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].

Financial Data and Key Metrics Changes - For Q1 2025, the company reported a net loss of $5.5 million, an improvement from a net loss of $6.5 million in Q1 2024 [37] - Loss from operations decreased to $3.8 million from $6 million in the same quarter last year [37] - Research and development expenses were $800,000, down from $1.7 million in Q1 2024, while general and administrative expenses decreased to $2.9 million from $4.3 million [37][38] Business Line Data and Key Metrics Changes - NRx has advanced its lead candidates, NRx 100 and NRx 101, in the regulatory process with the US FDA, aiming for revenue generation in the near term [6][10] - The company has established a network of clinics under Hope Therapeutics, which is expected to be revenue-generating and profitable soon [10][34] - The company anticipates clinic revenue well before the end of the year, with a focus on non-dilutive financing for clinic acquisitions [7][17] Market Data and Key Metrics Changes - The market for NRx 100, an intravenous preservative-free ketamine for treating suicidal depression, is projected to be significant, with potential sales reaching billions [27][26] - The company expects the market for NRx 101, targeting bipolar depression with suicidality or akathisia, to exceed $2 billion initially and potentially over $5 billion broadly [33][28] Company Strategy and Development Direction - NRx aims to address the national epidemic of suicidality, depression, and PTSD through innovative medicines and direct patient care via Hope Therapeutics [6][10] - The company plans to establish a national network of interventional psychiatry clinics, combining neuroplastic treatments and protocols [33][34] - NRx is focused on gaining FDA approval for its products to expand patient access and improve treatment options for mental health conditions [26][39] Management's Comments on Operating Environment and Future Outlook - Management highlighted the increased focus from the US government on treating suicidal depression and PTSD, particularly in military and veteran communities [9] - The company is optimistic about its path to revenue generation and profitability by the end of 2025, supported by ongoing financing discussions and partnerships [38][36] - Management expressed confidence in the potential for NRx 100 and NRx 101 to provide life-saving treatments and significant market opportunities [27][39] Other Important Information - NRx has filed a patent for its novel preservative-free formulation of NRx 100, potentially protecting the product until 2045 [11][23] - The company has manufacturing capacity to supply over 1 million doses of ketamine per month upon FDA approval [11][22] - NRx is navigating the complexities of acquiring medical treatment facilities under state regulations as part of its growth strategy [16][34] Q&A Session Summary Question: What does the recent IP buy you if approved? - Management indicated that the strength of the patent application is believed to be strong, potentially providing market exclusivity for an extended period if the preservative-free ketamine is approved [41][42] Question: Consideration for NRx 100 going international? - Management confirmed intentions to make NRx 100 available internationally, noting that European countries are more sensitive to toxic substances, which could enhance market potential [47]

Financial Data and Key Metrics Changes - For Q1 2025, the company reported a net loss of $5.5 million, an improvement from a net loss of $6.5 million in Q1 2024, and a loss from operations of $3.8 million compared to a loss of $6 million in the same quarter last year [33] - Research and development expenses were $800,000, down from $1.7 million in Q1 2024, while general and administrative expenses decreased to $2.9 million from $4.3 million [33] - As of March 31, 2025, the company had approximately $5.5 million in cash and cash equivalents, with expectations that current capital and ongoing financing discussions will support operations through at least the end of 2025 [33] Business Line Data and Key Metrics Changes - NRx Pharmaceuticals is advancing its lead candidates, NRx 100 and NRx 101, in the regulatory process with the FDA, aiming for revenue generation in the near future [5][9] - The company has initiated the filing of a New Drug Application (NDA) for NRx 100, a preservative-free intravenous ketamine for treating suicidal depression, supported by data from four well-controlled clinical trials [9][16] - NRx 101, a fixed-dose oral combination for treating suicidal depression, is also preparing for NDA filing, with expectations for accelerated approval due to its unique efficacy profile [11][28] Market Data and Key Metrics Changes - The market for NRx 100 is projected to be significant, with the current market for intranasal ketamine expected to generate $1.3 billion in sales for J&J's SPRAVATO, which does not demonstrate antisuicidal properties [24] - The potential market for NRx 101 in bipolar depression is estimated to exceed $2 billion for the initial indication, with the broader bipolar market potentially exceeding $5 billion [29] Company Strategy and Development Direction - The company is focused on establishing a national network of clinics through its subsidiary, Hope Therapeutics, to provide integrated care for patients with suicidality, depression, and PTSD [12][29] - NRx aims to create a comprehensive treatment model combining NMDA antagonist drugs with neuroplastic therapies, anticipating that integrated therapies could lead to sustained remission rates approaching 90% [13][14] - The company plans to expand its clinic network, having signed agreements to acquire several interventional psychiatry practices, with a goal of generating significant revenue from these clinics [30][31] Management's Comments on Operating Environment and Future Outlook - Management highlighted the increasing focus from the U.S. government on treating suicidal depression and PTSD, particularly in military and veteran communities, which aligns with the company's mission [8] - The company anticipates becoming a revenue-generating entity by early next year if it continues to execute its plans effectively [15] - Management expressed confidence in the potential for NRx 100 and NRx 101 to address significant unmet medical needs in mental health treatment [35] Other Important Information - The company has filed a patent for its novel preservative-free formulation of NRx 100, potentially protecting the product until 2045 [10][20] - NRx has manufacturing capacity to supply over 1 million doses of ketamine per month, should it gain FDA approval [10][20] Q&A Session Summary Question: What does the recent IP buy you if approved? - Management indicated that the strength of the patent application is believed to be strong, and having a preservative-free ketamine could provide market exclusivity for an extended period [39][41] Question: Consideration for NRx 100 going international? - Management confirmed intentions to make NRx 100 available internationally, noting that European countries are more sensitive to toxic substances, which could enhance its market potential [43]

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

Core Insights - NRx Pharmaceuticals has reported continued momentum into 2025, advancing regulatory filings for NRX-100 and NRX-101, and enhancing its commercial opportunities with new intellectual property protection for NRX-100 [1][5] - The company is focused on expanding its HOPE Therapeutics network of interventional psychiatry clinics, with planned acquisitions aimed at addressing mental health treatment needs [1][14] Key Research and Development and Corporate Activities - NRX-100, a preservative-free IV ketamine for suicidal depression, aims to address a significant public health crisis, with over 13 million adults in the U.S. considering suicide annually [2] - The company has completed stability and sterility assays for NRX-100, demonstrating three years of room temperature shelf stability, and is on track for a New Drug Application (NDA) submission in Q2 2025 [3] - An Abbreviated New Drug Application (aNDA) for existing ketamine indications is planned for Q2 2025, based on the belief that preservative-free formulations will be preferred [4] - The FDA has waived the $4.3 million NDA submission fee for NRX-100, recognizing its public health benefits and small business status [5] - NRX-101, an oral treatment for suicidal bipolar depression, is progressing towards NDA submission with anticipated PDUFA dates in 2025, supported by strong clinical trial data [12][13] Financial Overview - For Q1 2025, the company reported a net loss of $5.5 million, an improvement from a net loss of $6.5 million in Q1 2024, with operational losses also reduced [21] - As of March 31, 2025, NRx Pharmaceuticals had approximately $5.5 million in cash and cash equivalents, with ongoing financing discussions expected to support operations through the end of 2025 [22] HOPE Therapeutics Expansion - HOPE Therapeutics is developing a national network of clinics focused on neuroplastic therapies for treating depression and related conditions, with initial acquisitions expected to generate approximately $15 million in pro forma revenues [14][16] - The company is negotiating additional clinic acquisitions that could represent around $20 million in potential pro forma revenue [17] - Financing agreements totaling $10.3 million have been signed to support these acquisitions, which are non-dilutive to NRx shareholders [19][20]

Core Insights - HOPE Therapeutics, Inc. has signed a term sheet with Universal Capital, LLC to secure $7.8 million in acquisition capital for expanding its network of interventional psychiatry clinics, aiming for a total of $10.3 million in acquisition capital through additional funding [1][8] Company Overview - HOPE Therapeutics is a subsidiary of NRx Pharmaceuticals, focused on establishing a network of clinics that provide neuroplastic treatments, including ketamine and transcranial magnetic stimulation (TMS), for severe depression and PTSD [2][6] - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics for central nervous system disorders, including NRX-101, which is designated as a Breakthrough Therapy by the FDA for suicidal treatment-resistant bipolar depression [7][9] Industry Context - Neuroplastic treatments are gaining recognition for their effectiveness in treating severe depression and PTSD, with clinical trials demonstrating their ability to foster new synaptic connections in the brain [2][3] - The U.S. Department of Veterans Affairs has highlighted the importance of psychedelic treatments, such as ketamine, in addressing veteran suicide, indicating a growing acceptance of these therapies in mainstream mental health care [3][4] Financial Strategy - The funding from Universal Capital is part of a broader strategy to acquire best-in-class clinics, with plans for future funding as additional assets are identified [4][8] - The company aims to address the mental health crisis in the U.S., where over 13 million Americans plan to commit suicide each year, emphasizing the urgent need for effective treatment options [4]

Core Insights - HOPE Therapeutics, Inc. has signed a definitive agreement to acquire Kadima Neuropsychiatry Institute, which will serve as a clinical model for HOPE's treatment offerings and continue its role in neuroplastic therapy research [1][4][6] - Kadima is recognized as a leading interventional psychiatry clinic in California, known for pioneering ketamine treatment for CNS disorders and is profitable with expected growth [2][6] - Dr. David Feifel, a prominent figure in interventional psychiatry, will join HOPE as Chief Medical Innovation Officer, enhancing the company's leadership in mental healthcare [3][6] Company Overview - NRx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing therapeutics for CNS disorders, including suicidal bipolar depression and PTSD, with its investigational drug NRX-101 designated as a Breakthrough Therapy by the FDA [5][6] - HOPE Therapeutics aims to build a network of interventional psychiatry clinics offering treatments such as ketamine and TMS, supported by a digital therapeutic platform [8] Strategic Implications - The acquisition of Kadima is expected to be accretive to revenue and EBITDA for both NRx and HOPE, indicating a positive financial outlook post-acquisition [6] - The integration of Kadima's expertise and clinical model is aligned with HOPE's strategy to redefine mental healthcare access and delivery [4][6]

Core Points - NRx Pharmaceuticals will release its Q1 2025 financial results on May 15, 2025, after market close, followed by a conference call at 4:30 PM ET to discuss the results and provide a corporate update [1][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 [3] - The company is developing NRX-101, which has received FDA-designated Breakthrough Therapy status for treating suicidal treatment-resistant bipolar depression and chronic pain, with plans to file for Accelerated Approval [3] - NRx has initiated a New Drug Application for NRX-100 (IV ketamine) for suicidal depression, based on clinical trial results and data from French health authorities [4] Subsidiary Information - HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals, is establishing a network of interventional psychiatry clinics to provide ketamine and other therapies for suicidal depression and related disorders [5]