NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) is a clinical-stage biopharmaceutical company focused on developing and distributing novel therapeutics for central nervous system disorders, including suicidal depression, chronic pain, PTSD, schizophrenia, and other serious conditions. The company operates through two subsidiaries, NeuroRx, Inc. and HOPE Therapeutics, Inc., which address drug development and medical care delivery, respectively. Its product portfolio includes innovative drug candidates targeting NMDA receptors and therapies for psychiatric and neurological conditions.
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NeuroRx, Inc. - Develops novel therapeutics for central nervous system disorders, including suicidal depression, chronic pain, PTSD, schizophrenia, and complicated urinary tract infections. Key drug candidates include:
- NRX-101 - An oral fixed-dose combination of D-cycloserine and lurasidone for bipolar depression and other indications.
- NRX-100 - A preservative-free formulation of ketamine for intravenous infusion, targeting suicidal depression.
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HOPE Therapeutics, Inc. - Operates interventional psychiatric clinics offering therapies for suicidal depression and PTSD, including ketamine and NMDA-targeted drugs. Distributes ketamine under 503b pharmacy licensure to address national shortages and plans to expand into psychedelic treatments, neuromodulatory devices, and digital therapeutics.
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| Name | Position | External Roles | Short Bio | |
|---|---|---|---|---|
Matthew Duffy Executive | Chief Business Officer | Co-Chief Executive Officer, HOPE Therapeutics, Inc. | Matthew Duffy is the Chief Business Officer at NRXP and also serves as Co-Chief Executive Officer at HOPE Therapeutics, Inc., with extensive experience in the pharmaceutical industry and capital markets. | |
Michael Abrams Executive | Chief Financial Officer | Michael Abrams is a seasoned finance professional and investment banker with nearly three decades of experience. He is currently serving as the Chief Financial Officer at NRx Pharmaceuticals since November 18, 2024 , and previously held CFO roles at Arch Therapeutics, Inc., RiseIT Solutions, Inc., and FitLife Brands, Inc.. | ||
Chaim Hurvitz Board | Member of the Board of Directors | CEO of CH Health ; Director at Galmed Pharmaceuticals Ltd. ; Head of Pharmaceutical Branch at Manufacturers Association of Israel | Chaim Hurvitz has served as a board member at NRXP since May 2021. He previously served as a board member of NeuroRx, Inc. starting in May 2015 , and brings extensive leadership experience in the pharmaceutical industry. | |
Dennis McBride Board | Member of the Board of Directors | Research Professor at Virginia Tech; Adjunct Professor at Georgetown University School of Medicine; President Emeritus at Potomac Institute for Policy Studies | Dennis McBride, Ph.D. has served as a member of the Board of Directors at NRXP since June 13, 2024. He has extensive expertise in neuroscience and digital therapeutics, and he also leads roles outside NRXP as a Research Professor at Virginia Tech and an Adjunct Professor at Georgetown University School of Medicine. | |
Jonathan Javitt Board | Chairman of the Board of Directors | Adjunct Professor of Ophthalmology at Johns Hopkins School of Medicine ; Senior Fellow at Potomac Institute for Policy Studies | Jonathan Javitt is currently Chairman of the Board and Chief Scientist at NRXP, having been re-elected as Chairman in December 2023, and he previously served as CEO from May 2021 until March 2022. | |
Michael Taylor Board | Class I member of the Board of Directors | Michael Taylor has over 25 years of experience in global credit markets, having served as Managing Director at Stone & Youngberg LLC and Oppenheimer & Co. Inc., and as Partner at Adi Dassler International Family Office. He currently serves as a Class I member of the Board of Directors at NRXP since January 15, 2025. | ||
Patrick J. Flynn Board | Board Member and Chair of the Audit Committee | Advisor to Good Measures ; Board Member at Common Sensing Inc. | Patrick J. Flynn has served as a board member and Chair of the Audit Committee at NRXP since May 2021. He brings over 30 years of audit compliance and business expertise to the company. |
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Regarding the $300 million potential milestone deal for NRX‑100 and its tiered royalty structure, what are the key risks and timeline uncertainties associated with finalizing this deal, and how might delays impact your commercialization plans?
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With simultaneous filings of an NDA for depression indications and an ANDA for preservative‑free ketamine, what specific regulatory hurdles and manufacturing challenges do you anticipate that could affect the approval timelines for both applications?
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Given your strategy to acquire multiple precision psychiatry clinics in Florida that currently generate around $5 million in revenue each, how do you plan to integrate these disparate operations while ensuring consistent EBITDA growth and operational efficiency?
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After reducing research and development expenses significantly to lower operating losses, what measures are in place to ensure that these cost reductions will not compromise ongoing innovation and the advancement of your clinical pipeline?
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As you explore the spinout of Hope Therapeutics to deliver non‑dilutive shareholder benefits, can you outline the anticipated timeline and structural safeguards to protect NRXP shareholders amid potential regulatory and financing challenges?
Competitors mentioned in the company's latest 10K filing.
| Company | Description |
|---|---|
The company is identified as one of the chief competitors in the psychiatry area, leveraging its substantial financial, technical, research, marketing, sales, and distribution resources to compete effectively in the market. | |
This competitor is noted for its greater development capabilities and experience in obtaining regulatory approvals, manufacturing, and marketing pharmaceutical products, posing significant competition in the psychiatry area. | |
The company is highlighted as a major competitor in the psychiatry area, benefiting from its extensive resources and established presence in the pharmaceutical industry. | |
This competitor is mentioned as part of the intense competition in the psychiatry area, focusing on innovative treatments and therapies. | |
The company is listed among the chief competitors in the psychiatry area, contributing to the competitive landscape with its specialized focus. | |
This competitor is identified as part of the competitive field in the psychiatry area, leveraging its expertise and resources to challenge market entrants. |
Notable M&A activity and strategic investments in the past 3 years.
| Company | Year | Details |
|---|---|---|
Kadima Neuropsychiatry Institute | 2025 | Planned acquisition by HOPE Therapeutics to establish Kadima as the flagship clinic in HOPE's international network; the deal includes a $27M funding transaction (with $25M aimed at HOPE and $2M toward NRx common stock) and brings on board Dr. David Feifel as Chief Medical Innovation Officer. |
Dura Medical | 2025 | Completed acquisition under a definitive agreement that was signed on March 31, 2025, designed to anchor HOPE's expansion on Florida’s west coast with services like Ketamine Infusion Therapy, TMS, Spravato®, and Stellate Ganglion Blocks, while also appointing founder Stephen Durand as Director of Clinic Operations. |
Neurospa TMS Holdings, LLC | 2025 | Planned acquisition via a binding Letter of Intent to acquire a majority interest in Neurospa, which operates six revenue-generating clinics on Florida’s Gulf Coast offering key interventions such as Ketamine Infusion Therapy, TMS, and Spravato®, and is expected to be accretive to HOPE’s revenue. |
Interventional Psychiatry Clinics (Florida & West Coast) | 2024 | Planned acquisition involving two separate non-binding Letters of Intent—one for Florida clinics (signed October 30, 2024) and another for a premier West Coast clinic (signed October 3, 2024); these revenue- and EBITDA-positive clinics are set to form the growth foundation of HOPE’s network and include a commitment from a pioneering leader as CMIO. |
NeuroRx, Inc. | 2021 | Completed merger where NeuroRx merged with Big Rock Partners Acquisition Corp. (later renamed NRx Pharmaceuticals, Inc.) via a reverse recapitalization on May 24, 2021, including a $10M PIPE investment to accelerate product development. |
Recent press releases and 8-K filings for NRXP.
- NRx Pharmaceuticals, Inc. has filed a Citizen Petition with the US Food and Drug Administration (FDA) seeking the removal of Benzethonium Chloride (BZT) from all forms of ketamine sold in the United States.
- BZT is a preservative with known toxicity that is not Generally Recognized as Safe (GRAS) by the FDA for parenteral products and has been prohibited in hand cleansers and topical antiseptics.
- NRx has filed an Abbreviated New Drug Application (ANDA) for a preservative-free preparation of ketamine, demonstrating support for 3-year room temperature stability and sterility.
- The company also initiated a New Drug Application (NDA) filing for NRX-100 (IV ketamine) under the Commissioner's National Priority Voucher Program for the treatment of suicidal depression.
- NRx's CEO stated that patients receiving repeated intravenous ketamine are exposed to a known toxic preservative that is no longer permitted in common topical products.
- NurExone Biologic Inc. announced new preclinical results for its lead product, ExoPTEN, demonstrating that 100% of small animals treated with a higher dose regained motor function after spinal cord injury.
- The study showed a dose-dependent effect, with 100% of animals in the high-dose group regaining walking ability, compared to 50% in the medium-dose group, and 1 out of 6 in the untreated control group.
- These results, confirmed by the CatWalk XT system, indicate improved balance, strength, coordination, and weight bearing.
- The company plans to initiate additional studies, optimize manufacturing, and prepare for regulatory submissions to launch first-in-human clinical trials.
- HOPE Therapeutics, a wholly-owned subsidiary of NRx Pharmaceuticals, Inc., has signed a binding Letter of Intent to acquire a 49% interest in Cohen and Associates, LLC.
- Cohen and Associates is a highly respected neuropsychiatry clinic in western Florida, expected to serve as a foundational clinic for HOPE in the Sarasota-Bradenton area.
- The acquisition is projected to be immediately accretive to revenue and EBITDA.
- NRX Pharmaceuticals submitted its abbreviated New Drug Application (ANDA) for NRX-100, a preservative-free IV ketamine formulation aimed at addressing the current drug shortage.
- The application covers use for approved indications including anesthesia and pain management, with an anticipated broader use to treat suicidal depression.
- The filing seeks FDA priority review and supports efforts to eliminate benzethonium chloride, a known neurotoxic preservative, from ketamine products.
- The move leverages a robust ketamine market, estimated at $750 million annually, with projected global growth to $3.35 billion by 2034.
- Financial Results: Q1 2025 net loss improved to $5.5M from $6.5M YoY with a cash balance of $5.5M supporting operations through the end of 2025 .
- Clinical Milestones: The NDA for NRX-100 is expected to be filed in Q2 2025 and NRX-101 is on track for Accelerated Approval with a PDUFA date before year-end 2025; a patent filing for NRX-100 could extend protection until 2045 .
- Acquisition Strategy: HOPE Therapeutics, a subsidiary, is expanding its clinic network with completed and planned acquisitions (Kadima, Dura Medical, Neurospa TMS) targeting approximately $15M in forward revenues, with additional assets under negotiation .
- Financing Updates: In January 2025, the company raised $8.9M via convertible debt and equity, and later secured term sheets for $10.3M in acquisition capital along with a $7.8M debt facility, with the initial tranche expected to close by June 19, 2025 .
- Financial Performance Improved: In Q1 2025, the company reported a net loss of $5.5 million and loss from operations of $3.8 million, marking improvements over Q1 2024 losses of $6.5 million and $6.0 million respectively.
- Enhanced Liquidity: As of March 31, 2025, NRX Pharmaceuticals held approximately $5.5 million in cash, bolstered by convertible debt and equity offerings.
- Pipeline Progress: The company is advancing its product pipeline with NDA filings for NRX-100 (planned for Q2 2025) and accelerated efforts for NRX-101, backed by strong clinical efficacy data.
- HOPE Therapeutics Financing: A term sheet from Universal Capital secured $7.8 million in debt financing, contributing to a total of $10.3 million in acquisition capital for interventional psychiatry clinic expansion.
- Strategic Expansion: Initiatives include acquisitions of companies like Dura Medical, Kadima, and NeuroSpa to drive pro-forma revenues of about $15 million and support long-term growth.
- HOPE Therapeutics, a subsidiary of NRX Pharmaceuticals (NASDAQ: NRXP), signed a definitive agreement to purchase the Kadima Neuropsychiatry Institute, which will serve as the clinical model for its expanding network of interventional psychiatry clinics.
- The Kadima Institute is recognized as a leading investigative site for CNS and psychedelic research, with a profitable record and forecasted growth in clinical innovations.
- Dr. David Feifel will join HOPE as Chief Medical Innovation Officer, strengthening the company’s leadership in interventional psychiatry and clinical trial work.
- NRx Pharmaceuticals has filed a patent application for its preservative‐free IV ketamine formulation, NRX-100, aimed at treating suicidal depression; if granted, the patent provides exclusivity until 2045.
- The formulation avoids benzethonium chloride to mitigate toxicity risks, and the company is on track with its NDA submission supported by a recent FDA fee waiver.
- FDA awards a $4.3 million filing fee waiver to NRX Pharmaceuticals for its New Drug Application for NRX-100, a preservative-free ketamine product designed for treating suicidal depression.
- The company expects to complete the NDA filing in Q2 2025 using current corporate resources, reinforcing its commitment to addressing unmet public health needs.
- The filing, dated April 17, 2025, is an 8-K report updating investors on a market offering adjustment by NRX Pharmaceuticals, Inc..
- The company increased the maximum aggregate offering price of its common stock to $20,000,000, noting prior sales of approximately $1.8 million under its At the Market Offering Agreement with H.C. Wainwright & Co., LLC.
- The update includes a legal opinion (Exhibit 5.1) affirming the validity of issuing the shares under the revised offering terms.