WILMINGTON, Del., July 29, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", or the "Company"), today announced that its CEO and Chairman will join a fireside chat at BTIG Virtual Biotechnology Conference on July 29 – 30, 2025.Prof. Jonathan Javitt, MD, MPH will join Prof. Samuel Wilkinson, MD, of the Yale School of Medicine, and  BTIG Research Analyst Dr. Thomas Shrader for a fireside chat to discuss neuroplasticity in the treatment of CNS disorders at 8:00 a.m. EDT on W ...

Core Viewpoint - HOPE Therapeutics, Inc. has signed a binding Letter of Intent to acquire a 49% interest in Cohen and Associates, LLC, a leading Interventional Psychiatry clinic in Florida, which is expected to enhance HOPE's clinical care capabilities in the region [1][2][8]. Company Overview - HOPE Therapeutics, Inc. is a subsidiary of NRx Pharmaceuticals, focused on building a network of interventional psychiatry clinics to provide treatments for suicidal depression and related disorders [8][9]. - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics for central nervous system disorders, including suicidal bipolar depression and PTSD [6]. Acquisition Details - The acquisition of Cohen is anticipated to be immediately accretive to revenue and EBITDA for HOPE Therapeutics [8]. - The transaction is subject to the execution of definitive documents and standard closing requirements, with further details to be disclosed later [5]. Cohen and Associates - Cohen and Associates, founded by Dr. Rebecca Cohen, is recognized for its comprehensive treatment options for suicidal depression, PTSD, and other CNS disorders, including ketamine and Transcranial Magnetic Stimulation (TMS) [2][3]. - Dr. Rebecca Cohen is an expert in mood and anxiety disorders, with a strong academic background and recognition in the field of TMS [3]. Leadership Statements - The leadership of HOPE Therapeutics expressed enthusiasm about the acquisition, highlighting Dr. Cohen's experience and commitment to patient care as a perfect fit for the company's mission [4][5].

Company has applied for new Commissioner's National Priority Vouchers (CNPV) for NRX-100. Continues to anticipate decisions on drug approval by year-end 2025 Application under CNPV program is accretive to already-filed Abbreviated New Drug Application (ANDA) for preservative-free ketamine, with proprietary formulation under priority review request Company has received and complied with FDA information request for updated drug ingredient and label information on NRX-100 Company has previously filed full Che ...

Core Insights - NRx Pharmaceuticals and its subsidiary HOPE Therapeutics have formed a strategic investor relations partnership with astr partners to enhance their visibility and investor engagement at a critical juncture in their development [1][2][3] Company Overview - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapeutics for central nervous system disorders, including suicidal bipolar depression, chronic pain, and PTSD [4] - The company is advancing NRX-101, which has received FDA designation as an investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression, and plans to file for Accelerated Approval [4] - NRx has filed an Abbreviated New Drug Application (ANDA) for NRX-100, a preservative-free IV ketamine, and is also pursuing a New Drug Application for the treatment of suicidal depression [5] HOPE Therapeutics Overview - HOPE Therapeutics is a wholly-owned subsidiary of NRx Pharmaceuticals, focused on building a network of interventional psychiatry clinics that provide ketamine and transcranial magnetic stimulation (TMS) therapies [6] - The company aims to offer lifesaving therapies for patients with suicidal depression and related disorders, supported by a digital therapeutic-enabled platform [6] Strategic Partnership - The partnership with astr partners is expected to leverage their extensive experience in biotech investor relations and relationships with specialist investors to enhance NRx and HOPE's market presence [2][3] - The investor relations program will include investor targeting, message development, earnings preparation, conference support, and proactive engagement [3]

Core Insights - NRx Pharmaceuticals and its subsidiary HOPE Therapeutics will participate in the H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference on June 16-17, 2025 [1][2] - Dr. Jonathan Javitt, CEO of NRx and Co-CEO of HOPE, will present the company's latest advancements, available on demand for registered attendees starting at 7:00 a.m. ET on June 16, 2025 [2][8] - The company will also engage in one-on-one meetings with investors during the conference [2] Company Overview - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapeutics for central nervous system disorders, including suicidal bipolar depression, chronic pain, and PTSD [4] - The company is advancing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain, with plans to file an NDA for Accelerated Approval [4] - NRx has filed an Abbreviated New Drug Application for NRX-100, a preservative-free IV ketamine, and is pursuing a New Drug Application for its use in treating suicidal depression [5] HOPE Therapeutics Overview - HOPE Therapeutics is a subsidiary of NRx Pharmaceuticals, focused on creating a network of interventional psychiatry clinics offering ketamine and other therapies for suicidal depression [6] - The company aims to enhance clinical benefits through a digital therapeutic-enabled platform that complements NMDA-targeted drug therapy [6]

Core Insights - NRx Pharmaceuticals has submitted an Abbreviated New Drug Application (ANDA) for NRX-100, a preservative-free IV ketamine formulation, to the FDA for use in approved indications such as anesthesia and pain management [1][2] Industry Overview - The current annual ketamine market is estimated at $750 million, with projections indicating growth to $3.35 billion globally by 2034 [2][6] - An estimated 5.1 million Americans have received ketamine for medical uses, with demand continuing to rise due to increased clinical focus [2][6] - There is a severe drug shortage of ketamine in the U.S., which is not expected to improve in the near future [6] Company Developments - NRx Pharmaceuticals aims to capture a significant share of the existing ketamine market with its NRX-100 formulation, which eliminates the neurotoxic preservative benzethonium chloride [3][5] - The company plans to file a citizen's petition with the FDA to remove benzethonium chloride from all intravenous ketamine presentations [3][6] - NRx anticipates submitting clinical trial data from over 1,000 patients and real-world data from more than 180,000 patients to support the extension of ketamine's labeled indications to include treatment for suicidal depression [4][8] Regulatory and Patent Status - The FDA has granted a waiver of the $4.3 million NDA fee for NRX-100, recognizing its public health value [5] - NRX-100 has received Fast Track Designation from the FDA, and the company has filed a patent for this novel formulation, seeking protection until 2045 [5][8]

Financial Performance - For Q1 2025, NRx Pharmaceuticals reported a net loss of $5.5 million, an improvement from a net loss of $6.5 million in Q1 2024, with a loss from operations of $3.8 million compared to $6.0 million in the prior year[21]. - NRx Pharmaceuticals raised $8.9 million in gross proceeds in January 2025 through a convertible debt offering and a registered direct equity offering, strengthening its balance sheet[18]. - Subsequent to Q1, the company signed financing agreements for $10.3 million in acquisition capital that is non-dilutive to shareholders[19]. - As of March 31, 2025, NRx Pharmaceuticals had approximately $5.5 million in cash and cash equivalents, with expectations to support operations through at least the end of 2025[21][22]. Drug Development and Regulatory Plans - The company plans to submit a New Drug Application (NDA) for NRX-100 (preservative-free IV ketamine) in Q2 2025, with an expected PDUFA date in 2025, and has received a $4.3 million NDA submission fee waiver from the FDA[4][8]. - NRX-101 is on track for NDA submission under Accelerated Approval, with anticipated PDUFA date in 2025, supported by strong clinical data and manufacturing stability[13]. - The company has developed a novel formulation, HTX-100, which is expected to undergo clinical testing in 2025/2026 and aims for FDA approval in late 2026[11]. Market Opportunities - NRX-100 targets the over $3 billion market for suicidal depression in the US, while NRX-101 addresses a market estimated at over $2 billion for bipolar depression[12][14]. Strategic Acquisitions - HOPE Therapeutics is acquiring Kadima Neuroscience Institute, Dura Medical, and Neurospa TMS Holdings, expected to generate approximately $15 million in forward-looking pro forma revenues[16]. - The company is negotiating additional clinic acquisitions that could represent ~$20 million in potential pro forma revenue, aiming for a total of $100 million in forward-looking revenue by year-end 2025[17].

NRx Pharmaceuticals (NRXP) Q1 2025 Earnings Call May 15, 2025 04:30 PM ET Company Participants Matthew Duffy - Chief Business Officer & Co-CEO of Hope TherapeuticsJonathan Javitt - Founder, Chairman, Chief Scientist & Co-CEO of Hope TherapeuticsMichael Abrams - CFO Conference Call Participants Thomas Shrader - MD & Healthcare AnalystEdward Woo - Director of Research & Senior Analyst Operator Good afternoon, ladies and gentlemen, and welcome to the NRx Pharmaceuticals First Quarter twenty twenty five Earning ...

NRx Pharmaceuticals (NRXP) Q1 2025 Earnings Call May 15, 2025 04:30 PM ET Speaker0 Good afternoon, ladies and gentlemen, and welcome to the NRx Pharmaceuticals First Quarter twenty twenty five Earnings Call. At this time, all lines are in a listen only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call, you require immediate assistance, please press 0 for the operator. This call is being recorded on Thursday, 05/15/2025. I would now like to turn ...

PART I - FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=ITEM%201.%20Financial%20Statements) The company reported a reduced net loss but faces a significant working capital deficit and going concern risk Condensed Consolidated Balance Sheet Data (in thousands) | | March 31, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $5,548 | $1,443 | | Total current assets | $7,256 | $3,302 | | Total assets | $7,590 | $3,651 | | **Liabilities and Stockholders' Deficit** | | | | Total current liabilities | $32,751 | $21,863 | | Total liabilities | $32,751 | $26,874 | | Total stockholders' deficit | $(25,161) | $(23,223) | Condensed Consolidated Statements of Operations (in thousands) | | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Total operating expenses | $3,847 | $5,998 | | Loss from operations | $(3,847) | $(5,998) | | Net loss | $(5,512) | $(6,528) | | Net loss per share (Basic and diluted) | $(0.34) | $(0.74) | Condensed Consolidated Statements of Cash Flows (in thousands) | | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(3,480) | $(3,671) | | Net cash used in investing activities | $0 | $0 | | Net cash provided by financing activities | $7,585 | $395 | | Net increase (decrease) in cash | $4,105 | $(3,276) | - The company has concluded that **substantial doubt exists regarding its ability to continue as a going concern** due to a history of net losses, negative cash flows, and a working capital deficit[24](index=24&type=chunk)[26](index=26&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail drug development progress, financing activities, and strategic acquisitions for its clinic network - The company's lead drug candidates, **NRX-101 and NRX-100**, are expected to be submitted for FDA approval in Q2 2025, while its subsidiary HOPE Therapeutics aims to generate revenue[21](index=21&type=chunk)[23](index=23&type=chunk) - The Alvogen License Agreement was terminated, resulting in an outstanding **refund liability of $4.7 million** due to Alvogen as of March 31, 2025[65](index=65&type=chunk)[66](index=66&type=chunk) - The company secured **approximately $15.0 million in gross proceeds** from Senior Secured Convertible Promissory Notes, with the final $5.4 million tranche closing in January 2025[25](index=25&type=chunk)[83](index=83&type=chunk) - A Registered Direct Offering in January 2025 generated **net proceeds of approximately $3.255 million** from the sale of common stock and warrants[105](index=105&type=chunk) - Post-quarter, subsidiary HOPE Therapeutics entered an agreement with **Kadima Neuropsychiatry Institute** to develop a national network of precision psychiatry clinics[166](index=166&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=37&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic shift to a revenue model, positive trial data, and reduced operating expenses - The company is transitioning from a pre-revenue biotech to a revenue-generating enterprise through its **new subsidiary, HOPE Therapeutics**[173](index=173&type=chunk) - Final data from the Phase 2b/3 trial of NRX-101 showed a **statistically significant reduction in akathisia (P=0.025)**, supporting a planned NDA submission based on this safety benefit[176](index=176&type=chunk)[178](index=178&type=chunk)[179](index=179&type=chunk) - HOPE Therapeutics has signed definitive agreements to acquire **Kadima Neuropsychiatry Institute and Dura Medical**, forming the foundation of a planned national clinic network[174](index=174&type=chunk)[175](index=175&type=chunk)[196](index=196&type=chunk) - R&D expenses decreased by $0.9 million and G&A expenses decreased by $1.3 million, driven by the conclusion of a phase 2 study and lower consultant fees[201](index=201&type=chunk)[202](index=202&type=chunk) - The company secured significant capital through a **$5.4 million convertible note tranche** and a **$3.5 million registered direct offering** in Q1 2025[190](index=190&type=chunk) Results of Operations Comparison (in thousands) | | Three months ended March 31, 2025 | Three months ended March 31, 2024 | Change ($) | | :--- | :--- | :--- | :--- | | Research and development | $804 | $1,748 | $(944) | | General and administrative | $2,943 | $4,250 | $(1,307) | | **Total operating expense** | **$3,847** | **$5,998** | **$(2,151)** | | **Net loss** | **$(5,512)** | **$(6,528)** | **$1,016** | [Quantitative and Qualitative Disclosures About Market Risk](index=52&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exempt from market risk disclosures as a smaller reporting company - The company is not required to provide quantitative and qualitative disclosures about market risk as it qualifies as a **smaller reporting company**[243](index=243&type=chunk) [Controls and Procedures](index=52&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective with no material changes during the quarter - Based on an evaluation as of March 31, 2025, the CEO and CFO concluded that the company's **disclosure controls and procedures were effective**[246](index=246&type=chunk) - **No material changes** occurred in the company's internal controls over financial reporting during the first quarter of 2025[247](index=247&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=53&type=section&id=ITEM%201.%20Legal%20Proceedings) The company reports no material legal proceedings that would adversely affect its financial position - The company is **not involved in any legal proceedings** that it believes could have a material adverse effect on its financial position or results of operations[96](index=96&type=chunk)[249](index=249&type=chunk) [Risk Factors](index=53&type=section&id=ITEM%201A.%20Risk%20Factors) No material changes to risk factors were reported since the last Annual Report on Form 10-K - **No material changes** have occurred to the risk factors disclosed in the company's Annual Report on Form 10-K filed on March 14, 2025[250](index=250&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=53&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No previously unreported unregistered sales of equity securities occurred during the first quarter of 2025 - There were **no unregistered sales of equity securities** during the three months ended March 31, 2025, that were not already reported[251](index=251&type=chunk) [Other Information](index=53&type=section&id=ITEM%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the quarter - **No directors or executive officers adopted or terminated a Rule 10b5-1 trading arrangement** during the quarter ended March 31, 2025[254](index=254&type=chunk) [Exhibits](index=53&type=section&id=ITEM%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including agreements and certifications