▸ Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.· · · · ● 1 ▸ Additional delays to the completion of clinical studies may result from modifications being made to the protocol during the clinical trial, if such modifications are warranted and/or required by the occurrences in the given trial.· · · ● ● 2 ▸ After approval, later discovery of previously unknown problems with a product will have adverse consequences for us.· · · ● ● 2 ▸ Any of these factors could have a material adverse effect on our business, financial condition, results of operations, cash flows or the price of our common stock.· · · ● ● 2 ▸ Conducting clinical trials of our drug candidates or commercial sales of a drug candidate may expose us to expensive product liability claims and we may not be able to maintain product liability insurance on reasonable terms or at all.· · · ● ● 2 ▸ Delays in the commencement or completion of pharmaceutical development, manufacturing or clinical efficacy and safety testing could result in increased costs to us and delay our ability to generate revenues.· · · ● ● 2 ▸ Even if a drug product is approved, the regulators may impose limitations on the use or marketing of such product.· · · ● ● 2 ▸ Global economic, political and social conditions, armed conflicts and uncertainties in the market that we serve may adversely impact our business.· · · ● ● 2 ▸ If securities analysts do not publish research or reports about us, or if they issue unfavorable commentary about us or our industry or downgrade our common stock, the price of our common stock could decline.· · · ● ● 2 ▸ If we are found to be infringing on patents or trade secrets owned by others, we may be forced to cease or alter our product development efforts, obtain a license to continue the development or sale of our products, and/or pay damages.· · · ● ● 2 ▸ If we are unable to design, conduct and complete clinical trials successfully, our drug candidates will not be able to receive regulatory approval.· · · ● ● 2 ▸ If we fail to obtain or maintain FDA and other regulatory clearances for our products, or if such clearances are delayed, we will be unable to commercially distribute and market our products.· · · ● ● 2 ▸ In the future, we may undertake international operations, which would subject us to risks inherent with operations outside of the U.S.· · · ● ● 2 ▸ Managing our growth as we expand operations may strain our resources and we may not successfully manage our growth.· · · ● ● 2 ▸ Our Charter will not prevent Jonathan Javitt and Daniel Javitt and their respective affiliates from engaging in business activities which compete with us or otherwise conflict with our interests.· · · ● ● 2 ▸ Our issuance of additional shares of common stock or convertible securities could make it difficult for another company to acquire us, may dilute your ownership of us and could adversely affect our stock price.· · · ● ● 2 ▸ Our plans to partially spin-off Hope as an independent, publicly traded company may not be completed on the currently contemplated timeline or at all and, if completed, may not achieve the intended benefits and expose us to new risks.· · · ● ● 2 ▸ Our product candidates are newly-formulated and we have not yet scaled manufacturing to levels that will be required for sustained sales.· · · ● ● 2 ▸ group Risks Related to Hope Therapeutics· · · ● ● 2 ▸ The obligations associated with being a public company will involve significant expenses and will require significant resources and management attention, which may divert from our business operations.· · · ● ● 2 ▸ The results of our current or future clinical trials may not support our product candidate claims or may result in the discovery of unexpected adverse side effects.· · · ● ● 2 ▸ The use of a controlled substance in our NRX-100 drug candidate subjects us to DEA scrutiny and compliance, which may result in additional expense and clinical delays.· · · ● ● 2 ▸ To be commercially successful, physicians must be persuaded that using our products are effective alternatives to existing therapies and treatments.· · · ● ● 2 ▸ We may engage in future acquisitions or strategic transactions, which may require us to seek additional financing or financial commitments, increase our expenses and/or present significant distractions to our management.· · · ● ● 2 ▸ We may not be able to identify, audit, negotiate, finance or close future acquisitions.· · · ● ● 2 rw ▸ We must enter into agreements with, and depend upon, one or more partners to assist us in commercializing our product candidates.· · · ● ● 2 ▸ We will have broad discretion in using the proceeds of shares sold to investors, and we may not spend the proceeds in an effective manner.· · · ● ● 2 ▸ With respect to clinical trials, discussions and guidance are not binding obligations on the part of regulatory authorities.· · · ● ● 2 ▸ If we fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.· · ● ● ● 3 ▸ Our business activities could face disruption due to pandemics and other public health emergencies.· · ● ● ● 3 ▸ Our performance depends on the financial health and strength of our potential customers, which in turn is dependent on the economic conditions of the markets in which we and our customers operate.· · ● ● ● 3 ▸ Our products will face significant competition in the markets for such products, and if they are unable to compete successfully, our business will suffer.· · ● ● ● 3 ▸ We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.· · ● ● ● 3 ▸ We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful and could result in a finding that such patents are unenforceable or invalid.· · ● ● ● 3 ▸ If we fail to meet the applicable continued listing requirements of the Nasdaq Capital Market, Nasdaq may delist our common stock, in which case the liquidity and market price of our common stock could decline.· ● ● ● ● 4 rw ▸ 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.· ● ● ● ● 4 ▸ 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.· ● ● ● ● 4 ▸ The Company is now subject to all the requirements of Nasdaq.Our common stock may become the target of a “short squeeze”.· · · ● · 1 ▸ We are subject to certain contractual obligations and limitations on our ability to consummate future financings under the August SPA (as defined below) and the Notes (as defined below) issued by us to the Investors (as defined below).· · · ● · 1 ▸ We have granted a first priority security interest in substantially all of our assets, which could materially and adversely affect our business, financial condition, and ability to operate.· · · ● · 1 ▸ 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.· ● ● ● · 3 ▸ Our business activities could face further disruption due to the COVID-19 pandemic.· ● · · · 1 ▸ 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· ● · · · 1 ▸ Additional delays to the completion of clinical studies may result from modifications being made to the protocolduringtheclinicaltrial,ifsuchmodificationsarewarrantedand/orrequiredbytheoccurrencesinthe giventrial.● ● ● · · 3 ▸ Conducting clinical trials of our drug candidates or commercial sales of a drug candidate may expose us to expensiveproductliabilityclaimsandwemaynotbeabletomaintainproductliabilityinsuranceonreasonable terms or atall.● ● ● · · 3 ▸ 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.● ● ● · · 3 ▸ FDA has not explained how the Congressionally-mandated standard of “may be effective” will be applied to ZYESAMI in FDA’s consideration of any future application for Emergency Use Authorization.● · · · · 1 ▸ 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.● · · · · 1 ▸ Globaleconomic,politicalandsocialconditions, armed conflictsanduncertaintiesinthemarketthatweservemayadversely impact ourbusiness.● ● ● · · 3 ▸ 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● · · · · 1 ▸ Ifsecuritiesanalystsdonotpublishresearchorreportsaboutus,oriftheyissueunfavorablecommentaryabout us or our industry or downgrade our Common Stock, the price of our Common Stock coulddecline.● ● ● · · 3 ▸ Ifwearefoundtobeinfringingonpatentsortradesecretsownedbyothers,wemaybeforcedtoceaseoralterour product development efforts, obtain a license to continue the development or sale of our products, and/or pay damages.● ● ● · · 3 ▸ Ifweareunabletodesign,conductandcompleteclinicaltrialssuccessfully,ourdrugcandidateswillnotbe able to receive regulatoryapproval.● ● ● · · 3 ▸ IfwefailtoobtainormaintainFDAandotherregulatoryclearancesforourproducts,orifsuchclearancesare delayed, wewillbeunabletocommerciallydistributeandmarketourproductsintheU.S.andin some international territories.● · · · · 1 ▸ Ifweweretoexperienceanyofthedifficultieslistedabove,oranyotherdifficulties,anyinternational developmentactivitiesandouroverallfinancialconditionmaysufferandcauseustoreduceordiscontinue our international development and registrationefforts.● ● ● · · 3 ▸ In the future, we may undertakeinternationaloperations,whichwouldsubjectustorisksinherentwithoperationsoutside of the U.S.● ● ● · · 3 ▸ Our business activities have been disrupted due to the outbreak of the COVID-19 pandemic.● · · · · 1 ▸ Our formulation of ZYESAMI is not covered by an issued patent and may be subject to future generic competition.● · · · · 1 ▸ Our initial application to the FDA for Emergency Use Authorization of ZYESAMI was not granted.● · · · · 1 ▸ Our issuance of additional shares of Common Stock or convertible securities could make it difficult for anothercompanytoacquireus,maydiluteyourownershipofusandcouldadverselyaffectourstockprice.● ● ● · · 3 ▸ OurCharterwillnotpreventJonathanJavittandDanielJavittandtheirrespectiveaffiliatesfromengagingin business activities which compete with us or otherwise conflict with ourinterests.● ● ● · · 3 ▸ Ourproductcandidatesarenewly-formulatedandwehavenotyetscaledmanufacturingtolevelsthatwillbe required for sustainedsales.● ● ● · · 3 ▸ Ourproductswillfacesignificantcompetitioninthemarketsforsuchproducts,andiftheyareunableto compete successfully, our business willsuffer.● ● · · · 2 ▸ Theissuanceofearnoutshareswouldincreasethenumberofshareseligibleforfutureresaleinthepublic market and result in dilution to ourstockholders.● · · · · 1 ▸ Theresultsofourcurrentorfutureclinicaltrialsmaynotsupportourproductcandidateclaimsormayresult in the discovery of unexpected adverse sideeffects.● ● ● · · 3 ▸ TheuseofacontrolledsubstanceinourNRX-100drugcandidatesubjectsustoDEAscrutinyandcompliance, which may result in additional expense and clinicaldelays.● ● ● · · 3 ▸ To becommerciallysuccessful,physiciansmustbepersuadedthatusingourproductsareeffectivealternatives to existing therapies andtreatments.● ● ● · · 3 ▸ We do not anticipate obtaining orphan drug protection for the treatment of COVID-19.● · · · · 1 ▸ Wewillhavebroaddiscretioninusingtheproceedsofsharessoldtoinvestors,andwemaynotspendtheproceeds in an effectivemanner.● ● ● · · 3 ▸ group Risks Related to Ownership of Our Common Stock● ● · ● ● 4 ▸ 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.● · · ● ● 3 ▸ 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.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 ▸ Business interruptions could limit our ability to operate our business.● ● ● ● ● 5 ▸ Certain of our stockholders have effective control of NRx, and their interests may conflict with NRx’s or yours in the future.● ● ● ● ● 5 ▸ Cyber security attacks, internal system or service failures may adversely impact our business and operations.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 ▸ Developments by competitors may establish standards of care that affect our ability to conduct our clinical trials as planned.● ● ● ● ● 5 ▸ Developments by competitors may render our products or technologies obsolete or non-competitive.● ● ● ● ● 5 ▸ Even if the results of Phase 2I 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.● ● ● ● ● 5 rw ▸ Future government regulation may affect the commercialization of our product candidate.● ● ● ● ● 5 ▸ Future products may never achieve market acceptance.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 ▸ International commercialization of our product candidates requires successful collaborations.● ● ● ● ● 5 ▸ Modifications to our products may require new NDA approvals.● ● ● ● ● 5 ▸ NRX-101 is still in Phase 2/3 of clinical testing.● ● ● ● ● 5 rw ▸ Our ability to protect and enforce our patents does not guarantee that we will secure the right to commercialize our patents.● ● ● ● ● 5 rw ▸ Our business depends upon securing and protecting critical intellectual property.● ● ● ● ● 5 ▸ Our business relies on certain licensing rights that can be terminated in certain circumstances.● ● ● ● ● 5 ▸ Our operating results and financial condition may fluctuate from period to period.● ● ● ● ● 5 ▸ Our patent position is highly uncertain and involves complex legal and factual questions.● ● ● ● ● 5 ▸ Our revenue stream will depend upon third-party reimbursement.● ● ● ● ● 5 ▸ group Risks Related to Clinical and Regulatory Matters● ● ● ● ● 5 ▸ group Risks Related to Intellectual Property● ● ● ● ● 5 ▸ group Risks Related to Our Business and Industry● ● ● ● ● 5 ▸ group Risks Related to Our Reliance on Third Parties● ● ● ● ● 5 ▸ group Risks Related to an Early-Stage Company● ● ● ● ● 5 ▸ Some of our other product candidates will require Risk Evaluation and Mitigation Strategies.● ● ● ● ● 5 ▸ Some of our products for clinical trials may be manufactured outside the U.S.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 rw ▸ The use of controlled substances in our product candidates may generate controversy.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 rw ▸ There are substantial penalties for failing to comply with DEA regulations.● ● ● ● ● 5 ▸ There can be no assurance that the data generated using modified protocols will be acceptable to regulators.● ● ● ● ● 5 ▸ We are reliant on third party manufacturers to produce controlled substances that conform to our specifications and the FDA’s strict regulatory requirements.● ● ● ● ● 5 ▸ We cannot predict whether regulatory agencies will determine that the data from our clinical trials of our product candidates supports marketing approval.● ● ● ● ● 5 ▸ We do not have direct control of third parties performing preclinical and clinical trials.● ● ● ● ● 5 ▸ We do not intend to pay cash dividends on our common stock for the foreseeable future.● ● ● ● ● 5 rw ▸ We have a limited operating history upon which to base an investment decision.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 ▸ We may have conflicts with our partners that could delay or prevent the development or commercialization of our product candidates.● ● ● ● ● 5 ▸ We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits.● ● ● ● ● 5 ▸ We may need to focus our future efforts in new therapeutic areas where we have little or no experience.● ● ● ● ● 5 ▸ We may not be able to demonstrate the reduced risk we believe is applicable.● ● ● ● ● 5 ▸ We may not be able to obtain Hatch-Waxman Act marketing exclusivity or equivalent regulatory data exclusivity protection in other jurisdictions for our products.● ● ● ● ● 5 ▸ We may not be successful in hiring and retaining key employees and contractors.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 ▸ We may not succeed at in-licensing drug candidates or technologies to expand our product pipeline.● ● ● ● ● 5 ▸ We may require additional licensing rights in the future, which may not be attainable.● ● ● ● ● 5 ▸ We may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit.● ● ● ● ● 5