As filed with the Securities and Exchange Commission on October 15, 2021

Registration Statement No. 333-       

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

Boston Therapeutics, Inc.
(Exact name of registrant as specified in its charter)

Boston Therapeutics, Inc.

5900 Hollis Street

Emeryville, CA 95608

(510) 428-5300
(Address and telephone number of registrant’s principal executive offices)

David Ludvigson

Boston Therapeutics, Inc.

Chief Executive Officer

5900 Hollis Street

Emeryville, CA 95608

(510) 428-5300
(Name, address, including zip code, and telephone number, including area code, of agent for service)

Approximate date of commencement of proposed saleto the public:

As soon as practicable after the effective dateof 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 1933check the following box:  ☒

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

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 registration statement.  ☐

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 registration statement.  ☐

Indicate by check mark whetherthe registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a 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 to Section 7(a)(2)(B) of the Securities Act. ☐

CALCULATION OF REGISTRATION FEE

The registrant herebyamends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant will filea further amendment which specifically states that this registration statement will thereafter become effective in accordance with Section 8(a)of the Securities Act of 1933, as amended, or until the registration statement will become effective on such date as the Securities andExchange Commission, acting pursuant to said Section 8(a), may determine.

The information inthis preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filedwith the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell nor does it seek an offerto buy these securities in any jurisdiction where the offer or sale is not permitted. 

SUBJECT TO COMPLETION, DATED OCTOBER 15, 2021

BOSTON THERAPEUTICS, INC.

22,587,176 Shares of Common Stock

This prospectus relates tothe sale from time to time of up to 22,587,176 shares of common stock held by the selling stockholders named in this prospectus, including14,392,900 shares of common stock issuable upon conversion of outstanding senior secured convertible promissory notes, or the Notes, and8,194,276 shares of common stock issuable upon exercise of certain outstanding warrants, the Warrants.  The shares or common stockissuable by us to the selling stockholders were sold in a private placement transaction that was completed on June 25, 2021. The Notesand Warrants are subject to a blocker provision, or the Blocker, which restricts the conversion of the Notes and exercise of a Warrantif, as a result of such exercise, the holder, together with its affiliates and any other person whose beneficial ownership of common stockwould be aggregated with the holder’s for purposes of Section 13(d) of the Securities Exchange Act of 1934, as amended, or the ExchangeAct, would beneficially own in excess of 9.99% of our then issued and outstanding shares of common stock (including the shares of CommonStock issuable upon such conversion and/or exercise).

We are not selling any commonstock under this prospectus and will not receive any of the proceeds from the sale of shares by the selling stockholders. We will, however,receive the net proceeds of any Warrants exercised for cash.

The selling stockholders identifiedin this prospectus may offer the shares from time to time through public or private transactions at fixed prices, at prevailing marketprices at the time of sale, at prices related to the prevailing market price, at varying prices determined at the time of sale, or atnegotiated prices. The registration of the shares of common stock on behalf of the selling stockholders, however, does not necessarilymean that any of the selling stockholders will offer or sell their shares under this registration statement or at any time in the nearfuture. We provide more information about how the selling stockholders may sell their shares of common stock in the section entitled “Planof Distribution” on page 84.

The selling stockholders willbear all commissions and discounts, if any, attributable to the sale or disposition of the shares, or interests therein and all costs,expenses and fees in connection with the registration of the shares. We will not be paying any underwriting discounts or commissions inthis offering or costs, expenses, and fees in connection with the registration of the shares of common stock described in this prospectus.We will pay the expenses of registering the shares.

Our common stock is tradedon the Pink Open Market maintained by OTC Markets Group, Inc. under the symbol “BTHE.” On October 11, 2021, the last reportedsale price of our common stock was $1.73 per share.

On January 25, 2021, our Board of Directors, orthe Board, and on January 27, 2021, the holders of at least a majority of our common stock (the “Majority Stockholders”),each adopted resolutions by written consent, to approve an amendment to our certificate of incorporation to effect a reverse stock split(the “Reverse Split”) of our common stock at a ratio of 1-for-173. The Reverse Split will be effected by filing a Certificateof Amendment to the Certificate of Incorporation (the “Amendment”) with the Secretary of State of the State of Delaware .We anticipate filing the Amendment upon approval of the Reverse Split by FINRA which is expectedto occur prior to or upon the effective date of the registration statement of which this prospectus forms a part. No fractional sharesof common stock will be issued in connection with the Reverse Split, and all such fractional interests will be rounded up to the nearestwhole number. Issued and outstanding stock options and warrants will be split on the same basis and exercise prices will be adjusted accordingly.All information presented in this prospectus assumes a 1-for-173 reverse stock split of our outstanding shares of common stock, stockoptions and warrants and, unless otherwise indicated, all such amounts and corresponding share price, per share and stock option and warrantexercise price data set forth in this prospectus have been adjusted to give effect to the assumed Reverse Split.

An investment in our commonstock involves a high degree of risk. See “Risk Factors” on page 10 of this prospectus for more information onthese risks.

Neither the U.S. Securities and Exchange Commissionnor any state securities commission has approved or disapproved of these securities, or passed upon the adequacy or accuracy of this prospectus. Anyrepresentation to the contrary is a criminal offense.

The date of this prospectus is         ,2021.

TABLE OF CONTENTS

We have not authorized anyone to provide anyinformation or to make any representations other than those contained in this prospectus or in any free writing prospectus prepared byor on behalf of us or to which we have referred you. We take no responsibility for and can provide no assurance as to the reliabilityof, any other information that others may give to you. The information contained in this prospectus is accurate only as of the date ofthis prospectus, regardless of the time of delivery of this prospectus or any sale of our common stock.

You should rely only on the information containedin this prospectus. No dealer, salesperson or other person is authorized to give information that is not contained in this prospectus.This prospectus is not an offer to sell nor is it seeking an offer to buy these securities in any jurisdiction where the offer or saleis not permitted. The information in this prospectus is accurate only as of the date of this prospectus, regardless of the time of deliveryof this prospectus or of any sale of these securities.

ABOUT THIS PROSPECTUS

In this prospectus, unless otherwise noted, referencesto “the Company,” “BTHE,” “we,” “us,” and “our” refer to Boston Therapeutics,Inc., our its subsidiaries.

Neither we, nor any of our officers, directors,agents or representatives or underwriters, make any representation to you about the legality of an investment in our common stock. Youshould not interpret the contents of this prospectus or any free writing prospectus to be legal, business, investment or tax advice. Youshould consult with your own advisors for that type of advice and consult with them about the legal, tax, business, financial and otherissues that you should consider before investing in our common stock.

You should rely only on the information containedin this prospectus or in any amended prospectus that we may authorize to be delivered or made available to you. We and the underwriterhave not authorized anyone to provide you with different information.

The information in this prospectus is accurateonly as of the date hereof, regardless of the time of its delivery or any sale of shares of our common stock.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements.These forward-looking statements contain information about our expectations, beliefs or intentions regarding our product development andcommercialization efforts, business, financial condition, results of operations, strategies or prospects, and other similar matters. Theseforward-looking statements are based on management’s current expectations and assumptions about future events, which are inherentlysubject to uncertainties, risks and changes in circumstances that are difficult to predict. These statements may be identified by wordssuch as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,”“believes,” “should,” “intends,” “estimates,” and other words of similar meaning.

These statements relate to future events or ourfuture operational or financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actualresults, performance or achievements to be materially different from any future results, performance or achievements expressed or impliedby these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, amongother things, those listed under the section titled “Risk Factors” and elsewhere in this prospectus, in any related prospectussupplement and in any related free writing prospectus.

Any forward-looking statement in this prospectus,in any related prospectus supplement and in any related free writing prospectus reflects our current view with respect to future eventsand is subject to these and other risks, uncertainties and assumptions relating to our business, results of operations, industry and futuregrowth. Given these uncertainties, you should not place undue reliance on these forward-looking statements. No forward-looking statementis a guarantee of future performance. You should read this prospectus, any related prospectus supplement and any related free writingprospectus and the documents that we reference herein and therein and have filed as exhibits hereto and thereto completely and with theunderstanding that our actual future results may be materially different from any future results expressed or implied by these forward-lookingstatements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, evenif new information becomes available in the future.

This prospectus, any related prospectus supplementand any related free writing prospectus also contain or may contain estimates, projections and other information concerning our industry,our business and the markets for our products, including data regarding the estimated size of those markets and their projected growthrates. We obtained the industry and market data in this prospectus from our own research as well as from industry and general publications,surveys and studies conducted by third parties. This data involves a number of assumptions and limitations and contains projections andestimates of the future performance of the industries in which we operate that are subject to a high degree of uncertainty, includingthose discussed in “Risk Factors.” We caution you not to give undue weight to such projections, assumptions and estimates.Further, industry and general publications, studies and surveys generally state that they have been obtained from sources believed tobe reliable, although they do not guarantee the accuracy or completeness of such information. While we believe that these publications,studies and surveys are reliable, we have not independently verified the data contained in them. In addition, while we believe that theresults and estimates from our internal research are reliable, such results and estimates have not been verified by any independent source.

RISK FACTORS

An investment in our securities involves ahigh degree of risk. Before making an investment decision, you should give careful consideration to the following risk factors, in additionto the other information included in this prospectus, including our financial statements and related notes, before deciding whether toinvest in our securities. The occurrence of any of the adverse developments described in the following risk factors could materially andadversely harm our business, financial condition, results of operations or prospects. In that case, the trading price of our common stockcould decline, and you may lose all or part of your investment.

Risks Related to Our Financial Position andNeed for Additional Capital

The COVID-19 pandemic could materially adversely affect our business,financial condition and results of operations.

The COVID-19 pandemic, themeasures attempted to contain and mitigate the effects of the virus, including travel bans and restrictions, shelter-in-place, quarantineand other similar governmental orders and restrictions on trade put in place around the world have caused widespread disruption in globaleconomies, productivity and financial markets and have materially altered the way in which we conduct our day-to-day business.

The full extent to which theCOVID-19 pandemic and the various responses to it impact our business, operations and financial results will depend on numerous evolvingfactors that we may not be able to accurately predict, including: the duration and scope of the pandemic, including any potential futurewaves of the pandemic; governmental, business and individuals’ actions that have been and continue to be taken in response to thepandemic; the effect on players and their willingness and ability to pay entry fees for the games on our platform; the effect on our thirdparty developers and their willingness and ability to engage with our services and our platform; disruptions or restrictions on our employees’ability to work and travel; and interruptions related to our cloud networking and platform infrastructure and partners, and developerand user service and support providers. As the COVID-19 pandemic continues, we may not be able to provide the same level of services andsupport that our developers and players expect from us, which could negatively impact our business and operations. While substantiallyall of our business operations can be performed remotely, many of our employees are juggling additional work-related and personal challenges,including adjusting communication and work practices to collaborate remotely with work colleagues and business partners, managing technicaland communication challenges of working from home on a daily basis, looking after children as a result of remote-learning and school closures,making plans for childcare and caring for themselves, family members or other dependents who are or may become ill. We will continue toactively monitor the issues raised by the COVID-19 pandemic and may take further actions that alter our business operations, includingas may be required by federal, state, local or foreign authorities or that we determine are in the best interests of our employees, players,partners, game developers and stockholders.

The COVID-19 pandemic and resultingshelter-in-place, quarantine and other similar governmental orders and restrictions have also led to increased player engagement withthe games on our platform relative to historic trends. These increases in player activity may not be indicative of our financial and operatingresults in future periods. The long-term effects of the COVID-19 pandemic on society and player behavior are highly uncertain, and thereis no assurance that player engagement will not decrease, as the full impacts of the pandemic on society and the global economy becomemore clear.

In addition to the potentialdirect impacts to our business, the U.S. economy has been, and is likely to continue to be, significantly weakened as a result of theactions taken in response to COVID-19. A weakened U.S. economy may impact our third-party developers and players and their engagementwith our platform, and the ability of our business partners to navigate this complex social health and economic environment, any of whichcould result in disruption to our business and results of our operations.

The duration and extent ofthe impact from the COVID-19 pandemic depends on future developments that cannot be accurately predicted at this time, such as the severityand transmission rate of the virus, the existence of any additional waves of the pandemic, the extent and effectiveness of containmentactions, treatment and prevention measures, including vaccines, and the impact of these and other factors on our employees, third-partydevelopers, players and other business partners. If we are not able to respond to and manage the impact of such events effectively, ourbusiness may be harmed.

We have incurred significant losses sinceinception and expect to incur losses in the future. We cannot be certain that we will achieve or sustain profitability.

We have incurred significant losses since inceptionthrough December 31, 2020 and expect to incur losses in the future. Our accumulated deficit as of June 30, 2021 and December 31, 2020was approximately $102.1 million and $97.3 million, respectively, and we incurred net losses each year since inception. We expect thatour losses may continue for at least the next few years as we will be required to invest significant additional funds toward the continueddevelopment and commercialization of our technology. Our ability to achieve or sustain profitability depends on numerous factors, manyof which are beyond our control, including the market acceptance of our products and future product candidates, future product development,our ability to achieve marketing clearance from the FDA and international regulatory clearance for future product candidates, our abilityto compete effectively against an increasing number of competitors and new products, and our market penetration and margins. In spiteof efforts to ramp sales of our products, we may never be able to generate sufficient revenue to achieve or sustain profitability.

Our financial situation creates doubt whetherwe will continue as a going concern.

We have not generated substantial revenues todate. For the years ended December 31, 2020 and 2019, the Company had loss of $6.2 million and $5.5 million, respectively. For the sixmonths ended June 30, 2021, the Company had a net loss of approximately $4.8 million. There can be no assurances that we will be ableto achieve a level of revenues adequate to generate sufficient cash flow from operations or additional financing through private placements,public offerings and/or bank financing necessary to support our working capital requirements. To the extent that funds generated fromany private placements, public offerings and/or bank financing are insufficient, we will have to raise additional working capital. Noassurance can be given that additional financing will be available, or if available, will be on acceptable terms. These conditions raisesubstantial doubt about our ability to continue as a going concern. If adequate working capital is not available, we may be forced todiscontinue operations, which would cause investors to lose their entire investment. Our auditors have indicated that these conditionsraise substantial doubt about the Company’s ability to continue as a going concern.

We will need to raise additional funding,which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay,limit or terminate our product development efforts or other operations.

We will need to continue to seek capital fromtime to time to continue development of our advanced mobile POC diagnostic system and to acquire and develop other products. Once approvedfor commercialization, we cannot provide any assurances that any revenues it may generate in the future will be sufficient to fund ourongoing operations. We expect that our current cash position will be sufficient to fund our current operations for at least the next 4months. However, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additionalfunds sooner than planned, through public or private equity or debt financings, government or other third-party funding, marketing anddistribution arrangements and other collaborations, strategic alliances and licensing arrangements or a combination of these approaches.In any event, we will require additional capital to obtain regulatory approval for, and to commercialize, our product candidates. Raisingfunds in the current economic environment may present additional challenges. Even if we believe we have sufficient funds for our currentor future operating plans, we may seek additional capital if market conditions are favorable or if we have specific strategic considerations.

Any additional fundraising efforts may divertour management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates.In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all.Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance of additionalsecurities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares to decline. Thesale of additional equity or convertible securities may dilute our existing stockholders. The incurrence of indebtedness would resultin increased fixed payment obligations and we may be required to agree to certain restrictive covenants, such as limitations on our abilityto incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictionsthat could adversely impact our ability to conduct our business. We could also be required to seek funds through arrangements with collaborativepartners or otherwise at an earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of ourtechnologies or product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on ourbusiness, operating results and prospects.

If we are unable to obtain funding on a timelybasis, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs or the commercializationof any product candidate or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, whichcould materially affect our business, financial condition and results of operations.

Our inability to raise capital on acceptableterms in the future may cause us to delay, diminish, or curtail certain operational activities as we have done during the fiscal yearended December 31, 2020, including research and development activities, sales and marketing, and other operations, in order to reducecosts and sustain the business, and such inability would have a material adverse effect on our business and financial condition.

We expect capital outlays and operating expenditures to increase overthe next several years as we work to expand our commercial activities, expand our development activities, expand manufacturing operationsand expand our infrastructure. We may need to raise additional capital to, among other things:

Our present and future funding requirements will depend on many factors,including but not limited to:

Raising additional capital will cause dilution to our existingstockholders and may restrict our operations or require us to relinquish certain intellectual property rights.

We will seek additional capital through a combination of public andprivate equity offerings, debt financings, strategic partnerships and alliances, licensing arrangements and grants. To the extent thatwe raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our existing stockholdersmay be diluted, and the terms may include liquidation or other preferences that adversely affect the rights of our stockholders. Debtand receivables financings may be coupled with an equity component, such as warrants to purchase shares, which could also result in dilutionof our existing stockholders’ ownership. The incurrence of indebtedness would result in increased fixed payment obligations andcould also result in certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our abilityto acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conductour business. If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties,we may have to relinquish valuable rights to our product candidates, or grant licenses on terms that are not favorable to us. A failureto obtain adequate funds may cause us to curtail certain operational activities, including research and development, regulatory trials,sales and marketing, and manufacturing operations, in order to reduce costs and sustain the business, and would have a material adverseeffect on our business and financial condition.

We may be at risk of securities class action litigation.

We may be at risk of securities class action litigation. This riskis especially relevant for us due to our dependence on regulatory approvals of our diagnostic tests. In the past, life science companieshave experienced significant stock price volatility, particularly when associated with binary events such as clinical trials and productapprovals. Additionally, due to our price volatility and our high demand for cash to fund operations, we have had to conduct a numberof reverse stock splits and highly dilutive financings to continue as a going concern which exposes us to additional risk of securitiesclass action litigation. If we face such litigation, it could result in substantial costs and a diversion of management’s attentionand resources, which could harm our business and result in a decline in the market price of our common stock. If such lawsuits were successfulwe may not be able to pay awarded damages and we may be forced into bankruptcy which would likely result in the complete loss of yourinvestment.

Market and economic conditions may negatively impact our business,financial condition and share price.

In recent years, concerns over inflation, energy costs, geopoliticalissues, the U.S. mortgage market and a declining real estate market, unstable global credit markets and financial conditions, and volatileoil prices have led to periods of significant economic instability, diminished liquidity and credit availability, declines in consumerconfidence and discretionary spending, diminished expectations for the global economy and expectations of slower global economic growthgoing forward, increased unemployment rates, and increased credit defaults. Our general business strategy may be adversely affected byany such economic downturns, volatile business environments and unstable or unpredictable economic and market conditions. If these conditionsoccur, deteriorate or do not improve, it may make any necessary debt or equity financing more difficult to complete, more costly, andmore dilutive. Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effecton our growth strategy, financial performance, and share price and could require us to delay or abandon development or commercializationplans. In addition, there is a risk that one or more of our current and future service providers, manufacturers, suppliers, hospitalsand other medical facilities, our third party payors, and other partners could be negatively affected by these difficult economic times,which could adversely affect our ability to attain our operating goals on schedule and on budget or meet our business and financial objectives.

The small size of the Company’s accounting staff haslimited segregation of financial duties which could result in material misstatements in our financial statements in future periods.

The Company’s CEO and Controller have identifiedcontrol deficiencies regarding the lack of segregation of duties and the need for a stronger internal control environment. The small sizeof the Company’s accounting staff may prevent adequate controls in the future, such as segregation of duties, due to the cost/benefitof such remediation.

Although the Company has hired a Controller towork on SEC reporting and accounting matters, we expect that the Company will need to hire accounting personnel with the requisite knowledgeto improve the levels of review of accounting and financial reporting matters. The Company may experience delays in doing so and any suchadditional employees would require time and training to learn the Company’s business and operating processes and procedures. Forthe near-term future, until such personnel are in place, this will continue to be a weakness in the Company’s internal control overfinancial reporting that could result in material misstatements in the Company’s financial statements not being prevented or detected.

In addition, other control weaknesses or deficiencies may be identifiedin the future. If we are unable to correct such weaknesses or deficiencies in internal controls in a timely manner, our ability to record,process, summarize and report financial information accurately and within the time periods specified in the rules and forms of the SECwill be adversely affected, and could result in material misstatements in our financial statements in future periods. This failure couldnegatively affect the market price and trading liquidity of our common stock, cause investors to lose confidence in our reported financialinformation, subject us to civil and criminal investigations and penalties, and generally materially and adversely impact our businessand financial condition.

Risks Related to the Private Placement

Our obligations to the holders of our Notes are secured bya security interest in substantially all of our assets, so if we default on those obligations, the note holders could foreclose on ourassets.

Our obligations under the Notes are secured by a security interestin substantially all of our assets. As a result, if we default in our obligations under the Notes, the holders of the notes, acting throughtheir appointed agent, could foreclose on their security interests and liquidate some or all of these assets, which would harm our business,financial condition and results of operations and could require us to curtail or cease operations.

If the holders of our Notes elect to convert the principaland interest due under the Notes, our stockholders will experience substantial dilution in their investment.

The total remaining principal amount we oweto the holders of our Notes is approximately $8.4 million as of September 30, 2021. If the holders of these Notes were to elect to convert all of theprincipal amount (and assuming no interest has accrued on the principal amount) into shares of our common stock at the ConversionPrice of $2.0587, we would be required to issue approximately 7.2 million shares. These conversions would result in significantdilution to the investments of our existing stockholders.

The holders of our Notes have certain rights upon an eventof default under the Notes which could harm our business, financial condition and results of operations and could require us to curtailor cease or operations.

Under our Notes, the holders of the Notes may require us to redeemall or any portion of the Notes (including all accrued and unpaid interest thereon), in cash, at a price equal to the greater of (i) 115%of the amount to be redeemed and (ii) the product of (X) the Conversion Rate (as defined in the Notes) multiplied by (Y) the product of(1) 120% multiplied by (2) the greatest Closing Sale Price of the Common Stock on any Trading Day during the period commencing on theTrading Day immediately preceding such Event of Default (or deemed Event of Default disregarding any cure period in such Event of Defaultabove) and ending on the date the Company makes the entire payment required to be made. It is unlikely that we would have the cash toredeem the Notes as required. Furthermore, if we default on the payment of the notes, interest on the notes will accrue at the rate of18% per annum. If we were unable to come to an agreement with the holders of the Notes regarding payment, the holders could forecloseon their security interest, which could harm our business, financial condition and results of operations and could require use to curtailor cease our operations.

Risks Related to Product Development, RegulatoryApproval, Manufacturing and Commercialization

If we cannot successfully develop, maintain,commercialize, or obtain regulatory approvals for new and existing diagnostic assays, our financial results will be harmed and our abilityto compete will be harmed.

Our financial performance depends in part uponour ability to successfully develop and market new assays in a rapidly changing technological and economic environment, and to maintainand successfully commercialize previously cleared assays. If we fail to successfully introduce new assays or do not maintain approvalfor previously FDA-cleared assays, we could lose customers and market share. We could also lose market share if our competitors introducenew assays or technologies that render our assays less competitive or obsolete. In addition, delays in the introduction of new assaysdue to regulatory, developmental or other obstacles could negatively impact our revenue and market share, as well as our earnings. Factorsthat can influence our ability to introduce new assays, the timing associated with new product approvals and commercial success of theseassays include:

We are subject to many laws and governmentalregulations and any adverse regulatory action may materially adversely affect our financial condition and business operations.

The assays that we develop and commercialize inthe future are subject to regulation by numerous government agencies, including the FDA and comparable foreign agencies. To varying degrees,each of these agencies requires us to comply with laws and regulations governing the development, testing, manufacturing, labeling, marketingand distribution of our assays. In particular, FDA regulations govern activities such as product development, product testing, productlabeling, product storage, premarket clearance or approval, manufacturing, advertising, promotion, product sales, reporting of certainproduct failures and distribution. Our assays will require 510(k) clearance from the FDA prior to marketing.

We may be unable to obtain marketing clearancefor our assays in development. If such approval is obtained, it may:

Since 2009, the FDA has significantly increasedits oversight of companies subject to its regulations, including medical device companies, by hiring new investigators and stepping upinspections of manufacturing facilities. The FDA has recently also significantly increased the number of warning letters issued to companies.If the FDA were to conclude that we are not in compliance with applicable laws or regulations, or that any of our medical devices areineffective or pose an unreasonable health risk, the FDA could ban such medical devices, detain or seize adulterated or misbranded medicaldevices, order a recall, repair, replacement, or refund of such devices, refuse to grant pending pre-market approval applications or requirecertificates of foreign governments for exports, and/or require us to notify health professionals and others that the devices presentunreasonable risks of substantial harm to the public health. The FDA may also impose operating restrictions on a company-wide basis, enjoinand restrain certain violations of applicable law pertaining to medical devices and assess civil or criminal penalties against our officers,employees or us. The FDA may also recommend prosecution to the U.S. Department of Justice. Any adverse regulatory action, depending onits magnitude, may restrict us from effectively marketing and selling our diagnostic tests.

Foreign governmental regulations have become increasinglystringent and more common, and we may become subject to more rigorous regulation by foreign governmental authorities in the future. Penaltiesfor a company’s non-compliance with foreign governmental regulation could be severe, including revocation or suspension of a company’sbusiness license and criminal sanctions. Any domestic or foreign governmental law or regulation imposed in the future may have a materialadverse effect on us.

Our current and potential customers in the UnitedStates and elsewhere may also be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency,health information privacy and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civilpenalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.

The life sciences industry is highly competitiveand subject to rapid technological change. If our competitors and potential competitors develop superior assays and technologies, ourcompetitive position and results of operations would suffer.

We face intense competition from a number of companiesthat offer assays in our target markets, many of which have substantially greater financial resources and larger, more established marketing,sales and service operations than we do. The life sciences industry is characterized by rapid and continuous technological innovation.We may need to develop new technologies for our existing product and our assays to be competitive. One or more of our current or futurecompetitors could render our existing products or assays under development obsolete or uneconomical by technological advances. We mayalso encounter other problems in the process of delivering new assays to the marketplace, such as problems related to FDA clearance orregulations, design, development or manufacturing of such assays, and as a result we may be unsuccessful in selling such assays. Our futuresuccess depends on our ability to compete effectively against current technologies, as well as to respond effectively to technologicaladvances by developing and marketing assays that are competitive in the continually changing technological landscape.

If our assays do not perform as expectedor the reliability of the technology on which our assays are based is questioned, we could experience delayed or reduced market acceptanceof our assays, increased costs and damage to our reputation.

Our success depends on the market’s confidencethat we can provide reliable, high-quality analyzers and diagnostic program. We believe that customers in our target markets are likelyto be particularly sensitive to product defects and errors. Our reputation and the public image of our assays or technologies may be impairedif our assays fail to perform as expected or our assays are perceived as difficult to use. Despite quality control testing, defects orerrors could occur in our assays or technologies.

In the future, if our assays experience a materialdefect or error, this could result in loss or delay of revenues, delayed market acceptance, product recalls, damaged reputation, diversionof development resources, legal claims, increased insurance costs or increased service and warranty costs, any of which could harm ourbusiness. Such defects or errors could also prompt us to amend certain warning labels or narrow the scope of the use of our assays, eitherof which could hinder our success in the market. Even after any underlying concerns or problems are resolved, any widespread concernsregarding our technology or any manufacturing defects or performance errors in our assays could result in lost revenue, delayed marketacceptance, damaged reputation, increased service and warranty costs and claims against us.

COVID-19 diagnostic tests are subject tochanges in CLIA, FDA, and other regulatory requirements.

Our COVID-19 tests are subject to regulationsof the FDA, International Organization for Standards and other regulatory requirements. The regulations regarding the manufacture andsale of COVID-19 tests may be unclear and are subject to change. Newly promulgated regulations could require changes to our COVID-19 diagnostictests, necessitate additional procedures, or make it impractical or impossible for us to market our tests for certain uses, in certainmarkets, or at all. The FDA and other regulatory authorities also have the ability to impose new or additional requirements relating toCOVID-19 tests. The implementation of such changes or new or additional requirements may result in substantial additional costs and coulddelay or make it more difficult or complicated to sell our products. Further, our COVID-19 tests, if approved, will be marketed underan Emergency Use Authorization (EUA) from the FDA. The FDA may decide to withdraw EUA designation for the SARS CoV-2 pandemic, resultingin the need for us to apply for clearance to market under a 510(k) or other regulatory process. This could result in substantial additionalcosts and time to develop the necessary data and information for such clearance.

Disruptions at the FDA and other governmentagencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership andother personnel, or otherwise prevent new or modified products from being developed, cleared, approved, authorized, or commercializedin a timely manner or at all, which could negatively impact our business.

The ability of the FDA to review and clear, approve,or authorize new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory,and policy changes, the FDA’s ability to hire and retain key personnel and accept the payment of user fees, and other events thatmay otherwise affect the FDA’s ability to perform routine functions. Average review times at the agency have fluctuated in recentyears as a result. In addition, government funding of other government agencies that fund research and development activities is subjectto the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies may also slow the timenecessary for medical devices or modifications to be cleared or approved, medical devices to be reviewed and/or approved by necessarygovernment agencies, which would adversely affect our business. For example, over the last several years, including for 35 days beginningon December 22, 2018, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furloughcritical FDA employees and stop critical activities. Separately, in response to the global COVID-19 pandemic, on March 10, 2020 the FDAannounced its intention to postpone most foreign inspections of manufacturing facilities and products, and subsequently, on March 18,2020, the FDA announced its intention to temporarily postpone routine surveillance inspections of domestic manufacturing facilities. Regulatoryauthorities outside the United States may adopt similar restrictions or other policy measures in response to the COVID-19 pandemic. Ifa prolonged government shutdown occurs, or if global health concerns continue to prevent the FDA or other regulatory authorities fromconducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA orother regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on ourbusiness.

If our COVID-19 Antigen Panel, our COVID-19IgG/IgM Antibody panel, our S1 Assay Panel products or any of our other product candidates fail to achieve and sustain sufficient marketacceptance, we will not generate expected revenue and our growth prospects, operating results and financial condition may be harmed.

The commercialization of our COVID and S1 AssayPanel products and the future commercialization of our other product candidates in the United States and other jurisdictions in whichwe intend to pursue marketing clearance are key elements of our strategy. If we are not successful in conveying to hospitals and othercustomers that our current products and future product candidates provide equivalent or superior diagnostic information in a shorter periodof time compared to existing technologies, or that these products and future product candidates improve patient outcomes or decrease healthcarecosts, we may experience reluctance, or refusal, on the part of hospitals to order, and third-party payors to pay for performing a testin which our product is utilized.

These hurdles may make it difficult to demonstrateto hospitals and other healthcare providers that our current diagnostic products and future product candidates are appropriate optionsfor testing, may be superior to available tests and may be more cost-effective than alternative technologies.

If we fail to successfully commercialize our productsand product candidates, we may never receive a return on the significant investments in product development, sales and marketing, regulatory,manufacturing and quality assurance we have made and further investments we intend to make and may fail to generate revenue and gain economiesof scale from such investments.

If any of our products, or the malfunctioningof our products, causes or contributes to a death or a serious injury, we will be subject to medical device reporting regulations, whichcan result in voluntary corrective actions or agency enforcement actions.

Under the FDA medical device reporting regulations,medical device manufacturers are required to report to the FDA information that a device has or may have caused or contributed to a deathor serious injury or has malfunctioned in a way that would likely cause or contribute to death or serious injury if the malfunction ofthe device were to recur. If we fail to report these events to the FDA within the required timeframes, or at all, FDA could take enforcementaction against us. Any such adverse event involving our assays could also result in future voluntary corrective actions, such as recallsor customer notifications, or agency action, such as inspection or enforcement action. Any corrective action, whether voluntary or involuntary,as well as defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operating ourbusiness, and may harm our reputation and financial results.

Our assays may in the future be subjectto product recalls. A recall of our products, either voluntarily or at the direction of the FDA or another governmental authority, includinga third-country authority, or the discovery of serious safety issues with our products, could have a significant adverse impact on us.

The FDA and similar foreign governmental authoritieshave the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacture.In the case of the FDA, the authority to require a recall must be based on an FDA finding that there is reasonable probability that thedevice would cause serious injury or death. In addition, foreign governmental bodies have the authority to require the recall of our productsin the event of material deficiencies or defects in design or manufacture. Manufacturers may, under their own initiative, recall a productif any material deficiency in a device is found. The FDA requires that certain classifications of recalls be reported to the FDA withinten working days after the recall is initiated. A government-mandated or voluntary recall by us or one of our international distributorscould occur as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing errors, design or labelingdefects or other deficiencies and issues. Recalls of any of our assays would divert managerial and financial resources and have an adverseeffect on our reputation, results of operations and financial condition, which could impair our ability to produce our products in a cost-effectiveand timely manner in order to meet our customers’ demands. We may also be subject to liability claims, be required to bear othercosts, or take other actions that may have a negative impact on our future sales and our ability to generate profits. Companies are requiredto maintain certain records of recalls, even if they are not reportable to the FDA or another third-country competent authority. We mayinitiate voluntary recalls involving our products in the future that we determine do not require notification of the FDA or another third-countrycompetent authority. If the FDA disagrees with our determinations, it could require us to report those actions as recalls. A future recallannouncement could harm our reputation with customers and negatively affect our sales. In addition, the FDA could take enforcement actionfor failing to report the recalls when they occur.

We are also required to follow detailed recordkeepingrequirements for all Company-initiated medical device corrections and removals. In addition, in December 2012, the FDA issued a draftguidance intended to assist the FDA and industry in distinguishing medical device recalls from product enhancements. Per the guidance,if any change or group of changes to a device that addresses a violation of the FDCA, that change would generally constitute a medicaldevice recall and require submission of a recall report to the FDA.

If we become subject to claims relatingto improper handling, storage or disposal of hazardous materials, we could incur significant cost and time to comply.

We are subject to foreign, federal, state andlocal regulations governing the use, manufacture, storage, handling and disposal of materials and waste products. We may incur significantcosts complying with both existing and future environmental laws and regulations. In particular, we are subject to regulation by the OccupationalSafety and Health Administration, or OSHA, and the Environmental Protection Agency, or EPA, and to regulation under the Toxic SubstancesControl Act and the Resource Conservation and Recovery Act in the United States. OSHA or the EPA may adopt additional regulations in thefuture that may affect our research and development programs. The risk of accidental contamination or injury from hazardous materialscannot be eliminated completely. In the event of an accident, we could be held liable for any damages that result, and any liability couldexceed the limits or fall outside the coverage of our workers’ compensation insurance. We may not be able to maintain insuranceon acceptable terms, if at all.

Our diagnostic products have not been manufacturedin significant volume and are subject to unforeseen scale-up risks.

Although we have developed a process to manufactureour diagnostic products, there can be no assurance that we can manufacture our diagnostic products at a scale that is adequate for ourfuture commercial needs. We may face significant or unforeseen difficulties in manufacturing our diagnostic products, including but notlimited to:

These and other difficulties may only become apparentwhen scaling up to the manufacturing process of our diagnostic products to a more substantive commercial scale. If our diagnostic productscannot be manufactured in sufficient commercial quantities or manufacturing is delayed, our future prospects could be significantly impactedand our financial prospects would be materially harmed.

We or our suppliers may experience developmentor manufacturing problems or delays that could limit the growth of our revenue or increase our losses.

We may encounter unforeseen situations in themanufacturing of our diagnostic products that could result in delays or shortfalls in our production. Our suppliers may also face similardelays or shortfalls. In addition, our or our suppliers’ production processes may have to change to accommodate any significantfuture expansion of our manufacturing capacity, which may increase our or our suppliers’ manufacturing costs, delay production ofour diagnostic products, reduce our product gross margin and adversely impact our business. If we are unable to satisfy demand for ourdiagnostic products by successfully manufacturing and shipping our diagnostic products in a timely manner, our revenue could be impaired,market acceptance for our assays could be adversely affected and our customers might instead purchase our competitors’ assays. Inaddition, developing manufacturing procedures for assays under development may require developing specific production processes for thoseassays. Developing such processes could be time consuming and any unexpected difficulty in doing so can delay the introduction of a product.

We utilize third-party, single-source suppliersfor some components and materials used in our products and product candidates, and the loss of any of these suppliers could have an adverseimpact on our business.

We rely on single-source suppliers for some componentsand materials used in our products and product candidates. Our ability to supply our products commercially and to develop any future productsdepends, in part, on our ability to obtain these components in accordance with regulatory requirements and in sufficient quantities forclinical testing and commercialization. While our suppliers have generally met our demand for their products on a timely basis in thepast, these were with limited production quantities and we cannot assure that they will in the future be able to meet our demand for theirproducts, either because we do not have long-term agreements with those suppliers, our relative importance as a customer to those suppliers,or their ability to produce the components used in our products. For example, our supplier of printed electrodes has exited the printingbusiness. We purchased safety stock from the supplier prior to their discontinuing production and have begun qualification of a replacementsupplier.

While we believe replacement suppliers exist forall components and materials we obtain from single sources, establishing additional or replacement suppliers for any of these componentsor materials, if required, may not be accomplished quickly. Even if we are able to find a replacement supplier, the replacement supplierwould need to be qualified and may require additional regulatory authority approval, which could result in further delay. While we willseek to maintain adequate inventory of the single-source components and materials used in our products in the event of disruption, thoseinventories may not be sufficient.

If our third-party suppliers fail to deliver therequired commercial quantities of materials on a timely basis and at commercially reasonable prices, and we are unable to find one ormore replacement suppliers capable of production at a substantially equivalent cost in substantially equivalent volumes and quality ona timely basis, the continued commercialization of our products, the supply of our products to customers and the development of any futureproducts would be delayed, limited or prevented, which could have an adverse impact on our business.

Manufacturing risks may adversely affectour ability to manufacture products and could reduce our gross margins and negatively affect our operating results.

Our business strategy depends on our ability tomanufacture and assemble our current and proposed products in sufficient quantities and on a timely basis to meet consumer demand, whileadhering to product quality standards, complying with regulatory requirements and managing manufacturing costs. We are subject to numerousrisks relating to our manufacturing capabilities, including:

As demand for our products increases, we willneed to invest additional resources to purchase components, hire and train employees, and enhance our manufacturing processes and implementmanufacturing and quality systems. If we fail to increase our production capacity efficiently while also maintaining quality requirements,our sales may not increase in line with our forecasts and our operating margins could fluctuate or decline. In addition, while we expectmost new products will utilize the eLab instrument system and existing consumable cartridge, manufacturing of future products may requirethe modification of our production lines, the hiring of specialized employees, the identification of new suppliers for specific components,or the development of new manufacturing technologies. It may not be possible for us to manufacture these products at a cost or in quantitiessufficient to make these products commercially viable. Any future interruptions we experience in the manufacturing or shipping of ourproducts could delay our ability to recognize revenues in a particular quarter and could also adversely affect our relationships withour customers.

We expect to rely on third parties to conductstudies of our assays under development that will be required by the FDA or other regulatory authorities and those third parties may notperform satisfactorily.

We do not have the ability to independently conductthe field trial studies or other studies that may be required to obtain FDA and other regulatory clearances or approvals for our assays.Accordingly, we expect to rely on third parties, such as independent testing laboratories and hospitals, to conduct such studies. Ourreliance on these third parties will reduce our control over these activities. These third-party contractors may not complete activitieson schedule or conduct studies in accordance with regulatory requirements or our study design. We cannot control whether they devote sufficienttime, skill and resources to our studies. Our reliance on third parties that we do not control will not relieve us of any applicable requirementto prepare, and ensure compliance with, various procedures required under good clinical practices. If these third parties do not successfullycarry out their contractual duties or regulatory obligations or meet expected deadlines, if the third parties need to be replaced or ifthe quality or accuracy of the data they obtain is compromised due to their failure to adhere to our clinical protocols or regulatoryrequirements or for other reasons, our studies may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatoryapproval for additional assays.

Any clinical trials that we may conductmay not begin on time, or at all, may not be completed on schedule, or at all, or may be more expensive than we expect, which could preventor delay regulatory approval of our assays or impair our financial position.

The commencement or completion of any clinicaltrials that we may conduct may be delayed or halted for numerous reasons, including, but not limited to, the following:

Our clinical trial costs will increase if we havematerial delays in those trials or if we need to perform more or larger trials than planned. Adverse events during a clinical trial couldcause us to repeat a trial, terminate a trial or cancel an entire program. Should our clinical development plan be delayed, this couldhave a material adverse effect on our operations and financial condition.

Product liability claims could adverselyimpact our financial condition and our earnings and impair our reputation.

Our business exposes us to potential product liabilityrisks that are inherent in the design, manufacture and marketing of medical devices. Device failures, manufacturing defects, design flaws,or inadequate disclosure of product-related risks or product-related information with respect to our assays could result in an unsafecondition regarding, injury to, or death of, a patient. The occurrence of such a problem could result in product liability claims or arecall of, or safety alert relating to, one or more of our assays. Product liability claims or product recalls in the future, regardlessof their ultimate outcome, could have a material adverse effect on our business and reputation and on our ability to attract and retaincustomers for our assays.

If our diagnostic products do not performas expected, our operating results, reputation and business will suffer.

Our future success will depend on the market’sconfidence that our technologies can provide reliable, high-quality diagnostic results. We believe that our customers are likely to beparticularly sensitive to any defects or errors in our products. If our technology fails to perform a clinical test, then we could faceclaims against us or our reputation could suffer as a result of such failures. The failure of our current products or planned diagnosticproduct candidates to perform reliably or as expected could significantly impair our reputation and the public image of our products,and we may be subject to legal claims arising from any defects or errors.

Our products may not be able to competewith new diagnostic products or existing products developed by well-established competitors, which would negatively affect our business.

The diagnostic industry is focused on the testingof biological specimens in a laboratory or at the point-of-care and is highly competitive and rapidly changing. Important competitivefactors for our products include price, quality, performance, ease of use, and customer service.

A few large corporations produce a wide varietyof diagnostic tests and other medical devices and equipment. A larger number of mid-size companies generally compete only in the diagnosticindustry and a significant number of small companies produce only a few diagnostic products. As a result, the diagnostic test industryis highly fragmented and segmented.

Some of our principal competitors may have considerablygreater financial, technical and marketing resources than we do. Several companies produce diagnostic tests that compete directly withour testing product line, including Abbott (Alere), Siemens, Becton Dickinson, and Danaher. Some competitors offer broader product linesand may have greater name recognition than we have. These and other companies have or may have products incorporating advanced technologiesthat over time could directly compete with our testing product line.

As new products incorporating new technologiesenter the market, our products may become obsolete or a competitor’s products may be more effective or more effectively marketedand sold. If our competitors’ products take market share from our products through more effective marketing or competitive pricing,our revenues, margins and operating results could be adversely affected.

Our future revenues and operating resultsmay be negatively affected by ongoing consolidation in the healthcare industry.

There has been a significant amount of consolidationin the healthcare industry. This consolidation has increased the competition to provide goods and services to customers. In addition,group purchasing organizations and integrated health delivery networks have served to concentrate purchasing decisions for some customers,which has also placed pricing pressure on medical device suppliers. Due to ongoing consolidation, there could be additional pressure onthe prices of our products.

Undetected errors or defects in our productsor product candidates could harm our reputation, decrease market acceptance of our products or expose us to product liability claims.

Our products or product candidates may containundetected errors or defects. Disruptions or other performance problems with our products or product candidates may damage our customers’businesses and could harm our reputation. If that occurs, we may incur significant costs, the attention of our key personnel could bediverted or other significant customer relations problems may arise. We may also be subject to warranty and liability claims for damagesrelated to errors or defects in our products or product candidates. A material liability claim or other occurrence that harms our reputationor decreases market acceptance of our products or product candidates could harm our business and operating results.

The sale and use of products or product candidatesor services based on our technologies, or activities related to our research and clinical studies, could lead to the filing of productliability claims if someone were to allege that one of our products contained a design or manufacturing defect. A product liability claimcould result in substantial damages and be costly and time consuming to defend, either of which could materially harm our business orfinancial condition. We cannot assure you that our product liability insurance would adequately protect our assets from the financialimpact of defending a product liability claim. Any product liability claim brought against us, with or without merit, could increase ourproduct liability insurance rates or prevent us from securing insurance coverage in the future.

We currently develop, manufacture and testour products and product candidates and some of their components in a single facility. If these or any future facility or our equipmentwere damaged or destroyed, or if we experience a significant disruption in our operations for any reason, our ability to continue to operateour business could be materially harmed.

We currently develop, manufacture and test ourproducts and product candidates exclusively in a facility in Emeryville, California. If this or any future facility were to be damaged,destroyed or otherwise unable to operate, whether due to fire, floods, hurricanes, storms, tornadoes, other natural disasters, employeemalfeasance, terrorist acts, power outages, or otherwise, or if our business is disrupted for any other reason, we may not be able todevelop or test our products and product candidates as promptly as our potential customers expect, or possibly not at all.

The manufacture of components of our productsand product candidates involves complex processes, sophisticated equipment and strict adherence to specifications and quality systemsprocedures. Any unforeseen manufacturing problems, such as contamination of our facility, equipment malfunction, or failure to strictlyfollow procedures or meet specifications, could result in delays or shortfalls in production of our products. Identifying and resolvingthe cause of any manufacturing issues could require substantial time and resources. If we are unable to keep up with future demand forour products by successfully manufacturing and shipping our products in a timely manner, our revenue growth could be impaired and marketacceptance of our product candidates could be adversely affected.

The Sublease for our current facility expiresin December 2021. We will need to identify, contract, and relocate our operations to a new location. Moving our manufacturing and developmentfacility may interrupt our business resulting in higher costs and potentially lost revenue.

We maintain insurance coverage against damageto our property and equipment, subject to deductibles and other limitations that we believe is adequate. If we have underestimated ourinsurance needs with respect to an interruption, or if an interruption is not subject to coverage under our insurance policies, we maynot be able to cover our losses.

Third-Party reimbursement policies and potentialcost constraints could negatively affect our business.

The list of our product end-users includes hospitalsand other healthcare providers. If these end-users do not receive adequate reimbursement for the cost of our products from their patients’healthcare insurers or payors, the use of our products could be negatively impacted. Furthermore, the net sales of our products couldalso be adversely affected by changes in reimbursement policies of government or private healthcare payors.

Hospitals and other healthcare providers who purchasediagnostic products in the United States generally rely on third-party payors, such as private health insurance plans, Medicare and Medicaid,to reimburse all or part of the cost of the product. Due to the overall escalating cost of medical products and services, there is increasedpressures on the healthcare industry, both foreign and domestic, to reduce the cost of products and services. Given the efforts to controland reduce healthcare costs in the United States, available levels of reimbursement may change for our existing products or products underdevelopment. Third-party reimbursement and coverage may not be available or adequate in either the United States or international markets,current reimbursement amounts may be decreased in the future and future legislation, and regulation or reimbursement policies of third-partypayors, may reduce the demand for our products or our ability to sell our products on a profitable basis.

Ongoing changes in healthcare regulationcould negatively affect our revenues, business and financial condition.

There have been several proposed changes in theUnited States at the federal and state level for comprehensive reforms regarding the payment for, the availability of and reimbursementfor healthcare services. These proposals have ranged from fundamentally changing federal and state healthcare reimbursement programs,including providing comprehensive healthcare coverage to the public under government-funded programs, to minor modifications to existingprograms. One example is the Patient Protection and Affordable Care or the Affordable Care Act, the Federal healthcare reform law enactedin 2010.

Healthcare reform initiatives will continue tobe proposed and may reduce healthcare related funding in an effort. It is impossible to predict the ultimate content and timing of anyhealthcare reform legislation and its resulting impact on us. If significant reforms are made to the healthcare system in the United States,or in other jurisdictions, those reforms may increase our costs or otherwise negatively effect on our financial condition and resultsof operations.

In April 2017, the European Parliament passedthe Medical Devices Regulation (Regulation 2017/745), which repeals and replaces the European Union Medical Devices Directive and theActive Implantable Medical Devices Directive. Unlike directives, which must be implemented into the national laws of the European EconomicArea, which we refer to as the EEA, member States, the regulations would be directly applicable, i.e., without the need for adoption ofEEA member State laws implementing them, in all EEA member States and are intended to eliminate current differences in the regulationof medical devices among EEA member States. The Medical Devices Regulation, among other things, is intended to establish a uniform, transparent,predictable and sustainable regulatory framework across the EEA for medical devices and ensure a high level of safety and health whilesupporting innovation. The Medical Devices Regulation will, however, only become fully applicable three years after publication (in May2020). Once applicable, the Medical Devices Regulation will, among other things:

Expected to be implemented in 2022, the MedicalDevices Regulation may impose increased compliance obligations for us to access the EU market.

Legislative and other regulatory changescould have an effect on our business.

Changes in regulatory or economic conditions orin the laws and policies governing foreign trade, taxes, manufacturing, and development in the United States could impact our business.Economic and regulatory changes could also affect foreign currency exchange rates which, in turn, could affect our reported financialresults and our competitiveness on a worldwide basis.

Consolidation in the healthcare industrycould have an adverse effect on our revenues and results of operations.

Many healthcare companies, including healthcaresystems, are consolidating to create new companies with greater market power. As the healthcare industry consolidates, competition toprovide goods and services to industry participants will become more intense. These industry participants may try to use their marketpower to negotiate price concessions or reductions for diagnostic tests. If we are forced to reduce our prices because of consolidationin the healthcare industry, our projected revenues would decrease and our earnings, financial condition, and/or cash flows would suffer.

If we or our distributors do not complywith the U.S. federal and state fraud and abuse laws, including anti-kickback laws for any products approved in the U.S., or with similarforeign laws where we market our products, we could face significant liability.

There are numerous United States federal and statelaws pertaining to healthcare fraud and abuse, including anti-kickback laws, false claims, and physician transparency laws. Our relationshipswith physicians and surgeons, hospitals and our independent distributors are subject to scrutiny under these laws. Violations of theselaws are punishable by criminal and civil sanctions, including significant fines, damages and monetary penalties and in some instances,imprisonment and exclusion from participation in federal and state healthcare programs, including the Medicare, Medicaid and VeteransAdministration health programs.

Healthcare fraud and abuse regulations are complex,and even minor irregularities can potentially give rise to claims that a statute or prohibition has been violated. The laws that may affectour ability to operate include:

Efforts to ensure that our business arrangementswith third parties will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmentalauthorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involvingapplicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these lawsor any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties,damages, fines, exclusion from federal healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of ouroperations. To enforce compliance with the federal laws, the U.S. Department of Justice, or DOJ, has recently increased its scrutiny ofinteractions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictionsand settlements in the healthcare industry. Dealing with investigations can be time and resource consuming and can divert management’sattention from the business. In addition, settlements with the DOJ or other law enforcement agencies have forced healthcare providersto agree to additional onerous compliance and reporting requirements as part of a consent decree or corporate integrity agreement. Anyviolations of these laws, or any action against us for violation of these laws, even if we successfully defend against it, could havea material adverse effect on our reputation, business and financial condition.

Many foreign countries have enacted similar lawsaddressing fraud and abuse in the healthcare sector. The shifting commercial compliance environment and the need to build and maintainrobust and expandable systems to comply with different compliance requirements in multiple jurisdictions increases the possibility thatwe may run afoul of one or more of the requirements.

If we areunable to recruit, train and retain key personnel, we may not achieve our goals.

Our future success depends on our ability to recruit,develop, retain and motivate key personnel, including individuals for our senior management, research and development, engineering, manufacturingand sales and marketing teams. Additionally, we will need to hire a Chief Financial Officer and other financial personnel in the future.We do not have employment contracts with management personnel. Competition for qualified personnel is intense, particularly in the SanFrancisco Bay area. Our growth depends on attracting, retaining and motivating highly skilled personnel with the necessary technical orscientific background and ability to understand our products at a technical and clinical level. In addition, we will need to hire automationengineers and other manufacturing employees to meet demand for our products as we scale up our sales and marketing operations. Becauseof the complex and technical nature of our products and the dynamic market in which we compete, any failure to attract, develop, retainand motivate qualified personnel could materially harm our operating results and growth prospects.

Changes in tax laws or exposure to additionalincome tax liabilities could have a material impact on our financial condition and results of operations.

We are subject to income taxes as well as non-incomebased taxes in both the United States and various foreign jurisdictions. Changes in existing tax laws, treaties, regulations or policiesor the interpretation or enforcement thereof, or the enactment or adoption of new tax laws, treaties, regulations or policies could materiallyimpact our effective tax rate.

If we do not achieve, sustain or successfullymanage our anticipated growth, our business and prospects will be harmed.

If we are unable to obtain or sustain adequaterevenue growth, our financial results could suffer. Furthermore, significant growth will place strains on our management and our operationaland financial systems and processes and our operating costs may escalate even faster than planned. If we cannot effectively manage ourexpanding operations and our costs, we may not be able to grow effectively or we may grow at a slower pace. Additionally, if we do notsuccessfully forecast the timing of regulatory authorization for our additional tests, marketing and subsequent demand for our diagnostictests or manage our anticipated expenses accordingly, our operating results will be harmed.

Other companies or institutions have commercialassays or may develop and market novel or improved methods for infectious disease diagnostics, which may make our diagnostic platformless competitive or obsolete.

The market for diagnostics is large and established,and our competitors may possess significantly greater financial resources and have larger development and commercialization capabilitiesthan we do. We may be unable to compete effectively against these competitors either because their diagnostic platforms are superior orbecause they may have more expertise, experience, financial resources or stronger business relationships.

New technologies, techniques or assays couldemerge that might offer better combinations of price and performance than our current or future assays.

It is critical to our success that we anticipatechanges in technology and customer requirements and to successfully introduce, on a timely and cost-effective basis, new, enhanced andcompetitive technologies that meet the needs of current and prospective customers. If we do not successfully innovate and introduce newtechnology into our product lines or manage the transitions to new product offerings, our revenues, results of operations and businesswill be adversely impacted. Competitors may be able to respond more quickly and effectively than we can to new or changing opportunities,technologies, standards or customer requirements. We anticipate that we will face increased competition in the future as existing companiesand competitors develop new or improved diagnostic tests and as new companies enter the market with new technologies.

We could be exposed to liability if we experiencesecurity breaches or other disruptions, which could harm our reputation and business.

We may be subject to cyber-attacks whereby computerhackers may attempt to access our computer systems or our third-party IT service provider’s systems and, if successful, misappropriatepersonal or confidential information. In addition, a contractor or other third party with whom we do business may attempt to circumventour security measures or obtain such information and may purposefully or inadvertently cause a breach involving sensitive information.We will continue to evaluate and implement additional protective measures to reduce the risk and detect cyber incidents, but cyber-attacksare becoming more sophisticated and frequent and the techniques used in such attacks change rapidly. Even though we take cyber-securitymeasures that are continuously reviewed and updated, our information technology networks and infrastructure may still be vulnerable dueto sophisticated attacks by hackers or breaches.

Even the most well protected IT networks, systems,and facilities remain potentially vulnerable because the techniques used in security breaches are continually evolving and generally arenot recognized until launched against a target and, in fact, may not be detected. Any such compromise of our or our third party’sIT service providers’ data security and access, public disclosure, or loss of personal or confidential business information, couldresult in legal claims proceedings, liability under laws to protect, privacy of personal information, and regulatory penalties, disruptour operations, require significant management attention and resources to remedy any damages that result, damage our reputation and customerswillingness to transact business with us, any of which could adversely affect our business.

We expect to generate a portion of our revenueinternationally and are subject to various risks relating to those international activities which could adversely affect our operatingresults.

A portion of our revenue is expected to come frominternational sources. Engaging in international business involves a number of difficulties and risks, including:

As we expand internationally, our results of operationsand cash flows will become increasingly subject to fluctuations due to changes in foreign currency exchange rates. Our expenses are generallydenominated in U.S. dollars. If the value of the U.S. dollar increases relative to foreign currencies in the future, in the absence ofa corresponding change in local currency prices, our future revenue could be adversely affected as we convert future revenue from localcurrencies to U.S. dollars.

If we dedicate resources to our internationaloperations and are unable to manage these risks effectively, our business, operating results and prospects will suffer.

Our employees, independent contractors,principal investigators, consultants, commercial partners, distributors and vendors may engage in misconduct or other improper activities,including non-compliance with regulatory standards and requirements.

We are exposed to the risk of fraud or other misconductby our employees, independent contractors, principal investigators, consultants, commercial partners, distributors and vendors. Misconductby these parties could include intentional, reckless or negligent failures to: comply with the regulations of the FDA and other similarforeign regulatory bodies; provide true, complete and accurate information to the FDA and other similar regulatory bodies; comply withmanufacturing standards we have established; comply with healthcare fraud and abuse laws and regulations in the United States and similarforeign fraudulent misconduct laws; or report financial information or data accurately, or disclose unauthorized activities to us. Theselaws may impact, among other things, our activities with principal investigators and research subjects, as well as our sales, marketingand education programs. In particular, the promotion, sales, marketing and business arrangements in the healthcare industry are subjectto extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These lawsmay restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programsand other business arrangements. Such misconduct could also involve the improper use of information obtained in the course of clinicalstudies, which could result in regulatory sanctions and cause serious harm to our reputation. We currently have a code of conduct applicableto all of our employees, but it is not always possible to identify and deter employee misconduct, and our code of conduct and the otherprecautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses, or inprotecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actionscould have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, monetaryfines, disgorgement, individual imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal healthcareprograms, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of whichcould adversely affect our ability to operate our business and our results of operations. Any of these actions or investigations couldresult in substantial costs to us, including legal fees, and divert the attention of management from operating our business.

We have limited experience in marketingand selling our products, and if we are unable to expand, manage and maintain our direct sales and marketing organizations, or otherwisecommercialize our products, our business may be adversely affected.

Because we received CE-mark for our S1 Assay Panelin November of 2019 and began commercial sales activities in September 2020, we have limited experience marketing and selling our products.We began staffing our sales and marketing organization in 2021 and currently have a staff of 3. Our financial condition and operatingresults will be highly dependent upon the efforts of our sales and marketing organization. If we are unable to quickly build our salesand marketing team or if our sales and marketing efforts fail to adequately promote, market and sell our products, our sales may not increaseat levels that are in line with our forecasts.

Our future sales growth will depend in large parton our ability to successfully build and expand the size and geographic scope of our sales and marketing team. Accordingly, our futuresuccess will depend largely on our ability to hire, train, retain and motivate skilled sales and marketing personnel. Because the competitionfor individuals with their skillset is high, there is no assurance we will be able to hire and retain personnel on commercially reasonableterms. If we are unable to build and expand our sales and marketing capabilities, we may not be able to effectively commercialize ourproducts and our business and operating results may be adversely affected. Additionally, we will need to implement management informationsystems to support the sales and marketing operations. There is no assurance that these systems will be implemented and effective. Lackof these management information systems may negatively impact sales efforts.

Outside of the United States, we will sell ourproducts through distribution partners and there is no guarantee that we will be successful in attracting or retaining desirable distributionpartners for these markets or that we will be able to enter into such arrangements on favorable terms. Distributors may not commit thenecessary resources to market and sell our products effectively or may choose to favor marketing the products of our competitors. If distributorsdo not perform adequately, or if we are unable to enter into effective arrangements with distributors in particular geographic areas,we may not realize our sales growth.

Our ability to grow our business will belimited if we fail to develop and maintain new and existing distribution channels.

Our plan to grow our business depends on thirdparties and distributors to sell our products. The sale of our products depends in large part on our ability to sell products to thesecustomers and on the marketing and distribution abilities of the companies with which we collaborate.

Reliance on distributors and third-parties tomarket and sell our products could negatively impact our business for various reasons, including: (i) we may not be able to find suitabledistributors for our products on satisfactory terms, or at all; (ii) agreements with distributors may prematurely terminate or may resultin litigation between the parties; (iii) our distributors or other customers may not fulfill their contractual obligations and distributeour products in the manner or at the levels we expect; (iv) our distributors may prioritize other products or their own private labelproducts that compete with our products; (v) Our existing distributor relationships or contracts may preclude or limit us from enteringinto arrangements with other distributors; and (vi) we may not be able to negotiate new or renew existing distribution agreements on acceptableterms, or at all.

We will try to maintain and expand our businesswith distributors and third parties and make every effort to require that they fulfill their contractual obligations, but there can beno assurance that such companies will do so or that new distribution channels will be available on satisfactory terms. If we are unableto do so, our business will be negatively impacted.

Potential customers may not adopt rapidPoint-of-Care diagnostic testing.

Rapid point-of-care tests are beneficial because,among other things, they can be administered by healthcare providers in their own facilities or used by healthcare facilities withoutsending samples to central laboratories. But currently the majority of diagnostic tests used by healthcare providers in the U.S. are providedby clinical reference laboratories and hospital-based laboratories. In some international markets, such as Europe, diagnostic testingis performed primarily by centralized laboratories. Future sales of our products will depend, in part, on our ability to expand marketacceptance of rapid point-of-care testing and successfully compete against laboratory testing methods and products. However, we expectthat clinical reference and other hospital-based laboratories will continue to compete vigorously against our rapid point-of-care products.Even if we can demonstrate that our products are more cost effective, save time, or have better performance or other benefits, healthcareproviders may resist changing to rapid point-of-care tests and instead may choose to obtain diagnostic results through laboratory tests.If we fail to achieve and expand market acceptance of our rapid point-of-care diagnostic tests with customers, it would have a negativeeffect on our future sales growth.

Even if we receive regulatory approval forany of our product candidates, we may not be able to successfully commercialize the product and the revenue that we generate from theirsales, if any, may be limited.

If approved for marketing, the commercial successof our product candidates will depend upon each product’s acceptance by the medical community, including physicians, patients andhealth care payors. The degree of market acceptance for any of our product candidates will depend on a number of factors, including:

If any of our product candidates are approved,but do not achieve an adequate level of acceptance by physicians, health care payors, and patients, we may not generate sufficient revenuesand we may not be able to achieve or sustain profitability. Our efforts to educate the medical community and third-party payors on thebenefits of our product candidates may require significant resources and may never be successful.

In addition, even if we obtain regulatory approvals,the timing or scope of any approvals may prohibit or reduce our ability to commercialize our product candidates successfully. For example,if the approval process takes too long, we may miss market opportunities and give other companies the ability to develop competing productsor establish market dominance. Any regulatory approval we ultimately obtain may be limited or subject to restrictions or post-approvalcommitments that render our product candidates not commercially viable. For example, regulatory authorities may approve any of our productcandidates for fewer or more limited indications than we request, may grant approval contingent on the performance of costly post-marketingclinical trials, or may approve any of our product candidates with a label that does not include the labeling claims necessary or desirablefor the successful commercialization for that indication. Further, the FDA or comparable foreign regulatory authorities may place conditionson approvals or require risk management plans or a Risk Evaluation and Mitigation Strategy (“REMS”) to assure the safe useof the drug. If the FDA or applicable foreign regulatory agency concludes a REMS is needed, the sponsor of the BLA must submit a proposedREMS; the regulatory agencies will not approve the BLA without an approved REMS, if required. A REMS could include medication guides,physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other riskminimization tools. The regulatory agencies may also require a REMS for an approved product when new safety information emerges. Any ofthese limitations on approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing of our productcandidates. Moreover, product approvals may be withdrawn for non-compliance with regulatory standards or if problems occur following theinitial marketing of the product. Any of the foregoing scenarios could materially harm the commercial success of our product candidates.

Adverse events involving our products maylead the FDA or applicable foreign regulatory agency to delay or deny clearance for our products or result in product recalls that couldharm our reputation, business and financial results.

Once a product receives regulatory clearance orapproval, the agency has the authority to require the recall of commercialized products in the event of adverse side effects, materialdeficiencies or defects in design or manufacture. The authority to require a recall must be based on a regulatory finding that there isa reasonable probability that the product would cause serious injury or death. Manufacturers may, under their own initiative, recall aproduct if any material deficiency in a product is found. A government-mandated or voluntary recall by us or one of our distributors couldoccur as a result of adverse side effects, impurities or other product contamination, manufacturing errors, design or labeling defectsor other deficiencies and issues. Recalls of any of our products would divert managerial and financial resources and have an adverse effecton our financial condition and results of operations. The regulatory agencies require that certain classifications of recalls be reportedto them within ten (10) working days after the recall is initiated. Companies are required to maintain certain records of recalls, evenif they are not reportable to the regulatory agency. We may initiate voluntary recalls involving our products in the future that we determinedo not require notification of the regulatory agencies. If the regulatory agency disagrees with our determinations, they could requireus to report those actions as recalls. A future recall announcement could harm our reputation with customers and negatively affect oursales. In addition, the regulatory agency could take enforcement action for failing to report the recalls when they were conducted.

The in-licensing of technologies and thesuccessful testing and early development of technologies in the laboratory may not be indicative of future results and may not resultin commercially viable technologies or products. Further, our future products may have to be modified from their originally conceivedversions in order to reach or be successful in the market.

Positive results from laboratory testing and earlydevelopmental successes, may not be predictive of future successful development, commercialization and sales results and should not berelied upon as evidence that products developed from our technologies will become commercially viable and successful. Further, the productswe plan to develop in the future may have to be significantly modified from their originally conceived versions in order for us to controlcosts, compete with similar products, receive market acceptance, meet specific development and commercialization timeframes, avoid potentialinfringement of the proprietary rights of others, or otherwise succeed in developing our business and earning ongoing revenues. This canbe a costly and resource draining activity. What appear to be promising technologies when we license them may not lead to viable technologiesor products, or to commercial success.

We utilize third-party, single-source suppliersfor some components and materials used in our products and product candidates, and the loss of any of these suppliers could have an adverseimpact on our business.

We rely on single-source suppliers for some componentsand materials used in our products and product candidates. Our ability to supply our products commercially and to develop any future productsdepends, in part, on our ability to obtain these components in accordance with regulatory requirements and in sufficient quantities forclinical testing and commercialization. While our suppliers have generally met our demand for their products on a timely basis in thepast, these were with limited production quantities and we cannot assure that they will in the future be able to meet our demand for theirproducts, either because we do not have long-term agreements with those suppliers, our relative importance as a customer to those suppliers,or their ability to produce the components used in our products. For example, our supplier of printed electrodes has exited the printingbusiness. We purchased safety stock from the supplier prior to their discontinuing production and have begun qualification of a replacementsupplier.

While we believe replacement suppliers exist forall components and materials we obtain from single sources, establishing additional or replacement suppliers for any of these componentsor materials, if required, may not be accomplished quickly. Even if we are able to find a replacement supplier, the replacement supplierwould need to be qualified and may require additional regulatory authority approval, which could result in further delay. While we willseek to maintain adequate inventory of the single-source components and materials used in our products in the event of disruption, thoseinventories may not be sufficient.

If our third-party suppliers fail to deliver therequired commercial quantities of materials on a timely basis and at commercially reasonable prices, and we are unable to find one ormore replacement suppliers capable of production at a substantially equivalent cost in substantially equivalent volumes and quality ona timely basis, the continued commercialization of our products, the supply of our products to customers and the development of any futureproducts would be delayed, limited or prevented, which could have an adverse impact on our business.

Manufacturing risks may adversely affectour ability to manufacture products and could reduce our gross margins and negatively affect our operating results.

Our business strategy depends on our ability tomanufacture and assemble our current and proposed products in sufficient quantities and on a timely basis to meet consumer demand, whileadhering to product quality standards, complying with regulatory requirements and managing manufacturing costs. We are subject to numerousrisks relating to our manufacturing capabilities, including:

As demand for our products increases, we willneed to invest additional resources to purchase components, hire and train employees, and enhance our manufacturing processes and implementmanufacturing and quality systems. If we fail to increase our production capacity efficiently while also maintaining quality requirements,our sales may not increase in line with our forecasts and our operating margins could fluctuate or decline. In addition, while we expectmost new products will utilize the eLab instrument system and existing consumable cartridge, manufacturing of future products may requirethe modification of our production lines, the hiring of specialized employees, the identification of new suppliers for specific components,or the development of new manufacturing technologies. It may not be possible for us to manufacture these products at a cost or in quantitiessufficient to make these products commercially viable. Any future interruptions we experience in the manufacturing or shipping of ourproducts could delay our ability to recognize revenues in a particular quarter and could also adversely affect our relationships withour customers.

Risks Related to Intellectual Property

The extent to which we can protect our businessand technologies through intellectual property rights that we own, acquire or license is uncertain.

We employ a variety of proprietary and patentedtechnologies and methods in connection with the assays that we sell or are developing. We license some of these technologies from thirdparties. We cannot provide any assurance that the intellectual property rights that we own or license provide effective protection fromcompetitive threats or that we would prevail in any litigation in which our intellectual property rights are challenged. In addition,we may not be successful in obtaining new proprietary or patented technologies or methods in the future, whether through acquiring ownershipor through licenses from third parties.

Our currently pending or future patent applicationsmay not result in issued patents, and we cannot predict how long it may take for a patent to issue on any of our pending patent applications,assuming a patent does issue.

Other parties may challenge patents issued orexclusively licensed to us, or courts or administrative agencies may hold our patents or the patents we license on an exclusive basisto be invalid or unenforceable. We may not be successful in defending challenges made against our patents and other intellectual propertyrights. Any third-party challenge to any of our patents could result in the unenforceability or invalidity of some or all of the claimsof such patents and could be time consuming and expensive.

The extent to which the patent rights oflife sciences companies effectively protect their diagnostic tests and technologies is often highly uncertain and involves complex legaland factual questions for which important legal principles remain unresolved.

No consistent policy regarding the proper scopeof allowable claims of patents held by life sciences companies has emerged to date in the United States. Various courts, including theU.S. Supreme Court, have rendered decisions that impact the scope of patentability of certain inventions or discoveries relating to diagnostictests or genomic diagnostic testing. These decisions generally stand for the proposition that inventions that recite laws of nature arenot themselves patentable unless they have sufficient additional features that provide practical assurance that the processes are genuineinventive applications of those laws rather than patent drafting efforts designed to monopolize a law of nature itself. What constitutesa “sufficient” additional feature for this purpose is uncertain. Although we do not generally rely on gene sequence patents,this evolving case law in the United States may adversely impact our ability to obtain new patents and may facilitate third-party challengesto our existing owned and exclusively licensed patents.

We cannot predict the breadth of claims that maybe allowed or enforced in patents we own or in those to which we have exclusive license rights. For example:

Changes in either the patent laws or ininterpretations of patent laws in the United States or other countries may diminish the value of our intellectual property rights.

On September 16, 2011, the Leahy-Smith AmericaInvents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act includes a number of significant changes to U.S. patentlaw. These include provisions that affect the way patent applications are prosecuted, redefine prior art, may affect patent litigationand switch the U.S. patent system from a “first-to-invent” system to a “first-to-file” system. Under a first-to-filesystem, assuming the other requirements for patentability are met, the first inventor to file a patent application generally will be entitledto the patent on an invention regardless of whether another inventor had made the invention earlier. The U.S. Patent and Trademark Office,or USPTO, recently developed new regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantivechanges to patent law associated with the Leahy-Smith Act, including the first-to-file provisions in particular, only became effectiveon March 16, 2013. Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. However,the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our owned and licensedpatent applications and the enforcement or defense of issued patents that we own or license, all of which could have a material adverseeffect on our business and financial condition.

Patent applications in the United States and manyforeign jurisdictions are not published until at least eighteen months after filing and it is possible for a patent application filedin the United States to be maintained in secrecy until a patent issues on the application. In addition, publications in the scientificliterature often lag behind actual discoveries. We therefore cannot be certain that others have not filed patent applications that coverinventions that are the subject of pending applications that we own or exclusively license or that we were the first to invent the technology(if filed prior to the Leahy-Smith Act) or first to file (if filed after the Leahy-Smith Act). Our competitors may have filed, and mayin the future file, patent applications covering technology that is similar to or the same as our technology. Any such patent applicationmay have priority over patent applications that we own and, if a patent issues on such patent application, we could be required to obtaina license to such patent in order to carry on our business. If another party has filed a U.S. patent application covering an inventionthat is similar to, or the same as, an invention that we own, we may have to participate in an interference or other proceeding in theUSPTO or a court to determine priority of invention in the United States, for applications and patents made prior to the enactment ofthe Leahy-Smith Act. For applications and patents made following the enactment of the Leahy-Smith Act, we may have to participate in aderivation proceeding to resolve disputes relating to inventorship. The costs of these proceedings could be substantial, and it is possiblethat such efforts would be unsuccessful, resulting in our inability to obtain or retain any U.S. patent rights with respect to such invention.

In addition, the laws of foreign jurisdictionsmay not protect our rights to the same extent as the laws of the United States. For example, European patent law restricts the patentabilityof methods of treatment of the human body more than U.S. law does. Publications of discoveries in scientific literature often lag behindthe actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 monthsafter filing, or in some cases not at all. Therefore, we cannot be certain that we were the first to make the inventions claimed in ourowned or licensed patents or pending patent applications, or that we or our licensors were the first to file for patent protection ofsuch inventions. Moreover, the USPTO might require that the term of a patent issuing from a pending patent application be disclaimed andlimited to the term of another patent that is commonly owned or names a common inventor. As a result, the issuance, scope, validity, term,enforceability and commercial value of our patent rights are highly uncertain.

The patent prosecution process is expensiveand time-consuming, is highly uncertain and involves complex legal and factual questions. Recent patent reform legislation could increasethe uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.

Our success depends in large part on our abilityto obtain and maintain patent protection in the United States and other countries with respect to our proprietary technology and productcandidates. We seek to protect our proprietary position by filing in the United States and in certain foreign jurisdictions patent applicationsrelated to our novel technologies and product candidates that are important to our business.

The patent prosecution process is expensive andtime-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or ina timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output before itis too late to obtain patent protection. In addition, we may not pursue or obtain patent protection in all major markets. Moreover, insome circumstances, we may not have the right to control the preparation, filing or prosecution of patent applications, or to maintainthe patents, covering technology that we license from third parties. In some circumstances, our licensors may have the right to enforcethe licensed patents without our involvement or consent, or to decide not to enforce or to allow us to enforce the licensed patents. Therefore,these patents and patent applications may not be prosecuted and enforced in a manner consistent with the best interests of our business.If any of our licensors fail to maintain such patents, or lose rights to those patents, the rights that we have licensed may be reducedor eliminated and our right to develop and commercialize any of our product candidates that are the subject of such licensed rights couldbe adversely affected.

Our pending and future patent applications maynot result in patents being issued which protect our technology or products, in whole or in part, or which effectively prevent othersfrom commercializing competitive technologies and products. In particular, during prosecution of any patent application, the issuanceof any patents based on the application may depend upon our ability to generate additional nonclinical or clinical data that support thepatentability of our proposed claims. We may not be able to generate sufficient additional data on a timely basis, or at all. Moreover,changes in either the patent laws or interpretation of the patent laws in the United States or other countries may diminish the valueof our patents or narrow the scope of our patent protection.

Moreover, we may be subject to a third-party pre-issuancesubmission of prior art to the USPTO, or become involved in opposition, derivation, reexamination, inter partes review,post-grant review or interference proceedings or other patent office proceedings or litigation, in the United States or elsewhere, challengingour patent rights or the patent rights of others. An adverse determination in any such submission or proceeding could reduce the scopeof, or invalidate, our patent rights; allow third parties to commercialize our technology or products and compete directly with us, withoutpayment to us; or result in our inability to manufacture or commercialize products without infringing third-party patent rights. In addition,if the breadth or strength of protection provided by our owned and licensed patents and patent applications is threatened, it could dissuadecompanies from collaborating with us to license, develop or commercialize current or future product candidates.

Obtaining and maintaining our patent protectiondepends upon compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patentagencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

The USPTO and various foreign governmental patentagencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent prosecution processand following the issuance of a patent. There are situations in which noncompliance with these requirements can result in abandonmentor lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In suchan event, competitors might be able to enter the market earlier than would otherwise have been the case if our patent were in force.

Our intellectual property rights may notbe sufficient to protect our competitive position and to prevent others from manufacturing, using or selling competing assays.

The scope of our owned and exclusively licensedintellectual property rights may not be sufficient to prevent others from manufacturing, using or selling competing assays. Competitorscould purchase our product and attempt to replicate some or all of the competitive advantages we derive from our development efforts,willfully infringe our intellectual property rights, design around our protected technology or develop their own competitive technologiesand thereby avoid infringing our intellectual property rights. If our intellectual property is not sufficient to effectively prevent ourcompetitors from developing and selling similar diagnostic tests, our competitive position and our business could be adversely affected.

We may become involved in disputes relatingto our intellectual property rights, and may need to resort to litigation in order to defend and enforce our intellectual property rights.

Extensive litigation regarding patents and otherintellectual property rights has been common in the medical diagnostic testing industry. Litigation may be necessary to assert infringementclaims, protect trade secrets or know-how and determine the enforceability, scope and validity of certain proprietary rights. Litigationmay even be necessary to resolve disputes of inventorship or ownership of proprietary rights. The defense and prosecution of intellectualproperty lawsuits, USPTO interference or derivation proceedings and related legal and administrative proceedings (e.g., a re-examination)in the United States and internationally involve complex legal and factual questions. As a result, such proceedings are costly and timeconsuming to pursue, and their outcome is uncertain.

Even if we prevail in such a proceeding in whichwe assert our intellectual property rights against third parties, the remedy we obtain may not be commercially meaningful or adequatelycompensate us for any damages we may have suffered. If we do not prevail in such a proceeding, our patents could potentially be declaredto be invalid, unenforceable or narrowed in scope, or we could otherwise lose valuable intellectual property rights. Similar proceedingsinvolving the intellectual property we exclusively license could also have an impact on our business. Further, if any of our other ownedor exclusively licensed patents are declared invalid, unenforceable or narrowed in scope, our competitive position could be adverselyaffected.

We could face claims that our activitiesor the manufacture, use or sale of our assays infringe the intellectual property rights of others, which could cause us to pay damagesor licensing fees and limit our ability to sell some or all of our assays and services.

Our research, development and commercializationactivities may infringe or be claimed to infringe patents or other intellectual property rights owned by other parties of which we maybe unaware because the relevant patent applications may have been filed but not yet published. Certain of our competitors and other companieshave substantial patent portfolios and may attempt to use patent litigation as a means to obtain a competitive advantage or to extractlicensing revenue. In addition to patent infringement claims, we may also be subject to other claims relating to the violation of intellectualproperty rights, such as claims that we have misappropriated trade secrets or infringed third party trademarks. The risks of being involvedin such litigation may also increase as we gain greater visibility as a public company and as we gain commercial acceptance of our diagnostictests and move into new markets and applications for our assays.

Regardless of merit or outcome, our involvementin any litigation, interference or other administrative proceedings could cause us to incur substantial expense and could significantlydivert the efforts of our technical and management personnel. Any public announcements related to litigation or interference proceedingsinitiated or threatened against us could cause our share price to decline. An adverse determination, or any actions we take or agreementswe enter into in order to resolve or avoid disputes, may subject us to the loss of our proprietary position or to significant liabilities,or require us to seek licenses that may include substantial cost and ongoing royalties. Licenses may not be available from third partiesor may not be obtainable on satisfactory terms. An adverse determination or a failure to obtain necessary licenses may restrict or preventus from manufacturing and selling our diagnostic tests and offering our services. These outcomes could materially harm our business, financialcondition and results of operations.

We may not be able to adequately protectour intellectual property outside of the United States.

The laws of some foreign countries do not protectintellectual property rights to the same extent as the laws of the United States, and many companies have encountered significant problemsin protecting and defending such rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developingcountries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to medicaldevices, diagnostic testing and biotechnology, which could make it difficult for us to stop the infringement of our patents and for licensors,if they were to seek to do so, to stop infringement of patents that are licensed to us. Proceedings to enforce our patent rights in foreignjurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business. Additionally,prosecuting and maintaining intellectual property (particularly patent) rights are very costly endeavors, and for these and other reasonswe may not pursue or obtain patent protection in all major markets. We do not know whether legal and government fees will increase substantiallyand therefore are unable to predict whether cost may factor into our global intellectual property strategy.

In addition to the risks associated with patentrights, the laws in some foreign jurisdictions may not provide protection for our trade secrets and other intellectual property. If ourtrade secrets or other intellectual property are misappropriated in foreign jurisdictions, we may be without adequate remedies to addressthese issues. Additionally, we also rely on confidentiality and assignment of invention agreements to protect our intellectual propertyin foreign jurisdictions. These agreements may provide for contractual remedies in the event of misappropriation, but we do not know towhat extent, if any, these agreements, and any remedies for their breach, will be enforced by a foreign court. If our intellectual propertyis misappropriated or infringed upon and an adequate remedy is not available, our future prospects will likely diminish. The sale of diagnostictests that infringe our intellectual property rights, particularly if such diagnostic tests are offered at a lower cost, could negativelyimpact our ability to achieve commercial success and may materially and adversely harm our business.

Our failure to secure trademark registrationscould adversely affect our business and our ability to market our assays and product candidates.

Our trademark applications in the United Statesand any other jurisdictions where we may file may not be allowed for registration, and our registered trademarks may not be maintainedor enforced. During trademark registration proceedings, we may receive rejections. Although we are given an opportunity to respond tothose rejections, we may be unable to overcome such rejections. In addition, in the USPTO and in corresponding foreign agencies, thirdparties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellationproceedings may be filed against our applications and/or registrations, and our applications and/or registrations may not survive suchproceedings. Failure to secure such trademark registrations in the United States and in foreign jurisdictions could adversely affect ourbusiness and our ability to market our diagnostic tests and product candidates.

We may be unable to adequately prevent disclosureof trade secrets and other proprietary information, or the misappropriation of the intellectual property we regard as our own.

We rely on trade secrets to protect our proprietaryknow how and technological advances, particularly where we do not believe patent protection is appropriate or obtainable. Nevertheless,trade secrets are difficult to protect. We rely in part on confidentiality agreements with our employees, consultants, third party contractors,third party collaborators and other advisors to protect our trade secrets and other proprietary information. These agreements generallyrequire that the other party to the agreement keep confidential and not disclose to third parties all confidential information developedby us or made known to the other party by us during the course of the other party’s relationship with us. These agreements may noteffectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosureof confidential information. Monitoring unauthorized disclosure is difficult, and we do not know whether the steps we have taken to preventsuch disclosure are, or will be, adequate. If we were to seek to pursue a claim that a third party had illegally obtained and was usingour trade secrets, it would be expensive and time consuming, and the outcome would be unpredictable. Further, courts outside the UnitedStates may be less willing to protect trade secrets. In addition, others may independently discover our trade secrets and proprietaryinformation and therefore be free to use such trade secrets and proprietary information. Costly and time consuming litigation could benecessary to enforce and determine the scope of our proprietary rights. In addition, our trade secrets and proprietary information maybe misappropriated as a result of breaches of our electronic or physical security systems in which case we may have no legal recourse.Failure to obtain, or maintain, trade secret protection could enable competitors to use our proprietary information to develop assaysthat compete with our assays or cause additional, material adverse effects upon our competitive business position.

We may be subject to claims that our employeeshave wrongfully used or disclosed alleged trade secrets of their former employers.

As is common in our industry, we employ individualswho were previously employed at other companies in our industry or in related industries, including our competitors or potential competitors.We may be subject to claims that we or these employees have inadvertently or otherwise used or disclosed trade secrets or other proprietaryinformation of their former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defendingagainst these claims, litigation could result in substantial costs and be a distraction to management.

Third parties may initiate legal proceedingsalleging that we are infringing their intellectual property rights, the outcome of which would be uncertain.

Our commercial success dependsupon our ability to develop, manufacture, market and sell our product candidates without infringing the proprietary rights of third parties.There is considerable intellectual property litigation in the life sciences industry. We cannot guarantee that our product candidateswill not infringe third-party patents or other proprietary rights. We may become party to, or threatened with, future adversarial proceedingsor litigation regarding intellectual property rights with respect to our products and technology, including inter partes review,interference, or derivation proceedings before the USPTO and similar bodies in other countries. Third parties may assert infringementclaims against us based on existing intellectual property rights and intellectual property rights that may be granted in the future.

If we are found to infringea third party’s intellectual property rights, we could be required to obtain a license from such third party to continue developingand marketing our products. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Evenif we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensedto us. We could be forced, including by court order, to cease commercializing the infringing technology or product. In addition, we couldbe found liable for monetary damages, including treble damages and attorneys’ fees if we are found to have willfully infringed apatent. A finding of infringement could prevent us from commercializing our product candidates or force us to cease some of our businessoperations, which could materially harm our business. Claims that we have misappropriated the confidential information or trade secretsof third parties could have a similar negative impact on our business.

Obtaining and maintainingour patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed bygovernmental patent agencies, and our own patent protection could be reduced or eliminated for noncompliance with these requirements.

Periodic maintenance feesand annuities on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime ofthe patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, feepayment and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by paymentof a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonmentor lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncomplianceevents that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respondto official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. Insuch an event, our competitors might be able to enter our markets, which could have a material adverse effect on our business.

Intellectual property litigation could causeus to spend substantial resources and distract our personnel from their normal responsibilities.

Even if resolved in our favor,litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distractour technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the resultsof hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to benegative, it could have an adverse effect on the price of our common stock. Such litigation or proceedings could increase our operatinglosses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We maynot have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may beable to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources.Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise our ability tocompete in the marketplace.

We may spend considerable resources developingand maintaining patents, licensing agreements and other intellectual property that may later be abandoned or may otherwise never resultin products brought to market.

Not all technologies and candidate products thatinitially show potential as the basis for future products ultimately meet the rigors of our development process and as a result may beabandoned and/or never otherwise result in products brought to market. In some cases, prior to abandonment we may be required toincur significant costs developing and maintaining intellectual property and/or maintaining license agreements and our business couldbe harmed by such costs.

We rely on information technology, and ifwe are unable to protect against service interruptions, data corruption, cyber-based attacks or network security breaches, our operationscould be disrupted, and our business could be negatively affected.

We rely on information technology networks andsystems to process, transmit and store electronic and financial information; to coordinate our business; and to communicate within ourCompany and with customers, suppliers, partners and other third parties. These information technology systems may be susceptible to damage,disruptions or shutdowns, hardware or software failures, power outages, computer viruses, cyber-attacks, telecommunication failures, usererrors or catastrophic events. If our information technology systems suffer severe damage, disruption or shutdown, and our business continuityplans do not effectively resolve the issues in a timely manner, our operations could be disrupted, and our business could be negativelyaffected. In addition, cyber-attacks could lead to potential unauthorized access and disclosure of confidential information, and dataloss and corruption. There is no assurance that we will not experience these service interruptions or cyber-attacks in the future.

Risks Related to the Company and our Business

We have a limited operating history and may face difficulties encounteredby companies early in their commercialization in competitive and rapidly evolving markets.

We received CE-Mark for our eLab instrument and S1 Assay panel in Novemberof 2019 and began commercializing these products in the fourth quarter of 2020. We have also developed products for COVID-19 with theintent to file for FDA EUA. The application for our COVID-19 antibody test was not reviewed by the FDA due to the volume of EUA requeststhe Agency has received for similar tests. The EUA application for our COVID-19 antigen test was reviewed by the FDA and additional clinicaland analytical information was requested. The Company is conducting the additional work and intends to refile the EUA upon completion.

Accordingly, we have a relatively limited operating history upon whichto evaluate our business and forecast our future sales and operating results. In assessing our business prospects, you should considerthe various risks and difficulties frequently encountered by companies early in their commercialization in competitive and rapidly evolvingmarkets, particularly companies that develop and sell medical devices. These risks include our ability to:

We may not have the institutional knowledge or experience to be ableto effectively address these and other risks that may face our business. In addition, we may not be able to develop insights into trendsthat could emerge and negatively affect our business and may fail to respond effectively to those trends. As a result of these or otherrisks, we may not be able to execute key components of our business strategy, and our business, financial condition and operating resultsmay suffer.

Sales cycles for our products may be lengthy,which can cause variability and unpredictability in our business.

Some of our products may require lengthy and unpredictablesales cycles, which makes it more difficult to accurately forecast revenues and may cause revenues and operating results to vary fromperiod to period. Our products may involve sales to large public and private institutions which may require many levels of approval andmay be dependent on economic or political conditions and the availability of funding from government or public health agencies which canvary from period to period. There can be no assurance that purchases or funding from these agencies will occur or continue. As a result,we may expend considerable resources on unsuccessful sales efforts or we may not be able to complete transactions at all or on a scheduleand in an amount consistent with our objectives.

We have limited commercial scale capabilities.If we are unable to successfully implement commercial capabilities and manage our growth, our business will be harmed.

We have been a development stage company and wewill need to establish and significantly expand our operations and capabilities. We expect this expansion to occur rapidly and continueto an even greater degree in the future as we continue to commercialize our products, build a sales and marketing organization, and seekmarketing clearance from the FDA and international regulatory bodies for our future product candidates. Our growth will place a significantstrain on our management, operating and financial systems and our sales, marketing, manufacturing, engineering, product development, andadministrative resources. As a result of our growth, operating costs may escalate even faster than planned, and some of our internal systemsand processes, including those relating to manufacturing our products, will need to be established and may need to be enhanced, updatedor replaced. Additionally, our anticipated growth will increase demands placed on our suppliers, resulting in an increased need for usto manage our suppliers and monitor for quality assurance. If we cannot effectively manage our expanding operations, manufacturing capacityand costs, including scaling to meet increased demand and properly managing suppliers, we may not be able to grow or we may grow at aslower pace than expected and our business could be adversely affected.

We face substantial competition, which mayresult in others discovering, developing or commercializing products before or more successfully than we do.

The development and commercialization of medicaldevices is highly competitive. We compete with a variety of multinational pharmaceutical companies and specialized biotechnology companies,as well as products and processes being developed at universities and other research institutions. Our competitors have developed, aredeveloping or will develop product candidates and processes competitive with our product candidates. Competitive therapeutic treatmentsinclude those that have already been approved and accepted by the medical community and any new treatments that may enter the market.We believe that a significant number of products are currently available, under development, and may become commercially available inthe future, for the treatment of indications for which we may try to develop product candidates. 

More established companies may have a competitiveadvantage over us due to their greater size, cash flows and institutional experience. Compared to us, many of our competitors may havesignificantly greater financial, technical and human resources. As a result of these factors, our competitors may have an advantage inmarketing their approved products and may obtain regulatory approval of their product candidates before we are able to, which may limitour ability to develop or commercialize our product candidates. Our competitors may also develop drugs that are safer, more effective,more widely used and less expensive than ours, and may also be more successful than us in manufacturing and marketing their products.

Mergers and acquisitions in the pharmaceuticaland biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller andother early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large andestablished companies. These companies compete with us in recruiting and retaining qualified scientific, management and commercial personnel,establishing clinical trial sites and subject registration for clinical trials, as well as in acquiring technologies complementary to,or necessary for, our programs.

Our technologies and products under development,and our business, may fail if we are not able to successfully commercialize them and ultimately generate significant revenues as a result.

Successful development of technologies and ourproduct candidates will require significant additional investment, including costs associated with additional development, completingtrials and obtaining regulatory approval, as well as the ability to manufacture or have others manufacture our products in sufficientquantities at acceptable costs while also preserving product quality. Difficulties often encountered in scaling up production includeproblems involving production yields, quality control and assurance, shortage of qualified personnel, production costs and process controls.In addition, we are subject to inherent risks associated with new technologies and products. These risks include the possibility thatany of our technologies or future products may:

Furthermore, we may be faced with lengthy marketpartner or distributor evaluation and approval processes. Consequently, we may incur substantial expenses and devote significant managementeffort in order to customize products for market partner or distributor acceptance, though there can be no assurance of such acceptance.As a result, we cannot accurately predict the volume or timing of any future sales.

Customers may not adopt our products quickly,or at all.

Customers in the sector in which we operate canbe generally cautious in their adoption of new products and technologies. In addition, given the relative novelty of our future plannedproducts, customers of those products may require education regarding their utility and use, which may delay their adoption. There canbe no assurance that customers will adopt our products quickly, or at all.

The significant level of competition inthe markets for our products developed in the future may result in pricing pressure, reduced margins or the inability of our future productsto achieve market acceptance.

The markets for our future products are intenselycompetitive and rapidly changing. We may be unable to compete successfully, which may result in price reductions, reduced margins andthe inability to achieve market acceptance for our products.

Our competitors may have longer operating histories,significantly greater resources, greater brand recognition and large customer bases than we do. As a result, they may be able to devotegreater resources to the manufacture, promotion or sale of their products, receive greater resources and support from market partnersand independent distributors, initiate or withstand substantial price competition or more readily take advantage of acquisition or otheropportunities.

We may rely on third parties for the productionof our future products. If these parties do not produce our products at a satisfactory quality, in a timely manner, in sufficientquantities or at an acceptable cost, our sales and development efforts could be delayed or otherwise negatively affected.

We may rely on third parties for the manufactureof our future products. Our reliance on third parties to manufacture our future products may present significant risks to us, includingthe following:

If we need to enter into agreements for the manufacturingof our future products, there can be no assurance we will be able to do so on favorable terms, if at all.

If we are unable to establish successfulrelations with third-party market partners or distributors, or these market partners or distributors do not focus adequate resources onselling our products or are otherwise unsuccessful in selling them, sales of our products may not develop.

We anticipate relying on independent market partnersand distributors to distribute and assist us with the marketing and sale of our products. Our future revenue generation and growth willdepend in large part on our success in establishing and maintaining this sales and distribution channel. If our market partners and distributorsare unable to sell our products, or receive negative feedback from end users, they may not continue to purchase or market our products.In addition, there can be no assurance that our market partners and distributors will focus adequate resources on selling our productsto end users or will be successful in selling them. Many of our potential market partners and distributors are in the business of distributingand sometimes manufacturing other, possibly competing, products. As a result, these market partners and distributors may perceiveour products as a threat to various product lines currently being distributed or manufactured by them. In addition, these market partnersand distributors may earn higher margins by selling competing products or combinations of competing products. If we are unable to establishsuccessful relationships with independent market partners and distributors, we will need to further develop our own sales and distributioncapabilities, which would be expensive and time-consuming and might not be successful.

The use of our products may be limited byregulations, and we may be exposed to product liability and remediation claims.

The use of our planned products may be regulatedby various local, state, federal and foreign regulators. Even if we are able to comply with all such regulations and obtain all necessaryregistrations, we cannot provide assurance that our future products will not cause injury to the environment, people, or animals and/orotherwise have unintended adverse consequences, under all circumstances. For example, our products may be improperly combined with otherchemicals or, even when properly combined, our products may be blamed for damage caused by those other chemicals. The costs of remediationor products liability could materially adversely affect our results, financial condition and operations.

We may be held liable for, or incur coststo settle, liability and remediation claims if any products we develop, or any products that use or incorporate any of our technologies,cause injury or are found unsuitable during product testing, manufacturing, marketing, sale or use. These risks exist even with respectto products that have received, or may in the future receive, regulatory approval, registration or clearance for commercial use. We cannotguarantee that we will be able to avoid product liability exposure.

At the stage customary to do so, we expect tomaintain product liability insurance at levels we believe are sufficient and consistent with industry standards for like companies andproducts. However, we cannot guarantee that our product liability insurance will be sufficient to help us avoid product liability-relatedlosses. In the future, it is possible that meaningful insurance coverage may not be available on commercially reasonable terms or at all.In addition, a product liability claim could result in liability to us greater than our assets or insurance coverage. Moreover, even ifwe have adequate insurance coverage, product liability claims or recalls could result in negative publicity or force us to devote significanttime and attention to these matters, which could harm our business.

There may be limitations on the effectivenessof our internal controls, and a failure of our control systems to prevent error or fraud may materially harm our Company.

We do not expect that internal control over financialaccounting and disclosure, even if timely and well established, will prevent all error and all fraud. A control system, no matter howwell designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met.Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must beconsidered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provideabsolute assurance that all control issues and instances of fraud, if any, have been detected. Failure of our control systems to preventerror or fraud could materially adversely affect our business.

Risks Related to this Offering and Our CommonStock

There has been a limited public market forour common stock, and we do not know whether one will develop to provide you adequate liquidity. Furthermore, the trading price for ourcommon stock, should an active trading market develop, may be volatile and could be subject to wide fluctuations in per-share price.

Our common stock is quoted on the Pink Open Marketunder the trading symbol “BTHE”; historically, however, there has been a limited public market for our common stock. Althoughwe have applied to list our Common Stock on the Nasdaq Stock Market, we cannot assure you that an active trading market for our commonstock will develop or be sustained. The liquidity of any market for the shares of our common stock will depend on a number of factors,including:

Even if an active trading market develops, themarket price for our common stock may be highly volatile and could be subject to wide fluctuations. In addition, the price of shares ofour common stock could decline significantly if our future operating results fail to meet or exceed the expectations of market analystsand investors and actual or anticipated variations in our quarterly operating results could negatively affect our share price.

The volatility of the price of our common stockmay also be impacted by the risks discussed under this “Risk Factors” section, in addition to other factors, including:

Our outstanding warrants and preferred stockmay affect the market price and liquidity of the common stock.

As of October 1, 2021, we had approximately 5,300,084shares of common stock and warrants for the purchase up to approximately an additional 3,450,613 shares of common stock outstanding. Wealso have outstanding 963,964 shares of our series B preferred stock outstanding, which is convertible into approximately 5.6 millionshares of common stock, as well as 1,000,000 shares of our series C preferred stock outstanding, which is convertible into approximately35 million shares of common stock. As described more fully below, holders of our notes and warrants may elect to receive a substantialnumber of shares of common stock upon conversion of the notes and/or exercise of the warrants. The amount of common stock reserved forissuance may have an adverse impact on our ability to raise capital and may affect the price and liquidity of our common stock in thepublic market. In addition, the issuance of these shares of common stock will have a dilutive effect on current stockholders’ownership.

The conversion of outstanding convertiblenotes into shares of common stock could materially dilute our current stockholders.

As of the date of this prospectus, we had approximately$8.4 million aggregate principal amount of convertible notes outstanding, convertible into shares of our common stock at a fixed priceof $2.0587 per share. The conversion prices of these notes may be less than the market price of our common stock at the time of conversion,and which may be subject to future adjustment due to certain events, including our issuance of common stock or common stock equivalentsat an effective price per share lower than the conversion rate then in effect. If the entire principal amount of all the outstanding convertiblenotes is converted into shares of common stock, we would be required to issue an aggregate of no less than approximately 4.1million sharesof common stock. If we issue all of these shares, the ownership of our current stockholders will be diluted.

Because our common stock may be deemed alow-priced “penny” stock, an investment in our common stock should be considered high-risk and subject to marketability restrictions.

Historically, the trading price of our commonstock has been $5.00 per share or lower, and deemed a penny stock, as defined in Rule 3a51-1 under the Exchange Act, and subject to thepenny stock rules of the Exchange Act specified in rules 15g-1 through 15g-100. Those rules require broker–dealers, before effectingtransactions in any penny stock, to:

Consequently, the penny stock rules may restrictthe ability or willingness of broker-dealers to sell the common stock and may affect the ability of holders to sell their common stockin the secondary market and the price at which such holders can sell any such securities. These additional procedures could also limitour ability to raise additional capital in the future.

Financial Industry Regulatory Authority(“FINRA”) sales practice requirements may also limit a stockholder’s ability to buy and sell our common stock, whichcould depress the price of our common stock.

In addition to the “penny stock” rulesdescribed above, FINRA has adopted rules that require a broker-dealer to have reasonable grounds for believing that the investment issuitable for that customer before recommending an investment to a customer. Prior to recommending speculative low-priced securities totheir non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financialstatus, tax status, investment objectives and other information. Under interpretations of these rules, FINRA believes that there is ahigh probability that speculative low-priced securities will not be suitable for at least some customers. Thus, the FINRA requirementsmake it more difficult for broker-dealers to recommend that their customers buy our common stock, which may limit your ability to buyand sell our shares of common stock, have an adverse effect on the market for our shares of common stock, and thereby depress our priceper share of common stock.

If securities or industry analysts do notpublish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock priceand trading volume could decline.

The trading market for our common stock may beinfluenced by the research and reports that industry or securities analysts publish about us or our business. We do not currently have,and may never obtain, research coverage by securities and industry analysts. If no or few securities or industry analysts commence coverageof us, the trading price for our common stock may be negatively affected. In the event that we receive securities or industry analystcoverage, if any of the analysts who cover us issue an adverse or misleading opinion regarding us, our business model, our intellectualproperty or our stock performance, or if our operating results fail to meet the expectations of analysts, our stock price would likelydecline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility inthe financial markets, which in turn could cause our stock price or trading volume to decline.

Certain provisions of our certificate ofincorporation and Delaware law make it more difficult for a third party to acquire us and make a takeover more difficult to complete,even if such a transaction were in stockholders’ interest.

Our certificate of incorporation and the DelawareGeneral Corporation Law contain certain provisions that may have the effect of making it more difficult or delaying attempts by othersto obtain control of our Company, even when these attempts may be in the best interests of our stockholders. We also are subject to theanti-takeover provisions of the Delaware General Corporation Law, which prohibits us from engaging in a “business combination”with an “interested stockholder” unless the business combination is approved in a prescribed manner and prohibits the votingof shares held by persons acquiring certain numbers of shares without obtaining requisite approval. The statutes and our certificate ofincorporation have the effect of making it more difficult to effect a change in control of our Company.

We do not currently or for the foreseeablefuture intend to pay dividends on our common stock.

We have never declared or paid any cash dividendson our common stock. We currently anticipate that we will retain future earnings for the development, operation and expansion of our businessand do not anticipate declaring or paying any cash dividends for the foreseeable future. As a result, any return on your investment inour common stock will be limited to the appreciation in the price of our common stock, if any.

INDUSTRY AND MARKET DATA

This prospectus contains estimates and other statisticaldata made by independent parties and by us relating to market size and growth and other data about our industry. We obtained the industryand market data in this prospectus from our own research as well as from industry and general publications, surveys and studies conductedby third parties. These data involve a number of assumptions and limitations and contain projections and estimates of the future performanceof the industries in which we operate that are subject to a high degree of uncertainty, including those discussed in “Risk Factors.”We caution you not to give undue weight to such projections, assumptions and estimates. Further, industry and general publications, studiesand surveys generally state that they have been obtained from sources believed to be reliable, although they do not guarantee the accuracyor completeness of such information. While we believe that these publications, studies and surveys are reliable, we have not independentlyverified the data contained in them. In addition, while we believe that the results and estimates from our internal research are reliable,such results and estimates have not been verified by any independent source. 

USE OF PROCEEDS

The net proceeds from any disposition of the sharesof common stock covered hereby will be received by the selling stockholders. We will not receive any of the proceeds from any such sharesof common stock offered by this prospectus. We will, however, receive the net proceeds of any Warrants exercised for cash. We expect touse the proceeds received from the exercise of the Warrants, if any, for general working capital purposes.

DIVIDEND POLICY

We plan to retain any earnings for the foreseeablefuture for our operations. We have never paid any dividends on our common stock and do not anticipate paying any cash dividends in theforeseeable future. Any future determination to pay cash dividends will be at the sole discretion of our Board and will depend on ourfinancial condition, operating results, capital requirements and such other factors as our Board deems relevant.

MARKET FOR REGISTRANT’SCOMMON EQUITY AND RELATED STOCKHOLDER MATTERS

Our common stock is quoted on the Pink Open Marketmaintained by OTC Markets Group, Inc. under the symbol “BTHE.” Our common stock trades on a limited or sporadic basis andshould not be deemed to constitute an established public trading market. There is no assurance that there will be liquidity in the commonstock.

Stockholders

As of October 1, 2021, there were 1,752 stockholdersof record, which total does not include stockholders who hold their shares in “street name.” The transfer agent for our commonstock is Worldwide Stock Transfer, LLC.

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Dividends

We have not paid any dividends on our common stockto date and do not anticipate that we will pay dividends in the foreseeable future. Any payment of cash dividends on our common stockin the future will be dependent upon the amount of funds legally available, our earnings, if any, our financial condition, our anticipatedcapital requirements and other factors that the Board may think are relevant. However, we currently intend for the foreseeable futureto follow a policy of retaining all of our earnings, if any, to finance the development and expansion of our business and, therefore,do not expect to pay any dividends on our common stock during such time.

UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIALINFORMATION

On January 26, 2021,Boston Therapeutics, Inc., a Delaware corporation (the “Company”), BTHE Acquisition Inc., a California corporation and wholly-ownedsubsidiary of the Company (“Merger Sub”), and Nanomix, Inc., a California corporation (“Nanomix”), entered intoan Agreement and Plan of Merger (the “Merger Agreement”), pursuant to which, among other matters, and subject to the satisfactionor waiver of the conditions set forth in the Merger Agreement, Merger Sub will merge with and into Nanomix, with Nanomix continuing asa wholly-owned subsidiary of the Company and the surviving corporation of the merger (the “Merger”). The Merger is intendedto qualify for federal income tax purposes as a tax-free reorganization under the provisions of Section 368(a) of the InternalRevenue Code of 1986, as amended. The merger closed on June 4, 2021.

The unaudited pro forma condensedcombined financial information has been prepared to illustrate the effect of the Business Combination and has been prepared for informationalpurposes only.

The historical financial statementshave been adjusted in the unaudited pro forma condensed combined financial information to give pro forma effect to events that are (1)directly attributable to the Business Combination, (2) factually supportable, and (3) with respect to the statements of operations, expectedto have a continuing impact on the results of the post-combination company. No pro forma adjustments were required to eliminate activitiesbetween the companies.

The pro forma basic and dilutedearnings per share amounts presented in the unaudited pro forma condensed combined statements of operations are based upon the numberof the post combination shares outstanding assuming the Business Combination occurred on January 1, 2020 and 2019.

UNAUDITED PRO FORMA CONDENSED COMBINED BALANCESHEET AS OF MARCH 31, 2021 AND DECEMBER 31, 2020

UNAUDITED PROFORMA CONDENSED COMBINED STATEMENTOF OPERATIONS FOR THE THREE MONTHS ENDED MARCH 31, 2021 AND 2020