Asfiled with the U.S. Securities and Exchange Commission on May 5, 2023

RegistrationNo. 333-         

UNITEDSTATES

SECURITIESAND EXCHANGE COMMISSION

Washington,D.C. 20549

FORMS-1 

REGISTRATIONSTATEMENT

UNDER

THESECURITIES ACT OF 1933

180Life Sciences Corp. 

(Exactname of registrant as specified in its charter)

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

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

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

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

Copiesto:

FahdM.T. Riaz, Esq.
Stephen P. Alicanti, Esq.
DLA Piper LLP (US)
One Liberty Place
1650 Market Street, Suite 5000
Philadelphia, Pennsylvania 19103
(215) 656-3316 

Approximatedate of commencement of proposed sale to the public: From time to time after this registration statement becomes effective.

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

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

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

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

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

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

Theregistrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until theregistrant shall file a further amendment which specifically states that this registration statement shall thereafter become effectivein accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on suchdate as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

Theinformation contained in this prospectus is not complete and may be changed. The selling stockholder may not sell these securities untilthe registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell thesesecurities and is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

SUBJECTTO COMPLETION, DATED MAY 5, 2023

PRELIMINARYPROSPECTUS

4,448,713Shares of Common Stock 

Thisprospectus relates solely to the offer and sale from time to time of up to an aggregate of 4,448,713 shares of our common stock, parvalue $0.0001 per share, of 180 Life Sciences Corp., a Delaware corporation (the “Company,” “we,”“our” or “us”), by the selling stockholder identified in this prospectus (the “SellingStockholder”). The shares of common stock being registered for resale hereunder consist of: (i) 306,604 shares of common stockissuable upon the exercise of the July 2022 Common Warrants (as defined herein), (ii) 2,571,429 shares of common stock issuable uponthe exercise of the December 2022 Common Warrants (as defined herein), and (iii) 1,570,680 shares of common stock issuable upon the exerciseof the April 2023 Common Warrants (as defined herein) (together with the July 2022 Common Warrants and the December 2022 Common Warrants,the “Warrants,” and all of the shares of common stock issuable upon exercise of the Warrants, the “Shares”)acquired by the Selling Stockholder, in each case, pursuant to securities purchase agreements between us and the Selling Stockholder.

Eachof the July 2022 Common Warrants, the December 2022 Common Warrants and the April 2023 Common Warrants are exercisable at an exerciseprice of $1.78. We are not selling any common stock under this prospectus and will not receive any of the proceeds from the sale of theShares by the Selling Stockholder. However, if all of the July 2022 Common Warrants, the December 2022 Common Warrants and the April2023 Common Warrants that are covered by this prospectus are exercised for cash, we may receive proceeds of up to approximately $545,755,$4.6 million and $2.8 million, respectively. We intend to use those proceeds, if any, for research and development, and general corporatepurposes, including the preparation and submission of a marketing authorization application for Dupuytren’s contracture in theUK and legal expenses. We will bear all other costs, expenses and fees in connection with the registration of the Shares. The SellingStockholder will bear all commissions and discounts, if any, attributable to the sales of Shares.

TheSelling Stockholder may offer such Shares from time to time as it may determine through public or private transactions or through othermeans described in the section entitled “Plan of Distribution” beginning on page 136 of this prospectus, at prevailingmarket prices, at prices related to prevailing market prices or at privately negotiated prices. This prospectus does not necessarilymean that the Selling Stockholder will offer or sell the Shares. We cannot predict when or in what amounts the Selling Stockholder maysell any of the Shares offered by this prospectus. Any Shares subject to resale hereunder will have been issued by us and acquired bythe Selling Stockholder prior to any resale of such Shares pursuant to this prospectus. Because all of the Shares offered under thisprospectus are being offered by the Selling Stockholder, we cannot currently determine the price or prices at which the Shares may besold under this prospectus.

Ourcommon stock is traded on the Nasdaq Capital Market (“Nasdaq”) under the symbol “ATNF”. On May4, 2023, the last reported sale price for our common stock as reported on Nasdaq was $1.06 per share.

INVESTINGIN OUR SECURITIES INVOLVES SUBSTANTIAL RISKS. SEE THE SECTION TITLED “RISK FACTORS” BEGINNING ON PAGE 5 OF THISPROSPECTUS TO READ ABOUT FACTORS YOU SHOULD CONSIDER BEFORE BUYING OUR SECURITIES.

NEITHERTHE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR PASSEDUPON THE ADEQUACY OR ACCURACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.

Thedate of this prospectus is      , 2023.

TABLEOF CONTENTS

GLOSSARY

Theitems below are abbreviations and definitions of certain terms used in this prospectus, certain of which are commonly used in the pharmaceuticaland biotechnology industry.

Unlessthe context requires otherwise, references to the “Company,” “we,” “us,” “our,”“180 Life”, “180LS” and “180 Life Sciences Corp.” refer specifically to 180Life Sciences Corp. and its consolidated subsidiaries. References to “KBL” refer to the Company prior to the Closing(defined below).

Ourlogo and some of our trademarks and tradenames are used in this prospectus. This prospectus also includes trademarks, tradenames andservice marks that are the property of others. Solely for convenience, trademarks, tradenames and service marks referred to in this prospectusmay appear without the ®, ™ and SM symbols. References to our trademarks, tradenames and service marks are not intended toindicate in any way that we will not assert to the fullest extent under applicable law our rights or the rights of the applicable licensorsif any, nor that respective owners to other intellectual property rights will not assert, to the fullest extent under applicable law,their rights thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationshipwith, or endorsement or sponsorship of us by, any other companies.

Themarket data and certain other statistical information used throughout this prospectus are based on independent industry publications,reports by market research firms or other independent sources that we believe to be reliable sources; however, we have not commissionedany of the market or survey data that is presented in this prospectus. Industry publications and third-party research, surveys and studiesgenerally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee theaccuracy or completeness of such information. We are responsible for all of the disclosures contained in this prospectus, and we believethese industry publications and third-party research, surveys and studies are reliable. While we are not aware of any misstatements regardingany third-party information presented in this prospectus, their estimates, in particular, as they relate to projections, involve numerousassumptions, are subject to risks and uncertainties, and are subject to change based on various factors, including those discussed underthe section entitled “Risk Factors” of this prospectus. These and other factors could cause our future performanceto differ materially from our assumptions and estimates. Some market and other data included herein, as well as the data of competitorsas they relate to 180 Life Sciences Corp., is also based on our good faith estimates.

ABOUTTHIS PROSPECTUS

Thisprospectus is part of a registration statement on Form S-1 that we filed with the SEC using a “shelf” registration process.Under this shelf registration process, the Selling Stockholder may, from time to time, sell the shares of common stock offered by themdescribed in this prospectus. We will not receive any proceeds from the sale by such Selling Stockholder of the Shares offered by themdescribed in this prospectus. We will not receive any proceeds from the sale of Shares pursuant to this prospectus, except with respectto amounts received by us upon the exercise of the Warrants for cash.

Neitherwe nor the Selling Stockholder have authorized anyone to provide you with any information or to make any representations other than thosecontained in this prospectus or any applicable prospectus supplement or any free writing prospectus prepared by or on behalf of us orto which we have referred you. Neither we nor the Selling Stockholder take responsibility for, and can provide no assurance as to thereliability of, any other information that others may give you. Neither we nor the Selling Stockholder will make an offer to sell thesesecurities in any jurisdiction where the offer or sale is not permitted. You should not assume that the information contained in thisprospectus is accurate as of any date other than the date of this prospectus. Our business, financial condition, results of operationsand prospects may have changed since that date.

Wemay also provide a prospectus supplement or post-effective amendment to the registration statement to add information to, or update orchange information contained in, this prospectus. You should read both this prospectus and any applicable prospectus supplement or post-effectiveamendment to the registration statement together with the additional information to which we refer you in the section of this prospectusentitled “Where You Can Find More Information.”

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

CAUTIONARYNOTE REGARDING FORWARD-LOOKING STATEMENTS

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

Inparticular, forward-looking statements include, but are not limited to, any statements that are not statements of current or historicalfacts, such as statements relating to our expectations for the clinical and preclinical development, manufacturing, regulatory approval,and commercialization of our product candidates, the accuracy of our estimates regarding expenses, future revenues and capital requirements,our ability to execute our plans to develop and market new drug products and the timing and costs of these development programs, andestimates of the sufficiency of our existing capital resources combined with future anticipated cash flows to finance our operating requirements.

Suchstatements are based on management’s current expectations, but actual results may differ materially due to various factors, including,but not limited to:

Anyforward-looking statements in this prospectus reflect our current views with respect to future events or to our future financial performanceand involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements tobe materially different from any future results, performance or achievements expressed or implied by these forward-looking statements.Given these uncertainties, you should not place undue reliance on these forward-looking statements. All forward-looking statements includedherein speak only as of the date of this prospectus. All subsequent written and oral forward-looking statements attributable to us, orpersons acting on our behalf, are expressly qualified in their entirety by the cautionary statements above. Except as required by law,we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes availablein the future.

RISKFACTORS

Youshould carefully consider all of the following risk factors and all the other information contained in this prospectus, including theconsolidated financial statements. If any of the following risks occur, our business, financial condition or results of operations maybe materially and adversely affected. The risk factors described below are not necessarily exhaustive and you are encouraged to performyour own investigation with respect to us and our business.

RisksRelated to Our Business Operations

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

Ourcurrent cash balance is only sufficient to fund our planned business operations through the second quarter of 2023. If additional capitalis not available, we may not be able to pursue our planned business operations, may be forced to change our planned business operations,or may take other actions that could adversely impact our stockholders.

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

Ourfuture capital needs depend on many factors, including: (i) the scope, duration and expenditures associated with our research, developmentand commercialization efforts; (ii) continued scientific progress in our programs; (iii) the outcome of potential partnering or licensingtransactions, if any; (iv) competing technological developments; (v) our proprietary patent position; and (vi) the regulatory approvalprocess for our products.

Wewill need to raise substantial additional funds through public or private equity offerings, debt financings or strategic alliances andlicensing arrangements to finance our planned business operations. We may not be able to obtain additional financing on terms favorableto us, if at all. General market conditions, as well as the ongoing COVID-19 pandemic, raising interest rates and inflation, as wellas global conflicts which as the ongoing conflict between Ukraine and Russia, as well as the potential implications of a Congressionalimpasse over the U.S. debt limit or possible future U.S. governmental shutdowns over budget disagreements, may make it difficult forus to seek financing from the capital markets, and the terms of any financing may adversely affect the holdings or the rights of ourstockholders. For example, if we raise additional funds by issuing equity securities, further dilution to our stockholders will result,which may substantially dilute the value of their investment. Any equity financing may also have the effect of reducing the conversionor exercise price of our outstanding convertible or exercisable securities, which could result in the issuance (or potential issuance)of a significant number of additional shares of our common stock. In addition, as a condition to providing additional funds to us, futureinvestors may demand, and may be granted, rights superior to those of existing stockholders. Debt financing, if available, may involverestrictive covenants that could limit our flexibility to conduct future business activities and, in the event of insolvency, could bepaid before holders of equity securities received any distribution of our assets. We may be required to relinquish rights to our technologiesor product candidates, or grant licenses through alliance, joint venture or agreements on terms that are not favorable to us, in orderto raise additional funds. If adequate funds are not available, we may have to delay, reduce or eliminate one or more of our plannedactivities with respect to our business, or terminate our operations. These actions would likely reduce the market price of our commonstock.

Wewill need additional capital which may not be available on commercially acceptable terms, if at all, which raises questions about ourability to continue as a going concern.

Asof December 31, 2022, we had an accumulated deficit of $107,408,545 and working capital of $3,270,608, and for the year ended December31, 2022, a net loss of $38,726,259 and cash used in operating activities of $12,127,585. As of May 5, 2023, we had cash on hand ofapproximately $3.2 million. The accompanying consolidated financial statements have been prepared assuming we will continue as a goingconcern. As we are not generating revenues, we need to raise a significant amount of capital in order to pay our debts and cover ouroperating costs. While we recently raised funds through the sale of equity in July 2022 ($6.5 million of gross proceeds) and December2022 ($6.0 million of gross proceeds), there is no assurance that we will be able to raise additional needed capital or that such capitalwill be available under favorable terms.

Weare subject to all the substantial risks inherent in the development of a new business enterprise within an extremely competitive industry.Due to the absence of a long-standing operating history and the emerging nature of the markets in which we compete, we anticipate operatinglosses until we can successfully implement our business strategy, which includes all associated revenue streams. We may never ever achieveprofitable operations or generate significant revenues.

Wecurrently have a monthly cash requirement spend of approximately $900,000. We believe that in the aggregate, we will require significantadditional capital funding to support and expand the research and development and marketing of our products, fund future clinical trials,repay debt obligations, provide capital expenditures for additional equipment and development costs, payment obligations, office spaceand systems for managing the business, and cover other operating costs until our planned revenue streams from products are fully-implementedand begin to offset our operating costs, if ever.

Sinceour inception, we have funded our operations with the proceeds from equity and debt financings. We have experienced liquidity issuesdue to, among other reasons, our limited ability to raise adequate capital on acceptable terms. We have historically relied upon thesale of equity and debt funding that is convertible into shares of our common stock to fund our operations and have devoted significantefforts to reduce that exposure. We anticipate that we will need to issue equity to fund our operations and fund our operating expensesfor the foreseeable future. If we are unable to achieve operational profitability or we are not successful in securing other forms offinancing, we will have to evaluate alternative actions to reduce our operating expenses and conserve cash.

Theseconditions raise substantial doubt about our ability to continue as a going concern for the next twelve months from the date of issuanceof the auditor’s report set forth herein. The accompanying consolidated financial statements have been prepared in accordance withaccounting principles generally accepted in the United States on a going concern basis, which contemplates the realization of assetsand the satisfaction of liabilities in the normal course of business. Accordingly, the consolidated financial statements do not includeany adjustments relating to the recoverability of assets and classification of liabilities that might be necessary should we be unableto continue as a going concern. The consolidated financial statements included herein also include a going concern footnote.

Additionally,wherever possible, our board of directors (“Board of Directors” or “Board”))will attempt to usenon-cash consideration to satisfy obligations. In many instances, we believe that the non-cash consideration will consist of restrictedshares of our common stock, preferred stock or warrants to purchase shares of our common stock. Our Board has authority, without actionor vote of the stockholders, but subject to Nasdaq rules and regulations (which generally require stockholder approval for any transactionswhich would result in the issuance of more than 20% of our then outstanding shares of common stock or voting rights representing over20% of our then outstanding shares of stock, subject to certain exceptions), to issue all or part of the authorized but unissued sharesof common stock, preferred stock or warrants to purchase such shares of common stock. In addition, we may attempt to raise capital byselling shares of our common stock, possibly at a discount to market in the future. These actions will result in dilution of the ownershipinterests of existing stockholders, may further dilute common stock book value, and that dilution may be material. Such issuances mayalso serve to enhance existing management’s ability to maintain control of us, because the shares may be issued to parties or entitiescommitted to supporting existing management.

Wehave significant and increasing liquidity needs and require additional funding.

Researchand development, management and administrative expenses, including legal expenses, and cash used for operations will continue to be significantand may increase substantially in the future in connection with new research and development initiatives, clinical trials, continuedproduct commercialization efforts and the launch of our future product candidates. We will need to raise additional capital to fund ouroperations, continue to conduct clinical trials to support potential regulatory approval of marketing applications, and to fund commercializationof our future product candidates.

Theamount and timing of our future funding requirements will depend on many factors, including, but not limited to:

Whilewe expect to fund our future capital requirements from a number of sources, such as cash flow from operations and the proceeds from furtherpublic and/or private offerings, we cannot assure you that any of these funding sources will be available to us on favorable terms, orat all. Further, even if we can raise funds from all of the above sources, the amounts raised may not be sufficient to meet our futurecapital requirements.

Wemay need to raise additional capital, which may not be available on favorable terms, if at all, causing dilution to our stockholders,restricting our operations or adversely affecting our ability to operate our business.

Wemay not be able to obtain additional financing on terms favorable to us, if at all, including as a result of macroeconomic conditionssuch as a severe or prolonged economic downturn. Disruption, uncertainty or volatility in the capital markets could increase our costof capital or limit our ability to raise funds needed to operate our business. Disruptions could be caused by Federal Reserve policiesand actions, currency concerns, inflation, economic downturn or uncertainty, monetary policies, failures of financial institutions, U.S.debt management concerns, and U.S. debt limit and budget disputes, including government shutdowns, European and worldwide sovereign debtconcerns, other global or geopolitical events, or other factors. Current macroeconomic conditions have negatively impacted the U.S. bankingsector, including for example, the recent closures and FDIC receiverships of Silicon Valley Bank and Signature Bank. Although we do nothave any accounts at or business relationships with these banks, we may be negatively impacted by other disruptions to the U.S. bankingsystem caused by these or similar developments.

Ourresults of operations may be adversely affected by fluctuations in currency values.

Weexpend expenses in currencies other than the U.S. dollar. Our reporting currency is the United States dollar. The functional currencyof certain subsidiaries is the Canadian Dollar (“CAD”) or British Pound (“£” or “GBP”).The resulting translation adjustments are recognized in stockholders’ equity as a component of accumulated other comprehensiveincome. Comprehensive income is defined as the change in equity of an entity from all sources other than investments by owners or distributionsto owners and includes foreign currency translation adjustments as described above. During the years ended December 31, 2022 and 2021,we recorded other comprehensive (loss) income of ($3,702,963) and $180,554, respectively, as a result of foreign currency translationadjustments.

Foreigncurrency gains and losses resulting from transactions denominated in foreign currencies, including intercompany transactions, are includedin results of operations. We recognized ($12,777) and ($69) of foreign currency transaction (losses) for the years ended December 31,2022 and 2021, respectively. Such amounts have been classified within general and administrative expenses in the accompanying consolidatedstatements of operations and comprehensive loss.

Changesin the value of the currencies which we pay expenses (and in the future receive revenues), versus each other, and the U.S. dollar, couldresult in an adverse charge being recorded to our income statement.

Globaleconomic conditions could materially adversely affect our business, results of operations, financial condition and growth.

Adversemacroeconomic conditions, including inflation, slower growth or recession, new or increased tariffs, changes to fiscal and monetary policy,tighter credit, higher interest rates, high unemployment and currency fluctuations, as well as the potential implications of a Congressionalimpasse over the U.S. debt limit or possible future U.S. governmental shutdowns over budget disagreements, could materially adverselyaffect our operations, expenses, access to capital and the market for our planned future products. In addition, consumer confidence andspending could be adversely affected in response to financial market volatility, negative financial news, conditions in the real estateand mortgage markets, declines in income or asset values, changes to fuel and other energy costs, labor and healthcare costs and othereconomic factors.

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

Adownturn in the economic environment could also lead to limitations on our ability to sell equity or issue new debt; reduce liquidity;and result in declines in the fair value of our financial instruments. These and other economic factors could materially adversely affectour business, results of operations, financial condition and growth.

Ourindustry and the broader U.S. economy have experienced higher than expected inflationary pressures during 2022, related to continuedsupply chain disruptions, labor shortages and geopolitical instability. Should these conditions persist our business, future resultsof operations and cash flows could be materially and adversely affected.

Calendar2022 has seen significant increases in the costs of certain materials, products and shipping costs, as a result of availability constraints,supply chain disruption, increased demand, labor shortages associated with a fully employed U.S. labor force, high inflation and otherfactors. Supply and demand fundamentals have been further aggravated by disruptions in global energy supply caused by multiple geopoliticalevents, including the ongoing conflict between Russia and Ukraine. Service, materials and shipping costs have also increased accordinglywith general supply chain and inflation issues seen throughout the U.S. leading to increased operating costs. Recent supply chain constraintsand inflationary pressures may adversely impact our operating costs and may negatively impact our future product costs, consulting costsand expenses which could have a material adverse effect on our business, financial condition, results of operations and cash flows.

Economicuncertainty may affect our access to capital and/or increase the costs of such capital.

Globaleconomic conditions continue to be volatile and uncertain due to, among other things, consumer confidence in future economic conditions,fears of recession and trade wars, the price of energy, fluctuating interest rates, the availability and cost of consumer credit, theavailability and timing of government stimulus programs, levels of unemployment, increased inflation, tax rates, and the war betweenUkraine and Russia which began in February 2022, and the potential implications of a Congressional impasse over the U.S. debt limit orpossible future U.S. governmental shutdowns over budget disagreements. These conditions remain unpredictable and create uncertaintiesabout our ability to raise capital in the future. In the event required capital becomes unavailable in the future, or more costly, itcould have a material adverse effect on our business, future results of operations, and financial condition.

Wemay not receive any amounts under our pre-merger directors’ and officers’ insurance policy in connection with certain litigationmatters.

OnJune 29, 2022, AmTrust International Underwriters DAC (“AmTrust”), which was the premerger directors’ and officers’insurance policy underwriter for KBL, filed a declaratory relief action against us in the U.S. District Court for the Northern Districtof California (the “Declaratory Relief Action”) seeking declaration of AmTrust’s obligations under the directors’and officers’ insurance policy. In the Declaratory Relief Action, AmTrust is claiming that as a result of the merger, we are nolonger the insured under the subject insurance policy, notwithstanding the fact that the fees which we seek to recover from AmTrust relateto matters occurring prior to the merger. On September 20, 2022, we filed our Answer and Counterclaims against AmTrust for bad faithbreach of AmTrust’s insurance coverage obligations to us under the subject directors’ and officers’ insurance policy,and seeking damages of at least $2 million in compensatory damages, together with applicable punitive damages. In addition, we broughta Third-Party Complaint against our excess insurance carrier, Freedom Specialty Insurance Company (“Freedom”) seekingdeclaratory relief that Freedom will also be required to honor its policy coverage as soon as the amount of AmTrust’s insurancecoverage obligations to us have been exhausted. On October 25, 2022, AmTrust filed its Answer to our Counterclaims and, on October 27,2022, Freedom filed its Answer to the Third-Party Complaint.

OnNovember 22, 2022, we filed a Motion for Summary Adjudication against both AmTrust and Freedom. The Motion was fully briefed, and a hearingwas held on March 9, 2023. The standard to prevail on a Motion for Summary Adjudication in the Court is high to prevail and requiresa judge to find that there are no disputed issues of fact so that they can rule on the issues as a matter of law. In this instance thejudge found three major issues could be decided as a matter of law in our favor and that one issue, the Change in Control exclusion,requires further discovery.

OnApril 21, 2023, the Court issued an Order Granting in Part and Denying in Part our Motion for Partial Summary Judgment. Specifically,the Court granted summary adjudication in our favor on the following issues: (a) that we are, in fact, an insured under both the AmTrustand Freedom insurance policies; (b) that certain SEC subpoena related expenses for defendants Dr. Marlene Krauss, the Company’sformer Chief Executive Officer and Director, and George Hornig, the former Chairman of the Board, are within the basic scope of coverageunder both the AmTrust and Freedom insurance policies; and (c) that the Insured vs. Insured exclusion relied upon by AmTrust and Freedomis not applicable to bar any such coverage.

TheCourt also found that there were issues of disputed facts as to the Change in Control exclusion contained within the policies, whichtherefore precluded the Court from granting the remainder of our requests for summary adjudication as a matter of law. Accordingly, theCourt, at this time, denied our further requests for summary adjudication and deemed that for the time being, the Change in Control issueis to be determined at the time of trial, in order to find that the policies (i) provide coverage for the fees which we had advancedand will advance to Dr. Marlene Krauss and George Hornig; (ii) that AmTrust has breached the policy; (iii) that AmTrust must pay suchexpenses of the Company; and that, once the AmTrust policy has been exhausted, (iv) Freedom will be obligated to pay such expenses ofthe Company pursuant to its policy. We intend to continue to vigorously pursue this final matter in order to establish our entitlementto full payment by both AmTrust and Freedom of the subject advancement expenses of the Company.

While we continue to believe we have a strongcase against both AmTrust and Freedom, and we believe the Court ruling in our favor in regards to the matters discussed above is a significantpositive outcome for us, there can be no assurance that we will prevail in this action.

Weare dependent on the success of our future product candidates, some of which may not receive regulatory approval or be successfully commercialized.

Oursuccess will depend on our ability to successfully develop and commercialize our future product candidates through our development programs,including our product candidate for the treatment of Dupuytren’s Contracture and any other product candidates developed throughour fibrosis & anti-TNF, CBD derivatives, and α7nAChR development platforms. We may never be able to develop products whichreceive regulatory approval in the United States or elsewhere. There can be no assurance that the FDA, MHRA, EMA or any other regulatoryauthority will approve these product candidates.

Ourability to successfully commercialize our future product candidates will depend on, among other things, our ability to successfully completepre-clinical and other non-clinical studies and clinical trials and to receive regulatory approvals from the FDA, MHRA, EMA and similarforeign regulatory authorities. Delays in the regulatory process could have a material adverse effect on our business, results of operationsand financial condition.

Ourability to generate revenue from any of our potential products is subject to our ability to obtain regulatory approval and fulfill numerousother requirements and we may never be successful in generating revenues or becoming profitable.

Ourability to become and remain profitable depends on our ability to generate revenue or execute other business development arrangements.We do not expect to generate significant revenue, if any, unless and until we are able to obtain regulatory approval for, and successfullycommercialize the product candidates we are developing or may develop. Successful commercialization, to the extent it occurs, will requireachievement of many key milestones, including demonstrating safety and efficacy in clinical trials, obtaining regulatory approval forthese product candidates, manufacturing, marketing and selling, or entering into other agreements to commercialize, those products forwhich we may obtain regulatory approval, satisfying any post-marketing requirements and obtaining reimbursement for our products fromprivate insurance or government payors. Because of the uncertainties and risks associated with these activities, we cannot accuratelyand precisely predict the timing and amount, if any, of revenues, the extent of any further losses or when we might achieve profitability.We may never succeed in these activities and, even if we do, we may never generate revenues that are sufficient enough for us to achieveprofitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annualbasis.

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

Wehave recently grown our business and will need to increase the size and complexity of our organization in the future, and we may experiencedifficulties in managing our growth and executing our growth strategy.

Ourmanagement, personnel and systems currently in place may not be adequate to support our business plan and future growth. We will needto increase our number of full-time equivalent employees in order to conduct Phase 1, 2 and 3 clinical trials of our future productsand to establish a commercial organization and commercial infrastructure. As a result of these future activities, the complexity of ourbusiness operations is expected to substantially increase. We will need to develop and expand our scientific, manufacturing, sales andmarketing, managerial, compliance, operational, financial and other resources to support our planned research, development, manufacturingand commercialization activities.

Ourneed to effectively manage our operations, growth and various projects requires that we:

Wehave utilized and continue to utilize the services of part-time outside consultants and contractors to perform a number of tasks forour company, including tasks related to compliance programs, clinical trial management, regulatory affairs, formulation development andother drug development functions. Our growth strategy may entail expanding our use of consultants and contractors to implement theseand other tasks going forward. If we are not able to effectively expand our organization by hiring new employees and expanding our useof consultants and contractors, we may be unable to successfully implement the tasks necessary to effectively execute on our plannedresearch, development, manufacturing and commercialization activities and, accordingly, may not achieve our research, development andcommercialization goals.

Weface liability for previously restated financial statements and/or certain actions of our prior management which led to such restatements.

Wefiled a Current Report on Form 8-K on December 31, 2020 and another Current Report on Form 8-K on February 3, 2021, where we announcedthat due to matters we discovered which related to KBL, prior to the Business Combination, certain historical financial statements wereunreliable. As a result, we restated our financial statements for the three and six months ended June 30, 2020 and for the three andnine months ended September 30, 2020, because of errors in such financial statements which were identified after such financial statementswere filed with the SEC in our original quarterly reports for the quarters ended June 30, 2020 and September 30, 2020. While we believethese restatements are the result of the actions of, and are the responsibility of, the management of KBL (none of whom remain employedby us), we may be subject to stockholder litigation, SEC actions, fines and penalties, rating downgrades, negative publicity and difficultiesin attracting and retaining key clients, employees and management personnel as a result of such restatements. Additionally, our securitiesmay trade at prices lower than similarly situated companies which have not had to restate their financial statements.

Ourfailure to appropriately adjust processes resulting from significant one-time transactions may result in a misstatement in the financialstatements.

Inthe course of our annual audit but prior to filing, we discovered that an error occurred which caused the fair value of our public warrantsto be overstated by an immaterial amount. This error was corrected before the 2022 financial statements were filed. While we believethat the fair value of warrants in the financial statements for the year ended December 31, 2022 are correctly stated, it is possiblethat similar errors which could have a material adverse effect on our financial condition and results of operations, could require usto restate our financial statements for prior periods or in the future.

Operatingresults may vary significantly in future periods.

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

Wedepend on our key personnel and our ability to attract and retain employees.

Ourfuture growth and success depend on our ability to recruit, retain, manage and motivate our employees. We are highly dependent on ourcurrent management and scientific personnel, including our Chief Executive Officer, Dr. James N. Woody, our Co-Chairmen, Sir Marc Feldmann,Ph.D., and Lawrence Steinman, M.D., our Chief Scientific Officer, Jonathan Rothbard, Ph.D., and our scientist, Jagdeep Nanchahal. Theinability to hire or retain experienced management personnel could adversely affect our ability to execute our business plan and harmour operating results. Due to the specialized scientific and managerial nature of our business, we rely heavily on our ability to attractand retain qualified scientific, technical and managerial personnel. The competition for qualified personnel in the biotechnologicalfield is intense and we may be unable to continue to attract and retain qualified personnel necessary for the development of our businessor to recruit suitable replacement personnel.

Problemsin our manufacturing process for our future chemical entities, failure to comply with manufacturing regulations or unexpected increasesin our manufacturing costs could harm our business, results of operations and financial condition.

Weare responsible for the manufacture and supply of our future product candidates in the CBD derivatives and α7nAChR programs forcommercial use and for use in clinical trials. The manufacturing of our future product candidates necessitates compliance with GMPs andother regulatory requirements in international jurisdictions. Our ability to successfully manufacture our future product candidates willinvolve manufacture of finished products and labeling and packaging, which includes product information, tamper proof evidence and anti-counterfeitfeatures, under tightly controlled processes and procedures. In addition, we will have to ensure chemical consistency among our batches,including clinical trial batches and, if approved, marketing batches. Demonstrating such consistency may require typical manufacturingcontrols as well as clinical data. We will also have to ensure that our batches conform to complex release specifications. If we areunable to manufacture our future product candidates in accordance with regulatory specifications, or if there are disruptions in ourmanufacturing process due to damage, loss or otherwise, or failure to pass regulatory inspections of our manufacturing facilities, wemay not be able to meet demand or supply sufficient product for use in clinical trials, and this may also harm our ability to commercializeour future product candidates on a timely or cost-competitive basis, if at all.

Wemay not develop and expand our manufacturing capability in time to meet demand for our product candidates, and the FDA, MHRA or otherforeign regulatory authorities may not accept our facilities or those of our contract manufacturers as being suitable for the productionof our products and product candidates. Any problems in our manufacturing process could materially adversely affect our business, resultsof operations and financial condition.

Ourmemorandum of understanding with Celltrion Healthcare may not result in the parties entering into a definitive agreement.

InSeptember 2021, we entered into a non-binding memorandum of understanding with Celltrion Healthcare, a biopharmaceutical company, forthe supply of an anti-TNF biosimilar drug used in our ongoing development of anti-TNF products. The parties have not entered into a definitiveagreement regarding such relationship to date, and such definitive agreement may not ultimately be entered into on terms contemplated,if at all. In the event that we are unable to come to mutually agreeable definitive terms with Celltrion Healthcare, we will need tolocate an alternative supplier of the anti-TNF biosimilar drug, and we may be unable to find an alternative supplier or such alternativesupplier may require less favorable terms than are currently contemplated. Any of the above may materially adversely affect our business,results of operations and financial condition.

Weexpect to face intense competition from companies with greater resources and experience than we have; and may face competition from competitorsseeking to market our products under a Section 505(b)(2) application.

Thepharmaceutical industry is highly competitive and subject to rapid change. The industry continues to expand and evolve as an increasingnumber of competitors and potential competitors enter the market. Many of these competitors and potential competitors have substantiallygreater financial, technological, managerial and research and development resources and experience than our company. Some of these competitorsand potential competitors have more experience than our company in the development of pharmaceutical products, including validation proceduresand regulatory matters. In addition, our future product candidates, if successfully developed, will compete with product offerings fromlarge and well-established companies that have greater marketing and sales experience and capabilities than our company or our collaborationpartners have. In particular, Insys Therapeutics, Inc. is developing CBD in Infantile Spasms (“IS”), and potentiallyother indications. Zogenix, Inc. has reported positive data in two Phase 3 trials of low dose fenfluramine in Dravet syndrome and hascommenced a Phase 3 trial with this product in Lennox Gastaut Syndrome. Biocodex recently received regulatory approval from the FDA forthe drug Stiripentol (Diacomit) for the treatment of Dravet syndrome. Other companies with greater resources than our company may announcesimilar plans in the future. In addition, there are non-FDA approved CBD preparations being made available from companies in the medicalmarijuana industry, which might attempt to compete with our future product candidates.

Manyof our competitors have significantly greater financial and technical resources, experience and expertise in:

Principalcompetitive factors in our industry include:

Additionally,competitors may also seek to market versions of our drug products via a section 505(b)(2) application, which is a type of NDA providedin section 505(b)(2) of the FDC Act. A Section 505(b)(2) NDA is in contrast to an NDA under section 505(b)(1) of the FDA Act, which iscommonly known as a Full NDA because it requires the applicant to undertake all of the nonclinical and clinical investigations necessaryfor the approval of the application. In contrast, a Section 505(b)(2) NDA application is one for which one or more of the investigationsrelied on by the applicant for approval were not conducted by or for the applicant and for which the applicant has not obtained a rightof reference or use from the person by or for whom the investigations were conducted. Section 505(b)(2) applications may be submittedfor drug products that represent a modification, such as a new indication or new dosage form, of a previously approved drug. Section505(b)(2) applications may rely on the FDA’s previous findings for the safety and effectiveness of the previously approved drugin addition to information obtained by the 505(b)(2) applicant to support the modification of the previously approved drug. PreparingSection 505(b)(2) applications may be less costly and less time-consuming than preparing a Full NDA based entirely on new data and information.Section 505(b)(2) applications are subject to the same patent certification procedures as an ANDA.

Ifwe are unable to compete successfully, our commercial opportunities will be reduced and our business, results of operations and financialconditions may be materially harmed.

Ourfuture product candidates, if approved, may be unable to achieve the expected market acceptance and, consequently, limit our abilityto generate revenue from new products.

Evenwhen product development is successful and regulatory approval has been obtained, our ability to generate sufficient revenue dependson the acceptance of our products by physicians and patients. We cannot assure you that any of our future product candidates will achievethe expected level of market acceptance and revenue if and when they obtain the requisite regulatory approvals. The market acceptanceof any product depends on a number of factors, including the indication statement, warnings required by regulatory authorities in theproduct label and new competing products. Market acceptance can also be influenced by continued demonstration of efficacy and safetyin commercial use, physicians’ willingness to prescribe the product, reimbursement from third-party payors such as government healthcare programs and private third-party payors, the price of the product, the nature of any post-approval risk management activities mandatedby regulatory authorities, competition, and marketing and distribution support. Further, our U.S. distribution depends on the adequateperformance of a reimbursement support hub and contracted specialty pharmacies in a closed-distribution network. An ineffective or inefficientU.S. distribution model at launch may lead to inability to fulfill demand, and consequently a loss of revenue. The success and acceptanceof a product in one country may be negatively affected by its activities in another. If we fail to adapt our approach to clinical trialsin the U.S. market to meet the needs of EMA, MHRA or other European regulatory authorities, or to generate the health economics and outcomesresearch data needed to support pricing and reimbursement negotiations or decisions in Europe, we may have difficulties obtaining marketingauthorization for our products from EMA/European Commission or the MHRA and may have difficulties obtaining pricing and reimbursementapproval for our products at a national level. Any factors preventing or limiting the market acceptance of our products could have amaterial adverse effect on our business, results of operations and financial condition.

Allof our patents in the Anti-TNF and Fibrosis program are method of use patents, which may result in biosimilar drugs being used withoutour permission.

Thesuccess of our most advanced drug development platform depends on the enforceability of our method of use patents, as there are currentlymany biosimilar anti-TNF drugs in the market. If we are unable to obtain composition of matter patents, and enforce such patents, ourability to generate revenue from the anti-TNF platform may be significantly limited and competitors may be able to use our research tobring competing drugs to market which would reduce our market share.

Themajority of our license agreements provide the licensors and/or counter-parties the right to use and/or exploit such licensed intellectualproperty.

Themajority of our license agreements provide the licensors and/or counter-parties the right to use and/or exploit such licensed intellectualproperty, and in some cases provide them ownership of such intellectual property, know-how and research results. As such, we may be incompetition with parties who we have license agreements with, will likely not have the sole right to monetize, sell or distribute ourproduct candidates and may be subject to restrictions on use and territory of sales. Any or all of the above may have a material adverseeffect on our results of operations and cash flows and ultimately the value of our securities.

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

Fromtime to time, we may publicly disclose preliminary, interim or topline data from our preclinical studies and clinical trials, which isbased on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change aspatient enrollment and treatment continues and more patient data become available. For example, any positive results from our preclinicaltesting, Phase 1 and Phase 2 clinical trials of our product candidate for any product candidate may not necessarily be predictive ofthe results from planned or future clinical trials for such product candidates. Many companies in the pharmaceutical and biotechnologyindustries have suffered significant setbacks in clinical trials after achieving positive results in pre-clinical and early clinicaldevelopment, and we cannot be certain that we will not face similar setbacks. These setbacks have been caused by, among other things,pre-clinical findings while clinical trials were underway or safety or efficacy observations in clinical trials, including adverse events.Adverse differences between previous preliminary or interim data and future interim or final data could significantly harm our businessprospects. We may also announce topline data following the completion of a preclinical study or clinical trial, which may be subjectto change following a more comprehensive review of the data related to the particular study or trial. We also make assumptions, estimations,calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefullyevaluate all data. As a result, the interim, topline or preliminary results that we report may differ from future results of the samestudies, or different conclusions or considerations may qualify such results, once additional data has been received and fully evaluated.Preliminary, interim, or topline data also remains subject to audit and verification procedures that may result in the final data beingmaterially different from the data we previously published. As a result, preliminary, interim, and topline data should be viewed withcaution until the final data is available.

Further,others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analysesor may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvabilityor commercialization of the particular product candidate or product and our company in general. In addition, the information we chooseto publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or othersmay not agree with what we determine to be material or otherwise appropriate information to include in our disclosure. Moreover, ourinterpretation of clinical data or our conclusions based on the preclinical in vitro and in vivo models may prove inaccurate, as preclinicaland clinical data can be susceptible to varying interpretations and analyses, and many companies that believed their product candidatesperformed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain FDA approval or a marketing authorizationgranted by the European Commission.

Ifwe fail to produce positive results in our future clinical trials, the development timeline and regulatory approval and commercializationprospects for such product candidates, and, correspondingly, our business and financial prospects, would be materially adversely affected.

Wehave limited marketing experience, and we may not be able to successfully commercialize any of our future product candidates, even ifthey are approved in the future.

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

Ifthe price for any of our future approved products decreases or if governmental and other third-party payors do not provide coverage andadequate reimbursement levels, our revenue and prospects for profitability will suffer.

Patientswho are prescribed medicine for the treatment of their conditions generally rely on third-party payors to reimburse all or part of thecosts associated with their prescription drugs. Reimbursement systems in international markets vary significantly by country and by region,and reimbursement approvals generally must be obtained on a country-by-country basis. Coverage and adequate reimbursement from governmentalhealthcare programs, such as Medicare and Medicaid, and commercial payors is critical to new product acceptance. Coverage decisions maydepend upon clinical and economic standards that disfavor new drug products when more established or lower cost therapeutic alternativesare already available or subsequently become available. Even if we obtain coverage for our future product candidates, the resulting reimbursementpayment rates may require co-payments that patients find unacceptably high. Patients may not use our future product candidates if coverageis not provided or reimbursement is inadequate to cover a significant portion of a patient’s cost.

Inaddition, the market for our future product candidates in the United States will depend significantly on access to third-party payors’drug formularies, or lists of medications for which third-party payors provide coverage and reimbursement. The industry competition tobe included in such formularies often leads to downward pricing pressures on pharmaceutical companies. Also, third-party payors may refuseto include a particular branded drug in their formularies or otherwise restrict patient access to a branded drug when a less costly genericequivalent or other alternative is available.

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

Inaddition, where we have chosen to collaborate with a third party on product candidate development and commercialization, our partnermay elect to reduce the price of our products to increase the likelihood of obtaining reimbursement approvals. In many countries, productscannot be commercially launched until reimbursement is approved and the negotiation process in some countries can exceed 12 months. Inaddition, pricing and reimbursement decisions in certain countries can be affected by decisions made in other countries, which can leadto mandatory price reductions and/or additional reimbursement restrictions across a number of other countries, which may adversely affectsales and profitability. In the event that countries impose prices that are not sufficient to allow us or our partners to generate aprofit, our partners may refuse to launch the product in such countries or withdraw the product from the market, which would adverselyaffect sales and profitability.

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

Lossof our future manufacturing facilities, stored inventory or laboratory facilities through fire, theft or other causes, could have anadverse effect on our ability to meet demand for our future product candidates or to continue product development activities and to conductour business. Failure to supply our partners with commercial products may lead to adverse consequences, including the right of partnersto assume responsibility for product supply. Even if we obtain insurance coverage to compensate us for such business interruptions, suchcoverage may prove insufficient to fully compensate us for the damage to our business resulting from any significant property or casualtyloss to our inventory.

Ifproduct liability lawsuits are successfully brought against us, we will incur substantial liabilities and may be required to limit thecommercialization of our future product candidates.

Althoughwe have never had any product liability claims or lawsuits brought against us, we face potential product liability exposure related tothe testing of our future product candidates in human clinical trials, and we will face exposure to claims in jurisdictions where wemarket and distribute in the future. We may face exposure to claims by an even greater number of persons when we begin marketing anddistributing our products commercially in the United States and elsewhere. In the future, an individual may bring a liability claim againstus alleging that one of our future product candidates caused an injury. While we plan to take what we believe are appropriate precautions,we may be unable to avoid significant liability if any product liability lawsuit is brought against us. Large judgments have been awardedin class action or individual lawsuits based on drugs that had unanticipated side effects. Although we plan to purchase insurance tocover product liability lawsuits, if we cannot successfully defend our company against product liability claims, or if such insurancecoverage is inadequate, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result indecreased demand for our products, reputational damage, withdrawal of clinical trial participation participants, litigation costs, productrecall costs, monetary awards, increased costs for liability insurance, lost revenues and business interruption.

Ouremployees may have previously engaged, and/or may in the future engage, in misconduct or other improper activities, including noncompliancewith regulatory standards and legal requirements.

Weare exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to comply withFDA, SEC or Office of Inspector General regulations, or regulations of any other applicable regulatory authority, failure to provideaccurate information to the FDA or the SEC, failure to disclose accurate information in SEC filings, failure to comply with applicablemanufacturing standards, other federal, state or foreign laws and regulations, report information or data accurately or disclose unauthorizedactivities. Employee misconduct could also involve the improper use of information, including information obtained in the course of clinicaltrials, or illegal appropriation of drug product, which could result in government investigations and serious harm to our reputation.Despite our adoption of a Code of Ethics, employee misconduct is not always possible to identify and deter. The precautions we take todetect and prevent these prohibited activities may not be effective in controlling unknown or unmanaged risks or losses or in protectingus from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.If any such actions are instituted against our company, and we are not successful in defending our company or asserting our rights, thoseactions could have a significant impact on our business, including the imposition of significant fines or other sanctions.

Weare subject to the U.S. Foreign Corrupt Practices Act and other anti-corruption laws, as well as export control laws, customs laws, sanctionslaws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties,other remedial measures, and legal expenses, which could adversely affect our business, results of operations and financial condition.

Ouroperations are subject to anti-corruption laws, including the U.S. Foreign Corrupt Practices Act (“FCPA”), and otheranti-corruption laws that apply in countries in which we do business. The FCPA and these other laws generally prohibit our company andour employees and intermediaries from bribing, being bribed or making other prohibited payments to government officials or other personsto obtain or retain business or gain some other business advantage. We and our commercial partners operate in a number of jurisdictionsthat pose a high risk of potential FCPA violations, and we participate in collaborations and relationships with third parties whose actionscould potentially subject us to liability under the FCPA or local anti-corruption laws. In addition, we cannot predict the nature, scopeor effect of future regulatory requirements to which our international operations might be subject or the manner in which existing lawsmight be administered or interpreted.

Weare also subject to other laws and regulations governing our international operations, including regulations administered by the governmentsof the United States, Canada, Israel, the United Kingdom and authorities in the European Union, including applicable export control regulations,economic sanctions on countries and persons, customs requirements and currency exchange regulations, collectively referred to as theTrade Control Laws.

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

Securitybreaches, loss of data and other disruptions could compromise sensitive information related to our business, prevent us from accessingcritical information or expose us to liability, which could adversely affect our business and our reputation.

Inthe ordinary course of business, we expect to collect and store sensitive data, including legally protected patient health information,credit card information, personally identifiable information about our employees, intellectual property, and proprietary business information.The secure processing, storage, maintenance and transmission of this critical information is vital to our operations and business strategy,and we devote significant resources to protecting such information. Although we take measures to protect sensitive information from unauthorizedaccess or disclosure, our information technology and infrastructure may be vulnerable to attacks by hackers, or viruses, breaches orinterruptions due to employee error, malfeasance or other disruptions, or lapses in compliance with privacy and security mandates. Anysuch virus, breach or interruption could compromise our networks and the information stored there could be accessed by unauthorized parties,publicly disclosed, lost or stolen. We have measures in place that are designed to prevent, and if necessary, to detect and respond tosuch security incidents and breaches of privacy and security mandates. However, in the future, any such access, disclosure or other lossof information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, suchas HIPAA and European Union General Data Protection Regulation (“GDPR”), government enforcement actions and regulatorypenalties. Unauthorized access, loss or dissemination could also disrupt our operations, including our ability to process samples, providetest results, share and monitor safety data, bill payors or patients, provide customer support services, conduct research and developmentactivities, process and prepare company financial information, manage various general and administrative aspects of our business andmay damage our reputation, any of which could adversely affect our business, financial condition and results of operations.

GDPR,which applies to all EU member states includes substantial fines for breaches of the data protection rules and may require us to putin place additional mechanisms ensuring compliance with the new and changing data protection rules. GDPR is a complex law and the regulatoryguidance is still evolving, including with respect to how GDPR should be applied in the context of clinical trials or other transactionsfrom which we may gain access to personal data. GDPR increases our costs of compliance and results in greater legal risks.

Ourresearch and development programs and product candidates are in development. As a result, we are unable to predict if or when we willsuccessfully develop or commercialize our product candidates.

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

Evenif we obtain the required financing or establish a collaboration to enable us to conduct late-stage clinical development of our productcandidates and pipeline assets, we cannot be certain that such clinical development would be successful, or that we will obtain regulatoryapproval or be able to successfully commercialize any of our product candidates and generate revenue. Success in preclinical testingand early clinical trials does not ensure that later clinical trials will be successful, and the clinical trial process may fail to demonstratethat our product candidates are safe and effective for their proposed uses. Any such failure could cause us to abandon further developmentof any one or more of our product candidates and may delay development of other product candidates. Product candidates in later stagesof clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies andinitial clinical trials. Any delay in, or termination of, our clinical trials will delay and possibly preclude the submission of anyNDAs with the FDA, Marketing Authorisation Applications (MAA) or Conditional Marketing Authorisations (CMA) with the MHRA, or similarauthorizations with other foreign regulatory agencies, and, ultimately, our ability to commercialize our product candidates and generateproduct revenue.

Wehave not previously submitted an NDA to the FDA, or MAA or CMA to the MHRA, or similar drug approval filings to comparable foreign authorities,for any product candidate, and we cannot be certain that any of our product candidates will receive regulatory approval. Further, ourproduct candidates may not receive regulatory approval even if they are successful in clinical trials. If we do not receive regulatoryapprovals for our product candidates, we may not be able to continue our operations. Even if we successfully obtain regulatory approvalsto market one or more of our product candidates, our revenues will be dependent, in part, upon our or our collaborators’ and futurecollaborators’ ability to obtain regulatory approval for the companion diagnostics to be used with our product candidates, if required,and upon the size of the markets in the territories for which we gain regulatory approval and have commercial rights. If the marketsfor patient subsets that we are targeting are not as significant as we estimate, we may not generate significant revenues from salesof such products, if approved.

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

Thesuccessful commercialization of our product candidates, if approved, will depend on achieving market acceptance and we may not be ableto gain sufficient acceptance to generate significant revenue.

Evenif our product candidates are successfully developed and receive regulatory approval, they may not gain market acceptance among physicians,patients, healthcare payors such as private insurers or governments and other funding parties and the medical community. The degree ofmarket acceptance for any of our products will depend on a number of factors, including:

Diseaseindications may be small subsets of a disease that could be parsed into smaller and smaller indications as different subsets of diseasesare defined. This increasingly fine characterization of diseases could have negative consequences; including creating an approved indicationthat is so small as not to have a viable market for us. If future technology allows characterization of a disease in a way that is differentfrom the characterization used for large pivotal studies, it may make those studies invalid or reduce their usefulness, and may requirerepeating all or a portion of the studies. Future technology may supply better prognostic ability which could reduce the portion of patientsprojected to need a new therapy. Even after being cleared by regulatory authorities, a product may later be shown to be unsafe or notto have its purported effect, thereby preventing its widespread use or requiring withdrawal from the market.

Wemay not be successful in establishing development and commercialization collaborations which could adversely affect, and potentiallyprohibit, our ability to develop our product candidates.

Developingpharmaceutical products, conducting clinical trials, obtaining regulatory approval, establishing manufacturing capabilities and marketingapproved products is expensive, and therefore we have, and may in the future, seek to enter into collaborations with companies that havemore resources and experience in order to continue to develop and commercialize our product candidates. We also may be required due tofinancial or scientific constraints to enter into additional collaboration agreements to research and/or to develop and commercializeour product candidates. The establishment and realization of such collaborations may not be possible or may be problematic. There canbe no assurance that we will be able to establish such additional collaborations on favorable terms, if at all, or that our current orfuture collaborative arrangements will be successful or maintained for any specific product candidate or indication. If we are unableto reach successful agreements with suitable collaboration partners for the ongoing development and commercialization of our productcandidates, we may face increased costs, we may be forced to limit the scope and number of our product candidates we can commerciallydevelop or the territories in which we commercialize such product candidates, and we may be unable to commercialize products or programsfor which a suitable collaboration partner cannot be found. If we fail to achieve successful collaborations, our operating results andfinancial condition will be materially and adversely affected.

Inaddition, the terms of any collaboration agreements may place restrictions on our activities with respect to other products, includingby limiting our ability to grant licenses or develop products with other third parties, or in different indications, diseases or geographicallocations, or may place additional obligations on us with respect to development or commercialization of our product candidates. If wefail to comply with or breach any provision of a collaboration agreement, a collaborator may have the right to terminate, in whole orin part, such agreement or to seek damages.

Ourcollaboration and licensing agreements are, and may in the future be, complex and involve sharing or division of ownership of certaindata, know-how and intellectual property rights among the various parties. Accordingly, our collaborators could interpret certain provisionsdifferently than we or our other collaborators which could lead to unexpected or inadvertent disputes with collaborators. In addition,these agreements might make additional collaborations, partnering or mergers and acquisitions difficult.

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

Wewill not be able to successfully commercialize our product candidates without establishing sales and marketing capabilities internallyor through collaborators.

Wemay not be able to find suitable sales and marketing staff and collaborators for all of our product candidates. The development of amarketing and sales capability will require significant expenditures, management resources and time. The cost of establishing such asales force may exceed any potential product revenue, or our marketing and sales efforts may be unsuccessful. If we are unable to developan internal marketing and sales capability in a timely fashion, or at all, or if we are unable to enter into a marketing and sales arrangementwith a third party on acceptable terms, we may be unable to effectively market and sell approved products, if any, which would preventus from being able to generate revenue and attain profitability. Further, we may not develop an internal marketing and sales capabilityif we are unable to successfully develop and seek regulatory approval for our product candidates.

Wewill rely upon third-party contractors and service providers for the execution of some aspects of our development programs. Failure ofthese collaborators to provide services of a suitable quality and within acceptable timeframes may cause the delay or failure of ourdevelopment programs.

Weoutsource certain functions, tests and services to third parties, partners, medical institutions and collaborators and plan to outsourcemanufacturing to collaborators and/or contract manufacturers, and we will rely on third parties for quality assurance, clinical monitoring,clinical data management and regulatory expertise. In particular, we rely on our partners to run our clinical trials. There is no assurancethat such individuals or organizations will be able to provide the functions, tests, drug supply or services as agreed upon or to acceptablequality standards, and we could suffer significant delays in the development of our products or processes. In particular, certain thirdparty service providers may be unable to comply with their contractual obligations to us due to disruptions caused by the COVID-19 pandemic,including reduced operations or headcount reductions, or otherwise, and in certain cases we may have limited recourse if the non-complianceis due to factors outside of the service provider’s control.

Ourbusiness is highly dependent on the success of our product candidates. If we are unable to successfully complete clinical development,obtain regulatory approval for or commercialize one or more of our product candidates, or if we experience delays in doing so, our businesswill be materially harmed.

Ourfuture success and ability to generate significant revenue from our product candidates, which we do not expect will occur for severalyears, is dependent on our ability to successfully develop, obtain regulatory approval for and commercialize one or more of our productcandidates, including our Dupuytren’s Contracture product candidate, which has recently completed a successful Phase 2b clinicaltrial in the United Kingdom, a condition that affects the development of fibrous connective tissue in the palm of the hand. All of ourother product candidates are in earlier stages of development and will require substantial additional investment for manufacturing, preclinicaltesting, clinical development, regulatory review and approval in one or more jurisdictions. If any of our product candidates encountersafety or efficacy problems, development delays or regulatory issues or other problems, our development plans and business would be materiallyharmed.

Wemay not have the financial resources to continue development of our product candidates. Even if clinical trials are completed, we mayexperience other issues that may delay or prevent regulatory approval of, or our ability to commercialize, our product candidates, including:

Ourproduct candidates will require additional, time-consuming development efforts prior to commercial sale, including preclinical studies,clinical trials and approval by the FDA, EMA, MHRA and/or other applicable foreign regulatory authorities. All product candidates areprone to the risks of failure that are inherent in pharmaceutical product development, including the possibility that such product candidatewill not be shown to be sufficiently safe and effective for approval by regulatory authorities. In addition, we cannot assure stockholdersthat any such products that are approved will be manufactured or produced economically, successfully commercialized or widely acceptedin the marketplace or be more effective than other commercially available alternatives.

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

Wehave three separate programs for producing anti-inflammatory agents: (1) investigating new clinical opportunities for anti-TNF, (2) identifyingorally available, small molecules that are agonists of α7 nicotinic acetylcholine receptor, and (3) identifying patentable analogsof CBD that initially will be used as pain medications, that are at various stages of preclinical development. Due to the significantresources required for the development of our product candidates, we must focus on specific diseases and disease pathways and decidewhich product candidates to pursue and advance and the amount of resources to allocate to each. Our decisions concerning the allocationof research, development, collaboration, management and financial resources toward particular product candidates or therapeutic areasmay not lead to the development of any viable commercial products and may divert resources away from better opportunities. If we makeincorrect determinations regarding the viability or market potential of any of our product candidates or misinterpret trends in the pharmaceuticalindustry, our business, financial condition, and results of operations could be materially adversely affected. As a result, we may (i)fail to capitalize on viable commercial products or profitable market opportunities, (ii) be required to forego or delay pursuit of opportunitieswith other product candidates or other diseases and disease pathways that may later prove to have greater commercial potential than thosewe choose to pursue, or (iii) relinquish valuable rights to such product candidates through collaboration, licensing, or other royaltyarrangements in cases in which it would have been advantageous for us to invest additional resources to retain sole development and commercializationrights.

Thetimelines of our clinical trials may be impacted by numerous factors and any delays may adversely affect our ability to execute our currentbusiness strategy.

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

Eventswhich may result in a delay or unsuccessful completion of clinical trials include:

Ifinitiation or completion of any of our clinical trials for our product candidates are delayed for any of the above reasons or for otherreasons, our development costs may increase, our approval process could be delayed, any periods after commercial launch and before expirationof patent protection may be reduced and our competitors may have more time to bring products to market before we do. Any of these eventscould impair the commercial potential of our product candidates and could have a material adverse effect on our business.

Clinicaltrials of our product candidates may not uncover all possible adverse effects that patients may experience.

Clinicaltrials are conducted in representative samples of the potential patient population, which may have significant variability. Clinicaltrials are by design based on a limited number of subjects and of limited duration for exposure to the product used to determine whether,on a potentially statistically significant basis, the planned safety and efficacy of any product candidate can be achieved. As with theresults of any statistical sampling, we cannot be sure that all side effects of our product candidates may be uncovered, and it may bethe case that only with a significantly larger number of patients exposed to the product candidate for a longer duration, that a morecomplete safety profile is identified. Further, even larger clinical trials may not identify rare serious adverse effects or the durationof such studies may not be sufficient to identify when those events may occur. Patients treated with our products, if approved, may experienceadverse reactions and it is possible that the FDA, MHRA or other regulatory authorities may ask for additional safety data as a conditionof, or in connection with, our efforts to obtain approval of our product candidates. If safety problems occur or are identified afterour product candidates reach the market, we may, or regulatory authorities may require us to amend the labeling of our products, recallour products or even withdraw approval for our products.

Failurecan occur at any stage of our drug development efforts.

Wemay experience numerous unforeseen events during, or as a result of, testing that could delay or prevent us from obtaining regulatoryapproval for, or commercializing our drug candidates, including but not limited to:

Werely on third parties to conduct our pre-clinical studies and clinical studies and trials, and if they do not perform their obligationsto us, we may not be able to obtain approval for additional indications.

Wedo not currently have the ability to independently conduct pre-clinical studies or clinical studies and trials, and we have to date reliedon third parties, such as third-party contract research and governmental organizations and medical institutions to conduct studies andtrials for us. Our reliance on third parties for development activities reduces our control over these activities. These third partiesmay not complete activities on schedule or may not conduct our pre-clinical studies and our clinical studies and trials in accordancewith regulatory requirements or our study design. If these third parties do not successfully carry out their contractual duties or meetexpected deadlines, we may be adversely affected, and our efforts to obtain regulatory approvals for and commercialize indications maybe delayed.

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

Althoughwe also rely on third parties to manage the data from our studies and trials, we are responsible for confirming that each of our studiesand trials is conducted in accordance with its general investigational plan and protocol. Moreover, the FDA and foreign regulatory agencieswill require us to comply with applicable regulations and standards, including Good Laboratory Practice (GLP) and Good Clinical Practice(GCP), for conducting, recording and reporting the results of such studies and trials to assure that the data and the results are credibleand accurate and that the human study and trial participants are adequately protected. Our reliance on third-parties does not relieveus of these obligations and requirements, and we may fail to obtain regulatory approval for any additional indications if these requirementsare not met.

Wewill need to continue to develop and maintain distribution and production capabilities or relationships to be successful.

Wemay not be able to successfully manufacture any product, either independently or under manufacturing arrangements, if any, with thirdparty manufacturers. Moreover, if any manufacturer should cease doing business with us or experience delays, shortages of supply or excessivedemands on their capacity, we may not be able to obtain adequate quantities of product in a timely manner, or at all. Manufacturers,and in certain situations their suppliers, are required to comply with current NDA commitments and current good manufacturing practices(cGMP) requirements enforced by the FDA, and similar requirements of other countries. The failure by a manufacturer to comply with theserequirements could affect its ability to provide us with products. Although we intend to rely on third-party contract manufacturers,we are ultimately responsible for ensuring that our products are manufactured in accordance with cGMP. In addition, if, during a preapprovalinspection or other inspection of our third-party manufacturers’ facility or facilities, the FDA determines that the facility isnot in compliance with cGMP, any of our marketing applications that lists such facility as a manufacturer may not be approved or approvalmay be delayed until the facility comes into compliance with cGMP and completes a successful re-inspection by the FDA.

Anymanufacturing problem, natural disaster, or epidemic, affecting manufacturing facilities, or the loss of a contract manufacturer couldbe disruptive to our operations and result in lost sales. Additionally, we will be reliant on third parties to supply the raw materialsneeded to manufacture our products. Any reliance on suppliers may involve several risks, including a potential inability to obtain criticalmaterials and reduced control over production costs, delivery schedules, reliability and quality. Any unanticipated disruption to futurecontract manufacture caused by problems at suppliers could delay shipment of products, increase our cost of goods sold and result inlost sales. If our suppliers were unable to supply us with adequate supply of our drugs, it could have a material adverse effect on ourability to successfully commercialize our drug candidates.

Ifwe fail to discover, develop and commercialize other product candidates, we may be unable to grow our business and our ability to achieveour strategic objectives would be impaired. In addition, we may also seek to commercialize certain treatments that may not be proprietaryto us.

Althoughthe development and commercialization of our current product candidates are our initial focus, as part of our long-term growth strategy,we plan to develop other product candidates. While we believe our planned products may have potential applicability to other uses, wehave not conducted any clinical trials on these other uses and we may not be successful in developing product candidates for other uses.In addition, we intend to devote capital and resources for basic research to discover and identify additional product candidates. Theseresearch programs require technical, financial and human resources, whether or not any product candidates are ultimately identified.Our research programs may initially show promise in identifying potential product candidates, yet fail to yield product candidates forclinical development for many reasons, including the following:

Ifwe do not achieve our projected development and commercialization goals within the timeframes we expect, the development and commercializationof our product candidates may be delayed, and our business and results of operations may be harmed.

Forplanning purposes, we seek to estimate the timing of the accomplishment of various scientific, clinical, regulatory and other productdevelopment objectives. These milestones may include our expectations regarding the commencement or completion of scientific studiesand clinical trials, the submission of regulatory filings, or commercialization objectives. From time to time, we may publicly announcethe expected timing of some of these milestones, such as the completion of an ongoing clinical trial, the initiation of other clinicalprograms, receipt of marketing approval or a commercial launch of a product. The potential achievement of many of these milestones maybe outside of our control. Each of these milestones is based on a variety of assumptions which, if not realized as expected, may causethe timing of such potential achievement of the respective milestones to vary considerably from our estimates, including:

Ifwe fail to achieve any announced milestones in the timeframes we expect, the development and commercialization of our product candidatesmay be delayed, and our business and results of operations may be harmed, and it could negatively impact our share price performance.Please see the section entitled “Business” in this prospectus for more information.

Ifwe rely on a sole source of supply to manufacture our products we could be impacted by the viability of our supplier.

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

Wemay not be able to sufficiently scale-up manufacturing of our drug candidates.

Wemay not be able to successfully increase in a sufficient manner the manufacturing capacity for our drug candidates, whether in collaborationwith third-party manufacturers or on our own, in a timely or cost-effective manner or at all. If a contract manufacturer makes improvementsin the manufacturing process for our drug candidates, we may not own, or may have to share, the intellectual property rights to thoseimprovements.

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

Ouroperations are subject to risks associated with ongoing and potential future global conflicts.

Currently,there is an ongoing conflict involving Russia and Ukraine and the war between the two countries continues to evolve as military activityproceeds and additional sanctions are imposed. The war is increasingly affecting economic and global financial markets and exacerbatingongoing economic challenges, including issues such as rising inflation and global supply-chain disruption. While we do not believe thisconflict currently has a material impact on our financial accounting and reporting, the degree to which we will be affected in the futurelargely depends on the nature and duration of uncertain and unpredictable events, and our business could be impacted. Furthermore, futureglobal conflicts or wars could create further economic challenges, including, but not limited to, increases in inflation and furtherglobal supply-chain disruption. Consequently, the ongoing Russia/Ukraine conflict and/or other future global conflicts could result inan increase in operating expenses and/or a decrease in any future revenue and could further have a material adverse effect on our resultsof operations and cash flow.

Risks Relatedto Development and Regulatory Approval of our Future Product Candidates

Clinicaltrials are expensive, time-consuming, uncertain and susceptible to change, delay or termination. The results of clinical trials are opento differing interpretations.

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

Regulatoryagencies may not accept clinical trial designs submitted by us, and may analyze or interpret the results of clinical trials differentlythan us. Even if the results of our clinical trials are favorable, the clinical trials for a number of our future product candidatesare expected to continue for several years and may take significantly longer to complete. In addition, the FDA, MHRA or other regulatoryauthorities, including state, local and foreign authorities, or an IRB, with respect to a trial at our institution, may suspend, delayor terminate our clinical trials at any time, require us to conduct additional clinical trials, require a particular clinical trial tocontinue for a longer duration than originally planned, require a change to our development plans such that we conduct clinical trialsfor a product candidate in a different order, e.g., in a step-wise fashion rather than running two trials of the same product candidatein parallel, or could suspend or terminate the registrations and quota allotments we require in order to procure and handle controlledsubstances, for various reasons, including the following, any of which could have a material adverse effect on our business, financialcondition and results of operations:

Wemay find it difficult to enroll patients in our clinical trials, which could delay or prevent clinical trials of our product candidates.

Identifyingand qualifying patients to participate in clinical trials of our product candidates is critical to our success. The timing of our clinicaltrials depends on the speed at which we can recruit eligible patients to participate in testing our product candidates. We have experienceddelays in some of our clinical trials, and we may experience similar delays in the future. These delays could result in increased costs,delays in advancing our product development, or termination of the clinical trials altogether.

Wemay not be able to identify, recruit and enroll a sufficient number of patients, or those with required or desired characteristics toachieve diversity in a study, to complete our clinical trials within the expected timeframe. Patient enrollment can be impacted by factorsincluding, but not limited to:

Inparticular, each of the conditions for which we plan to evaluate our product candidates are diseases with limited patient pools fromwhich to draw for clinical trials. The eligibility criteria of our clinical trials will further limit the pool of available study participants.Additionally, the process of finding and diagnosing patients may prove costly. The treating physicians in our clinical trials may alsouse their medical discretion in advising patients enrolled in our clinical trials to withdraw from our studies to try alternative therapies.In addition, the ongoing COVID-19 pandemic may impact patient ability and willingness to travel to clinical trial sites as a result ofquarantines and other restrictions, which may negatively impact enrollment in our clinical trials.

Wemay not be able to initiate or continue clinical trials if we cannot enroll the required eligible patients per protocol to participatein the clinical trials required by the FDA or the EMA, MHRA or other regulatory agencies. Our ability to successfully initiate, enrolland complete a clinical trial in any foreign country is subject to numerous risks unique to conducting business in foreign countries,including:

Ifwe have difficulty enrolling a sufficient number of patients to conduct our clinical trials as planned, we may need to delay, limit orterminate ongoing or planned clinical trials, any of which would have an adverse effect on our ability to complete clinical trials andultimately our results of operations.

Anyfailure by our company to comply with existing regulations could harm our reputation and operating results.

Weare subject to extensive regulation by U.S. federal and state and foreign governments in each of the U.S., European and Canadian markets,in which we plan to sell our products, or in markets where we have product candidates progressing through the approval process.

Wemust adhere to all regulatory requirements including FDA’s GLP, GCP and GMP requirements, pharmacovigilance requirements, advertisingand promotion restrictions, reporting and recordkeeping requirements, and their European equivalents. If we or our suppliers fail tocomply with applicable regulations, including FDA pre-or post-approval requirements, then the FDA or other foreign regulatory authoritiescould sanction our company. Even if a drug is approved by the FDA or other competent authorities, regulatory authorities may impose significantrestrictions on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-marketing trials.Any of our product candidates which may be approved in the United States will be subject to ongoing regulatory requirements for manufacturing,labeling, packaging, storage, distribution, import, export, advertising, promotion, sampling, recordkeeping and submission of safetyand other post-market information, including both federal and state requirements. In addition, manufacturers and manufacturers’facilities are required to comply with extensive FDA requirements, including ensuring that quality control and manufacturing proceduresconform to GMP. As such, we and our contract manufacturers (in the event contract manufacturers are appointed in the future) are subjectto continual review and periodic inspections to assess compliance with GMP. Accordingly, we and others with whom we work will have tospend time, money and effort in all areas of regulatory compliance, including manufacturing, production, quality control and qualityassurance. We will also be required to report certain adverse reactions and production problems, if any, to the FDA, and to comply withrequirements concerning advertising and promotion for our products. Promotional communications with respect to prescription drugs aresubject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approvedlabel. Similar restrictions and requirements exist in the European Union and other markets where we operate.

Ifa regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency,or problems with the facility where the product is manufactured, or disagrees with the promotion, marketing or labeling of the product,it may impose restrictions on that product or on our company, including requiring withdrawal of the product from the market. If we failto comply with applicable regulatory requirements, a regulatory agency or enforcement authority may issue warning letters, impose civilor criminal penalties, suspend regulatory approval, suspend any of our ongoing clinical trials, refuse to approve pending applicationsor supplements to approved applications submitted by us, impose restrictions on our operations, or seize or detain products or requirea product recall.

Inaddition, it is possible that our future products will be regulated by the DEA, under the Controlled Substances Act or under similarlaws elsewhere. DEA scheduling is a separate process that can delay when a drug may become available to patients beyond an NDA approvaldate, and the timing and outcome of such DEA process is uncertain. See also “Risks Related to Controlled Substances”,below.

Inaddition, any government investigation of alleged violations of law could require us to spend significant time and resources in responseand could generate negative publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affectour ability to commercialize and generate revenue from our future product candidates. If regulatory sanctions are applied or if regulatoryapproval is withdrawn, the value of our business and our operating results may be adversely affected.

Anyaction against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses,divert our management’s attention from the operation of our business and damage our reputation. We expect to spend significantresources on compliance efforts and such expenses are unpredictable. Changing laws, regulations and standards might also create uncertainty,higher expenses and increase insurance costs. As a result, we intend to invest all reasonably necessary resources to comply with evolvingstandards, and this investment might result in increased management and administrative expenses and a diversion of management time andattention from revenue-generating activities to compliance activities.

Weare subject to federal, state and foreign healthcare laws and regulations and implementation of or changes to such healthcare laws andregulations could adversely affect our business and results of operations.

Inboth the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory proposals to changethe healthcare system in ways that could impact our ability to sell our future product candidates. If we are found to be in violationof any of these laws or any other federal, state or foreign regulations, we may be subject to administrative, civil and/or criminal penalties,damages, fines, individual imprisonment, we from federal health care programs and the restructuring of our operations. Any of these couldhave a material adverse effect on our business and financial results. Since many of these laws have not been fully interpreted by thecourts, there is an increased risk that we may be found in violation of one or more of their provisions. Any action against us for violationof these laws, even if we ultimately are successful in our defense, will cause us to incur significant legal expenses and divert ourmanagement’s attention away from the operation of our business. In addition, in many foreign countries, particularly the countriesof the European Union the pricing of prescription drugs is subject to government control.

Insome foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governingdrug pricing vary widely from country to country.

Forexample, some EU jurisdictions operate positive and negative list systems under which products may only be marketed once a reimbursementprice has been agreed. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trialsthat compare the cost-effectiveness of a particular product candidate to currently available therapies. Other member states allow companiesto fix their own prices for medicines but monitor and control company profits. Such differences in national pricing regimes may createprice differentials between EU member states. There can be no assurance that any country that has price controls or reimbursement limitationsfor pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our products. Historically, productslaunched in the United Kingdom and European Union do not follow price structures of the United States In the United Kingdom and EuropeanUnion, the downward pressure on healthcare costs in general, particularly prescription medicines, has become intense. As a result, barriersto entry of new products are becoming increasingly high and patients are unlikely to use a drug product that is not reimbursed by theirgovernment. We may face competition from lower-priced products in foreign countries that have placed price controls on pharmaceuticalproducts. In addition, the importation of foreign products may compete with any future product that we may market, which could negativelyimpact our profitability.

Specifically,in the United States, we expect that the ACA, as well as other healthcare reform measures that may be adopted in the future, may resultin more rigorous coverage criteria and in additional downward pressure on the price that we may receive for any approved product. Therehave been judicial challenges to certain aspects of the ACA and numerous legislative attempts to repeal and/or replace the ACA in wholeor in part, and we expect there will be additional challenges and amendments to the ACA in the future. At this time, the full effectthat the ACA will have on our business in the future remains unclear. An expansion in the government’s role in the U.S. healthcareindustry may cause general downward pressure on the prices of prescription drug products, lower reimbursements or any other product forwhich we obtain regulatory approval, reduce product utilization and adversely affect our business and results of operations. Any reductionin reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementationof cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, orcommercialize any of our future product candidates for which we may receive regulatory approval.

Informationobtained from expanded access studies may not reliably predict the efficacy of our future product candidates in company-sponsored clinicaltrials and may lead to adverse events that could limit approval.

Theexpanded access studies we are currently supporting are uncontrolled, carried out by individual investigators and not typically conductedin strict compliance with GCPs, all of which can lead to a treatment effect which may differ from that in placebo-controlled trials.These studies provide only anecdotal evidence of efficacy for regulatory review. These studies contain no control or comparator groupfor reference and this patient data is not designed to be aggregated or reported as study results. Moreover, data from such small numbersof patients may be highly variable. Information obtained from these studies, including the statistical principles that we and the independentinvestigators have chosen to apply to the data, may not reliably predict data collected via systematic evaluation of the efficacy incompany-sponsored clinical trials or evaluated via other statistical principles that may be applied in those trials. Reliance on suchinformation to design our clinical trials may lead to trials that are not adequately designed to demonstrate efficacy and could delayor prevent our ability to seek approval of our future product candidates.

Expandedaccess programs provide supportive safety information for regulatory review. Physicians conducting these studies may use our future productcandidates in a manner inconsistent with the protocol, including in children with conditions beyond those being studied in trials whichwe sponsor. Any adverse events or reactions experienced by subjects in the expanded access program may be attributed to our future productcandidates and may limit our ability to obtain regulatory approval with labeling that we consider desirable, or at all.

Thereis a high rate of failure for drug candidates proceeding through clinical trials.

Generally,there is a high rate of failure for drug candidates proceeding through clinical trials. We may suffer significant setbacks in our clinicaltrials similar to the experience of a number of other companies in the pharmaceutical and biotechnology industries, even after receivingpromising results in earlier trials. Further, even if we view the results of a clinical trial to be positive, the FDA, MHRA or otherregulatory authorities may disagree with our interpretation of the data. In the event that we obtain negative results from clinical trialsfor product candidates or other problems related to potential chemistry, manufacturing and control issues or other hurdles occur andour future product candidates are not approved, we may not be able to generate sufficient revenue or obtain financing to continue ouroperations, our ability to execute on our current business plan may be materially impaired, and our reputation in the industry and inthe investment community might be significantly damaged. In addition, our inability to properly design, commence and complete clinicaltrials may negatively impact the timing and results of our clinical trials and ability to seek approvals for our drug candidates.

Ifwe are found in violation of federal or state “fraud and abuse” laws or similar laws in other jurisdictions, we may be requiredto pay a penalty and/or be suspended from participation in federal or state health care programs, which may adversely affect our business,financial condition and results of operations.

Inthe United States, we are subject to various federal and state health care “fraud and abuse” laws, including anti-kickbacklaws, false claims laws and other laws intended to reduce fraud and abuse in federal and state health care programs, which could affectour company particularly upon successful commercialization of our products in the United States The Medicare and Medicaid Patient ProtectionAct of 1987, or federal Anti-Kickback Statute, makes it illegal for any person, including a prescription drug manufacturer (or a partyacting on its behalf), to knowingly and willfully solicit, receive, offer or pay any remuneration that is intended to induce the referralof business, including the purchase, order or prescription of a particular drug for which payment may be made under a federal healthcare program, such as Medicare or Medicaid. Under federal law, some arrangements, known as safe harbors, are deemed not to violate thefederal Anti-Kickback Statute. Although we seek to structure our business arrangements in compliance with all applicable requirements,it is often difficult to determine precisely how the law will be applied in specific circumstances. Accordingly, it is possible thatour practices may be challenged under the federal Anti-Kickback Statute and Federal False Claims Act. Violations of fraud and abuse lawsmay be punishable by criminal and/or civil sanctions, including fines and/or exclusion or suspension from federal and state health careprograms such as Medicare and Medicaid and debarment from contracting with the U.S. government. In addition, private individuals havethe ability to bring actions on behalf of the government under the federal False Claims Act as well as under the false claims laws ofseveral states.

Whilewe believe that we have structured our business arrangements to comply with these laws, the government could allege violations of, orconvict us of violating, these laws. If we are found in violation of one of these laws, we could be required to pay a penalty and couldbe suspended or excluded from participation in federal or state health care programs, and our business, results of operations and financialcondition may be adversely affected.

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

Seriousadverse events or other safety risks could require us to abandon development and preclude, delay or limit approval of our future productcandidates, limit the scope of any approved label or market acceptance, or cause the recall or loss of marketing approval of productsthat are already marketed.

Ifany of our future product candidates prior to or after any approval for commercial sale, cause serious or unexpected side effects, orare associated with other safety risks such as misuse, abuse or diversion, a number of potentially significant negative consequencescould result, including:

Wemay voluntarily suspend or terminate our clinical trials if at any time we believe that the products present an unacceptable risk toparticipants, or if preliminary data demonstrates that our future product candidates are unlikely to receive regulatory approval or unlikelyto be successfully commercialized. Following receipt of approval for commercial sale of a product, we may voluntarily withdraw or recallthat product from the market if at any time we believe that its use, or a person’s exposure to it, may cause adverse health consequencesor death. To date, we have not withdrawn, recalled or taken any other action, voluntary or mandatory, to remove an approved product fromthe market. In addition, regulatory agencies, IRBs or data safety monitoring boards may at any time recommend the temporary or permanentdiscontinuation of our clinical trials or request that we cease using investigators in the clinical trials if they believe that the clinicaltrials are not being conducted in accordance with applicable regulatory requirements, or that they present an unacceptable safety riskto participants. Although we have never been asked by a regulatory agency, IRB or data safety monitoring board to temporarily or permanentlydiscontinue a clinical trial, if we elect or are forced to suspend or terminate a clinical trial of any of our future product candidates,the commercial prospects for that product will be harmed and our ability to generate product revenue from that product may be delayedor eliminated. Furthermore, any of these events may result in labeling statements such as warnings or contraindications. In addition,such events or labeling could prevent us or our partners from achieving or maintaining market acceptance of the affected product andcould substantially increase the costs of commercializing our future product candidates and impair our ability to generate revenue fromthe commercialization of these products either by our company or by our collaboration partners.

Thedevelopment of REMS for our future product candidates could cause delays in the approval process and would add additional layers of regulatoryrequirements that could impact our ability to commercialize our future product candidates in the United States and reduce their marketpotential.

Evenif the FDA approves our NDA for any of our future product candidates without requiring a REMS as a condition of approval of the NDA,the FDA may, post-approval, require a REMS for any of our future product candidates if it becomes aware of new safety information thatmakes a REMS necessary to ensure that the benefits of the drug outweigh the potential risks. REMS elements can include medication guides,communication plans for health care professionals, and elements to assure safe use (“ETASU”). ETASU can include, butare not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, specialmonitoring and the use of patient registries. Moreover, product approval may require substantial post-approval testing and surveillanceto monitor the drug’s safety or efficacy. We may be required to adopt a REMS for our future product candidates to ensure that thebenefits outweigh the risks of abuse, misuse, diversion and other potential safety concerns. There can be no assurance that the FDA willapprove a manageable REMS for our future product candidates, which could create material and significant limits on our ability to successfullycommercialize our future product candidates in the United States Delays in the REMS approval process could result in delays in the NDAapproval process. In addition, as part of the REMS, the FDA could require significant restrictions, such as restrictions on the prescription,distribution and patient use of the product, which could significantly impact our ability to effectively commercialize our future productcandidates, and dramatically reduce their market potential, thereby adversely impacting our business, financial condition and resultsof operations. Even if initial REMS are not highly restrictive, if, after launch, our future product candidates were to be subject tosignificant abuse/non-medical use or diversion from illicit channels, this could lead to negative regulatory consequences, includinga more restrictive REMS.

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

Weare not permitted to commercialize, market, promote or sell any product candidate in the United States without obtaining regulatory approvalfrom the FDA. Foreign regulatory authorities, such as the EMA and MHRA, impose similar requirements. The time required to obtain approvalby the FDA and comparable foreign authorities is inherently unpredictable, but typically takes many years following the commencementof clinical trials and depends upon numerous factors, including substantial discretion of the regulatory authorities. In addition, approvalpolicies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’sclinical development and may vary among jurisdictions. To date, we have not submitted an NDA to the FDA or similar drug approval submissionsto comparable foreign regulatory authorities for our most advanced product candidate for the early stage treatment of Dupuytren’sContracture, or any other product candidate. We must complete additional preclinical studies and clinical trials to demonstrate the safetyand efficacy of our product candidates in humans before we will be able to obtain these approvals.

Clinicaltesting is expensive, difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome. Wecannot guarantee that any clinical trial design that we submit will be accepted by FDA, MHRA or other comparable foreign regulatory authorities,or that clinical trials will be conducted as planned or completed on schedule, if at all. The clinical development of our initial andpotential additional product candidates is susceptible to the risk of failure inherent at any stage of development, including failureto demonstrate efficacy in a clinical trial or across a broad population of patients, the occurrence of adverse events that are severeor medically or commercially unacceptable, failure to comply with protocols or applicable regulatory requirements, and determinationby the FDA, MHRA or any other comparable foreign regulatory authority that a product candidate may not continue development or is notapprovable. It is possible that even if any of our product candidates has a beneficial effect, that effect will not be detected duringclinical evaluation as a result of one or more of a variety of factors, including the size, duration, design, measurements, conduct oranalysis of our clinical trials. Conversely, as a result of the same factors, our clinical trials may indicate an apparent positive effectof such product candidate that is greater than the actual positive effect, if any. Similarly, in our clinical trials, we may fail todetect toxicity of, or intolerability caused by, such product candidate, or mistakenly believe that our product candidates are toxicor not well tolerated when that is not in fact the case. Serious adverse events, or SAEs, or other adverse effects, as well as tolerabilityissues, could hinder or prevent market acceptance of the product candidate at issue.

Ourcurrent and future product candidates could fail to receive regulatory approval for many reasons, including the following:

Thislengthy approval process as well as the unpredictability of clinical trial results may result in us failing to obtain regulatory approvalto market any product candidate we develop, which would substantially harm our business, results of operations and prospects. The FDA,MHRA or other comparable foreign authorities have substantial discretion in the approval process and determining when or whether regulatoryapproval will be granted for any product candidate that we develop. Even if we believe the data collected from future clinical trialsof our product candidates are promising, such data may not be sufficient to support approval by the FDA or any other regulatory authority.

Inaddition, even if we were to obtain approval, regulatory authorities may approve any of our product candidates for fewer or more limitedindications than we request, may not approve the price we intend to charge for our products, may grant approval contingent on the performanceof costly post-marketing clinical trials, or may approve a product candidate with labeling that does not include the claims necessaryor desirable for the successful commercialization of that product candidate. Any of the foregoing scenarios could materially harm thecommercial prospects for our product candidates.

Risks Relatedto our Reliance Upon Third Parties

Ourexisting collaboration arrangements and any that we may enter into in the future may not be successful, which could adversely affectour ability to develop and commercialize our future product candidates.

Weare a party to, and may seek additional, collaboration arrangements with pharmaceutical or biotechnology companies for the developmentor commercialization of our future product candidates. We may, with respect to our future product candidates, enter into new arrangementson a selective basis depending on the merits of retaining commercialization rights for ourselves as compared to entering into selectivecollaboration arrangements with leading pharmaceutical or biotechnology companies for each product candidate, both in the United Statesand internationally. To the extent that we decide to enter into collaboration agreements, we will face significant competition in seekingappropriate collaborators and the terms of any collaboration or other arrangements that we may establish may not be favorable to us.

Anyexisting or future collaboration that we enter into may not be successful. The success of our collaboration arrangements will dependheavily on the efforts and activities of our collaborators. Collaborators generally have significant discretion in determining the effortsand resources that they will apply to these collaborations. Disagreements between parties to a collaboration arrangement regarding development,intellectual property, regulatory or commercialization matters, can lead to delays in the development process or commercialization ofthe applicable product candidate and, in some cases, termination of the collaboration arrangement. These disagreements can be difficultto resolve if neither of the parties has final decision-making authority. Any such termination or expiration could harm our businessreputation and may adversely affect it financially.

Weexpect to depend on a limited number of suppliers for materials and components in order to manufacture our future product candidates.The loss of these suppliers, or their failure to supply us on a timely basis, could cause delays in our current and future capacity andadversely affect our business.

Weexpect to depend on a limited number of suppliers for the materials and components required to manufacture our future product candidates.As a result, we may not be able to obtain sufficient quantities of critical materials and components in the future. A delay or interruptionby our suppliers may also harm our business, results of operations and financial condition. In addition, the lead time needed to establisha relationship with a new supplier can be lengthy, and we may experience delays in meeting demand in the event we must switch to a newsupplier. The time and effort to qualify for and, in some cases, obtain regulatory approval for a new supplier could result in additionalcosts, diversion of resources or reduced manufacturing yields, any of which would negatively impact our operating results. Our dependenceon single-source suppliers exposes us to numerous risks, including the following: our suppliers may cease or reduce production or deliveries,they may be subject to government investigations and regulatory actions that limit or prevent production capabilities for an extendedperiod of time, raise prices or renegotiate terms; our suppliers may become insolvent; we may be unable to locate a suitable replacementsupplier on acceptable terms or on a timely basis, or at all; and delays caused by supply issues may harm our reputation, frustrate ourcustomers and cause them to turn to our competitors for future needs.

Risks Relatedto our Intellectual Property

Wemay not be able to adequately protect our future product candidates or our proprietary technology in the marketplace.

Oursuccess will depend, in part, on our ability to obtain patents, protect our trade secrets and operate without infringing on the proprietaryrights of others. We rely upon a combination of patents, trade secret protection (i.e., know-how), and confidentiality agreements toprotect the intellectual property of our future product candidates. The strengths of patents in the pharmaceutical field involve complexlegal and scientific questions and can be uncertain. Where appropriate, we seek patent protection for certain aspects of our productsand technology. Filing, prosecuting and defending patents globally can be prohibitively expensive.

Ourpolicy is to look to patent technologies with commercial potential in jurisdictions with significant commercial opportunities. However,patent protection may not be available for some of the products or technology we are developing. If we must spend significant time andmoney protecting, defending or enforcing our patents, designing around patents held by others or licensing, potentially for large fees,patents or other proprietary rights held by others, our business, results of operations and financial condition may be harmed. We maynot develop additional proprietary products that are patentable. As of the date hereof, we have an extensive portfolio of patents, includingmany granted patents and patents pending approval.

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

Publicationof information related to our future product candidates by our company or others may prevent us from obtaining or enforcing patents relatingto these products and product candidates. Furthermore, others may independently develop similar products, may duplicate our products,or may design around our patent rights. In addition, any of our issued patents may be opposed and/or declared invalid or unenforceable.If we fail to adequately protect our intellectual property, we may face competition from companies who attempt to create a generic productto compete with our future product candidates. We may also face competition from companies who develop a substantially similar productto our future product candidates that is not covered by any of our patents.

Manycompanies have encountered significant problems in protecting, defending and enforcing intellectual property rights in foreign jurisdictions.The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and otherintellectual property rights, particularly those relating to pharmaceuticals, which could make it difficult for us to stop the infringementof our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patentrights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business.

Ifthird parties claim that intellectual property used by our company infringes upon their intellectual property, our operating profitscould be adversely affected.

Thereis a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual property rightsin the pharmaceutical industry. We may, from time to time, be notified of claims that we are infringing upon patents, trademarks, copyrightsor other intellectual property rights owned by third parties, and we cannot provide assurances that other companies will not, in thefuture, pursue such infringement claims against us, our commercial partners or any third-party proprietary technologies we have licensed.If we were found to infringe upon a patent or other intellectual property right, or if we failed to obtain or renew a license under apatent or other intellectual property right from a third party, or if a third party from whom we were licensing technologies was foundto infringe upon a patent or other intellectual property rights of another third party, we may be required to pay damages, includingdamages of up to three times the damages found or assessed, if the infringement is found to be willful, suspend the manufacture of certainproducts or reengineer or rebrand our products, if feasible, or we may be unable to enter certain new product markets. Any such claimscould also be expensive and time consuming to defend and divert management’s attention and resources. Our competitive positioncould suffer as a result. In addition, if we have declined or failed to enter into a valid non-disclosure or assignment agreement forany reason, we may not own the invention or our intellectual property, and our products may not be adequately protected. Thus, we cannotguarantee that any of our future product candidates, or our commercialization thereof, does not and will not infringe any third party’sintellectual property.

Ifwe are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology andproducts could be significantly diminished.

Werely on trade secrets to protect our proprietary technologies, especially where we do not believe patent protection is appropriate orobtainable. However, trade secrets are difficult to protect. We rely in part on confidentiality agreements with current and former employees,consultants, outside scientific collaborators, sponsored researchers, contract manufacturers, vendors and other advisors to protect ourtrade secrets and other proprietary information. These agreements may not effectively prevent disclosure of confidential informationand may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, we cannot guaranteethat we have executed these agreements with each party that may have or have had access to our trade secrets. Any party with whom weor they have executed such an agreement may breach that agreement and disclose our proprietary information, including our trade secrets,and we may not be able to obtain adequate remedies for such breaches.

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

Theexpiration or loss of patent protection may adversely affect our future revenues and operating earnings.

Werely on patent, trademark, trade secret and other intellectual property protection in the discovery, development, manufacturing and saleof our product candidates. In particular, patent protection is important in the development and eventual commercialization of our productcandidates. Patents covering our product candidates normally provide market exclusivity, which is important in order to improve the probabilitythat our product candidates are able to become profitable.

Oneof our patents relating to our Fibrosis and anti-TNF program will expire in 2033; however, the majority of the patent portfolio has alonger lifespan. While we are seeking additional patent coverage which may protect the technology underlying these patents, there canbe no assurances that such additional patent protection will be granted, or if granted, that these patents will not be infringed uponor otherwise held enforceable. Even if we are successful in obtaining a patent, patents have a limited lifespan. In the United States,the natural expiration of a utility patent is generally 20 years after it is filed. Various extensions may be available; however, thelife of a patent, and the protection it affords, is limited. Without patent protection of our product candidates, we may be open to competitionfrom generic versions of such methods and compositions.

Ifwe do not obtain protection under the Hatch-Waxman Amendments by extending the patent term, our business may be harmed.

Ourcommercial success will largely depend on our ability to obtain and maintain patent and other intellectual property in the United Statesand other countries with respect to our product candidates. Given the amount of time required for the development, testing and regulatoryreview of new product candidates, patents protecting our product candidates might expire before or shortly after such candidates beginto be commercialized. We expect to seek extensions of patent terms in the United States and, if available, in other countries where weare prosecuting patents.

Dependingupon the timing, duration and specifics of FDA marketing approval of our product candidates, one or more of our U.S. patents may be eligiblefor limited patent term extension, or PTE, under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as theHatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent restoration term of up to five years beyond the normal expirationof the patent as compensation for patent term lost during development and the FDA regulatory review process, which is limited to theapproved indication (and potentially additional indications approved during the period of extension) covered by the patent. This extensionis limited to only one patent that covers the approved product, the approved use of the product, or a method of manufacturing the product.However, the applicable authorities, including the FDA and the U.S. Patent and Trademark Office (“USPTO”) in the UnitedStates, and any equivalent regulatory authority in other countries, may not agree with our assessment of whether such extensions areavailable, and may refuse to grant extensions to our patents, or may grant more limited extensions than we request. We may not be grantedan extension because of, for example, failing to apply within applicable deadlines, failing to apply prior to expiration of relevantpatents or otherwise failing to satisfy applicable requirements. Moreover, the applicable time-period or the scope of patent protectionafforded could be less than we request. Even if we are able to obtain an extension, the patent term may still expire before or shortlyafter we receive FDA marketing approval. If we are unable to extend the expiration date of our existing patents or obtain new patentswith longer expiry dates, our competitors may be able to take advantage of our investment in development and clinical trials by referencingour clinical and preclinical data to obtain approval of competing products following our patent expiration and launch their product earlierthan might otherwise be the case.

Risks Relatedto Controlled Substances

Controlledsubstance legislation differs between countries, and legislation in certain countries may restrict or limit our ability to sell our futureproduct candidates.

Mostcountries are parties to the Single Convention on Narcotic Drugs 1961 and the Convention on Psychotropic Substances 1971, which governsinternational trade and domestic control of narcotic substances, including cannabis extracts. Countries may interpret and implement theirtreaty obligations in a way that creates a legal obstacle to us obtaining marketing approval for our future products in those countries.These countries may not be willing or able to amend or otherwise modify their laws and regulations to permit our future products to bemarketed, or achieving such amendments to the laws and regulations may take a prolonged period of time. In that case, we would be unableto market our future product candidates in those countries in the near future or perhaps at all.

Theproduct candidates that we are developing may be subject to U.S. controlled substance laws and regulations and failure to comply withthese laws and regulations, or the cost of compliance with these laws and regulations, may adversely affect the results of our businessoperations, both during clinical development and post approval, and our financial condition.

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

Whilecannabis is a Schedule I controlled substance, products approved for medical use in the United States that contain cannabis or cannabisextracts should be placed in Schedules II-V, since approval by the FDA satisfies the “accepted medical use” requirement.If and when any of our future product candidates receive FDA approval, the DEA will make a scheduling determination. If the FDA, theDEA or any foreign regulatory authority determines that our future product candidates may have potential for abuse, it may require usto generate more clinical or other data than we currently anticipate to establish whether or to what extent the substance has an abusepotential, which could increase the cost and/or delay the launch of that product.

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

Individualstates have also established controlled substance laws and regulations. Although state-controlled substances laws often mirror federallaw, because the states are separate jurisdictions, they may separately schedule our future product candidates as well. State schedulingmay delay commercial sale of any product for which we obtain federal regulatory approval and adverse scheduling could have a materialadverse effect on the commercial attractiveness of such product. We or our partners must also obtain separate state registrations, permitsor licenses in order to be able to obtain, handle, and distribute controlled substances for clinical trials or commercial sale, and failureto meet applicable regulatory requirements could lead to enforcement and sanctions by the states in addition to those from the DEA orotherwise arising under federal law.

Becauseour products may be controlled substances in the United States, to conduct clinical trials in the United States, each of our researchsites must submit a research protocol to the DEA and obtain and maintain a DEA researcher registration that will allow those sites tohandle and dispense our products and to obtain product from our importer. If the DEA delays or denies the grant of a research registrationto one or more research sites, the clinical trial could be significantly delayed, and we could lose clinical trial sites. The importerfor the clinical trials must also obtain an importer registration and an import permit for each import.

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

Thelegalization and use of medical and recreational cannabis in the United States and abroad may impact our business.

Thereis a substantial amount of change occurring in the United States regarding the use of medical and recreational cannabis products. Whilecannabis products not approved by the FDA are Schedule I substances as defined under federal law, and their possession and use is notpermitted according to federal law (except for research purposes, under DEA registration), according to worldpoplulationreview.com, atleast 39 states and the District of Columbia have enacted state laws to enable possession and use of cannabis for medical purposes, andat least 19 states and the District of Columbia for recreational purposes. The U.S. Farm Bill, which was passed in 2018, descheduledcertain material derived from hemp plants with extremely low THC content. Although our business is quite distinct from that of onlineand dispensary cannabis companies, future legislation authorizing the sale, distribution, use, and insurance reimbursement of non-FDAapproved cannabis products could affect our business.

AccountingRisks

Ourgoodwill and intangible assets have been impaired in the past and are subject to future impairment risks.

Asdiscussed in the following risk factor, we had material impairment charges to our goodwill and in process R&D during the year endedDecember 31, 2022.

Ourintangible assets were approximately $10.7 million as of December 31, 2022, representing 55% of our total assets. We assess the potentialimpairment of indefinite-lived intangible assets and goodwill at least annually and otherwise when there is evidence that events or changesin circumstances indicate that an impairment condition may exist. Many of the factors used in assessing fair value are outside the controlof management, and it is reasonably likely that assumptions and estimates will change in future periods. These changes could result infuture impairments. Events and circumstances that we consider important which could trigger impairment include the following:

Whenthere is indication that the carrying value of intangible assets may not be recoverable based upon the existence of one or more of theabove indicators, an impairment loss is recognized if the carrying amount of the asset exceeds its fair value. When there is an indicationof impairment of goodwill, an impairment loss is recognized to the extent that the carrying amount of the goodwill exceeds its impliedfair value.

Itis possible that changes in circumstances, existing at that time or at other times in the future, or in the numerous variables associatedwith the assumptions and estimates made by us in assessing the appropriate valuation of its indefinite-lived intangible assets or goodwill,could in the future require us to record impairment charges, which would adversely affect future reported results of operations and stockholders’equity, although such charges would not affect our cash flow.

Wehave in the past, and may in the future, impair long-lived assets and intangible assets, including goodwill and acquired in-process researchand development.

Wereview long-lived assets and certain identifiable assets (including intangible assets) for impairment whenever circumstances and situationschange such that there is an indication that the carrying amounts may not be recovered. An impairment exists when the carrying valueof the long-lived or intangible asset (including goodwill and acquired in-process research and development) is not recoverable and exceedsits estimated fair value. Goodwill represents the difference between the purchase price and the fair value of assets and liabilitiesacquired in a business combination. We review goodwill yearly, or more frequently whenever circumstances and situations change such thatthere is an indication that the carrying amounts may not be recovered, for impairment by initially considering qualitative factors todetermine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount, including goodwill,as a basis for determining whether it is necessary to perform a quantitative analysis. If it is determined that it is more likely thannot that the fair value of reporting unit is less than its carrying amount, a quantitative analysis is performed to identify goodwillimpairment.

Ourpublicly traded stock closed at $78.00 per share as of December 31, 2021; during 2022, the market value of our single reporting unitsignificantly declined. As of March 31, 2022, June 30, 2022, September 30, 2022 and December 31, 2022, the market value of our publiclytraded stock fell to $51.80, $16.96, $13.30 and $3.39, per share, respectively, and as such, we elected to conduct a quantitative analysisof goodwill to assess for impairment as of September 30, 2022 and December 31, 2022. We determined the fair market value of its singlereporting unit and compared that value with the carrying amount of the reporting unit and determined that goodwill was impaired as ofboth measurement dates. As of September 30, 2022 and December 31, 2022, the carrying value exceeded the fair market value by $18,872,850and $14,674,428, respectively. To recognize the impairment of goodwill, we recorded losses for these amounts at the end of the thirdand fourth quarters, which appear as a loss on goodwill impairment of $33,547,278 on the income statement for the year ended December31, 2022. See “Note 5 - Intangible Assets and Impairment of Long-lived Assets” in the consolidated financial statementsincluded herein beginning on page F-1, for further information.

Intangibleassets and in-process research and development (“IP R&D”) assets represent the fair value assigned to technologiesthat were acquired on July 16, 2019 in connection with the Reorganization, which have not reached technological feasibility and haveno alternative future use. IP R&D assets are considered to be indefinite-lived until the completion or abandonment of the associatedresearch and development projects. During the period that the IP R&D assets are considered indefinite-lived, they are tested forimpairment on an annual basis, or more frequently if we become aware of any events occurring or changes in circumstances that indicatethat the fair value of the IP R&D assets are less than their carrying amounts. If and when development is complete, which generallyoccurs upon regulatory approval, and we are able to commercialize products associated with the IP R&D assets, these assets are thendeemed definite-lived and are amortized based on their estimated useful lives at that point in time. If development is terminated orabandoned, we may record a full or partial impairment charge related to the IP R&D assets, calculated as the excess of the carryingvalue of the IP R&D assets over their estimated fair value.

Asof December 31, 2022, the carrying amount of the IP R&D assets on the balance sheet was $12,405,084 (which consists of carrying amountsof $1,462,084 and $10,943,000 related to our CBR Pharma subsidiary and its 180 LP subsidiary, respectively). Per the valuation obtainedfrom a third party as of year-end, the fair market value of our IP R&D assets was determined to be $9,063,000 (which consists offair values of $0 and $9,063,000 related to our CBR Pharma subsidiary and 180 LP subsidiary, respectively). As of this measurement date,the carrying values of the CBR Pharma and 180 LP subsidiaries’ assets exceeded their fair market values by $1,462,084 and $1,880,000,respectively. As such, management determined that the consolidated IP R&D assets were impaired by $3,342,084 and, in order to recognizethe impairment, we recorded a loss for this amount during the fourth quarter of 2022, which appears as a loss on impairment to IP R&Dassets on the income statement. This reduced the IP R&D asset balances of its CBR Pharma subsidiary and its 180 LP subsidiary tozero and $9,063,000, respectively, as of December 31, 2022; the total consolidated IP R&D asset balance is $9,063,000 after impairment.See “Note 5 - Intangible Assets and Impairment of Long-lived Assets” in the consolidated financial statements includedherein beginning on page F-1, for further information.

Acontinued period of low trading prices of our common stock may force us to incur further material impairments of our reporting units,which could have a material effect on the value of our assets and cause the value of our securities to decline in value. Additionally,we have in the past, and may in the future, determine that impairments in our intangible assets, including acquired in-process researchand development, are necessary and may be material. An impairment recognized in one period may not be reversed in a subsequent period,even if the value of our common stock increases in the future. We have in the past and could in the future incur additional impairmentsof long-lived assets and/or intangible assets, including acquired in-process research and development and goodwill, which may be material.

Wehave identified material weaknesses in our disclosure controls and procedures and internal control over financial reporting. If not remediated,our failure to establish and maintain effective disclosure controls and procedures and internal control over financial reporting couldresult in material misstatements in our financial statements and a failure to meet our reporting and financial obligations, each of whichcould have a material adverse effect on our financial condition and the trading price of our securities.

Ourmanagement, including our principal financial officer, conducted an evaluation of the effectiveness of our internal control over financialreporting as of December 31, 2022 using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission(“COSO”) in “Internal Control - Integrated Framework” (2013).

Managementconcluded that certain aspects of our internal control over financial reporting was not effective as of December 31, 2022, based on thosecriteria. Specifically, management’s conclusion was based on the following material weakness:

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

Maintainingeffective disclosure controls and procedures and effective internal control over financial reporting are necessary for us to producereliable financial statements and we are committed to remediating its material weaknesses in such controls as promptly as possible. However,there can be no assurance as to when these material weaknesses will be remediated or that additional material weaknesses will not arisein the future. Any failure to remediate the material weaknesses, or the development of new material weaknesses in our internal controlover financial reporting, could result in material misstatements in our financial statements and cause us to fail to meet our reportingand financial obligations on a timely and accurate basis. If our financial statements are not accurate, investors may not have a completeunderstanding of our operations or may lose confidence in our reported financial information. Likewise, if our financial statements arenot filed on a timely basis as required by the SEC and Nasdaq, we could face severe consequences from those authorities. In any of thesecases, it could result in a material adverse effect on our business, on our financial condition or have a negative effect on the tradingprice of our common stock and warrants. Further, if we fail to remedy this deficiency (or any other future deficiencies) or maintainthe adequacy of our disclosure controls and procedures and our internal controls, we could be subject to regulatory scrutiny, civil orcriminal penalties or stockholder litigation against us or our management.

Wecan give no assurance that the measures we have taken and plan to take in the future will remediate the material weakness identifiedor that any additional material weaknesses or restatements of our financial statements will not arise in the future due to a failureto implement and maintain adequate internal control over financial reporting or circumvention of those controls.

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

Inaddition, even if we are successful in strengthening our controls and procedures, those controls and procedures may not be adequate toprevent or identify irregularities or facilitate the fair presentation of our financial statements or our periodic reports filed withthe SEC. This may require us to restate prior financial statements.

Wemay experience adverse impacts on our reported results of operations as a result of adopting new accounting standards or interpretations.

Ourimplementation of and compliance with changes in accounting rules, including new accounting rules and interpretations, could adverselyaffect our reported financial position or operating results or cause unanticipated fluctuations in our reported operating results infuture periods.

RisksRelated to our Common Stock and Warrants

Themarket price of our common stock has been extremely volatile and may continue to be volatile due to numerous circumstances beyond ourcontrol.

Themarket price of our common stock has fluctuated, and may continue to fluctuate, widely, due to many factors, some of which may be beyondour control. These factors include, without limitation:

Stockmarkets in general and our stock price in particular have recently experienced extreme price and volume fluctuations that have oftenbeen unrelated or disproportionate to the operating performance of those companies and our company. For example, during 2022, the saleprices of our common stock ranged from a post-split adjusted high of $80.70 per share (on January 5, 2022) to a low of $1.18 per share(on December 23, 2022). During this time, we have not experienced any material changes in our financial condition or results of operationsthat would explain such price volatility or trading volume; however, we have sold equity which was dilutive to existing stockholders.These broad market fluctuations may adversely affect the trading price of our securities. Additionally, these and other external factorshave caused and may continue to cause the market price and demand for our common stock to fluctuate substantially, which may limit orprevent our stockholders from readily selling their shares of our common stock and may otherwise negatively affect the liquidity of ourcommon stock.

Informationavailable in public media that is published by third parties, including blogs, articles, message boards and social and other media mayinclude statements not attributable to us and may not be reliable or accurate.

Weare aware of a large volume of information being disseminated by third parties relating to our operations, including in blogs, messageboards and social and other media. Such information as reported by third parties may not be accurate, may lead to significant volatilityin our securities and may ultimately result in our common stock or other securities declining in value.

Ouroutstanding options and warrants may adversely affect the trading price of our securities.

As of May 3, 2023, we had (i) outstanding stockoptions to purchase an aggregate of 148,321 shares of common stock at a weighted average exercise price of $85.19 per share; (ii) outstandingwarrants to purchase 5,006,409 shares of common stock at a weighted average exercise price of $21.78 per share. For the life of the optionsand warrants, the holders have the opportunity to profit from a rise in the market price of our common stock without assuming the riskof ownership. The issuance of shares upon the exercise of outstanding securities will also dilute the ownership interests of our existingstockholders.

Theavailability of these shares for public resale, as well as any actual resales of these shares, could adversely affect the trading priceof our common stock. We cannot predict the size of future issuances of our common stock pursuant to the exercise of outstanding optionsor warrants or conversion of other securities, or the effect, if any, that future issuances and sales of shares of our common stock mayhave on the market price of our common stock. Sales or distributions of substantial amounts of our common stock (including shares issuedin connection with an acquisition), or the perception that such sales could occur, may cause the market price of our common stock todecline.

Inaddition, the common stock issuable upon exercise/conversion of outstanding convertible securities may represent overhang that may alsoadversely affect the market price of our common stock. Overhang occurs when there is a greater supply of a company’s stock in themarket than there is demand for that stock. When this happens the price of our stock will decrease, and any additional shares which stockholdersattempt to sell in the market will only further decrease the share price. If the share volume of our common stock cannot absorb sharessold by holders of our outstanding convertible securities, then the value of our common stock will likely decrease.

Ouroutstanding public warrants are significantly out of the money.

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

Asignificant number of our shares are eligible for sale and their sale or potential sale may depress the market price of our common stock.

Sales of a significant number of shares of ourcommon stock in the public market could harm the market price of our common stock. Most of our common stock is available for resale inthe public market, including (a) options to purchase 148,321 shares of common stock with a weighted average exercise price of $85.19 pershare; and (b) warrants to purchase 5,006,409 shares of common stock with a weighted average exercise price of $21.78 per share. If asignificant number of shares were sold, such sales would increase the supply of our common stock, thereby potentially causing a decreasein its price. Some or all of our shares of common stock may be offered from time to time in the open market pursuant to effective registrationstatements and/or compliance with Rule 144, which sales could have a depressive effect on the market for our shares of common stock. Subjectto certain restrictions, a person who has held restricted shares for a period of six months may generally sell common stock into the market.The sale of a significant portion of such shares when such shares are eligible for public sale may cause the value of our common stockto decline in value.

Theremay not be sufficient liquidity in the market for our securities in order for investors to sell their shares. The market price of ourcommon stock may continue to be volatile.

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

Asa consequence, there may be periods of several days or more when trading activity in our shares is minimal or non-existent, as comparedto a mature issuer which has a large and steady volume of trading activity that will generally support continuous sales without an adverseeffect on share price. It is possible that a broader or more active public trading market for our common stock will not develop or besustained, or that trading levels will not continue. These factors may materially adversely affect the market price of our common stock,regardless of our performance. In addition, the public stock markets have experienced extreme price and trading volume volatility. Thisvolatility has significantly affected the market prices of securities of many companies for reasons frequently unrelated to the operatingperformance of the specific companies. These broad market fluctuations may adversely affect the market price of our common stock.

Weface significant penalties and damages in the event registration statements we have previously filed to register certain securities soldin our prior offerings are subsequently suspended or terminated.

Pursuantto certain prior private offerings of securities, we entered into registration rights agreements which required us to file certain registrationstatements to register the resale of the privately sold shares and certain securities issuable upon exercise/conversion thereof, andto maintain the effectiveness of such registration statements for certain periods of time. To date, all such required registration statementshave been declared effective by the SEC. However, in the event the registration statements are subsequently suspended or terminated,or we otherwise fail to meet certain requirements set forth in the registration rights agreements, we could be required to pay significantpenalties which could adversely affect our cash flow and cause the value of our securities to decline in value.

Provisionsof the Warrants could discourage an acquisition of us by a third party.

Certainprovisions of the Warrants could make it more difficult or expensive for a third party to acquire us. The Warrants prohibit us from engagingin certain transactions constituting “fundamental transactions” unless, among other things, the surviving entity assumesour obligations under each of the July 2022 Common Warrants, the December 2022 Common Warrants and the April 2023 Common Warrants, asapplicable. Further, each of July 2022 Common Warrants, the December 2022 Common Warrants and the April 2023 Common Warrants providethat, in the event of certain transactions constituting “fundamental transactions,” with some exception, holders of suchwarrants will have the right, at their option, to require us to repurchase such warrants at a price described in the applicable warrants(based on the Black Scholes Value of such warrants). These and other provisions of the Warrants could prevent or deter a third partyfrom acquiring us even where the acquisition could be beneficial to stockholders.

Futuresales and issuances of our common stock or rights to purchase common stock, could result in additional dilution to our stockholders andcould cause the price of our common stock to decline.

Wemay issue additional common stock, convertible securities, or other equity in the future. We also issue common stock to our employees,directors, and other service providers pursuant to our equity incentive plans. Such issuances could be dilutive to investors and couldcause the price of our common stock to decline. New investors in such issuances could also receive rights senior to those of currentstockholders.

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

Salesof a substantial number of shares of our common stock could occur at any time. The issuance of new shares of our common stock could resultin resales of our common stock by our current stockholders concerned about the potential ownership dilution of their holdings. In turn,these resales could have the effect of depressing the market price for our common stock.

Futuresales of our common stock could cause our stock price to decline.

Ifour stockholders sell substantial amounts of our common stock in the public market, the market price of our common stock could decreasesignificantly. The perception in the public market that our stockholders might sell shares of our common stock could also depress themarket price of our common stock. Up to $125,000,000 in total aggregate value of securities have been registered by us on a “shelf”registration statement on Form S-3 that we filed with the Securities and Exchange Commission on June 3, 2022, and which was declaredeffective on June 24, 2022. As of March 28, 2023, there is an aggregate of over $6.0 million in securities which are eligible for salein the public markets from time to time. Additionally, if our existing stockholders sell, or indicate an intention to sell, substantialamounts of our common stock in the public market, the trading price of our common stock could decline significantly. The market pricefor shares of our common stock may drop significantly when such securities are sold in the public markets. A decline in the price ofshares of our common stock might impede our ability to raise capital through the issuance of additional shares of our common stock orother equity securities.

Risks Associatedwith Our Governing Documents and Delaware Law

OurCertificate of Incorporation provides for indemnification of officers and directors at our expense and limits their liability, whichmay result in a major cost to us and hurt the interests of our stockholders because corporate resources may be expended for the benefitof officers or directors.

OurCertificate of Incorporation provides for indemnification as follows: “To the fullest extent permitted by applicable law, the Corporationis authorized to provide indemnification of, and advancement of expenses to, such agents of the Corporation (and any other persons towhich Delaware law permits the Corporation to provide indemnification) through Bylaw provisions, agreements with such agents or otherpersons, vote of stockholders or disinterested directors or otherwise, in excess of the indemnification and advancement otherwise permittedby Section 145 of the Delaware General Corporation Law, subject only to limits created by applicable Delaware law (statutory or non-statutory),with respect to actions for breach of duty to the Corporation, its stockholders and others.”

Wehave been advised that, in the opinion of the SEC, indemnification for liabilities arising under federal securities laws is against publicpolicy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification for liabilitiesarising under federal securities laws, other than the payment by us of expenses incurred or paid by a director, officer or controllingperson in the successful defense of any action, suit or proceeding, is asserted by a director, officer or controlling person in connectionwith our activities, we will (unless in the opinion of our counsel, the matter has been settled by controlling precedent) submit to acourt of appropriate jurisdiction, the question whether indemnification by us is against public policy as expressed in the SecuritiesAct and will be governed by the final adjudication of such issue. The legal process relating to this matter if it were to occur is likelyto be very costly and may result in us receiving negative publicity, either of which factors is likely to materially reduce the marketand price for our shares.

OurCertificate of Incorporation contains a specific provision that limits the liability of our directors for monetary damages to us andour stockholders and requires us, under certain circumstances, to indemnify officers, directors and employees.

Thelimitation of monetary liability against our directors, officers and employees under Delaware law and the existence of indemnificationrights to them may result in substantial expenditures by us and may discourage lawsuits against our directors, officers and employees.

OurCertificate of Incorporation contains a specific provision that limits the liability of our directors for monetary damages to us andour stockholders. We also have contractual indemnification obligations under our employment and engagement agreements with our executiveofficers and directors. The foregoing indemnification obligations could result in us incurring substantial expenditures to cover thecost of settlement or damage awards against our directors and officers, which we may be unable to recoup. These provisions and resultantcosts may also discourage us from bringing a lawsuit against our directors and officers for breaches of their fiduciary duties and maysimilarly discourage the filing of derivative litigation by our stockholders against our directors and officers, even though such actions,if successful, might otherwise benefit us and our stockholders.

Ourdirectors have the right to authorize the issuance of shares of preferred stock and additional shares of our common stock.

Ourdirectors, within the limitations and restrictions contained in our Certificate of Incorporation and without further action by our stockholders,have the authority to issue shares of preferred stock from time to time in one or more series and to fix the number of shares and therelative rights, conversion rights, voting rights, and terms of redemption, liquidation preferences and any other preferences, specialrights and qualifications of any such series. Any issuance of shares of preferred stock could adversely affect the rights of holdersof our common stock. Should we issue additional shares of our common stock at a later time, each investor’s ownership interestin our stock would be proportionally reduced.

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

OurCertificate of Incorporation and our Amended and Restated Bylaws and Delaware law contain provisions that may discourage, delay or preventa merger, acquisition or other change in control that stockholders may consider favorable, including transactions in which you mightotherwise receive a premium for your shares of our common stock or warrants. These provisions may also prevent or delay attempts by ourstockholders to replace or remove our management. Our corporate governance documents include the following provisions:

Asa Delaware corporation, we are also subject to provisions of Delaware law, including Section 203 of the Delaware General CorporationLaw, which limits the ability of stockholders holding shares representing more than 15% of the voting power of our outstanding votingstock from engaging in certain business combinations with us. Any provision of our Certificate of Incorporation or our Amended and RestatedBylaws or Delaware law that has the effect of delaying or deterring a change in control could limit the opportunity for our stockholdersto receive a premium for their shares of our common stock and could also affect the price that some investors are willing to pay forour common stock.

Theexistence of the foregoing provisions and anti-takeover measures could limit the price that investors might be willing to pay in thefuture for shares of our common stock or warrants. They could also deter potential acquirers of our company, thereby reducing the likelihoodthat you could receive a premium for your common stock or warrants in an acquisition.

OurCertificate of Incorporation contains exclusive forum provisions that may discourage lawsuits against us and our directors and officers.

OurCertificate of Incorporation provides that unless the corporation consents in writing to the selection of an alternative forum, the Courtof Chancery of the State of Delaware, will be the sole and exclusive forum for (i) any derivative action or proceeding brought on behalfof us, (ii) any action asserting a claim for breach of a fiduciary duty owed by any current or former director, officer, employee orstockholder of the Company to us or our stockholders, (iii) any action asserting a claim arising pursuant to any provision of the DelawareGeneral Corporation Law, our Certificate of Incorporation or Bylaws, or (iv) any action asserting a claim governed by the internal affairsdoctrine.

Thechoice of forum provision in our Certificate of Incorporation does not waive our compliance with our obligations under the federal securitieslaws and the rules and regulations thereunder. Moreover, the provision does not apply to suits brought to enforce a duty or liabilitycreated by the Exchange Act or by the Securities Act. Section 27 of the Exchange Act creates exclusive federal jurisdiction over allsuits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder, and Section 22 ofthe Securities Act creates concurrent jurisdiction for federal and state courts with respect to suits brought to enforce a duty or liabilitycreated by the Securities Act or the rules and regulations thereunder. Accordingly, both state and federal courts have jurisdiction toentertain claims under the Securities Act.

Theseexclusive forum provisions may limit the ability of our stockholders to bring a claim in a judicial forum that such stockholders findfavorable for disputes with us or our directors or officers, which may discourage such lawsuits against us and our directors and officers.Alternatively, if a court were to find one or more of these exclusive forum provisions inapplicable to, or unenforceable in respect of,one or more of the specified types of actions or proceedings described above, we may incur additional costs associated with resolvingsuch matters in other jurisdictions or forums, which could materially and adversely affect our business, financial condition or resultsof operations.

OurCertificate of Incorporation contains provisions whereby we renounced any interest in any corporate opportunity offered to any directoror officer, subject to certain exceptions.

OurSection Amended and Restated Certificate of Incorporation, as amended, provides that to the extent allowed by law, the doctrine of corporateopportunity, or any other analogous doctrine, does not apply with respect to us or any of our officers or directors, or any of theirrespective affiliates, and that we renounce any expectancy that any of our directors or officers will offer any such corporate opportunityof which he or she may become aware to us, except that the doctrine of corporate opportunity shall apply with respect to any of our directorsor officers only with respect to a corporate opportunity (i) that was offered to such person solely in his or her capacity as a our directoror officer, (ii) that is one we are legally and contractually permitted to undertake and would otherwise be reasonable for us to pursue,and (iii) to the extent the director or officer is permitted to refer such opportunity to us without violating any legal obligation.

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

Ourdirectors allocate their time to other businesses thereby causing conflicts of interest in their determination as to how much time todevote to our affairs.

Ourdirectors are not required to, and do not, commit their full time to our affairs, and certain of our directors hold positions, includingother directorships, with other companies in the life sciences industry, which may result in a conflict of interest in allocating theirtime between our operations and others which they provide services to. If our directors’ other business affairs require them todevote substantial amounts of time to such affairs in excess of their current commitment levels, it could limit their ability to devotetime to our affairs which may have a negative impact on our operations. Additionally, such persons may have conflicts of interest inallocating their time among various business activities. These conflicts may not be resolved in our favor. Additionally, our directorsmay, because of our corporate opportunity waiver, discussed above, may choose to, or be required to, provide corporate opportunitiesto the other companies which they are affiliated with. Actual or perceived conflicts of interest may have a material adverse effect onour results of operations which may have a material adverse effect on the value of our securities.

Compliance,Reporting and Listing Risks

Weincur significant costs to ensure compliance with U.S. and Nasdaq reporting and corporate governance requirements.

Weincur significant costs associated with our public company reporting requirements and with applicable U.S. and Nasdaq corporate governancerequirements, including requirements under the Sarbanes-Oxley Act of 2002 and other rules implemented by the SEC and Nasdaq. The rulesof Nasdaq include requiring us to maintain independent directors, comply with other corporate governance requirements and pay annuallisting and stock issuance fees. All of such SEC and Nasdaq obligations require a commitment of additional resources including, but notlimited, to additional expenses, and may result in the diversion of our senior management’s time and attention from our day-to-dayoperations. We expect all of these applicable rules and regulations to significantly increase our legal and financial compliance costsand to make some activities more time consuming and costly. We also expect that these applicable rules and regulations may make it moredifficult and more expensive for us to obtain director and officer liability insurance and we may be required to accept reduced policylimits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be more difficultfor us to attract and retain qualified individuals to serve on our Board or as executive officers.

Weincur increased costs as a result of being a reporting company, and given our limited capital resources, such additional costs may havean adverse impact on our profitability.

Weare an SEC-reporting company. The rules and regulations under the Exchange Act require reporting companies to provide periodic reportswith interactive data files, which require that we engage legal, accounting and auditing professionals, and eXtensible Business ReportingLanguage (XBRL) and EDGAR (Electronic Data Gathering, Analysis, and Retrieval) service providers. The engagement of such services canbe costly, and we may continue to incur additional losses, which may adversely affect our ability to continue as a going concern. Inaddition, the Sarbanes-Oxley Act of 2002, as well as a variety of related rules implemented by the SEC, have required changes in corporategovernance practices and generally increased the disclosure requirements of public companies. For example, as a result of being a reportingcompany, we are required to file periodic and current reports and other information with the SEC and we have adopted policies regardingdisclosure controls and procedures and regularly evaluate those controls and procedures.

Theadditional costs we continue to incur in connection with being a reporting company (expected to be several hundred thousand dollars peryear) will continue to further stretch our limited capital resources. Due to our limited resources, we have to allocate resources awayfrom other productive uses in order to continue to comply with our obligations as an SEC reporting company. Further, there is no guaranteethat we will have sufficient resources to continue to meet our reporting and filing obligations with the SEC as they come due.

Wehave not been in compliance in the past with the continued listing standards of Nasdaq and may not be able to comply with Nasdaq’scontinued listing standards in the future.

Ourcommon stock and Public Warrants trade on Nasdaq under the symbols “ATNF” and “ATNFW,” respectively. Notwithstandingsuch listing, there can be no assurance any broker will be interested in trading our securities. Therefore, it may be difficult to sellour securities publicly. There is also no guarantee that we will be able to maintain our listings on Nasdaq for any period of time byperpetually satisfying Nasdaq’s continued listing requirements. While we are currently in compliance with Nasdaq’s continuedlisting standards, we have in the past been out of compliance with such continued listing standards and our failure to continue to meetthese requirements may result in our securities being delisted from Nasdaq.

Conditionsrequired for continued listing on Nasdaq include requiring that we maintain at least $2.5 million in stockholders’ equity, $35million of market value of listed securities, or $500,000 in net income over the prior two years or two of the prior three years, havinga majority of independent directors, a three member audit committee (consisting of all independent directors), and maintaining a bidprice above $1.00 per share. Our stockholders’ equity may not remain above Nasdaq’s $2.5 million minimum, our market valueof listed securities may not remain above $35 million, we may not generate over $500,000 of yearly net income, and we may not be ableto maintain independent directors or maintain a stock price above $1.00.

Ifwe fail to comply with Nasdaq rules and requirements, our stock may be delisted. In addition, even if we demonstrate compliance withthe requirements above, we will have to continue to meet other objective and subjective listing requirements to continue to be listedon Nasdaq. Delisting from Nasdaq could make trading our common stock and/or Public Warrants more difficult for investors, potentiallyleading to declines in our share price and liquidity. Without a Nasdaq listing, stockholders may have a difficult time getting a quotefor the sale or purchase of our stock, the sale or purchase of our stock would likely be made more difficult and the trading volume andliquidity of our stock could decline. Delisting from Nasdaq could also result in negative publicity and could also make it more difficultfor us to raise additional capital. The absence of such a listing may adversely affect the acceptance of our common stock and/or PublicWarrants as currency or the value accorded by other parties. Further, if we are delisted, we would also incur additional costs understate blue sky laws in connection with any sales of our securities. These requirements could severely limit the market liquidity of ourcommon stock and/or Public Warrants and the ability of our stockholders to sell our common stock and/or Public Warrants in the secondarymarket. If our common stock and/or Public Warrants are delisted by Nasdaq, our common stock and/or Public Warrants may be eligible totrade on an over-the-counter quotation system, such as the OTCQB Market, where an investor may find it more difficult to sell our stockor obtain accurate quotations as to the market value of our common stock and/or Public Warrants. In the event our common stock and/orPublic Warrants are delisted from Nasdaq, we may not be able to list our common stock and/or Public Warrants on another national securitiesexchange or obtain quotation on an over-the counter quotation system.

GeneralRisk Factors

Provisionsin our Certificate of Incorporation and Delaware law may inhibit a takeover of us, which could limit the price investors might be willingto pay in the future for our common stock and could entrench management.

OurCertificate of Incorporation contains provisions that may discourage unsolicited takeover proposals that stockholders may consider tobe in their best interests. These provisions include a staggered board of directors and the ability of our Board to designate the termsof and issue new series of preferred shares, which may make it more difficult for the removal of management and may discourage transactionsthat otherwise could involve payment of a premium over prevailing market prices for our securities. We are also subject to anti-takeoverprovisions under Delaware law, which could delay or prevent a change of control of the Company. Together, these provisions may make itmore difficult for the removal of management and may discourage transactions that otherwise could involve payment of a premium over prevailingmarket prices for our securities.

Failureto adequately manage our planned aggressive growth strategy may harm our business or increase our risk of failure.

Forthe foreseeable future, we intend to pursue an aggressive growth strategy for the expansion of our operations through increased productdevelopment and marketing. Our ability to rapidly expand our operations will depend upon many factors, including our ability to workin a regulated environment, market value-added products effectively to independent pharmacies, establish and maintain strategic relationshipswith suppliers, and obtain adequate capital resources on acceptable terms. Any restrictions on our ability to expand may have a materiallyadverse effect on our business, results of operations, and financial condition. Accordingly, we may be unable to achieve our targetsfor sales growth, and our operations may not be successful or achieve anticipated operating results.

Additionally,our growth may place a significant strain on our managerial, administrative, operational, and financial resources and our infrastructure.Our future success will depend, in part, upon the ability of our senior management to manage growth effectively. This will require usto, among other things:

Asa result, we may lack the resources to deploy our services on a timely and cost-effective basis. Failure to accomplish any of these requirementscould impair our ability to deliver services in a timely fashion or attract and retain new customers.

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

Inthe ordinary course of our business, we expect to collect and store sensitive data, including valuable and commercially sensitive intellectualproperty, clinical trial data, our proprietary business information and that of our future customers, suppliers and business partners,and personally identifiable information of our customers, clinical trial subjects and employees, patients, in our data centers and onour networks. The secure processing, maintenance and transmission of this information is critical to our operations. Despite our securitymeasures, our information technology and infrastructure may be vulnerable to attacks by hackers or breached due to employee error, malfeasanceor other disruptions. Any such breach could compromise our networks and the information stored there could be accessed, publicly disclosed,lost or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability underlaws that protect the privacy of personal information, regulatory penalties, disrupt our operations, damage our reputation, and causea loss of confidence in our products and our ability to conduct clinical trials, which could adversely affect our business and reputationand lead to delays in gaining regulatory approvals for our future product candidates. Although we maintain business interruption insurancecoverage, our insurance might not cover all losses from any future breaches of our systems.

Failureof our information technology systems, including cybersecurity attacks or other data security incidents, could significantly disruptthe operation of our business.

Ourbusiness increasingly depends on the use of information technologies, which means that certain key areas such as research and development,production and sales are to a large extent dependent on our information systems or those of third-party providers. Our ability to executeour business plan and to comply with regulators’ requirements with respect to data control and data integrity, depends, in part,on the continued and uninterrupted performance of our information technology systems, or IT systems and the IT systems supplied by third-partyservice providers. As information systems and the use of software and related applications by our company, our business partners, suppliers,and customers become more cloud-based, there has been an increase in global cybersecurity vulnerabilities and threats, including moresophisticated and targeted cyber-related attacks that pose a risk to the security of our information systems and networks and the confidentiality,availability and integrity of data and information. In addition, our IT systems are vulnerable to damage from a variety of sources, includingtelecommunications or network failures, malicious human acts and natural disasters. Moreover, despite network security and backup measures,some of our servers are potentially vulnerable to physical or electronic break-ins, computer viruses and similar disruptive problems.Despite the precautionary measures we and our third-party service providers have taken to prevent unanticipated problems that could affectour IT systems, a successful cybersecurity attack or other data security incident could result in the misappropriation and/or loss ofconfidential or personal information, create system interruptions, or deploy malicious software that attacks our systems. It is alsopossible that a cybersecurity attack might not be noticed for some period of time. In addition, sustained or repeated system failuresor problems arising during the upgrade of any of our IT systems that interrupt our ability to generate and maintain data, and in particularto operate our proprietary technology platform, could adversely affect our ability to operate our business. The occurrence of a cybersecurityattack or incident could result in business interruptions from the disruption of our IT systems, or negative publicity resulting in reputationaldamage with our stockholders and other stakeholders and/or increased costs to prevent, respond to or mitigate cybersecurity events. Inaddition, the unauthorized dissemination of sensitive personal information or proprietary or confidential information could expose usor other third–parties to regulatory fines or penalties, litigation and potential liability, or otherwise harm our business.

Wemay acquire other companies which could divert our management’s attention, result in additional dilution to our stockholders andotherwise disrupt our operations and harm our operating results.

Wemay in the future seek to acquire businesses, products or technologies that we believe could complement or expand our product offerings,enhance our technical capabilities or otherwise offer growth opportunities. The pursuit of potential acquisitions may divert the attentionof management and cause us to incur various expenses in identifying, investigating and pursuing suitable acquisitions, whether or notthey are consummated. If we acquire additional businesses, we may not be able to integrate the acquired personnel, operations and technologiessuccessfully, effectively manage the combined business following the acquisition or realize anticipated cost savings or synergies. Wealso may not achieve the anticipated benefits from the acquired business due to a number of factors, including: