NRXP · Read the filing

Item 1A. Risk Factors

We are an early-stage company with a history of losses and our business faces significant risks and uncertainties, which are summarized below and are more fully described in the following section. Our business, prospects, financial condition, and results of operations could be materially and adversely affected if one or more of these risks occurs. In addition, other events that we do not currently anticipate, or that we currently deem immaterial, may also affect our business, prospects, financial condition and results of operations. Accordingly, in evaluating our business, we encourage you to consider the following discussion of risk factors, in its entirety, in addition to other information contained in or incorporated by reference into this annual report and our other public filings with the SEC. The following summary of the Risk Factors is subject to the full description of the Risk Factors set forth in this Item 1A.

Risk Factors Summary

• We are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical instability due to the ongoing military conflict between Russia and Ukraine.

• Managing our growth as we expand operations may strain our resources.

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• We do not intend to pay dividends on our Common Stock for the foreseeable future.

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Risks Related to an Early-Stage Company

We are an early-stage company with a history of losses. We have not been profitable historically and may not achieve or maintain profitability in the future.

We experienced net losses in each year since inception, including net losses of $93.1 million and $39.8 million for the years ended, December 31, 2021, and 2022, respectively. We believe we will continue to incur operating losses and negative cash flow in the near-term as we continue to invest significantly in our business, in particular across our research and development efforts, clinical trial programs and future sales and marketing efforts.

Theseinvestmentsmaynotresultinrevenueorgrowthinourbusiness.Inaddition,asanewly- public company, we incur significant additional legal, accounting and other expenses that we did not incur as a private company. These increased expenditures may make it harder for us to achieve and maintain future profitability. Until we have a product candidate approved by the FDA, which could take several years, revenuegrowthwillnotbepossible,andweareunlikelytoachieveormaintainprofitability.Further,therecan be no assurance that the products under development by us will be approved for sales in the U.S. or elsewhere.

We expect a substantial portion of our revenue going forward to be generated from the sale and distribution of our product candidates, but until one of our product candidates is approved for sale, it is difficult for us to predict our future operating results. Even if we succeed in developing and commercializing one or more of our product candidates, we expect to incur substantial net losses and negative cash flows fortheforeseeablefuturedueinparttoincreasingresearchanddevelopmentexpenses,includingclinicaltrials, and increasing expenses from leasing additional facilities and hiring additional personnel. As a result, we will need to generate significant revenues in order to achieve and maintain profitability. We may not be able to generate these revenues or achieve profitability in the future. Even if we do achieve profitability,we may not be able to sustain or increase profitability.

We may incur significant losses in the future for a number of reasons, and we may encounterunforeseen expenses, difficulties, complications and delays and other unknown events. As a result, our losses may be larger than anticipated, we may incur significant losses for the foreseeable future, and we may not achieve profitabilitywhenexpected,oratall,andevenifwedo,wemaynotbeabletomaintainorincreaseprofitability. Furthermore, if our future growth and operating performance fail to meet investor or analyst expectations, or if we have future negative cash flow or losses resulting from our investment in acquiring customers or expanding our operations, this could have a material adverse effect on our business, financialcondition and results of operations.

Our operating results and financial condition may fluctuate from period to period.

If and when any of product candidates are successfully commercialized, we anticipate that our operatingresultsandfinancialconditionwillfluctuatefromquarter-to-quarterandyear-to-yearduetoa numberoffactors,manyofwhichwillnotbewithinourcontrol.Bothourbusinessandthepharmaceutical industryarechangingandevolvingrapidly,andouroperatingresultsinanygivenyearmaynotbeuseful inpredictingourfutureoperatingresults.Ifouroperatingresultsdonotmeettheguidancethatweprovide tothemarketplaceortheexpectationsofsecuritiesanalystsorinvestors,themarketpriceofourCommon Stockwilllikelydecline.Fluctuationsinourfutureoperatingresultsandfinancialconditionmaybeduetoa number of factors,including:

• our ability to compete with competitors and new entrants into our markets;

• the products and services that we are able to sell during any period;

• the timing of our sales and distribution of our products to customers;

• the geographic distribution of our sales;

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• expenses and/or liabilities resulting from litigation;

• general economic and industry conditions that affect customer demand;

• changes in accounting rules and tax laws; and

• global geopolitical conditions.

We have a limited operating history upon which to base an investment decision.

Our limited operating history may hinder your ability to evaluate our prospects due to a lack of historical financial data and our unproven potential to generate profits. You should evaluate the likelihood of financial and operational success in light of the risks, uncertainties, expenses and difficulties associated with an early-stage business, many of which may be beyond our control,including:

• our potential inability to obtain regulatory approvals, and

• our potential inability to manufacture, sell and market our products.

Our operations have been limited to organizing and staffing our company, acquiring, developing and securing our proprietary technology and intellectual property and undertaking preclinical studies and early-stage clinical trials of our principal product candidates. These operations provide a limited basis for you to assess our ability to commercialize our product candidates. Further, the pro forma condensed combined financial information included in this registration statement may not be a good prediction of our future results of operations and financial condition.

We need to raise additional capital to operate our business. If we fail to obtain the capital necessary to fund our operations, we will be unable to continue or complete our product development and we may not be able to continue as a going concern.

We are a company focused on product development and have not generated any product revenues to date. Until, and if, we receive approval from the FDA and other regulatory authorities for our product candidates, we cannot sell our drugs and will not have product revenues. We had cash and cash equivalents of approximately $20.1 million as of December 31, 2022, and the Company raised an additional $2.9 million, before fees and other costs, through an offering in March 2023. However, we will need to continue to seek capital from time to time to continue the development and potential commercialization of our product candidates, including any expansion of our clinical programs to facilitate a larger safety database for the use of NRX-101 as a chronic, or chronic-intermittent, treatment as advised by FDA in our recent Type B meeting, and to acquire anddevelopotherproductcandidates.Accordingly,webelievethatwe will needtoraisesubstantialadditional capital to fund our continuing operations and the development and potential commercialization of our product candidates during calendar year 2023. We may raise capital through future share offerings, the issuance of debtinstrumentsandgrantmonies.Ouractualcapitalrequirementswilldependonmanyfactors.Forinstance, our business or operations may change in a manner that would consume available funds more rapidly than anticipated and substantial additional funding may be required to maintain operations, fund expansion, develop new or enhanced products, acquire complementary products, business or technologies or otherwise respond to competitive pressures and opportunities, such as a change in the regulatory environment or a change

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in preferred depression treatment. If we experience unanticipated cash requirements, we may need to seek additional sources of financing, which may not be available on favorable terms, if at all.

We may not be able to secure funding when we need it or on favorable terms. If we cannot raise adequate funds to satisfy our capital requirements, we will have to delay, scale-back or eliminate our researchanddevelopmentactivities,clinicalstudiesorfutureoperationsandwemaybeunabletocomplete plannednonclinicalstudiesandclinicaltrialsorobtainapprovalofourproductcandidatesfromtheFDA andotherregulatoryauthorities.Inaddition,wecouldbeforcedtodiscontinueproductdevelopment,reduce orforegosalesandmarketingeffortsandattractivebusinessopportunities,reduceoverhead,or be unable to continue as a going concern. We may also be required to obtain funds through arrangements with collaborators, which arrangementsmayrequireustorelinquishrightstocertaintechnologiesorproductsthatweotherwisewould not consider relinquishing, including rights to future product candidates or certain major geographic markets. We may further have to license our technology to others. This could result in sharing revenues which we might otherwise retain for ourselves. Any of these actions may harm our business, financial condition and results ofoperations.

The amount of capital we may need depends on many factors, including the progress, timing and scope of our product development programs; the progress, timing and scope of our nonclinical studies and clinical trials; the time and cost necessary to obtain regulatory approvals; the time and cost necessary to further develop manufacturing processes and arrange for contract manufacturing; our ability to enter into and maintain collaborative, licensing and other commercial relationships; and our partners’ commitment of time and resources to the development and commercialization of our products.

We may be unable to access the capital markets and even if we can raise additional funding, we may be required to do so on terms that are dilutive.

The capital markets have been unpredictable in the recent past for unprofitable companies such as ours. In addition, it is generally difficult for companies to raise capital under current market conditions. The amountofcapitalthatacompanysuchasoursisabletoraiseoftendependsonvariablesthatarebeyondour control.Asaresult,wecannotassureyouthatwewillbeabletosecurefinancingontermsattractivetous, oratall.Ifweareabletoconsummateafinancingarrangement,theamountraisedmaynotbesufficientto meet our future needs. If adequate funds are not available on acceptable terms, or at all, our business, resultsofoperations,financialconditionandourcontinuedviabilitywillbemateriallyadverselyaffected.

Wewillhavebroaddiscretioninusingtheproceedsofsharessoldtoinvestors,andwemaynotspendtheproceeds in an effectivemanner.

We are not limited in the use of proceeds of shares sold to investors. We may use such proceeds for working capital and general corporate purposes to support our growth, to pay dividends on our outstanding securities, or for acquisitions or other strategic investments. We have not allocated such funds to any particular purpose, and our management will have the discretion to allocate the proceeds as it determines. We may not apply the proceeds effectively.

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Risks Related to Our Business and Industry

NRX-101 is still in Phase II/III of clinical testing.

NRX-101isinPhaseIIb/IIIofclinicaltestingwithBreakthroughTherapydesignation, a Biomarker LetterandaSpecial ProtocolAgreementissuedbytheFDAonApril20,2018.ASpecialProtocolAgreementisamechanism bywhichtheFDAindicatesthattheproposedclinicaltrial,ifsuccessful,willbeadequatetosupportan application for drug approval. FDA approval requires that a drug candidate complete a Phase III study program, which tests the safety and efficacy of the drug candidate on a large sample of patients. We are conducting a new registrational study of NRX-101 for severe bipolar depression in patients with ASIB after initial stabilization with NRX-100 (ketamine). We are using newly-manufactured material that was manufactured using the expected commercial process. In addition, we have initiated a Phase II clinical study for bipolar depression with sub-acute suicidal ideation and behavior. This population is significantly larger than the Bipolar Depression population with ASIB, and does not require initial stabilization with NRX-100. On January 3, 2023, the Company announced that its first clinical trial site had been contracted for a Phase 3 clinical trial of NRX-101 for the treatment of Severe Bipolar Depression in patients with Acute Suicidal Ideation and Behavior, a potentially lethal condition that currently takes the lives of thousands of Americans each year. Because NRX-101 is a Breakthrough Therapy, we anticipate being able to file a New Drug Application (“NDA”) based upon a single, successful Phase III trial. While we cannot predict with any certainty if or when we might submit an NDA for regulatory approval of NRX-101,we aim to submit an NDA to the FDA on a rolling basis for the regulatory approval and commercialization of NRX-101 in the U.S. in 2023.

Ourproductcandidatesarenewly-formulatedandwehavenotyetscaledmanufacturingtolevelsthatwillbe required for sustainedsales.

NRX-101 has been formulated under cGMP and long-term stability (i.e., five years) has beenachieved for our solid dose formulation of NRX-101. Although the Company completed a Type C meeting in which FDA agreed to the Company's Chemical Manufacturing Control and stability program for drug manufacture, and production of NRx-101 has been transferred to a commercial scale cGMP manufacturingfacility in South Carolina, we have yet to attempt large scale manufacturing.

The outcome of any current or future disputes, claims, arbitration and litigation could have a material adverse effect on our business, financial condition and results of operations.

We are currently involved in a dispute with GEM Yield Bahamas Limited and GEM Global Yield LLC SCS (collectively, “GEM”). On August 12, 2022, the Company received a demand for arbitration (the “Demand”) from GEM. The Demand claims that the Company’s subsidiary, NeuroRx, Inc. (“NeuroRx”), failed to satisfy its obligation to pay GEM a commitment fee in the amount of HK$ 15,000,000 (approximately US$[1,914,087] at current exchange rates) pursuant to a Share Subscription Facility Agreement, executed on October 18, 2019, by and among NeuroRx and GEM. NeuroRx expects to vigorously defend its position that payment of the commitment fee is neither due nor owing under the terms of the Agreement. In the event of an adverse ruling, there can be no assurance that we would not be required to pay damages in an amount that may have a material adverse effect on our business, financial condition or results of operations.

IfwefailtoobtainormaintainFDAandotherregulatoryclearancesforourproducts,orifsuchclearancesare delayed, wewillbeunabletocommerciallydistributeandmarketourproducts.

Our products are subject to rigorous regulation by national regulators around in the world, and by the FDA in the U.S. The process of seeking regulatory clearance or approval to market a drug product is expensive and time consuming and, notwithstanding the effort and expense incurred, clearance or approval is never guaranteed. If we are not successful in obtaining timely clearance or approval of our products from the FDA, we may never be able to generate significant revenue in the U.S. and may beforcedtofocusoninternationalmarketswherewe currently do not have a presence or an established partnership, whichwilllimittherevenue potential of our products.

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In the U.S., the FDA permits commercial distribution of a new drug product only after the producthasreceivedapprovalofanNDAfiledwiththeFDA,seekingpermissiontomarkettheproductin interstate commerce in the U.S. The NDA process is costly, lengthy and uncertain. Any NDA applicationfiledbyuswillhavetobesupportedbyextensivedata,including,butnotlimitedto,technical, nonclinical, clinical trial, manufacturing and labelling data, to demonstrate to the FDA’s satisfaction the safetyandefficacyoftheproductforitsintendeduse.

Obtaining clearances or approvals from the FDA and from the regulatory agencies in other countries could result in unexpected and significant costs for us and consume management’s time and other resources. The FDA and other agencies could ask us to supplement our submissions, collect non-clinical data, conduct additional clinical trials or engage in other time-consuming actions, or they could simply deny our applications. In addition, even if we obtain an NDA approval or pre-market approvals in other countries, the approval could be revoked or other restrictions imposed if post-market data demonstrates safety issues or lack of effectiveness. We cannot predict with certainty how, or when, the FDA will act. If we are unable to obtain the necessary regulatory approvals, our financial condition and cash flow may be adversely affected, and our ability to grow domestically and internationally may be limited. Additionally, even if cleared or approved, our products may not be approved for the specific indications that are most necessary or desirable for successful commercialization or profitability.

Our revenue stream will depend upon third-party reimbursement.

Once our product candidates are cleared or approved by the regulatory authorities, the commercial success of our products in both domestic and international markets will be substantially dependent on whether third-party coverage and reimbursement is available for patients that use our products. However, theavailabilityofinsurancecoverageandreimbursementfornewlyapproveddrugsisuncertain,andtherefore, third-party coverage may be particularly difficult to obtain even if our products are approved by national regulatory authorities as safe and efficacious. Many patients using existing approved therapies are generally reimbursed all or part of the product cost by governmental and non-governmental insurance plans. Such payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement of new drugs, and, as a result, they may not cover or provide adequate payment for these products. Submission of applications for reimbursement approval generally does not occur prior to the filing of an NDA for that product and may not be granted for as long as many months after NDA approval. In order to obtain reimbursement arrangements for these products, we or our commercialization partners may have toagreetoanetsalespricelowerthanthenetsalespricewemightchargeinothersaleschannels. The continuing efforts of government and third-party payors to contain or reduce the costs of healthcare may limit our revenue. Initial dependence on the commercial success of our products may make our revenues particularly susceptible to any cost containment or reductionefforts.

We may have conflicts with our partners that could delay or prevent the development or commercialization of our product candidates.

We are not aware of any material commercialconflictsthatcoulddelayorpreventdevelopmentorcommercialization.However,commercial conflicts such as the interpretation of contractual obligations, payments for services, development obligations or the ownership of intellectual property could arise in any joint development activity. If any conflicts arise with any of our partners, such partner may act in a manner that is adverse to our bestinterests. Any such disagreement could result in one or more of the following, each of which could delay or prevent the development or commercialization of our product candidates, and in turn prevent us from generating revenues:unwillingnessonthepartofapartnertopayusashareinprofitsthatwebelieveareduetousunder a collaboration; uncertainty regarding ownership of intellectual property rights arising from our collaborative activities, which could prevent us from entering into additional collaborations; unwillingness onthepartofapartnertokeepusinformedregardingtheprogressofitsdevelopmentandcommercialization activities or to permit public disclosure of the results of those activities; initiating of litigation or alternative dispute resolution options by either party to resolve the dispute; or attempts by either party toterminate the agreement.

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Ourproductswillfacesignificantcompetitioninthemarketsforsuchproducts,andiftheyareunableto compete successfully, our business willsuffer.

Our product candidates face, and will continue to face, intense competition from large pharmaceutical companies, specialty pharmaceutical and biotechnology companies as well as academic and research institutions. We compete in an industry that is characterized by: (i) rapid technological change, (ii) evolving industry standards, (iii) emerging competition and (iv) new product introductions. Our competitors have existing products and technologies that will compete with our products and technologies and may develop andcommercializeadditionalproductsandtechnologiesthatwillcompetewithourproductsandtechnologies.

Because several competing companies and institutions have greater financial resources than us, they may be able to: (i) provide broader services and product lines, (ii) make greater investments in research and development, and (iii) carry on larger R&D initiatives. Our competitors also have greater development capabilities than we do and have substantially greater experience in undertaking non-clinical and clinical testing of products, obtaining regulatory approvals, and manufacturing and marketing pharmaceutical products. They also have greater name recognition and better access to customers than us. Our chief competitors in the psychiatry area include companies such as Johnson & Johnson, Pfizer, Eli Lilly, Sage Therapeutics,Axsome,andRelmada,amongothers.

Wearefacedwithintensecompetitionandrapidtechnologicalchange,whichmaymakeitmoredifficultforus to achieve significant market penetration. If we cannot compete successfully for market share against other drugcompanies,wemaynotachievesufficientproductrevenuesandourbusinesswillsuffer.

The market for our product candidates is characterized by intense competition and rapid technological advances. If our product candidates receive regulatory approval in any jurisdiction, they will compete with a number of existing and future drugs and therapies developed, manufactured and marketed by others. If our competitors’ existing products or new products are more effective than or considered superior to our future products, the commercial opportunity for our product candidates will be reduced or eliminated. Existingorfuturecompetingproductsmayprovidegreatertherapeuticconvenienceorclinicalorotherbenefits for a specific indication than our products, or may offer comparable performance at a lower cost. We face competition from fully integrated pharmaceutical companies and smaller companies that are collaborating with larger pharmaceutical companies, academic institutions, government agencies and other public and private research organizations. If we are successful in penetrating the relevant markets for treatment with our product candidates, other companies may be attracted to the market. Many of our competitors have productsalreadyapprovedorindevelopment.Inaddition,manyofthesecompetitors,eitheraloneortogether with their collaborative partners, are larger than we are and have substantially greater financial, technical, research, marketing, sales, distribution and other resources than we do. Our competitors may develop or market products that are more effective or commercially attractive than any that we are developing or marketing. Our competitors may obtain regulatory approvals, and introduce and commercialize products before we do. These developments could have a significant negative effect on our financial condition. Even ifweareabletocompetesuccessfully,wemaynotbeable todosoinaprofitablemanner.

Future products may never achieve market acceptance.

Future products that we may develop may never gain market acceptance among physicians, patients and the medical community. The degree of market acceptance of any of our products will depend on a numberoffactors,includingtheactualandperceivedeffectivenessandreliabilityofourproducts;theresults of any long-term clinical trials relating to use of our products; the availability, relative cost and perceived advantages and disadvantages of alternative technologies; the degree to which treatments using ourproducts are approved for reimbursement by public and private insurers; the strength of our marketing and distribution infrastructure; and the level of education and awareness among physicians and hospitals concerning our products. The failure of any of our products to significantly penetrate current or new markets would negatively impact our business, financial condition and results ofoperations.

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To becommerciallysuccessful,physiciansmustbepersuadedthatusingourproductsareeffectivealternatives to existing therapies andtreatments.

We believe that doctors and other physicians will not widely adopt our products unless they determine, based on experience, clinical data, and published peer reviewed journal articles, that the use of our products provides an effective alternative to other therapies and treatments. Patient studies or clinical experience may indicate that treatment with our products does not provide patients with sufficient benefits and/or improvement in quality of life. We believe that recommendations and support for the use of our products from medical societies and / or influential physicians will be essential for widespread market acceptance. Our products are still in the developmentstageanditisprematuretoattempttogainsupportfromphysiciansatthistime.Wecanprovide no assurance that such support will ever be obtained. If our products do not receive such support from these physicians and from long-term data, physicians may not use or continue to use, and hospitals may not purchase or continue to purchase, ourproducts.

We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits.

The testing and marketing of medical products entails an inherent risk of product liability. We may be heldliableifseriousadversereactionsfromtheuseofourproductcandidatesoccur.Ifwecannotsuccessfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our product candidates. Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of pharmaceutical products we develop, alone or with corporate collaborators. We currentlycarryclinicaltrialsliabilityinsurance,butwedonotcurrentlycarryproductliabilityinsurance.

While we plan to obtain product liability insurance as we near commercialization, we, or any corporate collaborators, may not be able to obtain insurance at a reasonable cost, if at all. Even if our agreements with any future corporate collaborators entitle us to indemnification against losses, such indemnification may not be available or adequate if any claim arises.

We may not be able to obtain Hatch-Waxman Act marketing exclusivity or equivalent regulatory data exclusivity protection in other jurisdictions for our products.

Should we not obtain or fail to maintain patent protection on our products, we intend to rely, in part, on Hatch-Waxman exclusivity for the commercialization of our products in the U.S. The Hatch- Waxman Act provides marketing exclusivity to the first applicant to gain approval of an NDA under specific provisions of the Federal Food, Drug, and Cosmetic Act (“FFDCA”) for a product using an active ingredient that the FDA has not previously approved (i.e., five years) or for a new dosage form, route or indication(i.e.,threeyears).Thismarketexclusivitywillnotpreventthe FDA fromapprovingacompetitor’s NDA if the competitor’s NDA is based on studies it has performed and not on our studies. However, there can be no assurance that we will obtain Hatch-Waxman exclusivity for our products or that such exclusivity, if obtained, will protect us from directcompetition.

Similarly, in the European Union, new products authorized for marketing (i.e., reference products) qualifyforeightyearsofdataexclusivityandanadditionaltwoyearsofmarketexclusivityuponmarketing authorization, which, if obtained, would prevent generic applicants from relying on our preclinical and clinicaltrialdata.However,therecanbenoassurancethatEuropeanauthoritieswillgrantdataexclusivity forourproducts.EvenifEuropeandataexclusivityisgrantedforourproducts,thatmaynotprotectusfrom directcompetition.Acompetitorwithagenericversionofourproductsmaybeabletoobtainapprovalof their product during our product’s period of data exclusivity by submitting a marketing authorization application(“MAA”)withalessthanfullpackageofnonclinicalandclinicaldata.

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In the future, we may undertakeinternationaloperations,whichwouldsubjectustorisksinherentwithoperationsoutside of the U.S.

Althoughwedonothaveanyforeignmanufacturingordistributionoperationsatthistime,wemayseektoobtainmarketclearancesinforeignmarketsthatwedeemcouldgeneratesignificantopportunities. However, even with the cooperation of a commercialization partner, conducting drug development in foreign countries involves inherent risks, including, but not limited to: difficulties in staffing, funding and managing foreign operations; unexpected changes in regulatory requirements; export restrictions; tariffs and other trade barriers; difficulties in protecting, acquiring, enforcing and litigating intellectualproperty rights; fluctuations in currency exchange rates; and potentially adverse tax consequences.

We would need to obtain approvals from the appropriate regulatory, pricing and reimbursement authorities to market any of our proposed products internationally, and we may be unable to obtain foreign regulatory approvals. Pursuing foreign regulatory approvals would be time-consuming and expensive. The regulations can vary among countries and foreign regulatory authorities may require different or additional clinicaltrials than the trials we conducted to obtain FDA approval for our product candidates. In addition, adverse clinical trial results in such countries, such as death or injury due to side effects, could jeopardize not only regulatoryapproval,butifapprovalisgranted,mayalsoleadtomarketingrestrictions.Ourproductcandidates may also face foreign regulatory requirements applicable to controlledsubstances.

Ifweweretoexperienceanyofthedifficultieslistedabove,oranyotherdifficulties,anyinternational developmentactivitiesandouroverallfinancialconditionmaysufferandcauseustoreduceordiscontinue our international development and registrationefforts.

International commercialization of our product candidates requires successful collaborations.

We plan to commercialize some of our products internationally through collaborative relationships with foreign partners. We have limited foreign regulatory, clinical and commercial resources. Future partners are critical to our international success. However, we may not be able to enter into collaboration agreements with appropriate partners for important foreign markets on acceptable terms, or at all. Future collaborations with foreign partners may not be effective or profitable forus.

Our business activities could face further disruption due to the COVID-19 pandemic.

We are continuing to monitor the latest developments regarding the COVID-19 pandemic on our business, operations and financial condition and results, and have made certain assumptions regarding the pandemic for purposes of our operational planning and financial projections, including assumptions regarding the duration and severity of the pandemic and the global macroeconomic impact of the pandemic. Despite careful tracking and planning, however, we are unable to accurately predict the extent of the impact of the pandemic on our business, operations and financial condition and results due to the uncertainty of future developments. If there is a resurgence of the COVID-19 pandemic, the research and development of our products will be delayed and we may be unable to perform fully on our contracts, which will likely result in increases in costs and reduction in revenue. These cost increases may not be fully recoverable or adequately covered by insurance. The long-term effects of the COVID-19 pandemic to the global economy and to us continue to be difficult to assess or predict and may include a decline in the market prices of our products, risks to employee health and safety, risks for the deployment of our products and services and reduced sales in geographic locations impacted. Any prolonged restrictive measures put in place to control a resurgence of the COVID-19 pandemic or other adverse public health developments in any of our targeted markets may have a material and adverse effect on our business operations and results of operations.

For additional information on how the COVID-19 pandemic has already impacted our business, operations and financial condition and results, see our historical consolidated financial statements, presented elsewhere in this annual report.

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Globaleconomic,politicalandsocialconditions, armed conflictsanduncertaintiesinthemarketthatweservemayadversely impact ourbusiness.

Our performance depends on the financial health and strength of our customers, which in turn is dependent on the economic conditions of the markets in which we and our customers operate. The recent declines in the global economy, difficulties in the financial services sector and credit markets, continuing geopolitical uncertainties and other macroeconomic factors all affect the spending behavior of potential customers. The economic uncertainty in Europe, the U.S., India, China and other countries may cause end-users to further delay or reduce technology purchases.

We also face risks from financial difficulties or other uncertainties experienced by our suppliers, distributors or other third parties on which we rely. If third parties are unable to supply us with required materials or components or otherwise assist us in operating our business, our business could be harmed.

For example, the possibility of trade disputes and tariffs between countries with whom we are engaged may impact the cost of raw materials, finished products or components used in our products and our ability to sell our products in various markets. Other changes in U.S. social, political, regulatory and economic conditionsorinlawsandpoliciesgoverningforeigntrade,manufacturing,developmentandinvestmentcould also adversely affect our business.

Our business, financial condition, and results of operations may be materially adversely affected by the negative impact on the global economy and capital markets resulting from new international conflicts or any other geopolitical tensions.

U.S. and global markets generally experience volatility and disruption as a result of geopolitical tensions and military conflicts, including significant volatility in commodity prices, credit and capital markets, as well as supply chain disruptions.

Additionally, international sanctions and other penalties can disrupt payment systems and imports/exports and lead to instability and lack of liquidity in capital markets, potentially making it more difficult for us to obtain additional funds. Any such disruptions may also magnify theimpact of other risks described in this annual report.

We may not be successful in hiring and retaining key employees and contractors.

Our future operations and successes depend in large part upon the continued service of key members of our senior management team whom we are highly dependent upon to manage our business, including our Chief Executive Officer. If he terminates his relationship with us, such a departure could have a material adverse effect on our business.

Our future success also depends on our ability to identify, attract, hire or engage, retain and motivate other well-qualified managerial, technical, clinical and regulatory personnel. We will need to hire additional qualified personnel with expertise in nonclinical pharmacology and toxicology, pharmaceutical development, clinical research, regulatory affairs, manufacturing, sales and marketing. We compete for qualified individuals with numerous biopharmaceutical companies, universities and other research institutions. Competition for such individuals, particularly in the U.S., isintense,andwemaynotbeabletohiresufficientpersonnel to support our efforts. There can be no assurance that these professionals will be available in the market, or that we will be able to retain existing professionals or to meet or to continue to meet their compensation requirements. Furthermore, the cost base in relation to such compensation, which may include equity compensation,mayincreasesignificantly,whichcouldhaveamaterialadverseeffectonus.Failuretoestablish and maintain an effective management team and work force could adversely affect our ability to operate, grow and manage our business.

Ouremployeesmayengageinmisconductorotherimproperactivities,includingnoncompliancewithregulatory standards andrequirements.

We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to:

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information to the FDA or comparable foreign regulatory authorities;

• report financial information or data accurately; or

• disclose unauthorized activities to us.

In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensivelawsandregulationsintendedtopreventfraud,kickbacks,self-dealingandotherabusivepractices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion,salescommission,customerincentiveprogramsandotherbusinessarrangements.Employee misconductcouldalsoinvolvetheimproperuseofinformationobtainedinthecourseofclinicaltrials,which couldresultinregulatorysanctionsandseriousharmtoourreputation.WehaveadoptedaBusinessCode of Conduct and Anti-Corruption Policy, but it is not always possible to identify and deter employee misconduct,andtheprecautionswetaketodetectandpreventthisactivitymaynotbeeffectiveincontrolling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actionsorlawsuitsstemmingfromafailuretobeincompliancewithsuchlawsorregulations.Ifanysuch actionsareinstitutedagainstus,andwearenotsuccessfulindefendingourselvesorassertingourrights,those actionscouldhaveasignificantimpactonourbusinessandresultsofoperations,includingtheimposition of significant fines or othersanctions.

Our relationships with customers and payors will be subject to applicable anti-kickback, fraud and abuse, transparency,andotherhealthcarelawsandregulations,whichcouldexposeusetocriminalsanctions,civil penalties,contractualdamages,reputationalharm,administrativeburdens.

Healthcare providers, physicians and payors play a primary role in the recommendation and prescription of any product candidates for which we may obtain marketing approval. Our arrangements with payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute any product candidates for which we may obtain marketing approval. Restrictions under applicable federal, state and foreign healthcare laws and regulations may affect our ability to operate, including:

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Managingourgrowthasweexpandoperationsmaystrainourresourcesandwemaynotsuccessfullymanage ourgrowth.

Weexpecttoneedtogrowrapidlyinordertosupportadditional,larger,andpotentiallyinternational, pivotalclinicaltrialsofourdrugcandidates,whichwillplaceasignificantstrainonourfinancial,managerial andoperationalresources.Inordertoachieveandmanagegrowtheffectively,wemustcontinuetoimprove andexpandouroperationalandfinancialmanagementcapabilities.Moreover,wewillneedtoincreasestaffing andtotrain,motivateandmanageouremployees.Alloftheseactivitieswillincreaseourexpensesand may require us to raise additional capital sooner than expected. If we grow significantly, such growth will place a significant strain on our management and on our administrative, operational and financial resources. To manage this growth, we must expand our facilities, augment our operational, financial and management systems, internal controls and infrastructure and hire and train additional qualified personnel. Our future successisheavilydependentupongrowthandacceptanceofourfutureproducts.Ifweareunabletoscaleour business appropriately or otherwise adapt to anticipated growth and new product introduction, our business and financial condition will beharmed.

We may expand our business through the acquisition of rights to new drug candidates that could disrupt our business, harm our financial condition and may also dilute current stockholders’ ownership interests in our company.

Our business strategy includes expanding our products and capabilities, and we may seek acquisitions of drug candidates or technologies to do so. Acquisitions involve numerous risks, including substantial cash expenditures; potentially dilutive issuances of equity securities; incurrence of debt and contingent liabilities, someofwhichmaybedifficultorimpossibletoidentifyatthetimeofacquisition;difficultiesinassimilating the acquired technologies or the operations of the acquired companies; diverting our management’s attention away from other business concerns; risks of entering markets in which we have limited or no direct experience; and the potential loss of our key employees or key employees of the acquiredcompanies.

We cannot assure you that any acquisition will result in short-term or long-term benefits to us. We may incorrectlyjudgethevalueorworthofanacquiredproduct,companyorbusiness.Anysuchtransactioncould also result in impairment of goodwill and other intangibles, write-offs and other related expenses. In addition, our future success would depend in part on our ability to manage the rapid growth associated with some of these acquisitions. We cannot assure you that we will be able to make the combination of our business with that of acquired products, businesses or companies work or be successful. Furthermore, the development or expansion of our business or any acquired products, business or companies may require a substantial capital investment by us. We may not have these necessary funds or they might not be available to us on acceptable terms or at all. We may also seek to raise funds by selling shares of our preferred or Common Stock, which could dilute each current stockholder’s ownership interest inNRx.

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Developments by competitors may render our products or technologies obsolete or non-competitive.

Alternativetechnologiesandproductsarebeingdevelopedtotreatdepressionandsomemaytarget suicidalbipolardepressionandpost-traumaticstressdisorder(“PTSD”).Many of the organizationscompetingwithushavesubstantiallygreatercapitalresources,largerresearchanddevelopment staffs and facilities, greater experience in drug development and in obtaining regulatory approvals and greater manufacturing and marketing capabilities than we do. Our competitors may market less expensive or more effective drugs that would compete with our drug candidates or reach market with competing drugs before we are able to reach market with our drug candidates. These organizations also compete with us to attract qualified personnel and partners for acquisitions, joint ventures or othercollaborations.

Business interruptions could limit our ability to operate our business.

Our operations as well as those of our collaborators on which we depend are vulnerable to damage or interruption from computer viruses, human error, natural disasters, electrical and telecommunicationfailures, international acts of terror and similar events. We have not established a formal disaster recovery plan and our back-up operations and our business interruption insurance may not be adequate to compensate us for losses we may suffer. A significant business interruption could result in losses or damages incurred by us and require us to cease or curtail ouroperations.

Cyber security attacks, internal system or service failures may adversely impact our business and operations.

Any system or service disruptions, including those caused by projects to improve our information technology systems, if not anticipated and appropriately mitigated, could disrupt our business and impair our ability to effectively provide products and related services to our customers and could have a material adverse effect on our business. We could also be subject to systems failures, including network, software or hardware failures, whether caused by us, third-party service providers, intruders or hackers, computer viruses,naturaldisasters,powershortagesorterroristattacks.

Cybersecuritythreatsareevolvingandinclude, but are not limited to, malicious software, phishing and other unauthorized attempts to gain access to sensitive, confidential or otherwise protected information related to us or our products, customers or suppliers, or other acts that could lead to disruptions in our business. The COVID-19 pandemic has forced manyofouremployeestoshifttowork-from-homearrangements,whichincreasesourvulnerabilitytoemail phishing, social engineering or “hacking” through our remote networks, and similar cyber-attacksaimed atemployeesworkingremotely.Becausethetechniquesusedbycyber-attackerstoaccessorsabotagenetworks change frequently and may not be recognized until launched against a target, we may be unable to anticipate these tactics. Any such failures to prevent or mitigate cyber-attacks could cause loss of data and interruptions or delays in our business, cause us to incur remediation costs or subject us to claims and damage our reputation.

In addition, the failure or disruption of our communications or utilities could cause us to interrupt or suspend our operations or otherwise adversely affect our business. Although we utilize various procedures and controls to monitor and mitigate the risk of these threats and training our employees to recognize attacks, there can be no assurance that these procedures and controls will be sufficient. Our property and business interruption insurance may be inadequate to compensate us for all losses that may occur as a result of any system or operational failure or disruption which would adversely affect our business, results of operations and financial condition. Moreover, expenditures incurred in implementing cybersecurityandotherproceduresandcontrolscouldadverselyaffectourresultsofoperationsandfinancial condition.

FailuretoachieveandmaintaineffectiveinternalcontrolsoverfinancialreportinginaccordancewithSection404 of the Sarbanes-Oxley Act could impair our ability to produce timely and accurate financial statements or complywithapplicableregulationsandhaveamaterialadverseeffectonourbusiness.

Our management has significant requirements for enhanced financial reporting and internal controls as apubliccompany.Theprocessofdesigningandimplementingeffectiveinternalcontrolsisacontinuouseffort that will require us to anticipate and react to changes in our business and the economic and regulatory environments and to expend significant resources to maintain a system of internal controls that is adequate to satisfy our reporting obligations as a public company.

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If we are unable to establish and maintain appropriate internalfinancialreportingcontrolsandprocedures, in accordance with Section 404 of the Sarbanes-Oxley Act, itcould impact our operating results, result in material misstatements in our consolidated financial statements and causeustofailtomeetourreportingobligations on a timely basis. Testing and maintaining internal controls may divert management’s attention from other matters that are important to our business. Our independentregisteredpublicaccountingfirmmayberequiredtoattesttotheeffectivenessofourinternal controloverfinancialreportingonanannualbasis in the future.

Matters impacting our internal controls may cause us to be unable to report our financial information onatimelybasisandtherebysubjectustoadverseregulatoryconsequences,includingsanctionsbytheSEC or violations of applicable stock exchange listing rules, which may result in a breach of thecovenants under existing or future financing arrangements. There also could be a negative reaction in the financial markets due to a loss of investor confidence in us and the reliability of our financial statements. Confidence in the reliability of our financial statements also could suffer if we or our independent registered public accounting firm continue to report a material weakness in our internal controls over financial reporting. This could materially adversely affect us and lead to a decline in the market price of our Common Stock.

Risks Related to Clinical and Regulatory Matters

If we fail to obtain the necessary regulatory approvals, or if such approvals are limited, we will not be allowed to commercialize our drug candidates, and we will not generate product revenues.

Satisfaction of all regulatory requirements for commercialization of a drug candidate typically takes many years, is dependent upon the type, complexity and novelty of the product candidate, and requires the expenditure of substantial resources for research and development. Our research and clinicalapproaches may notleadtodrugsthatregulatorsconsidersafe for humansandeffectivefor indicated uses we are studying. Regulators may require additional studies, in which case we and any product collaborators would have to expend additional time and resources and would likely delay the date of potentiallyreceivingregulatoryapproval.Theapprovalprocessmayalsobedelayedbychangesingovernment regulation, future legislation or administrative action or changes in regulatory policy that occur prior to or during our regulatoryreview.

Delays in obtaining regulatory approvals would:

Even if we comply with all regulatory requirements, our product candidates may never obtain regulatory approval. If we fail to obtain regulatory approval for any of our product candidates we will have fewer commercial products, if any, and corresponding lower product revenues, if any.

Evenifadrugproductisapproved,theregulatorsmayimposelimitationsontheuseormarketingofsuch product.

Even if our product candidates receive regulatory approval from regulators, they may limit the approved indications for use of the product, require that contraindications, warnings or precautions be included in the product labeling, including a black boxed warning. Regulators may also require us or our collaborators to commit to perform lengthy Phase IV post-approval clinical efficacy or safety studies, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution restrictions or other risk management mechanisms that could materially affect the potential market and profitability of the product. Our expending of additional resources on such trials or programs would have an adverse effect on our operating results and financial condition.

After approval, certain circumstances may require additional regulatory notification, review, orapproval, as well as further testing. These may include some types of changes to the approved product, such as adding new indications, manufacturing changes, and additional labeling claims, or new safetyinformation.

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Afterapproval,laterdiscoveryofpreviouslyunknownproblemswithaproductwillhaveadverseconsequences forus.

Later discovery of previously unknown problems with a product, including adverse events of unanticipatedseverityorfrequency,orwithmanufacturingprocesses,orfailuretocomplywithregulatory requirements,mayresultinmandatoryrevisionstotheapprovedlabelingtoaddnewsafetyinformation; impositionofpost-marketstudiesorclinicaltrialstoassessnewsafetyrisks;orimpositionofdistribution orotherrestrictionsundera REMS program.Otherpotential consequences include, among otherthings:

Ifweareunabletodesign,conductandcompleteclinicaltrialssuccessfully,ourdrugcandidateswillnotbe able to receive regulatoryapproval.

In order to obtain regulatory approval for any of our drug candidates, we must submit an NDA or request for EUA that demonstrates with substantive evidence that the drug candidate is both safe and effectiveinhumansforitsintendeduse.Thisdemonstrationrequiressignificantresearchandanimaltests, whicharereferredtoaspreclinicalstudies,aswellashumantests,whicharereferredtoasclinicaltrials.

Results from Phase I clinical programs may not support moving a drug candidate to Phase II or Phase IIIclinicaltrials.PhaseIIIclinicaltrialsmaynotdemonstratethesafetyorefficacyofourdrugcandidates. Successinpreclinicalstudiesandearlyclinicaltrialsdoesnotensurethatlaterclinicaltrialswillbesuccessful. Results of later clinical trials may not replicate the results of prior clinical trials and preclinicalstudies.

Even if the results of Phase III clinical trials are positive, we may have to commit substantial time and additional resources to conducting further preclinical studies and clinical trials before obtaining FDA approval for any of our drug candidates.

Clinicaltrialsareveryexpensiveanddifficulttodesignandimplement,inpartbecausetheyaresubject to rigorous requirements. The clinical trial process also consumes a significant amount of time.Furthermore, if participating patients in clinical trials suffer drug-related adverse reactions during the course ofsuch clinical trials, or if we or the FDA believe that participating patients are being exposed to unacceptable health risks, such clinical trials will have to be suspended or terminated. Failure can occur at any stage of the clinical trials, and we could encounter problems that cause abandonment or repetition of clinical trials. Thesuccessinclinicaltrialsdependsonreachingstatisticallysignificantchangesinpatients’symptomsbased on clinician-rated scales. Due in part to a lack of consensus on standardized processes for assessing clinical outcomes, these scores may or may not be reliable, useful or acceptable to regulatoryagencies.

We do not know whether any of our planned clinical trials will result in marketable drugs. In addition, completion of clinical trials can be delayed by numerous factors, including:

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• slower than expected rates of patient recruitment and enrollment;

• unanticipated patient dropout rates; and

Any of these delays could significantly impact the timing, approval and commercialization of our drug candidates and could significantly increase our overall costs of drug development.

Even if clinical trials are completed as planned, their results may not support expectations or intended marketing claims. The clinical trials process may fail to demonstrate that our drug candidates are safe and effective for indicated uses. Such failure would cause us to abandon a drug candidate and could delay development of other drug candidates.

We cannot predict whether regulatory agencies will determine that the data from our clinical trials of our product candidates supports marketing approval.

The FDA’s and other regulatory agencies’ decision to approve our drug candidates will depend on our ability to demonstrate with substantial clinical evidence through well-controlled clinical trials, that the product candidates are effective, as measured statistically by comparing the overall improvement in actively- treated patients against improvement in the control group (usually a placebo control). However, there is a possibility that our data may fail to show a statistically significant difference from the placebo-control or the active control. Alternatively, there is a possibility that our data may be statistically significant, but that the actual clinical benefit of the product candidates may not be considered to be clinically significant, clinically relevant or clinically meaningful. Consequently, we believe that regulators may consider additional data, suchasa“responder”analysis,secondaryefficacyendpointsandsafetywhenevaluatingwhetherourproduct candidates can be approved. We cannot predict whether the regulatory agencies will find that our clinical trialresultsprovidecompelling“responder”orothersecondaryendpointdata.Evenifwebelievethatthedata from our trials will support marketing approval in the U.S. or in Europe, we cannot predict whether the agencies will agree with our analysis and approve ourapplications.

There is no guarantee that regulatory authorities will grant NDA approval of our current or future product candidatesandfailuretoobtainnecessaryclearancesorapprovalsforourcurrentandfutureproductcandidates would adversely affect our ability to grow ourbusiness.

We initiated a Phase IIb/III clinical research program of NRX-101 during the second half of 2017 under an FDA Investigational New Drug (“IND”) application that was granted Fast Track designation by the FDA in August 2017 and was granted the Breakthrough Therapy designation by the FDA in November 2018. In April 2018, the FDA granted a Special Protocol Agreement. We successfully completed a Phase II clinical trial of NRX-101 in patients with severe bipolar depression and acute suicidal ideation followingstabilizationwithasingledoseof ketamineandsawastatisticallysignificantreductionindepression (P=0.04) and suicidal ideation (P=0.02) compared to lurasidone alone over 42 days of treatment.Ifthisstatistically-significantadvantageisreplicatedinthe current PhaseIIIclinical trial, under the terms agreed to with the FDA in our Special Protocol Agreement, we aim to submit a NDA to the FDA [on a rolling basis] for the regulatory approval and commercialization of NRX-101 in the U.S. in 2023.

We cannot assure investors that the FDA or any other regulator will approve or clear NRX-101 or other product candidates for the indications that are necessary or desirable for successful commercialization. Indeed, the FDA may refuse our requests for NDA market approval of new products, new intended uses or indications to existing or future products. Failure to receive approval for our new products would have an adverse effect on our ability to expand ourbusiness.

Withrespecttoclinicaltrials,discussionsandguidancearenotbindingobligationsonthepartofregulatory authorities.

Regulatoryauthoritiesmayrevisepreviousguidanceordecidetoignorepreviousguidanceatanytime duringthecourseofourclinicalactivitiesorafterthecompletionofourclinicaltrials.Evenwithsuccessful clinicalsafetyandefficacydata,includingsuchdatafromaclinicaltrialconductedpursuanttoaspecial protocolagreement,wemayberequiredtoconductadditional,expensiveclinicaltrialstoobtainregulatory approval.

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Theresultsofourcurrentorfutureclinicaltrialsmaynotsupportourproductcandidateclaimsormayresult in the discovery of unexpected adverse sideeffects.

Even if our clinical trials are completed as planned, we cannot be certain that their results will support ourdrugcandidates’claimsorthattheregulatoryauthoritieswillagreewithourconclusionsregardingthem. Success in pre-clinical studies and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the later trials will replicate the results of prior trials and pre-clinical studies. In particular, our clinical trials performed until now involve a relatively small patient population. Because of the small sample size, their results may not be indicative of future results. It is also possible that patientsenrolledinclinicaltrialswillexperienceadversesideeffectsthatarenotcurrentlypartoftheproduct candidate’s profile. Accordingly, the clinical trial process may fail to demonstrate that our drug candidates are safe and effective for the proposed indicated uses. If the FDA concludes that the clinical trials for any of our products for which we might seek clearance have failed to demonstrate safety and effectiveness, we would not receive regulatory clearance to market that product in the applicable countries for the indications sought. In addition, such an outcome could cause us to abandon the product candidate and might delay development of others. Any delay or termination of our clinical trials will delay the filing of any product submissions with regulatory authorities and, ultimately, our ability to commercialize our product candidates and generaterevenues.

Delaysinthecommencementorcompletionofpharmaceuticaldevelopment,manufacturingorclinicalefficacy andsafetytestingcouldresultinincreasedcoststousanddelayourabilitytogeneraterevenues.

We do not know whether our pharmaceutical development, manufacturing or clinical efficacy and safety testing will begin on time or be completed on schedule, if at all. For example, we may encounter delays during the manufacture of pilot scale batches including delays with our contract development or manufacturing organization, sourcing satisfactory quantities of active pharmaceutical ingredient, narcotic import and export permits, sourcing of excipients, contract disputes with our third-party vendors and manufacturers, or failure of the product to meet specification.

The commencement and completion of clinical trials can be disrupted for a variety of reasons, including difficulties in:

• finding suitable clinical sites;

• recruiting and enrolling patients to participate in a clinical trial;

• obtaining regulatory approval to commence a clinical trial;

• manufacturing sufficient quantities of a product candidate;

• investigator fraud, including data fabrication by clinical trial personnel;

• diversion of controlled substances by clinical trial personnel; and

• unforeseen safety issues; or

In addition, changes in regulatory requirements and guidance may occur and we may need to amend clinical trial protocols to reflect these changes, which could impact the cost, timing or successful completion of a clinical trial. If we experience delays in the commencement or completion of our clinical trials, the commercial prospects for our product

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candidates will be harmed, and our ability to generate product revenues will be delayed. Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also lead to the denial of regulatory approval of a product candidate.

We may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit.

Patient enrollment in clinical trials and completion of patient participation and follow-up depends on many factors, including the size of the patient population; the nature of the trial protocol; the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects; the availability of appropriate clinical trial investigators; support staff; the number of ongoing clinical trials in the same indication that compete for the same patients; and proximity of patients to clinical sites and ability to complywiththeeligibilityandexclusioncriteria for participationintheclinicaltrialandpatientcompliance. For example, patients may be discouraged from enrolling in our clinical trials if the trial protocol requires themtoundergoextensivepost-treatmentproceduresorfollow-uptoassessthesafetyandeffectivenessofour products or if they determine that the treatments received under the trial protocols are not attractive or involveunacceptablerisksordiscomforts.Patientsmayalsonotparticipateinourclinicaltrialsiftheychoose to participate in contemporaneous clinical trials of competitiveproducts. Pandemic or pandemic-like conditions may limit the ability of patients to participate in studies.

Development of sufficient and appropriate clinical protocols to demonstrate safety and efficacy are required and we may not adequately develop such protocols to support clearance and approval.

Regulatorsmayrequireustosubmitdataonagreaternumberofpatientsthanweoriginallyanticipated and/orforalongerfollow-upperiodorchangethedatacollectionrequirementsordataanalysisapplicable toourclinicaltrials.Theymayalsorequireadditionaldataoncertaincategoriesofpatients,shoulditemerge during the conduct of our clinical trials that certain categories of patients are likely to be affected in differentand/oradditionalmannerthanmostofthepatients.Inadditiontoregulatoryauthorityrequirements, our clinical trial requires the approval of the institutional review board (“IRB”) at each site selected for participation in our clinicaltrial.

Additional delays to the completion of clinical studies may result from modifications being made to the protocolduringtheclinicaltrial,ifsuchmodificationsarewarrantedand/orrequiredbytheoccurrencesinthe giventrial.

We may choose to make modifications to a clinical trial protocol during the clinical trial if such modifications are warranted and/or required by the occurrences in the trial. Each of such modifications has to be submitted to a regulatory authority. This could result in the delay or halt of a clinical trial while the modification is evaluated. In addition, depending on the magnitude and nature of the changes made, the regulatory authority could take the position that the data generated by the clinical trial cannot be pooled because the same protocol was not used throughout the trial. This might require the enrollment of additional subjects, which could result in the extension of the clinical trial and the FDA delaying clearance or approval of aproduct.

There can be no assurance that the data generated using modified protocols will be acceptable to regulators.

There can be no assurance that the data generated using modified protocols will be acceptable to the regulators or that if future modifications during the trial are necessary, any such modifications will be acceptable to regulators. If the regulators believe that prior approval is required for a particular modification, they can delay or halt a clinical trial while they evaluate additional information regarding the change.

If an adverse event occurs during a clinical trial, the regulators or an IRB may delay (clinical hold) or terminate the trial, which could adversely affect our business and prospects.

Serious injury or death resulting from a failure of one of our drug candidates during current or future clinical trials could result in the regulators delaying our clinical trials or denying or delaying clearance or approval of a product. Even though an adverse event may not be the result of the failure of our drug candidate, the regulators or an IRB could delay or

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halt a clinical trial for an indefinite period of time while an adverse event is reviewed, and likely would do so in the event of multiple such events.

Any delay or termination of our current or future clinical trials as a result of the risks summarized above, including delays in obtaining or maintaining required approvals from IRBs, delays in patient enrollment, the failure of patients to continue to participate in a clinical trial, and delays or termination of clinicaltrialsasaresultofprotocolmodificationsoradverseeventsduringthetrials,maycauseanincreasein costs and delays in the filing of any product submissions with the FDA, delay the approval and commercialization of our products or result in the failure of the clinical trial, which could adversely affect ourbusiness,operatingresultsandprospects.Lengthydelaysinthecompletionofclinicaltrialsofourproducts wouldadverselyaffectourbusinessandprospectsandcouldcauseustoceaseoperations.

Developments by competitors may establish standards of care that affect our ability to conduct our clinical trials as planned.

Changes in standards related to clinical trial design could affect our ability to design and conduct clinical trials as planned. For example, regulatory authorities may not allow us to compare our drug candidatestoplaceboinaparticularclinicalindicationwhereapprovedproductsareavailable.Inthatcase, boththecostandtheamountoftimerequiredtoconductaclinicaltrialcouldincrease.

Even if our products are approved by regulatory authorities, if we or our suppliers fail to comply with ongoing FDAregulationorifweexperienceunanticipatedproblemswithourproducts,theseproductscouldbesubjectto restrictions or withdrawal from themarket.

Any product for which we obtain clearance or approval, and the manufacturing processes, reporting requirements, post-approval clinical data and promotional activities for such product, will be subject to continued regulatory review, oversight and periodic inspections by the FDA. In particular, we and our suppliers are required to comply with the FDA’s Quality System Regulations (“QSR”), and International Standards Organization (“ISO”), regulations for the manufacture of our products and other regulations which cover the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and shipping of any product for which we obtain clearance or approval.

Regulatory bodies, such as the FDA, enforce these regulations through periodic inspections. The failure by us or one of our suppliers to comply with applicable statutes and regulations administered by the FDA and other regulatory bodies, or the failure to timely and adequately respond to any adverse inspectional observations or product safety issues could result in, among other things, enforcement actions by the FDA.

If any of these actions were to occur it would harm our reputation and cause our product sales and profitability to suffer and may prevent us from generating revenue. Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with all applicable regulatory requirements which could result in our failure to produce our products on a timely basis and in the required quantities, if atall.

Even if regulatory clearance or approval of a product is granted, such clearance or approval may be subject to limitations on the intended uses for which the product may be marketed and reduce the potential to successfully commercialize the product and generate revenue from the product. If the FDA determines that the product promotional materials, labeling, training or other marketing or educational activities constitute promotion of an unapproved use, it could request that we or our commercialization partners cease or modify our training or promotional materials or subject us to regulatory enforcement actions. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider such training or other promotional materials to constitute promotion of an unapproved use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims forreimbursement.

In addition, we may be required to conduct costly post-market testing and surveillance to monitor the safety or effectiveness of our products, and we must comply with adverse event and pharmacovigilance reporting requirements, including the reporting of adverse events which occur in connection with, and whether or not directly related to, our products. Later discovery of previously unknown problems with our products, including unanticipated adverse events or adverse

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events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements, may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement to recall, replace or refund the cost of any product we manufacture or distribute, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal penalties which would adversely affect our business, operating results and prospects.

Future government regulation may affect the commercialization of our product candidate.

We cannot predict the likelihood, nature or extent of adverse government regulation that may arise from future legislation or administrative action, either in the U.S. or abroad. If we are not able to maintainregulatorycompliance,wemaybesubjecttofines,suspensionorwithdrawalofregulatoryapprovals, product recalls, seizure of products, operating restrictions and criminal prosecution. Any of these events could prevent us from marketing our drugs and our business could suffer. If time and resources devoted are limited or there is a failure to fund the continued development of our drug candidates or there isotherwise afailuretoperformasweexpecttodo,wemaynotachieveclinicalandregulatorymilestonesandregulatory submissionsandrelatedproductintroductionsmaybedelayedorprevented,andrevenuesthatwewould receivefromtheseactivitieswillbelessthanexpected.

Conducting clinical trials of our drug candidates or commercial sales of a drug candidate may expose us to expensiveproductliabilityclaimsandwemaynotbeabletomaintainproductliabilityinsuranceonreasonable terms or atall.

The risk of product liability is inherent in the testing of pharmaceutical products. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit or terminate testing of one or more of our drug candidates. Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against product liability claims could prevent or inhibit the commercialization of our drug candidates. We currently carry clinical trial insurance but do not carry product liability insurance. If we successfully commercialize one or more of our drug candidates, we may face product liability claims, regardless of FDA approval for commercial manufacturing and sale. We may not be able to obtain such insurance at a reasonable cost, if at all. Even if our agreements with any current or future corporate collaborators entitle us to indemnification against product liability losses, such indemnification may not be available or adequate should any claim arise.

TheuseofacontrolledsubstanceinourNRX-100drugcandidatesubjectsustoDEAscrutinyandcompliance, which may result in additional expense and clinicaldelays.

TheU.S.DrugEnforcementAdministration(“DEA”)regulateschemicalcompoundsasScheduleI,II, III,IVorVsubstances,withScheduleIsubstancesconsideredtopresentthehighestriskofsubstanceabuse andScheduleVsubstancesthelowestrisk.OneoftheingredientsinNRX-100isketamine,aScheduleIII controlledsubstancewithhighabusepotential.Consequently,themanufacture,research,shipment,storage, sale and use of this drug candidate is subject to a high degree of oversight and regulation. None of our otherdrugscurrentlyunderdevelopment,includingNRX-101,includeascheduledchemical compound.

DEA oversight and regulation can have the following impact on our efforts to develop new drug candidates:

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Annual registration is required for any facility that manufactures, distributes, dispenses, imports or exports any controlled substance. The registration is specific to the particular location, activity and controlled substance schedule. For example, separate registrations are needed for import and manufacturing, and each registration will specify which schedules of controlled substances are authorized. Similarly, separate registrations are also required for separate facilities.

There are substantial penalties for failing to comply with DEA regulations.

The DEA typically inspects a facility to review its security measures prior to issuing a registration and on a periodic basis. Security requirements vary by controlled substance schedule, with the most stringent requirements applying to Schedule I and Schedule II substances. However, records must be maintained for thehandlingofallcontrolledsubstances,andperiodicreportsmayberequiredtobemadetotheDEAforthe distribution of certain controlled substances. Reports must also be made for thefts or significant losses of anycontrolledsubstance.Toenforcetheserequirements,theDEAconductsperiodicinspectionsofregistered establishments that handle controlled substances. Failure to maintain compliance with applicable requirements, particularly as manifested in loss or diversion, can result in administrative, civil or criminal enforcement. The DEA may seek civil penalties, refuse to renew necessary registrations, or initiate administrative proceedings to revoke those registrations. In some circumstances, violations could result in criminalproceedingsorconsentdecrees.Individualstatesalsoindependentlyregulatecontrolledsubstances.

There are limitations on the availability of controlled substances used in NRX-100 that may limit the availability of the active ingredients for this drug product.

The DEA limits the availability and production of all scheduled substances, including ketamine, through a quota system. The DEA requires substantial evidence and documentation of expected legitimate medical and scientific needs before assigning quotas to manufacturers. In future years, we may need greater amounts of controlled substances to sustain our Phase IIb/III development program for NRX-101 after stabilization with NRX-100, and we will need significantly greater amounts to implement our commercialization plans if the FDA approves our proposed formulations. Any delay or refusal by the DEA in establishing the procurement quota or a reduction in our quota for scheduled controlled substances or a failure to increase it over time as we anticipate could delay or stop the clinical development or commercial sale of some of our products or product candidates. This could have a material adverse effect on our business, results of operations, financial condition and prospects.

We may not be able to demonstrate the reduced risk we believe is applicable.

Schedule III drugs have lower abuse potential than Schedule I and II drugs. However, despite the foregoing reduced risk of abuse from Schedule III drugs, when compared to Schedule II drugs, there is no assurancethatsuchreducedriskcanbedemonstratedinwellcontrollednon-clinicaland/orclinicalstudiesin models of physical dependence, psychic dependence, addiction or precipitated withdrawal, or in studies of addictionorabuseliabilityinaddicts,ex-addictsorrecreationaldrugusers.Intheeventthatareducedriskof abusefromScheduleIIIdrugs,whencomparedtoScheduleIIdrugs,isdemonstratedinwellcontrollednon- clinical and/or clinical studies, there is no assurance that the FDA will agree to incorporation of such favorable language in the products prescribinginformation.

The use of controlled substances in our product candidates may generate controversy.

Products containing controlled substances may generate public controversy. Opponents of these products may seek restrictions on marketing and withdrawal of any regulatory approvals. In addition, these opponents may seek to generate negative publicity and media stories in an effort to persuade the medical community to reject these products. Political pressures and adverse publicity could lead to additional regulatory hurdles, delays in, increased expenses for, and limit or restrict the introduction and marketing of, our product candidates.

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We may need to focus our future efforts in new therapeutic areas where we have little or no experience.

Although our primary strategic interests are in the areas of depression therapies, NRX-101 has potential benefits in other therapeutic areas. If our drug development efforts in bipolar depression fails, or if the competitive landscape or investment climate for antidepressant drug development therapies is less attractive, we may need to change our strategic focus to include development of our product candidates, or of newly acquired product candidates, for therapeutic areas otherthandepression.Wehaveverylimiteddrugdevelopmentexperienceinothertherapeutic areas and we may be unsuccessful in making this change to a company with a focus in areas other than depression or a company with a focus in multiple therapeutic areas including depression.

Some of our products for clinical trials may be manufactured outside the U.S.

Currently, our new clinical trial supplies for NRX-101 are being manufactured in the U.S., though some supplies are sourced from outside the U.S. Switching or adding manufacturing capability outside the U.S. can involve substantial cost and require extensive management time and focus, additional regulatory filings and compliance with import/ export regulations. In addition, there is a natural transition period when a new manufacturing facility commenceswork.Asaresult,delays may occur,whichcanmateriallyimpactourabilitytomeetourdesired timelines, thereby increasing our costs and reducing our ability to generaterevenue.

Modifications to our products may require new NDA approvals.

Once a particular company product receives FDA approval or clearance, expanded uses or uses in new indications of our products may require additional human clinical trials and new regulatory approvals or clearances, including additional IND and NDA submissions and premarket approvals before we can begin clinicaldevelopment,and/orpriortomarketingandsales.IftheFDArequiresnewclearancesorapprovalsfor a particular use or indication, we may be required to conduct additional clinical studies, whichwould require additional expenditures and negatively impact our operating results. If the products are already being used for these new indications, we may also be subject to significant enforcement actions.

Conducting clinical trials and obtaining clearances and approvals can be a time-consuming process, anddelaysinobtainingrequiredfutureclearancesor approvals couldadverselyaffectourabilitytointroduce new or enhanced products in a timely manner, which in turn would harm our futuregrowth.

Some of our other product candidates will require Risk Evaluation and Mitigation Strategies.

The FDA Amendments Act of 2007 implemented safety-related changes to product labeling and requires the adoption of REMS. Some of our product candidates, including the controlled substance-based products and potentially others, will require REMS. The REMS may include requirements for special labeling or medication guides for patients, special communication plans to health care professionals and restrictions on distribution and use.

We cannot predict the specific REMS to be required as part of the FDA’s approval of any of our products. Depending on the extent of the REMS requirements, our costs to commercialize our products may increase significantly. Furthermore, controlled substances risks that are not adequately addressed through proposed REMS for our product candidates may also prevent or delay their approval for commercialization.

We are reliant on third party manufacturers to produce controlled substances that conform to our specifications and the FDA’s strict regulatory requirements.

The facilities of any of our future manufacturers of controlled substances must be approved by the FDA after we submit our NDA and before approval. We are dependent on the continued adherence of third-party manufacturers to cGMP manufacturing. If our manufacturers cannot successfully produce material that conforms to our specifications and the FDA’s strict regulatory requirements, they will not be able to secure FDA approval for their manufacturing facilities. If the FDA does not approve these facilities for the commercial manufacture, we will need to find alternative suppliers, which would

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result in significant delays in obtaining FDA approvals. These challenges may have a material adverse impact on our business, results of operations, financial condition andprospects.

Risks Related to Intellectual Property

Our business relies on certain licensing rights that can be terminated in certain circumstances.

Our ability to continue to develop our product candidates is dependent on the use of certain intellectual property that is licensed to us, or in the process of being licensed to us, by third parties. These licenses are granted, or being granted, pursuant to agreements setting forth certain terms and condition for maintaining such licenses. In the event that the terms and conditions are not met, the licenses are at risk of being revokedandthegrantingprocessmaybeterminated.TheprimarylicenseagreementsincludetheDevelopment and License Agreement, as amended, between Glytech LLC (“Glytech”) and NeuroRx (the “Glytech DLA”) and the Exclusive License Agreement, dated as of April 16, 2019, by and between NeuroRx and Sarah HerzogMemorialHospitalEzratNashim.

We may require additional licensing rights in the future, which may not be attainable.

Our ability to fully develop the full commercial potential of our product candidates may require us to acquire additional licensing rights from third parties in the future. There are no assurances that such rights will be available in the market when required, or that an agreement could be reached to license such rights from a third party on terms acceptable to us.

We may not succeed at in-licensing drug candidates or technologies to expand our product pipeline.

Wemaynotbeabletosuccessfullyin-license(i.e.,licensingof patenttechnologyorknow-howdeveloped by a third party in lieu of developing the technology ourselves) drug candidates or technologies to expand our product pipeline. The number of such candidates and technologies is limited. Competition among large pharmaceutical companies and biopharmaceutical companies for promising drug candidates and technologiesisintensebecausesuchcompaniesgenerallydesiretoexpandtheirproductpipelinesthroughin- licensing. If we are unable to carry out such in-licensing and expand our product pipeline, our potential future revenues maysuffer.

Our business depends upon securing and protecting critical intellectual property.

Our commercial success will depend in part on our obtaining and maintaining patent, trade secret, copyright and trademark protection of our technologies in the U.S. and other jurisdictions as well as successfully enforcing this intellectual property and defending this intellectual property against third-party challenges. We will only be able to protect our technologies from unauthorized use by third parties to the extent that valid and enforceable intellectual property protection, such as patents or trade secrets, cover them. In particular, we place considerable emphasis on obtaining patent and trade secret protection for significant new technologies, products and processes. Furthermore, the degree of future protectionofourproprietaryrightsisuncertainbecauselegalmeansaffordonlylimitedprotectionandmay not adequately protect our rights or permit us to gain or keep our competitive advantage. Moreover, the degreeoffutureprotectionofourproprietaryrightsisuncertainforproductsthatarecurrentlyintheearly stages of development because we cannot predict which of these products will ultimately reach the commercial market or whether the commercial versions of these products will incorporate proprietary technologies.

Our patent position is highly uncertain and involves complex legal and factual questions.

Our patent position is highly uncertain and involves complex legal and factual questions. Accordingly, we cannot predict the breadth of claims that may be allowed or enforced in our patents or in third-party patents.Forexample,weorourlicensorsmightnothavebeenthefirsttomaketheinventionscoveredbyeach of our pending patent applications and issued patents; we or our licensors might not have been the first to file patent applications for these inventions; others may independently develop similar or alternative technologies or duplicate any of our technologies; it is possible that none of our pending patent applications or the pending patent applications of our licensors will result in issued patents; our issued patents and issued patents of our licensors may not provide a basis for commercially viable technologies, or may not provide us with any

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competitive advantages, or may be challenged and invalidated by third parties; and, we may not develop additional proprietary technologies that arepatentable.

As a result, the validity of our owned and licensed patents may be challenged and we may not be able to obtain and enforce patents and to maintain trade secret protection for the full commercial extent of our technology. The extent to which we are unable to do so could materially harm our business.

We or our licensors have applied for and will continue to apply for patents for certain products. Such applications may not result in the issuance of any patents, and any patents now held or that may be issued may not provide us with adequate protection from competition. Furthermore, it is possible that patents issued or licensed to us may be challenged successfully. In that event, if we have a preferred competitive position because of such patents, any preferred position held by us would be lost. If we are unable to secure or to continue to maintain a preferred position, we could become subject to competition from the sale of generic products. Failure to receive, inability to protect, or expiration of our patents would adversely affect our business and operations.

Patents issued or licensed to us may be infringed by the products or processes of others. The cost of enforcing our patent rights against infringers, if such enforcement is required, could be significant, and we donotcurrentlyhavethefinancialresourcestofundsuchlitigation.Further,suchlitigationcangoonforyears and the time demands could interfere with our normal operations and may absorb significant management time. There has been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical industry. We may become a party to patent litigation and other proceedings. The cost to us of any patent litigation, even if resolved in our favor, could be substantial. Some of our competitors may be able to sustain the costs of such litigation more effectively than we can because of their substantially greater financialresources.

Unpatented trade secrets, improvements, confidential know-how and continuing technological innovation are important to our scientific and commercial success. Although we attempt to and will continuetoattempttoprotectourproprietaryinformationthroughrelianceontradesecretlawsandtheuse ofconfidentialityagreementswithourcorporatepartners,collaborators,employeesandconsultantsand otherappropriatemeans,thesemeasuresmaynoteffectivelypreventdisclosureofourproprietaryinformation, and,inanyevent,othersmaydevelopindependently,orobtainaccessto,thesameorsimilarinformation.

Ifwearefoundtobeinfringingonpatentsortradesecretsownedbyothers,wemaybeforcedtoceaseoralterour product development efforts, obtain a license to continue the development or sale of our products, and/or pay damages.

Our manufacturing processes and potential products may violate proprietary rights of patents that have been or may be granted to competitors, universities or others, or the trade secrets of those persons and entities. As the pharmaceutical industry expands and more patents are issued, the risk increases that our processes and potential products may give rise to claims that they infringe the patents or trade secrets of others. These other persons could bring legal actions against us claiming damages and seeking to enjoin clinical testing, manufacturing and marketing of the affected product or process. If any of these actions are successful, in addition to any potential liability for damages, we could be required to obtain a license in order to continue to conduct clinical tests, manufacture or market the affected product or use the affected process. Required licenses may not be available on acceptable terms, if at all, and the results of litigation are uncertain. If we become involved in litigation or other proceedings, it could consume a substantial portion of our financial resources and the efforts of ourpersonnel.

Our ability to protect and enforce our patents does not guaranty that we will secure the right to commercialize our patents.

A patent is a limited exclusionary right conferred upon an inventor, and his successors in title, in return for the making and disclosing of a new and non-obvious invention. This exclusionary right is of limited duration but, while in force, allows the patent holder to prevent others from making and/or using his invention. While a patent gives the holder this right to exclude others, it is not an authorization to commercialize the invention,whereotherpermissionsmayberequiredforpermissiblecommercializationtooccur.Forexample, a drug cannot be marketed without the appropriate authorization from

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the FDA, regardless of the existence of a patent covering the product. Further, the invention, even if patented itself, may not be able to be successfully commercialized if it infringes the valid patent rights of anotherparty.

We rely on confidentiality agreements to protect our trade secrets. If these agreements are breached by our employees or other parties, our trade secrets may become known to our competitors.

We rely on trade secrets that we seek to protect through confidentiality agreements with our employees and other parties. If these agreements are breached, our competitors may obtain and use our trade secrets to gain a competitive advantage over us. We may not have any remedies against our competitors and any remedies that may be available to us may not be adequate to protect our business or compensate usfor the damaging disclosure. In addition, we may have to expend resources to protect our interests from possible infringement by others.

If we are unable to obtain the statutory patent extension related to the review time in the U.S., we may need to rely on the 3-year Hatch-Waxman Act marketing exclusivity, the six-month pediatric exclusivity, any approved Orphan Drug exclusivities, potential future formulation patents and up to ten years of data exclusivity in Europe. See “Risks Related to Clinical and Regulatory Matters — We may not be able to obtain Hatch-Waxman Act marketing exclusivity or equivalent regulatory data exclusivity protection in other jurisdictions for ourproducts.”

We may not receive royalty or milestone revenue relating to our product candidates under our collaboration and future license agreements for several years, or at all.

We expect that our future collaboration agreements and future license agreements relating to our product candidates will provide for payments on achievement of development or commercialization milestones and for royalties on product sales. However, because none of our drug candidates has been approved for commercial sale, many of our drug candidates are at early stages of development and drug development entails a high risk of failure, we may never realize much of the milestone revenue provided for in our future collaboration and future license agreements and we do not expect to receive any royalty revenue for several years, if at all. Similarly, drugs we select to commercialize ourselves, or partner for later stage co-development and commercialization, may not generate revenue for several years, or at all.

Risks Related to Our Reliance on Third Parties

We do not have direct control of third parties performing preclinical and clinical trials.

We may depend on independent investigators and collaborators, such as universities and medical institutions,toconductourpreclinicalandclinicaltrialsunderagreementswithus.Theseinvestigatorsand collaborators are not our employees, and we cannot control the amount or timing of resources that they devote to our programs. They may not assign as great a priority to our programs or pursue them as diligentlyaswewouldifwewereundertakingsuchactivitiesourselves.Iftheseinvestigatorsorcollaborators failtodevotesufficienttimeandresourcestoourdrugdevelopmentprograms,oriftheirperformanceis substandard,theapprovalofourregulatorysubmissionsandourintroductionsofnewdrugswillbedelayed orprevented.

Our potential collaborators may also have relationships with other commercial entities, some of which may compete with us. If outside collaborators assist our competitors to our detriment, the approval of our regulatorysubmissionswillbedelayedandthesalesfromourproducts,ifanyarecommercialized,willbeless thanexpected.

If the third parties on which we rely to conduct our clinical trials and to assist us with pre-clinical development do not perform as contractually required or expected, we may not be able to obtain regulatory approval for or commercialize our products.

We do not have the ability to independently conduct all the pre-clinical and clinical trials for our products and we must rely on third parties, such as contract research organizations, medical institutions, clinical investigators and contract laboratories to conduct such trials. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if these third parties need to be replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our pre-clinical development activities or clinical trials may be extended, delayed, suspended or terminated, and

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we may not be able to obtain regulatory approval for, or successfully commercialize, our products on a timely basis, if at all, and our business, operating results and prospects may be adversely affected. Furthermore, our third-party clinical trial investigators may be delayed in conducting our clinical trials for reasons outside of theircontrol.

We have no manufacturing capabilities and depend on other parties for our manufacturing operations. If these manufacturers fail to meet our requirements and strict regulatory requirements, our product development and commercialization efforts may be materially harmed.

Wecurrentlydependoncontractmanufacturers.Weplantoenterintolong-termcommercialsupply agreementsforourproductcandidates.Ifanymanufacturerisunabletoproducerequiredquantitiesona timelybasisoratall,ouroperationswouldbedelayedandourbusinessharmed.Ourrelianceoncontract manufacturersexposesustoadditionalrisks,including:

Any of these factors could result in significant delay or suspension of our clinical trials, regulatory submissions, receipt of required approvals or commercialization of our products and harm our business. If we are not able to secure favorable arrangements with such third parties, our business and financialcondition could beharmed.

Wemustenterintoagreementswith,anddependupon,oneormorepartnerstoassistusincommercializingour productcandidates.

Our ability to commercialize depends upon our continued ability to purchase raw materials from suppliers, our ability to arrange manufacture at contract manufacturers, our ability to deploy commercial sales force via third party partnerships, and our ability to manage shipping and logistics. Any collaboration agreement we enter into may contain unfavorable terms, for example, with respect to product candidates covered, control over decisions and responsibilities, termination rights, payment, and other significant terms.

Our ability to receive any significant revenue from our product candidates covered by the collaboration agreement will be dependent on the efforts of our collaboration partner and may result in lower levels of income to us than if we marketed our product candidates entirely on our own. The collaboration partner may not fulfill its obligations or commercialize our product candidates as quickly as we would like. Even if the collaboration partner performs well, there is no assurance that our proposed products will achieve acceptance by patients, health care providers and insurance companies.

We could also become involved in disputes with our partner, which could lead to delays in or termination of our commercialization programs and time-consuming and expensive litigation or arbitration. If a collaboration partner terminates or breaches its agreement with us, or otherwise fails to complete its obligations in a timely manner, the chances of successfully developing or commercializing our product candidates would be materially and adversely affected.

Additionally,dependinguponthecollaborationpartnerthatwechoose,othercompaniesthatmight otherwise be interested in developing products with us could be less inclined to do so because of our relationshipwiththecollaborationpartner.Ifourabilitytoworkwithpresentorfuturestrategicpartners orcollaboratorsisadverselyaffectedasaresultofourcollaborationagreement,ourbusinessprospectsmay belimited,andourfinancialconditionmaybeadverselyaffected.

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Upon commercialization of our products, we may be dependent on third parties to market, distribute and sell ourproducts.Ifwearenotsuccessfulincontractingwiththirdpartiesfortheseservicesonfavorableterms,or at all, our product revenues could bedisappointing.

We have no experience selling, marketing or distributing products and no internal capability to do so. In order to commercialize our products, if any are approved by the FDA, we will either have to develop suchcapabilitiesinternallyorcollaboratewiththirdpartieswhocanperformtheseservicesforus.Ifwedecide tocommercializeanyofourdrugsourselves,wemaynotbeabletohirethenecessaryexperiencedpersonnel and build sales, marketing and distribution operations which are capable of successfully launching new drugs and generating sufficient product revenues. In addition, establishing such operations will take time and involve significantexpense.

If we decide to enter into new co-promotion or other licensing arrangements with third parties, we may be unable to locate acceptable collaborators because the number of potential collaborators is limited and because of competition from others for similar alliances with potential collaborators. Even if we are able to identify one or more acceptable new collaborators, we may not be able to enter into any collaborative arrangements on favorable terms, or at all.

In addition, any revenues we receive would depend upon our collaborators’ efforts which may not be adequate due to lack of attention or resource commitments, management turnover, change of strategic focus, business combinations or other factors outside of our control. Depending upon the terms of our collaboration, the remedies we have against an under-performing collaborator may be limited. If we were to terminate the relationship, it may be difficult or impossible to find a replacement collaborator on acceptable terms, or atall.

Risks Related to Ownership of Our Common Stock

Our issuance of additional shares of Common Stock or convertible securities could make it difficult for anothercompanytoacquireus,maydiluteyourownershipofusandcouldadverselyaffectourstockprice.

From time to time in the future, we may issue additional shares of our Common Stock or securities convertible into Common Stock pursuant to a variety of transactions, including acquisitions. The issuance by us of additional shares of our Common Stock or securities convertible into our Common Stock would dilute your ownership of us and the sale of a significant amount of such shares in the public market could adversely affect prevailing market prices of our Common Stock.

In the future, we expect to obtain financing or to further increase our capital resources by issuing additional shares of our capital stock or offering debt or other equity securities, including senior or subordinated notes, debt securities convertible into equity, or shares of preferred stock. Issuing additional shares of our capital stock, other equity securities, or securities convertible into equity may dilute the economic and voting rights of our existing stockholders, reduce the market price of our Common Stock, or both.

Debt securities convertible into equity could be subject to adjustments in the conversion ratio pursuant to which certain events may increase the number of equity securities issuable upon conversion. Preferred stock, if issued, could have a preference with respect to liquidating distributions or a preference with respect to dividend payments that could limit our ability to pay dividends to the holders of our Common Stock. Our decision to issue securities in any future offering will depend on market conditions and other factors beyond our control, which may adversely affect the amount, timing or nature of our future offerings. As a result, holders of our common stock bear the risk that our future offerings may reduce the market price of our Common Stock and dilute their percentage ownership. See the “Description of Capital Stock” section of this annual report.

Future sales, or the perception of future sales, of our Common Stock by us or our existing stockholders in the public market could cause the market price for our Common Stock to decline.

The sale of substantial amounts of shares of our Common Stock in the public market, or the perception that such sales could occur, could harm the prevailing market price of shares of our Common Stock. These sales, or the possibility that

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these sales may occur, also might make it more difficult for us to sell equity securities in the future at a time and at a price that we deem appropriate.

In addition, the shares of Common Stock reserved for future issuance under the NRx 2021OmnibusIncentivePlan(the“IncentivePlan”)areeligibleforsaleinthepublicmarketoncethose shares are issued, subject to provisions relating to various vesting agreements, lock-up agreements and, in somecases,limitationsonvolumeandmannerofsaleapplicabletoaffiliatesunderRule144oftheExchange Act, as applicable. The original number of shares reserved for future issuance under the Incentive Plan was 5,373,394. In addition, the Incentive Plan includes an evergreen feature that will allow our Board, in its sole discretion, to reserve additional shares of Common Stock for future issuance under the Incentive Plan each calendar year, beginning January 1, 2022 and ending on and including January 1, 2031, equal to the lesserof (A) 1% of the shares of Common Stock outstanding on the final day of the immediately preceding calendar year or (B) a smaller number of shares determined by the Board.

Accordingly, our stockholders and the holders of insider shares may sell large amounts of Common Stock or warrants in the open market or in privately negotiated transactions when permitted, which could havetheeffectofincreasingthevolatilityinthetradingpriceoftheCommonStockorthewarrantsorputting significant downward pressure on the price of the Common Stock or thewarrants.

Further,salesofCommonStockorwarrantsuponexpirationofanyapplicablelockupperiodscould encourage short sales of our Common Stock or warrants by market participants. Generally, short selling meanssellingasecurity,contractorcommoditynotownedbytheseller.Theselleriscommittedtoeventually purchasethefinancialinstrumentpreviouslysold.Shortsalesareusedtocapitalizeonanexpecteddecline inthesecurity’sprice.ShortsalesofourCommonStockorwarrantscouldhaveatendencytodepressthe priceofourCommonStockorwarrants,respectively,whichcouldincreasethepotentialforshortsales.

WecannotpredictthesizeoffutureissuancesofourCommonStockorwarrantsortheeffect,ifany, thatfutureissuancesandsalesofsharesofourCommonStockorwarrantswillhaveonthemarketpriceof our Common Stock or warrants. Sales of substantial amounts of Common Stock, or the perception that suchsalescouldoccur,mayadverselyaffectprevailingmarketpricesofourCommonStockorwarrants.

Wequalifyasa“smallerreportingcompany”withinthemeaningof the Securities Act, and if we take advantage of certain exemptions from disclosure requirements available to smaller reporting companies, it could make our securities less attractive to investors and may make it more difficult to compare our performance to the performance of other public companies.

We qualify as a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two (2) years of audited financial statements. We will remain a smaller reporting company until the last day of the fiscal year in which (i) the market value of our Common Stock held by non-affiliates exceeds $250 million as of the end of that year’s second fiscal quarter, or (ii) our annual revenues exceeded $100 million during such completed fiscal year and the market value of our Common Stock held by non-affiliates exceeds $700 million as of the end of thatyear’s second fiscal quarter. To the extent we take advantage of such reduced disclosure obligations, it may also make comparison of our financial statements with other public companies difficult or impossible.

Anti-takeover provisions in our governing documents and under Delaware law could make an acquisition of us more difficult, limit attempts by our stockholders to replace or remove our current management and limit the market price of our Common Stock.

The Charter, the Bylaws and DGCL contain provisions that could have the effect of rendering more difficult, delaying, or preventing an acquisition deemed undesirable by our Board. Among other things, the Charter and/or the Bylaws include the following provisions:

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These provisions, alone or together, could delay or prevent hostile takeovers and changes in control or changes in our management. We have elected in the Charter not to be subject to Section 203 of the DGCL, which prevents interested stockholders, such as certain stockholders holding more than 15% of our outstanding Common Stock, from engaging in certain business combinations unless (i) prior to the time such stockholder became an interested stockholder, the Board approved the transaction that resulted in such stockholder becoming an interested stockholder, (ii) upon consummation of the transaction that resulted in such stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the Common Stock, or (iii) following board approval, such business combination receives the approval of the holders of at least two-thirds of our outstanding Common Stock not held by such interested stockholder at an annual or special meeting of stockholders. However, the Charter contains provisions that have the same effect as Section 203 of the DGCL, except they provide that Jonathan Javitt and Daniel Javitt and their respective affiliates will not be deemed to be “interested stockholders” regardless of the percentage of Common Stock owned by them and, accordingly, will not be subject to such restrictions.

Any provision of the Charter, the Bylaws or DGCL that has the effect of delaying, preventing or deterring a change in control could limit the opportunity for our stockholders to receive a premium for their shares of our Common Stock and could also affect the price that some investors are willing to pay for our Common Stock.

The Charter and the Bylaws provide that the Court of Chancery of the State of Delaware will be the sole and exclusiveforumforsubstantiallyalldisputesbetweenusandourstockholders,whichcouldlimitourstockholders’ abilitytoobtainafavorablejudicialforumfordisputeswithusorourdirectors,officers,oremployees.

The Charter and the Bylaws provide that, unless we consent in writing to the selection of an alternative forum, the (a) Court of Chancery of the State of Delaware (the “Chancery Court”) (or, in the event that the Chancery Court does not have jurisdiction, the federal district court for the District of Delaware or other state courts of the State of Delaware) shall, to the fullest extent permitted by law, be the sole and exclusive forumfor:(i)anyderivativeaction,suitorproceedingbroughtonourbehalf;(ii)anyaction,suitorproceeding asserting a claim of breach of fiduciary duty owed by any of our directors, officers, or stockholders tous ortoourstockholders;(iii)anyaction,suitorproceedingassertingaclaimarisingpursuanttotheDGCL, theCharterortheBylaws;or(iv)anyaction,suitorproceedingassertingaclaimgovernedbytheinternal affairsdoctrine;and(b)subjecttotheforegoing,thefederaldistrictcourtsoftheU.S. shallbetheexclusiveforumfortheresolutionofanycomplaintassertingacauseofactionarisingunderthe Securities Act. Notwithstanding the foregoing, such forum selection provisions shall not apply to suits broughttoenforceanyliabilityordutycreatedbytheExchangeActoranyotherclaimforwhichthefederal courts of the U.S.have exclusive jurisdiction. The choice of forum provision may limit a stockholder’sabilitytobringaclaiminajudicialforumthatitfindsfavorablefordisputeswithusorour directors,officers,orotheremployees,whichmaydiscouragesuchlawsuitsagainstusandourdirectors, officers,andotheremployees.Alternatively,ifacourtweretofindthechoiceofforumprovisioncontained intheChartertobeinapplicableorunenforceableinanaction,wemayincuradditionalcostsassociated withresolvingsuchactioninotherjurisdictions,whichcouldharmourbusiness,resultsofoperations,and financialcondition.

Additionally, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulationsthereunder.Asnotedabove,

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theCharterandtheBylawswillprovidethatthefederaldistrictcourts of the U.S. shall have jurisdiction over any action arising under the SecuritiesAct.

Accordingly, there is uncertainty as to whether a court would enforce such provision. Our stockholders will not be deemed to have waived our compliance with the federal securities laws and the rules and regulations thereunder.

Certain of our stockholders have effective control of NRx, and their interests may conflict with NRx’s or yours in the future.

Jonathan Javitt and Daniel Javitt beneficially own approximately 20.2% and 13.4% of the outstanding shares of Common Stock, respectively. For so long as Jonathan Javitt and Daniel Javitt continue to own a significant percentage of Common Stock, Jonathan Javitt and Daniel Javitt will still be able to significantly influence the composition of our Board and the approval of actions requiring stockholder approval. Accordingly,forsuchperiodoftime,JonathanJavittandDanielJavittwillhavesignificantinfluencewith respect to our management, business plans and policies. In particular, for so long as Jonathan Javitt and DanielJavittcontinuetoownasignificantpercentageof CommonStock,JonathanJavittandDanielJavitt willbeableto influence thecompositionofourBoard andcouldprecludeanyunsolicitedacquisitionofNRx.Theconcentrationofownershipcoulddepriveyou ofanopportunitytoreceiveapremiumforyoursharesofCommonStockaspartofasaleofNRxand ultimately might affect the market price of Common Stock. SolongasJonathanJavittandDanielJavittcontinuetoownasignificant amount of our combined voting power, even if such amount is less than 50%, Jonathan Javitt and Daniel Javitt willcontinuetobeabletostronglyinfluenceoreffectivelycontrolourdecisions.

NotwithstandingJonathanJavitt’sandDanielJavitt’ssubstantialinfluenceoverNRx,we may from time to time enter into transactions with Jonathan Javitt and Daniel Javitt and their respective affiliates,orenterintotransactionsinwhichJonathanJavittandDanielJavittortheirrespectiveaffiliates otherwisehaveadirectorindirectmaterialinterest.Wehaveadoptedaformalwrittenpolicyforthereview andapprovaloftransactionswithrelatedpersons.Adescriptionofthepolicyweadoptedwithrespecttothe approvalorratificationof transactionsinwhichrelatedpersons,suchasJonathanJavittandDanielJavitt andtheirrespectiveaffiliates,haveadirectorindirectmaterialinterestisincludedinthis annual report.Formore information,see“CertainRelationshipsandRelatedPartyTransactions”sectionofthisannual report.

OurCharterwillnotpreventJonathanJavittandDanielJavittandtheirrespectiveaffiliatesfromengagingin business activities which compete with us or otherwise conflict with ourinterests.

Although Jonathan Javitt and Daniel Javitt are precluded from engaging, directly or indirectly, in the same business activities or similar business activities or lines of business in which our Company operates based on Jonathan Javitt’s prior employment contract and current consulting contract with us and the Glytech DLA, respectively, our Charter provides that none of Jonathan Javitt and Daniel Javitt or their respective affiliates will have any duty to refrain from engaging, directly or indirectly, in the same business activities or similar business activities or lines of business in which NRx operates. Jonathan Javitt and Daniel Javitt also may pursue corporate opportunities that may be complementary to our business and, as a result, those corporate opportunities may not be available tous.

We are no longer a “controlled company” under the corporate governance rules of Nasdaq. However, we continue to rely on an exception in the listing requirements to allow a non-independent director to sit on the Nominating and Governance Committee.

Previously, Jonathan Javitt and Daniel Javitt controlled the votes of the majority of our Common Stock. As a result, we were a “controlled company” for purposes of the Nasdaq corporate governance rules and were exempt from certain governance requirements otherwise required by Nasdaq, including requirements that we have a nominating and corporate governance committee that is composed entirely of independent directors with a written charter addressing the committee’s purpose andresponsibilities.

We are no longer a “controlled company” under the corporate governance rules of Nasdaq. Under the Nasdaq listing requirements, a company that ceases to be a “controlled company” must comply with the independent board committee

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requirements as they relate to the nominating and corporate governance. However, we continue to rely on Rule 5605(e)(3), which permits that one director, who is not an independent director and is not currently an executive officer or employee of the Company, may be appointed to the nominating and governance committee if the board, under exceptional and limited circumstances, determines that such individual's membership on the committee is required by the best interests of the Company and its Shareholders. Jonathan Javitt, who is not an independent director, continues to serve on the Company’s nominating and corporate governance committee because the Board has determined that his unique experience and qualifications as a scientist and a co-founder of the Company are beneficial to the Company.Until we are fully subject to the listing requirements, however, our stockholders will not have the same protections afforded to stockholders of companies that are subject to all of the corporate governance requirements of Nasdaq.

General Risk Factors

Our Common Stock price may be volatile or may decline regardless of our operating performance. You may lose some or all of your investment.

The trading price of our Common Stock is likely to be volatile. The stock market recently has experiencedextremevolatility.Thisvolatilityoftenhasbeenunrelatedordisproportionatetotheoperating performanceofparticularcompanies.Youmaynotbeabletoresellyoursharesatanattractivepriceduetoa numberoffactorssuchasthoselistedin“—RisksRelatedtoOurBusinessandIndustry”andthefollowing:

• our operating and financial performance and prospects;

• conditions that impact demand for our products;

• the size of our public float;

• changes in laws or regulations which adversely affect our industry or us;

• changes in senior management or key personnel;

• changes in our dividend policy;

• adverse resolution of new or pending litigation against us; and

These broad market and industry factors may materially reduce the market price of our Common Stock, regardless of our operating performance. In addition, price volatility may be greater if the public floatandtradingvolumeofourCommonStockislow.Asaresult, youmaysufferalossonyourinvestment.

Securities litigation could have a substantial cost and divert resources and the attention of executive management from our business regardless of the outcome of such litigation.

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Ifsecuritiesanalystsdonotpublishresearchorreportsaboutus,oriftheyissueunfavorablecommentaryabout us or our industry or downgrade our Common Stock, the price of our Common Stock coulddecline.

The trading market for our Common Stock will depend in part on the research and reports that third-partysecuritiesanalystspublishaboutusandtheindustriesinwhichweoperate.Wemaybeunable,or slow, to attract and maintain research coverage and if one or more analysts cease coverage of us, the price and trading volumeofoursecuritieswouldlikelybenegativelyimpacted.Ifanyoftheanalyststhatmaycoveruschange theirrecommendationregardingoursecuritiesadversely,orprovidemorefavorablerelativerecommendations about our competitors, the price of our securities would likely decline. If any analyst that may cover us ceasescoveringusorfailstoregularlypublishreportsonus, wecouldlosevisibilityinthefinancialmarkets, which could cause the price or trading volume of our securities to decline. Moreover, if one or more of the analysts who cover us downgrades our Common Stock, or if our reporting results do not meet their expectations, the market price of our Common Stock coulddecline.

Theobligationsassociatedwithbeingapubliccompanywillinvolvesignificantexpensesandwillrequire significantresourcesandmanagementattention,whichmaydivertfromourbusinessoperations.

Asapubliccompany,wearesubjecttothereportingrequirementsoftheExchangeActandtheSarbanes- Oxley Act. The Exchange Act requires that we file annual, quarterly and current reports with respect to our business and financial condition. The Sarbanes-Oxley Act requires, among other things, that we establish and maintain effective internal control over financial reporting. As a result, we will incur significant legal, accounting and other expenses that we did not previously incur. Our entire management team and many of ourotheremployeeswillneedtodevotesubstantialtimetocomplianceandmaynoteffectivelyorefficiently manage our transition into a publiccompany.

In addition, the need to establish the corporate infrastructure demanded of a public company may also divert management’s attention from implementing our business strategy, which could prevent us from improving our business, results of operations and financial condition. We have made, and will continue to make, changes to our internal control over financial reporting, including IT controls, and procedures for financial reporting and accounting systems to meet our reporting obligations as a public company. However, the measures we take may not be sufficient to satisfy our obligations as a public company. If we do not continue to develop and implement the right processes and tools to manage our changing enterprise and maintain our culture, our ability to compete successfully and achieve our business objectives could be impaired, which could negatively impact our business, financial condition and results of operations. In addition, we cannot predict or estimate the amount of additional costs we may incur to comply with these requirements. We anticipate that these costs will materially increase our general and administrative expenses.

These rules and regulations result in our incurring legal and financial compliance costs and will make some activities more time-consuming and costly. For example, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be more difficult for us to attract and retain qualified people to serve on our Board, our Board committees or as executive officers.

As a public reporting company, we are subject to rules and regulations established from time to time by the SECregardingourinternalcontroloverfinancialreporting.Ifwefailtoestablishandmaintaineffectiveinternal controloverfinancialreportinganddisclosurecontrolsandprocedures,wemaynotbeabletoaccurately reportourfinancialresultsorreporttheminatimelymanner.

As a public reporting company, we are subject to the rules and regulations established from time to time by the SEC and Nasdaq. These rules and regulations require, among other things that we establish and periodically evaluate procedures with respect to our internal control over financial reporting. Reporting obligations as a public company are likely to place a considerable strain on our financial and management systems, processes and controls, as well as on ourpersonnel.

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In addition, as a public company, we are required to document and test our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act so that our management can certify as to the effectiveness of our internal control over financial reporting. For additional information related to the risks and uncertainties of our compliance with the Sarbanes-OxleyAct,see“RiskRelatedtoanEarly-StageCompany—Failuretoachieveandmaintaineffective internal controls over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act could impairourabilitytoproducetimelyandaccuratefinancialstatementsorcomplywithapplicableregulations andhaveamaterialadverseeffectonourbusiness.”

If we fail to meet the applicable continued listing requirements of NASDAQ Global Market, NASDAQ may delist our common stock, in which case the liquidity and market price of our common stock could decline.

Our common stock is currently listed on the NASDAQ Global Market. In order to maintain that listing, we must satisfy certain continued listing requirements. including the requirement that our Common Stock maintain an average minimum bid price of $1.00. Since March 1, 2023, the closing sale price of our Common Stock as reported on Nasdaq has been less than $1.00. In the past, we have received a deficiency letter from Nasdaq for failing to maintain a minimum bid price of $1.00, but we have since regained compliance. If we are deficient in maintaining the necessary listing requirements, our common stock may be delisted. If our stock is delisted, an active trading market for our common stock may not be sustained and the market price of our common stock could decline.

Market price of our Common Stock may be volatile, which could subject us to securities class action litigation and result in substantial losses for our stockholders.

The market price of shares of our Common Stock could be subject to wide fluctuations in response to many risk factors listed in this section and the documents incorporated by reference in this prospectus supplement and the accompanying prospectus as well as other factors others beyond our control. Furthermore, the stock markets have experienced extreme price and volume fluctuations that have affected and continue to affect the market prices of equity securities of many companies. These fluctuations often have been unrelated or disproportionate to the operating performance of those companies. These broad market and industry fluctuations as well as general economic, political and market conditions, such as recessions, interest rate changes or international currency fluctuations, may negatively impact the market price of shares of our Common Stock. In addition, such fluctuations could subject us to securities class action litigation, which could result in substantial costs and divert our management’s attention from other business concerns, which could potentially harm our business. As a result of this volatility, our stockholders may not be able to sell their shares of our Common Stock at or above the price at which they purchased their shares of our Common Stock.

We do not intend to pay dividends on our Common Stock for the foreseeable future.

We currently intend to retain all available funds and any future earnings to fund the development and growth of our business. As a result, we do not anticipate declaring or paying any cash dividends on our CommonStockintheforeseeablefuture.Anydecisiontodeclareandpaydividendsinthefuturewillbemade at the discretion of our Board and will depend on, among other things, our business prospects, results of operations, financial condition, cash requirements and availability, legal requirements, certain restrictions related to our indebtedness, industry trends and other factors that our Board may deem relevant. Any such decision will also be subject to compliance with contractual restrictions and covenants in the agreements governing our current and future indebtedness. In addition, we may incur additional indebtedness, the terms of which may further restrict or prevent us from paying dividends on our Common Stock. As a result, you may have to sell some or all of your Common Stock after price appreciation in order to generate cash flow from your investment, which you may not be able to do. Our inability or decision not to pay dividends, particularly when others in our industry have elected to do so, could also adversely affect the market price of our CommonStock.

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Item 1B. Unresolved Staff Comments

None.

Item 2. Properties

Our principal executive office is located at 1201 Orange Street, Suite 600 Wilmington, DE 19801.

Item 3. Legal Proceedings.

On August 12, 2022, the Company received a demand for arbitration (the “Demand”) from GEM Yield Bahamas Limited and GEM Global Yield LLC SCS (collectively, “GEM”). The Demand claims that the Company’s subsidiary, NeuroRx, Inc. (“NeuroRx"), failed to satisfy its obligation to pay GEM a commitment fee in the amount of HK$ 15,000,000 (approximately US$1,914,087 at current exchange rates) pursuant to a Share Subscription Facility Agreement, executed on October 18, 2019, by and among NeuroRx and GEM (the “Agreement”). NeuroRx expects to vigorously defend its position that payment of the commitment fee is neither due nor owing under the terms of the Agreement.

On November 12, 2022, NRx Pharmaceuticals, Inc. (“NRx” or the “Company”) entered into a Settlement Agreement and Asset Purchase Agreement (“APA”) with Relief Therapeutics Holding AG and Relief Therapeutics International (the “Relief Parties”) to settle the outstanding lawsuit with respect to the Binding Collaboration Agreement dated September 18, 2020 between the Company and the Relief Parties (the “Collaboration Agreement”). The closing under the APA occurred on December 17, 2022 and the parties dismissed their respective claims against each other.

On March 27, 2023, the Company received a copy of a Charge of Discrimination (“Charge”) reportedly filed with the Equal Employment Opportunities Commission and the Texas Workforce Commission Civil Rights Division by Carrier Carretta, the Company’s former Vice President of Clinical Development and Medical Affairs. The Charge includes claims for unlawful discrimination and harassment because of sex, unlawfully retaliated for opposing unlawful discrimination and breach of her employment contract.

The Company intends to work towards a resolution through Ms. Carretta’s attorney, but if a settlement cannot be reached, the Company intends to vigorously defend itself against the claims made by Ms. Carretta. At this time, it is too early to determine the probability of an adverse outcome with respect to such claims or make any reasonable estimate of the quantum of any adverse outcome.

In addition to the matters described above, we may become involved in various legal actions incidental to our business. As of the date of this annual report, we are not involved in any other legal proceedings that we believe could have a material adverse effect on our financial position or results of operations, but regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, and diversion of management resources.

Item 4. Mine Safety Disclosures

Not applicable.

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PART II

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Principal Market or Markets

Our shares of common stock are currently quoted on the Nasdaq Capital Market under the symbol “NRXP.” Our common stock commenced trading on the Nasdaq Capital Market on May 25, 2021. Prior to such date, our shares of common stock were traded on the Nasdaq Capital Market under the symbol “BRPA.”

Approximate Number of Holders of Common Stock

As of December 31, 2022 there were approximately 54 record holders of the Company’s common stock. The actual number of stockholders is greater than the number of record holders because stockholders who are beneficial owners but whose shares are held in street name by brokers or other nominees are not counted as separate record holders.

Dividends

Holders of our common stock are entitled to receive such dividends as may be declared by our Board. No dividends have been declared or paid with respect to our common stock and no dividends are anticipated to be paid in the foreseeable future. Any future decisions as to the payment of dividends will be at the discretion of our Board, subject to applicable law.

Recent Sales by the Company of Unregistered Securities

On March 8, 2023, NRx Pharmaceuticals entered into a securities purchase agreement (the “Securities Purchase Agreement”) with accredited investors (the “Investors”), providing for the issuance and sale of 3,866,666 shares of the Company’s common stock (“Common Stock”) and warrants to purchase up to 3,866,666 shares of Common Stock (the “Investor Warrants”) in a registered direct offering priced at-the-market under Nasdaq rules for a purchase price of $0.75 per share (the “Offering”). The Investors have agreed not to transfer the Common Stock for six months following the date hereof. The Investor Warrants will have an exercise price of $0.75 per share, will be initially exercisable beginning six months following the date of issuance (the “Initial Exercise Date”) and will expire 5 years from the Initial Exercise Date. The aggregate gross proceeds to the Company from the Offering are expected to be approximately $2.9 million. The closing of the sale of these securities occurred on March 9, 2023.

Repurchases of Securities

None.

Use of Proceeds

The Company intends to use the net proceeds from the March 9, 2023 offering detailed above for working capital and general corporate purposes.

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Item 6. [Reserved]

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

You should read the following discussion and analysis of NRx Pharmaceuticals’ financial condition and plan of operations together with NRx Pharmaceuticals' consolidated financial statements and the related notes appearing elsewhere herein. In addition to historical information, this discussion and analysis contains forward looking statements that involve risks, uncertainties and assumptions. NRx Pharmaceuticals’ actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section entitled “Risk Factors” included elsewhere herein.

Overview

On May 24, 2021, Big Rock Partners Acquisition Group (“BRPA”), a special purpose acquisition company, consummated the Agreement and Plan of Merger (as amended, the “Merger Agreement”) with NeuroRx, Inc., a Delaware corporation (“NeuroRx”), and Big Rock Merger Corp., a Delaware corporation and wholly owned, direct subsidiary of BRPA (“Merger Sub”). Pursuant to the Merger Agreement, on May 24, 2021 (the “Closing Date”), which has been accounted for as a reverse recapitalization, Merger Sub was merged with and into NeuroRx, with NeuroRx surviving the merger (the “Merger” and, together with the other transactions contemplated by the Merger Agreement, the “Business Combination”). On the Closing Date, BRPA changed its name to NRX Pharmaceuticals, Inc. (“NRx Pharmaceuticals” or the “Company”).

NRx Pharmaceuticals is a clinical stage pharmaceutical company that is developing, through its wholly owned operating subsidiary, NeuroRx, NRX-100 and NRX-101, the first oral therapeutic for the treatment of Bipolar Depression in patients with Acute Suicidal Ideation and Behavior (ASIB) and Sub-Acute Suicidal Ideation and Behavior (“SSIB”). NRX-100 and NRX-101 were developed based upon 30 years of basic science and clinical expertise contributed by Dr. Daniel Javitt, MD, PhD, related to the role of the brain’s N-methyl-D-aspartate (“NMDA”) receptor in regulating human thought processes in general and in regulating depression and suicidality. The NRX-100 and NRX-101 investigational therapy begins with a single dose of ketamine (NRX-100), a Food & Drug Administration (“FDA”) approved anesthetic, followed by approximately six weeks of daily oral NRX-101. NRX-101 is being developed as a rapid-onset and sustained treatment for bipolar depression with ASIB and SSIB. NRX-101 combines d-Cycloserine, a NMDA receptor modulator, and lurasidone, a 5-HT2a receptor antagonist.

NRX-101 has been awarded Fast Track designation, Breakthrough Therapy designation, a Biomarker Letter of Support, and a Special Protocol Agreement by the FDA. Peer-reviewed and published results from Phase II clinical studies demonstrate a significant decline and stabilization in symptoms of depression and suicidality following administration of DCS in combination with antidepressants. Findings from one of these studies found that bipolar patients who were already receiving a 5-HT2a antagonist demonstrated more than a 50% reduction in symptoms of depression and a 75% reduction in suicidal ideation when ketamine and DCS were added to their treatment regimen. Side effects for patients in a Phase 2a combination study of DCS and 5HT2a included mild sedation, headaches and hypomania. Breakthrough Therapy designation was awarded based on data from the STABIL-B study (NCT02974010) that demonstrated a statistically significant advantage of NRX-101 vs. lurasidone (the active ingredient used in the market leading branded bipolar depression agent) in maintaining remission from depression and suicidality following a single stabilizing dose of ketamine.

In March 2022, NRx Pharmaceuticals announced a primary focus on its psychiatry franchise and the late-stage development of NRX-101 for the treatment of bipolar depression in patients with suicidality. NRX-101 is a fixed dose combination of D-cycloserine, an NMDA antagonist, and lurasidone, a 5-HT2A atypical antipsychotic and antidepressant, for the maintenance of remission from severe bipolar depression following initial stabilization with ketamine. The previously undiscovered synergy between these two drug classes in the treatment of CNS disorders, combined with the efficacy of D-cycloserine in the treatment of depression and PTSD, is the subject of 47 issued patents and more than 43 pending patents owned by or licensed to NRx Pharmaceuticals.

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NRX-101 in Severe Bipolar Depression in Patients with Acute Suicidal Ideation and Behavior (ASIB) After Initial Stabilization with ketamine

NRX-101 Indication – Bipolar Depression in Patients with Sub-acute Suicidal Ideation and Behavior (SSIB)

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Consolidated NRX-101 Program in Suicidal Treatment-Resistant Bipolar Depression

Based on the comments and guidance from the FDA in its recent Type B meeting regarding the registrational Acute Suicidality trial and a potentially broader indication, as well as the guidance it received from the DSMB regarding the ongoing Phase IIb/3 clinical study of NRX-101 for the treatment of severe bipolar depression in patients with SSIB, the Company is evaluating changes to its registrational program for NRX-101 and will seek to consolidate patients originally expected to enroll in the ASIB study into the currently enrolling Phase IIb/3 trial. This would potentially allow registration of NRX-101 for Suicidal Treatment-Resistant Bipolar Depression, regardless of the mechanism of stabilization. With the FDA’s guidance to enroll patients for the acute (SPA) study in the outpatient setting only after stabilization, the design of this trial has effectively converged with the currently enrolling phase IIb/3 trial; patients within both groups are deemed to have treatment resistant bipolar depression with suicidality. This broader indication may also offer significant advantages in commercialization, while negating the need for a separate NDA for ketamine in Suicidal stabilization.

● We expect top-line data from this trial in the first quarter of 2024.

NRX-101 Indication – Post Traumatic Stress Disorder

Since inception, NRx Pharmaceuticals has incurred significant operating losses. For the years ended December 31, 2022 and 2021, NRx Pharmaceuticals’ net loss was $39.8 million and $93.1 million, respectively. As of December 31, 2022, NRx Pharmaceuticals had an accumulated deficit of $223.0 million.

Components of Results of Operations

Operating expenses

Research and development expenses

NRx Pharmaceuticals’ research and development expenses consist primarily of costs associated with NRx Pharmaceuticals’ clinical trials, salaries, payroll taxes, employee benefits, and equity-based compensation charges for those individuals involved in ongoing research and development efforts. Research and development costs are expensed as incurred. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received.

General and administrative expenses

General and administrative expenses consist primarily of salaries, stock-based compensation, consultant fees, and professional fees for legal and accounting services.

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Settlement Expense

Settlement expense consists primarily of settlement expenses related to the GEM Warrant. See Note 8 “Commitments and Contingencies – Share Subscription Facility Agreement – GEM” of the notes to the Company’s consolidated financial statements included elsewhere in this report for further information.

Reimbursement of expenses from Relief Therapeutics

Reimbursement of expenses from Relief Therapeutics consisted of reimbursable expenses as part of the Collaboration Agreement. See Note 8 “Commitments and Contingencies – Relief Therapeutics Collaboration Agreement” of the notes to the Company’s consolidated financial statements included elsewhere in this report for further information.

Results of operations for the years ended December 31, 2022 and 2021

The following table sets forth NRx Pharmaceuticals’ selected statements of operations data for the following periods (in thousands):

Years Ended December 31, Change

Operating expenses:

Reimbursement of expenses from Relief Therapeutics — (771) 771

Other (income) expenses:

Gain on extinguishment of debt $ — $ (121) $ 121

Interest income (249) — (249)

Interest expense — 18 (18)

Change in fair value of convertible note payable 505 — 505

Change in fair value of warrant liabilities (255) (1,692) 1,437

Operating expenses

Research and development expenses

For the year ended December 31, 2022, NRx Pharmaceuticals recorded $17.0 million of research and development expenses compared to $20.3 million for the year ended December 31, 2021. The decrease of $3.2 million is related primarily to a decrease of $2.5 million in clinical trials and development expenses related to ZYESAMI, $0.7 million in stock-based compensation expense, $0.8 million related to fees paid to regulatory and process development consultants, partially offset by an increase of $0.5 in other regulatory and process development costs and $0.3 million in shipping, freight, and delivery costs. The $17.0 million and $20.3 million of research and development expenses for the years ended December 31, 2022 and 2021, respectively, include $0.6 million and $1.3 million, respectively, of non-cash stock-based compensation.

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General and administrative expenses

For the year ended December 31, 2022, NRx Pharmaceuticals recorded $27.3 million of general and administrative expenses compared to $74.9 million for the year ended December 31, 2021. The decrease of $47.6 million was primarily, related to a decrease of $53.3 million in consultant fees, of which $41.0 million related to the fair value of common stock issued in accordance to the Shareholder Agreement described in footnote 9 of the Company’s 2022 Audited Financial Statements under “VaccineCo Agreement and Issuance of Shares” and $4.8 million related to the fair value of the 200,000 shares of Common Stock issued pursuant to the BCMA as further describe in footnote 9 of the Company’s 2022 Audited Financial Statements under “Common Stock,” and $3.5 million in stock-based compensation expense, partially offset by an increase of $3.7 million in insurance expenses, $3.4 million in legal, professional and accounting fees, $1.5 million in employee expenses, and $0.6 million in other general and administrative expenses. The $27.3 million and $74.9 million of general and administrative expenses for the years ended December 31, 2022 and 2021, respectively, include $3.0 million and $60.3 million, respectively, of non-cash stock-based compensation.

Settlement expense

For the year ended December 31, 2022, NRx Pharmaceuticals recorded no settlement expense compared to $21.4 million of settlement expense for the year ended December 31, 2021 related to the GEM Warrant reflecting the incremental value of the warrant from the date of issuance through the date of exercise. Settlement expense is a non-cash expense related to the GEM Warrant.

Reimbursement of expenses from Relief Therapeutics

For the year ended December 31, 2022, NRx Pharmaceuticals received no reimbursement of expenses from Relief Therapeutics compared to $0.8 million of reimbursement of expenses from Relief Therapeutics for the year ended December 31, 2021.

Other (income) expenses

Gain on extinguishment of debt

For the year ended December 31, 2022, NRx Pharmaceuticals recorded no gain on extinguishment of debt compared to $0.1 million for the year ended December 31, 2021 which was related to the decrease of $0.1 million related to the forgiveness of the PPP Loan which resulted in a gain on extinguishment for the outstanding principal and accrued and unpaid interest.

Interest income

For the year ended December 31, 2022, NRx Pharmaceuticals recorded $0.2 million of interest income.

Change in fair value of convertible note payable

For the year ended December 31, 2022, NRx Pharmaceuticals recorded $0.5 million related to the change in fair value of the convertible note payable which is accounted for under the fair value option.

Change in fair value of warrant liabilities

For the year ended December 31, 2022, NRx Pharmaceuticals recorded a gain of $0.3 million related to the change in fair value of the warrant liabilities compared to a gain of $1.7 million for the year ended December 31, 2021. The decrease of $1.4 million related to the decrease in the fair value of certain Substitute Warrants and the Placement Warrants assumed pursuant to the Merger Agreement.

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Change in fair value of Earnout Cash liability

For the year ended December 31, 2022, NRx Pharmaceuticals recorded a gain of $4.6 million related to the change in fair value of the Earnout Cash liability compared to a gain of $20.9 million for the year ended December 31, 2021. The gains are a result of the decrease in the fair value of the Earnout Cash liability pursuant to the Merger Agreement. The gains primarily resulted from not achieving the Earnout Cash milestones by December 31, 2022 due to changes to the anticipated re-start date of the NRX-101 Phase III clinical trial, slower enrollment in the NIH’s ZYESAMI clinical trial, and the FDA’s November decision not to approve EUA for ZYESAMI.

Liquidity and Capital Resources

NRX Pharmaceuticals, Inc. NRXP US Equity

NRXP · 10-K · period ended 2022-12-31

Item 1A. Risk Factors

Item 1B. Unresolved Staff Comments

Item 2. Properties

Item 3. Legal Proceedings.

Item 4. Mine Safety Disclosures

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Item 6. [Reserved]

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

NRX Pharmaceuticals, Inc. NRXP US Equity☆

NRXP · 10-K · period ended 2022-12-31

Item 1A. Risk Factors

Item 1B. Unresolved Staff Comments

Item 2. Properties

Item 3. Legal Proceedings.

Item 4. Mine Safety Disclosures

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Item 6. [Reserved]

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

NRX Pharmaceuticals, Inc. NRXP US Equity