Asfiled with the U.S. Securities and Exchange Commission on January 31, 2024

Registration No. 333-         

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIESACT OF 1933

180 Life Sciences Corp. 

(Exact name of registrant as specified in itscharter)

3000 El Camino Real, Bldg. 4, Suite 200
Palo Alto, CA 94306
(650) 507-0669

(Address, including zip code, and telephonenumber, including area code, of registrant’s principal executive offices)

James N. Woody, M.D., Ph.D.
Chief Executive Officer
180 Life Sciences Corp.
3000 El Camino Real, Bldg. 4, Suite 200
Palo Alto, CA 94306
(650) 507-0669

(Name, address, including zip code, and telephonenumber, including area code, of agent for service)

Copies to:

Approximate date of commencementof proposed sale to the public: From time to time after this registration statement becomes effective.

If any of the securities beingregistered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, checkthe following box:  ☒

If this Form is filed to registeradditional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list theSecurities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

If this Form is a post-effectiveamendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registrationstatement number of the earlier effective registration statement for the same offering.  ☐

If this Form is a post-effectiveamendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registrationstatement number of the earlier effective registration statement for the same offering.  ☐

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

If an emerging growth company,indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financialaccounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act.  ☐ 

The registrant hereby amends this registration statement on suchdate or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically statesthat this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of1933 or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuantto said Section 8(a), may determine.

The information containedin this prospectus is not complete and may be changed. The selling stockholder may not sell these securities until the registration statementfiled with the Securities and Exchange Commission is 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.

SUBJECT TO COMPLETION,DATED JANUARY 31, 2024

PRELIMINARY PROSPECTUS

13,950,976 Shares of Common Stock 

This prospectus relates solelyto the offer and sale from time to time of up to an aggregate of 13,950,976 shares of our common stock, par value $0.0001 per share, of180 Life Sciences Corp., a Delaware corporation (the “Company,” “we,” “our” or“us”), by the selling stockholder identified in this prospectus (the “Selling Stockholder”). Theshares of common stock being registered for resale hereunder consist of: (i) 9,064,098 shares of common stock issuable upon the exerciseof the December 2023 Pre-Funded Warrants (as defined herein under “December 2023 Warrants and Related Transactions”),and (ii) 4,886,878 shares of common stock issuable upon the exercise of the December 2023 Common Warrants (as defined herein under“December 2023 Warrants and Related Transactions”)(together the December 2023 Pre-Funded Warrants and the December2023 Common Warrants, the “Warrants,” and all of the shares of common stock issuable upon exercise of the Warrants,the “Shares”) acquired by the Selling Stockholder, in each case, pursuant to securities purchase agreements betweenus and the Selling Stockholder and amendments thereto.

Each of the December 2023Common Warrants are exercisable at an exercise price of $0.17. The exercise price of the December 2023 Pre-Funded Warrants ($0.0001 pershare) has already been paid to us. We are not selling any common stock under this prospectus and will not receive any of the proceedsfrom the sale of the Shares by the Selling Stockholder. However, if all of the December 2023 Common Warrants that are covered by thisprospectus are exercised for cash, we may receive proceeds of up to approximately $1,540,897. We intend to use those proceeds, if any,for research and development, and general corporate purposes, including the potential expenses related to completing a reverse mergerand legal expenses. We will bear all other costs, expenses and fees in connection with the registration of the Shares. The Selling Stockholderwill bear all commissions and discounts, if any, attributable to the sales of Shares.

The Selling Stockholder mayoffer such Shares from time to time as it may determine through public or private transactions or through other means described in thesection entitled “Plan of Distribution” beginning on page 161 of this prospectus, at prevailing market prices, at pricesrelated to prevailing market prices or at privately negotiated prices. This prospectus does not necessarily mean that the Selling Stockholderwill offer or sell the Shares. We cannot predict when or in what amounts the Selling Stockholder may sell any of the Shares offered bythis prospectus. Any Shares subject to resale hereunder will have been issued by us and acquired by the Selling Stockholder prior to anyresale of such Shares pursuant to this prospectus. Because all of the Shares offered under this prospectus are being offered by the SellingStockholder, we cannot currently determine the price or prices at which the Shares may be sold under this prospectus.

Our common stock is traded on the Nasdaq Capital Market (“Nasdaq”) underthe symbol “ATNF”. On January 30, 2024, the last reported sale price for our common stock as reported on Nasdaq was $0.2046per share.

INVESTING IN OURSECURITIES INVOLVES SUBSTANTIAL RISKS. SEE THE SECTION TITLED “RISK FACTORS” BEGINNING ON PAGE 5 OF THIS PROSPECTUSTO READ ABOUT FACTORS YOU SHOULD CONSIDER BEFORE BUYING OUR SECURITIES.

NEITHER THE SECURITIESAND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR PASSED UPON THE ADEQUACYOR ACCURACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.

The date of this prospectus is          , 2024.

TABLE OF CONTENTS

Glossary

The items below are abbreviationsand definitions of certain terms used in this prospectus, certain of which are commonly used in the pharmaceutical and biotechnology industry.

Unless the context requiresotherwise, references to the “Company,” “we,” “us,” “our,”“180 Life”, “180LS” and “180 Life Sciences Corp.” refer specifically to 180 LifeSciences Corp. and its consolidated subsidiaries. References to “KBL” refer to the Company prior to the Closing (definedbelow).

Our logo and some of our trademarksand tradenames are used in this prospectus. This prospectus also includes trademarks, tradenames and service marks that are the propertyof others. Solely for convenience, trademarks, tradenames and service marks referred to in this prospectus may appear without the ®,™ and SM symbols. References to our trademarks, tradenames and service marks are not intended to indicate in any way that we willnot assert to the fullest extent under applicable law our rights or the rights of the applicable licensors if any, nor that respectiveowners to other intellectual property rights will not assert, to the fullest extent under applicable law, their rights thereto. We donot intend the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorshipof us by, any other companies.

The market data and certainother statistical information used throughout this prospectus are based on independent industry publications, reports by market researchfirms or other independent sources that we believe to be reliable sources; however, we have not commissioned any of the market or surveydata that is presented in this prospectus. Industry publications and third-party research, surveys and studies generally indicate thattheir information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completenessof such information. We are responsible for all of the disclosures contained in this prospectus, and we believe these industry publicationsand third-party research, surveys and studies are reliable, provided that we have not commissioned any such information. While we arenot aware of any misstatements regarding any third-party information presented in this prospectus, their estimates, in particular, asthey relate to projections, involve numerous assumptions, are subject to risks and uncertainties, and are subject to change based on variousfactors, including those discussed under the section entitled “Risk Factors” of this prospectus. These and other factorscould cause our future performance to differ materially from our assumptions and estimates. Some market and other data included herein,as well as the data of competitors as they relate to 180 Life Sciences Corp., is also based on our good faith estimates.

ABOUT THIS PROSPECTUS

This prospectus is part ofa registration statement on Form S-1 that we filed with the SEC. Under this registration statement, the Selling Stockholder may, fromtime to time, sell the shares of common stock offered by them described in this prospectus. We will not receive any proceeds from thesale by such Selling Stockholder of the Shares offered by them described in this prospectus. We will not receive any proceeds from thesale of Shares pursuant to this prospectus, except with respect to amounts received by us upon the exercise of the Warrants for cash.

Neither we nor the SellingStockholder have authorized anyone to provide you with any information or to make any representations other than those contained in thisprospectus or any applicable prospectus supplement or any free writing prospectus prepared by or on behalf of us or to which we have referredyou. Neither we nor the Selling Stockholder take responsibility for, and can provide no assurance as to the reliability of, any otherinformation that others may give you. Neither we nor the Selling Stockholder will make an offer to sell these securities in any jurisdictionwhere the offer or sale is not permitted. You should not assume that the information contained in this prospectus is accurate as of anydate other than the date of this prospectus. Our business, financial condition, results of operations and prospects may have changed sincethat date.

We may also provide a prospectussupplement or post-effective amendment to the registration statement to add information to, or update or change information containedin, this prospectus. You should read both this prospectus and any applicable prospectus supplement or post-effective amendment to theregistration statement together with the additional information to which we refer you in the section of this prospectus entitled “WhereYou Can Find More Information.”

We were originally formedas KBL Merger Corp. IV, a blank check company organized under the laws of the State of Delaware on September 7, 2016, which consummatedits initial public offering on June 7, 2017. On July 25, 2019, we entered into a business combination agreement and, on the Closing, weconsummated the Business Combination and changed our name to 180 Life Sciences Corp.

CAUTIONARYNOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-lookingstatements under federal securities laws, including within the meaning of the Private Securities Litigation Reform Act of 1995.In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,”“continue,” “could,” “estimate,” “expect,” “intend,”“may,” “ongoing,” “plan,” “potential,” “predict,”“project,” “should,” or the negative of these terms or other comparable terminology, although notall forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results, andwill not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-lookingstatements are based on information available at the time the statements are made and involve known and unknown risks, uncertainties andother factors that may cause our results, levels of activity, performance or achievements to be materially different from the informationexpressed or implied by the forward-looking statements in this prospectus.

In particular, forward-lookingstatements include, but are not limited to, any statements that are not statements of current or historical facts, such as statementsrelating to our expectations for the clinical and preclinical development, manufacturing, regulatory approval, and commercialization ofour product candidates, the accuracy of our estimates regarding expenses, future revenues and capital requirements, our ability to executeour plans to develop and market new drug products and the timing and costs of these development programs, and estimates of the sufficiencyof our existing capital resources combined with future anticipated cash flows to finance our operating requirements.

Such statements are basedon management’s current expectations, but actual results may differ materially due to various factors, including, but not limitedto:

Any forward-looking statementsin this prospectus reflect our current views with respect to future events or to our future financial performance and involve known andunknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially differentfrom any future results, performance or achievements expressed or implied by these forward-looking statements. Given these uncertainties,you should not place undue reliance on these forward-looking statements. All forward-looking statements included herein speak only asof the date of this prospectus. All subsequent written and oral forward-looking statements attributable to us, or persons acting on ourbehalf, are expressly qualified in their entirety by the cautionary statements above. Except as required by law, we assume no obligationto update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

RISK FACTORS

You should carefully considerall of the following risk factors and all the other information contained in this prospectus, including the consolidated financial statements.If any of the following risks occur, our business, financial condition or results of operations may be materially and adversely affected.The risk factors described below are not necessarily exhaustive and you are encouraged to perform your own investigation with respectto us and our business.

Risks Related to Our Business Operations

Our business, financial conditionand results of operations are subject to various risks and uncertainties, including those described below. This section discusses factorsthat, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. Ourbusiness, financial condition or results of operations could be materially adversely affected by any of these risks. It is not possibleto predict or identify all such factors. Consequently, the following description of Risk Factors is not a complete discussion of all potentialrisks or uncertainties applicable to our business.

Our current cash balanceis only expected to be sufficient to fund our planned business operations through approximately May 2024. If additional capital is notavailable, we may not be able to pursue our planned business operations, may be forced to change our planned business operations, or maytake other actions that could adversely impact our stockholders, including seeking bankruptcy protection.

We are a clinical stage biotechnologycompany that currently has no revenue. Thus, our business does not generate the cash necessary to finance our planned business operations.We will require significant additional capital to: (i) develop FDA and/or MHRA-approved products and commercialize such products;(ii) fund research and development activities relating to, and obtain regulatory approval for, our product candidates; (iii) protectour intellectual property; (iv) attract and retain highly-qualified personnel; (v) respond effectively to competitive pressures;and (vi) acquire complementary businesses or technologies.

Our future capital needs dependon many factors, including: (i) the scope, duration and expenditures associated with our research, development and commercializationefforts; (ii) continued scientific progress in our programs; (iii) the outcome of potential partnering or licensing transactions,if any; (iv) competing technological developments; (v) our proprietary patent position; and (vi) the regulatory approvalprocess for our products.

We will need to raise substantialadditional funds through public or private equity offerings, debt financings or strategic alliances and licensing arrangements to financeour planned business operations. We may not be able to obtain additional financing on terms favorable to us, if at all. General marketconditions, rising interest rates and inflation, as well as global conflicts such as the ongoing conflict between Ukraine and Russia,and Israel and Hamas, may make it difficult for us to seek financing from the capital markets, and the terms of any financing may adverselyaffect the holdings or the rights of our stockholders. For example, if we raise additional funds by issuing equity securities, furtherdilution to our stockholders will result, which may substantially dilute the value of their investment. Any equity financing may alsohave the effect of reducing the conversion or exercise price of our outstanding convertible or exercisable securities, which could resultin the issuance (or potential issuance) of a significant number of additional shares of our common stock. In addition, as a conditionto providing additional funds to us, future investors may demand, and may be granted, rights superior to those of existing stockholders.Debt financing, if available, may involve restrictive covenants that could limit our flexibility to conduct future business activitiesand, in the event of insolvency, could be paid before holders of equity securities received any distribution of our assets. We may berequired to relinquish rights to our technologies or product candidates, or grant licenses through alliance, joint venture or agreementson terms that are not favorable to us, in order to raise additional funds. If adequate funds are not available, we may have to delay,reduce or eliminate one or more of our planned activities with respect to our business, or terminate our operations, or may be forcedto seek bankruptcy protection. These actions would likely reduce the market price of our common stock.

We will need additionalcapital which may not be available on commercially acceptable terms, if at all, which raises questions about our ability to continue asa going concern.

As of September 30, 2023,we had an accumulated deficit of $126,116,552 and a working capital deficit of $1,435,947, and for the three and nine months ended September30, 2023, a net loss of $10,265,760 and $18,708,007, respectively, and cash used in operating activities for the nine months ended September30, 2023, of $8,762,209. As of January 29, 2024, we had cash on hand of approximately $1.46 million. The accompanying Consolidated FinancialStatements have been prepared assuming we will continue as a going concern. As we are not generating revenues, we need to raise a significantamount of capital in order to pay our debts and cover our operating costs. While we recently raised funds through the sale of equity inJuly 2022 (approximately $6.5 million of gross proceeds), December 2022 (approximately $6.0 million of gross proceeds), April 2023 (approximately$3.0 million of gross proceeds) and August 2023 (approximately $3 million), there is no assurance that we will be able to raise additionalneeded capital or that such capital will be available under favorable terms.

We are subject to all thesubstantial risks inherent in the development of a new business enterprise within an extremely competitive industry. Due to the absenceof a long-standing operating history and the emerging nature of the markets in which we compete, we anticipate operating losses untilwe can successfully implement our business strategy, which includes all associated revenue streams. We may never ever achieve profitableoperations or generate significant revenues.

We currently have a monthlycash requirement spend of approximately $380,000. We believe that in the aggregate, we will require significant additional capital fundingto support and expand the research and development and marketing of our products, fund future clinical trials, repay debt obligations,provide capital expenditures for additional equipment and development costs, payment obligations, office space and systems for managingthe business, and cover other operating costs until our planned revenue streams from products are fully-implemented and begin to offsetour operating costs, if ever.

Since our inception, we havefunded our operations with the proceeds from equity and debt financings. We have experienced liquidity issues due to, among other reasons,our limited ability to raise adequate capital on acceptable terms. We have historically relied upon the sale of equity and debt fundingthat is convertible into shares of our common stock to fund our operations and have devoted significant efforts to reduce that exposure.We anticipate that we will need to issue equity to fund our operations and fund our operating expenses for the foreseeable future. Ifwe are unable to achieve operational profitability or we are not successful in securing other forms of financing, we will have to evaluatealternative actions to reduce our operating expenses and conserve cash.

These conditions raise substantialdoubt about our ability to continue as a going concern. The Consolidated Financial Statements included herein have been prepared in accordancewith accounting principles generally accepted in the United States on a going concern basis, which contemplates the realization of assetsand the satisfaction of liabilities in the normal course of business. Accordingly, the Consolidated Financial Statements included hereindo not include any adjustments relating to the recoverability of assets and classification of liabilities that might be necessary shouldwe be unable to continue as a going concern. The Consolidated Financial Statements included herein also include a going concern footnote.

Additionally, wherever possible,our board of directors (“Board of Directors” or “Board”) will attempt to use non-cash considerationto satisfy obligations. In many instances, we believe that the non-cash consideration will consist of restricted shares of our commonstock, preferred stock or warrants to purchase shares of our common stock. Our Board has authority, without action or vote of the stockholders,but subject to Nasdaq rules and regulations (which generally require stockholder approval for any transactions which would result in theissuance of more than 20% of our then outstanding shares of common stock or voting rights representing over 20% of our then outstandingshares of stock, subject to certain exceptions), to issue all or part of the authorized but unissued shares of common stock, preferredstock or warrants to purchase such shares of common stock. In addition, we may attempt to raise capital by selling shares of our commonstock, possibly at a discount to market in the future. These actions will result in dilution of the ownership interests of existing stockholders,may further dilute common stock book value, and that dilution may be material. Such issuances may also serve to enhance existing management’sability to maintain control of us, because the shares may be issued to parties or entities committed to supporting existing management.

We will need to raiseadditional capital, which may not be available on favorable terms, if at all, causing dilution to our stockholders, restricting our operationsor adversely affecting our ability to operate our business.

We may not be able to obtainadditional financing on terms favorable to us, if at all, including as a result of macroeconomic conditions such as a severe or prolongedeconomic downturn. Disruption, uncertainty or volatility in the capital markets could increase our cost of capital or limit our abilityto raise funds needed to operate our business. Disruptions could be caused by Federal Reserve policies and actions, currency concerns,inflation, economic downturn or uncertainty, monetary policies, failures of financial institutions, U.S. debt management concerns, andU.S. debt limit and budget disputes, including government shutdowns, European and worldwide sovereign debt concerns, other global or geopoliticalevents, or other factors. Current macroeconomic conditions have negatively impacted the U.S. banking sector, including for example, therecent closures and FDIC receiverships of Silicon Valley Bank and Signature Bank. Although we do not have any accounts at or businessrelationships with these banks, we may be negatively impacted by other disruptions to the U.S. banking system caused by these or similardevelopments.

We face corporate governancerisks and negative perceptions of investors associated with the fact that we do not currently have any independent directors and do notcurrently have any members of our audit committee or compensation committee.

Currently, our only directorsare Lawrence Steinman, M.D., James N. Woody, M.D., Ph.D., and Sir Marc Feldmann, Ph.D., none of which are independent. Our prior independentdirectors, Francis Knuettel II, Pam Marrone, Teresa DeLuca, Larry Gold, Russell Ray, and Donald A. McGovern, Jr., each resigned from theCompany on December 17, 2023. As such, there are no independent members of the Board of Directors, and no members on our audit committeeor compensation committee, available to second and/or approve related party transactions involving Dr. Steinman, Dr. Woody or Dr. Feldmann.Therefore, investors may perceive that because no other directors are approving related party transactions involving Dr. Steinman, Dr.Woody or Dr. Feldmann, that such transactions are not fair to the Company. We may also face negative perceptions, corporate governancerisks, or stockholder claims, due to the fact that we do not have an audit committee or compensation committee. The price of our CommonStock may be adversely affected and/or devalued compared to similarly sized companies with multiple unrelated and independent officersand directors, and functioning audit committees and compensation committees, due to the investing public’s perception of limitationsfacing our Company due to the above. Our lack of independent directors also means that we are not in compliance with Nasdaq’s continuedlisting rules. See also “We are not in compliance with the continued listing standards of Nasdaq, may not be able to comply withNasdaq’s continued listing standards in the future, and as a result our common stock and warrants may be delisted from Nasdaq.”,below.

We have significantand increasing liquidity needs and require additional funding.

Research and development,management and administrative expenses, including legal expenses, and cash used for operations will continue to be significant and mayincrease substantially in the future in connection with new research and development initiatives, clinical trials, continued product commercializationefforts and the launch of our future product candidates. We will need to raise additional capital to fund our operations, continue toconduct clinical trials to support potential regulatory approval of marketing applications, and to fund commercialization of our futureproduct candidates.

The amount and timing of ourfuture funding requirements will depend on many factors, including, but not limited to:

While we expect to fund ourfuture capital requirements from a number of sources, such as cash flow from operations and the proceeds from further public and/or privateofferings, we cannot assure you that any of these funding sources will be available to us on favorable terms, or at all. Further, evenif we can raise funds from all of the above sources, the amounts raised may not be sufficient to meet our future capital requirements.

Our License Agreementswith the University of Oxford and other licensors may be terminated in certain circumstances without our consent.

All of our License Agreementswith the University of Oxford and other licensors remain subject to various conditions and covenants, and provide for certain terminationrights to the licensors. Those agreements typically allow termination by the licensor due to our failure to pay amounts due timely, ourfailure to cure a material breach under the terms of the applicable license agreement, and our insolvency. As a result, if we are deemedinsolvent, or in the event we seek bankruptcy protection, the licensors of our license agreements may terminate their license agreementswith us. In the event such license agreements are terminated, we could lose the right to develop all of our platforms and technologies,may lose any investments made towards developing such platforms and technologies, and may be left without any intellectual property, productpathways, or development opportunities. Such terminations may result in the value of our securities declining in value or becoming worthless,the need for us to change our business plan, and may result in the Company seeking bankruptcy protection.

We owe a significantamount of money to the University of Oxford, which funds we do not have. The university may take actions against us to enforce their rightsto payment in the future, which could have a material adverse effect on us and our operations.

Due to recent financialconstraints, the Company has been unable to timely pay amounts due to the University of Oxford (“Oxford”), the licensorof the majority of the Company’s licenses and patents and the Company’s research partner. Oxford alleges that anaggregate of approximately £929,030 is owed from the Company and one of its subsidiaries to Oxford under the terms of licensesand agreements with Oxford and related parties. The Company is currently in ongoing discussions with Oxford to reduce that amountand enter into a payment plan with regards to the amounts owed; however, no definitive terms or extensions have been agreed to date.Oxford has also notified the Company that it is not willing to discuss any new projects or arrangements until all outstandinginvoices have been paid or a payment plan has been agreed to; has engaged a law firm to seek the collection of the amounts owed, together with interest; and hasthreatened legal proceedings against us. While we are hopeful that we can come to mutually agreeable terms regarding a settlement,payment plan, and/or extension, with Oxford, we may not have sufficient funds to pay amounts due to Oxford in the near term, if atall, and Oxford may take action against us, including filing legal proceedings against us seeking amounts due and interest,attempting to terminate their relationship with us, and/or filing a wind-up petition against one of the Company’s subsidiariesin the UK. If Oxford were to take legal action against us or terminate their relationship with us, we may be forced to scale backour business plan and/or seek bankruptcy protection. We may be subject to litigation and damages for our failure to pay amounts dueto Oxford, and may be forced to pay interest and penalties, which funds we do not currently have. We plan to seek to raise fundingin the future to support our operations, and to pay amounts due to Oxford, through a combination of equity offerings, debt financingor other capital sources, including potentially collaborations, licenses and other similar arrangements, which may not be availableon favorable terms, if at all. The sale of additional equity or debt securities, if accomplished, may result in dilution to our thenstockholders. Additionally, in December 2023, we engaged A.G.P./Alliance Global Partners as financial advisor to explore andevaluate strategic alternatives to enhance shareholder value. Potential strategic alternatives that may be explored or evaluated bythe Company as part of this process include, but are not limited to, an acquisition, merger, reverse merger, other businesscombination, sale of assets, licensing or other strategic transactions involving the Company. The Company does not intend to discussor disclose further developments during this process unless and until its Board of Directors has approved a specific action orotherwise determined that further disclosure is appropriate. There is no assurance that the strategic review process will result inthe approval or completion of any specific transaction or outcome.

Our results of operationsmay be adversely affected by fluctuations in currency values.

We expend expenses in currenciesother than the U.S. dollar. Our reporting currency is the United States dollar. The functional currency of certain subsidiaries is theCanadian Dollar (“CAD”) or British Pound (“£” or “GBP”). The resultingtranslation adjustments are recognized in stockholders’ equity as a component of accumulated other comprehensive income. Comprehensiveincome is defined as the change in equity of an entity from all sources other than investments by owners or distributions to owners andincludes foreign currency translation adjustments as described above. During the years ended December 31, 2022 and 2021 and the nine monthsended September 30, 2023 and 2022, we recorded other comprehensive (loss) income of ($3,702,963) and $180,554 and $36,712 and($4,507,204), respectively, as a result of foreign currency translation adjustments.

Changes in the value of thecurrencies which we pay expenses (and in the future receive revenues), versus each other, and the U.S. dollar, could result in an adversecharge being recorded to our income statement.

Global economic conditionscould materially adversely affect our business, results of operations, financial condition and growth.

Adverse macroeconomic conditions,including inflation, slower growth or recession, new or increased tariffs, changes to fiscal and monetary policy, tighter credit, higherinterest rates, high unemployment and currency fluctuations, as well as the potential implications of a Congressional impasse over theU.S. debt limit or possible future U.S. governmental shutdowns over budget disagreements, could materially adversely affect our operations,expenses, access to capital and the market for our planned future products. In addition, consumer confidence and spending could be adverselyaffected in response to financial market volatility, negative financial news, conditions in the real estate and mortgage markets, declinesin income or asset values, changes to fuel and other energy costs, labor and healthcare costs and other economic factors.

In addition, uncertainty about,or a decline in, global or regional economic conditions could have a significant impact on our funding sources, suppliers and partners.Potential effects include financial instability; inability to obtain credit to finance operations and purchases of our future plannedproducts; and insolvency.

A downturn in the economicenvironment could also lead to limitations on our ability to sell equity or issue new debt; reduce liquidity; and result in declines inthe fair value of our financial instruments. These and other economic factors could materially adversely affect our business, resultsof operations, financial condition and growth.

Our industry and thebroader U.S. economy have experienced higher than expected inflationary pressures during 2022 and 2023, related to continued supply chaindisruptions, labor shortages and geopolitical instability. Should these conditions persist our business, future results of operationsand cash flows could be materially and adversely affected.

During 2022 and the earlypart of 2023, there were significant increases in the costs of certain materials, products and shipping costs, as a result of availabilityconstraints, supply chain disruption, increased demand, labor shortages associated with a fully employed U.S. labor force, high inflationand other factors. Supply and demand fundamentals have been further aggravated by disruptions in global energy supply caused by multiplegeopolitical events, including the ongoing conflict between Russia and Ukraine, and Israel and Hamas, which threatens to spread to otherMiddle Eastern countries. Service, materials and shipping costs have also increased accordingly with general supply chain and inflationissues seen throughout the U.S. leading to increased operating costs. Supply chain constraints and inflationary pressures have in thepast and may in the future, adversely impact our operating costs and may negatively impact our future product costs, consulting costsand expenses which could have a material adverse effect on our business, financial condition, results of operations and cash flows.

Economic uncertaintymay affect our access to capital and/or increase the costs of such capital.

Global economic conditionscontinue to be volatile and uncertain due to, among other things, consumer confidence in future economic conditions, fears of recessionand trade wars, the price of energy, fluctuating interest rates, the availability and cost of consumer credit, the availability and timingof government stimulus programs, levels of unemployment, increased inflation, tax rates, and the war between Ukraine and Russia whichbegan in February 2022, and Israel and Hamas, which began in October 2023 and which threatens to spread to other Middle Eastern countries.These conditions remain unpredictable and create uncertainties about our ability to raise capital in the future. In the event requiredcapital becomes unavailable in the future, or more costly, it could have a material adverse effect on our business, future results ofoperations, and financial condition.

We may not receive anyamounts under our pre-merger directors’ and officers’ insurance policy in connection with certain litigation matters.

On June 29, 2022, AmTrustInternational Underwriters DAC (“AmTrust”), which was the premerger directors’ and officers’ insurancepolicy underwriter for KBL, filed a declaratory relief action against us in the U.S. District Court for the Northern District of California(the “Declaratory Relief Action”) seeking declaration of AmTrust’s obligations under the directors’and officers’ insurance policy. In the Declaratory Relief Action, AmTrust is claiming that as a result of the merger, we are nolonger the insured under the subject insurance policy, notwithstanding the fact that the fees which we seek to recover from AmTrust relateto matters occurring prior to the merger.

On April 21, 2023, the Courtissued an Order Granting in Part and Denying in Part the Company’s Motion for Partial Summary Judgment. Specifically, the Courtgranted summary adjudication in favor of the Company on the following issues: (a) that the Company is, in fact, an insured underboth the AmTrust and Freedom insurance policies; (b) that certain SEC subpoena related expenses for defendants Dr. Marlene Krauss,the Company’s former Chief Executive Officer and Director, and George Hornig, the former Chairman of the Board, are within the basicscope of coverage under both the AmTrust and Freedom insurance policies; and (c) that the Insured vs. Insured exclusion relied uponby AmTrust and Freedom is not applicable to bar any such coverage.

The Court also found thatthere were issues of disputed facts as to the Change in Control exclusion contained within the policies, which therefore precluded theCourt from granting the remainder of the Company’s requests for summary adjudication as a matter of law. Accordingly, the Court,at this time, denied the Company’s further requests for summary adjudication and deemed that for the time being, the Change in Controlissue is to be determined at the time of trial, in order to find that the policies (i) provide coverage for the fees which the Companyhas advanced and will advance to Dr. Marlene Krauss and George Hornig; (ii) that AmTrust has breached the policy; (iii) thatAmTrust must pay such expenses of the Company; and that, once the AmTrust policy has been exhausted, (iv) Freedom will be obligatedto pay such expenses of the Company pursuant to its policy.

On August 4, 2023, the Courtgranted the Company’s request to file a second motion for partial summary judgment in this case, this one being on the issue ofwhether AmTrust should be required to advance to the Company the defense costs being incurred by Dr. Marlene Krauss and George Hornigduring the pendency of the case. The Company filed such Motion for Partial Summary Judgment, and it has now been fully briefed by theparties. The hearing for such motion was held on January 11, 2024, however the Judge took the matter under submission and has not yetissued any decision on the Motion.  The parties have commenced written discovery proceedings against each other, and it is anticipatedthat depositions will also occur. The Company intends to continue to vigorously pursue this matter in order to establish the Company’sentitlement to full payment by both AmTrust and Freedom of the subject advancement expenses of the Company.

While the Company continuesto believe it has a strong case against both AmTrust and Freedom and believes the Court ruling in its favor in regards to the mattersdiscussed above is a significant positive outcome for the Company, there can be no assurance that the Company will prevail in this action.

Our ability to generaterevenue from any of our potential products is subject to our ability to obtain regulatory approval and fulfill numerous other requirementsand we may never be successful in generating revenues or becoming profitable.

Our ability to become andremain profitable depends on our ability to generate revenue or execute other business development arrangements. We do not expect to generatesignificant revenue, if any, unless and until we are able to obtain regulatory approval for, and successfully commercialize the productcandidates we are developing or may develop. Successful commercialization, to the extent it occurs, will require achievement of many keymilestones, including demonstrating safety and efficacy in clinical trials, obtaining regulatory approval for these product candidates,manufacturing, marketing and selling, or entering into other agreements to commercialize, those products for which we may obtain regulatoryapproval, satisfying any post-marketing requirements and obtaining reimbursement for our products from private insurance or governmentpayors. Because of the uncertainties and risks associated with these activities, we cannot accurately and precisely predict the timingand amount, if any, of revenues, the extent of any further losses or when we might achieve profitability. We may never succeed in theseactivities and, even if we do, we may never generate revenues that are sufficient enough for us to achieve profitability. Even if we doachieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.

Our failure to become andremain profitable may depress the market price of our common stock and could impair our ability to raise capital, expand our business,diversify our product offerings or continue our operations.

We have recently grownour business and will need to increase the size and complexity of our organization in the future, and we may experience difficulties inmanaging our growth and executing our growth strategy.

Our management, personneland systems currently in place may not be adequate to support our business plan and future growth. We will need to increase our numberof full-time equivalent employees in order to conduct Phase 1, 2 and 3 clinical trials of our future products and to establish a commercialorganization and commercial infrastructure. As a result of these future activities, the complexity of our business operations is expectedto substantially increase. We will need to develop and expand our scientific, manufacturing, sales and marketing, managerial, compliance,operational, financial and other resources to support our planned research, development, manufacturing and commercialization activities.

Our need to effectively manageour operations, growth and various projects requires that we:

We have utilized and continueto utilize the services of part-time outside consultants and contractors to perform a number of tasks for our company, including tasksrelated to compliance programs, clinical trial management, regulatory affairs, formulation development and other drug development functions.Our growth strategy may entail expanding our use of consultants and contractors to implement these and other tasks going forward. If weare not able to effectively expand our organization by hiring new employees and expanding our use of consultants and contractors, we maybe unable to successfully implement the tasks necessary to effectively execute on our planned research, development, manufacturing andcommercialization activities and, accordingly, may not achieve our research, development and commercialization goals.

We face liability forpreviously restated financial statements and/or certain actions of our prior management which led to such restatements.

We filed a Current Reporton Form 8-K on December 31, 2020 and another Current Report on Form 8-K on February 3, 2021, where we announced that due to matters wediscovered which related to KBL, prior to the Business Combination, certain historical financial statements were unreliable. As a result,we restated our financial statements for the three and six months ended June 30, 2020 and for the three and nine months ended September30, 2020, because of errors in such financial statements which were identified after such financial statements were filed with the SECin our original quarterly reports for the quarters ended June 30, 2020 and September 30, 2020. While we believe these restatements arethe result of the actions of, and are the responsibility of, the management of KBL (none of whom remain employed by us), we may be subjectto stockholder litigation, SEC actions, fines and penalties, rating downgrades, negative publicity and difficulties in attracting andretaining key clients, employees and management personnel as a result of such restatements. Additionally, our securities may trade atprices lower than similarly situated companies which have not had to restate their financial statements.

Our failure to appropriatelyadjust processes resulting from significant one-time transactions may result in a misstatement in the financial statements.

In the course of our annualaudit but prior to filing, we discovered that an error occurred which caused the fair value of our public warrants to be overstated byan immaterial amount. This error was corrected before the 2022 financial statements were filed. While we believe that the fair value ofwarrants in our financial statements for the year ended December 31, 2022 and since such date are correctly stated, it is possible thatsimilar errors which could have a material adverse effect on our financial condition and results of operations, could require us to restateour financial statements for prior periods or in the future.

Operating results mayvary significantly in future periods.

Our financial results areunpredictable and may fluctuate, for among other reasons, due to commercial sales of our future product candidates; our achievement ofproduct development objectives and milestones; clinical trial enrollment and expenses; research and development expenses; and the timingand nature of contract manufacturing and contract research payments. A high portion of our costs are predetermined on an annual basis,due in part to our significant research and development costs. Thus, small declines in future revenue could disproportionately affectfinancial results in a quarter.

We depend on our keypersonnel and our ability to attract and retain employees.

Our future growth and successdepend on our ability to recruit, retain, manage and motivate our employees. We are highly dependent on our current management and scientificpersonnel, including our Chief Executive Officer, Dr. James N. Woody, our Co-Chairmen, Sir Marc Feldmann, Ph.D., and Lawrence Steinman,M.D., our Chief Scientific Officer, Jonathan Rothbard, Ph.D., and our scientist, Jagdeep Nanchahal. The inability to hire or retain experiencedmanagement personnel could adversely affect our ability to execute our business plan and harm our operating results. Due to the specializedscientific and managerial nature of our business, we rely heavily on our ability to attract and retain qualified scientific, technicaland managerial personnel. The competition for qualified personnel in the biotechnological field is intense and we may be unable to continueto attract and retain qualified personnel necessary for the development of our business or to recruit suitable replacement personnel.

Problems in our manufacturingprocess for our future chemical entities, failure to comply with manufacturing regulations or unexpected increases in our manufacturingcosts could harm our business, results of operations and financial condition.

We are responsible for themanufacture and supply of our future product candidates in the CBD derivatives and α7nAChR programs for commercial use and for usein clinical trials. The manufacturing of our future product candidates necessitates compliance with GMPs and other regulatory requirementsin international jurisdictions. Our ability to successfully manufacture our future product candidates will involve manufacture of finishedproducts and labeling and packaging, which includes product information, tamper proof evidence and anti-counterfeit features, under tightlycontrolled processes and procedures. In addition, we will have to ensure chemical consistency among our batches, including clinical trialbatches and, if approved, marketing batches. Demonstrating such consistency may require typical manufacturing controls as well as clinicaldata. We will also have to ensure that our batches conform to complex release specifications. If we are unable to manufacture our futureproduct candidates in accordance with regulatory specifications, or if there are disruptions in our manufacturing process due to damage,loss or otherwise, or failure to pass regulatory inspections of our manufacturing facilities, we may not be able to meet demand or supplysufficient product for use in clinical trials, and this may also harm our ability to commercialize our future product candidates on atimely or cost-competitive basis, if at all.

We may not develop and expandour manufacturing capability in time to meet demand for our product candidates, and the FDA, MHRA or other foreign regulatory authoritiesmay not accept our facilities or those of our contract manufacturers as being suitable for the production of our products and productcandidates. Any problems in our manufacturing process could materially adversely affect our business, results of operations and financialcondition.

Our memorandum of understandingwith Celltrion Healthcare may not result in the parties entering into a definitive agreement.

In September 2021, we enteredinto a non-binding memorandum of understanding with Celltrion Healthcare, a biopharmaceutical company, for the supply of an anti-TNF biosimilardrug used in our ongoing development of anti-TNF products. The parties have not entered into a definitive agreement regarding such relationshipto date, and such definitive agreement may not ultimately be entered into on terms contemplated, if at all. In the event that we are unableto come to mutually agreeable definitive terms with Celltrion Healthcare, the Company has been in discussions with an alternative supplierof the anti-TNF biosimilar drug which has expressed interest in proceeding. We may ultimately be unable to find an alternative supplieror such alternative supplier may require less favorable terms than are currently contemplated. Any of the above may materially adverselyaffect our business, results of operations and financial condition.

We expect to face intensecompetition from companies with greater resources and experience than we have; and may face competition from competitors seeking to marketour products under a Section 505(b)(2) application.

The pharmaceutical industryis highly competitive and subject to rapid change. The industry continues to expand and evolve as an increasing number of competitorsand potential competitors enter the market. Many of these competitors and potential competitors have substantially greater financial,technological, managerial and research and development resources and experience than our company. Some of these competitors and potentialcompetitors have more experience than our company in the development of pharmaceutical products, including validation procedures and regulatorymatters. In addition, our future product candidates, if successfully developed, will compete with product offerings from large and well-establishedcompanies that have greater marketing and sales experience and capabilities than our company or our collaboration partners have. In particular,Insys Therapeutics, Inc. is developing CBD in Infantile Spasms (“IS”), and potentially other indications. Zogenix,Inc. has reported positive data in two Phase 3 trials of low dose fenfluramine in Dravet syndrome and has commenced a Phase 3 trial withthis product in Lennox Gastaut Syndrome. Biocodex recently received regulatory approval from the FDA for the drug Stiripentol (Diacomit) forthe treatment of Dravet syndrome. Other companies with greater resources than our company may announce similar plans in the future. Inaddition, there are non-FDA approved CBD preparations being made available from companies in the medical marijuana industry, which mightattempt to compete with our future product candidates.

Many of our competitors havesignificantly greater financial and technical resources, experience and expertise in:

Principal competitive factorsin our industry include:

Additionally, competitorsmay also seek to market versions of our drug products via a section 505(b)(2) application, which is a type of NDA provided in section505(b)(2) of the FDC Act. A Section 505(b)(2) NDA is in contrast to an NDA under section 505(b)(1) of the FDC Act, whichis commonly known as a Full NDA because it requires the applicant to undertake all of the nonclinical and clinical investigations necessaryfor the approval of the application. In contrast, a Section 505(b)(2) NDA application is one for which one or more of the investigationsrelied on by the applicant for approval were not conducted by or for the applicant and for which the applicant has not obtained a rightof reference or use from the person by or for whom the investigations were conducted. Section 505(b)(2) applications may be submittedfor drug products that represent a modification, such as a new indication or new dosage form, of a previously approved drug. Section 505(b)(2) applicationsmay rely on the FDA’s previous findings for the safety and effectiveness of the previously approved drug in addition to informationobtained by the 505(b)(2) applicant to support the modification of the previously approved drug. Preparing Section 505(b)(2) applicationsmay be less costly and less time-consuming than preparing a Full NDA based entirely on new data and information. Section 505(b)(2) applicationsare subject to the same patent certification procedures as an ANDA.

If we are unable to competesuccessfully, our commercial opportunities will be reduced and our business, results of operations and financial conditions may be materiallyharmed.

Our future product candidates,if approved, may be unable to achieve the expected market acceptance and, consequently, limit our ability to generate revenue from newproducts.

Even when product developmentis successful and regulatory approval has been obtained, our ability to generate sufficient revenue depends on the acceptance of our productsby physicians and patients. We cannot assure you that any of our future product candidates will achieve the expected level of market acceptanceand revenue if and when they obtain the requisite regulatory approvals. The market acceptance of any product depends on a number of factors,including the indication statement, warnings required by regulatory authorities in the product label and new competing products. Marketacceptance can also be influenced by continued demonstration of efficacy and safety in commercial use, physicians’ willingness toprescribe the product, reimbursement from third-party payors such as government health care programs and private third-party payors, theprice of the product, the nature of any post-approval risk management activities mandated by regulatory authorities, competition, andmarketing and distribution support. Further, our U.S. distribution depends on the adequate performance of a reimbursement support huband contracted specialty pharmacies in a closed-distribution network. An ineffective or inefficient U.S. distribution model at launchmay lead to inability to fulfill demand, and consequently a loss of revenue. The success and acceptance of a product in one country maybe negatively affected by its activities in another. If we fail to adapt our approach to clinical trials in the U.S. market to meet theneeds of EMA, MHRA or other European regulatory authorities, or to generate the health economics and outcomes research data needed tosupport pricing and reimbursement negotiations or decisions in Europe, we may have difficulties obtaining marketing authorization forour products from EMA/European Commission or the MHRA and may have difficulties obtaining pricing and reimbursement approval for our productsat a national level. Any factors preventing or limiting the market acceptance of our products could have a material adverse effect onour business, results of operations and financial condition.

All of our patents inthe Anti-TNF and Fibrosis program are method of use patents, which may result in biosimilar drugs being used without our permission.

The success of our most advanceddrug development platform depends on the enforceability of our method of use patents, as there are currently many biosimilar anti-TNFdrugs in the market. If we are unable to obtain composition of matter patents, and enforce such patents, our ability to generate revenuefrom the anti-TNF platform may be significantly limited and competitors may be able to use our research to bring competing drugs to marketwhich would reduce our market share.

The majority of ourlicense agreements provide the licensors and/or counter-parties the right to use and/or exploit such licensed intellectual property.

The majority of our licenseagreements provide the licensors and/or counter-parties the right to use and/or exploit such licensed intellectual property, and in somecases provide them ownership of such intellectual property, know-how and research results. As such, we may be in competition with partieswho we have license agreements with, will likely not have the sole right to monetize, sell or distribute our product candidates and maybe subject to restrictions on use and territory of sales. Any or all of the above may have a material adverse effect on our results ofoperations and cash flows and ultimately the value of our securities.

Interim, topline andpreliminary data from our clinical trials may change as more patient data becomes available, and is subject to audit and verificationprocedures that could result in material changes in the final data.

From time to time, we maypublicly disclose preliminary, interim or topline data from our preclinical studies and clinical trials, which is based on a preliminaryanalysis of then-available data, and the results and related findings and conclusions are subject to change as patient enrollment andtreatment continues and more patient data become available. For example, any positive results from our preclinical testing, Phase 1 andPhase 2 clinical trials of our product candidate for any product candidate may not necessarily be predictive of the results from plannedor future clinical trials for such product candidates. Many companies in the pharmaceutical and biotechnology industries have sufferedsignificant setbacks in clinical trials after achieving positive results in pre-clinical and early clinical development, and we cannotbe certain that we will not face similar setbacks. These setbacks have been caused by, among other things, pre-clinical findings whileclinical trials were underway or safety or efficacy observations in clinical trials, including adverse events. Adverse differences betweenprevious preliminary or interim data and future interim or final data could significantly harm our business prospects. We may also announcetopline data following the completion of a preclinical study or clinical trial, which may be subject to change following a more comprehensivereview of the data related to the particular study or trial. We also make assumptions, estimations, calculations and conclusions as partof our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, theinterim, topline or preliminary results that we report may differ from future results of the same studies, or different conclusions orconsiderations may qualify such results, once additional data has been received and fully evaluated. Preliminary, interim, or toplinedata also remains subject to audit and verification procedures that may result in the final data being materially different from the datawe previously published. As a result, preliminary, interim, and topline data should be viewed with caution until the final data is available.

Further, others, includingregulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret orweigh the importance of data differently, which could impact the value of the particular program, the approvability or commercializationof the particular product candidate or product and our company in general. In addition, the information we choose to publicly discloseregarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree withwhat we determine to be material or otherwise appropriate information to include in our disclosure. Moreover, our interpretation of clinicaldata or our conclusions based on the preclinical in vitro and in vivo models may prove inaccurate, as preclinical and clinical data canbe susceptible to varying interpretations and analyses, and many companies that believed their product candidates performed satisfactorilyin preclinical studies and clinical trials nonetheless failed to obtain FDA approval or a marketing authorization granted by the EuropeanCommission.

If we fail to produce positiveresults in our future clinical trials, the development timeline and regulatory approval and commercialization prospects for such productcandidates, and, correspondingly, our business and financial prospects, would be materially adversely affected.

We have limited marketingexperience, and we may not be able to successfully commercialize any of our future product candidates, even if they are approved in thefuture.

Our ability to generate revenuesultimately will depend on our ability to sell our approved products and secure adequate third-party reimbursement. We currently have noexperience in marketing and selling our products. The commercial success of our future products depends on a number of factors beyondour control, including the willingness of physicians to prescribe our future products to patients, payors’ willingness and abilityto pay for our future products, the level of pricing achieved, patients’ response to our future products, and the ability of ourfuture marketing partners to generate sales. There can be no guarantee that we will be able to establish or maintain the personnel, systems,arrangements and capabilities necessary to successfully commercialize our future products or any product candidate approved by the FDA,MHRA or other regulatory authority in the future. If we fail to establish or maintain successful marketing, sales and reimbursement capabilitiesor fail to enter into successful marketing arrangements with third parties, our product revenues may suffer.

If the price for anyof our future approved products decreases or if governmental and other third-party payors do not provide coverage and adequate reimbursementlevels, our revenue and prospects for profitability will suffer.

Patients who are prescribedmedicine for the treatment of their conditions generally rely on third-party payors to reimburse all or part of the costs associated withtheir prescription drugs. Reimbursement systems in international markets vary significantly by country and by region, and reimbursementapprovals generally must be obtained on a country-by-country basis. Coverage and adequate reimbursement from governmental healthcare programs,such as Medicare and Medicaid, and commercial payors is critical to new product acceptance. Coverage decisions may depend upon clinicaland economic standards that disfavor new drug products when more established or lower cost therapeutic alternatives are already availableor subsequently become available. Even if we obtain coverage for our future product candidates, the resulting reimbursement payment ratesmay require co-payments that patients find unacceptably high. Patients may not use our future product candidates if coverage is not providedor reimbursement is inadequate to cover a significant portion of a patient’s cost.

In addition, the market forour future product candidates in the United States will depend significantly on access to third-party payors’ drug formularies,or lists of medications for which third-party payors provide coverage and reimbursement. The industry competition to be included in suchformularies often leads to downward pricing pressures on pharmaceutical companies. Also, third-party payors may refuse to include a particularbranded drug in their formularies or otherwise restrict patient access to a branded drug when a less costly generic equivalent or otheralternative is available.

Third-party payors, whetherforeign or domestic, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs.The current environment is putting pressure on companies to price products below what they may feel is appropriate. Our future revenuesand overall success could be negatively impacted if we sell future product candidates at less than an optimized price. In addition, inthe United States, no uniform policy of coverage and reimbursement for drug products exists among third-party payors. Therefore, coverageand reimbursement for our future product candidates may differ significantly from payor to payor. As a result, the coverage determinationprocess is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of ourfuture product candidates to each payor separately, with no assurance that coverage will be obtained. If we are unable to obtain coverageof, and adequate payment levels for, our future product candidates, physicians may limit how much or under what circumstances they willprescribe or administer them and patients may decline to purchase them. This could affect our ability to successfully commercialize ourproduct candidates, and thereby adversely impact our profitability, results of operations, financial condition and future success.

In addition, where we havechosen to collaborate with a third party on product candidate development and commercialization, our partner may elect to reduce the priceof our products to increase the likelihood of obtaining reimbursement approvals. In many countries, products cannot be commercially launcheduntil reimbursement is approved and the negotiation process in some countries can exceed 12 months. In addition, pricing and reimbursementdecisions in certain countries can be affected by decisions made in other countries, which can lead to mandatory price reductions and/oradditional reimbursement restrictions across a number of other countries, which may adversely affect sales and profitability. In the eventthat countries impose prices that are not sufficient to allow us or our partners to generate a profit, our partners may refuse to launchthe product in such countries or withdraw the product from the market, which would adversely affect sales and profitability.

Business interruptionscould delay us in the process of developing our future product candidates and could disrupt our product sales.

Loss of our future manufacturingfacilities, stored inventory or laboratory facilities through fire, theft or other causes, could have an adverse effect on our abilityto meet demand for our future product candidates or to continue product development activities and to conduct our business. Failure tosupply our partners with commercial products may lead to adverse consequences, including the right of partners to assume responsibilityfor product supply. Even if we obtain insurance coverage to compensate us for such business interruptions, such coverage may prove insufficientto fully compensate us for the damage to our business resulting from any significant property or casualty loss to our inventory.

If product liabilitylawsuits are successfully brought against us, we will incur substantial liabilities and may be required to limit the commercializationof our future product candidates.

Although we have never hadany product liability claims or lawsuits brought against us, we face potential product liability exposure related to the testing of ourfuture product candidates in human clinical trials, and we will face exposure to claims in jurisdictions where we market and distributein the future. We may face exposure to claims by an even greater number of persons when we begin marketing and distributing our productscommercially in the United States and elsewhere. In the future, an individual may bring a liability claim against us alleging that oneof our future product candidates caused an injury. While we plan to take what we believe are appropriate precautions, we may be unableto avoid significant liability if any product liability lawsuit is brought against us. Large judgments have been awarded in class actionor individual lawsuits based on drugs that had unanticipated side effects. Although we plan to purchase insurance to cover product liabilitylawsuits, if we cannot successfully defend our company against product liability claims, or if such insurance coverage is inadequate,we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in decreased demand for ourproducts, reputational damage, withdrawal of clinical trial participation participants, litigation costs, product recall costs, monetaryawards, increased costs for liability insurance, lost revenues and business interruption.

Our employees may havepreviously engaged, and/or may in the future engage, in misconduct or other improper activities, including noncompliance with regulatorystandards and legal requirements.

We are exposed to the riskof employee fraud or other misconduct. Misconduct by employees could include intentional failures to comply with FDA, SEC or Office ofInspector General regulations, or regulations of any other applicable regulatory authority, failure to provide accurate information tothe FDA or the SEC, failure to disclose accurate information in SEC filings, failure to comply with applicable manufacturing standards,other federal, state or foreign laws and regulations, report information or data accurately or disclose unauthorized activities. Employeemisconduct could also involve the improper use of information, including information obtained in the course of clinical trials, or illegalappropriation of drug product, which could result in government investigations and serious harm to our reputation. Despite our adoptionof a Code of Ethics, employee misconduct is not always possible to identify and deter. The precautions we take to detect and prevent theseprohibited activities may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigationsor other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are institutedagainst our company, and we are not successful in defending our company or asserting our rights, those actions could have a significantimpact on our business, including the imposition of significant fines or other sanctions.

We are subject to theU.S. Foreign Corrupt Practices Act and other anti-corruption laws, as well as export control laws, customs laws, sanctions laws and otherlaws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedialmeasures, and legal expenses, which could adversely affect our business, results of operations and financial condition.

Our operations are subjectto anti-corruption laws, including the U.S. Foreign Corrupt Practices Act (“FCPA”), and other anti-corruption lawsthat apply in countries in which we do business. The FCPA and these other laws generally prohibit our company and our employees and intermediariesfrom bribing, being bribed or making other prohibited payments to government officials or other persons to obtain or retain business orgain some other business advantage. We and our commercial partners operate in a number of jurisdictions that pose a high risk of potentialFCPA violations, and we participate in collaborations and relationships with third parties whose actions could potentially subject usto liability under the FCPA or local anti-corruption laws. In addition, we cannot predict the nature, scope or effect of future regulatoryrequirements to which our international operations might be subject or the manner in which existing laws might be administered or interpreted.

We are also subject to otherlaws and regulations governing our international operations, including regulations administered by the governments of the United States,Canada, Israel, the United Kingdom and authorities in the European Union, including applicable export control regulations, economic sanctionson countries and persons, customs requirements and currency exchange regulations, collectively referred to as the Trade Control Laws.

However, there is no assurancethat we will be completely effective in ensuring our compliance with all applicable anti-corruption laws, including the FCPA or otherlegal requirements, including Trade Control Laws. If we are not in compliance with the FCPA and other anti-corruption laws or Trade ControlLaws, we may be subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses, whichcould have an adverse impact on our business, financial condition, results of operations and liquidity. Likewise, any investigation ofany potential violations of the FCPA, other anti-corruption laws by the United States or other authorities could also have an adverseimpact on our reputation, business, financial condition and results of operations.

Security breaches, lossof data and other disruptions could compromise sensitive information related to our business, prevent us from accessing critical informationor expose us to liability, which could adversely affect our business and our reputation.

In the ordinary course ofbusiness, we expect to collect and store sensitive data, including legally protected patient health information, credit card information,personally identifiable information about our employees, intellectual property, and proprietary business information. The secure processing,storage, maintenance and transmission of this critical information is vital to our operations and business strategy, and we devote significantresources to protecting such information. Although we take measures to protect sensitive information from unauthorized access or disclosure,our information technology and infrastructure may be vulnerable to attacks by hackers, or viruses, breaches or interruptions due to employeeerror, malfeasance or other disruptions, or lapses in compliance with privacy and security mandates. Any such virus, breach or interruptioncould compromise our networks and the information stored there could be accessed by unauthorized parties, publicly disclosed, lost orstolen. We have measures in place that are designed to prevent, and if necessary, to detect and respond to such security incidents andbreaches of privacy and security mandates. However, in the future, any such access, disclosure or other loss of information could resultin legal claims or proceedings, liability under laws that protect the privacy of personal information, such as HIPAA and European UnionGeneral Data Protection Regulation (“GDPR”), government enforcement actions and regulatory penalties. Unauthorizedaccess, loss or dissemination could also disrupt our operations, including our ability to process samples, provide test results, shareand monitor safety data, bill payors or patients, provide customer support services, conduct research and development activities, processand prepare company financial information, manage various general and administrative aspects of our business and may damage our reputation,any of which could adversely affect our business, financial condition and results of operations.

GDPR, which applies to allEU member states includes substantial fines for breaches of the data protection rules and may require us to put in place additional mechanismsensuring compliance with the new and changing data protection rules. GDPR is a complex law and the regulatory guidance is still evolving,including with respect to how GDPR should be applied in the context of clinical trials or other transactions from which we may gain accessto personal data. GDPR increases our costs of compliance and results in greater legal risks.

Our research and developmentprograms and product candidates are in development. As a result, we are unable to predict if or when we will successfully develop or commercializeour product candidates.

Our clinical-stage productcandidates as well as our other drug pipeline candidates will require significant further investment and regulatory approvals prior tocommercialization. Each of our product candidates will require clinical trial designs that meet the standards and requirements of FDA,MHRA or other comparable foreign regulatory authorities, the selection of suitable end points and patients for our clinical trials andadditional clinical development, management of clinical, preclinical and manufacturing activities, obtaining regulatory approval, obtainingmanufacturing supply, building of a commercial organization, substantial investment and significant marketing efforts before we generateany revenues from product sales. We are not permitted to market or promote any of our product candidates before we receive regulatoryapproval from the FDA, MHRA or other comparable foreign regulatory authorities, and we may never receive such regulatory approval forany of our product candidates. By such time, if ever, as we may receive necessary regulatory approvals for our product candidates, thestandard of care for the treatment of diseases associated with our product candidates may have evolved such that it would be necessaryto modify our plans for full approval and commercial acceptance of our products may be limited by a change in the standard of care.

Even if we obtain the requiredfinancing or establish a collaboration to enable us to conduct late-stage clinical development of our product candidates and pipelineassets, we cannot be certain that such clinical development would be successful, or that we will obtain regulatory approval or be ableto successfully commercialize any of our product candidates and generate revenue. Success in preclinical testing and early clinical trialsdoes not ensure that later clinical trials will be successful, and the clinical trial process may fail to demonstrate that our productcandidates are safe and effective for their proposed uses. Any such failure could cause us to abandon further development of any one ormore of our product candidates and may delay development of other product candidates. Product candidates in later stages of clinical trialsmay fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials.Any delay in, or termination of, our clinical trials will delay and possibly preclude the submission of any NDAs with the FDA, MarketingAuthorisation Applications (MAA) or Conditional Marketing Authorisations (CMA) with the MHRA, or similar authorizations withother foreign regulatory agencies, and, ultimately, our ability to commercialize our product candidates and generate product revenue.

We have not previously submittedan NDA to the FDA, or MAA or CMA to the MHRA, or similar drug approval filings to comparable foreign authorities, for any product candidate,and we cannot be certain that any of our product candidates will receive regulatory approval. Further, our product candidates may notreceive regulatory approval even if they are successful in clinical trials. If we do not receive regulatory approvals for our productcandidates, we may not be able to continue our operations. Even if we successfully obtain regulatory approvals to market one or more ofour product candidates, our revenues will be dependent, in part, upon our or our collaborators’ and future collaborators’ability to obtain regulatory approval for the companion diagnostics to be used with our product candidates, if required, and upon thesize of the markets in the territories for which we gain regulatory approval and have commercial rights. If the markets for patient subsetsthat we are targeting are not as significant as we estimate, we may not generate significant revenues from sales of such products, ifapproved.

Further, even if any productcandidate we develop was to receive marketing approval or be commercialized for use in combination with other existing therapies, we wouldcontinue to bear the risks that the FDA, MHRA or other similar foreign regulatory authorities could revoke approval of the therapy usedin combination with our product candidate or that safety, efficacy, manufacturing or supply issues could arise with these existing therapies.

The successful commercializationof our product candidates, if approved, will depend on achieving market acceptance and we may not be able to gain sufficient acceptanceto generate significant revenue.

Even if our product candidatesare successfully developed and receive regulatory approval, they may not gain market acceptance among physicians, patients, healthcarepayors such as private insurers or governments and other funding parties and the medical community. The degree of market acceptance forany of our products will depend on a number of factors, including:

Disease indications may besmall subsets of a disease that could be parsed into smaller and smaller indications as different subsets of diseases are defined. Thisincreasingly fine characterization of diseases could have negative consequences; including creating an approved indication that is sosmall as not to have a viable market for us. If future technology allows characterization of a disease in a way that is different fromthe characterization used for large pivotal studies, it may make those studies invalid or reduce their usefulness, and may require repeatingall or a portion of the studies. Future technology may supply better prognostic ability which could reduce the portion of patients projectedto need a new therapy. Even after being cleared by regulatory authorities, a product may later be shown to be unsafe or not to have itspurported effect, thereby preventing its widespread use or requiring withdrawal from the market.

We may not be successfulin establishing development and commercialization collaborations which could adversely affect, and potentially prohibit, our ability todevelop our product candidates.

Developing pharmaceuticalproducts, conducting clinical trials, obtaining regulatory approval, establishing manufacturing capabilities and marketing approved productsis expensive, and therefore we have, and may in the future, seek to enter into collaborations with companies that have more resourcesand experience in order to continue to develop and commercialize our product candidates. We also may be required due to financial or scientificconstraints to enter into additional collaboration agreements to research and/or to develop and commercialize our product candidates.The establishment and realization of such collaborations may not be possible or may be problematic. There can be no assurance that wewill be able to establish such additional collaborations on favorable terms, if at all, or that our current or future collaborative arrangementswill be successful or maintained for any specific product candidate or indication. If we are unable to reach successful agreements withsuitable collaboration partners for the ongoing development and commercialization of our product candidates, we may face increased costs,we may be forced to limit the scope and number of our product candidates we can commercially develop or the territories in which we commercializesuch product candidates, and we may be unable to commercialize products or programs for which a suitable collaboration partner cannotbe found. If we fail to achieve successful collaborations, our operating results and financial condition will be materially and adverselyaffected.

In addition, the terms ofany collaboration agreements may place restrictions on our activities with respect to other products, including by limiting our abilityto grant licenses or develop products with other third parties, or in different indications, diseases or geographical locations, or mayplace additional obligations on us with respect to development or commercialization of our product candidates. If we fail to comply withor breach any provision of a collaboration agreement, a collaborator may have the right to terminate, in whole or in part, such agreementor to seek damages.

Our collaboration and licensingagreements are, and may in the future be, complex and involve sharing or division of ownership of certain data, know-how and intellectualproperty rights among the various parties. Accordingly, our collaborators could interpret certain provisions differently than we or ourother collaborators which could lead to unexpected or inadvertent disputes with collaborators. In addition, these agreements might makeadditional collaborations, partnering or mergers and acquisitions difficult.

There is no assurance thata collaborator who is acquired by a third party would not attempt to change certain contract provisions that could negatively affect ourcollaboration. The acquiring company may also not accept the terms or assignment of our contracts and may seek to terminate the agreements.Any one of our collaborators could breach covenants, restrictions and/or sub-license agreement provisions leading us into disputes andpotential breaches of our agreements with other partners.

We will not be ableto successfully commercialize our product candidates without establishing sales and marketing capabilities internally or through collaborators.

We may not be able to findsuitable sales and marketing staff and collaborators for all of our product candidates. The development of a marketing and sales capabilitywill require significant expenditures, management resources and time. The cost of establishing such a sales force may exceed any potentialproduct revenue, or our marketing and sales efforts may be unsuccessful. If we are unable to develop an internal marketing and sales capabilityin a timely fashion, or at all, or if we are unable to enter into a marketing and sales arrangement with a third party on acceptable terms,we may be unable to effectively market and sell approved products, if any, which would prevent us from being able to generate revenueand attain profitability. Further, we may not develop an internal marketing and sales capability if we are unable to successfully developand seek regulatory approval for our product candidates.

We will rely upon third-partycontractors and service providers for the execution of some aspects of our development programs. Failure of these collaborators to provideservices of a suitable quality and within acceptable timeframes may cause the delay or failure of our development programs.

We outsource certain functions,tests and services to third parties, partners, medical institutions and collaborators and plan to outsource manufacturing to collaboratorsand/or contract manufacturers, and we will rely on third parties for quality assurance, clinical monitoring, clinical data managementand regulatory expertise. In particular, we rely on our partners to run our clinical trials. There is no assurance that such individualsor organizations will be able to provide the functions, tests, drug supply or services as agreed upon or to acceptable quality standards,and we could suffer significant delays in the development of our products or processes. In particular, certain third party service providersmay be unable to comply with their contractual obligations to us due to disruptions caused by lack of qualified employees and consultants,reduced operations or headcount reductions, or otherwise, and in certain cases we may have limited recourse if the non-compliance is dueto factors outside of the service provider’s control.

Our business is highlydependent on the success of our product candidates. If we are unable to successfully complete clinical development, obtain regulatoryapproval for or commercialize one or more of our product candidates, or if we experience delays in doing so, our business will be materiallyharmed.

Our future success and abilityto generate significant revenue from our product candidates, which we do not expect will occur for several years, is dependent on ourability to successfully develop, obtain regulatory approval for and commercialize one or more of our product candidates, including ourDupuytren’s Contracture product candidate, which has previously completed a successful Phase 2b clinical trial in the United Kingdom,a condition that affects the development of fibrous connective tissue in the palm of the hand. All of our other product candidates arein earlier stages of development and will require substantial additional investment for manufacturing, preclinical testing, clinical development,regulatory review and approval in one or more jurisdictions. If any of our product candidates encounter safety or efficacy problems, developmentdelays or regulatory issues or other problems, our development plans and business would be materially harmed.

We may not have the financialresources to continue development of our product candidates. Even if clinical trials are completed, we may experience other issues thatmay delay or prevent regulatory approval of, or our ability to commercialize, our product candidates, including:

Our product candidates willrequire additional, time-consuming development efforts prior to commercial sale, including preclinical studies, clinical trials and approvalby the FDA, EMA, MHRA and/or other applicable foreign regulatory authorities. All product candidates are prone to the risks of failurethat are inherent in pharmaceutical product development, including the possibility that such product candidate will not be shown to besufficiently safe and effective for approval by regulatory authorities. In addition, we cannot assure stockholders that any such productsthat are approved will be manufactured or produced economically, successfully commercialized or widely accepted in the marketplace orbe more effective than other commercially available alternatives.

Due to the significantresources required for the development of our product pipeline, and depending on our ability to access capital, we must prioritize thedevelopment of certain product candidates over others. Moreover, we may fail to expend our limited resources on product candidates orindications that may have been more profitable or for which there is a greater likelihood of success.

We have three separate programsfor producing anti-inflammatory agents: (1) investigating new clinical opportunities for anti-TNF, (2) identifying orally available,small molecules that are agonists of α7 nicotinic acetylcholine receptor, and (3) identifying patentable analogs of CBD thatinitially will be used as pain medications, that are at various stages of preclinical development. Due to the significant resources requiredfor the development of our product candidates, we must focus on specific diseases and disease pathways and decide which product candidatesto pursue and advance and the amount of resources to allocate to each. Our decisions concerning the allocation of research, development,collaboration, management and financial resources toward particular product candidates or therapeutic areas may not lead to the developmentof any viable commercial products and may divert resources away from better opportunities. If we make incorrect determinations regardingthe viability or market potential of any of our product candidates or misinterpret trends in the pharmaceutical industry, our business,financial condition, and results of operations could be materially adversely affected. As a result, we may (i) fail to capitalizeon viable commercial products or profitable market opportunities, (ii) be required to forego or delay pursuit of opportunities withother product candidates or other diseases and disease pathways that may later prove to have greater commercial potential than those wechoose to pursue, or (iii) relinquish valuable rights to such product candidates through collaboration, licensing, or other royaltyarrangements in cases in which it would have been advantageous for us to invest additional resources to retain sole development and commercializationrights.

The timelines of ourclinical trials may be impacted by numerous factors and any delays may adversely affect our ability to execute our current business strategy.

Clinical testing is expensive,difficult to design and implement, can take many years to complete, and is uncertain as to outcome. We may experience delays in clinicaltrials at any stage of development and testing of our product candidates. Our planned clinical trials may not begin on time, have an effectivedesign, enroll a sufficient number of subjects, or be completed on schedule, if at all.

Events which may result ina delay or unsuccessful completion of clinical trials include:

If initiation or completionof any of our clinical trials for our product candidates are delayed for any of the above reasons or for other reasons, our developmentcosts may increase, our approval process could be delayed, any periods after commercial launch and before expiration of patent protectionmay be reduced and our competitors may have more time to bring products to market before we do. Any of these events could impair the commercialpotential of our product candidates and could have a material adverse effect on our business.

Clinical trials of ourproduct candidates may not uncover all possible adverse effects that patients may experience.

Clinical trials are conductedin representative samples of the potential patient population, which may have significant variability. Clinical trials are by design basedon a limited number of subjects and of limited duration for exposure to the product used to determine whether, on a potentially statisticallysignificant basis, the planned safety and efficacy of any product candidate can be achieved. As with the results of any statistical sampling,we cannot be sure that all side effects of our product candidates may be uncovered, and it may be the case that only with a significantlylarger number of patients exposed to the product candidate for a longer duration, that a more complete safety profile is identified. Further,even larger clinical trials may not identify rare serious adverse effects or the duration of such studies may not be sufficient to identifywhen those events may occur. Patients treated with our products, if approved, may experience adverse reactions and it is possible thatthe FDA, MHRA or other regulatory authorities may ask for additional safety data as a condition of, or in connection with, our effortsto obtain approval of our product candidates. If safety problems occur or are identified after our product candidates reach the market,we may, or regulatory authorities may require us to amend the labeling of our products, recall our products or even withdraw approvalfor our products.

Failure can occur atany stage of our drug development efforts.

We may experience numerousunforeseen events during, or as a result of, testing that could delay or prevent us from obtaining regulatory approval for, or commercializingour drug candidates, including but not limited to:

We rely on third partiesto conduct our pre-clinical studies and clinical studies and trials, and if they do not perform their obligations to us, we may not beable to obtain approval for additional indications.

We do not currently have theability to independently conduct pre-clinical studies or clinical studies and trials, and we have to date relied on third parties, suchas third-party contract research and governmental organizations and medical institutions to conduct studies and trials for us. Our relianceon third parties for development activities reduces our control over these activities. These third parties may not complete activitieson schedule or may not conduct our pre-clinical studies and our clinical studies and trials in accordance with regulatory requirementsor our study design. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we maybe adversely affected, and our efforts to obtain regulatory approvals for and commercialize indications may be delayed.

If we conduct studies withother parties, we may not have control over all decisions associated with that trial. To the extent that we disagree with the other partyon such issues as study design, study timing and the like, it could adversely affect our drug development plans.

Although we also rely on thirdparties to manage the data from our studies and trials, we are responsible for confirming that each of our studies and trials is conductedin accordance with its general investigational plan and protocol. Moreover, the FDA and foreign regulatory agencies will require us tocomply with applicable regulations and standards, including Good Laboratory Practice (GLP) and Good Clinical Practice (GCP), forconducting, recording and reporting the results of such studies and trials to assure that the data and the results are credible and accurateand that the human study and trial participants are adequately protected. Our reliance on third-parties does not relieve us of these obligationsand requirements, and we may fail to obtain regulatory approval for any additional indications if these requirements are not met.

We will need to continueto develop and maintain distribution and production capabilities or relationships to be successful.

We may not be able to successfullymanufacture any product, either independently or under manufacturing arrangements, if any, with third party manufacturers. Moreover, ifany manufacturer should cease doing business with us or experience delays, shortages of supply or excessive demands on their capacity,we may not be able to obtain adequate quantities of product in a timely manner, or at all. Manufacturers, and in certain situations theirsuppliers, are required to comply with current NDA commitments and current good manufacturing practices (cGMP) requirements enforcedby the FDA, and similar requirements of other countries. The failure by a manufacturer to comply with these requirements could affectits ability to provide us with products. Although we intend to rely on third-party contract manufacturers, we are ultimately responsiblefor ensuring that our products are manufactured in accordance with cGMP. In addition, if, during a preapproval inspection or other inspectionof our third-party manufacturers’ facility or facilities, the FDA determines that the facility is not in compliance with cGMP, anyof our marketing applications that lists such facility as a manufacturer may not be approved or approval may be delayed until the facilitycomes into compliance with cGMP and completes a successful re-inspection by the FDA.

Any manufacturing problem,natural disaster, or epidemic, affecting manufacturing facilities, or the loss of a contract manufacturer could be disruptive to our operationsand result in lost sales. Additionally, we will be reliant on third parties to supply the raw materials needed to manufacture our products.Any reliance on suppliers may involve several risks, including a potential inability to obtain critical materials and reduced controlover production costs, delivery schedules, reliability and quality. Any unanticipated disruption to future contract manufacture causedby problems at suppliers could delay shipment of products, increase our cost of goods sold and result in lost sales. If our supplierswere unable to supply us with adequate supply of our drugs, it could have a material adverse effect on our ability to successfully commercializeour drug candidates.

If we fail to discover,develop and commercialize other product candidates, we may be unable to grow our business and our ability to achieve our strategic objectiveswould be impaired. In addition, we may also seek to commercialize certain treatments that may not be proprietary to us.

Although the development andcommercialization of our current product candidates are our initial focus, as part of our long-term growth strategy, we plan to developother product candidates. While we believe our planned products may have potential applicability to other uses, we have not conductedany clinical trials on these other uses and we may not be successful in developing product candidates for other uses. In addition, weintend to devote capital and resources for basic research to discover and identify additional product candidates. These research programsrequire technical, financial and human resources, whether or not any product candidates are ultimately identified. Our research programsmay initially show promise in identifying potential product candidates, yet fail to yield product candidates for clinical developmentfor many reasons, including the following:

If we do not achieveour projected development and commercialization goals within the timeframes we expect, the development and commercialization of our productcandidates may be delayed, and our business and results of operations may be harmed.

For planning purposes, weseek to estimate the timing of the accomplishment of various scientific, clinical, regulatory and other product development objectives.These milestones may include our expectations regarding the commencement or completion of scientific studies and clinical trials, thesubmission of regulatory filings, or commercialization objectives. From time to time, we may publicly announce the expected timing ofsome of these milestones, such as the completion of an ongoing clinical trial, the initiation of other clinical programs, receipt of marketingapproval or a commercial launch of a product. The potential achievement of many of these milestones may be outside of our control. Eachof these milestones is based on a variety of assumptions which, if not realized as expected, may cause the timing of such potential achievementof the respective milestones to vary considerably from our estimates, including:

If we fail to achieve anyannounced milestones in the timeframes we expect, the development and commercialization of our product candidates may be delayed, andour business and results of operations may be harmed, and it could negatively impact our share price performance. Please see the sectionentitled “Business” in this prospectus for more information.

If we rely on a solesource of supply to manufacture our products we could be impacted by the viability of our supplier.

We intend to attempt to sourceour products from more than one supplier. We also intend to enter into contracts with any supplier of our products to contractually obligatethem to meet our requirements. However, if we are reliant on a single supplier and that supplier cannot or will not meet our requirements(for whatever reason), our business could be adversely impacted.

We may not be able tosufficiently scale-up manufacturing of our drug candidates.

We may not be able to successfullyincrease in a sufficient manner the manufacturing capacity for our drug candidates, whether in collaboration with third-party manufacturersor on our own, in a timely or cost-effective manner or at all. If a contract manufacturer makes improvements in the manufacturing processfor our drug candidates, we may not own, or may have to share, the intellectual property rights to those improvements.

Significant scale-up of manufacturingmay require additional validation studies, which are costly and which the FDA must review and approve. In addition, quality issues mayarise during those scale-up activities because of the inherent properties of a drug candidate itself or of a drug candidate in combinationwith other components added during the manufacturing and packaging process, or during shipping and storage of the finished product oractive pharmaceutical ingredients. If we are unable to successfully scale-up manufacture of any of our drug candidates in sufficient qualityand quantity, the development of that drug candidate and regulatory approval or commercial launch for any resulting drug products maybe delayed or there may be a shortage in supply, which could significantly harm our business.

Our operations are subjectto risks associated with ongoing and potential future global conflicts.

In February 2022, an armedconflict escalated between Russia and Ukraine. The sanctions announced by the United States and other countries against Russia and Belarusfollowing Russia’s invasion of Ukraine to date include restrictions on selling or importing goods, services, or technology in orfrom affected regions and travel bans and asset freezes impacting connected individuals and political, military, business, and financialorganizations in Russia and Belarus. The United States and other countries could impose wider sanctions and take other actions shouldthe conflict further escalate. Separately, in October 2023, Israel and certain Iranian-backed Palestinian forces began an armed conflictin Israel, the Gaza Strip, and surrounding areas, which threatens to spread to other Middle Eastern countries including Lebanon and Iran.

These wars are increasinglyaffecting economic and global financial markets and exacerbating ongoing economic challenges, including issues such as rising inflationand global supply-chain disruption. While we do not believe these conflicts currently have a material impact on our financial accountingand reporting, the degree to which we will be affected in the future largely depends on the nature and duration of uncertain and unpredictableevents, and our business could be impacted. Additionally, we currently have agreements and relationships in place with Yissum ResearchDevelopment Company of the Hebrew University of Jerusalem, Ltd. (“Yissum”), located in Israel, and Yissum’s operationsmay be materially affected by the ongoing war in Israel, which may delay, prevent, or materially increase the cost of, the ongoing servicesYissum is required to provide to the Company. Furthermore, future global conflicts or wars could create further economic challenges, including,but not limited to, increases in inflation and further global supply-chain disruption. Consequently, the ongoing Russia/Ukraine Hamas/Israelconflicts and/or other future global conflicts, could result in an increase in operating expenses and/or a decrease in any future revenueand could further have a material adverse effect on our results of operations and cash flow.

We may enter intostrategic transactions in the future which may result in a material change in our operations and/or a change of control.

In December 2023 we engagedA.G.P./Alliance Global Partners as financial advisor to explore and evaluate strategic alternatives to enhance shareholder value. Potentialstrategic alternatives that may be explored or evaluated by the Company as part of this process include, but are not limited to, an acquisition,merger, reverse merger, other business combination, sale of assets, licensing or other strategic transactions involving the Company. TheCompany does not intend to discuss or disclose further developments during this process unless and until its Board of Directors has approveda specific action or otherwise determined that further disclosure is appropriate. There is no assurance that the strategic review processwill result in the approval or completion of any specific transaction or outcome.

The Board of Directors andmanagement team are committed to acting in the best interests of the Company, its stockholders and its stakeholders. There is no deadlineor definitive timetable set for completion of the strategic alternatives review process and there can be no assurance that this processwill result in the Company pursuing a transaction or any other strategic outcome.

As a result of the above,in the future, we may enter into transactions with parties seeking to merge and/or acquire us and/or our operations. While we have notentered into any agreements or understandings with any such parties to date, in the event that we do enter into such a transaction ortransactions in the future, new shares of common stock or preferred stock could be issued resulting in substantial dilution to our thencurrent stockholders and/or a change of control. As a result, our new majority stockholders may change the composition of our Board ofDirectors and may replace our current management. Any future transaction may also result in a change in our business focus. We have notentered into any agreements relating to any strategic transaction involving the Company as of the date of this prospectus and may notenter into such agreements in the future. Any future strategic transaction involving the Company or its operations may have a materialeffect on our operations, cash flows, results of operations, prospects, plan of operations, the listing of our common stock on Nasdaq,our officers, directors and majority stockholder(s), and the value of our securities.

Risks Related to a Potential Future Reverse Stock Split of Our CommonStock

A reverse stock splitmay not increase our stock price and have the desired effect of maintaining compliance with the rules of the Nasdaq.

TheCompany is seeking stockholder approval of an amendment to our Second Amended and Restated Certificate of Incorporation, as amended, ata special meeting of stockholders planned to be held on February 16, 2024, to effect a reverse stock split of our issued and outstandingshares of our Common Stock, by a ratio of between one-for-four to one-for-forty, inclusive, with the exact ratio to be set at a wholenumber to be determined by our Board of Directors or a duly authorized committee thereof in its discretion, at any time after approvalof the amendment and prior to February 16, 2025.

The Board is seeking approvalfor a reverse stock split, and expects that a reverse stock split of our common stock will increase the market price of our common stock,so that we are able to regain and maintain compliance with the Nasdaq minimum bid price listing standard. However, the effect of the reversestock split upon the market price of our common stock cannot be predicted with any certainty, and the history of similar reverse stocksplits for companies in like circumstances is varied. The price per share of our common stock after the reverse stock split may not reflectthe exchange ratio implemented by the Board of Directors and the price per share following the effective time of the reverse stock splitmay not be maintained for any period of time following the reverse stock split. Accordingly, the total market capitalization of our commonstock following a reverse stock split may be lower than before the reverse stock split.

Under applicable Nasdaq rules,to regain compliance with the $1.00 minimum closing bid price requirement and maintain our listing on the Nasdaq Capital Market, the $1.00closing bid price must be maintained for a minimum of ten (10) consecutive business days. Accordingly, we cannot assure you that we willbe able to maintain our Nasdaq listing after a reverse stock split is effected (assuming approved by stockholders) or that the marketprice per share after a reverse stock split will exceed or remain in excess of the $1.00 minimum bid price for a sustained period of time.

It is possible that the pershare price of our common stock after a reverse stock split will not rise in proportion to the reduction in the number of shares of ourcommon stock outstanding resulting from the reverse stock split, and the market price per post-reverse stock split share may not exceedor remain in excess of the $1.00 minimum bid price for a sustained period of time, and the reverse stock split may not result in a pershare price that would attract brokers and investors who do not trade in lower priced stocks. Even if we effect the reverse stock split,the market price of our common stock may decrease due to factors unrelated to the stock split. In any case, the market price of our commonstock may also be based on other factors which may be unrelated to the number of shares outstanding, including our future performance.If the reverse stock split is consummated and the trading price of the common stock declines, the percentage decline as an absolute numberand as a percentage of our overall market capitalization may be greater than would occur in the absence of the reverse stock split. Evenif the market price per post-reverse stock split share of our common stock remains in excess of $1.00 per share, we may be delisted dueto a failure to meet other continued listing requirements, including Nasdaq requirements related to the minimum stockholders’ equity,the minimum number of shares that must be in the public float, the minimum market value of the public float and the minimum number ofround lot holders.

A reverse stock splitmay decrease the liquidity of our common stock.

The liquidity of our commonstock may be harmed by a reverse stock split given the reduced number of shares of common stock that would be outstanding after a reversestock split, particularly if the stock price does not increase as a result of the reverse stock split. In addition, investors might considerthe increased proportion of unissued authorized shares of common stock to issued shares to have an anti-takeover effect under certaincircumstances, because the proportion allows for dilutive issuances which could prevent certain stockholders from changing the compositionof the Board of Directors or render tender offers for a combination with another entity more difficult to successfully complete. The Boardof Directors does not intend for a reverse stock split to have any anti-takeover effects.

Risks Related to Development and Regulatory Approval of our FutureProduct Candidates

Clinical trials areexpensive, time-consuming, uncertain and susceptible to change, delay or termination. The results of clinical trials are open to differinginterpretations.

We have three separate programsfor producing anti-inflammatory agents: (1) investigating new clinical opportunities for anti-TNF, (2) identifying orally available,small molecules that are agonists of α7 nicotinic acetylcholine receptor, and (3) identifying patentable analogs of CBD thatinitially will be used as pain medications. However, these programs, including the related clinical trials, are expensive, time consumingand difficult to design and implement.

Regulatory agencies may notaccept clinical trial designs submitted by us, and may analyze or interpret the results of clinical trials differently than us. Even ifthe results of our clinical trials are favorable, the clinical trials for a number of our future product candidates are expected to continuefor several years and may take significantly longer to complete. In addition, the FDA, MHRA or other regulatory authorities, includingstate, local and foreign authorities, or an IRB, with respect to a trial at our institution, may suspend, delay or terminate our clinicaltrials at any time, require us to conduct additional clinical trials, require a particular clinical trial to continue for a longer durationthan originally planned, require a change to our development plans such that we conduct clinical trials for a product candidate in a differentorder, e.g., in a step-wise fashion rather than running two trials of the same product candidate in parallel, or could suspend or terminatethe registrations and quota allotments we require in order to procure and handle controlled substances, for various reasons, includingthe following, any of which could have a material adverse effect on our business, financial condition and results of operations:

We may find it difficultto enroll patients in our clinical trials, which could delay or prevent clinical trials of our product candidates.

Identifying and qualifyingpatients to participate in clinical trials of our product candidates is critical to our success. The timing of our clinical trials dependson the speed at which we can recruit eligible patients to participate in testing our product candidates. We have experienced delays insome of our clinical trials, and we may experience similar delays in the future. These delays could result in increased costs, delaysin advancing our product development, or termination of the clinical trials altogether.

We may not be able to identify,recruit and enroll a sufficient number of patients, or those with required or desired characteristics to achieve diversity in a study,to complete our clinical trials within the expected timeframe. Patient enrollment can be impacted by factors including, but not limitedto:

In particular, each of theconditions for which we plan to evaluate our product candidates are diseases with limited patient pools from which to draw for clinicaltrials. The eligibility criteria of our clinical trials will further limit the pool of available study participants. Additionally, theprocess of finding and diagnosing patients may prove costly. The treating physicians in our clinical trials may also use their medicaldiscretion in advising patients enrolled in our clinical trials to withdraw from our studies to try alternative therapies. In addition,pandemics or epidemics may impact patient ability and willingness to travel to clinical trial sites as a result of quarantines and otherrestrictions, which may negatively impact enrollment in our clinical trials, for example, our trials have in the past had difficulty recruitinga sufficient number of patients due to the COVID-19 pandemic.

We may not be able to initiateor continue clinical trials if we cannot enroll the required eligible patients per protocol to participate in the clinical trials requiredby the FDA or the EMA, MHRA or other regulatory agencies. Our ability to successfully initiate, enroll and complete a clinical trial inany foreign country is subject to numerous risks unique to conducting business in foreign countries, including:

If we have difficulty enrollinga sufficient number of patients to conduct our clinical trials as planned, we may need to delay, limit or terminate ongoing or plannedclinical trials, any of which would have an adverse effect on our ability to complete clinical trials and ultimately our results of operations.

Any failure by our companyto comply with existing regulations could harm our reputation and operating results.

We are subject to extensiveregulation by U.S. federal and state and foreign governments in each of the U.S., European and Canadian markets, in which we plan to sellour products, or in markets where we have product candidates progressing through the approval process.

We must adhere to all regulatoryrequirements including FDA’s GLP, GCP and GMP requirements, pharmacovigilance requirements, advertising and promotion restrictions,reporting and recordkeeping requirements, and their European equivalents. If we or our suppliers fail to comply with applicable regulations,including FDA pre-or post-approval requirements, then the FDA or other foreign regulatory authorities could sanction our company. Evenif a drug is approved by the FDA or other competent authorities, regulatory authorities may impose significant restrictions on a product’sindicated uses or marketing or impose ongoing requirements for potentially costly post-marketing trials. Any of our product candidateswhich may be approved in the United States will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging,storage, distribution, import, export, advertising, promotion, sampling, recordkeeping and submission of safety and other post-marketinformation, including both federal and state requirements. In addition, manufacturers and manufacturers’ facilities are requiredto comply with extensive FDA requirements, including ensuring that quality control and manufacturing procedures conform to GMP. As such,we and our contract manufacturers (in the event contract manufacturers are appointed in the future) are subject to continual reviewand periodic inspections to assess compliance with GMP. Accordingly, we and others with whom we work will have to spend time, money andeffort in all areas of regulatory compliance, including manufacturing, production, quality control and quality assurance. We will alsobe required to report certain adverse reactions and production problems, if any, to the FDA, and to comply with requirements concerningadvertising and promotion for our products. Promotional communications with respect to prescription drugs are subject to a variety oflegal and regulatory restrictions and must be consistent with the information in the product’s approved label. Similar restrictionsand requirements exist in the European Union and other markets where we operate.

If a regulatory agency discoverspreviously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facilitywhere the product is manufactured, or disagrees with the promotion, marketing or labeling of the product, it may impose restrictions onthat product or on our company, including requiring withdrawal of the product from the market. If we fail to comply with applicable regulatoryrequirements, a regulatory agency or enforcement authority may issue warning letters, impose civil or criminal penalties, suspend regulatoryapproval, suspend any of our ongoing clinical trials, refuse to approve pending applications or supplements to approved applications submittedby us, impose restrictions on our operations, or seize or detain products or require a product recall.

In addition, it is possiblethat our future products will be regulated by the DEA, under the Controlled Substances Act or under similar laws elsewhere. DEA schedulingis a separate process that can delay when a drug may become available to patients beyond an NDA approval date, and the timing and outcomeof such DEA process is uncertain. See also “Risks Related to Controlled Substances”, below.

In addition, any governmentinvestigation of alleged violations of law could require us to spend significant time and resources in response and could generate negativepublicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability to commercializeand generate revenue from our future product candidates. If regulatory sanctions are applied or if regulatory approval is withdrawn, thevalue of our business and our operating results may be adversely affected.

Any action against us forviolation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses, divert our management’sattention from the operation of our business and damage our reputation. We expect to spend significant resources on compliance effortsand such expenses are unpredictable. Changing laws, regulations and standards might also create uncertainty, higher expenses and increaseinsurance costs. As a result, we intend to invest all reasonably necessary resources to comply with evolving standards, and this investmentmight result in increased management and administrative expenses and a diversion of management time and attention from revenue-generatingactivities to compliance activities.

We are subject to federal,state and foreign healthcare laws and regulations and implementation of or changes to such healthcare laws and regulations could adverselyaffect our business and results of operations.

In both the United Statesand certain foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the healthcare system inways that could impact our ability to sell our future product candidates. If we are found to be in violation of any of these laws or anyother federal, state or foreign regulations, we may be subject to administrative, civil and/or criminal penalties, damages, fines, individualimprisonment, we from federal health care programs and the restructuring of our operations. Any of these could have a material adverseeffect on our business and financial results. Since many of these laws have not been fully interpreted by the courts, there is an increasedrisk that we may be found in violation of one or more of their provisions. Any action against us for violation of these laws, even ifwe ultimately are successful in our defense, will cause us to incur significant legal expenses and divert our management’s attentionaway from the operation of our business. In addition, in many foreign countries, particularly the countries of the European Union thepricing of prescription drugs is subject to government control.

In some foreign countries,the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widelyfrom country to country.

For example, some EU jurisdictionsoperate positive and negative list systems under which products may only be marketed once a reimbursement price has been agreed. To obtainreimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost-effectivenessof a particular product candidate to currently available therapies. Other member states allow companies to fix their own prices for medicinesbut monitor and control company profits. Such differences in national pricing regimes may create price differentials between EU memberstates. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products willallow favorable reimbursement and pricing arrangements for any of our products. Historically, products launched in the United Kingdomand European Union do not follow price structures of the United States In the United Kingdom and European Union, the downward pressureon healthcare costs in general, particularly prescription medicines, has become intense. As a result, barriers to entry of new productsare becoming increasingly high and patients are unlikely to use a drug product that is not reimbursed by their government. We may facecompetition from lower-priced products in foreign countries that have placed price controls on pharmaceutical products. In addition, theimportation of foreign products may compete with any future product that we may market, which could negatively impact our profitability.

Specifically, in the UnitedStates, we expect that the ACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorouscoverage criteria and in additional downward pressure on the price that we may receive for any approved product. There have been judicialchallenges to certain aspects of the ACA and numerous legislative attempts to repeal and/or replace the ACA in whole or in part, and weexpect there will be additional challenges and amendments to the ACA in the future. At this time, the full effect that the ACA will haveon our business in the future remains unclear. An expansion in the government’s role in the U.S. healthcare industry may cause generaldownward pressure on the prices of prescription drug products, lower reimbursements or any other product for which we obtain regulatoryapproval, reduce product utilization and adversely affect our business and results of operations. Any reduction in reimbursement fromMedicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containmentmeasures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize any ofour future product candidates for which we may receive regulatory approval.

Information obtainedfrom expanded access studies may not reliably predict the efficacy of our future product candidates in company-sponsored clinical trialsand may lead to adverse events that could limit approval.

The expanded access studieswe are currently supporting are uncontrolled, carried out by individual investigators and not typically conducted in strict compliancewith GCPs, all of which can lead to a treatment effect which may differ from that in placebo-controlled trials. These studies provideonly anecdotal evidence of efficacy for regulatory review. These studies contain no control or comparator group for reference and thispatient data is not designed to be aggregated or reported as study results. Moreover, data from such small numbers of patients may behighly variable. Information obtained from these studies, including the statistical principles that we and the independent investigatorshave chosen to apply to the data, may not reliably predict data collected via systematic evaluation of the efficacy in company-sponsoredclinical trials or evaluated via other statistical principles that may be applied in those trials. Reliance on such information to designour clinical trials may lead to trials that are not adequately designed to demonstrate efficacy and could delay or prevent our abilityto seek approval of our future product candidates.

Expanded access programs providesupportive safety information for regulatory review. Physicians conducting these studies may use our future product candidates in a mannerinconsistent with the protocol, including in children with conditions beyond those being studied in trials which we sponsor. Any adverseevents or reactions experienced by subjects in the expanded access program may be attributed to our future product candidates and maylimit our ability to obtain regulatory approval with labeling that we consider desirable, or at all.

There is a high rateof failure for drug candidates proceeding through clinical trials.

Generally, there is a highrate of failure for drug candidates proceeding through clinical trials. We may suffer significant setbacks in our clinical trials similarto the experience of a number of other companies in the pharmaceutical and biotechnology industries, even after receiving promising resultsin earlier trials. Further, even if we view the results of a clinical trial to be positive, the FDA, MHRA or other regulatory authoritiesmay disagree with our interpretation of the data. In the event that we obtain negative results from clinical trials for product candidatesor other problems related to potential chemistry, manufacturing and control issues or other hurdles occur and our future product candidatesare not approved, we may not be able to generate sufficient revenue or obtain financing to continue our operations, our ability to executeon our current business plan may be materially impaired, and our reputation in the industry and in the investment community might be significantlydamaged. In addition, our inability to properly design, commence and complete clinical trials may negatively impact the timing and resultsof our clinical trials and ability to seek approvals for our drug candidates.

If we are found in violationof federal or state “fraud and abuse” laws or similar laws in other jurisdictions, we may be required to pay a penalty and/orbe suspended from participation in federal or state health care programs, which may adversely affect our business, financial conditionand results of operations.

In the United States, we aresubject to various federal and state health care “fraud and abuse” laws, including anti-kickback laws, false claims laws andother laws intended to reduce fraud and abuse in federal and state health care programs, which could affect our company particularly uponsuccessful commercialization of our products in the United States The Medicare and Medicaid Patient Protection Act of 1987, or federalAnti-Kickback Statute, makes it illegal for any person, including a prescription drug manufacturer (or a party acting on its behalf),to knowingly and willfully solicit, receive, offer or pay any remuneration that is intended to induce the referral of business, includingthe purchase, order or prescription of a particular drug for which payment may be made under a federal health care program, such as Medicareor Medicaid. Under federal law, some arrangements, known as safe harbors, are deemed not to violate the federal Anti-Kickback Statute.Although we seek to structure our business arrangements in compliance with all applicable requirements, it is often difficult to determineprecisely how the law will be applied in specific circumstances. Accordingly, it is possible that our practices may be challenged underthe federal Anti-Kickback Statute and Federal False Claims Act. Violations of fraud and abuse laws may be punishable by criminal and/orcivil sanctions, including fines and/or exclusion or suspension from federal and state health care programs such as Medicare and Medicaidand debarment from contracting with the U.S. government. In addition, private individuals have the ability to bring actions on behalfof the government under the federal False Claims Act as well as under the false claims laws of several states.

While we believe that we havestructured our business arrangements to comply with these laws, the government could allege violations of, or convict us of violating,these laws. If we are found in violation of one of these laws, we could be required to pay a penalty and could be suspended or excludedfrom participation in federal or state health care programs, and our business, results of operations and financial condition may be adverselyaffected.

The Member States of the EuropeanUnion and other countries also have anti-kickback laws and can impose penalties in case of infringement, which, in some jurisdictions,can also be enforced by competitors.

Serious adverse eventsor other safety risks could require us to abandon development and preclude, delay or limit approval of our future product candidates,limit the scope of any approved label or market acceptance, or cause the recall or loss of marketing approval of products that are alreadymarketed.

If any of our future productcandidates prior to or after any approval for commercial sale, cause serious or unexpected side effects, or are associated with othersafety risks such as misuse, abuse or diversion, a number of potentially significant negative consequences could result, including:

We may voluntarily suspendor terminate our clinical trials if at any time we believe that the products present an unacceptable risk to participants, or if preliminarydata demonstrates that our future product candidates are unlikely to receive regulatory approval or unlikely to be successfully commercialized.Following receipt of approval for commercial sale of a product, we may voluntarily withdraw or recall that product from the market ifat any time we believe that its use, or a person’s exposure to it, may cause adverse health consequences or death. To date, we havenot withdrawn, recalled or taken any other action, voluntary or mandatory, to remove an approved product from the market, have not receivedapproval for any products, and have not marketed any approved product. In addition, regulatory agencies, IRBs or data safety monitoringboards may at any time recommend the temporary or permanent discontinuation of our clinical trials or request that we cease using investigatorsin the clinical trials if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements,or that they present an unacceptable safety risk to participants. Although we have never been asked by a regulatory agency, IRB or datasafety monitoring board to temporarily or permanently discontinue a clinical trial, if we elect or are forced to suspend or terminatea clinical trial of any of our future product candidates, the commercial prospects for that product will be harmed and our ability togenerate product revenue from that product may be delayed or eliminated. Furthermore, any of these events may result in labeling statementssuch as warnings or contraindications. In addition, such events or labeling could prevent us or our partners from achieving or maintainingmarket acceptance of the affected product and could substantially increase the costs of commercializing our future product candidatesand impair our ability to generate revenue from the commercialization of these products either by our company or by our collaborationpartners.

The development of REMSfor our future product candidates could cause delays in the approval process and would add additional layers of regulatory requirementsthat could impact our ability to commercialize our future product candidates in the United States and reduce their market potential.

Even if the FDA approves ourNDA for any of our future product candidates without requiring a REMS as a condition of approval of the NDA, the FDA may, post-approval,require a REMS for any of our future product candidates if it becomes aware of new safety information that makes a REMS necessary to ensurethat the benefits of the drug outweigh the potential risks. REMS elements can include medication guides, communication plans for healthcare professionals, and elements to assure safe use (“ETASU”). ETASU can include, but are not limited to, special trainingor certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring and the use of patientregistries. Moreover, product approval may require substantial post-approval testing and surveillance to monitor the drug’s safetyor efficacy. We may be required to adopt a REMS for our future product candidates to ensure that the benefits outweigh the risks of abuse,misuse, diversion and other potential safety concerns. There can be no assurance that the FDA will approve a manageable REMS for our futureproduct candidates, which could create material and significant limits on our ability to successfully commercialize our future productcandidates in the United States Delays in the REMS approval process could result in delays in the NDA approval process. In addition, aspart of the REMS, the FDA could require significant restrictions, such as restrictions on the prescription, distribution and patient useof the product, which could significantly impact our ability to effectively commercialize our future product candidates, and dramaticallyreduce their market potential, thereby adversely impacting our business, financial condition and results of operations. Even if initialREMS are not highly restrictive, if, after launch, our future product candidates were to be subject to significant abuse/non-medical useor diversion from illicit channels, this could lead to negative regulatory consequences, including a more restrictive REMS.

The regulatory approvalprocesses of the FDA and comparable foreign authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimatelyunable to obtain regulatory approval for our product candidates, our business will be substantially harmed.

We are not permitted to commercialize,market, promote or sell any product candidate in the United States without obtaining regulatory approval from the FDA. Foreign regulatoryauthorities, such as the EMA and MHRA, impose similar requirements. The time required to obtain approval by the FDA and comparable foreignauthorities is inherently unpredictable, but typically takes many years following the commencement of clinical trials and depends uponnumerous factors, including substantial discretion of the regulatory authorities. In addition, approval policies, regulations, or thetype and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical developmentand may vary among jurisdictions. To date, we have not submitted an NDA to the FDA or similar drug approval submissions to comparableforeign regulatory authorities for our most advanced product candidate for the early stage treatment of Dupuytren’s Contracture,or any other product candidate. We must complete additional preclinical studies and clinical trials to demonstrate the safety and efficacyof our product candidates in humans before we will be able to obtain these approvals.

Clinical testing is expensive,difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome. We cannot guarantee thatany clinical trial design that we submit will be accepted by FDA, MHRA or other comparable foreign regulatory authorities, or that clinicaltrials will be conducted as planned or completed on schedule, if at all. The clinical development of our initial and potential additionalproduct candidates is susceptible to the risk of failure inherent at any stage of development, including failure to demonstrate efficacyin a clinical trial or across a broad population of patients, the occurrence of adverse events that are severe or medically or commerciallyunacceptable, failure to comply with protocols or applicable regulatory requirements, and determination by the FDA, MHRA or any othercomparable foreign regulatory authority that a product candidate may not continue development or is not approvable. It is possible thateven if any of our product candidates has a beneficial effect, that effect will not be detected during clinical evaluation as a resultof one or more of a variety of factors, including the size, duration, design, measurements, conduct or analysis of our clinical trials.Conversely, as a result of the same factors, our clinical trials may indicate an apparent positive effect of such product candidate thatis greater than the actual positive effect, if any. Similarly, in our clinical trials, we may fail to detect toxicity of, or intolerabilitycaused by, such product candidate, or mistakenly believe that our product candidates are toxic or not well tolerated when that is notin fact the case. Serious adverse events, or SAEs, or other adverse effects, as well as tolerability issues, could hinder or prevent marketacceptance of the product candidate at issue.

Our current and future productcandidates could fail to receive regulatory approval for many reasons, including the following:

This lengthy approval processas well as the unpredictability of clinical trial results may result in us failing to obtain regulatory approval to market any productcandidate we develop, which would substantially harm our business, results of operations and prospects. The FDA, MHRA or other comparableforeign authorities have substantial discretion in the approval process and determining when or whether regulatory approval will be grantedfor any product candidate that we develop. Even if we believe the data collected from future clinical trials of our product candidatesare promising, such data may not be sufficient to support approval by the FDA or any other regulatory authority.

In addition, even if we wereto obtain approval, regulatory authorities may approve any of our product candidates for fewer or more limited indications than we request,may not approve the price we intend to charge for our products, may grant approval contingent on the performance of costly post-marketingclinical trials, or may approve a product candidate with labeling that does not include the claims necessary or desirable for the successfulcommercialization of that product candidate. Any of the foregoing scenarios could materially harm the commercial prospects for our productcandidates.

Risks Related to our Reliance Upon Third Parties

Our existing collaborationarrangements with certain universities and any that we may enter into in the future with other partners may not be successful, which couldadversely affect our ability to develop and commercialize our future product candidates.

We are seeking collaborationarrangements with pharmaceutical or biotechnology companies for the development or commercialization of our future product candidates.We may, with respect to our future product candidates, enter into new arrangements on a selective basis depending on the merits of retainingcommercialization rights for ourselves as compared to entering into selective collaboration arrangements with leading pharmaceutical orbiotechnology companies for each product candidate, both in the United States and internationally. To the extent that we decide to enterinto collaboration agreements, we will face significant competition in seeking appropriate collaborators and the terms of any collaborationor other arrangements that we may establish may not be favorable to us.

Any existing or future collaborationthat we enter into may not be successful. The success of our collaboration arrangements will depend heavily on the efforts and activitiesof our collaborators. Collaborators generally have significant discretion in determining the efforts and resources that they will applyto these collaborations. Disagreements between parties to a collaboration arrangement regarding development, intellectual property, regulatoryor commercialization matters, can lead to delays in the development process or commercialization of the applicable product candidate and,in some cases, termination of the collaboration arrangement. These disagreements can be difficult to resolve if neither of the partieshas final decision-making authority. Any such termination or expiration could harm our business reputation and may adversely affect itfinancially.

We expect to dependon a limited number of suppliers for materials and components in order to manufacture our future product candidates. The loss of thesesuppliers, or their failure to supply us on a timely basis, could cause delays in our current and future capacity and adversely affectour business.

We expect to depend on a limitednumber of suppliers for the materials and components required to manufacture our future product candidates. As a result, we may not beable to obtain sufficient quantities of critical materials and components in the future. A delay or interruption by our suppliers mayalso harm our business, results of operations and financial condition. In addition, the lead time needed to establish a relationship witha new supplier can be lengthy, and we may experience delays in meeting demand in the event we must switch to a new supplier. The timeand effort to qualify for and, in some cases, obtain regulatory approval for a new supplier could result in additional costs, diversionof resources or reduced manufacturing yields, any of which would negatively impact our operating results. Our dependence on single-sourcesuppliers exposes us to numerous risks, including the following: our suppliers may cease or reduce production or deliveries, they maybe subject to government investigations and regulatory actions that limit or prevent production capabilities for an extended period oftime, raise prices or renegotiate terms; our suppliers may become insolvent; we may be unable to locate a suitable replacement supplieron acceptable terms or on a timely basis, or at all; and delays caused by supply issues may harm our reputation, frustrate our customersand cause them to turn to our competitors for future needs.

Risks Related to our Intellectual Property

We may not be able toadequately protect our future product candidates or our proprietary technology in the marketplace.

Our success will depend, inpart, on our ability to obtain patents, protect our trade secrets and operate without infringing on the proprietary rights of others.We rely upon a combination of patents, trade secret protection (i.e., know-how), and confidentiality agreements to protect the intellectualproperty of our future product candidates. The strengths of patents in the pharmaceutical field involve complex legal and scientific questionsand can be uncertain. Where appropriate, we seek patent protection for certain aspects of our products and technology. Filing, prosecutingand defending patents globally can be prohibitively expensive.

Our policy is to look to patenttechnologies with commercial potential in jurisdictions with significant commercial opportunities. However, patent protection may notbe available for some of the products or technology we are developing. If we must spend significant time and money protecting, defendingor enforcing our patents, designing around patents held by others or licensing, potentially for large fees, patents or other proprietaryrights held by others, our business, results of operations and financial condition may be harmed. We may not develop additional proprietaryproducts that are patentable. As of the date hereof, we have an extensive portfolio of patents, including many granted patents and patentspending approval.

The patent positions of pharmaceuticalproducts are complex and uncertain. The scope and extent of patent protection for our future product candidates are particularly uncertain.Our future product candidates will be based on medicinal chemistry instead of cannabis plants. While we have sought patent protection,where appropriate, directed to, among other things, composition-of-matter for its specific formulations, their methods of use, and methodsof manufacture, we do not have and will not be able to obtain composition of matter protection on these previously known CBD derivativesper se. We anticipate that the products we develop in the future will be based upon synthetic compounds we may discover. Although we havesought, and will continue to seek, patent protection in the United States, Europe and other countries for our proprietary technologies,future product candidates, their methods of use, and methods of manufacture, any or all of them may not be subject to effective patentprotection. If any of our products are approved and marketed for an indication for which we do not have an issued patent, our abilityto use our patents to prevent a competitor from commercializing a non-branded version of our commercial products for that non-patentedindication could be significantly impaired or even eliminated.

Publication of informationrelated to our future product candidates by our company or others may prevent us from obtaining or enforcing patents relating to theseproducts and product candidates. Furthermore, others may independently develop similar products, may duplicate our products, or may designaround our patent rights. In addition, any of our issued patents may be opposed and/or declared invalid or unenforceable. If we fail toadequately protect our intellectual property, we may face competition from companies who attempt to create a generic product to competewith our future product candidates. We may also face competition from companies who develop a substantially similar product to our futureproduct candidates that is not covered by any of our patents.

Many companies have encounteredsignificant problems in protecting, defending and enforcing intellectual property rights in foreign jurisdictions. The legal systems ofcertain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual propertyrights, particularly those relating to pharmaceuticals, which could make it difficult for us to stop the infringement of our patents ormarketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreignjurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business.

If third parties claimthat intellectual property used by our company infringes upon their intellectual property, our operating profits could be adversely affected.

There is a substantial amountof litigation, both within and outside the United States, involving patent and other intellectual property rights in the pharmaceuticalindustry. We may, from time to time, be notified of claims that we are infringing upon patents, trademarks, copyrights or other intellectualproperty rights owned by third parties, and we cannot provide assurances that other companies will not, in the future, pursue such infringementclaims against us, our commercial partners or any third-party proprietary technologies we have licensed. If we were found to infringeupon a patent or other intellectual property right, or if we failed to obtain or renew a license under a patent or other intellectualproperty right from a third party, or if a third party from whom we were licensing technologies was found to infringe upon a patent orother intellectual property rights of another third party, we may be required to pay damages, including damages of up to three times thedamages found or assessed, if the infringement is found to be willful, suspend the manufacture of certain products or reengineer or rebrandour products, if feasible, or we may be unable to enter certain new product markets. Any such claims could also be expensive and timeconsuming to defend and divert management’s attention and resources. Our competitive position could suffer as a result. In addition,if we have declined or failed to enter into a valid non-disclosure or assignment agreement for any reason, we may not own the inventionor our intellectual property, and our products may not be adequately protected. Thus, we cannot guarantee that any of our future productcandidates, or our commercialization thereof, does not and will not infringe any third party’s intellectual property.

If we are not able toadequately prevent disclosure of trade secrets and other proprietary information, the value of our technology and products could be significantlydiminished.

We rely on trade secrets toprotect our proprietary technologies, especially where we do not believe patent protection is appropriate or obtainable. However, tradesecrets are difficult to protect. We rely in part on confidentiality agreements with current and former employees, consultants, outsidescientific collaborators, sponsored researchers, contract manufacturers, vendors and other advisors to protect our trade secrets and otherproprietary information. These agreements may not effectively prevent disclosure of confidential information and may not provide an adequateremedy in the event of unauthorized disclosure of confidential information. In addition, we cannot guarantee that we have executed theseagreements with each party that may have or have had access to our trade secrets. Any party with whom we or they have executed such anagreement may breach that agreement and disclose our proprietary information, including our trade secrets, and we may not be able to obtainadequate remedies for such breaches.

Enforcing a claim that a partyillegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. Also,some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of our trade secrets wereto be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those to whom they disclosesuch trade secrets, from using that technology or information to compete with us. If any of our trade secrets were to be disclosed toor independently developed by a competitor or other third-party, our competitive position would be harmed.

The expiration or lossof patent protection may adversely affect our future revenues and operating earnings.

We rely on patent, trademark,trade secret and other intellectual property protection in the discovery, development, manufacturing and sale of our product candidates.In particular, patent protection is important in the development and eventual commercialization of our product candidates. Patents coveringour product candidates normally provide market exclusivity, which is important in order to improve the probability that our product candidatesare able to become profitable.

One of our patents relatingto our Fibrosis and anti-TNF program will expire in 2033; however, the majority of the patent portfolio has a longer lifespan. While weare seeking additional patent coverage which may protect the technology underlying these patents, there can be no assurances that suchadditional patent protection will be granted, or if granted, that these patents will not be infringed upon or otherwise held enforceable.Even if we are successful in obtaining a patent, patents have a limited lifespan. In the United States, the natural expiration of a utilitypatent is generally 20 years after it is filed. Various extensions may be available; however, the life of a patent, and the protectionit affords, is limited. Without patent protection of our product candidates, we may be open to competition from generic versions of suchmethods and compositions.

If we do not obtainprotection under the Hatch-Waxman Amendments by extending the patent term, our business may be harmed.

Our commercial success willlargely depend on our ability to obtain and maintain patent and other intellectual property in the United States and other countries withrespect to our product candidates. Given the amount of time required for the development, testing and regulatory review of new productcandidates, patents protecting our product candidates might expire before or shortly after such candidates begin to be commercialized.We expect to seek extensions of patent terms in the United States and, if available, in other countries where we are prosecuting patents.

Depending upon the timing,duration and specifics of FDA marketing approval of our product candidates, one or more of our U.S. patents may be eligible for limitedpatent term extension, or PTE, under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-WaxmanAmendments. The Hatch-Waxman Amendments permit a patent restoration term of up to five years beyond the normal expiration of the patentas compensation for patent term lost during development and the FDA regulatory review process, which is limited to the approved indication(and potentially additional indications approved during the period of extension) covered by the patent. This extension is limitedto only one patent that covers the approved product, the approved use of the product, or a method of manufacturing the product. However,the applicable authorities, including the FDA and the U.S. Patent and Trademark Office (“USPTO”) in the UnitedStates, and any equivalent regulatory authority in other countries, may not agree with our assessment of whether such extensions are available,and may refuse to grant extensions to our patents, or may grant more limited extensions than we request. We may not be granted an extensionbecause of, for example, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwisefailing to satisfy applicable requirements. Moreover, the applicable time-period or the scope of patent protection afforded could be lessthan we request. Even if we are able to obtain an extension, the patent term may still expire before or shortly after we receive FDA marketingapproval. If we are unable to extend the expiration date of our existing patents or obtain new patents with longer expiry dates, our competitorsmay be able to take advantage of our investment in development and clinical trials by referencing our clinical and preclinical data toobtain approval of competing products following our patent expiration and launch their product earlier than might otherwise be the case.

Risks Related to Controlled Substances

Controlled substancelegislation differs between countries, and legislation in certain countries may restrict or limit our ability to sell our future productcandidates.

Most countries are partiesto the Single Convention on Narcotic Drugs 1961 and the Convention on Psychotropic Substances 1971, which governs international tradeand domestic control of narcotic substances, including cannabis extracts. Countries may interpret and implement their treaty obligationsin a way that creates a legal obstacle to us obtaining marketing approval for our future products in those countries. These countriesmay not be willing or able to amend or otherwise modify their laws and regulations to permit our future products to be marketed, or achievingsuch amendments to the laws and regulations may take a prolonged period of time. In that case, we would be unable to market our futureproduct candidates in those countries in the near future or perhaps at all.

The product candidatesthat we are developing may be subject to U.S. controlled substance laws and regulations and failure to comply with these laws and regulations,or the cost of compliance with these laws and regulations, may adversely affect the results of our business operations, both during clinicaldevelopment and post approval, and our financial condition.

The product candidates thatwe are developing may contain controlled substances as defined in The United States Federal Controlled Substances Act of 1970 and theCSA. Controlled substances that are pharmaceutical products are subject to a high degree of regulation under the CSA, which establishes,among other things, certain registration, manufacturing quotas, security, recordkeeping, reporting, import, export and other requirementsadministered by the DEA. The DEA classifies controlled substances into five schedules: Schedule I, II, III, IV or V substances. ScheduleI substances by definition have a high potential for abuse, no currently “accepted medical use” in the United States,lack accepted safety for use under medical supervision, and may not be prescribed, marketed or sold in the United States Pharmaceuticalproducts approved for use in the United States which contain a controlled substance are listed as Schedule II, III, IV or V, with ScheduleII substances considered to present the highest potential for abuse or dependence and Schedule V substances the lowest relative risk ofabuse among such substances.

While cannabis is a ScheduleI controlled substance, products approved for medical use in the United States that contain cannabis or cannabis extracts should be placedin Schedules II-V, since approval by the FDA satisfies the “accepted medical use” requirement. If and when any of ourfuture product candidates receive FDA approval, the DEA will make a scheduling determination. If the FDA, the DEA or any foreign regulatoryauthority determines that our future product candidates may have potential for abuse, it may require us to generate more clinical or otherdata than we currently anticipate to establish whether or to what extent the substance has an abuse potential, which could increase thecost and/or delay the launch of that product.

Facilities conducting research,manufacturing, distributing, importing or exporting, or dispensing controlled substances must be registered (licensed) to performthese activities and have the security, control, recordkeeping, reporting and inventory mechanisms required by the DEA to prevent drugloss and diversion. All these facilities must renew their registrations annually, except dispensing facilities, which must renew everythree years. The DEA conducts periodic inspections of certain registered establishments that handle controlled substances. Obtaining thenecessary registrations may result in delay of the importation, manufacturing or distribution of our future products. Furthermore, failureto maintain compliance with the CSA, particularly non-compliance resulting in loss or diversion, can result in regulatory action thatcould have a material adverse effect on our business, financial condition and results of operations. The DEA may seek civil penalties,refuse to renew necessary registrations, or initiate proceedings to restrict, suspend or revoke those registrations. In certain circumstances,violations could lead to criminal proceedings.

Individual states have alsoestablished controlled substance laws and regulations. Although state-controlled substances laws often mirror federal law, because thestates are separate jurisdictions, they may separately schedule our future product candidates as well. State scheduling may delay commercialsale of any product for which we obtain federal regulatory approval and adverse scheduling could have a material adverse effect on thecommercial attractiveness of such product. We or our partners must also obtain separate state registrations, permits or licenses in orderto be able to obtain, handle, and distribute controlled substances for clinical trials or commercial sale, and failure to meet applicableregulatory requirements could lead to enforcement and sanctions by the states in addition to those from the DEA or otherwise arising underfederal law.

Because our products may becontrolled substances in the United States, to conduct clinical trials in the United States, each of our research sites must submit aresearch protocol to the DEA and obtain and maintain a DEA researcher registration that will allow those sites to handle and dispenseour products and to obtain product from our importer. If the DEA delays or denies the grant of a research registration to one or moreresearch sites, the clinical trial could be significantly delayed, and we could lose clinical trial sites. The importer for the clinicaltrials must also obtain an importer registration and an import permit for each import.

The legislation on cannabisin the European Union differs among the member states, as this area is not yet fully harmonized. In Germany, for example, cannabis isregulated as a controlled substance (Betäubungsmittel) and its handling requires specific authorization.

The legalization anduse of medical and recreational cannabis in the United States and abroad may impact our business.

There is a substantial amountof change occurring in the United States regarding the use of medical and recreational cannabis products. While cannabis products notapproved by the FDA are Schedule I substances as defined under federal law, and their possession and use is not permitted according tofederal law (except for research purposes, under DEA registration), according to the website worldpoplulationreview.com, at least 38 statesand the District of Columbia have enacted state laws to enable possession and use of cannabis for medical purposes, and at least 19 statesand the District of Columbia for recreational purposes. The U.S. Farm Bill, which was passed in 2018, descheduled certain material derivedfrom hemp plants with extremely low THC content. Although our business is quite distinct from that of online and dispensary cannabis companies,future legislation authorizing the sale, distribution, use, and insurance reimbursement of non-FDA approved cannabis products could affectour business.

Accounting Risks

We have in the past,and may in the future, impair long-lived assets and intangible assets, including goodwill and acquired in-process research and development.

We review long-lived assetsand certain identifiable assets (including intangible assets) for impairment whenever circumstances and situations change such thatthere is an indication that the carrying amounts may not be recovered. An impairment exists when the carrying value of the long-livedor intangible asset (including goodwill and acquired in-process research and development) is not recoverable and exceeds its estimatedfair value. Goodwill represents the difference between the purchase price and the fair value of assets and liabilities acquired in a businesscombination. We review goodwill yearly, or more frequently whenever circumstances and situations change such that there is an indicationthat the carrying amounts may not be recovered, for impairment by initially considering qualitative factors to determine whether it ismore likely than not that the fair value of a reporting unit is less than its carrying amount, including goodwill, as a basis for determiningwhether it is necessary to perform a quantitative analysis. If it is determined that it is more likely than not that the fair value ofreporting unit is less than its carrying amount, a quantitative analysis is performed to identify goodwill impairment.

Our publicly-traded stockclosed at $78.00 per share as of December 31, 2021; during 2022, the market value of our single reporting unit significantly declined.As of March 31, 2022, June 30, 2022, September 30, 2022 and December 31, 2022, the market value of our publicly traded stock fell to $51.80,$16.96, $13.30 and $3.39, per share, respectively, and as such, we elected to conduct a quantitative analysis of goodwill to assess forimpairment as of September 30, 2022 and December 31, 2022. We determined the fair market value of its single reporting unit and comparedthat value with the carrying amount of the reporting unit and determined that goodwill was impaired as of both measurement dates. As ofSeptember 30, 2022 and December 31, 2022, the carrying value exceeded the fair market value by $18,872,850 and $14,674,428, respectively.To recognize the impairment of goodwill, we recorded losses for these amounts at the end of the third and fourth quarters, which appearas a loss on goodwill impairment of $33,547,278 on the income statement for the year ended December 31, 2022.

Intangible assets and in-processresearch and development (“IP R&D”) assets represent the fair value assigned to technologies that were acquiredon July 16, 2019 in connection with the Reorganization, which have not reached technological feasibility and have no alternative futureuse. IP R&D assets are considered to be indefinite-lived until the completion or abandonment of the associated research and developmentprojects. During the period that the IP R&D assets are considered indefinite-lived, they are tested for impairment on an annual basis,or more frequently if we become aware of any events occurring or changes in circumstances that indicate that the fair value of the IPR&D assets are less than their carrying amounts. If and when development is complete, which generally occurs upon regulatory approval,and we are able to commercialize products associated with the IP R&D assets, these assets are then deemed definite-lived and are amortizedbased on their estimated useful lives at that point in time. If development is terminated or abandoned, we may record a full or partialimpairment charge related to the IP R&D assets, calculated as the excess of the carrying value of the IP R&D assets over theirestimated fair value.

As of December 31, 2022, thecarrying amount of the IP R&D assets on the balance sheet was $12,405,084 (which consists of carrying value of $1,462,084 and $10,943,000related to the Company’s CBR Pharma subsidiary and its 180 LP subsidiary, respectively). Per the valuation obtained from a thirdparty as of year-end, the fair market value of the Company’s IP R&D assets was determined to be $9,063,000 (which consists offair market values of $0 and $9,063,000 related to the Company’s CBR Pharma subsidiary and 180 LP subsidiary, respectively). Asof this measurement date, the carrying value of the CBR Pharma and 180 LP subsidiaries’ assets exceeded their fair market valuesby $1,462,084 and $1,880,000, respectively. As such, management determined that the consolidated IP R&D assets were impaired by $3,342,084,and in order to recognize the impairment, the Company recorded a loss for this amount during the fourth quarter of 2022, which appearsas a loss on impairment of IP R&D assets on the income statement. This reduced the IP R&D asset balances of its CBR Pharma subsidiaryand its 180 LP subsidiary to zero and $9,063,000, respectively, as of December 31, 2022; the total consolidated IP R&D asset balanceis $9,063,000 after impairment.

As of September 30, 2023,the carrying amount of the IP R&D assets on the balance sheet was $9,063,000 (which consists of a balance related to the Company’s180 LP subsidiary); the Company typically assesses asset impairment on an annual basis unless a triggering event or other facts or circumstancesindicate that an evaluation should be performed at an earlier date. At the end of the current period, the Company assessed general economicconditions, industry and market considerations, the Company’s financial performance and all relevant legal, regulatory, and politicalfactors that might indicate the possibility of impairment and concluded that, when these factors were collectively evaluated, it is likelythat the asset is impaired. The Company recorded a loss in the amount of $9,063,000, which appears as a loss on impairment to IP R&Dassets on the income statement for the three and nine months ended September 30, 2023.

An impairment recognized inone period may not be reversed in a subsequent period, even if the value of our common stock increases in the future. We have in the pastand could in the future incur additional impairments of long-lived assets and/or intangible assets, including acquired in-process researchand development and goodwill, which may be material.

We have identified materialweaknesses in our disclosure controls and procedures and internal control over financial reporting. If not remediated, our failure toestablish and maintain effective disclosure controls and procedures and internal control over financial reporting could result in materialmisstatements in our financial statements and a failure to meet our reporting and financial obligations, each of which could have a materialadverse effect on our financial condition and the trading price of our securities.

Our management, includingour principal financial officer, conducted an evaluation of the effectiveness of our internal control over financial reporting as of December31, 2022 using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) in“Internal Control - Integrated Framework” (2013).

Management also concludedthat certain aspects of our internal control over financial reporting was not effective as of September 30, 2023, based on those criteria.Specifically, management’s conclusion was based on the following material weakness:

A material weakness is a deficiency,or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a materialmisstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. Accordingly, a materialweakness increases the risk that the financial information we report contains material errors. A control deficiency exists when the designor operation of a control does not allow management or employees, in the normal course of performing their assigned functions, to preventor detect misstatements on a timely basis.

Maintaining effective disclosurecontrols and procedures and effective internal control over financial reporting are necessary for us to produce reliable financial statementsand we are committed to remediating its material weaknesses in such controls as promptly as possible. However, there can be no assuranceas to when these material weaknesses will be remediated or that additional material weaknesses will not arise in the future. Any failureto remediate the material weaknesses, or the development of new material weaknesses in our internal control over financial reporting,could result in material misstatements in our financial statements and cause us to fail to meet our reporting and financial obligationson a timely and accurate basis. If our financial statements are not accurate, investors may not have a complete understanding of our operationsor may lose confidence in our reported financial information. Likewise, if our financial statements are not filed on a timely basis asrequired by the SEC and Nasdaq, we could face severe consequences from those authorities. In any of these cases, it could result in amaterial adverse effect on our business, on our financial condition or have a negative effect on the trading price of our common stockand warrants. Further, if we fail to remedy this deficiency (or any other future deficiencies) or maintain the adequacy of our disclosurecontrols and procedures and our internal controls, we could be subject to regulatory scrutiny, civil or criminal penalties or stockholderlitigation against us or our management.

We can give no assurance thatthe measures we have taken and plan to take in the future will remediate the material weakness identified or that any additional materialweaknesses or restatements of our financial statements will not arise in the future due to a failure to implement and maintain adequateinternal control over financial reporting or circumvention of those controls.

Further, in the future, ifwe cannot conclude that we have effective internal control over our financial reporting, or if our independent registered public accountingfirm is unable to provide an unqualified opinion regarding the effectiveness of our internal control over financial reporting (to theextent we may be required in the future), investors could lose confidence in the reliability of our financial statements, which couldlead to a decline in our stock price. Failure to comply with reporting requirements could also subject us to sanctions and/or investigationsby the SEC or Nasdaq, as applicable, or other regulatory authorities.

In addition, even if we aresuccessful in strengthening our controls and procedures, those controls and procedures may not be adequate to prevent or identify irregularitiesor facilitate the fair presentation of our financial statements or our periodic reports filed with the SEC. This may require us to restateprior financial statements.

We may experience adverseimpacts on our reported results of operations as a result of adopting new accounting standards or interpretations.

Our implementation of andcompliance with changes in accounting rules, including new accounting rules and interpretations, could adversely affect our reported financialposition or operating results or cause unanticipated fluctuations in our reported operating results in future periods.

Risks Related to our Common Stock and Warrants

The market price ofour common stock has been extremely volatile and may continue to be volatile due to numerous circumstances beyond our control.

The market price of our commonstock has fluctuated, and may continue to fluctuate, widely, due to many factors, some of which may be beyond our control. These factorsinclude, without limitation:

Stock markets in general andour stock price in particular have recently experienced extreme price and volume fluctuations that have often been unrelated or disproportionateto the operating performance of those companies and our company. For example, during 2022, the sale prices of our common stock rangedfrom a post-split adjusted high of $80.70 per share to a low of $1.18 per share and during 2023, the sale prices of our commons tock rangedfrom a high of $7.15 per share to a low of $0.15 per share. During this time, we do not believe that we have experienced any materialchanges in our financial condition or results of operations that would explain such price volatility or trading volume; however, we havesold equity which was dilutive to existing stockholders. These broad market fluctuations may adversely affect the trading price of oursecurities. Additionally, these and other external factors have caused and may continue to cause the market price and demand for our commonstock to fluctuate substantially, which may limit or prevent our stockholders from readily selling their shares of our common stock andmay otherwise negatively affect the liquidity of our common stock.

Information availablein public media that is published by third parties, including blogs, articles, message boards and social and other media may include statementsnot attributable to us and may not be reliable or accurate.

We are aware of a large volumeof information being disseminated by third parties relating to our operations, including in blogs, message boards and social and othermedia. Such information as reported by third parties may not be accurate, may lead to significant volatility in our securities and mayultimately result in our common stock or other securities declining in value.

The exercise of ouroutstanding options and warrants, and the sale of common stock upon exercise thereof, may adversely affect the trading price of our securities.

As of January 29, 2024, we had (i) outstanding stock options topurchase an aggregate of 338,228 shares of common stock at a weighted average exercise price of $33.38 per share; (ii) outstandingpre-funded warrants to purchase 4,886,878 shares of common stock (the resale of the shares of common stock issuable upon exercise thereofare being registered pursuant to the registration statement of which this prospectus forms a part); and (iii) outstanding warrantsto purchase 18,685,892 shares of common stock at a weighted average exercise price of $5.58 per share (when not including the pre-fundedwarrants)(the resale of 9,064,098 shares of common stock issuable upon exercise thereof are being registered pursuant to the registrationstatement of which this prospectus forms a part). For the life of the options and warrants, the holders have the opportunity to profitfrom a rise in the market price of our common stock without assuming the risk of ownership. The issuance of shares upon the exercise ofoutstanding securities will also dilute the ownership interests of our existing stockholders.

The availability of theseshares for public resale, as well as any actual resales of these shares, could adversely affect the trading price of our common stock.We cannot predict the size of future issuances of our common stock pursuant to the exercise of outstanding options or warrants or conversionof other securities, or the effect, if any, that future issuances and sales of shares of our common stock may have on the market priceof our common stock. Sales or distributions of substantial amounts of our common stock (including shares issued in connection with anacquisition), or the perception that such sales could occur, may cause the market price of our common stock to decline.

In addition, the common stockissuable upon exercise/conversion of outstanding convertible securities may represent overhang that may also adversely affect the marketprice of our common stock. Overhang occurs when there is a greater supply of a company’s stock in the market than there is demandfor that stock. When this happens the price of our stock will decrease, and any additional shares which stockholders attempt to sell inthe market will only further decrease the share price. If the share volume of our common stock cannot absorb shares sold by holders ofour outstanding convertible securities, then the value of our common stock will likely decrease.

Finally, the shares issuable upon exercise of outstanding options andwarrants, and more specifically the December 2023 Pre-Funded Warrants and December 2023 Common Warrants, the shares of common stock issuableupon exercise of which are being registered in the registration statement of which this prospectus forms a part, will cause significantdilution to existing stockholders, as such aggregate shares of common stock issuable upon exercise thereof (13,950,976 shares), totalsmore than 137% of our currently outstanding shares of common stock (10,158,832 shares) and will likely cause the per-share value of ourcommon stock to decline, possibly significantly.

Our outstanding publicwarrants are significantly out of the money.

Each Public Warrant entitlesthe holder to purchase one-fortieth of one share of common stock at an exercise price of $5.75 per 1/40^th of one share($230.00 per whole share), subject to adjustment. No fractional shares will be issued upon exercise of the Public Warrants. The PublicWarrants became exercisable 12 months from the closing of the IPO and expire five years after the completion of the Business Combination(November 6, 2025). The Public Warrants are significantly out of the money and because no fractional shares will be issued upon exerciseof the Public Warrants, the Public Warrants are only exercisable in multiples of 40. As a result, the Public Warrants may not have anysignificant value. Additionally, warrant holders not holding at least 40 Public Warrants or who hold Public Warrants which would be exercisablefor a fractional share of common stock, must sell any warrants to obtain value from the fractional interest. As a result, the tradingof the Public Warrants may be limited or sporadic, and such Public Warrants may not have any significant value. Any holder of Public Warrantsholding less than 40 Public Warrants or a number of Public Warrants not evenly divisible by 40 will not receive any common stock uponthe exercise of Public Warrant, as no fractional shares of common stock are issuable upon exercise thereof.

A significant numberof our shares are eligible for sale and their sale or potential sale may depress the market price of our common stock and cause significantdilution to existing stockholders.

Sales of a significant number of shares of our common stock in thepublic market could harm the market price of our common stock. Most of our common stock is available for immediate resale in the publicmarket, including (a) options to purchase 338,228 shares of common stock with a weighted average exercise price of $33.38 per share;(b) pre-funded warrants to purchase 4,886,878 shares of common stock (the resale of the shares of common stock issuable upon exercisethereof are being registered pursuant to the registration statement of which this prospectus forms a part); and (c) warrants to purchase18,685,892 shares of common stock with a weighted average exercise price of $5.58 per share (the resale of 9,064,098 shares of commonstock issuable upon exercise thereof is being registered pursuant to the registration statement of which this prospectus forms a part).If a significant number of shares were sold, such sales would increase the supply of our common stock, thereby potentially causing a decreasein its price. For example, the shares issuable upon exercise of the December 2023 Pre-Funded Warrants and December 2023 Common Warrants,which shares of common stock are being registered in the registration statement of which this prospectus forms a part, will cause significantdilution to existing stockholders, as such aggregate shares of common stock issuable upon exercise thereof (13,950,976 shares), totalsmore than 137% of our currently outstanding shares of common stock (10,158,832) and will likely cause the per-share value of our commonstock to decline, possibly significantly. Some or all of our shares of common stock may be offered from time to time in the open marketpursuant to effective registration statements and/or compliance with Rule 144, which sales could have a depressive effect on themarket for our shares of common stock. Subject to certain restrictions, a person who has held restricted shares for a period of six monthsmay generally sell common stock into the market. The sale of a significant portion of such shares when such shares are eligible for publicsale may cause the value of our common stock to decline in value.

There may not be sufficientliquidity in the market for our securities in order for investors to sell their shares. The market price of our common stock may continueto be volatile.

The market price of our commonstock will likely continue to be highly volatile. Some of the factors that may materially affect the market price of our common stockare beyond our control, such as conditions or trends in the industry in which we operate or sales of our common stock. This situationis attributable to a number of factors, including the fact that we are a small company which is relatively unknown to stock analysts,stock brokers, institutional investors and others in the investment community that generate or influence sales volume, and that even ifwe came to the attention of such persons, they tend to be risk-averse and would be reluctant to follow an unproven company such as oursor purchase or recommend the purchase of our shares until such time as we became more seasoned and viable.

As a consequence, there maybe periods of several days or more when trading activity in our shares is minimal or non-existent, as compared to a mature issuer whichhas a large and steady volume of trading activity that will generally support continuous sales without an adverse effect on share price.It is possible that a broader or more active public trading market for our common stock will not develop or be sustained, or that tradinglevels will not continue. These factors may materially adversely affect the market price of our common stock, regardless of our performance.In addition, the public stock markets have experienced extreme price and trading volume volatility. This volatility has significantlyaffected the market prices of securities of many companies for reasons frequently unrelated to the operating performance of the specificcompanies. These broad market fluctuations may adversely affect the market price of our common stock.

We face significantpenalties and damages in the event registration statements we have previously filed to register certain securities sold in our prior offeringsare subsequently suspended or terminated.

Pursuant to certain priorprivate offerings of securities, we entered into registration rights agreements which required us to file certain registration statementsto register the resale of the privately sold shares and certain securities issuable upon exercise/conversion thereof, and to maintainthe effectiveness of such registration statements for certain periods of time. To date, all such required registration statements havebeen declared effective by the SEC. However, in the event the registration statements are subsequently suspended or terminated, or weotherwise fail to meet certain requirements set forth in the registration rights agreements, we could be required to pay significant penaltieswhich could adversely affect our cash flow and cause the value of our securities to decline in value.

Provisions of certainoutstanding warrants could discourage an acquisition of us by a third party.

Provisions of certain outstandingwarrants could make it more difficult or expensive for a third party to acquire us. Certain outstanding warrants prohibit us from engagingin certain transactions constituting “fundamental transactions” unless, among other things, the surviving entity assumes ourobligations under each of the outstanding warrants issued in connection with the July 2022 Offering, the December 2022 Offering, the April2023 Offering and August 2023 Offering (each as defined and/or discussed herein), and the outstanding December 2023 Pre-Funded Warrantsand December 2023 Common Warrants, respectively. Further, such outstanding warrants provide that, in the event of certain transactionsconstituting “fundamental transactions,” with some exception, holders of such warrants will have the right, at their option,to require us to repurchase such warrants at a price described in the applicable warrants (based on the Black Scholes Value of such warrants).These and other provisions of the Warrants could prevent or deter a third party from acquiring us even where the acquisition could bebeneficial to stockholders.

Future sales and issuancesof our common stock or rights to purchase common stock, could result in additional dilution to our stockholders and could cause the priceof our common stock to decline.

We may issue additional commonstock, convertible securities, or other equity in the future. We also issue common stock to our employees, directors, and other serviceproviders pursuant to our equity incentive plans. Such issuances could be dilutive to investors and could cause the price of our commonstock to decline. New investors in such issuances could also receive rights senior to those of current stockholders.

Resales of our commonstock in the public market may cause the market price of our common stock to fall.

Sales of a substantial numberof shares of our common stock could occur at any time. The issuance of new shares of our common stock could result in resales of our commonstock by our current stockholders concerned about the potential ownership dilution of their holdings. In turn, these resales could havethe effect of depressing the market price for our common stock.

Future sales of ourcommon stock could cause our stock price to decline.

If our stockholders sell substantialamounts of our common stock in the public market, the market price of our common stock could decrease significantly. The perception inthe public market that our stockholders might sell shares of our common stock could also depress the market price of our common stock.Up to $125,000,000 in total aggregate value of securities have been registered by us on a “shelf” registration statementon Form S-3 that we filed with the Commission on June 3, 2022, and which was declared effective on June 24, 2022. However, as of January29, 2024, our public float was less than $75 million, and under SEC regulations for so long as our public float remains less than $75million, the amount we can raise through primary public offerings of securities in any twelve-month period using our shelf registrationstatement on Form S-3 is limited to an aggregate of one-third of our public float. At such time as our public float again exceeds $75million, the number of securities we may sell under a Form S-3 registration statement will no longer be limited by such rules. Additionally,if our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market, thetrading price of our common stock could decline significantly. The market price for shares of our common stock may drop significantlywhen such securities are sold in the public markets. A decline in the price of shares of our common stock might impede our ability toraise capital through the issuance of additional shares of our common stock or other equity securities.

Risks Associated with Our Governing Documents and Delaware Law

Our Certificate of Incorporationprovides for indemnification of officers and directors at our expense and limits their liability, which may result in a major cost tous and hurt the interests of our stockholders because corporate resources may be expended for the benefit of officers or directors.

Our Certificate of Incorporationprovides for indemnification as follows: “To the fullest extent permitted by applicable law, the Corporation is authorized to provideindemnification of, and advancement of expenses to, such agents of the Corporation (and any other persons to which Delaware law permitsthe Corporation to provide indemnification) through Bylaw provisions, agreements with such agents or other persons, vote of stockholdersor disinterested directors or otherwise, in excess of the indemnification and advancement otherwise permitted by Section 145 of the DelawareGeneral Corporation Law, subject only to limits created by applicable Delaware law (statutory or non-statutory), with respect to actionsfor breach of duty to the Corporation, its stockholders and others.”

We have been advised that,in the opinion of the SEC, indemnification for liabilities arising under federal securities laws is against public policy as expressedin the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification for liabilities arising under federalsecurities laws, other than the payment by us of expenses incurred or paid by a director, officer or controlling person in the successfuldefense of any action, suit or proceeding, is asserted by a director, officer or controlling person in connection with our activities,we will (unless in the opinion of our counsel, the matter has been settled by controlling precedent) submit to a court of appropriatejurisdiction, the question whether indemnification by us is against public policy as expressed in the Securities Act and will be governedby the final adjudication of such issue. The legal process relating to this matter if it were to occur is likely to be very costly andmay result in us receiving negative publicity, either of which factors is likely to materially reduce the market and price for our shares.

Our Certificate of Incorporationcontains a specific provision that limits the liability of our directors for monetary damages to us and our stockholders and requiresus, under certain circumstances, to indemnify officers, directors and employees.

The limitation of monetaryliability against our directors, officers and employees under Delaware law and the existence of indemnification rights to them may resultin substantial expenditures by us and may discourage lawsuits against our directors, officers and employees.

Our Certificate of Incorporationcontains a specific provision that limits the liability of our directors for monetary damages to us and our stockholders. We also havecontractual indemnification obligations under our employment and engagement agreements with our executive officers and directors. Theforegoing indemnification obligations could result in us incurring substantial expenditures to cover the cost of settlement or damageawards against our directors and officers, which we may be unable to recoup. These provisions and resultant costs may also discourageus from bringing a lawsuit against our directors and officers for breaches of their fiduciary duties and may similarly discourage thefiling of derivative litigation by our stockholders against our directors and officers, even though such actions, if successful, mightotherwise benefit us and our stockholders.

Our directors have theright to authorize the issuance of shares of preferred stock and additional shares of our common stock.

Our directors, within thelimitations and restrictions contained in our Certificate of Incorporation and without further action by our stockholders, have the authorityto issue shares of preferred stock from time to time in one or more series and to fix the number of shares and the relative rights, conversionrights, voting rights, and terms of redemption, liquidation preferences and any other preferences, special rights and qualifications ofany such series. Any issuance of shares of preferred stock could adversely affect the rights of holders of our common stock. Should weissue additional shares of our common stock at a later time, each investor’s ownership interest in our stock would be proportionallyreduced.

Anti-takeover provisionsin our Certificate of Incorporation and our Second Amended and Restated Bylaws, as well as provisions of Delaware law, might discourage,delay or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our commonstock.

Our Certificate of Incorporationand our Second Amended and Restated Bylaws and Delaware law contain provisions that may discourage, delay or prevent a merger, acquisitionor other change in control that stockholders may consider favorable, including transactions in which you might otherwise receive a premiumfor your shares of our common stock or warrants. These provisions may also prevent or delay attempts by our stockholders to replace orremove our management. Our corporate governance documents include the following provisions:

As a Delaware corporation,we are also subject to provisions of Delaware law, including Section 203 of the Delaware General Corporation Law, which limits the abilityof stockholders holding shares representing more than 15% of the voting power of our outstanding voting stock from engaging in certainbusiness combinations with us. Any provision of our Certificate of Incorporation or our Second Amended and Restated Bylaws or Delawarelaw that has the effect of delaying or deterring a change in control could limit the opportunity for our stockholders to receive a premiumfor their shares of our common stock and could also affect the price that some investors are willing to pay for our common stock.

The existence of the foregoingprovisions and anti-takeover measures could limit the price that investors might be willing to pay in the future for shares of our commonstock or warrants. They could also deter potential acquirers of our company, thereby reducing the likelihood that you could receive apremium for your common stock or warrants in an acquisition.

Our Certificate of Incorporationcontains exclusive forum provisions that may discourage lawsuits against us and our directors and officers.

Our Certificate of Incorporationprovides that unless the corporation consents in writing to the selection of an alternative forum, the Court of Chancery of the Stateof Delaware, will be the sole and exclusive forum for (i) any derivative action or proceeding brought on behalf of us, (ii) anyaction asserting a claim for breach of a fiduciary duty owed by any current or former director, officer, employee or stockholder of theCompany to us or our stockholders, (iii) any action asserting a claim arising pursuant to any provision of the Delaware General CorporationLaw, our Certificate of Incorporation or Bylaws, or (iv) any action asserting a claim governed by the internal affairs doctrine.

The choice of forum provisionin our Certificate of Incorporation does not waive our compliance with our obligations under the federal securities laws and the rulesand regulations thereunder. Moreover, the provision does not apply to suits brought to enforce a duty or liability created by the ExchangeAct or by the Securities Act. Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforceany duty or liability created by the Exchange Act or the rules and regulations thereunder, and Section 22 of the Securities Act createsconcurrent jurisdiction for federal and state courts with respect to suits brought to enforce a duty or liability created by the SecuritiesAct or the rules and regulations thereunder. Accordingly, both state and federal courts have jurisdiction to entertain claims under theSecurities Act.

These exclusive forum provisionsmay limit the ability of our stockholders to bring a claim in a judicial forum that such stockholders find favorable for disputes withus or our directors or officers, which may discourage such lawsuits against us and our directors and officers. Alternatively, if a courtwere to find one or more of these exclusive forum provisions inapplicable to, or unenforceable in respect of, one or more of the specifiedtypes of actions or proceedings described above, we may incur additional costs associated with resolving such matters in other jurisdictionsor forums, which could materially and adversely affect our business, financial condition or results of operations.

Our Certificate of Incorporationcontains provisions whereby we renounced any interest in any corporate opportunity offered to any director or officer, subject to certainexceptions.

Our Section Amended and RestatedCertificate of Incorporation, as amended, provides that to the extent allowed by law, the doctrine of corporate opportunity, or any otheranalogous doctrine, does not apply with respect to us or any of our officers or directors, or any of their respective affiliates, andthat we renounce any expectancy that any of our directors or officers will offer any such corporate opportunity of which he or she maybecome aware to us, except that the doctrine of corporate opportunity shall apply with respect to any of our directors or officers onlywith respect to a corporate opportunity (i) that was offered to such person solely in his or her capacity as a our director or officer,(ii) that is one we are legally and contractually permitted to undertake and would otherwise be reasonable for us to pursue, and(iii) to the extent the director or officer is permitted to refer such opportunity to us without violating any legal obligation.

Additionally, each of ourofficers and directors presently has, and any of them in the future may have, additional fiduciary or contractual obligations to otherentities pursuant to which such officer or director may be required to present a business opportunity to such entity, subject to his orher fiduciary duties under applicable law. Accordingly, there may arise conflicts of interest in whether to present a potential businesscombination opportunity to our company. These conflicts may not be resolved in our favor. Our renouncement of corporate opportunitiesmay have a material adverse effect on our results of operations moving forward and/or create conflicts of interest or perceived conflictsof interest which may have a material adverse effect on the value of our securities.

Our directors allocatetheir time to other businesses thereby causing conflicts of interest in their determination as to how much time to devote to our affairs.

Our directors are not requiredto, and do not, commit their full time to our affairs, and certain of our directors hold positions, including other directorships, withother companies in the life sciences industry, which may result in a conflict of interest in allocating their time between our operationsand others which they provide services to. If our directors’ other business affairs require them to devote substantial amounts oftime to such affairs in excess of their current commitment levels, it could limit their ability to devote time to our affairs which mayhave a negative impact on our operations. Additionally, such persons may have conflicts of interest in allocating their time among variousbusiness activities. These conflicts may not be resolved in our favor. Additionally, our directors may, because of our corporate opportunitywaiver, discussed above, may choose to, or be required to, provide corporate opportunities to the other companies which they are affiliatedwith. Actual or perceived conflicts of interest may have a material adverse effect on our results of operations which may have a materialadverse effect on the value of our securities.

Compliance, Reporting and Listing Risks

We incur significantcosts to ensure compliance with U.S. and Nasdaq reporting and corporate governance requirements.

We incur significant costsassociated with our public company reporting requirements and with applicable U.S. and Nasdaq corporate governance requirements, includingrequirements under the Sarbanes-Oxley Act of 2002 and other rules implemented by the SEC and Nasdaq. The rules of Nasdaq include requiringus to maintain independent directors, comply with other corporate governance requirements and pay annual listing and stock issuance fees.All of such SEC and Nasdaq obligations require a commitment of additional resources including, but not limited, to additional expenses,and may result in the diversion of our senior management’s time and attention from our day-to-day operations. We expect all of theseapplicable rules and regulations to significantly increase our legal and financial compliance costs and to make some activities more timeconsuming and costly. We also expect that these applicable rules and regulations may make it more difficult and more expensive for usto obtain director and officer liability insurance and we may be required to accept reduced policy limits and coverage or incur substantiallyhigher costs to obtain the same or similar coverage. As a result, it may be more difficult for us to attract and retain qualified individualsto serve on our Board or as executive officers.

We incur increased costsas a result of being a reporting company, and given our limited capital resources, such additional costs may have an adverse impact onour profitability.

We are an SEC-reporting company.The rules and regulations under the Exchange Act require reporting companies to provide periodic reports with interactive data files,which require that we engage legal, accounting and auditing professionals, and eXtensible Business Reporting Language (XBRL) andEDGAR (Electronic Data Gathering, Analysis, and Retrieval) service providers. The engagement of such services can be costly, andwe may continue to incur additional losses, which may adversely affect our ability to continue as a going concern. In addition, the Sarbanes-OxleyAct of 2002, as well as a variety of related rules implemented by the SEC, have required changes in corporate governance practices andgenerally increased the disclosure requirements of public companies. For example, as a result of being a reporting company, we are requiredto file periodic and current reports and other information with the SEC and we have adopted policies regarding disclosure controls andprocedures and regularly evaluate those controls and procedures.

The additional costs we continueto incur in connection with being a reporting company (expected to be several hundred thousand dollars per year) will continue tofurther stretch our limited capital resources. Due to our limited resources, we have to allocate resources away from other productiveuses in order to continue to comply with our obligations as an SEC reporting company. Further, there is no guarantee that we will havesufficient resources to continue to meet our reporting and filing obligations with the SEC as they come due.

We are not in compliancewith the continued listing standards of Nasdaq, may not be able to comply with Nasdaq’s continued listing standards in the future,and as a result our common stock and warrants may be delisted from Nasdaq.

Our common stock and PublicWarrants trade on Nasdaq under the symbols “ATNF” and “ATNFW,” respectively. Notwithstanding such listing,there can be no assurance any broker will be interested in trading our securities. Therefore, it may be difficult to sell our securitiespublicly. There is also no guarantee that we will be able to maintain our listings on Nasdaq for any period of time by perpetually satisfyingNasdaq’s continued listing requirements.

On September 7, 2023, theCompany received written notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifyingthe Company that it is not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) forcontinued listing on The Nasdaq Capital Market. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bidprice of $1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement existsif the deficiency continues for a period of thirty (30) consecutive business days. Based on the closing bid price of the Company’scommon stock for the thirty (30) consecutive business days from July 26, 2023 to September 6, 2023, the Company no longer meets theminimum bid price requirement.

The notification letter statedthat the Company has 180 calendar days or until March 5, 2024, to regain compliance with Nasdaq Listing Rule 5550(a)(2). To regain compliance,the bid price of the Company’s common stock must have a closing bid price of at least $1.00 per share for a minimum of 10 consecutivebusiness days. If the Company does not regain compliance by March 5, 2024, an additional 180 days may be granted to regain compliance,so long as the Company meets The Nasdaq Capital Market initial listing criteria (except for the bid price requirement) and notifiesNasdaq in writing of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary.If the Company does not qualify for the second compliance period or fails to regain compliance during the second 180-day period, the Company’scommon stock will be subject to delisting, at which point the Company would have an opportunity to appeal the delisting determinationto a Hearings Panel.

The Company intends to monitorthe closing bid price of its common stock and may, if appropriate, consider implementing available options to regain compliance with theminimum bid price requirement under the Nasdaq Listing Rules, including affecting a reverse stock split. The Company plans to hold a specialstockholders’ meeting on February 16, 2024, to seek approval, for among other things, an amendment to our Second Amended and RestatedCertificate of Incorporation, as amended, to effect a reverse stock split of our issued and outstanding shares of our Common Stock, bya ratio of between one-for-four to one-for-forty, inclusive, with the exact ratio to be set at a whole number to be determined by ourBoard of Directors or a duly authorized committee thereof in its discretion, at any time after approval of the amendment and prior toFebruary 16, 2025.

On October 11, 2023, the Companyreceived written notice from Nasdaq notifying the Company that it was not in compliance with the shareholder approval requirements setforth in Nasdaq Listing Rule 5635(d), which require prior shareholder approval for transactions, other than public offerings, involvingthe issuance of 20% or more of the pre-transaction shares outstanding at less than the applicable Minimum Price (as defined in ListingRule 5635(d)(1)(A)).

The Staff’s determinationunder Listing Rule 5635(d) relates to the offering and issuance by the Company of an aggregate of: (i) 666,925 shares of theCompany’s Common Stock, at a price of $0.65 per share, (ii) pre-funded warrants to purchase up to 3,948,460 shares of CommonStock, at a price of $0.6499 per pre-funded warrant and (iii) warrants to purchase up to 4,615,385 shares of common stock. The offeringprice per share and associated common warrant was $0.65 and the offering price per pre-funded warrant and associated common warrant was$0.6499.

The Staff determined thatthe offering was not a “public offering” for the purposes of Nasdaq’s shareholder approval rules due to the type ofoffering, a best efforts offering pursuant to a placement agency agreement, and the fact that one investor purchased 98% of the offering.As a result, because the offering represented greater than 20% of the Common Stock outstanding and was priced below the Minimum Price,the Staff determined that the Company was required to obtain prior shareholder approval under Listing Rule 5635(d).

The October 11, 2023 letterprovided the Company 45 days to submit a plan to regain compliance. The plan of compliance was subsequently submitted by the Company toNasdaq on November 9, 2023, and on November 14, 2023, Nasdaq granted the Company an extension, until December 15, 2023, to complete certaintransactions set forth in the plan of compliance, in order to remedy its prior violation of Nasdaq rules as described in the October 11,2023 letter from Nasdaq.

The Company undertook severaltransactions in November and December 2023, including amending the terms of the warrants discussed above, to not be exercisable untilthe Company’s stockholders approve such issuance in accordance with the Nasdaq Listing Rules, in order to regain compliance withListing Rule 5635(d)(1)(A)).

As a result of those transactions,on December 14, 2023, Nasdaq provided the Company written notice that the Company has complied with the terms of the prior extension;that the Company complies with Listing Rule 5635(d)(1)(A)); and that the matter is now closed.

On November 15, 2023, theCompany received a letter from Nasdaq notifying the Company that it was not in compliance with the minimum stockholders’ equityrequirement for continued listing on the Nasdaq Capital Market. Nasdaq Listing Rule 5550(b)(1) (the “Rule”) requirescompanies listed on the Nasdaq Capital Market to maintain stockholders’ equity of at least $2,500,000. In the Company’s QuarterlyReport on Form 10-Q for the quarter ended September 30, 2023, the Company reported a stockholders’ deficit of ($149,327), whichis below the minimum stockholders’ equity required for continued listing pursuant to the Rule. Additionally, the Company does notmeet the alternative Nasdaq continued listing standards under Nasdaq Listing Rules.

Nasdaq provided the Companyuntil January 2, 2024 to submit to Nasdaq a plan to regain compliance. We submitted the plan to regain compliance in a timely manner,and on January 11, 2023, Nasdaq advised the Company that it has determined to grant the Company an extension to regain compliance withthe Rule.

The terms of the extensionare as follows: on or before May 13, 2024, the Company must complete certain transactions described in greater detail in the complianceplan, contemplated to result in the Company increasing its stockholders’ equity to more than $2.5 million, and opt for one of thetwo following alternatives to evidence compliance with the Rule: Alternative 1: The Company must furnish to the SEC and Nasdaq a publiclyavailable report (e.g., a Form 8-K) including: 1. A disclosure of Staff’s deficiency letter and the specific deficiency(ies) cited;2. A description of the completed transaction or event that enabled the Company to satisfy the stockholders’ equity requirementfor continued listing; and 3. An affirmative statement that, as of the date of the report, the Company believes it has regained compliancewith the stockholders’ equity requirement based upon the specific transaction or event referenced in Step 2; or Alternative 2: TheCompany must furnish to the SEC and Nasdaq a publicly available report including: 1. Steps 1 & 2 set forth above; 2. A balance sheetno older than 60 days with pro forma adjustments for any significant transactions or event occurring on or before the report date; and3. that the Company believes it satisfies the stockholders’ equity requirement as of the report date. The pro forma balance sheetmust evidence compliance with the stockholders’ equity requirement.

Additionally, in either casethe Company is required to disclose that Nasdaq will continue to monitor the Company’s ongoing compliance with the stockholders’equity requirement and, if at the time of its next periodic report the Company does not evidence compliance, that it may be subject todelisting.

Regardless of which alternativethe Company chooses, if the Company fails to evidence compliance upon filing its next periodic report with the SEC following the end ofsuch compliance period (i.e., its Quarterly Report for the Quarter ended June 30, 2024), the Company may be subject to delisting. In theevent the Company does not satisfy these terms, Nasdaq will provide written notification that its securities will be delisted. At thattime, the Company may appeal Nasdaq’s determination to a Hearings Panel.

The Company is currently evaluatingvarious courses of action to regain compliance and is hopeful that it can regain compliance with Nasdaq’s minimum stockholders’equity standard within the compliance period. However, there can be no assurance that the Company will be able to complete the transactionscontemplated in the compliance plan, which the Company expects will allow it to regain compliance with the Rule, or that such transactionswill result in the Company regaining compliance with the Rule, within the compliance period granted by Nasdaq, if at all.

Among the conditions requiredfor continued listing on The Nasdaq Capital Market, Nasdaq requires us to maintain at least $2.5 million in stockholders’ equityor $500,000 in net income over the prior two years or two of the prior three years. As discussed above, as of September 30, 2023, ourstockholders’ equity was below $2.5 million and we did not otherwise meet the net income requirements described above, and as such,we are not currently in compliance with Nasdaq’s continue listing standards relating to minimum stockholders’ equity. If wefail to timely remedy our compliance with such applicable requirement, our common stock and Public Warrants may be delisted.

Our failure to meet Nasdaq’scontinued listing requirements for the reasons above, or any other reason, may result in our securities being delisted from Nasdaq.

Additional conditions requiredfor continued listing on Nasdaq include requiring that we have a majority of independent directors, a two person compensation committeeand a three-member audit committee (each consisting of all independent directors). Our prior independent directors, Francis Knuettel II,Pam Marrone, Teresa DeLuca, Larry Gold, Russell Ray, and Donald A. McGovern, Jr., each resigned from the Company on December 17, 2023.As such, we do not currently have any independent directors and do not currently have any audit committee or compensation committee members.As such, we are also not in compliance with the independent director/audit committee/compensation committee rules of Nasdaq. In the eventthat Nasdaq does not provide us sufficient time to cure such deficiency, our Common Stock and Public Warrants may be subject to delistingfrom Nasdaq. Additionally, we may be unable to find independent directors who are willing to serve as members of our Board of Directorsand/or members of our audit committee or compensation committee, and even assuming we are provided a cure period by Nasdaq, may be unableto cure such deficiency in any such cure period. As a result, our Common Stock and Public Warrants may be delisted from Nasdaq.

Even if we demonstrate compliancewith the requirements of Nasdaq, we will have to continue to meet other objective and subjective listing requirements to continue to belisted on The Nasdaq Capital Market. Delisting from The Nasdaq Capital Market could make trading our common stock and Public Warrantsmore difficult for investors, potentially leading to declines in our share price and liquidity. Without a Nasdaq Capital Market listing,stockholders may have a difficult time getting a quote for the sale or purchase of our common stock and Public Warrants, the sale or purchaseof our common stock and Public Warrants would likely be made more difficult, and the trading volume and liquidity of our common stockand Public Warrants could decline. Delisting from The Nasdaq Capital Market could also result in negative publicity and could also makeit more difficult for us to raise additional capital. The absence of such a listing may adversely affect the acceptance of our commonstock as currency or the value accorded by other parties. Further, if we are delisted, we would also incur additional costs under stateblue sky laws in connection with any sales of our securities. These requirements could severely limit the market liquidity of our commonstock and Public Warrants and the ability of our stockholders and warrant holders to sell our common stock and Public Warrants in thesecondary market. If our common stock and Public Warrants are delisted by Nasdaq, our common stock and Public Warrants may be eligibleto trade on an over-the-counter quotation system, such as the OTCQB Market or the OTC Pink market, where an investor may find it moredifficult to sell our common stock and Public Warrants or obtain accurate quotations as to the market value of our common stock and PublicWarrants. In the event our common stock and Public Warrants is delisted from The Nasdaq Capital Market, we may not be able to list ourcommon stock on another national securities exchange or obtain quotation on an over-the counter quotation system.

General Risk Factors

Provisions in our Certificateof Incorporation and Delaware law may inhibit a takeover of us, which could limit the price investors might be willing to pay in the futurefor our common stock and could entrench management.

Our Certificate of Incorporationcontains provisions that may discourage unsolicited takeover proposals that stockholders may consider to be in their best interests. Theseprovisions include a staggered board of directors and the ability of our Board to designate the terms of and issue new series of preferredshares, which may make it more difficult for the removal of management and may discourage transactions that otherwise could involve paymentof a premium over prevailing market prices for our securities. We are also subject to anti-takeover provisions under Delaware law, whichcould delay or prevent a change of control of the Company. Together, these provisions may make it more difficult for the removal of managementand may discourage transactions that otherwise could involve payment of a premium over prevailing market prices for our securities.

Our proprietary information,or that of our customers, suppliers and business partners, may be lost or we may suffer security breaches.

In the ordinary course ofour business, we expect to collect and store sensitive data, including valuable and commercially sensitive intellectual property, clinicaltrial data, our proprietary business information and that of our future customers, suppliers and business partners, and personally identifiableinformation of our customers, clinical trial subjects and employees, patients, in our data centers and on our networks. The secure processing,maintenance and transmission of this information is critical to our operations. Despite our security measures, our information technologyand infrastructure may be vulnerable to attacks by hackers or breached due to employee error, malfeasance or other disruptions. Any suchbreach could compromise our networks and the information stored there could be accessed, publicly disclosed, lost or stolen. Any suchaccess, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacyof personal information, regulatory penalties, disrupt our operations, damage our reputation, and cause a loss of confidence in our productsand our ability to conduct clinical trials, which could adversely affect our business and reputation and lead to delays in gaining regulatoryapprovals for our future product candidates. Although we maintain business interruption insurance coverage, our insurance might not coverall losses from any future breaches of our systems.

Failure of our informationtechnology systems, including cybersecurity attacks or other data security incidents, could significantly disrupt the operation of ourbusiness.

Our business increasinglydepends on the use of information technologies, which means that certain key areas such as research and development, production and salesare to a large extent dependent on our information systems or those of third-party providers. Our ability to execute our business planand to comply with regulators’ requirements with respect to data control and data integrity, depends, in part, on the continuedand uninterrupted performance of our information technology systems, or IT systems and the IT systems supplied by third-party serviceproviders. As information systems and the use of software and related applications by our company, our business partners, suppliers, andcustomers become more cloud-based, there has been an increase in global cybersecurity vulnerabilities and threats, including more sophisticatedand targeted cyber-related attacks that pose a risk to the security of our information systems and networks and the confidentiality, availabilityand integrity of data and information. In addition, our IT systems are vulnerable to damage from a variety of sources, including telecommunicationsor network failures, malicious human acts and natural disasters. Moreover, despite network security and backup measures, some of our serversare potentially vulnerable to physical or electronic break-ins, computer viruses and similar disruptive problems. Despite the precautionarymeasures we and our third-party service providers have taken to prevent unanticipated problems that could affect our IT systems, a successfulcybersecurity attack or other data security incident could result in the misappropriation and/or loss of confidential or personal information,create system interruptions, or deploy malicious software that attacks our systems. It is also possible that a cybersecurity attack mightnot be noticed for some period of time. In addition, sustained or repeated system failures or problems arising during the upgrade of anyof our IT systems that interrupt our ability to generate and maintain data, and in particular to operate our proprietary technology platform,could adversely affect our ability to operate our business. The occurrence of a cybersecurity attack or incident could result in businessinterruptions from the disruption of our IT systems, or negative publicity resulting in reputational damage with our stockholders andother stakeholders and/or increased costs to prevent, respond to or mitigate cybersecurity events. In addition, the unauthorized disseminationof sensitive personal information or proprietary or confidential information could expose us or other third–parties to regulatoryfines or penalties, litigation and potential liability, or otherwise harm our business.

We may acquire othercompanies which could divert our management’s attention, result in additional dilution to our stockholders and otherwise disruptour operations and harm our operating results.

We may in the future seekto acquire businesses, products or technologies that we believe could complement or expand our product offerings, enhance our technicalcapabilities or otherwise offer growth opportunities. The pursuit of potential acquisitions may divert the attention of management andcause us to incur various expenses in identifying, investigating and pursuing suitable acquisitions, whether or not they are consummated.If we acquire additional businesses, we may not be able to integrate the acquired personnel, operations and technologies successfully,effectively manage the combined business following the acquisition or realize anticipated cost savings or synergies. We also may not achievethe anticipated benefits from the acquired business due to a number of factors, including:

In the future, if our acquisitionsdo not yield expected returns, we may be required to take charges to our operating results arising from the impairment assessment process.Acquisitions may also result in dilutive issuances of equity securities or the incurrence of debt, which could adversely affect our operatingresults. In addition, if an acquired business fails to meet our expectations, our business, results of operations and financial conditionmay be adversely affected.

If we make any acquisitions,they may disrupt or have a negative impact on our business.

If we make acquisitions inthe future, funding permitting, which may not be available on favorable terms, if at all, we could have difficulty integrating the acquiredcompany’s assets, personnel and operations with our own. We do not anticipate that any acquisitions or mergers we may enter intoin the future would result in a change of control of the Company. In addition, the key personnel of the acquired business may not be willingto work for us. We cannot predict the effect expansion may have on our core business. Regardless of whether we are successful in makingan acquisition, the negotiations could disrupt our ongoing business, distract our management and employees and increase our expenses.In addition to the risks described above, acquisitions are accompanied by a number of inherent risks, including, without limitation, thefollowing:

Our business could be severelyimpaired if and to the extent that we are unable to succeed in addressing any of these risks or other problems encountered in connectionwith an acquisition, many of which cannot be presently identified. These risks and problems could disrupt our ongoing business, distractour management and employees, increase our expenses and adversely affect our results of operations.

We may apply workingcapital and future funding to uses that ultimately do not improve our operating results or increase the value of our securities.

In general, we have completediscretion over the use of our working capital and any new investment capital we may obtain in the future. Because of the number and varietyof factors that could determine our use of funds, our ultimate expenditure of funds (and their uses) may vary substantially fromour current intended operating plan for such funds.

We intend to use existingworking capital and future funding for research and development, and general corporate purposes, including the potential expenses relatedto completing a reverse merger and legal expenses. We will also use capital for general working capital purposes. However, we do not havemore specific plans for the use and expenditure of our capital. Our management has broad discretion to use any or all of our availablecapital reserves. Our capital could be applied in ways that do not improve our operating results or otherwise increase the value of astockholder’s investment.

We have never paid ordeclared any dividends on our common stock.

We have never paid or declaredany dividends on our common stock or preferred stock. Likewise, we do not anticipate paying, in the near future, dividends or distributionson our common stock. Any future dividends on common stock will be declared at the discretion of our Board and will depend, among otherthings, on our earnings, our financial requirements for future operations and growth, and other facts as we may then deem appropriate.Since we do not anticipate paying cash dividends on our common stock, return on your investment, if any, will depend solely on an increase,if any, in the market value of our common stock.

Stockholders may bediluted significantly through our efforts to obtain financing and satisfy obligations through the issuance of additional shares of ourcommon stock.

Wherever possible, our Boardwill attempt to use non-cash consideration to satisfy obligations. In many instances, we believe that the non-cash consideration willconsist of restricted shares of our common stock or where shares are to be issued to our officers, directors and applicable consultants.Our Board of Directors has authority, without action or vote of the stockholders, but subject to Nasdaq rules and regulations (which generallyrequire stockholder approval for any transactions which would result in the issuance of more than 20% of our then outstanding shares ofcommon stock or voting rights representing over 20% of our then outstanding shares of stock, subject to certain exceptions), to issueall or part of the authorized but unissued shares of common stock. In addition, we may attempt to raise capital by selling shares of ourcommon stock, possibly at a discount to market. These actions will result in dilution of the ownership interests of existing stockholders,which may further dilute common stock book value, and that dilution may be material. Such issuances may also serve to enhance existingmanagement’s ability to maintain control of the Company because the shares may be issued to parties or entities committed to supportingexisting management.

Our growth depends inpart on the success of our strategic relationships with third parties.

In order to grow our business,we anticipate that we will need to continue to depend on our relationships with third parties, including our technology providers. Identifyingpartners, and negotiating and documenting relationships with them, requires significant time and resources. Our competitors may be effectivein providing incentives to third parties to favor their products or services, or utilization of, our products and services. In addition,acquisitions of our partners by our competitors could result in a decrease in the number of our current and potential customers. If weare unsuccessful in establishing or maintaining our relationships with third parties, our ability to compete in the marketplace or togrow our revenue could be impaired and our results of operations may suffer. Even if we are successful, we cannot assure you that theserelationships will result in increased customer use of our products or increased revenue.

Claims, litigation,government investigations, and other proceedings may adversely affect our business and results of operations.

We are currently subject to,and expect to continue to be regularly subject to, actual and threatened claims, litigation, reviews, investigations, and other proceedings.In addition, we have filed lawsuits against certain parties for matters we discovered which related to KBL, prior to the Business Combination.Any of these types of proceedings may have an adverse effect on us because of legal costs, disruption of our operations, diversion ofmanagement resources, negative publicity, and other factors. Our current legal proceedings are described under, and incorporated by referencein, “Business-Legal Proceedings”. The outcomes of these matters are inherently unpredictable and subject tosignificant uncertainties. Determining legal reserves and possible losses from such matters involves judgment and may not reflect thefull range of uncertainties and unpredictable outcomes. Until the final resolution of such matters, we may be exposed to losses in excessof the amount recorded, and such amounts could be material. Should any of our estimates and assumptions change or prove to have been incorrect,it could have a material effect on our business, consolidated financial position, results of operations, or cash flows. In addition, itis possible that a resolution of one or more such proceedings, including as a result of a settlement, could require us to make substantialfuture payments, prevent us from offering certain products or services, require us to change our business practices in a manner materiallyadverse to our business, requiring development of non-infringing or otherwise altered products or technologies, damaging our reputation,or otherwise having a material effect on our operations.

Changes in laws or regulations,or a failure to comply with any laws and regulations, may adversely affect our business, investments and results of operations.

We are subject to laws, regulationsand rules enacted by national, regional and local governments. In particular, we are required to comply with certain SEC, Nasdaq and otherlegal or regulatory requirements. Compliance with, and monitoring of, applicable laws, regulations and rules may be difficult, time consumingand costly. Those laws, regulations and rules and their interpretation and application may also change from time to time and those changescould have a material adverse effect on our business, investments and results of operations. In addition, a failure to comply with applicablelaws, regulations and rules, as interpreted and applied, could have a material adverse effect on our business and results of operations.

Certain of our executiveofficers and directors are now, and all of them may in the future become, affiliated with entities engaged in business activities similarto those conducted by us and, accordingly, may have conflicts of interest in determining to which entity a particular business opportunityshould be presented.

Our executive officers anddirectors are, or may in the future become, affiliated with entities that are engaged in business activities similar to those that areconducted by us. Our officers and directors also may become aware of business opportunities which may be appropriate for presentationto us and the other entities to which they owe certain fiduciary or contractual duties. Accordingly, they may have conflicts of interestin determining whether a particular business opportunity should be presented to our company or to another entity. These conflicts maynot be resolved in our favor and a potential opportunity may be presented to another entity prior to its presentation to us. Our Certificateof Incorporation provides that we renounce our interest in any corporate opportunity offered to any director or officer unless such opportunityis expressly offered to such person solely in his or her capacity as a director or officer of our company and such opportunity is onewe are legally and contractually permitted to undertake and would otherwise be reasonable for us to pursue.

Our executive officers,directors, security holders and their respective affiliates may have competitive pecuniary interests that conflict with our interests.

We have not adopted a policythat expressly prohibits our directors, executive officers, security holders or affiliates from having a direct or indirect pecuniaryor financial interest in any investment to be acquired or disposed of by us or in any transaction to which we are a party or have an interest.In fact, we may enter into a strategic transaction with a target business that is affiliated with our directors or executive officers.Nor do we have a policy that expressly prohibits any such persons from engaging for their own account in business activities of the typesconducted by us. Accordingly, such persons or entities may have a conflict between their interests and ours. Certain of our officers anddirectors hold positions with companies which may be competitors of us. See also the biographies of our officers and directors below under“Management”.

We may be adverselyaffected by climate change or by legal, regulatory or market responses to such change.

The long-term effects of climatechange are difficult to predict; however, such effects may be widespread. Impacts from climate change may include physical risks (suchas rising sea levels or frequency and severity of extreme weather conditions-which may affect our current operations due to among otherthings, the fact that a majority of our operations we are based in California, which is prone to inclement weather), social and humaneffects (such as population dislocations or harm to health and well-being), compliance costs and transition risks (such as regulatoryor technology changes) and other adverse effects. The effects of climate change could increase the cost of certain products, commoditiesand energy (including utilities), which in turn may impact our ability to procure goods or services required for the operation of ourbusiness. Climate change could also lead to increased costs as a result of physical damage to or destruction of our facilities, loss ofinventory, and business interruption due to weather events that may be attributable to climate change. These events and impacts couldmaterially adversely affect our business operations, financial position or results of operation.

Environmental, socialand governance matters may impact our business and reputation.

Governmental authorities,non-governmental organizations, customers, investors, external stakeholders and employees are increasingly sensitive to environmental,social and governance, or ESG, concerns, such as diversity and inclusion, climate change, water use, recyclability or recoverability ofpackaging, and plastic waste. This focus on ESG concerns may lead to new requirements that could result in increased costs associatedwith developing, manufacturing and distributing our products. Our ability to compete could also be affected by changing customer preferencesand requirements, such as growing demand for more environmentally friendly products, packaging or supplier practices, or by failure tomeet such customer expectations or demand. We risk negative stockholder reaction, including from proxy advisory services, as well as damageto our brand and reputation, if we do not act responsibly, or if we are perceived to not be acting responsibly in key ESG areas, includingequitable access to medicines, product quality and safety, diversity and inclusion, environmental stewardship, support for local communities,corporate governance and transparency, and addressing human capital factors in our operations. If we do not meet the ESG expectationsof our investors, customers and other stakeholders, we could experience reduced demand for our products, loss of customers, and othernegative impacts on our business and results of operations.

The United Kingdom’swithdrawal from the European Union could result in increased regulatory and legal complexity, which may make it more difficult for usto do business in the United Kingdom and/or Europe and impose additional challenges in securing regulatory approval of our product candidatesin the United Kingdom and/or Europe.

The United Kingdom’sexit from the European Union as of January 31, 2020, with a transitional period up to December 31, 2020, commonly referred to as “Brexit”,has caused political and economic uncertainty, including in the regulatory framework applicable to our operations and product candidatesin the United Kingdom and the European Union, and this uncertainty may persist for years. Brexit could, among other outcomes, disruptthe free movement of goods, services and people between the United Kingdom and the European Union, and result in increased legal and regulatorycomplexities, as well as potential higher costs of conducting business in Europe. As one of the Brexit consequences, the EMA has relocatedfrom the United Kingdom to the Netherlands. This has led to a significant reduction of the EMA workforce, which has resulted and couldfurther result in significant disruption and delays in its administrative procedures, such as granting clinical trial authorization oropinions for marketing authorization, disruption of importation and export of active substance and other components of new drug formulations,and disruption of the supply chain for clinical trial product and final authorized formulations.

The cumulative effects ofthe disruption to the regulatory framework may add considerably to the development lead time to marketing authorization and commercializationof products in the European Union and/or the United Kingdom It is possible that there will be increased regulatory complexities, whichcan disrupt the timing of our clinical trials and regulatory approvals. In addition, changes in, and legal uncertainty with regard to,national and international laws and regulations may present difficulties for our clinical and regulatory strategy. Any delay in obtaining,or an inability to obtain, any marketing approvals, as a result of Brexit or otherwise, would prevent us from commercializing our productcandidates in the United Kingdom and/or the European Union and restrict our ability to generate revenues and achieve and sustain profitability.

In addition, as a result ofBrexit, other European countries may seek to conduct referenda with respect to their continuing membership with the European Union. Giventhese possibilities and others we may not anticipate, as well as the absence of comparable precedent, it is unclear what financial, regulatoryand legal implications the withdrawal of the United Kingdom from the European Union will have, how such withdrawal will affect us, andthe full extent to which our business could be adversely affected.

The increasing use ofsocial media platforms presents new risks and challenges to our business.

Social media is increasinglybeing used to communicate about pharmaceutical companies’ research, product candidates, and the diseases such product candidatesare being developed to prevent. Social media practices in the pharmaceutical industry continue to evolve and regulations relating to suchuse are not always clear. This evolution creates uncertainty and risk of noncompliance with regulations applicable to our business, resultingin potential regulatory actions against us. For example, subjects may use social media channels to comment on their experience in an ongoingblinded clinical trial or to report an alleged adverse event. When such events occur, there is a risk that we fail to monitor and complywith applicable adverse event reporting obligations, or we may not be able to defend our business or the public’s legitimate interestsin the face of the political and market pressures generated by social media due to restrictions on what we may say about our investigationalproduct candidates. There is also a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or commentsabout us on any social media or networking website. Certain data protection regulations, such as the GDPR, apply to personal data containedon social media. If any of these events were to occur or we otherwise fail to comply with applicable regulations, we could incur liability,face regulatory actions or incur harm to our business, including damage to our reputation.

We may incur indebtednessin the future which could reduce our financial flexibility, increase interest expense and adversely impact our operations and our costs.

We may incur significant amountsof indebtedness in the future. Our level of indebtedness could affect our operations in several ways, including the following:

A high level of indebtednessincreases the risk that we may default on our debt obligations. We may not be able to generate sufficient cash flows to pay the principalor interest on our debt, and future working capital, borrowings or equity financing may not be available to pay or refinance such debt.If we do not have sufficient funds and are otherwise unable to arrange financing, we may have to sell significant assets or have a portionof our assets foreclosed upon which could have a material adverse effect on our business, financial condition and results of operations.

We may be adverselyimpacted by changes in accounting standards.

Our consolidated financialstatements are subject to the application of the accounting principles generally accepted in the United States of America (“U.S.GAAP”), which periodically is revised or reinterpreted. From time to time, we are required to adopt new or revised accountingstandards issued by recognized authoritative bodies, including the Financial Accounting Standards Board (“FASB”) andthe SEC. It is possible that future accounting standards may require changes to the accounting treatment in our consolidated financialstatements and may require us to make significant changes to our financial systems. Such changes might have a materially adverse impacton our financial position or results of operations.

For all of the foregoingreasons and others set forth herein, an investment in our securities involves a high degree of risk.

December 2023 Warrantsand Related Transactions

On August 14, 2023, we issuedand sold to certain investors, including a certain institutional investor (the “Purchaser”), who is the Selling Stockholdernamed in this prospectus, an aggregate of: (i) 666,925 shares (the “August 2023 Shares”) of the Company’s CommonStock, (ii) pre-funded warrants (the “August 2023 Pre-Funded Warrants”) to purchase up to 3,948,460 shares of CommonStock, and (iii) warrants (the “August 2023 Common Warrants”) to purchase up to 4,615,385 shares of Common Stock, inthe case of the Purchaser, pursuant to a securities purchase agreement, dated as of August 9, 2023, between the Company and the Purchaser(the “August 2023 SPA”).

On October 11, 2023, the Companyreceived written notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifyingthe Company that it was not in compliance with the shareholder approval requirements set forth in Nasdaq Listing Rule 5635(d), which requiresprior shareholder approval for transactions, other than public offerings, involving the issuance of 20% or more of the pre-transactionshares outstanding at less than the applicable Minimum Price (as defined in Listing Rule 5635(d)(1)(A)).

Nasdaq’s determinationunder Listing Rule 5635(d) related to the August 2023 offering (the “August 2023 Offering”). The offering price pershare of Common Stock and associated August 2023 Common Warrant was $0.65 and the offering price per August 2023 Pre-Funded Warrant andassociated August 2023 Common Warrant was $0.6499.

Nasdaq determined that theAugust 2023 Offering was not a “public offering” for the purposes of Nasdaq’s shareholder approval rules due to thetype of offering, a best efforts offering pursuant to a placement agency agreement, and the fact that one investor purchased 98% of theAugust 2023 Offering. As a result, because the August 2023 Offering represented greater than 20% of the Common Stock outstanding and waspriced below the Minimum Price, Nasdaq determined that the Company was required to obtain prior shareholder approval under Listing Rule5635(d). In November and December 2023, the Company took various actions to amend the terms of the August 2023 Offering to comply withListing Rule 5635(d), as discussed below.

On November 28, 2023, theCompany entered into Amendment No. 1 to the August 2023 SPA with the Purchaser (the “November 2023 SPA Amendment”),pursuant to which (i) the Purchaser agreed to pay an additional $830,769.30 in connection with the repricing of the August 2023 Sharesand August 2023 Pre-Funded Warrants (the “Repricing Amount”), (ii) the Company agreed to issue to the Purchaser (x)pre-funded warrants to purchase up to 4,886,878 shares of Common Stock, with an exercise price of $0.0001 per share (the “December2023 Pre-Funded Warrants”), and (y) warrants to purchase up to 9,064,098 shares of Common Stock, with an exercise price of $0.17per share (the “December 2023 Common Warrants” and, together with the December 2023 Pre-Funded Warrants, the “Warrants”),and (iii) the Company and the Purchaser agreed to enter into the Warrant Amendment Agreement (as defined and described below).

The Warrants will not be exercisableuntil the Company obtains stockholder approval for the issuance of the 13,950,976 shares of Common Stock upon exercise of the Warrants(the “Warrant Shares”)(“Stockholder Approval”, and the date of such Stockholder Approval, the “StockholderApproval Date”), at which point the December 2023 Pre-Funded Warrants will remain exercisable until all of the December 2023Pre-Funded Warrants are exercised in full, and the December 2023 Common Warrants will remain exercisable until the fifth anniversary ofthe Stockholder Approval Date (as defined below).

The November 2023 SPA Amendmentcontains certain customary representations, warranties and agreements by the Company, customary conditions to closing, indemnificationobligations of the Company, other obligations of the parties, and termination provisions. Pursuant to the November 2023 SPA Amendment,the Company has agreed that, subject to certain exceptions, it will not conduct any issuances of Common Stock (or equivalents thereof)from the Closing Date until 15 days after the Stockholder Approval Date. The November 2023 SPA Amendment also requires the Company tofile a registration statement with the SEC to register the resale by the Purchaser of the Warrant Shares within sixty (60) days of theStockholder Approval Date.

In accordance with the November2023 SPA Amendment, the Company entered into a warrant amendment agreement with the Purchaser, dated November 28, 2023 (the “WarrantAmendment Agreement”), whereby the Company agreed to amend the following outstanding warrants held by the Purchaser: (i) warrantsto purchase up to 2,571,429 shares of Common Stock, issued on December 22, 2022, and amended in January 2023, April 2023 and August 2023(the “December 2022 Warrants”); (ii) warrants to purchase up to 306,604 shares of Common Stock, issued on July 20,2022 and amended in April 2023 and August 2023 (the “July 2022 Warrants”); (iii) warrants to purchase up to 1,570,680shares of Common Stock, issued on April 10, 2023 and August 2023 (the “April and August 2023 Warrants”, and collectivelywith the December 2022 Warrants and July 2022 Warrants, the “December 2022 Through August 2023 Warrants”); and (iv)warrants to purchase up to 4,615,385 shares of Common Stock underlying the August 2023 Common Warrants (collectively, the “ExistingCommon Warrants”). Pursuant to the Warrant Amendment Agreement, the Existing Common Warrants will be amended (the “WarrantAmendment”) such that they will not be exercisable until the company obtains stockholder approval for the issuance of up to9,064,098 shares of Common Stock upon exercise of the Existing Common Warrants (the “Existing Common Warrant Shares”).The Existing Common Warrants will have an exercise price equal to $0.17 per share, and the Existing Common Warrants will expire on thefifth anniversary of the Stockholder Approval Date (the “Repricing and Extension”). The other terms of the ExistingCommon Warrants remain unchanged.

The closing of the transactionsdiscussed above occurred on December 1, 2023 (the “Closing Date”). Upon the closing of the transactions, the Companyregained compliance with Nasdaq Listing Rule 5635(d).

For purposes of obtainingStockholder Approval of the issuance of the Warrant Shares and the Existing Common Warrant Shares, the Company has agreed to hold a StockholderMeeting (as defined in the November 2023 SPA Amendment) on or prior to the date that is ninety (90) days following the Closing Date (andhas scheduled such meeting for February 16, 2024). If the Company does not obtain Stockholder Approval at the first Stockholder Meeting,the Company will call a Stockholder Meeting every ninety (90) days thereafter until the earlier of: (i) the date on which StockholderApproval is obtained or (ii) the Warrants and the Existing Common Warrants are no longer outstanding.

Simultaneously with the closingof the transactions, the Company entered into a warrant agent agreement (the “Warrant Agent Agreement”) with ContinentalStock Transfer & Trust Company (“Continental”), pursuant to which Continental will act as warrant agent with respectto the Warrants.

Theform of Warrant Agent Agreement, the form of Pre-Funded Warrant, the form of Common Warrant, the Warrant Amendment Agreement and the November2023 SPA Amendment were filed as Exhibits 4.1, 4.2, 4.3, 4.4 and 10.1 respectively, to the Company’s Current Report on Form 8-Kfiled with the SEC on November 30, 2023. 

The registration statement,of which the Prospectus forms a part, registers the resale of the shares of Common Stock issuable upon exercise of the December 2023 CommonWarrants and December 2023 Pre-Funded Warrants. We have not registered, and are not registering, the December 2023 Common Warrants orDecember 2023 Pre-Funded Warrants, themselves.

December 2023 Pre-Funded Warrants

The following summary ofthe material terms of the December 2023 Pre-Funded Warrants is not intended to be a complete summary of the rights and preferences ofsuch warrants. We urge you to read each of the warrants in their entirety for a complete description of the rights and preferences ofthe warrants.

The following summary ofthe material terms of the December 2023 Pre-Funded Warrants is not intended to be a complete summary of the rights and preferences ofsuch warrants. We urge you to read each of the warrants in their entirety for a complete description of the rights and preferences ofthe warrants.

Duration and ExercisePrice

Each December 2023 Pre-FundedWarrant has an exercise price of $0.0001 per share. The December 2023 Pre-Funded Warrants will be immediately exercisable following theStockholder Approval Date and may be exercised at any time until the December 2023 Pre-Funded Warrants are exercised in full. The exerciseprice and number of shares of Common Stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends,stock splits, reorganizations or similar events affecting our Common Stock and the exercise price, as described in the December 2023 Pre-FundedWarrant.

Exercisability

The December 2023 Pre-FundedWarrants will be exercisable, at the option of the holder thereof, in whole or in part, by delivering a duly executed exercise notice.A holder (together with its affiliates) may not exercise any portion of the December 2023 Pre-Funded Warrant to the extent that the holderwould own more than 4.99% of the outstanding Common Stock immediately after exercise, except that upon at least 61 days’ prior noticefrom the holder to us, the holder may increase the amount of ownership of outstanding stock after exercising the holder’s December2023 Pre-Funded Warrants up to 9.99% of the number of shares of Common Stock outstanding immediately after giving effect to the exercise,as such percentage ownership is determined in accordance with the terms of the December 2023 Pre-Funded Warrants. No fractional sharesof Common Stock will be issued in connection with the exercise of a December 2023 Pre-Funded Warrant. In lieu of fractional shares, wewill pay the holder an amount in cash equal to the fractional amount multiplied by the exercise price.

Cashless Exercise

In lieu of making the cashpayment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect insteadto receive upon such exercise (either in whole or in part) the net number of shares of Common Stock determined according to a formulaset forth in the December 2023 Pre-Funded Warrants.

Fundamental Transactions

In the event of a fundamentaltransaction, as described in the December 2023 Pre-Funded Warrants and generally including any reorganization, recapitalization or reclassificationof our Common Stock pursuant to which the shares of Common Stock are converted or exchanged for other securities, cash, or property, thesale, transfer or other disposition of all or substantially all of our properties or assets, our consolidation or merger with or intoanother person pursuant to which we are not the surviving entity, the acquisition of more than 50% of our outstanding voting securities,the holders of the December 2023 Pre-Funded Warrants will be entitled to receive upon exercise of the December 2023 Pre-Funded Warrantsthe kind and amount of securities, cash or other property that the holders would have received had they exercised the December 2023 Pre-FundedWarrants immediately prior to such fundamental transaction. In addition, the holders of the December 2023 Pre-Funded Warrants have theright to require us or a successor entity to redeem the December 2023 Pre-Funded Warrant for the cash paid in the fundamental transactionin the amount of the Black Scholes value of the unexercised portion of the December 2023 Pre-Funded Warrant on the date of the consummationof the fundamental transaction.

Transferability

Subject to applicable laws,a December 2023 Pre-Funded Warrant may be transferred at the option of the holder upon surrender of the December 2023 Pre-Funded Warranttogether with the appropriate instruments of transfer.

Exchange Listing

We do not intend to list theDecember 2023 Pre-Funded Warrants on any securities exchange or nationally recognized trading system.

Rights as a Stockholder

Except as otherwise providedin the December 2023 Pre-Funded Warrants or by virtue of such holder’s ownership of, the holders of the December 2023 Pre-FundedWarrants do not have the rights or privileges of holders of our Common Stock, including any voting rights, until they exercise their December2023 Pre-Funded Warrants.

Warrant Agent

The December 2023 Pre-FundedWarrants are issued in registered form under a warrant agent agreement between Continental Stock Transfer & Trust Company, as warrantagent, and us. The December 2023 Pre-Funded Warrants are initially represented only by one or more global warrants deposited with thewarrant agent, as custodian on behalf of The Depository Trust Company, or DTC, and registered in the name of Cede & Co., a nomineeof DTC, or as otherwise directed by DTC.

December 2023 Common Warrants

The following summary ofthe material terms of the December 2023 Common Warrants is not intended to be a complete summary of the rights and preferences of suchwarrants. We urge you to read each of the warrants in their entirety for a complete description of the rights and preferences of the warrants.

Duration and ExercisePrice

Each December 2023 CommonWarrant has an exercise price of $0.17 per share. The December 2023 Common Warrants will be exercisable on the Stockholder ApprovalDate and will expire on the fifth anniversary of the Stockholder Approval Date. The exercise price and number of shares of Common Stockissuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similarevents affecting our Common Stock and the exercise price, as described in the December 2023 Common Warrant. December 2023 Common Warrantswere issued separately from the December 2023 Pre-Funded Warrants and may be transferred separately.

Exercisability

The December 2023 Common Warrantswill be exercisable, at the option of each holder, in whole or in part, by delivering a duly executed exercise notice accompanied by paymentin full for the number of shares of Common Stock purchased upon such exercise (except in the case of a cashless exercise as discussedbelow). A holder (together with its affiliates) may not exercise any portion of the December 2023 Common Warrant to the extent that theholder would own more than 4.99% of the outstanding Common Stock immediately after exercise, except that upon at least 61 days’prior notice from the holder to us, the holder may increase the amount of ownership of outstanding stock after exercising the holder’sDecember 2023 Common Warrants up to 9.99% of the number of shares of Common Stock outstanding immediately after giving effect to the exercise,as such percentage ownership is determined in accordance with the terms of the December 2023 Common Warrants. No fractional shares ofCommon Stock will be issued in connection with the exercise of a December 2023 Common Warrant. In lieu of fractional shares, we will paythe holder an amount in cash equal to the fractional amount multiplied by the exercise price.

Cashless Exercise

If, at the time a holder exercisesits December 2023 Common Warrants, a registration statement registering the issuance of the shares of Common Stock underlying the December2023 Common Warrants under the Securities Act is not then effective or available, then in lieu of making the cash payment otherwise contemplatedto be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise(either in whole or in part) the net number of shares of Common Stock determined according to a formula set forth in the December 2023Common Warrants.

Fundamental Transaction

In the event of a fundamentaltransaction, as described in the December 2023 Common Warrants and generally including any reorganization, recapitalization or reclassificationof our Common Stock pursuant to which the shares of Common Stock are converted or exchanged for other securities, cash, or property, thesale, transfer or other disposition of all or substantially all of our properties or assets, our consolidation or merger with or intoanother person pursuant to which we are not the surviving entity, the acquisition of more than 50% of our outstanding voting securities,the holders of the December 2023 Common Warrants will be entitled to receive upon exercise of the December 2023 Common Warrants the kindand amount of securities, cash or other property that the holders would have received had they exercised the December 2023 Common Warrantsimmediately prior to such fundamental transaction. In addition, the holders of the December 2023 Common Warrants have the right to requireus or a successor entity to redeem the December 2023 Common Warrant for the cash paid in the fundamental transaction in the amount ofthe Black Scholes value of the unexercised portion of the December 2023 Common Warrant on the date of the consummation of the fundamentaltransaction.

Transferability

Subject to applicable laws,a December 2023 Common Warrant may be transferred at the option of the holder upon surrender of the December 2023 Common Warrant togetherwith the appropriate instruments of transfer.

Exchange Listing

We do not intend to list theDecember 2023 Common Warrants on any securities exchange or nationally recognized trading system.

Right as a Stockholder

Except as otherwise providedin the December 2023 Common Warrants or by virtue of such holder’s ownership of, the holders of the December 2023 Common Warrantsdo not have the rights or privileges of holders of our Common Stock, including any voting rights, until they exercise their December 2023Common Warrants.

Warrant Agent

The December 2023 Common Warrantswere issued in registered form under a warrant agent agreement between Continental Stock Transfer & Trust Company, as warrant agent,and us. The December 2023 Common Warrants are initially represented only by one or more global warrants deposited with the warrant agent,as custodian on behalf of The Depository Trust Company, or DTC, and registered in the name of Cede & Co., a nominee of DTC, or asotherwise directed by DTC.

Use of Proceeds

We will not receive any ofthe proceeds from the sale by the Selling Stockholder of the Shares in this offering. Additionally, the exercise price of the December2023 Pre-Funded Warrants, $0.0001 per share, or $488.70 in aggregate, has already been paid to us. However, if all of the December 2023Common Warrants that are covered by this prospectus are exercised for cash, we may receive proceeds of up to approximately $1,540,897.We cannot predict when, or if, the Warrants will be exercised. It is possible that the December 2023 Common Warrants may expire and maynever be exercised for cash. We intend to use any proceeds from the exercise of the December 2023 Common Warrants for research and development,and general corporate purposes, including the potential expenses related to completing a reverse merger and legal expenses. Our managementwill have broad discretion over the use of proceeds from the exercise of the December 2023 Common Warrants.

The Selling Stockholder willpay any underwriting discounts and commissions and expenses incurred by the Selling Stockholder for brokerage, accounting, tax or legalservices or any other expenses incurred by the Selling Stockholder in disposing of the Shares. We will bear all other costs, fees andexpenses incurred in effecting the registration of the Shares covered by this prospectus, including all registration and filing fees,and fees and expenses of our counsel and our independent registered public accountants.

Market Price ofOur Common Stock and Related Stockholder Matters

Market Information

Our common stock, Public Warrants,rights and units were previously listed on Nasdaq under the symbols “KBLM”, “KBLMW”, “KBLMR” and “KBLMU”,respectively. Our units commenced public trading on April 7, 2017 and our common stock, Public Warrants and rights each commenced separatepublic trading on May 2, 2017. Our units automatically separated into the component securities upon consummation of the Business Combinationand, as a result, no longer trade as a separate security, and our common stock and Public Warrants began trading on Nasdaq under the symbols“ATNF” and “ATNFW,” respectively. Prior to the Closing, each unit consisted of one share of our common stock,one right convertible into 1/10th of one share of our common stock, and one warrant to purchase one half of one share of our common stockat an exercise price of $11.50 per whole share.

Holders