NRXP on Nasdaq

NRX Pharmaceuticals, Inc.

NRX Pharmaceuticals, Inc. is an American pharmaceutical preparations company based in Wilmington.1 Its shares trade on Nasdaq under the symbol NRXP.1

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Last updated Oct 21, 2026.

Overview

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  • TickerNRXP on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersWilmington, Delaware1
  • Incorporated inDE2
  • Business address1201 Orange Street, Suite 600, Wilmington, De 198012
  • Filer categoryNon-accelerated filer, Smaller reporting company2
  • Legal formCorporation

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”, the “Company”, “we”, “us” or “our”) is a clinical-stage bio-pharmaceutical company which develops and will distribute, through its wholly-owned operating subsidiary, NeuroRx, Inc., (NeuroRx), novel therapeutics for the treatment of central nervous system disorders including suicidal depression, chronic pain, post-traumatic stress disorder (PTSD) and schizophrenia. NRx is additionally the founder and majority owner of HOPE Therapeutics, Inc. (HOPE), a medical services company that offers interventional psychiatry care to patients with treatment-resistant depression and PTSD with a combination of neuroplastic drugs, transcranial magnetic stimulation (TMS), digital therapeutics, and hyperbaric therapy. All of our current drug development activities are focused on drugs that enhance neuroplasticity by modulating the N-methyl-D-aspartate (NMDA)…3 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-1324.4%Operating margin4
-2336.5%Net margin4

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Therapy brought in 70% of the revenue NRX Pharmaceuticals, Inc. broke down this way in fiscal 2025.

  1. Therapy$854.0K470%
  2. Procedures$371.0K430%
Products and services by year
Products and services2025
Therapy$854.0K
Procedures$371.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue3¢$505.0K
  • Research and development22¢$3.8M
  • Selling, general and admin75¢$13.1M

Out of $1.2M in revenue.4 The company lost money this year.

Financial statements

Revenue54$1.2M in 2025
0$500.0K$1.0M$1.5M2023: $0$020232024: $0$020242025: $1.2M$1.2M2025
Operating income678954-$16.2M in 2025+2175% since 2019
-$150.0M-$100.0M-$50.0M02019: -$713.2K-$713.2K20192020: -$51.4M-$51.4M2020+7105%2021: -$115.8M-$115.8M2021+125%2022: -$44.3M-$44.3M2022−62%2023: -$27.8M-$27.8M2023−37%2024: -$18.5M-$18.5M2024−34%2025: -$16.2M-$16.2M2025−12%
Net income678954-$28.6M in 2025
-$100.0M-$75.0M-$50.0M-$25.0M0$25.0M2019: $408.4K$408.4K20192020: -$51.8M-$51.8M20202021: -$93.1M-$93.1M2021+80%2022: -$39.8M-$39.8M2022−57%2023: -$30.1M-$30.1M2023−24%2024: -$25.1M-$25.1M2024−17%2025: -$28.6M-$28.6M2025+14%

Every line of the income statement as filed: the last 2 fiscal years, latest first.4

Period ending2025-12-312024-12-31
Net patient service revenue$1.2M$0
Cost of patient services$505.0K$0
Research and development$3.8M$6.2M
Selling, general and administrative$13.1M$13.5M
Depreciation and amortization$70.0K$5.0K
Settlement expense (income)$36.0K-$1.2M
Total operating expenses$17.4M$18.5M
Loss from operations-$16.2M-$18.5M
Interest income-$12.0K-$44.0K
Interest expense$671.0K$230.0K
Change in fair value of convertible notes payable$3.9M$2.7M
Change in fair value of warrant liabilities$4.9M$1.7M
Loss on issuance of Registered Direct Offering$730.0K$0
Loss on Consideration Shares and Warrants$1.3M$0
Convertible note default penalty$0$849.0K
Loss on convertible note conversions$6.2M$1.3M
Loss from equity method investments$35.0K$0
Gain on exercise of warrants-$5.4M$0
Total other expense, net$12.4M$6.6M
Net loss-$28.6M-$25.1M
Basic and diluted (in dollars per share)-$1.34-$2.36
Basic and diluted (in shares)21.4M shares10.6M shares

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Corporate structure

NRX Pharmaceuticals, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of NRX Pharmaceuticals, Inc.

  • Anson Funds Management LP Filed SCHEDULE 13G/A on NRX Pharmaceuticals, Inc., latest May 15, 2026 (3 filings since May 15, 2025)
  • B Group, Inc. Filed SCHEDULE 13G on NRX Pharmaceuticals, Inc., latest Aug 21, 2025
  • Daniel C. Javitt Filed SC 13D on NRX Pharmaceuticals, Inc., latest Sep 13, 2022
  • Jonathan C. Javitt Filed SC 13D/A on NRX Pharmaceuticals, Inc., latest Jun 17, 2022 (3 filings since Nov 2, 2021)
  • NRX Pharmaceuticals, Inc. Wilmington, Delaware

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What NRX Pharmaceuticals, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$93.0K4 Dec 31, 2025$29.0K4 Dec 31, 2024+220.7%
Accumulated depreciation$30.0K4 Dec 31, 2025$19.0K4 Dec 31, 2024+57.9%
Property and equipment, net$63.0K4 Dec 31, 2025$10.0K4 Dec 31, 2024+530.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$7.8M4 Dec 31, 2025$1.4M4 Dec 31, 2024+440.3%
Stakes in other companies (equity method)$397.0K4 Dec 31, 2025$04 Dec 31, 2024

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$1.8M4 Dec 31, 2025$04 Dec 31, 2024
Intangible assets, net (excluding goodwill)$925.0K4 Dec 31, 2025$04 Dec 31, 2024

Properties, in its own words

Our principal executive office is located at 1201 Orange Street, Suite 600 Wilmington, DE 19801. We believe that our current facilities are suitable and adequate to meet our current needs. We believe that suitable additional space or substitute space will be available in the future to accommodate our operations as needed.

Item 2 of the 10-K filed Mar 23, 2026.3

Leadership

Who has led NRX Pharmaceuticals, Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (20)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorMichael Taylor named Mar 7, 202540
  • DirectorPatrick Flynn named Mar 7, 202540

Former names

  • Big Rock Partners Acquisition Corp.Oct 13, 2017 to May 24, 20212

Timeline

  1. Oct 5, 20268-K Entered a material agreement41
  2. Sep 16, 20268-K Other events42
  3. Sep 14, 20268-K Regulation FD disclosure43
  4. Aug 17, 20268-K Results of operations44
  5. Aug 7, 20268-K Regulation FD disclosure45
  6. Jul 22, 20268-K Other events46
  7. Jun 4, 20268-K Entered a material agreement; Other events47
  8. Jun 2, 20268-K Other events48
  9. Mar 24, 20268-K Executive or director change; Shareholder vote49
  10. Feb 17, 20268-K Other events50
  11. Feb 17, 20268-K Other events51
  12. Feb 2, 20268-K Executive or director change52
  13. Jul 22, 2022New chief executive Stephen H. Willard becomes CEO13
  14. Mar 10, 2022New chief executive Robert Besthof becomes CEO12
  15. Jun 10, 2021New chief executive Jonathan C. Javitt becomes CEO14
  16. Dec 4, 2017New chief executive Richard Ackerman becomes CEO15

Calendar

Coming up

  1. Nov 13, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.18) a share, on Nov 14, 2025.53

When it reported results

  1. Aug 17, 2026Reported quarterly or annual results44
  2. Aug 18, 2025Reported quarterly or annual results54
  3. May 21, 2025Reported quarterly or annual results55
  4. Mar 21, 2025Reported quarterly or annual results56
  5. Nov 15, 2024Reported quarterly or annual results57
  6. Aug 15, 2024Reported quarterly or annual results58
  7. May 16, 2024Reported quarterly or annual results59
  8. Apr 2, 2024Reported quarterly or annual results60

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

275 filings to the SEC since October 2021: 10 annual reports, 17 quarterly reports, 97 major events, 46 insider forms, 8 large holders, 1 private raises, 96 other. The latest 20:

  1. Oct 5, 20268-K EDGAR
  2. Sep 16, 20268-K EDGAR
  3. Sep 14, 20268-K EDGAR
  4. Aug 17, 20268-K EDGAR
  5. Aug 14, 202610-Q EDGAR
  6. Aug 7, 20268-K EDGAR
  7. Jul 22, 20268-K EDGAR
  8. Jun 4, 20268-K EDGAR
  9. Jun 3, 2026424B5 EDGAR
  10. Jun 2, 20268-K EDGAR
  11. Jun 2, 2026424B5 EDGAR
  12. May 22, 202625-NSE EDGAR
  13. May 15, 202610-Q EDGAR
  14. May 15, 2026SCHEDULE 13G/A EDGAR
  15. Mar 24, 20268-K EDGAR
  16. Mar 23, 202610-K EDGAR
  17. Feb 24, 2026DEFA14A EDGAR
  18. Feb 23, 2026ARS EDGAR
  19. Feb 23, 2026DEF 14A EDGAR
  20. Feb 17, 20264 EDGAR

The 275 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

28 open-market trades by officers, directors and large owners since October 2021: 18 buys and 10 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Dec 17, 2024Javitt Jonathan CChairman and Chief ScientistBuy40,000$1.17$46.8KForm 4
Aug 30, 2023Gorovitz AaronDirectorBuy35,000$0.32$11.2KForm 4
Aug 30, 2023Hurvitz ChaimDirectorBuy70,000$0.29$20.3KForm 4
Aug 23, 2023Javitt Jonathan CChairman and Chief ScientistBuy100,000$0.33$33.0KForm 4
Aug 22, 2023Javitt Jonathan CChairman and Chief ScientistBuy200,000$0.32$64.0KForm 4
Dec 16, 2022Willard Stephen HCHIEF EXECUTIVE OFFICERBuy50,000$1.17$58.5KForm 4
Dec 16, 2022VAN VOORHEES SETHCHIEF FINANCIAL OFFICERBuy30,000$1.10$33.0KForm 4
Dec 7, 2022Javitt Jonathan CChairman and Chief ScientistSale400,000$1.00$400.0KForm 4
Nov 30, 2022Javitt Daniel C.10% ownerSale8,441$1.50$12.7KForm 4
Nov 29, 2022Javitt Daniel C.10% ownerSale13,730$1.50$20.6KForm 4
Nov 28, 2022Flynn Patrick JohnDirectorBuy11,750$1.25$14.7KForm 4
Nov 25, 2022VAN VOORHEES SETHCHIEF FINANCIAL OFFICERBuy16,337$1.11$18.2KForm 4
Nov 25, 2022VAN VOORHEES SETHCHIEF FINANCIAL OFFICERBuy16,337$1.11$18.2KForm 4
Nov 18, 2022Hurvitz ChaimDirectorBuy40,408$1.10$44.4KForm 4
Nov 18, 2022Hurvitz ChaimDirectorBuy40,408$1.10$44.4KForm 4
Nov 17, 2022Hurvitz ChaimDirectorBuy171,780$1.08$185.5KForm 4
Nov 17, 2022Hurvitz ChaimDirectorBuy171,780$1.08$185.5KForm 4
Nov 17, 2022Javitt Daniel C.10% ownerSale33,018$1.05$34.7KForm 4
Nov 16, 2022Hurvitz ChaimDirectorBuy287,812$0.99$284.9KForm 4
Nov 16, 2022Hurvitz ChaimDirectorBuy287,812$0.99$284.9KForm 4

All 28 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2024Jonathan Javitt69$575.0K$825.0K65
2024Richard Narido$435.0K65
2024Stephen Willard$395.8K65
2024Matthew Duffy$338.0K65
2024Michael Abrams55$20.3K65
2023Chief Executive OfficerChief Scientist and Chairman$602.8K$630.2K65
2023Former ChiefExecutive Officer$500.0K65
2023Former Chief Financial Officer$255.0K$298.0K65
2023Chief Business Officer$60.0K$159.0K65

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$3.5M 2025–2025
Money received by yearMoney received by year, 2025–2025: $3.5M in all. Private raises (Form D) $3.5M.$0$1M$2M$3M$4M2025 · Private raises (Form D): $3.5M2025
Figures by year
YearPrivate raises (Form D)Total
2025$3.5M$3.5M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Jan 27, 2025Raised $3.5 million in a private offering of securities40 Form D: 2 investors so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 46. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
B Group, Inc.4,091,767$16.7M9.5%+1,091,767
Vanguard Capital Management LLC1,618,159$6.6M0.0%+457,975
Ameriprise Financial Inc928,728$3.8M0.0%New
Balyasny Asset Management L.P.893,864$3.7M0.0%New
Citadel Advisors LLC680,043$2.8M0.0%New
AdvisorShares Investments LLC659,018$2.7M0.3%+238,551
Commonwealth Equity Services, LLC454,418$1.9M0.0%+56,987
UBS Group AG423,115$1.7M0.0%+397,888
Geode Capital Management, LLC314,659$1.3M0.0%+4,547
BlackRock, Inc.220,460$901.7K0.0%+121,465
Marshall Wace, Llp194,580$795.8K0.0%New
Vanguard Fiduciary Trust Co182,718$747.3K0.0%+13,138
Jane Street Group, LLC119,018$486.8K0.0%+74,866
Bleakley Financial Group, LLC117,216$479.4K0.0%+12
State Street Corp116,084$474.8K0.0%+29,100
Northern Trust Corp62,951$257.5K0.0%+19,482
Chicago Partners Investment Group LLC46,388$190.7K0.0%+11,909
Quadrature Capital Ltd43,605$178.3K0.0%New
One Wealth Management Investment & Advisory Services, LLC43,309$177.1K0.2%No change
Morgan Stanley40,901$167.3K0.0%+30,873
Renaissance Technologies LLC38,600$157.9K0.0%New
Global Retirement Partners, LLC33,300$136.2K0.0%New
Two Sigma Investments, LP26,429$108.1K0.0%New
Truist Financial Corp20,000$81.8K0.0%New
ExodusPoint Capital Management, LP19,308$79.0K0.0%New

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How NRX Pharmaceuticals, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARNRX Pharmaceuticals, Inc.1
  • CIK0001719406
  • Employer ID (EIN)82-28444313
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address1201 Orange Street, Suite 600, Wilmington, DE 198011
  • Phone484-254-61341
  • Shares outstanding43,295,767 as of Aug 14, 202611
  • Public float$57.4M as of Jun 30, 20253
  • AuditorWeinberg & Company P.A., Los Angeles, CA PCAOB ID 572; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceOct 13, 20171
  • Filings473 in all: 8-K (130), 4 (47), 424B3 (44), 3 (30), 10-Q (26), 424B5 (15), CORRESP (15), DEF 14A (13)1
    All 47 form types

    UPLOAD (12), PRE 14A (11), 425 (10), EFFECT (10), SC 13G/A (10), 10-K (9), SC 13G (8), DEFA14A (7), 10-K/A (6), 8-K/A (5), S-1 (5), S-4/A (5), SC 13D (5), SC 13D/A (5), 4/A (4), S-1/A (4), 25-NSE (3), POS AM (3), 10-Q/A (2), ARS (2), D (2), NT 10-Q (2), POS EX (2), S-3 (2), S-3/A (2), SCHEDULE 13G (2), SCHEDULE 13G/A (2), SEC STAFF LETTER (2), 424B4 (1), 424B7 (1), 5 (1), 8-A12B (1), CERTNAS (1), NT 10-K (1), PRER14A (1), RW (1), S-1MEF (1), S-4 (1), S-8 (1)

  • Latest filingsAnnual report (10-K) Mar 23, 2026
    Quarterly report (10-Q) Aug 14, 2026
    Proxy statement (DEF 14A) Feb 23, 2026
    Latest 8-K (8-K) Oct 5, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareNRXPNasdaq
Warrants to purchase one share of Common StockNRXPWNasdaq

From the cover page of the 10-K filed Mar 23, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks NRX Pharmaceuticals, Inc. names in Item 1A of its 10-K filed Mar 23, 2026: 75 risks under these headings, as written.3

  • The Company's business involves significant risks and uncertainties that make an investment in it speculative and risky. The following is a summary list of the principal risk factors that could materially adversely affect the Company's business, financial condition, liquidity and results of operations. These are not the only risks and uncertainties the Company faces, and you should carefully review and consider the full discussion of the Company's risk factors in the section titled “Risk Factors”, together with the other information in this Annual Report on Form 10-K.
  • Risks Related to an Early-Stage Company
  • Our operating results and financial condition may fluctuate from period to period.
  • We have a limited operating history upon which to base an investment decision.
  • 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 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.
  • 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.
  • Risks Related to Our Business and Industry
  • NRX-101 is still in Phase 2/3 of clinical testing.
  • Our product candidates are newly-formulated and we have not yet scaled manufacturing to levels that will be required for sustained sales.
  • 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.
  • 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.
The other 65 risks
  • Our revenue stream will depend upon third-party reimbursement.
  • We may have conflicts with our partners that could delay or prevent the development or commercialization of our product candidates.
  • Our products will face significant competition in the markets for such products, and if they are unable to compete successfully, our business will suffer.
  • We are faced with intense competition and rapid technological change, which may make it more difficult for us to achieve significant market penetration. If we cannot compete successfully for market share against other drug companies, we may not achieve sufficient product revenues and our business will suffer.
  • Future products may never achieve market acceptance.
  • To be commercially successful, physicians must be persuaded that using our products are effective alternatives to existing therapies and treatments.
  • We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits.
  • We may not be able to obtain Hatch-Waxman Act marketing exclusivity or equivalent regulatory data exclusivity protection in other jurisdictions for our products.
  • In the future, we may undertake international operations, which would subject us to risks inherent with operations outside of the U.S.
  • International commercialization of our product candidates requires successful collaborations.
  • Our business activities could face disruption due to pandemics and other public health emergencies.
  • Global economic, political and social conditions, armed conflicts and uncertainties in the market that we serve may adversely impact 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.
  • We may not be successful in hiring and retaining key employees and contractors.
  • Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Our relationships with potential customers and payors will be subject to applicable anti-kickback, fraud and abuse, transparency, and other healthcare laws and regulations, which could expose use to criminal sanctions, civil penalties, contractual damages, reputational harm, and administrative burdens.
  • Managing our growth as we expand operations may strain our resources and we may not successfully manage our growth.
  • 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.
  • Business interruptions could limit our ability to operate our business.
  • Cyber security attacks, internal system or service failures may adversely impact our business and operations.
  • Failure to achieve and maintain effective internal controls over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act could impair our ability to produce timely and accurate financial statements or comply with applicable regulations and have a material adverse effect on our business.
  • Risks Related to Hope Therapeutics
  • 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.
  • 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.
  • We may not be able to identify, audit, negotiate, finance or close future acquisitions.
  • Developments by competitors may render our products or technologies obsolete or non-competitive.
  • 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.
  • Even if a drug product is approved, the regulators may impose limitations on the use or marketing of such product.
  • After approval, later discovery of previously unknown problems with a product will have adverse consequences for us.
  • If we are unable to design, conduct and complete clinical trials successfully, our drug candidates will not be able to receive regulatory approval.
  • We cannot predict whether regulatory agencies will determine that the data from our clinical trials of our product candidates supports marketing approval.
  • There is no guarantee that regulatory authorities will grant NDA approval of our current or future product candidates and failure to obtain necessary clearances or approvals for our current and future product candidates would adversely affect our ability to grow our business.
  • With respect to clinical trials, discussions and guidance are not binding obligations on the part of regulatory authorities.
  • 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.
  • 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.
  • We may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit.
  • 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.
  • 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.
  • There can be no assurance that the data generated using modified protocols will be acceptable to regulators.
  • 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.
  • Developments by competitors may establish standards of care that affect our ability to conduct our clinical trials as planned.
  • Even if our products are approved by regulatory authorities, if we or our suppliers fail to comply with ongoing FDA regulation or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market.
  • Future government regulation may affect the commercialization of our product candidate.
  • 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.
  • 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.
  • There are substantial penalties for failing to comply with DEA regulations.
  • 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.
  • We may not be able to demonstrate the reduced risk we believe is applicable.
  • The use of controlled substances in our product candidates may generate controversy.
  • We may need to focus our future efforts in new therapeutic areas where we have little or no experience.
  • Some of our products for clinical trials may be manufactured outside the U.S.
  • Modifications to our products may require new NDA approvals.
  • Some of our other product candidates will require Risk Evaluation and Mitigation Strategies.
  • We are reliant on third party manufacturers to produce controlled substances that conform to our specifications and the FDA’s strict regulatory requirements.
  • 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.
  • Risks Related to Intellectual Property
  • Our business relies on certain licensing rights that can be terminated in certain circumstances.
  • We may require additional licensing rights in the future, which may not be attainable.
  • We may not succeed at in-licensing drug candidates or technologies to expand our product pipeline.
  • Our business depends upon securing and protecting critical intellectual property.
  • Our patent position is highly uncertain and involves complex legal and factual questions.
  • 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.
  • We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
  • 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.
  • Our ability to protect and enforce our patents does not guarantee that we will secure the right to commercialize our patents.
  • 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 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.

Legal proceedings

On November 12, 2022, 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 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, 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”).

On July 17, 2023, the Company and GEM entered into a settlement and release agreement (the “Settlement Agreement”) pursuant to which the parties agreed to dismiss the arbitration proceeding with prejudice. Pursuant to the Settlement Agreement on August 31, 2023, the Company issued 67,568 shares of common stock to GEM in full satisfaction of the Settlement Agreement for the approximately $0.3 million which was previously accrued and expensed as “Settlement expense.” The shares are registered under a prospectus supplement to the Company’s registration statement on Form S-3 and are subject to a restriction that they cannot be sold or traded for a period of six months from the effective date of the Settlement Agreement.

The opening of Item 3, Legal Proceedings.3

Sources

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