference is madeto the copy of the contract or document filed as an exhibit to the registration statement, and each statement is qualified in all respectsby that reference. Our filings, including the registration statement, will also be available to you on the Internet web site maintainedby the SEC at http://www.sec.gov.

 

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SIGYNTHERAPEUTICS, INC.

 

Indexto Financial Statements

 

CONTENTS

 

  Page
Report of Independent Registered Public Accounting Firm (PCAOB ID NO. 6651) F-2
Consolidated Balance Sheets F-3
Consolidated Statements of Operations F-4
Consolidated Statements of Changes in Shareholders’ Equity F-5
Consolidated Statements of Cash Flows F-6
Notes to Consolidated Financial Statements F-7

 

F-1

 

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

Tothe Board of Directors and

Stockholdersof Sigyn Therapeutics, Inc.

 

Opinionon the Financial Statements

 

Wehave audited the accompanying consolidated balance sheets of Sigyn Therapeutics, Inc. (the Company) as of December 31, 2021 and 2020,and the related consolidated statements of operations, changes in shareholders’ equity, and cash flows for each of the two yearsended December 31, 2021, and the related notes (collectively referred to as the financial statements). In our opinion, the financialstatements present fairly, in all material respects, the financial position of the Company as of December 31, 2021 and 2020, and theresults of its operations and its cash flows for each of the two years in the period ended December 31, 2021, in conformity with accountingprinciples generally accepted in the United States of America.

 

TheCompany’s Ability to Continue as a Going Concern

 

Theaccompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussedin Note 2 to the financial statements, the Company has suffered recurring losses from operations, has a net capital deficiency, and negativecash flows from operating activities, therefore, the Company has stated that substantial doubt exists about its ability to continue asa going concern. Management’s plans in regard to these matters are also described in Note 2. The financial statements do not includeany adjustments that might result from the outcome of this uncertainty.

 

Basisfor Opinion

 

Thesefinancial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financialstatements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (UnitedStates) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securitieslaws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

 

Weconducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtainreasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Companyis not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our auditswe are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinionon the effectiveness of the entity’s internal control over financial reporting. Accordingly, we express no such opinion.

 

Ouraudits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to erroror fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regardingthe amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significantestimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our auditsprovide a reasonable basis for our opinion.

 

CriticalAudit Matters

 

Thecritical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicatedor required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financialstatements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit mattersdoes not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical auditmatters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.

 

GoingConcern

 

Asdescribed further in Note 2 to the consolidated financial statements, the Company has incurred losses each year from inception throughDecember 31, 2021 and expects to incur additional losses in the future.

 

Wedetermined the Company’s ability to continue as a going concern is a critical audit matter due to the estimation and uncertaintyregarding the Company’s future cash flows and the risk of bias in management’s judgments and assumptions in estimating thesecash flows.

 

Ouraudit procedures related to the Company’s assertion on its ability to continue as a going concern included the following, amongothers:

 

Wereviewed the Company’s working capital and liquidity ratios and forecasted revenue, operating expenses, and uses and sources ofcash used in management’s assessment of whether the Company has sufficient liquidity to fund operations for at least one year fromthe financial statement issuance date. This testing included inquiries with management, comparison of prior period forecasts to actualresults, consideration of positive and negative evidence impacting management’s forecasts, the Company’s financing arrangementsin place as of the report date, market and industry factors and consideration of the Company’s relationships with its financingpartners.

 

InventoryValuation

 

Asdescribed in Note 3 to the consolidated financial statements, based on the significant advancement of Sigyn Therapy, the Company decidedin the 4th quarter of 2021 to assess the value of retail business operations that were a focus of the Company prior to the merger transactionconsummated on October 19, 2020. Related to this assessment, management determined the wholesale liquidation value of its sapphire geminventory to be 5-10% of the previously reported retail value, based on communications with certified gemologists, the variance betweenretail and wholesale valuations, and current market conditions. As a result, the Company has valued the inventory at $50,000 and recordedan impairment of assets of $536,047 in the year ended December 31, 2021 and is classified in other expenses in the Consolidated Statementsof Operations.

 

Weevaluated and tested the certified gemologists inventory valuation report and subsequent company communications with this expert.

 

ParisKreit & Chiu CPA LLP

(formerlyknown as Benjamin & Ko)

 

Wehave served as the Company’s auditor since 2021.

 

NewYork, New York

 

March21, 2022

 

F-2

 

 

SIGYNTHERAPEUTICS, INC.

CONSOLIDATEDBALANCE SHEETS

 

         
   December 31, 
   2021   2020 
         
ASSETS          
Current assets:          
Cash  $340,956   $84,402 
Accounts receivable   -    - 
Inventories   50,000    586,047 
Notes receivable   -    - 
Other current assets   2,075    - 
Total current assets   393,031    670,449 
           
Property and equipment, net   28,046    1,728 
Intangible assets, net   5,700    21,905 
Operating lease right-of-use assets, net   262,771    - 
Other assets   20,711    - 
Total assets  $710,259   $694,082 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable  $39,674   $16,005 
Accrued payroll and payroll taxes   1,072    59,707 
Short-term convertible notes payable, less unamortized debt issuance costs of $53,614 and $97,832, respectively   647,202    518,668 
Current portion of operating lease liabilities   46,091    - 
Other current liabilities   179    523 
Total current liabilities   734,218    594,903 
Long-term liabilities:          
Operating lease liabilities, net of current portion   240,625    - 
Total long-term liabilities   240,625    - 
Total liabilities   974,843    594,903 
           
Stockholders’ equity (deficit)          
Common stock, $0.0001 par value, 1,000,000,000 shares authorized; 37,295,803 and 35,201,513 shares issued and outstanding at December 31, 2021 and 2020, respectively   3,730    3,520 
Additional paid-in capital   3,997,445    1,356,799 
Accumulated deficit   (4,265,759)   (1,261,140)
Total stockholders’ equity (deficit)   (264,584)   99,179 
Total liabilities and stockholders’ equity (deficit)  $710,259   $694,082 

 

Seeaccompanying notes to consolidated financial statements

 

F-3

 

 

SIGYNTHERAPEUTICS, INC.

CONSOLIDATEDSTATEMENTS OF OPERATIONS

 

         
   Years Ended December 31, 
   2021   2020 
         
Net revenues  $-   $- 
           
Gross Profit   -    - 
           
Operating expenses:          
Marketing expenses   -    705 
Research and development   734,014    419,362 
General and administrative   1,274,203    496,367 
Total operating expenses   2,008,217    916,434 
Loss from operations   (2,008,217)   (916,434)
           
Other expense:          
Impairment of assets   536,047    - 
Interest expense   30,867    - 
Interest expense - debt discount   368,205    - 
Interest expense - original issuance costs   61,283    343,156 
Total other expense   996,402    343,156 
           
Loss before income taxes   (3,004,619)   (1,259,590)
Income taxes   -    - 
           
Net loss  $(3,004,619)  $(1,259,590)
           
Net loss per share, basic and diluted  $(0.08)  $(0.17)
           
Weighted average number of shares outstanding          
Basic and diluted   36,396,585    7,351,272 

 

Seeaccompanying notes to consolidated financial statements

 

F-4

 

 

SIGYNTHERAPEUTICS, INC.

CONSOLIDATEDSTATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

 

   Shares   Amount   in Capital   Deficit   (Deficit) 
   Common Stock  

Additional

Paid-in

   Accumulated  

Total Stockholders’

Equity

 
   Shares   Amount   Capital   Deficit   (Deficit) 
Balance as of January 1, 2020   500,000   $50   $590   $(1,550)  $(910)
Common stock issued in conjunction with reverse merger   33,686,169    3,368    606,813    -    610,181 
Warrants issued to third parties in conjunction with debt issuance   -    -    223,560    -    223,560 
Beneficial conversion feature in conjunction with debt issuance   -    -    129,938    -    129,938 
Common stock issued to third parties in conjunction with exchange of debt   1,015,344    102    395,898    -    396,000 
Net loss   -    -    -    (1,259,590)   (1,259,590)
Balance as of December 31, 2020   35,201,513   $3,520   $1,356,799   $(1,261,140)  $99,179 
                          
Common stock issued to third party for services   188,000    19    249,081    -    249,100 
Warrants issued to third parties in conjunction with debt issuance   -    -    188,069    -    188,069 
Beneficial conversion feature in conjunction with debt issuance   -    -    101,972    -    101,972 
Common stock and warrants issued for cash   1,492,000    149    1,864,851    -    1,865,000 
Common stock issued in conjunction with cashless exercise of warrants   57,147    6    (6)   -    - 
Common stock issued to third parties in conjunction with conversion of debt   357,143    36    236,679    -    236,715 
Net loss   -    -    -    (3,004,619)   (3,004,619)
Balance as of December 31, 2021   37,295,803   $3,730   $3,997,445   $(4,265,759)  $(264,584)

 

Seeaccompanying notes to consolidated financial statements

 

F-5

 

 

SIGYNTHERAPEUTICS, INC.

CONSOLIDATEDSTATEMENTS OF CASH FLOWS

 

   2021   2020 
   For the Years Ended December 31, 
   2021   2020 
         
Cash flows from operating activities:          
Net loss  $(3,004,619)  $(1,259,590)
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation expense   2,946    346 
Amortization expense   16,205    10,954 
Stock issued for services   249,100    - 
Accretion of debt discount   368,205    275,333 
Accretion of original issuance costs   61,283    67,823 
Interest expense converted to notes payable   30,800    - 
Impairment of assets   536,047    - 
Changes in operating assets and liabilities:          
Other current assets   (2,075)   - 
Other assets   (20,711)   - 
Accounts payable   23,669    15,095 
Accrued payroll and payroll taxes   (58,635)   59,707 
Other current liabilities   23,603    523 
Net cash used in operating activities   (1,774,182)   (829,809)
           
Cash flows from investing activities:          
Purchase of property and equipment   (29,264)   - 
Website development costs   -    (10,799)
Net cash used in investing activities   (29,264)   (10,799)
           
Cash flows from financing activities:          
Proceeds from short-term convertible notes   250,000    925,010 
Repayment of short-term convertible notes   (55,000)   - 
Common stock and warrants issued for cash   1,865,000    - 
Net cash provided by financing activities   2,060,000    925,010 
           
Net increase in cash        84,402 
           
Cash at beginning of period   84,402    - 
Cash at end of period  $340,956   $84,402 
           
Supplemental disclosures of cash flow information:          
Cash paid during the period for:          
Interest  $-   $- 
Income taxes  $-   $- 
           
Non-cash investing and financing activities:          
Beneficial conversion feature in conjunction with debt issuance  $101,972   $129,938 
Warrants issued to third parties in conjunction with debt issuance  $188,069   $223,560 
Original issue discount issued in conjunction with debt  $126,030   $85,495 
Common stock issued to third parties in conjunction with conversion of debt  $236,715   $396,000 
Issuance of common stock in conjunction with cashless exercise of warrants  $6   $- 

 

Seeaccompanying notes to consolidated financial statements

 

F-6

 

 

SIGYNTHERAPEUTICS, INC.

NOTESTO THE CONSOLIDATED FINANCIAL STATEMENTS

FORTHE YEARS ENDED DECEMBER 31, 2021 AND 2020

 

NOTE1 – ORGANIZATION AND PRINCIPAL ACTIVITIES

 

CorporateHistory and Background

 

SigynTherapeutics, Inc. (“Sigyn” or the “Company”) is a development-stage therapeutic technology company headquarteredin San Diego, California USA. Our business focus is the clinical advancement of Sigyn Therapy, a multi-function blood purification technologydesigned to overcome the limitations of previous drugs and devices to treat life-threatening inflammatory disorders, including sepsis,the leading cause of hospital deaths worldwide.

 

Weare advancing Sigyn Therapy to treat pathogen-associated conditions that precipitate sepsis and other high-mortality disorders that arenot addressed with approved drug therapies. To address these unmet therapeutic needs, we designed SigynTherapy to extract pathogen sources of life-threating inflammation from the bloodstream in concert with the depletion of pro-inflammatorycytokines, whose dysregulated production (the cytokine storm) plays a prominent role in each of our therapeutic indication opportunities.

 

Inaddition to sepsis, our candidate treatment indications include, but are not limited to; emerging pandemic threats, drug resistant pathogens,hepatic encephalopathy, bridge to liver transplant, and community-acquired pneumonia (“CAP”), which is a leading cause ofdeath among infectious diseases, the leading cause of death in children under five years of age, and a catalyst for approximately 50%of sepsis and septic shock cases.

 

PublicMerger Agreement

 

OnOctober 19, 2020, Sigyn Therapeutics, Inc, a Delaware corporation (the “Registrant”) formerly known as Reign Resources Corporation,completed a Share Exchange Agreement (the “Agreement”) with Sigyn Therapeutics, Inc., a private entity incorporated in theState of Delaware on October 19, 2019.

 

Inthe Share Exchange Agreement, we acquired 100%of the issued and outstanding shares of privately held Sigyn Therapeutics Inc., common stock in exchange for 75%of the fully paid and nonassessable shares of our common stock outstanding (the “Acquisition”). In conjunction with thetransaction, we changed our name from Reign Resources Corporation to Sigyn Therapeutics, Inc. pursuant to an amendment to ourarticles of incorporation that was filed with the State of Delaware. Subsequently, our trading symbol was changed to SIGY. TheAcquisition was treated as a “tax-free exchange” under Section 368 of the Internal Revenue Code of 1986 and resulted inthe private Sigyn Therapeutics corporate entity becoming a wholly owned subsidiary known as Sigyn Medical Corporation. Uponthe closing of the Acquisition, we appointed James A. Joyce and Craig P. Roberts to serve as members of our Board ofDirectors.

 

Asof March 14, 2022, we have a total 37,295,803 shares issued and outstanding, of which 11,655,803 shares are held by non-affiliate shareholders.

 

AboutSigyn Therapy

 

Ourbusiness focus is the clinical advancement of Sigyn Therapy, a multi-function blood purification technology designed to overcome thelimitations of previous drugs and devices to treat life-threatening inflammatory disorders, including sepsis, the leading cause of hospitaldeaths worldwide.

 

Weare advancing Sigyn Therapy to treat pathogen-associated conditions that precipitate sepsis and other high-mortality disorders that arenot addressed with approved drug therapies. To address these unmet therapeutic needs, we designed SigynTherapy to extract pathogen sources of life-threating inflammation from the bloodstream in concert with the depletion of pro-inflammatorycytokines, whose dysregulated production (the cytokine storm) plays a prominent role in each of our therapeutic indication opportunities.

 

Inaddition to sepsis, our candidate treatment indications include, but are not limited to; emerging pandemic threats, drug resistant pathogens,hepatic encephalopathy, bridge to liver transplant, and CAP, which is a leading cause of death among infectious diseases, the leadingcause of death in children under five years of age, and a catalyst for approximately 50% of sepsis and septic shock cases.

 

F-7

 

 

PostPublic Merger Developments

 

Sincethe consummation of our public merger on October 19, 2020, we have advanced Sigyn Therapy from conceptual design to clinical application.We initiated and completed six (6) in vitro blood plasma studies that have validated the ability of Sigyn Therapy to address abroad-spectrum of relevant therapeutic targets, including endotoxin (gram-negative bacterial toxin);peptidoglycan and lipoteichoic acid (gram-positive bacterial toxins); viral pathogens (including SARS-CoV-2); hepatic toxins (ammonia,bile acid, and bilirubin); CytoVesicles (extracellular vesicles that transport inflammatory cytokine cargos); and tumor necrosis factoralpha (TNF alpha), interleukin-1 beta (IL-1b), and interleukin 6 (IL-6), which are pro-inflammatorycytokines whose dysregulated production (the cytokine storm) precipitate sepsis and play a prominent role in each of our therapeuticopportunities.

 

Subsequentto these milestone achievements, we announced the completion of in vivo animal studies on February 23, 2022, that demonstratedSigyn Therapy to be safe and well tolerated.

 

Inthe studies, Sigyn Therapy was administered via standard dialysis machines utilizing conventional blood-tubing sets, for periods of upto six hours in eight (8) porcine (pig) subjects, each weighing approximately 40-45 kilograms. The studies were comprised of a pilotphase (two subjects), which evaluated the feasibility of the study protocol in the first-in-mammal use of Sigyn Therapy; and an expansionphase (six subjects) to further assess treatment safety and refine pre-treatment set-up and operating procedures. Sigyn Therapy was welltolerated by all eight animal subjects and no serious adverse events were reported in any treated animal subject. Important criteriafor treatment safety – including hemodynamic parameters, serum chemistries and hematologic measurements – were stable acrossall subjects.

 

Thestudies were conducted by a clinical team at Innovative BioTherapies, Inc. (“IBT”), under a contract with the Universityof Michigan to utilize animal care, associated institutional review oversight, as well as surgical suite facilities located within theNorth Campus Research Complex. IBT is uniquely experienced in providing development services that support the clinical advancement ofextracorporeal devices. The treatment protocol of the study was reviewed and approved by the University of Michigan Institutional AnimalCare and Use Committee (IACUC).

 

Weplan to incorporate the data resulting from our in vivo and invitro studies into an Investigational Device Exemption (IDE) thatwe are drafting for submission to the FDA to support the potential initiation of human clinical studies.

 

NOTE2 – BASIS OF PRESENTATION

 

Theaccompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United Statesof America and include all adjustments necessary for the fair presentation of the Company’s financial position and results of operationsfor the periods presented.

 

TheCompany currently operates in one business segment. The Company is not organized by market and is managed and operated as one business.A single management team reports to the chief operating decision maker, the Chief Executive Officer, who comprehensively manages theentire business. The Company does not currently operate any separate lines of businesses or separate business entities.

 

GoingConcern

 

Theaccompanying financial statements have been prepared assuming the Company will continue as a going concern, which contemplates, amongother things, the realization of assets and satisfaction of liabilities in the normal course of business. The Company had an accumulateddeficit of $4,265,759at December 31, 2021, had a working capitaldeficit of approximately $341,000 atDecember 31, 2021, had net losses of $3,004,619and $1,259,590for the years ended December 31, 2021 and2020, respectively, and net cash used in operating activities of $1,774,182and $829,809for the years ended December 31, 2021 and2020, respectively, with no revenue earned since inception, and a lack of operational history. These matters raise substantial doubtabout the Company’s ability to continue as a going concern.

 

F-8

 

 

Whilethe Company is attempting to expand its research and development activities, the Company’s cash position may not be significantenough to support the Company’s daily operations. Management intends to raise additional funds by way of a private offering oran asset sale transaction. Management believes that the actions presently being taken to further implement its business plan and generaterevenues provide the opportunity for the Company to continue as a going concern. While management believes in the viability of its strategyto generate revenues and in its ability to raise additional funds or transact an asset sale, there can be no assurances to that effector on terms acceptable to the Company. The ability of the Company to continue as a going concern is dependent upon the Company’sability to further implement its business plan and generate revenues.

 

Thefinancial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

 

NOTE3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Thissummary of significant accounting policies of the Company is presented to assist in understanding the Company’s financial statements.The financial statements and notes are representations of the Company’s management, which is responsible for their integrity andobjectivity. These accounting policies conform to GAAP and have been consistently applied in the preparation of the financial statements.

 

Useof Estimates

 

Thepreparation of these consolidated financial statements in accordance with accounting principles generally accepted in the United Statesof America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosuresof contingent assets and liabilities at the dates of the consolidated financial statements and the reported amounts of net sales andexpenses during the reported periods. Actual results may differ from those estimates and such differences may be material to the consolidatedfinancial statements. The more significant estimates and assumptions by management include among others: realizability of inventory,common stock valuation, and the recoverability of intangibles. The current economic environment has increased the degree of uncertaintyinherent in these estimates and assumptions.

 

Cash

 

TheCompany’s cash is held in bank accounts in the United States and is insured by the Federal Deposit Insurance Corporation (“FDIC”)up to $250,000. The Company has not experienced any cash losses.

 

IncomeTaxes

 

Incometaxes are accounted for under an asset and liability approach. This process involves calculating the temporary and permanent differencesbetween the carrying amounts of the assets and liabilities for financial reporting purposes and the amounts used for income tax purposes.The temporary differences result in deferred tax assets and liabilities, which would be recorded on the Balance Sheets in accordancewith Accounting Standards Codification (“ASC”) ASC 740, Income Taxes, which established financial accounting and reportingstandards for the effect of income taxes. The likelihood that its deferred tax assets will be recovered from future taxable income mustbe assessed and, to the extent that recovery is not likely, a valuation allowance is established. Changes in the valuation allowancein a period are recorded through the income tax provision in the consolidated Statements of Operations.

 

ASC740-10 clarifies the accounting for uncertainty in income taxes recognized in an entity’s consolidated financial statements andprescribes a recognition threshold and measurement attributes for financial statement disclosure of tax positions taken or expected tobe taken on a tax return. Under ASC 740-10, the impact of an uncertain income tax position on the income tax return must be recognizedat the largest amount that is more-likely-than-not to be sustained upon audit by the relevant taxing authority. An uncertain income taxposition will not be recognized if it has less than a 50% likelihood of being sustained. Additionally, ASC 740-10 provides guidance onderecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. The Company does nothave a liability for unrecognized income tax benefits.

 

F-9

 

 

Advertisingand Marketing Costs

 

Advertisingexpenses are recorded as general and administrative expenses when they are incurred. The Company had no advertising expenses for yearended December 31, 2021 and had $705 for the year ended December 31, 2020.

 

Researchand Development

 

Allresearch and development costs are expensed as incurred. The Company incurred research and development expense of $734,014 and $419,362for the years ended December 31, 2021 and 2020, respectively.

 

Inventories

 

Inconjunction with the October 19, 2020 Share Exchange Agreement, the Company kept the gem inventory of Reign Resources Corporation. Inventoriesare stated at the lower of cost or market (net realizable value) on a lot basis each quarter. A lot is determined by the cut, clarity,size, and weight of the sapphires. Inventory consists of sapphire jewels that meet rigorous grading criteria and are of cuts and sizesmost commonly used in the jewelry industry. As of December 31, 2021 and 2020, the Company carried primarily loose sapphire jewels, jewelryfor sale on our website, and jewelry held as samples. Samples are used to show potential customers what the jewelry would look like.Promotional items given to customers that are not expected to be returned will be removed from inventory and expensed. There have beenno promotional items given to customers as of December 31, 2021. The Company performs its own in-house assessment based on gem guideand the current market price for metals to value its inventory on an annual basis or if circumstances dictate sooner to determine ifthe estimated fair value is greater or less than cost. In addition, the inventory is reviewed each quarter by the Company against industryprices from gem-guide and if there is a potential impairment, the Company would appraise the inventory. The estimated fair value is subjectto significant change due to changes in popularity of cut, perceived grade of the clarity of the sapphires, the number, type and sizeof inclusions, the availability of other similar quality and size sapphires, and other factors. As a result, the internal assessed valueof the sapphires could be significantly lower from the current estimated fair value. Loose sapphire jewels do not degrade in qualityover time.

 

Basedon the significant advancement of Sigyn Therapy, the Company decided in the 4th quarter of 2021 to assess the value of retailbusiness operations that were a focus of the Company prior to the merger transaction consummated on October 19, 2020.

 

Relatedto this assessment, management determined the wholesale liquidation value of its sapphire gem inventory to be 5-10% of the previouslyreported retail value, based on communications with certified gemologists, the variance between retail and wholesale valuations, andcurrent market conditions. As a result, the Company has valued the inventory at $50,000 and recorded an impairment of assets of $536,047in the year ended December 31, 2021 and is classified in other expenses in the consolidated Statements of Operations.

 

Propertyand Equipment

 

Propertyand equipment are carried at cost and are depreciated on a straight-line basis over the estimated useful lives of the assets, generallyfive years.The cost of repairs and maintenance is expensed as incurred; major replacements and improvements are capitalized. When assets are retiredor disposed of, the cost and accumulated depreciation are removed from the accounts, and any resulting gains or losses are included inincome in the year of disposition.

 

IntangibleAssets

 

Intangibleassets consist primarily of website development costs. Our intangible assets are being amortized on a straight-line basis over a periodof three years.

 

Assignmentof Patent

 

OnJanuary 8, 2020, James Joyce, the Company’s CEO and Craig Roberts, the Company’s CTO, assigned to the Company the rightsto patent 62/881,740 pertaining to the devices, systems and methods for the broad-spectrum reduction of pro-inflammatory cytokines inblood in exchange for founder’s shares.

 

F-10

 

 

Impairmentof Long-lived Assets

 

Weperiodically evaluate whether the carrying value of property, equipment and intangible assets has been impaired when circumstances indicatethe carrying value of those assets may not be recoverable. The carrying amount is not recoverable if it exceeds the sum of the undiscountedcash flows expected to result from the use and eventual disposition of the asset. If the carrying value is not recoverable, the impairmentloss is measured as the excess of the asset’s carrying value over its fair value.

 

Ourimpairment analysis requires management to apply judgment in estimating future cash flows as well as asset fair values, including forecastinguseful lives of the assets, assessing the probability of different outcomes, and selecting the undiscounted rate that reflects the riskinherent in future cash flows. If the carrying value is not recoverable, we assess the fair value of long-lived assets using commonlyaccepted techniques, and may use more than one method, including, but not limited to, recent third-party comparable sales and discountedcash flow models. If actual results are not consistent with our assumptions and estimates, or our assumptions and estimates change dueto new information, we may be exposed to an impairment charge in the future. As of December 31, 2021 and 2020, the Company had not experiencedimpairment losses on its long-lived assets.

 

FairValue of Financial Instruments

 

Theprovisions of accounting guidance, Financial Accounting Standards Board (“FASB”) Topic ASC 825, Financial Instruments– Overall, requires all entities to disclose the fair value of financial instruments, both assets and liabilities recognizedand not recognized on the balance sheet, for which it is practicable to estimate fair value, and defines fair value of a financial instrumentas the amount at which the instrument could be exchanged in a current transaction between willing parties. As of December 31, 2021 and2020, the fair value of cash, accounts payable, accrued expenses, and notes payable approximated carrying value due to the short maturityof the instruments, quoted market prices or interest rates which fluctuate with market rates.

 

FairValue Measurements

 

Fairvalue is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principalor most advantageous market for the asset or liability, in an orderly transaction between market participants on the measurement date.Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.The fair value hierarchy is based on three levels of inputs, of which the first two are considered observable and the last unobservable,as follows:

 

Level 1 – Quoted prices in active markets for identical assets or liabilities.
   
Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
   
Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the measurement of the fair value of the assets or liabilities

 

Thecarrying value of financial assets and liabilities recorded at fair value are measured on a recurring or nonrecurring basis. Financialassets and liabilities measured on a non-recurring basis are those that are adjusted to fair value when a significant event occurs. Therewere no financial assets or liabilities carried and measured on a nonrecurring basis during the reporting periods. Financial assets andliabilities measured on a recurring basis are those that are adjusted to fair value each time a financial statement is prepared. Therehave been no transfers between levels.

 

Basicand Diluted Earnings Per Share

 

Basicnet loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period,without consideration for common stock equivalents. Diluted earnings (loss) per share are computed on the basis of the weighted averagenumber of common shares (including common stock subject to redemption) plus dilutive potential common shares outstanding for the reportingperiod. In periods where losses are reported, the weighted-average number of common stock outstanding excludes common stock equivalents,because their inclusion would be anti-dilutive.

 

F-11

 

 

Basicand diluted earnings (loss) per share are the same since net losses for all periods presented and including the additional potentialcommon shares would have an anti-dilutive effect.

 

Stock-BasedCompensation

 

Inaccordance with ASC No. 718, Compensation – Stock Compensation (“ASC 718”), we measure the compensation costsof share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements overthe period during which employees are required to provide services. Share-based compensation arrangements include stock options, restrictedshare plans, performance-based awards, share appreciation rights and employee share purchase plans. As such, compensation cost is measuredon the date of grant at their fair value. Such compensation amounts, if any, are amortized over the respective vesting periods of theoption grant.

 

Non-EmployeeStock-Based Compensation

 

Inaccordance with ASC 505, Equity Based Payments to Non-Employees, issuances of the Company’s common stock or warrants foracquiring goods or services are measured at the fair value of the consideration received or the fair value of the equity instrumentsissued, whichever is more reliably measurable. The measurement date for the fair value of the equity instruments issued to consultantsor vendors is determined at the earlier of (i) the date at which a commitment for performance to earn the equity instruments is reached(a “performance commitment” which would include a penalty considered to be of a magnitude that is a sufficiently large disincentivefor nonperformance) or (ii) the date at which performance is complete. Although situations may arise in which counter performance maybe required over a period of time, the equity award granted to the party performing the service is fully vested and non-forfeitable onthe date of the agreement. As a result, in this situation in which vesting periods do not exist as the instruments fully vested on thedate of agreement, the Company determines such date to be the measurement date and will record the estimated fair market value of theinstruments granted as a prepaid expense and amortize such amount to general and administrative expense in the accompanying statementof operations over the contract period. When it is appropriate for the Company to recognize the cost of a transaction during financialreporting periods prior to the measurement date, for purposes of recognition of costs during those periods, the equity instrument ismeasured at the then-current fair values at each of those interim financial reporting dates.

 

Reclassifications

 

Certainprior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect onthe reported results of operations. An adjustment has been made to the Consolidated Statements of Operations for fiscal year ended December31, 2020, to reclass $391,906 of costs to research and development previously classified in general and administrative.

 

Concentrations,Risks, and Uncertainties

 

BusinessRisk

 

Substantialbusiness risks and uncertainties are inherent to an entity, including the potential risk of business failure.

 

TheCompany is headquartered and operates in the United States. To date, the Company has generated no revenues from operations. There canbe no assurance that the Company will be able to raise additional capital and failure to do so would have a material adverse effect onthe Company’s financial position, results of operations and cash flows. Also, the success of the Company’s operations issubject to numerous contingencies, some of which are beyond management’s control. Currently, these contingencies include generaleconomic conditions, price of components, competition, and governmental and political conditions.

 

InterestRate Risk

 

Financialassets and liabilities do not have material interest rate risk.

 

F-12

 

 

CreditRisk

 

TheCompany is exposed to credit risk from its cash in banks. The credit risk on cash in banks is limited because the counterparties arerecognized financial institutions.

 

Seasonality

 

Thebusiness is not subject to substantial seasonal fluctuations.

 

MajorSuppliers

 

SigynTherapy is comprised of components that are supplied by various industry vendors. Additionally, the Company is reliant on third-partyorganizations to conduct clinical development studies that are necessary to advance Sigyn Therapy toward the marketplace.

 

Shouldthe relationship with an industry vendor or third-party clinical development organization be interrupted or discontinued, it is believedthat alternate component suppliers and third-party clinical development organizations could be identified to support the continued advancementof Sigyn Therapy.

 

RecentAccounting Pronouncements

 

InAugust 2018, the FASB issued ASU No. 2018-13, Fair Value Measurements (Topic 820): Disclosure Framework—Changes to the DisclosureRequirements for Fair Value Measurement. This standard removes, modifies, and adds certain disclosure requirements for fair valuemeasurements. This pronouncement is effective for fiscal years, and for interim periods within those fiscal years, beginning after December15, 2019, with early adoption permitted. The Company adopted ASU No. 2018-13 in the first quarter of fiscal 2020, coinciding with thestandard’s effective date, and had an immaterial impact from this standard.

 

InAugust 2018, the FASB issued ASU No. 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40):Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. This standardaligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirementsfor capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-usesoftware license). The Company’s accounting for the service element of a hosting arrangement that is a service contract is notaffected by the proposed amendments and will continue to be expensed as incurred in accordance with existing guidance. This standarddoes not expand on existing disclosure requirements except to require a description of the nature of hosting arrangements that are servicecontracts. This standard is effective for fiscal years, and for interim periods within those fiscal years, beginning after December 15,2019. Early adoption is permitted, including adoption in any interim period for which financial statements have not been issued. Entitiescan choose to adopt the new guidance prospectively or retrospectively. The Company adopted the updated disclosure requirements of ASUNo. 2018-15 prospectively in the first quarter of fiscal 2020, coinciding with the standard’s effective date, and had an immaterialimpact from this standard.

 

InDecember 2019, the FASB issued ASU No. 2019-12, Simplifying the Accounting for Income Taxes. This standard simplifies the accountingfor income taxes by removing certain exceptions to the general principles in ASC 740, Income Taxes, while also clarifying andamending existing guidance, including interim-period accounting for enacted changes in tax law. This standard is effective for fiscalyears, and for interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Companyadopted ASU No. 2019-12 in the first quarter of fiscal 2021, coinciding with the standard’s effective date, and had an immaterialimpact from this standard.

 

InAugust 2020, the FASB issued ASU No. 2020-06, Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging– Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’sOwn Equity, which simplifies accounting for convertible instruments by removing major separation models required under current GAAP.The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception andit also simplifies the diluted earnings per share calculation in certain areas. This ASU is effective for annual reporting periods beginningafter December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscalyears beginning after December 15, 2020. This update permits the use of either the modified retrospective or fully retrospective methodof transition. The Company is currently evaluating the impact this ASU will have on its consolidated financial statements and relateddisclosures.

 

F-13

 

 

Otherrecently issued accounting updates are not expected to have a material impact on the Company’s consolidated financial statements.

 

NOTE4 – EQUIPMENT

Equipmentconsisted of the following as of:

 

      December 31,   December 31, 
   Estimated Life  2021   2020 
            
Office equipment  5 years  $28,181   $1,787 
Computer equipment  3 years   3,157    287 
Accumulated depreciation      (3,292)   (346)
      $28,046   $1,728 

 

Depreciationexpense was $2,946 and $346 for the years ended December 31, 2021 and 2020, respectively, and is classified in general and administrativeexpenses in the Consolidated Statements of Operations.

 

NOTE5 – INTANGIBLE ASSETS

 

Intangibleassets consisted of the following as of:

 

   Estimated life  December 31, 2021   December 31, 2020 
Trademarks  3 years  $-   $22,060 
Website  3 years   10,799    10,799 
Accumulated amortization      (5,099)   (10,954)
      $5,700   $21,905 

 

Asof December 31, 2021, estimated future amortization expenses related to intangible assets were as follows:

 

   Intangible Assets 
2022  $3,600 
2023   2,100 
Total  $5,700 

 

TheCompany had amortization expense of $16,205 and $10,954 for the years ended December 31, 2021 and 2020, respectively.

 

OnJanuary 8, 2020, James Joyce, the Company’s CEO and Craig Roberts, the Company’s COO, assigned to the Company the rightsto patent 62/881,740 pertaining to the devices, systems and methods for the broad-spectrum reduction of pro-inflammatory cytokines inblood.

 

F-14

 

 

NOTE6 – CONVERTIBLE PROMISSORY DEBENTURES

 

Convertiblenotes payable consisted of the following:

 

   December 30, 2021   December 31, 2020 
         
Total convertible notes payable   700,816    616,500 
January 28, 2020 ($457,380) 0% interest per annum outstanding principal and interest due October 20, 2022  $457,380   $385,000 
June 23, 2020 ($60,500) 0% interest per annum outstanding principal and interest due October 20, 2022   60,500    50,000 
September 17, 2020 ($199,650) 0% interest per annum outstanding principal and interest due October 20, 2022. On October 28, 2021, Osher elected to convert $16,714 of the aggregate principal amount of the Note of $199,650, into 42,857 common shares.   182,936    181,500 
           
Total convertible notes payable   700,816    616,500 
Original issue discount   (53,614)   (19,667)
Debt discount   -    (78,165)
           
Total convertible notes payable  $647,202   $518,668 

 

CurrentNoteholders

 

Osher– $457,380

 

OnJanuary 28, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “PurchaseAgreement”) with respect to the sale and issuance to institutional investor Osher CapitalPartners LLC (“Osher”) of (i) $385,000 aggregate principal amount of Original Issue Discount Senior Convertible Debenturedue January 26, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants to purchase upto an aggregate of 80,209 shares of the Company’s Common Stock at an exercise price of $7.00 per share. The aggregate cash subscriptionamount received by the Company from Osher for the issuance of the note and warrants was $350,005 which was issued at a $34,995 originalissue discount from the face value of the Note. The conversion price for the principal in connectionwith voluntary conversions by a holder of the convertible notes is $0.094 per share, as amended on October 20, 2020, subject to adjustmentas provided therein, such as stock splits and stock dividends.

 

TheCompany and Osher amended the convertible debt agreement as follow on October 20, 2020:

 

The parties amended the Warrants dated January 28, 2020, for the number of warrant shares from 80,209 warrant shares to 4,113,083 warrant shares at an exercise price of $0.14 per share.
The parties amended the Note to provide for interest at 8% per annum.
The parties amended the Note for the maturity date from June 23, 2021 to October 20, 2021.

 

OnOctober 22, 2021, the Company and Osher amended convertible debt agreements as follows:

 

  The parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
  The parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
  In exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of the Company’s common stock at an exercise price of $1.00 per share.

 

F-15

 

 

Osher– $60,500 (as amended on October 20, 2020 to $55,000)

 

OnJune 23, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “PurchaseAgreement”) with respect to the sale and issuance to institutional investor Osher CapitalPartners LLC (“Osher”) of (i) $50,000 aggregate principal amount of Original Issue Discount Senior Convertible Debenture(the “Note”) due June 23, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants(“Warrants”) to purchase up to an aggregate of 10,000 shares of the Company’s Common Stock at an exercise price of$30.00 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrantswas $50,005 which was issued at a $0 original issue discount from the face value of the Note. Theconversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.39 per share,as amended on October 20, 2020, subject to adjustment as provided therein, such as stock splits and stock dividends.

 

TheCompany and Osher amended the convertible debt agreement as follow on October 20, 2020:

 

The parties amended the Note for the aggregate principal amount from $50,000 to $55,000. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants was $50,005 which was issued at an amended $4,995 original issue discount from the face value of the Note.
The parties amended the Warrants dated June 23, 2020, for the number of warrant shares from 10,000 warrant shares to 141,020 warrant shares at an exercise price of $0.59 per share.
The parties amended the Note for the maturity date from June 23, 2021 to October 20, 2021.

 

OnOctober 22, 2021, the Company and Osher amended convertible debt agreements as follows (see Note 12):

 

  The parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
  The parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
  In exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of the Company’s common stock at an exercise price of $1.00 per share.

 

Osher– $199,650

 

OnSeptember 17, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “PurchaseAgreement”) with respect to the sale and issuance to institutional investor Osher CapitalPartners LLC (“Osher”) of (i) $181,500 aggregate principal amount of Original Issue Discount Senior Convertible Debenture(the “Note”) due September 30, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock PurchaseWarrants (“Warrants’) to purchase up to an aggregate of 8,250 shares of the Company’s Common Stock at an exercise priceof $30.00 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrantswas $165,000 which was issued at a $16,500 original issue discount from the face value of the Note. Theconversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.39 per share,as amended on October 20, 2020, subject to adjustment as provided therein, such as stock splits and stock dividends.

 

TheCompany and Osher amended the convertible debt agreement as follow on October 20, 2020:

 

The parties amended the Warrants dated September 17, 2020, for the number of warrant shares from 8,250 warrant shares to 465,366 warrant shares at an exercise price of $0.59 per share.
The parties amended the Note for the maturity date from September 30, 2021 to October 20, 2021.

 

F-16

 

 

OnOctober 22, 2021, the Company and Osher amended convertible debt agreements as follows (see Note 12):

 

  The parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
  The parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
  In exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of the Company’s common stock at an exercise price of $1.00 per share.

 

OnOctober 28, 2021, Osher elected to convert $16,714 of the aggregate principal amount of the Note of $199,650, into 42,857 common shares.

 

PreviousNoteholders

 

PreviousNoteholder – $50,000 (as amended on October 20, 2020 to $55,000)

 

OnJune 23, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “PurchaseAgreement”) with respect to the sale and issuance to a previous noteholder of (i) $50,000 aggregate principal amount of OriginalIssue Discount Senior Convertible Debenture (the “Note”) due June 23, 2021, based on $1.00 for each $0.90909 paid by theprevious noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 10,000shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount receivedby the Company from the previous noteholder for the issuance of the Note and Warrants was $50,000 which was issued at a $0 original issuediscount from the face value of the Note. The conversion price for the principal in connectionwith voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustmentas provided therein, such as stock splits and stock dividends.

 

TheCompany and the previous noteholder amended the convertible debt agreement as follows on October 20, 2020:

 

The parties amended the Note for the aggregate principal amount from $50,000 to $55,000. The aggregate cash subscription amount received by the Company from the previous noteholder for the issuance of the Note and Warrants was $50,000 which was issued at an amended $5,000 original issue discount from the face value of the Note.
The parties amended the Warrants dated June 23, 2020, for the number of warrant shares from 10,000 warrant shares to 141,020 warrant shares at an exercise price of $0.59 per share.
The parties amended the Note for the maturity date from June 23, 2021 to October 20, 2021.

 

OnDecember 2, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $55,000, into 141,020 commonshares.

 

PreviousNoteholder - $25,000 (as amended on October 20, 2020 to $27,500)

 

OnAugust 18, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “PurchaseAgreement”) with respect to the sale and issuance to a previous noteholder of (i) $25,000 aggregate principal amount of OriginalIssue Discount Senior Convertible Debenture (the “Note”) due August 18, 2021, based on $1.00 for each $0.90909 paid by theprevious noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 5,000shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount receivedby the Company from the previous noteholder for the issuance of the Note and Warrants was $25,000 which was issued at a $0 original issuediscount from the face value of the Note. The conversion price for the principal in connectionwith voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustmentas provided therein, such as stock splits and stock dividends.

 

F-17

 

 

TheCompany and the previous noteholder amended the convertible debt agreement as follows on October 20, 2020:

 

The parties amended the Note for the aggregate principal amount from $25,000 to $27,500. The aggregate cash subscription amount received by the Company from the previous noteholder for the issuance of the Note and Warrants was $25,000 which was issued at an amended $2,500 original issue discount from the face value of the Note.
The parties amended the Warrants dated August 18, 2020, for the number of warrant shares from 5,000 warrant shares to 70,510 warrant shares at an exercise price of $0.59 per share.
The parties amended the Note for the maturity date from August 18, 2021 to October 20, 2021.

 

OnOctober 28, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $27,500, into 70,510 commonshares.

 

OnFebruary 19, 2021, the previous noteholder exercised the warrants pursuant to the cashless exercise provision of the warrant agreementinto 57,147 common shares. The common shares have not been issued as of March 14, 2022.

 

PreviousNoteholder – $93,500

 

OnSeptember 18, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “PurchaseAgreement”) with respect to the sale and issuance to a previous noteholder of (i) $93,500 aggregate principal amount of OriginalIssue Discount Senior Convertible Debenture (the “Note”) due September 30, 2021, based on $1.00 for each $0.90909 paid bythe previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of4,250 shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount receivedby the Company from the previous noteholder for the issuance of the Note and Warrants was $85,000 which was issued at a $8,500 originalissue discount from the face value of the Note. The conversion price for the principal in connectionwith voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustmentas provided therein, such as stock splits and stock dividends.

 

TheCompany and the previous noteholder amended the convertible debt agreement as follows on October 20, 2020:

 

The parties amended the Warrants dated September 18, 2020, for the number of warrant shares from 4,250 warrant shares to 239,734 warrant shares at an exercise price of $0.59 per share.
The parties amended the Note for the maturity date from September 30, 2021 to October 20, 2021.

 

OnDecember 2, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $93,500, into 239,734 commonshares.

 

PreviousNoteholder - $165,000

 

OnSeptember 21, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “PurchaseAgreement”) with respect to the sale and issuance to a previous noteholder of (i) $165,000 aggregate principal amount of OriginalIssue Discount Senior Convertible Debenture (the “Note”) due September 30, 2021, based on $1.00 for each $0.90909 paid bythe previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of7,500 shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount receivedby the Company from the previous noteholder for the issuance of the Note and Warrants was $150,000 which was issued at a $15,000 originalissue discount from the face value of the Note. The conversion price for the principal in connectionwith voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustmentas provided therein, such as stock splits and stock dividends.

 

TheCompany and the previous noteholder amended the convertible debt agreement as follow on October 20, 2020:

 

The parties amended the number of shares from the Warrants dated September 21, 2020, for the number of warrant shares from 7,500 warrant shares to 423,060 warrant shares at an exercise price of $0.59 per share.
The parties amended the Note for the maturity date from September 30, 2021 to October 20, 2021.

 

OnNovember 5, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $165,000, into 423,060 commonshares.

 

F-18

 

 

PreviousNoteholder – $27,500 (as amended on October 20, 2020 to $22,000)

 

OnSeptember 28, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “PurchaseAgreement”) with respect to the sale and issuance to a previous noteholder of (i) $27,500 aggregate principal amount of OriginalIssue Discount Senior Convertible Debenture (the “Note”) due August 28, 2021, based on $1.00 for each $0.90909 paid by theprevious noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 1,000shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount receivedby the Company from the previous noteholder for the issuance of the Note and Warrants was $20,000 which was issued at a $7,500 originalissue discount from the face value of the Note. The conversion price for the principal in connectionwith voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustmentas provided therein, such as stock splits and stock dividends.

 

TheCompany and the previous noteholder amended the convertible debt agreement as follows on October 20, 2020:

 

The parties amended the Note for the aggregate principal amount from $27,500 to $22,000. The aggregate cash subscription amount received by the Company from the previous noteholder for the issuance of the Note and Warrants was $20,000 which was issued at an amended $2,000 original issue discount from the face value of the Note.
The parties amended the Warrants dated September 28, 2020, for the number of warrant shares from 1,000 warrant shares to 56,408 warrant shares at an exercise price of $0.59 per share.
The parties amended the Note for the maturity date from August 18, 2021 to October 20, 2021.

 

OnOctober 27, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $22,000, into 56,408 commonshares.

 

PreviousNoteholder – $33,000

 

OnSeptember 29, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “PurchaseAgreement”) with respect to the sale and issuance to a previous noteholder of (i) $33,000 aggregate principal amount of OriginalIssue Discount Senior Convertible Debenture (the “Note”) due August 18, 2021, based on $1.00 for each $0.90909 paid by theprevious noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 1,500shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cash subscription amount receivedby the Company from the previous noteholder for the issuance of the Note and Warrants was $30,000 which was issued at a $3,000 originalissue discount from the face value of the Note. The conversion price for the principal in connectionwith voluntary conversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustmentas provided therein, such as stock splits and stock dividends.

 

TheCompany and the previous noteholder amended the convertible debt agreement as follows on October 20, 2020:

 

The parties amended the Warrants dated September 29, 2020, for the number of warrant shares from 1,500 warrant shares to 84,612 warrant shares at an exercise price of $0.59 per share.
The parties amended the Note for the maturity date from August 18, 2021 to October 20, 2021.

 

OnOctober 26, 2020, the previous noteholder elected to convert the aggregate principal amount of the Note, $33,000, into 84,612 commonshares.

 

PreviousNoteholder – $110,000

 

OnFebruary 10, 2021, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respectto the sale and issuance to a previous noteholder of (i) $110,000 aggregate principal amount of Note due February 11, 2022 based on $1.00for each $0.90909 paid by the previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchaseup to an aggregate of 157,143 shares of the Company’s Common Stock at an exercise price of $1.20 per share. The aggregate cashsubscription amount received by the Company from the previous noteholder for the issuance of the Note and Warrants was $100,000 whichwas issued at a $10,000 original issue discount from the face value of the Note. The conversionprice for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.70 per share, subject toadjustment as provided therein, such as stock splits and stock dividends.

 

F-19

 

 

OnMay 10, 2021, the previous noteholder elected to convert the aggregate principal amount of a $110,000 convertible note issued on February10, 2021 into 157,143 shares of the Company’s common stock.

 

PreviousNoteholder – $55,000

 

OnMay 4, 2021, the Company repaid the aggregate principal amount of a $55,000 convertible debenture that was entered into on April 7, 2021with a previous noteholder. The note was a 10% Original Issue Discount Senior Convertible Debenture (the “Note”) which includeda five-year Common Stock Purchase Warrant (“Warrants’) to purchase up to an aggregate of 71,429 shares of the Company’sCommon Stock at an exercise price of $1.20 per share. The aggregate cash subscription amount received by the Company from the previousnoteholder for the issuance of the Note and Warrants was $50,000 which was issued at a $5,000 original issue discount from the face valueof the Note.

 

PreviousNoteholder – $110,000

 

OnFebruary 10, 2021, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respectto the sale and issuance to a previous noteholder of (i) $110,000 aggregate principal amount of Note due February 11, 2022 based on $1.00for each $0.90909 paid by the previous noteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchaseup to an aggregate of 157,143 shares of the Company’s Common Stock at an exercise price of $1.20 per share. The aggregate cashsubscription amount received by the Company from the previous noteholder for the issuance of the Note and Warrants was $100,000 whichwas issued at a $10,000 original issue discount from the face value of the Note. The conversionprice for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.70 per share, subject toadjustment as provided therein, such as stock splits and stock dividends.

 

OnOctober 25, 2021, the previous noteholder elected to convert the aggregate principal amount of the Note, $110,000, into 157,143 commonshares.

 

NOTE7 – STOCKHOLDERS’ EQUITY

TheCompany has authorized 1,000,000,000 shares of par value $0.0001 common stock, of which 37,295,803 shares are outstanding at December31, 2021.

 

CommonStock

 

OnOctober 28, 2021, Osher elected to convert $16,714 of the aggregate principal amount of the Note of $199,650, into 42,857 common shares.

 

OnOctober 25, 2021, Osher elected to convert the aggregate principal amount of the Note, $110,000, into 157,143 common shares.

 

OnOctober 20, 2021, the entered into a securities purchase agreement with an accredited investor that resulted in the issuance of 320,000shares of common stock and warrants to purchase an aggregate of 320,000 shares of the Company’s common stock for total proceedstotaling $400,000. The offering allowed for qualified investors to purchase one share of the Company’s common stock at $1.25. Foreach share purchased, the investor received a five-year warrant to purchase one share of common stock at $1.25 per share. No commissionswere paid in the offering. This issuance was pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transactionexempt from registration.

 

F-20

 

 

OnOctober 14, 2021, the Company issued a total of 47,000 shares of its common stock valued at $37,600 (based on the stock price of theCompany’s common stock on the date of issuance) to a third party, for communications to the financial industry.

 

OnJuly 14, 2021, the Company issued a total of 47,000 shares of its common stock valued at $47,000 (based on the stock price of the Company’scommon stock on the date of issuance) to a third party, for communications to the financial industry.

 

OnMay 10, 2021, Brio Capital elected to convert the aggregate principal amount of a $110,000 convertible note issued on February 10, 2021into 157,143 shares of the Company’s common stock.

 

InApril 2021, the Company initiated an offering of up to $1.5 million of the Company’s restricted common shares. The offering allowedfor qualified investors to purchase one share of the Company’s common stock $1.25. For each share purchased, the investor receiveda five-year warrant to purchase one share of common stock at $1.75 per share. On May 10, 2021, the Company closed the offering to investorsand subsequently disclosed that it had entered into securities purchase agreements with accredited investors that resulted in the issuanceof 1,172,000 shares of common stock and warrants to purchase an aggregate of 1,172,000 shares of the Company’s common stock fortotal proceeds totaling $1,465,000. No commissions were paid in the offering. This issuance was pursuant to Section 4(a)(2) of the SecuritiesAct of 1933, as amended, in a transaction exempt from registration.

 

OnApril 14, 2021, the Company issued a total of 47,000 shares of its restricted common stock valued at $82,250 (based on the stock priceof the Company’s common stock on the date of issuance) to a third party, for communications to the financial industry. This issuancewas pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transaction exempt from registration.

 

OnFebruary 19, 2021, a previous noteholder exercised the warrants pursuant to the cashless exercise provision of the warrant agreementinto 57,147 common shares. The common shares have not been issued as of March 14, 2022.

 

OnJanuary 14, 2021, the Company issued a total of 47,000 shares of its restricted common stock valued at $82,250 (based on the stock priceof the Company’s common stock on the date of issuance) to a third party, for communications to the financial industry. This issuancewas pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transaction exempt from registration.

 

Duringthe year ended December 31, 2020, the Company issued 1,015,344 common shares to third parties in conjunction with the exchange of convertiblepromissory debentures.

 

OnOctober 19, 2020, the Company issued 33,686,169 common shares in conjunction with acquisition.

 

Warrants

 

OnOctober 22, 2021, the Company and Osher amended convertible debt agreements for the maturity date from October 20, 2021 to October 20,2022. In exchange for the extension of the Note, the Company issued Osher 450,000 warrants to purchase an aggregate of 450,000 sharesof the Company’s common stock, valued at $197,501 (based on the Black Scholes valuation model on the date of grant) (see Note 6).The warrants are exercisable for a period of five years at $1.00 per share in whole or in part, as either a cash exercise or as a cashlessexercise, and fully vest at grant date. The Company is amortizing the value of the warrants ratably through October 20, 2022. The Companyrecorded $40,041 and $0 for the years ended December 31, 2021 and 2020, respectively, and is classified in other expenses in the consolidatedStatements of Operations.

 

F-21

 

 

NOTE8 – OPERATING LEASES

 

OnMay 27, 2021, the Company entered into a sixty-three month lease for its corporate office at $5,955 per month commencing June 15, 2021maturing September 30, 2026. The Company accounts for this lease in accordance with ASC 842. Adoptionof the standard resulted in the initial recognition of operating lease ROU asset of $290,827 andoperating lease liability of $290,827 as of June 15, 2021.

 

Operatinglease right-of-use (“ROU”) assets and liabilities are recognized at commencement date based on the present value of leasepayments over the lease term. ROU assets represent our right to use an underlying asset for the lease term and lease liabilities representour obligation to make lease payments arising from the lease. Generally, the implicit rate of interest in arrangements is not readilydeterminable and the Company utilizes its incremental borrowing rate in determining the present value of lease payments. The Company’sincremental borrowing rate is a hypothetical rate based on its understanding of what its credit rating would be. The operating leaseROU asset includes any lease payments made and excludes lease incentives. Our variable lease payments primarily consist of maintenanceand other operating expenses from our real estate leases. Variable lease payments are excluded from the ROU assets and lease liabilitiesand are recognized in the period in which the obligation for those payments is incurred. Our lease terms may include options to extendor terminate the lease when it is reasonably certain that we will exercise that option. Lease expense for minimum lease payments is recognizedon a straight-line basis over the lease term.

 

Wehave lease agreements with lease and non-lease components. We have elected to account for these lease and non-lease components as a singlelease component. We are also electing not to apply the recognition requirements to short-term leases of twelve months or less and insteadwill recognize lease payments as expense on a straight-line basis over the lease term.

 

Thecomponents of lease expense and supplemental cash flow information related to leases for the period are as follows:

 

Inaccordance with ASC 842, the components of lease expense were as follows:

 

   Years ended December 31, 
         
   2021   2020 
Operating lease expense  $41,811   $- 
Short term lease cost  $-   $- 
Total lease expense  $41,811   $- 

 

Inaccordance with ASC 842, other information related to leases was as follows:

 

Years ended December 31,  2021   2020 
Operating cash flows from operating leases  $17,866   $- 
Cash paid for amounts included in the measurement of lease liabilities  $17,866   $- 
           
Weighted-average remaining lease term—operating leases    4.67 years     - 
Weighted-average discount rate—operating leases   10%   - 

 

F-22

 

 

Inaccordance with ASC 842, maturities of operating lease liabilities as of December 31, 2021 were as follows:

 

   Operating 
Year ending:  Lease 
2022  $72,714 
2023   74,895 
2024   77,142 
2025   79,456 
2026   54,225 
Total undiscounted cash flows  $358,431 
      
Reconciliation of lease liabilities:     
Weighted-average remaining lease terms    4.67 years  
Weighted-average discount rate   10%
Present values  $286,716 
      
Lease liabilities—current   46,091 
Lease liabilities—long-term   240,625 
Lease liabilities—total  $286,716 
      
Difference between undiscounted and discounted cash flows  $71,715 

 

Operatinglease cost was $41,811 and $0 for the years ended December 31, 2021 and 2020, respectively.

 

NOTE9 – RELATED PARTY TRANSACTIONS

 

Otherthan as set forth below, and as disclosed in Notes 5 and 7, there have not been any transaction entered into or been a participant inwhich a related person had or will have a direct or indirect material interest.

 

EmploymentAgreements

 

Mr.Joyce receives an annual base salary of $455,000, plus bonus compensation not to exceed 50% of salary. Mr. Joyce’s employment alsoprovides for medical insurance, disability benefits and one year of severance pay if his employment is terminated without cause or dueto a change in control. Additionally, the Company has agreed to maintain a beneficial ownership target of 9% for Mr. Joyce. Mr. Joyce’scompensation was approved by the Reign Resources Corporation Board of Directors on October 6, 2020 and was among conditions of the ShareExchange Agreement that was completed with Sigyn Therapeutics, Inc. on October 19, 2020. The Company incurred compensation expense of $496,125(including $18,542 of 2020 payroll paid in 2021) and $418,842, and employee benefits of $31,126 and $22,516, for the years ended December31, 2021 and 2020, respectively.

 

Sigynhad no employment agreement with its CTO but still incurred compensation on behalf of the CTO. The Company incurred compensation expenseof $259,000 and $233,981, and employee benefits of $21,704 and $22,024, for the years ended December 31, 2021 and 2020, respectively.

 

Bonus

 

OnJuly 21, 2021, as a result of achieving certain milestones, the Board of Directors agreed to pay each of the Company’s CEO andCTO a performance bonus equal to 5% of their annual salary totaling $34,750.

 

NOTE10 – INCOME TAXES

 

AtDecember 31, 2021, net operating loss carry forwards for Federal and state income tax purposes totaling approximately $1,408,000 availableto reduce future income which under the Tax Cuts and Jobs Act of 2018, allows for an indefinite carryforward period, with carryforwardslimited to 80% of each subsequent year’s net income. There is no income tax affect due to the recognition of a full valuation allowanceon the expected tax benefits of future loss carry forwards based on uncertainty surrounding realization of such assets.

 

F-23

 

 

Areconciliation of the statutory income tax rates and the effective tax rate is as follows:

 

 SCHEDULEOF RECONCILIATION OF STATUTORY INCOME TAX RATES AND EFFECTIVE TAX RATE

   December 31, 
   2021   2020 
         
Statutory U.S. federal rate   21.0%   21.0%
State income tax, net of federal benefit   7.0%   7.0%
Permanent differences   0.0%   0.0%
Valuation allowance   (28.0)%   (28.0)%
           
Provision for income taxes   0.0%   0.0%

 

Thetax effects of the temporary differences and carry forwards that give rise to deferred tax assets consist of the following:

 

         
   December 31, 
   2021   2020 
         
Deferred tax assets:          
Net operating loss carry forwards  $1,073,527   $352,912 
Valuation allowance   (1,073,527)   (352,912)
           
Total  $-   $- 

 

Majortax jurisdictions are the United States and California. All of the tax years will remain open three and four years for examination bythe Federal and state tax authorities, respectively, from the date of utilization of the net operating loss. There are no tax auditspending.

 

NOTE11 – EARNINGS PER SHARE

 

FASBASC Topic 260, Earnings Per Share, requires a reconciliation of the numerator and denominator of the basic and diluted earnings(loss) per share (EPS) computations.

 

Basicearnings (loss) per share are computed by dividing net earnings available to common shareholders by the weighted-average number of commonshares outstanding during the period. Diluted earnings (loss) per share is computed similar to basic earnings per share except that thedenominator is increased to include the number of additional common shares that would have been outstanding if the potential common shareshad been issued and if the additional common shares were dilutive. In periods where losses are reported, the weighted-average numberof common stock outstanding excludes common stock equivalents, because their inclusion would be anti-dilutive.

 

Basicand diluted earnings (loss) per share are the same since net losses for all periods presented and including the additional potentialcommon shares would have an anti-dilutive effect.

 

F-24

 

 

Thefollowing table sets forth the computation of basic and diluted net income per share:

 

   Years Ended December 31, 
   2021   2020 
         
Net loss attributable to the common stockholders  $(3,004,619)  $(1,259,590)
           
Basic weighted average outstanding shares of common stock   36,396,585    7,351,272 
Dilutive effect of options and warrants   -    - 
Diluted weighted average common stock and common stock equivalents   36,396,585    7,351,272 
           
Loss per share:          
Basic and diluted  $(0.08)  $(0.17)

 

NOTE12 – COMMITMENTS AND CONTINGENCIES

 

Legal

 

Fromtime to time, various lawsuits and legal proceedings may arise in the ordinary course of business. However, litigation is subject toinherent uncertainties and an adverse result in these or other matters may arise from time to time that may harm our business. We arecurrently not aware of any legal proceedings or claims that it believes will have a material adverse effect on its business, financialcondition or operating results.

 

NOTE13 – SUBSEQUENT EVENTS

 

TheCompany evaluated all events or transactions that occurred after December 31, 2020 up through the date the financial statements wereavailable to be issued. During this period, the Company did not have any material recognizable subsequent events required to be disclosedas of and for the period ended December 31, 2020 except for the following:

 

Mr.Ferrell was hired March 9, 2022 as the Company’s Chief Financial Officer. Mr. Ferrell receives an annual base salary of $250,000,plus discretionary bonus compensation not to exceed 40% of salary. Mr. Ferrell’s employment also provides for medical insurance,disability benefits and three months of severance pay if his employment is terminated without cause or due to a change in control. Additionally,Mr. Ferrell will be granted up to 600,000 options to purchase 600,000 of the Company’s common shares upon the implementation ofa Company employee option plan.

 

ConvertiblePromissory Debentures

 

Osher– $110,000

 

OnMarch 23, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respectto the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”) of (i) $110,000 aggregate principalamount of Note due March 23, 2023 based on $1.00 for each $0.90909 paid by the previous noteholder and (ii) five-year Common Stock PurchaseWarrants (“Warrants’) to purchase up to an aggregate of 220,000 shares of the Company’s Common Stock at an exerciseprice of $0.50 per share. The aggregate cash subscription amount received by the Company from the previous noteholder for the issuanceof the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The conversionprice for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.50 per share, subject toadjustment as provided therein, such as stock splits and stock dividends.

 

Brio– $110,000

 

OnMarch 23, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respectto the sale and issuance to institutional investor Brio Capital Master Fund Ltd. (“Brio”) of (i) $110,000 aggregate principalamount of Note due March 23, 2023 based on $1.00 for each $0.90909 paid by the previous noteholder and (ii) five-year Common Stock PurchaseWarrants (“Warrants’) to purchase up to an aggregate of 220,000 shares of the Company’s Common Stock at an exerciseprice of $0.50 per share. The aggregate cash subscription amount received by the Company from the previous noteholder for the issuanceof the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the face value of the Note. The conversionprice for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.50 per share, subject toadjustment as provided therein, such as stock splits and stock dividends.

 

F-25

 

 

PART1. FINANCIAL INFORMATION

 

ITEM1. FINANCIAL STATEMENTS

 

SIGYNTHERAPEUTICS, INC.

UNAUDITEDCONDENSED CONSOLIDATED BALANCE SHEETS

 

   March 31, 2022   December 31, 2021 
         
ASSETS          
Current assets:          
Cash  $81,385   $340,956 
Inventories   50,000    50,000 
Other current assets   12,245    2,075 
Total current assets   143,630    393,031 
           
Property and equipment, net   26,342    28,046 
Intangible assets, net   4,800    5,700 
Operating lease right-of-use assets, net   251,931    262,771 
Other assets   20,711    20,711 
Total assets  $447,414   $710,259 
           
LIABILITIES AND STOCKHOLDERS’ DEFICIT          
Current liabilities:          
Accounts payable  $196,147   $39,674 
Short-term convertible notes payable, less unamortized debt issuance costs of $215,896 and $53,614, respectively   704,920    647,202 
Current portion of operating lease liabilities   47,794    46,091 
Other current liabilities   1,987    1,251 
Total current liabilities   950,848    734,218 
Long-term liabilities:          
Operating lease liabilities, net of current portion   228,135    240,625 
Total long-term liabilities   228,135    240,625 
Total liabilities   1,178,983    974,843 
           
Stockholders’ deficit:          
Common stock, $0.0001 par value, 1,000,000,000 shares authorized; 37,295,803 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively   3,730    3,730 
Additional paid-in capital   4,208,506    3,997,445 
Accumulated deficit   (4,943,805)   (4,265,759)
Total stockholders’ deficit   (731,569)   (264,584)
Total liabilities and stockholders’ deficit  $447,414   $710,259 

 

Seeaccompanying notes to unaudited condensed consolidated financial statements.

 

F-26
 

 

SIGYNTHERAPEUTICS, INC.

UNAUDITEDCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

   2022   2021 
   Three Months Ended March 31, 
   2022   2021 
         
Net revenues  $-   $- 
           
Gross Profit   -    - 
           
Operating expenses:          
Marketing expenses   250    82,250 
Research and development   228,342    116,516 
General and administrative   380,644    203,330 
Total operating expenses   609,236    402,096 
Loss from operations   (609,236)   (402,096)
           
Other expense:          
Interest expense   31    - 
Interest expense - debt discount   52,257    50,860 
Interest expense - original issuance costs   16,522    8,726 
Total other expense   68,810    59,586 
           
Loss before income taxes   (678,046)   (461,682)
Income taxes   -    - 
           
Net loss  $(678,046)  $(461,682)
           
Net loss per share, basic and diluted  $(0.02)  $(0.01)
           
Weighted average number of shares outstanding Basic and diluted   37,295,803    35,266,601 

 

Seeaccompanying notes to unaudited condensed consolidated financial statements.

 

F-27
 

 

SIGYNTHERAPEUTICS, INC.

UNAUDITEDCONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

 

   Shares   Amount   in Capital   Deficit   Deficit 
   Common Stock   Additional Paid   Accumulated   Total Stockholders’ 
   Shares   Amount   in Capital   Deficit   Deficit 
Balance as of December 31, 2020   35,201,513   $3,520   $1,356,799   $(1,261,140)  $99,179 
Common stock issued to third party for services   47,000    5    82,245    -    82,250 
Warrants issued to third parties in conjunction with debt issuance   -    -    113,910    -    113,910 
Beneficial conversion feature in conjunction with debt issuance   -    -    86,090    -    86,090 
Common stock issued in conjunction with cashless exercise of warrants   57,147    6    (6)   -    - 
Net loss   -    -    -    (461,682)   (461,682)
Balance as of March 31, 2021   35,305,660   $3,531   $1,639,038   $(1,722,822)  $(80,253)
                          
Balance as of December 31, 2021   37,295,803   $3,730   $3,997,445   $(4,265,759)  $(264,584)
Warrants issued to third parties in conjunction with debt issuance   -    -    162,362    -    162,362 
Amortization of warrants issued in connection with a debt modification   -    -    48,699    -    48,699 
Net loss   -    -    -    (678,046)   (678,046)
Balance as of March 31, 2022   37,295,803   $3,730   $4,208,506   $(4,943,805)  $(731,569)

 

Seeaccompanying notes to unaudited condensed consolidated financial statements.

 

F-28
 

 

SIGYNTHERAPEUTICS, INC.

UNAUDITEDCONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

   2022   2021 
   Three Months Ended March 31, 
   2022   2021 
         
Cash flows from operating activities:          
Net loss  $(678,046)  $(461,682)
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation expense   1,704    344 
Amortization expense   900    10,354 
Stock issued for services   -    82,250 
Accretion of debt discount   52,257    50,860 
Accretion of original issuance costs   16,522    8,726 
Changes in operating assets and liabilities:          
Other current assets   (10,170)   - 
Accounts payable   156,473    28,055 
Accrued payroll and payroll taxes   -    5,007 
Other current liabilities   789    1,662 
Net cash used in operating activities   (459,571)   (274,424)
           
Cash flows from investing activities:          
Purchase of property and equipment   -    (2,871)
Net cash used in investing activities   -    (2,871)
           
Cash flows from financing activities:          
Proceeds from short-term convertible notes   200,000    200,000 
Net cash provided by financing activities   200,000    200,000 
           
Net decrease in cash   (259,571)   (77,295)
           
Cash at beginning of period   340,956    84,402 
Cash at end of period  $81,385   $7,107 
           
Supplemental disclosures of cash flow information:          
Cash paid during the period for:          
Interest  $-   $- 
Income taxes  $-   $- 
           
Non-cash investing and financing activities:          
Beneficial conversion feature in conjunction with debt issuance  $-   $86,090 
Amortization of warrants issued in connection with a debt modification  $48,699   $- 
Warrants issued to third parties in conjunction with debt issuance  $162,362   $113,910 
Original issue discount issued in conjunction with debt  $20,000   $85,495 

 

Seeaccompanying notes to unaudited condensed consolidated financial statements.

 

F-29
 

 

SIGYNTHERAPEUTICS, INC.

NOTESTO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE1 – ORGANIZATION AND PRINCIPAL ACTIVITIES

 

CorporateHistory and Background

 

SigynTherapeutics, Inc. (“Sigyn” or the “Company”) is a development-stage therapeutic technology company headquarteredin San Diego, California USA. Our business focus is the clinical advancement of Sigyn Therapy, a multi-functionblood purification technology designed to overcome the limitations of previous drugs and devices to treat life-threatening inflammatorydisorders, including sepsis, the leading cause of hospital deaths worldwide.

 

Weare advancing Sigyn Therapy to treat pathogen-associated conditions that precipitate sepsis and other high-mortality disorders that arenot addressed with approved drug therapies. To address these unmet therapeutic needs, we designed SigynTherapy to extract pathogen sources of life-threating inflammation from the bloodstream in concert with the depletion of pro-inflammatorycytokines, whose dysregulated production (the cytokine storm) plays a prominent role in each of our therapeutic indication opportunities.

 

Inaddition to sepsis, our candidate treatment indications include, but are not limited to; emerging pandemic threats, drug resistant pathogens,hepatic encephalopathy, bridge to liver transplant, and community-acquired pneumonia, which is a leading cause ofdeath among infectious diseases, the leading cause of death in children under five years of age, and a catalyst for approximately 50%of sepsis and septic shock cases.

 

MergerTransaction

 

OnOctober 19, 2020, Sigyn Therapeutics, Inc, a Delaware corporation (the “Registrant”) formerly known as Reign Resources Corporation,completed a Share Exchange Agreement (the “Agreement”) with Sigyn Therapeutics, Inc., a private entity incorporated in theState of Delaware on October 19, 2019.

 

Inthe Share Exchange Agreement, we acquired 100% of the issued and outstanding shares of privately held Sigyn Therapeutics common stockin exchange for 75% of the fully paid and nonassessable shares of our common stock outstanding (the “Acquisition”). In conjunctionwith the transaction, we changed our name from Reign Resources Corporation to Sigyn Therapeutics, Inc. pursuant to an amendment to ourarticles of incorporation that was filed with the State of Delaware. Subsequently, our trading symbol was changed to SIGY. TheAcquisition was treated as a “tax-free exchange” under Section 368 of the Internal Revenue Code of 1986 and resulted in theprivate Sigyn Therapeutics corporate entity becoming a wholly owned subsidiary known as Sigyn Medical Corporation. Upon the closingof the Acquisition, we appointed James A. Joyce and Craig P. Roberts to serve as members of our Board of Directors.

 

Asof May 13, 2022, we have a total 37,295,803shares issued and outstanding, of which 11,655,803shares are held by non-affiliate stockholders.

 

PostMerger Developments

 

Since the consummation of our public merger onOctober 19, 2020, we advanced Sigyn Therapy from conceptual design to clinical application. We initiated and completed several invitro studies that validated the ability of Sigyn Therapy to address a broad-spectrum of relevant therapeutic targets, includingendotoxin (gram-negative bacterial toxin); peptidoglycan and lipoteichoic acid (gram-positive bacterialtoxins); viral pathogens (including SARS-CoV-2); hepatic toxins (ammonia, bile acid, and bilirubin); CytoVesicles (extracellular vesiclesthat transport inflammatory cytokine cargos); and tumor necrosis factor alpha (TNF alpha), interleukin-1 beta (IL-1b), and interleukin6 (IL-6), which are pro-inflammatory cytokines whose dysregulated production (the cytokine storm) precipitate sepsis and play a prominentrole in each of our therapeutic opportunities. Subsequent to these in vitro milestones, we completed animal studies that demonstratedSigyn Therapy to be safe and well tolerated.

 

F-30
 

  

We plan to incorporate the data collected fromour post-merger studies into an Investigational Device Exemption (IDE) that we are drafting for submission to the U.S. Food and DrugAdministration (“FDA”) to support the initiation of human clinical studies in the United States.

 

NOTE2 – BASIS OF PRESENTATION

 

Theaccompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United Statesof America and include all adjustments necessary for the fair presentation of the Company’s financial position and results of operationsfor the periods presented.

 

TheCompany currently operates in one business segment. The Company is not organized by market and is managed and operated as one business.A single management team reports to the chief operating decision maker, the Chief Executive Officer, who comprehensively manages theentire business. The Company does not currently operate any separate lines of businesses or separate business entities.

 

GoingConcern

 

Theaccompanying financial statements have been prepared assuming the Company will continue as a going concern, which contemplates, amongother things, the realization of assets and satisfaction of liabilities in the normal course of business. The Company had an accumulateddeficit of $4,943,805 at March 31, 2022, had a working capital deficit of $807,218 and $341,187 at March 31, 2022 and December 31, 2021,respectively, had a net loss of $678,046 and $461,682 for the three months ended March 31, 2022 and 2021, respectively, and net cashused in operating activities of $459,571 and $274,424 for the three months ended March 31, 2022 and 2021, respectively, with no revenueearned since inception, and a lack of operational history. These matters raise substantial doubt about the Company’s ability tocontinue as a going concern.

 

Whilethe Company is attempting to expand operations and increase revenues, the Company’s cash position may not be significant enoughto support the Company’s daily operations. Management intends to raise additional funds by way of a private offering or an assetsale transaction. Management believes that the actions presently being taken to further implement its business plan and generate revenuesprovide the opportunity for the Company to continue as a going concern. While management believes in the viability of its strategy togenerate revenues and in its ability to raise additional funds or transact an asset sale, there can be no assurances to that effect oron terms acceptable to the Company. The ability of the Company to continue as a going concern is dependent upon the Company’s abilityto further implement its business plan and generate revenues.

 

Thefinancial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

 

NOTE3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Thissummary of significant accounting policies of the Company is presented to assist in understanding the Company’s financial statements.The financial statements and notes are representations of the Company’s management, which is responsible for their integrity andobjectivity. These accounting policies conform to GAAP and have been consistently applied in the preparation of the financial statements.

 

F-31
 

 

Useof Estimates

 

Thepreparation of these financial statements in accordance with accounting principles generally accepted in the United States of Americarequires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingentassets and liabilities at the dates of the financial statements and the reported amounts of net sales and expenses during the reportedperiods. Actual results may differ from those estimates and such differences may be material to the financial statements. The more significantestimates and assumptions by management include among others: common stock valuation, and the recoverability of intangibles. The currenteconomic environment has increased the degree of uncertainty inherent in these estimates and assumptions.

 

Cash

 

TheCompany’s cash is held in bank accounts in the United States and is insured by the Federal Deposit Insurance Corporation (FDIC)up to $250,000. The Company has not experienced any cash losses.

 

IncomeTaxes

 

Incometaxes are accounted for under an asset and liability approach. This process involves calculating the temporary and permanent differencesbetween the carrying amounts of the assets and liabilities for financial reporting purposes and the amounts used for income tax purposes.The temporary differences result in deferred tax assets and liabilities, which would be recorded on the Balance Sheets in accordancewith ASC 740, which established financial accounting and reporting standards for the effect of income taxes. The likelihood that itsdeferred tax assets will be recovered from future taxable income must be assessed and, to the extent that recovery is not likely, a valuationallowance is established. Changes in the valuation allowance in a period are recorded through the income tax provision in the consolidatedStatements of Operations.

 

ASC740-10-30 was adopted from the date of its inception. ASC 740-10 clarifies the accounting for uncertainty in income taxes recognizedin an entity’s consolidated financial statements and prescribes a recognition threshold and measurement attributes for financialstatement disclosure of tax positions taken or expected to be taken on a tax return. Under ASC 740-10, the impact of an uncertain incometax position on the income tax return must be recognized at the largest amount that is more-likely-than-not to be sustained upon auditby the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of beingsustained. Additionally, ASC 740-10 provides guidance on derecognition, classification, interest and penalties, accounting in interimperiods, disclosure and transition. As a result of the implementation of ASC 740-10 and currently, the Company does not have a liabilityfor unrecognized income tax benefits.

 

Advertisingand Marketing Costs

 

Advertisingexpenses are recorded as general and administrative expenses when they are incurred. The Company had advertising expenses of $250 and$82,250 for the three months ended March 31, 2022 and 2021, respectively.

 

Inventories

 

Inconjunction with the October 19, 2020 Share Exchange Agreement, the Company kept the gem inventory of Reign Resources Corporation. Inventoriesare stated at the lower of cost or market (net realizable value) on a lot basis each quarter. A lot is determined by the cut, clarity,size, and weight of the sapphires. Inventory consists of sapphire jewels that meet rigorous grading criteria and are of cuts and sizesmost commonly used in the jewelry industry. As of March 31, 2022 and December 31, 2021, the Company carried primarily loose sapphirejewels, jewelry for sale on our website, and jewelry held as samples. Samples are used to show potential customers what the jewelry wouldlook like. Promotional items given to customers that are not expected to be returned will be removed from inventory and expensed. Therehave been no promotional items given to customers as of March 31, 2022. The Company performs its own in-house assessment based on gemguide and the current market price for metals to value its inventory on an annual basis or if circumstances dictate sooner to determineif the estimated fair value is greater or less than cost. In addition, the inventory is reviewed each quarter by the Company againstindustry prices from gem-guide and if there is a potential impairment, the Company would appraise the inventory. The estimated fair valueis subject to significant change due to changes in popularity of cut, perceived grade of the clarity of the sapphires, the number, typeand size of inclusions, the availability of other similar quality and size sapphires, and other factors. As a result, the internal assessedvalue of the sapphires could be significantly lower from the current estimated fair value. Loose sapphire jewels do not degrade in qualityover time.

 

F-32
 

 

Basedon the significant advancement of Sigyn Therapy, the Company decided in the 4th quarter of 2021 to assess the value of retailbusiness operations that were a focus of the Company prior to the merger transaction consummated on October 19, 2020.

 

Relatedto this assessment, management determined the wholesale liquidation value of its sapphire gem inventory to be 5-10% of the previouslyreported retail value, based on communications with certified gemologists, the variance between retail and wholesale valuations, andcurrent market conditions. As a result, the Company has valued the inventory at $50,000 and recorded an impairment of assets of $536,047in the year ended December 31, 2021.

 

Propertyand Equipment

 

Propertyand equipment are carried at cost and are depreciated on a straight-line basis over the estimated useful lives of the assets, generallyfive years. The cost of repairs and maintenance is expensed as incurred; major replacements and improvements are capitalized. When assetsare retired or disposed of, the cost and accumulated depreciation are removed from the accounts, and any resulting gains or losses areincluded in income in the year of disposition.

 

IntangibleAssets

 

Intangibleassets consist primarily of website development costs. Our intangible assets are being amortized on a straight-line basis over a periodof three years.

 

Impairmentof Long-lived Assets

 

Weperiodically evaluate whether the carrying value of property, equipment and intangible assets has been impaired when circumstances indicatethe carrying value of those assets may not be recoverable. The carrying amount is not recoverable if it exceeds the sum of the undiscountedcash flows expected to result from the use and eventual disposition of the asset. If the carrying value is not recoverable, the impairmentloss is measured as the excess of the asset’s carrying value over its fair value.

 

Ourimpairment analyses require management to apply judgment in estimating future cash flows as well as asset fair values, including forecastinguseful lives of the assets, assessing the probability of different outcomes, and selecting the discount rate that reflects the risk inherentin future cash flows. If the carrying value is not recoverable, we assess the fair value of long-lived assets using commonly acceptedtechniques, and may use more than one method, including, but not limited to, recent third-party comparable sales and discounted cashflow models. If actual results are not consistent with our assumptions and estimates, or our assumptions and estimates change due tonew information, we may be exposed to an impairment charge in the future. As of March 31, 2022 and December 31, 2021, the Company hadnot experienced impairment losses on its long-lived assets.

 

FairValue of Financial Instruments

 

Theprovisions of accounting guidance, FASB Topic ASC 825 requires all entities to disclose the fair value of financial instruments, bothassets and liabilities recognized and not recognized on the balance sheet, for which it is practicable to estimate fair value, and definesfair value of a financial instrument as the amount at which the instrument could be exchanged in a current transaction between willingparties. As of March 31, 2022 and December 31, 2021, the fair value of cash, accounts payable, accrued expenses, and notes payable approximatedcarrying value due to the short maturity of the instruments, quoted market prices or interest rates which fluctuate with market rates.

 

FairValue Measurements

 

Fairvalue is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principalor most advantageous market for the asset or liability, in an orderly transaction between market participants on the measurement date.Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.The fair value hierarchy is based on three levels of inputs, of which the first two are considered observable and the last unobservable,as follows:

 

  Level 1 – Quoted prices in active markets for identical assets or liabilities.

 

F-33
 

 

  Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
     
  Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the measurement of the fair value of the assets or liabilities

 

Thecarrying value of financial assets and liabilities recorded at fair value are measured on a recurring or nonrecurring basis. Financialassets and liabilities measured on a non-recurring basis are those that are adjusted to fair value when a significant event occurs. Therewere no financial assets or liabilities carried and measured on a nonrecurring basis during the reporting periods. Financial assets andliabilities measured on a recurring basis are those that are adjusted to fair value each time a financial statement is prepared. Therehave been no transfers between levels.

 

Basicand diluted earnings per share

 

Basicnet loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period,without consideration for common stock equivalents. Diluted earnings (loss) per share are computed on the basis of the weighted averagenumber of common shares (including common stock subject to redemption) plus dilutive potential common shares outstanding for the reportingperiod. In periods where losses are reported, the weighted-average number of common stock outstanding excludes common stock equivalents,because their inclusion would be anti-dilutive.

 

Basicand diluted earnings (loss) per share are the same since net losses for all periods presented and including the additional potentialcommon shares would have an anti-dilutive effect.

 

StockBased Compensation

 

Inaccordance with ASC No. 718, Compensation – Stock Compensation (“ASC 718”), we measure the compensation costsof share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements overthe period during which employees are required to provide services. Share-based compensation arrangements include stock options, restrictedshare plans, performance-based awards, share appreciation rights and employee share purchase plans. As such, compensation cost is measuredon the date of grant at their fair value. Such compensation amounts, if any, are amortized over the respective vesting periods of theoption grant.

 

Non-EmployeeStock-Based Compensation

 

Inaccordance with ASC 505, Equity Based Payments to Non-Employees, issuances of the Company’s common stock or warrants foracquiring goods or services are measured at the fair value of the consideration received or the fair value of the equity instrumentsissued, whichever is more reliably measurable. The measurement date for the fair value of the equity instruments issued to consultantsor vendors is determined at the earlier of (i) the date at which a commitment for performance to earn the equity instruments is reached(a “performance commitment” which would include a penalty considered to be of a magnitude that is a sufficiently large disincentivefor nonperformance) or (ii) the date at which performance is complete. Although situations may arise in which counter performance maybe required over a period of time, the equity award granted to the party performing the service is fully vested and non-forfeitable onthe date of the agreement. As a result, in this situation in which vesting periods do not exist as the instruments fully vested on thedate of agreement, the Company determines such date to be the measurement date and will record the estimated fair market value of theinstruments granted as a prepaid expense and amortize such amount to general and administrative expense in the accompanying statementof operations over the contract period. When it is appropriate for the Company to recognize the cost of a transaction during financialreporting periods prior to the measurement date, for purposes of recognition of costs during those periods, the equity instrument ismeasured at the then-current fair values at each of those interim financial reporting dates.

 

Reclassifications

 

Certainprior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect onthe reported results of operations. An adjustment has been made to the Unaudited Condensed Consolidated Statements of Operations forthree months ended March 31, 2021, to reclass $93,266 of costs to research and development previously classified in general and administrative.In addition, an adjustment has been made to the Unaudited Condensed Consolidated Balance Sheetsas of December 31, 2021, to reclass $1,072 of other current liabilities previously classified in accrued payroll and payroll taxes.

 

F-34
 

 

Concentrations,Risks, and Uncertainties

 

BusinessRisk

 

Substantialbusiness risks and uncertainties are inherent to an entity, including the potential risk of business failure.

 

TheCompany is headquartered and operates in the United States. To date, the Company has generated no revenues from operations. There canbe no assurance that the Company will be able to raise additional capital and failure to do so would have a material adverse effect onthe Company’s financial position, results of operations and cash flows. Also, the success of the Company’s operations issubject to numerous contingencies, some of which are beyond management’s control. Currently, these contingencies include generaleconomic conditions, price of components, competition, and governmental and political conditions.

 

Interestrate risk

 

Financialassets and liabilities do not have material interest rate risk.

 

Creditrisk

 

TheCompany is exposed to credit risk from its cash in banks. The credit risk on cash in banks is limited because the counterparties arerecognized financial institutions.

 

Seasonality

 

Thebusiness is not subject to substantial seasonal fluctuations.

 

MajorSuppliers

 

SigynTherapy is comprised of components that are supplied by various industry vendors. Additionally, the Company is reliant on third-partyorganizations to conduct clinical development studies that are necessary to advance Sigyn Therapy toward the marketplace.

 

Shouldthe relationship with an industry vendor or third-party clinical development organization be interrupted or discontinued, it is believedthat alternate component suppliers and third-party clinical development organizations could be identified to support the continued advancementof Sigyn Therapy.

 

RecentAccounting Pronouncements

 

InDecember 2019, the FASB issued ASU No. 2019-12, Simplifying the Accounting for Income Taxes. This standard simplifies the accountingfor income taxes by removing certain exceptions to the general principles in ASC 740, Income Taxes, while also clarifying andamending existing guidance, including interim-period accounting for enacted changes in tax law. This standard is effective for fiscalyears, and for interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Companyadopted ASU No. 2019-12 in the first quarter of fiscal 2021, coinciding with the standard’s effective date, and had an immaterialimpact from this standard.

 

InAugust 2020, the FASB issued ASU No. 2020-06, Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging– Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’sOwn Equity, which simplifies accounting for convertible instruments by removing major separation models required under current GAAP.The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception andit also simplifies the diluted earnings per share calculation in certain areas. This ASU is effective for annual reporting periods beginningafter December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscalyears beginning after December 15, 2020. The Company adopted ASU No. 2020-06 in the first quarterof fiscal 2021, coinciding with the standard’s effective date, and had an immaterial impact from this standard s.

 

F-35
 

 

Otherrecently issued accounting updates are not expected to have a material impact on the Company’s unaudited condensed consolidatedfinancial statements.

 

NOTE4 – PROPERTY AND EQUIPMENT

 

Propertyand equipment consisted of the following as of:

 

      March 31,   December 31, 
   Estimated Life  2022   2021 
            
Office equipment  5 years  $28,181   $28,181 
Computer equipment  3 years   3,157    3,157 
Accumulated depreciation      (4,996)   (3,292)
      $26,342   $28,046 

 

Depreciationexpense was $1,704 and $344 for the three months ended March 31, 2022 and 2021, respectively, and is classified in general and administrativeexpenses in the unaudited condensed consolidated Statements of Operations.

 

NOTE5 – INTANGIBLE ASSETS

 

Intangibleassets consisted of the following as of:

 

   Estimated life 

March 31,

2022

  

December 31,

2021

 
Website  3 years  $10,799   $10,799 
Accumulated amortization      (5,999)   (5,099)
 Intangible assets, net     $4,800   $5,700 

 

Asof March 31, 2022, estimated future amortization expenses related to intangible assets were as follows:

 

   Intangible Assets 
2022 (remaining 9 months)  $2,100 
2023   2,100 
Intangible assets, net  $4,800 

 

TheCompany had amortization expense of $900 and $10,354 for the three months ended March 31, 2022 and 2021, respectively.

 

OnJanuary 8, 2020, James Joyce, the Company’s CEO and Craig Roberts, the Company’s CTO, assigned to the Company the rightsto patent 62/881,740 pertaining to the devices, systems and methods for the broad-spectrum reduction of pro-inflammatory cytokines inblood.

 

F-36
 

 

NOTE6 – CONVERTIBLE PROMISSORY DEBENTURES

 

Convertiblenotes payable consisted of the following:

 

  

March 31,

2022

  

December 31,

2021

 
         
  $457,380   $457,380 
January 28, 2020 ($457,380) – 0% interest per annum outstanding principal and interest due October 20, 2022  $457,380   $457,380 
June 23, 2020 ($60,500) – 0% interest per annum outstanding principal and interest due October 20, 2022   60,500    60,500 
September 17, 2020 ($199,650) – 0% interest per annum outstanding principal and interest due October 20, 2022. On October 28, 2021, Osher elected to convert $16,714 of the aggregate principal amount of the Note of $199,650, into 42,857 common shares.   182,936    182,936 
March 23, 2022 ($220,000) – 0% interest per annum outstanding principal and interest due October 23, 2023   220,000    - 
           
Total convertible notes payable   920,816    700,816 
Original issue discount   (57,092)   (53,614)
Debt discount   (158,804)   - 
           
Total convertible notes payable  $704,920   $647,202 

 

Principalpayments on convertible promissory debentures are due as follows:

 

Year ending December 31,    
2022  $700,816 
2023   220,000 
Total  $920,816 

 

CurrentNoteholders

 

Osher– $110,000

 

OnMarch 23, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respectto the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”)of (i) $110,000 aggregate principal amount of Note due March 23, 2023 based on $1.00 for each $0.90909 paid by the previous noteholderand (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 220,000 shares of the Company’sCommon Stock at an exercise price of $0.50 per share. The aggregate cash subscription amount received by the Company from the previousnoteholder for the issuance of the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the facevalue of the Note. The conversion price for the principal in connection with voluntary conversionsby a holder of the convertible notes is $0.50 per share, subject to adjustment as provided therein, such as stock splits and stockdividends.

 

Brio– $110,000

 

OnMarch 23, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “Note”) with respectto the sale and issuance to institutional investor Brio Capital Master Fund Ltd. (“Brio”)of (i) $110,000 aggregate principal amount of Note due March 23, 2023 based on $1.00 for each $0.90909 paid by the previous noteholderand (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 220,000 shares of the Company’sCommon Stock at an exercise price of $0.50 per share. The aggregate cash subscription amount received by the Company from the previousnoteholder for the issuance of the Note and Warrants was $100,000 which was issued at a $10,000 original issue discount from the facevalue of the Note. The conversion price for the principal in connection with voluntary conversionsby a holder of the convertible notes is $0.50 per share, subject to adjustment as provided therein, such as stock splits and stockdividends.

 

Osher– $457,380

 

OnJanuary 28, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “PurchaseAgreement”) with respect to the sale and issuance to institutional investor Osher CapitalPartners LLC (“Osher”) of (i) $385,000 aggregate principal amount of Original Issue Discount Senior Convertible Debenturedue January 26, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants to purchase upto an aggregate of 80,209 shares of the Company’s Common Stock at an exercise price of $7.00 per share. The aggregate cash subscriptionamount received by the Company from Osher for the issuance of the note and warrants was $350,005 which was issued at a $34,995 originalissue discount from the face value of the Note. The conversion price for the principal in connectionwith voluntary conversions by a holder of the convertible notes is $0.094 per share, as amended on October 20, 2020, subject to adjustmentas provided therein, such as stock splits and stock dividends.

 

F-37
 

 

TheCompany and Osher amended the convertible debt agreement as follows on October 20, 2020:

 

  The parties amended the Warrants dated January 28, 2020, for the number of warrant shares from 80,209 warrant shares to 4,113,083 warrant shares at an exercise price of $0.14 per share.
  The parties amended the Note to provide for interest at 8% per annum.
  The parties amended the Note for the maturity date from June 23, 2021 to October 20, 2021.

 

OnOctober 22, 2021, the Company and Osher amended convertible debt agreements as follows:

 

  The parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
     
  The parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
     
  In exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of the Company’s common stock at an exercise price of $1.00 per share.

 

Osher– $60,500 (as amended on October 20, 2020 to $55,000)

 

OnJune 23, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “PurchaseAgreement”) with respect to the sale and issuance to institutional investor Osher CapitalPartners LLC (“Osher”) of (i) $50,000 aggregate principal amount of Original Issue Discount Senior Convertible Debenture(the “Note”) due June 23, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants(“Warrants”) to purchase up to an aggregate of 10,000 shares of the Company’s Common Stock at an exercise price of$30.00 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrantswas $50,005 which was issued at a $0 original issue discount from the face value of the Note. Theconversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.39 per share,as amended on October 20, 2020, subject to adjustment as provided therein, such as stock splits and stock dividends.

 

TheCompany and Osher amended the convertible debt agreement as follow on October 20, 2020:

 

  The parties amended the Note for the aggregate principal amount from $50,000 to $55,000. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants was $50,005 which was issued at an amended $4,995 original issue discount from the face value of the Note.
  The parties amended the Warrants dated June 23, 2020, for the number of warrant shares from 10,000 warrant shares to 141,020 warrant shares at an exercise price of $0.59 per share.
  The parties amended the Note for the maturity date from June 23, 2021 to October 20, 2021.

 

OnOctober 22, 2021, the Company and Osher amended convertible debt agreements as follows (see Note 12):

 

  The parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
     
  The parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
     
  In exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of the Company’s common stock at an exercise price of $1.00 per share.

 

F-38
 

 

Osher– $199,650

 

OnSeptember 17, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “PurchaseAgreement”) with respect to the sale and issuance to institutional investor Osher CapitalPartners LLC (“Osher”) of (i) $181,500 aggregate principal amount of Original Issue Discount Senior Convertible Debenture(the “Note”) due September 30, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock PurchaseWarrants (“Warrants’) to purchase up to an aggregate of 8,250 shares of the Company’s Common Stock at an exercise priceof $30.00 per share. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrantswas $165,000 which was issued at a $16,500 original issue discount from the face value of the Note. Theconversion price for the principal in connection with voluntary conversions by a holder of the convertible notes is $0.39 per share,as amended on October 20, 2020, subject to adjustment as provided therein, such as stock splits and stock dividends.

 

TheCompany and Osher amended the convertible debt agreement as follow on October 20, 2020:

 

  The parties amended the Warrants dated September 17, 2020, for the number of warrant shares from 8,250 warrant shares to 465,366 warrant shares at an exercise price of $0.59 per share.
  The parties amended the Note for the maturity date from September 30, 2021 to October 20, 2021.

 

OnOctober 22, 2021, the Company and Osher amended convertible debt agreements as follows (see Note 12):

 

  The parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
     
  The parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
     
  In exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of the Company’s common stock at an exercise price of $1.00 per share.

 

OnOctober 28, 2021, Osher elected to convert $16,714 of the aggregate principal amount of the Note of $199,650, into 42,857 common shares.

 

PreviousNoteholders

 

Previousnotes were detailed in our Form 10-K filed on March 31, 2022. No changes occurred related to these notes during the period covered bythis Form 10-Q.

 

NOTE7 – STOCKHOLDERS’ DEFICIT

 

PreferredStock

 

TheCompany authorized 10,000,000 shares of par value $0.0001 preferred stock, of which none are issued and outstanding at March 31, 2022,and December 31, 2021, respectively.

 

CommonStock

 

TheCompany has authorized 1,000,000,000 shares of par value $0.0001 common stock, of which 37,295,803 shares are outstanding at March 31,2022, and December 31, 2021, respectively.

 

OnOctober 28, 2021, Osher elected to convert $16,714 of the aggregate principal amount of the Note of $199,650, into 42,857 common shares.

 

F-39
 

 

OnOctober 25, 2021, Osher elected to convert the aggregate principal amount of the Note, $110,000, into 157,143 common shares.

 

OnOctober 20, 2021, the entered into a securities purchase agreement with an accredited investor that resulted in the issuance of 320,000shares of common stock and warrants to purchase an aggregate of 320,000 shares of the Company’s common stock for total proceedstotaling $400,000. The offering allowed for qualified investors to purchase one share of the Company’s common stock at $1.25. Foreach share purchased, the investor received a five-year warrant to purchase one share of common stock at $1.25 per share. No commissionswere paid in the offering. This issuance was pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transactionexempt from registration.

 

OnOctober 14, 2021, the Company issued a total of 47,000 shares of its common stock valued at $37,600 (based on the stock price of theCompany’s common stock on the date of issuance) to a third party, for hosting webinar presentations with the financial community.

 

OnJuly 14, 2021, the Company issued a total of 47,000 shares of its common stock valued at $47,000 (based on the stock price of the Company’scommon stock on the date of issuance) to a third party, for hosting webinar presentations with the financial community.

 

OnMay 10, 2021, Brio Capital elected to convert the aggregate principal amount of a $110,000 convertible note issued on February 10, 2021into 157,143 shares of the Company’s common stock.

 

InApril 2021, the Company initiated an offering of up to $1.5 million of the Company’s restricted common shares. The offering allowedfor qualified investors to purchase one share of the Company’s common stock $1.25. For each share purchased, the investor receiveda five-year warrant to purchase one share of common stock at $1.75 per share. On May 10, 2021, the Company closed the offering to investorsand subsequently disclosed that it had entered into securities purchase agreements with accredited investors that resulted in the issuanceof 1,172,000 shares of common stock and warrants to purchase an aggregate of 1,172,000 shares of the Company’s common stock fortotal proceeds totaling $1,465,000. No commissions were paid in the offering. This issuance was pursuant to Section 4(a)(2) of the SecuritiesAct of 1933, as amended, in a transaction exempt from registration.

 

OnApril 14, 2021, the Company issued a total of 47,000 shares of its restricted common stock valued at $82,250 (based on the stock priceof the Company’s common stock on the date of issuance) to a third party, for communications to the financial industry. This issuancewas pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transaction exempt from registration.

 

OnFebruary 19, 2021, a previous noteholder exercised the warrants pursuant to the cashless exercise provision of the warrant agreementinto 57,147 common shares. The common shares have not been issued as of May 13, 2022.

 

OnJanuary 14, 2021, the Company issued a total of 47,000 shares of its restricted common stock valued at $82,250 (based on the stock priceof the Company’s common stock on the date of issuance) to a third party, for communications to the financial industry. This issuancewas pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transaction exempt from registration.

 

Warrants

 

OnOctober 22, 2021, the Company and Osher amended convertible debt agreements for the maturity date from October 20, 2021 to October 20,2022. In exchange for the extension of the Note, the Company issued Osher 450,000 warrants to purchase an aggregate of 450,000 sharesof the Company’s common stock, valued at $197,501 (based on the Black Scholes valuation model on the date of grant) (see Note 6).The warrants are exercisable for a period of five years at $1.00 per share in whole or in part, as either a cash exercise or as a cashlessexercise, and fully vest at grant date. The Company is accreting the value of the warrants ratably through October 20, 2022. The Companyrecorded $48,699 and $0 for the three months ended March 31, 2022 and 2021, respectively, and is classified in other expenses in theconsolidated Statements of Operations.

 

F-40
 

 

NOTE8 – OPERATING LEASES

 

OnMay 27, 2021, the Company entered into a sixty-three month lease for its corporate office at $5,955 per month commencing June 15, 2021maturing September 30, 2026. The Company accounts for this lease in accordance with ASC 842. Adoptionof the standard resulted in the initial recognition of operating lease ROU asset of $290,827 andoperating lease liability of $290,827 as of June 15, 2021.

 

Operatinglease right-of-use (“ROU”) assets and liabilities are recognized at commencement date based on the present value of leasepayments over the lease term. ROU assets represent our right to use an underlying asset for the lease term and lease liabilities representour obligation to make lease payments arising from the lease. Generally, the implicit rate of interest in arrangements is not readilydeterminable and the Company utilizes its incremental borrowing rate in determining the present value of lease payments. The Company’sincremental borrowing rate is a hypothetical rate based on its understanding of what its credit rating would be. The operating leaseROU asset includes any lease payments made and excludes lease incentives. Our variable lease payments primarily consist of maintenanceand other operating expenses from our real estate leases. Variable lease payments are excluded from the ROU assets and lease liabilitiesand are recognized in the period in which the obligation for those payments is incurred. Our lease terms may include options to extendor terminate the lease when it is reasonably certain that we will exercise that option. Lease expense for minimum lease payments is recognizedon a straight-line basis over the lease term.

 

Wehave lease agreements with lease and non-lease components. We have elected to account for these lease and non-lease components as a singlelease component. We are also electing not to apply the recognition requirements to short-term leases of twelve months or less and insteadwill recognize lease payments as expense on a straight-line basis over the lease term.

 

Thecomponents of lease expense and supplemental cash flow information related to leases for the period are as follows:

 

Inaccordance with ASC 842, the components of lease expense were as follows:

 

   2022   2021 
   Three Months ended March 31, 
   2022   2021 
Operating lease expense  $17,919   $- 
Short term lease cost  $-   $- 
Total lease expense  $17,919   $- 

 

Inaccordance with ASC 842, other information related to leases was as follows:

 

Three Months ended March 31,  2022   2021 
Operating cash flows from operating leases  $17,866   $- 
Cash paid for amounts included in the measurement of lease liabilities  $17,866   $- 
           
Weighted-average remaining lease term—operating leases    4.67 years     - 
Weighted-average discount rate—operating leases   10%   - 

 

Inaccordance with ASC 842, maturities of operating lease liabilities as of March 31, 2022 were as follows:

 

   Operating 
Year ending:  Lease 
2022 (remaining 9 months)  $54,848 
2023   74,895 
2024   77,142 
2025   79,456 
2026   54,225 
Total undiscounted cash flows  $340,566 
      
Reconciliation of lease liabilities:     
Weighted-average remaining lease terms    4.67 years  
Weighted-average discount rate   10%
Present values  $275,928 
      
Lease liabilities—current   47,794 
Lease liabilities—long-term   228,135 
Lease liabilities—total  $275,928 
      
Difference between undiscounted and discounted cash flows  $64,638 

 

Operatinglease cost was $17,919 and $0 for the three months ended March 31, 2022 and 2021, respectively.

 

F-41
 

 

NOTE9 – RELATED PARTY TRANSACTIONS

 

Otherthan as set forth below, and as disclosed in Notes 5 and 7, there have not been any transaction entered into or been a participant inwhich a related person had or will have a direct or indirect material interest.

 

EmploymentAgreements

 

Mr.Ferrell was hired March 9, 2022 as the Company’s Chief Financial Officer. Mr. Ferrell receives an annual base salary of $250,000,plus discretionary bonus compensation not to exceed 40% of salary. Mr. Ferrell’s employment also provides for medical insurance,disability benefits and three months of severance pay if his employment is terminated without cause or due to a change in control. Additionally,Mr. Ferrell will be granted up to 600,000 options to purchase 600,000 of the Company’s common shares upon the implementation ofa Company employee option plan. The Company incurred compensation expense of $10,417 and $0 and employee benefits of $1,140 and $0 forthe three months ended March 31, 2022 and 2021, respectively.

 

NOTE10 – EARNINGS PER SHARE

 

FASBASC Topic 260, Earnings Per Share, requires a reconciliation of the numerator and denominator of the basic and diluted earnings(loss) per share (EPS) computations.

 

Basicearnings (loss) per share are computed by dividing net earnings available to common stockholders by the weighted-average numberof common shares outstanding during the period. Diluted earnings (loss) per share is computed similar to basic earnings per share exceptthat the denominator is increased to include the number of additional common shares that would have been outstanding if the potentialcommon shares had been issued and if the additional common shares were dilutive. In periods where losses are reported, the weighted-averagenumber of common stock outstanding excludes common stock equivalents, because their inclusion would be anti-dilutive.

 

Basicand diluted earnings (loss) per share are the same since net losses for all periods presented and including the additional potentialcommon shares would have an anti-dilutive effect.

 

F-42
 

 

Thefollowing table sets forth the computation of basic and diluted net income per share:

 

   2022   2021 
   Three Months Ended March 31, 
   2022   2021 
         
Net loss attributable to the common stockholders  $(678,046)  $(461,682)
           
Basic weighted average outstanding shares of common stock   37,295,803    35,266,601 
Dilutive effect of options and warrants   -    - 
Diluted weighted average common stock and common stock equivalents   37,295,803    35,266,601 
           
Loss per share:          
Basic and diluted  $(0.02)  $(0.01)

 

NOTE11 – COMMITMENTS AND CONTINGENCIES

 

Legal

 

Fromtime to time, various lawsuits and legal proceedings may arise in the ordinary course of business. However, litigation is subject toinherent uncertainties and an adverse result in these or other matters may arise from time to time that may harm our business. We arecurrently not aware of any legal proceedings or claims that it believes will have a material adverse effect on its business, financialcondition or operating results.

 

NOTE12 – SUBSEQUENT EVENTS

 

TheCompany evaluated all events or transactions that occurred after March 31, 2022 up through the date the financial statements were availableto be issued. During this period, the Company did not have any material recognizable subsequent events required to be disclosed as ofand for the period ended March 31, 2022 except for the following:

 

OnApril 28, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “April 2022 Note”)totaling (i) $110,000 aggregate principal amount of April 2022 Note due April 28, 2023 based on $1.00 for each $0.90909 paid by the previousnoteholder and (ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 220,000 sharesof the Company’s Common Stock at an exercise price of $0.50 per share. The conversion pricefor the principal in connection with voluntary conversions by the holders of the convertible notes is $0.50 per share.

 

OnMay 10, 2022, the Company entered into an Original Issue Discount Senior Convertible Debenture (the “May 2022 Note”) totaling(i) $110,000 aggregate principal amount of Note due May 10, 2023 based on $1.00 for each $0.90909 paid by the previous noteholder and(ii) five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 220,000 shares of the Company’sCommon Stock at an exercise price of $0.50 per share. The conversion price for the principal inconnection with voluntary conversions by the holders of the convertible notes is $0.50 per share.

 

F-43
 

 

 

 

ClassA Units

EachClass A Unit Consisting of

OneShare of Common Stock and

OneSeries A Warrant to Purchase One Share of Common Stock

ClassB Units

EachClass B Unit Consisting of ___ Share of Series B Preferred Stock and One Series A Warrant to Purchase One Share of Common Stock

 

 

 

PROSPECTUS

 

 

 

, 2022

 

   
 

 

PARTII

 

INFORMATIONNOT REQUIRED IN THE PROSPECTUS

 

ITEM13. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION

 

Securities and Exchange Commission Registration Fee  $1,853 
FINRA Filing Fee   3,499 
Nasdaq Listing Fee   - 
Transfer Agent and Registrar Fees   - 
Printing and Engraving Expenses   - 
Legal Fees   - 
Accounting Fees and Expenses   - 
Miscellaneous   - 
Total  $- 

 

Allamounts are estimates other than the Commission’s registration fee. We are paying all expenses of the offeringlisted above.

 

ITEM14. INDEMNIFICATION OF DIRECTORS AND OFFICERS

 

Aspermitted by Section 102 of the Delaware General Corporation Law, we will adopt provisions in our Amended and Restated Certificate ofIncorporation and our Amended and Restated Bylaws that limit or eliminate the personal liability of our directors for a breach of theirfiduciary duty of care as a director. The duty of care generally requires that, when acting on behalf of the corporation, directors exercisean informed business judgment based on all material information reasonably available to them. Consequently, a director will not be personallyliable to us or our stockholders for monetary damages for breach of fiduciary duty as a director, except for liability for:

 

  any breach of the director’s duty of loyalty to us or our stockholders;
     
  any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;
     
  any act related to unlawful stock repurchases, redemptions or other distributions or payment of dividends; or
     
  any transaction from which the director derived an improper personal benefit.

 

Theselimitations of liability do not affect the availability of equitable remedies such as injunctive relief or rescission. Our Amended andRestated Certificate of Incorporation also authorizes us to indemnify our officers, directors and other agents to the fullest extentpermitted under Delaware law.

 

Aspermitted by Section 145 of the Delaware General Corporation Law, our Amended and Restated Bylaws will provide that:

 

  we may indemnify our directors, officers and employees to the fullest extent permitted by the Delaware General Corporation Law, subject to limited exceptions;

 

Aspermitted by Section 102 of the Delaware General Corporation Law, we will adopt provisions in our Amended and Restated Certificate ofIncorporation and our Amended and Restated Bylaws that limit or eliminate the personal liability of our directors for a breach of theirfiduciary duty of care as a director. The duty of care generally requires that, when acting on behalf of the corporation, directors exercisean informed business judgment based on all material information reasonably available to them. Consequently, a director will not be personallyliable to us or our stockholders for monetary damages for breach of fiduciary duty as a director, except for liability for:

 

  any breach of the director’s duty of loyalty to us or our stockholders;

 

 II-1 
 

 

  any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;
     
  any act related to unlawful stock repurchases, redemptions or other distributions or payment of dividends; or
     
  any transaction from which the director derived an improper personal benefit.

 

Theselimitations of liability do not affect the availability of equitable remedies such as injunctive relief or rescission. Our Amended andRestated Certificate of Incorporation also authorizes us to indemnify our officers, directors and other agents to the fullest extentpermitted under Delaware law.

 

Aspermitted by Section 145 of the Delaware General Corporation Law, our Amended and Restated Bylaws will provide that:

 

  we may indemnify our directors, officers and employees to the fullest extent permitted by the Delaware General Corporation Law, subject to limited exceptions.

 

Weplan to enter into an underwriting agreement that provides that the underwriters are obligated, under some circumstances, to indemnifyour directors, officers and controlling persons against specified liabilities, including liabilities under the Securities Act.

 

ITEM15. RECENT SALE OF UNREGISTERED SECURITIES

 

PreferredStock

 

TheCompany has 10,000,000 shares of par value $0.0001 preferred stock authorized, of which no preferred shares are issued and outstandingat June 22, 2022.

 

CommonStock

 

TheCompany has authorized 1,000,000,000 shares of par value $0.0001 common stock, of which 37,238,656 shares are outstanding at June 22, 2022.

 

OnOctober 28, 2021, an investor elected   to convert $16,714 of the aggregate principal amount of the Note of $199,650, into42,857 common shares.

 

OnOctober 25, 2021, an investor elected to convert the aggregate principal amount of the Note, $110,000, into 157,143 common shares.

 

OnOctober 20, 2021, the Company entered into a securities purchase agreement with an accredited investor that resulted in the issuanceof 320,000 shares of common stock and warrants to purchase an aggregate of 320,000 shares of the Company’s common stock for totalproceeds totaling $400,000. The offering allowed for qualified investors to purchase one share of the Company’s common stock at$1.25. For each share purchased, the investor received a five-year warrant to purchase one share of common stock at $1.25 per share.No commissions were paid in the offering. This issuance was pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, ina transaction exempt from registration.

 

OnOctober 14, 2021, the Company issued a total of 47,000 shares of its common stock valued at $37,600 (based on the stock price of theCompany’s common stock on the date of issuance) to a third party, for communications to the financial industry.

 

 II-2 
 

 

OnJuly 14, 2021, the Company issued a total of 47,000 shares of its common stock valued at $47,000 (based on the stock price of the Company’scommon stock on the date of issuance) to a third party, for communications to the financial industry.

 

OnMay 10, 2021, Brio Capital elected to convert the aggregate principal amount of a $110,000 convertible note issued on February 10, 2021into 157,143 shares of the Company’s common stock.

 

InApril 2021, the Company initiated an offering of up to $1.5 million of the Company’s restricted common shares. The offering allowedfor qualified investors to purchase one share of the Company’s common stock $1.25. For each share purchased, the investor receiveda five-year warrant to purchase one share of common stock at $1.75 per share. On May 10, 2021, the Company closed the offering to investorsand subsequently disclosed that it had entered into securities purchase agreements with accredited investors that resulted in the issuanceof 1,172,000 shares of common stock and warrants to purchase an aggregate of 1,172,000 shares of the Company’s common stock fortotal proceeds totalling $1,465,000. No commissions were paid in the offering. This issuance was pursuant to Section 4(a)(2) of the SecuritiesAct of 1933, as amended, in a transaction exempt from registration.

 

OnApril 14, 2021, the Company issued a total of 47,000 shares of its restricted common stock valued at $82,250 (based on the stock priceof the Company’s common stock on the date of issuance) to a third party, for communications to the financial industry. This issuancewas pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transaction exempt from registration.

 

OnFebruary 19, 2021, a previous noteholder exercised the warrants pursuant to the cashless exercise provision of the warrant agreementinto 57,147 common shares. The common shares have not been issued as of March 14, 2022.

 

OnJanuary 14, 2021, the Company issued a total of 47,000 shares of its restricted common stock valued at $82,250 (based on the stock priceof the Company’s common stock on the date of issuance) to a third party, for communications to the financial industry. This issuancewas pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, in a transaction exempt from registration.

 

Duringthe year ended December 31, 2020, the Company issued 1,015,344 common shares to third parties in conjunction with the exchange of convertiblepromissory debentures.

 

OnOctober 19, 2020, the Company issued 33,686,169 common shares in conjunction with acquisition.

 

Warrants

 

OnOctober 22, 2021, the Company and Osher amended convertible debt agreements for the maturity date from October 20, 2021 to October 20,2022. In exchange for the extension of the Note, the Company issued Osher 450,000 warrants to purchase an aggregate of 450,000 sharesof the Company’s common stock, valued at $197,501 (based on the Black Scholes valuation model on the date of grant) (see Note 6).The warrants are exercisable for a period of five years at $1.00 per share in whole or in part, as either a cash exercise or as a cashlessexercise, and fully vest at grant date. The Company is amortizing the value of the warrants ratably through October 20, 2022. The Companyrecorded $40,041 and $0 for the years ended December 31, 2021 and 2020, respectively, and is classified in other expenses in the consolidatedStatements of Operations.

 

CurrentNoteholders

 

Osher– $457,380

 

OnJanuary 28, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “PurchaseAgreement”) with respect to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”) of(i) $385,000 aggregate principal amount of Original Issue Discount Senior Convertible Debenture due January 26, 2021, based on $1.00for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants to purchase up to an aggregate of 80,209 shares ofthe Company’s Common Stock at an exercise price of $7.00 per share. The aggregate cash subscription amount received by the Companyfrom Osher for the issuance of the note and warrants was $350,005 which was issued at a $34,995 original issue discount from the facevalue of the Note. The conversion price for the principal in connection with voluntary conversions by a holder of the convertible notesis $0.094 per share, as amended on October 20, 2020, subject to adjustment as provided therein, such as stock splits and stock dividends.

 

 II-3 
 

 

TheCompany and Osher amended the convertible debt agreement as follow-on October 20, 2020:

 

  The parties amended the Warrants dated January 28, 2020, for the number of warrant shares from 80,209 warrant shares to 4,113,083 warrant shares at an exercise price of $0.14 per share.
  The parties amended the Note for the maturity date from June 23,2021 to October 20, 2021.

 

OnOctober 22, 2021, the Company and Osher amended convertible debt agreements as follows:

 

  The parties amended the October 20,2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
  The parties amended the October 20,2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
  In exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of the Company’s common stock at an exercise price of $1.00 per share.

 

Osher– $60,500

 

OnJune 23, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “PurchaseAgreement”) with respect to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”) of(i) $50,000 aggregate principal amount of Original Issue Discount Senior Convertible Debenture (the “Note”) due June 23,2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants (“Warrants”) to purchaseup to an aggregate of 10,000 shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregate cashsubscription amount received by the Company from Osher for the issuance of the Note and Warrants was $50,005 which was issued at a $0original issue discount from the face value of the Note. The conversion price for the principal in connection with voluntary conversionsby a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment as provided therein, suchas stock splits and stock dividends.

 

TheCompany and Osher amended the convertible debt agreement as follow-on October 20, 2020:

 

  The parties amended the Note for the aggregate principal amount from $50,000 to $55,000. The aggregate cash subscription amount received by the Company from Osher for the issuance of the Note and Warrants was $50,005 which was issued at an amended $4,995 original issue discount from the face value of the Note.
  The parties amended the Warrants dated June 23, 2020, for the number of warrant shares from 10,000 warrant shares to 141,020 warrant shares at an exercise price of $0.59 per share.
  The parties amended the Note for the maturity date from June 23, 2021 to October 20, 2021.

 

OnOctober 22, 2021, the Company and Osher amended convertible debt agreements as follows:

 

  The parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
  The parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
  In exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of the Company’s common stock at an exercise price of $1.00 per share.

 

 II-4 
 

 

Osher– $199,650

 

OnSeptember 17, 2020 (the “Original Issue Date”), the Company entered into a Securities Purchase Agreement (the “PurchaseAgreement”) with respect to the sale and issuance to institutional investor Osher Capital Partners LLC (“Osher”) of(i) $181,500 aggregate principal amount of Original Issue Discount Senior Convertible Debenture (the “Note”) due September30, 2021, based on $1.00 for each $0.90909 paid by Osher and (ii) five-year Common Stock Purchase Warrants (“Warrants’) topurchase up to an aggregate of 8,250 shares of the Company’s Common Stock at an exercise price of $30.00 per share. The aggregatecash subscription amount received by the Company from Osher for the issuance of the Note and Warrants was $165,000 which was issued ata $16,500 original issue discount from the face value of the Note. The conversion price for the principal in connection with voluntaryconversions by a holder of the convertible notes is $0.39 per share, as amended on October 20, 2020, subject to adjustment as providedtherein, such as stock splits and stock dividends.

 

TheCompany and Osher amended the convertible debt agreement as follow-on October 20, 2020:

 

  The parties amended the Warrants dated September 17, 2020, for the number of warrant shares from 8,250 warrant shares to 465,366 warrant shares at an exercise price of $0.59 per share.
  The parties amended the Note for the maturity date from September 30, 2021 to October 20, 2021.

 

OnOctober 22, 2021, the Company and Osher amended convertible debt agreements as follows:

 

  The parties amended the October 20, 2020 Notes for the maturity date from October 20, 2021 to October 20, 2022.
  The parties amended the October 20, 2020 Notes for the aggregate principal amount and accrued interest from $652,300 to $717,530 which is issued at a $65,230 original issue discount from the face value of the October 20, 2020 Notes now due October 20, 2022.
  In exchange for the extension of the Note, the Company issued Osher five-year warrants to purchase an aggregate of 450,000 shares of the Company’s common stock at an exercise price of $1.00 per share.

 

OnOctober 28, 2021, Osher elected to convert $16,714 of the aggregate principal amount of the Note of $199,650, into 42,857 common shares.

 

OnMarch 23, 2022, the Company entered into an Original Issue Discount Senior Convertible Debentures (the “Note”) totaling (i)$220,000 aggregate principal amount of Note due March 23, 2023 based on $1.00 for each $0.90909 paid by the previous noteholder and (ii)five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 440,000 shares of the Company’sCommon Stock at an exercise price of $0.50 per share. The conversion price for the principal in connection with voluntary conversionsby the holders of the convertible notes is $0.50 per share.

 

OnApril 28, 2022, the Company entered into an Original Issue Discount Senior Convertible Debentures (the “Note”) totaling (i)$220,000 aggregate principal amount of Note due April 28, 2023 based on $1.00 for each $0.90909 paid by the previous noteholder and (ii)five-year Common Stock Purchase Warrants (“Warrants’) to purchase up to an aggregate of 440,000 shares of the Company’sCommon Stock at an exercise price of $0.50 per share. The conversion price for the principal in connection with voluntary conversionsby the holders of the convertible notes is $0.50 per share.

 

Theseissuances have been made pursuant to transactions exempt from registration under Section 4(a)(2) of the Securities Act of 1933, as amended.

 

 II-5 
 

 

ITEM16. EXHIBITS

 

Exhibit

Number

  Description
1.1   Form of Underwriting Agreement**
     
3.1*   Amended and Restated Certificate of Incorporation, as filed with the Secretary of State of the State of Delaware on December 22, 2015 and as currently in effect. (Filed as Exhibit 3.1 to the Current Report on Form 8-K filed by the Registrant on December 24, 2015 and incorporated herein by reference)
     
3.2*   Bylaws of the Registrant, as currently in effect (Filed as Exhibit 3.2 to the Registration Statement on Form S-1 filed by the Registrant on May 27, 2015, and incorporated herein by reference).
     
4.1   Form of Representative’s Warrant**
     
4.2   Certificate of Designation for Series B Preferred Stock
     
4.3   Form of Series A Warrant**
     
5.1   Legal opinion of Jolie Kahn Esq. (to be added by amendment) **
     
10.1*+   Form of Indemnification Agreement between the Registrant and each of its directors and executive officers (Filed as Exhibit 10.1 to the Registration Statement on Form S-1 filed by the Registrant on May 27, 2015, and incorporated herein by reference).
     
10.2*+   Employment Agreement, dated April 1, 2015, between the Registrant and Joseph Segelman (Filed as Exhibit 10.2 to the Registration Statement on Form S-1 filed by the Registrant on May 27, 2015, and incorporated herein by reference).
     
10.3*+   Employment Agreement, dated April 1, 2015, between the Registrant and Chaya Segelman (Filed as Exhibit 10.3 to the Registration Statement on Form S-1 filed by the Registrant on May 27, 2015, and incorporated herein by reference).
     
10.4*+   2015 Equity Incentive Plan, as amended and currently in effect (Filed as Exhibit 10.8 to the Current Report on Form 8-K filed by the Registrant on December 24, 2015 and incorporated herein by reference)
     
10.5*+   Share Option Agreement, dated May 1, 2015, between the Registrant and Joseph Segelman (Filed as Exhibit 10.5 to the Registration Statement on Form S-1 filed by the Registrant on May 27, 2015, and incorporated herein by reference).
     
10.6*   Securities Purchase Agreement dated as of December 23, 2015 by and among the Registrant and the Purchasers defined and identified therein (Filed as Exhibit 10.1 to the Current Report on Form 8-K filed by the Registrant on December 24, 2015 and incorporated herein by reference)
     
10.7*   Form of Secured Convertible Note issued under the Securities Purchase Agreement included as Exhibit 10.6 (Filed as Exhibit 10.2 to the Current Report on Form 8-K filed by the Registrant on December 24, 2015 and incorporated herein by reference)
     
10.8*   Security Agreement dated as December 23, 2015 by and among the Company and the Collateral Agent and Secured Parties defined and identified therein. (Filed as Exhibit 10.3 to the Current Report on Form 8-K filed by the Registrant on December 24, 2015 and incorporated herein by reference)
     
10.9*   Corporate Guaranty dated as December 23, 2015 entered into by Australian Sapphire Corporation as guarantor for the benefit of the Collateral Agent and the Lenders defined and identified therein. (Filed as Exhibit 10.4 to the Current Report on Form 8-K filed by the Registrant on December 24, 2015 and incorporated herein by reference)
     
10.10*   Guarantor Security Agreement dated as December 23, 2015 by and among Australian Sapphire Corporation as guarantor and the Collateral Agent and Secured Parties defined and identified therein delivered in connection with the Corporate Guaranty included as Exhibit 10.9. (Filed as Exhibit 10.5 to the Current Report on Form 8-K filed by the Registrant on December 24, 2015 and incorporated herein by reference)

 

 II-6 
 

 

10.11*   Personal Guaranty dated as December 23, 2015 entered into by Joseph Segelman as guarantor for the benefit of the Collateral Agent and the Lenders defined and identified therein. (Filed as Exhibit 10.6 to the Current Report on Form 8-K filed by the Registrant on December 24, 2015 and incorporated herein by reference)
     
10.12*   Form of Common Stock Purchase Warrant issued under the Securities Purchase Agreement included as Exhibit 10.6 (Filed as Exhibit 10.7 to the Current Report on Form 8-K filed by the Registrant on December 24, 2015 and incorporated herein by reference)
     
10.13*   Asset Purchase Agreement dated December 1, 2016 (Filed as Exhibit 10.1 to the Current Report on Form 8-K filed by the Registrant on December 1, 2016 and incorporated herein by reference)
     
10.14*   Assignment and Assumption Agreement under the Asset Purchase Agreement dated December 1, 2016 (Filed as Exhibit 10.2 to the Current Report on Form 8-K filed by the Registrant on December 1, 2016 and incorporated herein by reference)
     
10.15*   Bill of Sale under the Asset Purchase Agreement dated December 1, 2016 (Filed as Exhibit 10.3 to the Current Report on Form 8-K filed by the Registrant on December 1, 2016 and incorporated herein by reference)
     
10.16*   Confidentiality and Proprietary Rights Agreement under the Asset Purchase Agreement dated December 1, 2016 (Filed as Exhibit 10.4 to the Current Report on Form 8-K filed by the Registrant on December 1, 2016 and incorporated herein by reference)
     
10.17*   Intellectual Property Assignment Agreement under the Asset Purchase Agreement dated December 1, 2016 (Filed as Exhibit 10.5 to the Current Report on Form 8-K filed by the Registrant on December 1, 2016 and incorporated herein by reference)
     
10.18*   Securities Purchase Agreement dated as of November 10, 2016 by and among the Registrant and the Purchasers defined and identified therein (Filed as Exhibit 10.1 to the Current Report on Form 8-K filed by the Registrant on November 10, 2016 and incorporated herein by reference)
     
10.19*   Form of Secured Convertible Note issued under the Securities Purchase Agreement included as Exhibit 10.1 (Filed as Exhibit 10.2 to the Current Report on Form 8-K filed by the Registrant on November 10, 2016 and incorporated herein by reference)
     
10.20*   Form of Common Stock Purchase Warrant issued under the Securities Purchase Agreement included as Exhibit 10.1 (Filed as Exhibit 10.7 to the Current Report on Form 8-K filed by the Registrant on November 10, 2016 and incorporated herein by reference)
     
21.1   Subsidiaries of the Registrant**
     
23.1   Consent of Paris Kreit & Chiu CPA LLP
     
23.2   Consent Jolie Kahn Esq. (included in Exhibit 5.1)**
     
24.1   Power of Attorney (included on the signature page)
     
101   The following materials from Reign Resources’ Annual Report on Form 10-K for the year ended December 31, 2016 are formatted in XBRL (Extensible Business Reporting Language): (I) the Balance Sheets, (ii) the Statements of Operations, (iii) Statement of Shareholders’ Deficit, (iv) the Statements of Cash Flow, and (v) Notes to Financial Statements.
     
107   Calculation of Filing Fee Table
     
*   Previously filed.
**   To be filed by amendment
+   Management contract or compensatory plan

 

Allreferences to Registrant’s Forms 8-K, 10-K and 10-Q include reference to File No. 000-55575

 

 II-7 
 

 

ITEM17. UNDERTAKINGS

 

Theundersigned registrant hereby undertakes to:

 

(1) File, during any period in which it offers or sells securities, a post-effective amendment to this registration statement to:

 

  (I) Include any prospectus required by Section 10(a)(3) of the Securities Act;
     
  (ii) Reflect in the prospectus any facts or events which, individually or together, represent a fundamental change in the information in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement;

 

  (iii) Include any additional or changed material information on the plan of distribution.

 

(2) For determining liability under the Securities Act, each post-effective amendment shall be deemed to be a new registration statement of the securities offered, and the offering of the securities at that time shall be deemed to be the initial bona fide offering.
   
(3) File a post-effective amendment to remove from registration any of the securities that remain unsold at the end of the offering.
   
(4) For determining liability of the undersigned registrant under the Securities Act to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:

 

  (i) Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424;
     
  (ii) Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;
     
  (iii) The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and
     
  (iv) Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.

 

Theundersigned registrant hereby undertakes to provide to the underwriter at the closing specified in the underwriting agreement certificatesin such denominations and registered in such names as required by the underwriter to permit prompt delivery to each purchaser.

 

Insofaras indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons ofthe registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the SEC suchindemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claimfor indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer,or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officeror controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel thematter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question of whether such indemnificationby it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

 

Theundersigned registrant hereby undertakes that:

 

(1)For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filedas part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuantto Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the timeit was declared effective.

 

(2)For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form ofprospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securitiesat that time shall be deemed to be the initial bona fide offering thereof.

 

 II-8 
 

 

SIGNATURES

 

Pursuantto the requirements of the Securities Act of 1933, the registrant has duly caused this Registration Statement to be signed on its behalfby the undersigned hereunto duly authorized.

 

  Sigyn Therapeutics, Inc.
     
Dated: June 22, 2022 By: /s/ James Joyce
    James Joyce
    Chief Executive Officer and Director
    (Principal Executive Officer)
     
Dated: June 22, 2022 By: /s/ Jeremy Ferrell
    Jeremy Ferrell
    Chief Financial Officer
    (Principal Financial and Accounting Officer)
     
Dated: June 22, 2022 By: /s/ Craig Roberts
    Craig Roberts
    Chief Technology Officer and Director

 

Eachof the undersigned, whose signature appears below, hereby constitutes and appoints James Joyce and Jeremy Ferrell and each of them, ashis or her true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution, to do any and all acts andthings and execute, in the name of the undersigned, any and all instruments which said attorney-in-fact and agent may deem necessaryor advisable in order to enable the Company to comply with the Securities Act and any requirements of the SEC in respect thereof, inconnection with the filing with the SEC of this Registration Statement on Form S-1 under the Securities Act, including specifically butwithout limitation, power and authority to sign the name of the undersigned to such Registration Statement, and any amendments to suchRegistration Statement, and any additional Registration Statement filed pursuant to Rule 462(b), and to file the same with all exhibitsthereto and other documents in connection therewith, with the SEC, to sign any and all applications, registration statements, noticesor other documents necessary or advisable to comply with applicable state securities laws, and to file the same, together with otherdocuments in connection therewith with the appropriate state securities authorities, granting unto said attorney-in-fact and agent, fullpower and authority to do and to perform each and every act and thing requisite or necessary to be done in and about the premises, asfully and to all intents and purposes as the undersigned might or could do in person, hereby ratifying and confirming all that said attorney-in-factand agent, or his substitute, may lawfully do or cause to be done by virtue hereof.

 

Pursuantto the requirements of the Securities Act of 1933, this Registration Statement has been signed by the following persons in the capacitiesand on the dates indicated:

 

Name   Title   Date
         
/s/ Mr. James Joyce   Chief Executive Officer and Director   June 22, 2022
Mr. James Joyce        
         
/s/ Mr. Craig Roberts   Chief Technology Officer and Director   June 22, 2022
Mr. Craig Roberts        
         
/s/ Mr. Jeremy Ferrell   Chief Financial Officer   June 22, 2022
Mr. Jeremy Ferrell        

 

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