PART I - FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=ITEM%201.%20Financial%20Statements) NRx Pharmaceuticals' Q2 2025 unaudited financial statements reveal a net loss of $23.1 million, a worsening stockholders' deficit, and a 'going concern' warning Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $2,910 | $1,443 | | Total Assets | $4,838 | $3,651 | | Total Liabilities | $40,453 | $26,874 | | Total stockholders' deficit | $(35,615) | $(23,223) | Condensed Consolidated Statements of Operations Highlights (in thousands) | Metric | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $1,791 | $4,552 | | General and administrative | $5,686 | $8,496 | | Loss from operations | $(7,577) | $(13,048) | | Net loss | $(23,092) | $(14,425) | | Net loss per share (Basic and diluted) | $(1.34) | $(1.49) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Metric | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(7,508) | $(6,233) | | Net cash provided by financing activities | $8,975 | $3,536 | | Net increase (decrease) in cash | $1,467 | $(2,697) | | Cash and cash equivalents at end of period | $2,910 | $1,898 | - The company's history of net losses and negative cash flows results in a working capital deficit, raising **substantial doubt about its ability to continue as a going concern** for the next twelve months[25](index=25&type=chunk)[30](index=30&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=43&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses strategic shifts, drug milestones, increased net loss from non-cash adjustments, and ongoing going concern doubts - The company pursues a dual strategy: developing novel CNS therapeutics (NRX-100, NRX-101) via NeuroRx and establishing revenue through HOPE Therapeutics' interventional psychiatry clinics[184](index=184&type=chunk) - Key regulatory milestones achieved for lead drug candidates include **ANDA filing for NRX-100 in Q2 2025**, initiation of **NDA filing for NRX-101**, and **expanded Fast Track Designation for NRX-100** for suicidal ideation in depression[185](index=185&type=chunk)[213](index=213&type=chunk) Results of Operations Comparison - Three Months Ended June 30 (in thousands) | Line Item | 2025 | 2024 | Change ($) | | :--- | :--- | :--- | :--- | | Research and development | $987 | $2,804 | $(1,817) | | General and administrative | $2,743 | $4,246 | $(1,503) | | **Loss from operations** | **$(3,730)** | **$(7,050)** | **$3,320** | | Total other expense | $13,851 | $847 | $13,004 | | **Net loss** | **$(17,581)** | **$(7,897)** | **$(9,684)** | Results of Operations Comparison - Six Months Ended June 30 (in thousands) | Line Item | 2025 | 2024 | Change ($) | | :--- | :--- | :--- | :--- | | Research and development | $1,791 | $4,552 | $(2,761) | | General and administrative | $5,686 | $8,496 | $(2,810) | | **Loss from operations** | **$(7,577)** | **$(13,048)** | **$5,471** | | Total other (income) expense | $15,515 | $1,377 | $14,139 | | **Net loss** | **$(23,092)** | **$(14,425)** | **$(8,667)** | - The company concludes **substantial doubt exists about its ability to continue as a going concern**, relying on additional equity or debt financing for operations[228](index=228&type=chunk)[255](index=255&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=61&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) NRx Pharmaceuticals is exempt from providing market risk disclosures as it qualifies as a smaller reporting company - The company is **exempt from this disclosure requirement** as it qualifies as a smaller reporting company[278](index=278&type=chunk) [Controls and Procedures](index=62&type=section&id=ITEM%204.%20Controls%20and%20Procedures) The CEO and CFO concluded disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - Management, including the CEO and CFO, concluded the company's **disclosure controls and procedures were effective** as of June 30, 2025[281](index=281&type=chunk) - No material changes to the company's **internal control over financial reporting** occurred during the quarter ended June 30, 2025[282](index=282&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=62&type=section&id=ITEM%201.%20Legal%20Proceedings) Incidental legal proceedings are not material; Kadima acquisition remains unclosed due to ongoing discussions - The company is involved in routine legal proceedings not expected to be **material**[284](index=284&type=chunk) - The acquisition of Kadima Neuropsychiatry Institute assets, agreed on May 9, 2025, has **not closed** due to ongoing discussions[285](index=285&type=chunk) [Risk Factors](index=63&type=section&id=ITEM%201A.%20Risk%20Factors) No material changes to risk factors; uncertainty surrounds Kadima and Dura Medical acquisitions' closing and benefits - No **material changes** from risk factors previously disclosed in the 2024 Annual Report on Form 10-K[287](index=287&type=chunk) - Key risk involves uncertainty of **Kadima and Dura Medical acquisitions**, with unfinalized financing and no assurance of closing or accretive stockholder value[288](index=288&type=chunk)[289](index=289&type=chunk)[290](index=290&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=63&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No previously unreported unregistered equity sales occurred during Q2 2025 - No previously unreported **unregistered sales of equity securities** occurred during Q2 2025[291](index=291&type=chunk) [Defaults Upon Senior Securities](index=64&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) No previously unreported defaults on senior securities occurred during Q2 2025 - No previously unreported **defaults upon senior securities** occurred during Q2 2025[292](index=292&type=chunk) [Other Information](index=64&type=section&id=ITEM%205.%20Other%20Information) No directors or executive officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading plans in Q2 2025 - No directors or executive officers adopted or terminated a **Rule 10b5-1 trading plan** during the quarter[294](index=294&type=chunk) [Exhibits](index=64&type=section&id=ITEM%206.%20Exhibits) This section lists filed exhibits, including Hope Therapeutics purchase agreements, CEO/CFO certifications, and XBRL data - The report includes exhibits such as the **Asset Purchase Agreement for Kadima**, **Membership Interest Purchase Agreement for Dura Medical**, and required **CEO/CFO certifications**[295](index=295&type=chunk)

Core Viewpoint - NRx Pharmaceuticals is preparing to release its second quarter 2025 financial results and will host a conference call to discuss these results, highlighting its ongoing developments in the biopharmaceutical sector focused on central nervous system disorders [1][2]. Company Overview - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company that develops therapeutics targeting central nervous system disorders, including suicidal depression, chronic pain, and PTSD [3]. - The company is working on two main products: NRX-100, a preservative-free intravenous ketamine, and NRX-101, an oral D-cycloserine/lurasidone [3]. - NRX-100 has received Fast Track Designation for treating suicidal ideation in depression, including bipolar depression, while NRX-101 has been granted Breakthrough Therapy Designation for treating suicidal bipolar depression [3]. Recent Developments - NRx Pharmaceuticals has filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application (NDA) for NRX-100, seeking to utilize the Commissioner's National Priority Voucher Program for treating suicidal depression [4]. - The NDA filing is based on results from well-controlled clinical trials conducted in collaboration with the US National Institutes of Health and the Government of France [4].

Core Viewpoint - NRx Pharmaceuticals, Inc. is set to release its second quarter 2025 financial results on August 14, 2025, and will host a conference call to discuss corporate and financial updates, including recent regulatory events and operational plans [1][2]. Company Overview - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapeutics for central nervous system disorders, including suicidal depression, chronic pain, and PTSD [3]. - The company is developing two key products: NRX-100, a preservative-free intravenous ketamine, and NRX-101, an oral D-cycloserine/lurasidone [3]. - NRX-100 has received Fast Track Designation for treating suicidal ideation in depression, while NRX-101 has been granted Breakthrough Therapy Designation for suicidal bipolar depression [3]. Regulatory Developments - NRx has filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application (NDA) for NRX-100, seeking to utilize the Commissioner's National Priority Voucher Program for treating suicidal depression [4]. - The NDA filing is based on results from well-controlled clinical trials conducted in collaboration with the US National Institutes of Health and the Government of France [4].

Core Viewpoint - NRx Pharmaceuticals has received Fast Track designation from the FDA for NRX-100, a treatment for suicidal ideation in patients with depression, significantly expanding its addressable population to 13 million Americans who consider suicide each year [1][6]. Group 1: Fast Track Designation - The FDA granted Fast Track designation to NRX-100, indicating its potential to address an unmet medical need based on preliminary data [2][6]. - This designation represents a 10-fold increase in the addressable population compared to the previous designation in 2017, which was limited to bipolar depression [1][6]. Group 2: Clinical Evidence - Controlled trials submitted to the FDA showed a statistically significant reduction in suicidal ideation, with a Columbia University study reporting a 55% response rate for patients treated with intravenous ketamine compared to 30% for the active comparator [3]. - A trial sponsored by the Government of France indicated that 63% of patients achieved full remission from suicidal ideation within three days, compared to 31% for placebo [3]. Group 3: Market Potential - NRX-100 is positioned to address the over $3 billion market for suicidal depression in the U.S. [10]. - The company aims to make this potentially life-saving therapy accessible to all Americans, not just those who can afford it [7]. Group 4: Regulatory and Development Plans - NRx Pharmaceuticals plans to submit patient-level data from clinical trials to support the application for the Commissioner's National Priority Voucher (CNPV) program, which could expedite the review process [2][12]. - The company has filed for an Abbreviated New Drug Application (ANDA) and is working on draft labeling for NRX-100 to comply with CNPV requirements [8][12]. Group 5: Product Differentiation - NRX-100 is the first preservative-free formulation of ketamine submitted to the FDA, addressing safety concerns associated with existing products that contain toxic preservatives [9]. - The company has demonstrated long-term stability and sterility with its patented formulation, which is manufactured in the U.S. [9].

Core Insights - HOPE Therapeutics, Inc. has received final clearance from the Florida Agency for Health Care Administration to close the acquisition of Dura Medical LLC, which is a revenue-generating and EBITDA positive entity [1][8] - Dura Medical specializes in precision treatment for mental health and chronic pain, utilizing advanced interventional psychiatry procedures [2][8] - The acquisition is expected to enhance HOPE's revenue and EBITDA, contributing to its expansion in Florida and beyond [5][8] Company Overview - HOPE Therapeutics is a subsidiary of NRx Pharmaceuticals, focusing on building a network of interventional psychiatry clinics that provide treatments such as ketamine therapy and Transcranial Magnetic Stimulation (TMS) [9] - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics for central nervous system disorders, including suicidal bipolar depression and PTSD [6] Dura Medical's Mission and Services - Dura Medical aims to reduce suicide rates in the community, with a goal to treat over 10,000 individuals by 2026 [4] - The clinic offers a comprehensive range of services, including Ketamine Infusion Therapy, TMS, and Spravato®, targeting conditions like depression, PTSD, and anxiety [2][3] Regulatory and Strategic Developments - The acquisition of Dura Medical is part of a broader strategy that includes previous acquisitions aimed at expanding coverage along the West Coast of Florida [8] - The intended closing of the acquisition is subject to standard closing conditions, indicating a structured approach to regulatory compliance [5][8]

Core Viewpoint - NRx Pharmaceuticals has filed a Citizen Petition with the FDA to remove Benzethonium Chloride from all forms of ketamine sold in the U.S. due to its known toxicity and lack of safety recognition by the FDA [1][2][6] Company Developments - 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 has filed an Abbreviated New Drug Application (ANDA) for a preservative-free ketamine and initiated a New Drug Application (NDA) for NRX-100 (IV ketamine) under the FDA's National Priority Voucher Program for treating suicidal depression [4] - NRx has demonstrated long-term stability and sterility for its preservative-free ketamine, which is crucial for its approval process [6] Industry Context - Benzethonium Chloride is a preservative that has been prohibited in hand cleansers and topical antiseptics by the FDA due to its toxicity [6] - The European Medicines Agency has also warned against the use of Benzethonium Chloride, indicating a growing concern over its safety in pharmaceutical products [2]

Company Overview - NRx Pharmaceuticals, Inc. 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 developing NRX-101, which has been designated as an FDA Breakthrough Therapy for suicidal treatment-resistant bipolar depression, with plans to file a New Drug Application (NDA) for Accelerated Approval [4] Recent Developments - NRx Pharmaceuticals has filed an Abbreviated New Drug Application (ANDA) for NRX-100, a preservative-free IV ketamine, for currently approved indications [5] - The company has initiated an NDA filing for NRX-100 for the treatment of suicidal depression, based on clinical trial results and new data from French health authorities [5] - NRx has received Fast Track Designation from the US FDA for the development of NRX-100 to treat patients with acute suicidality and has filed a patent for this novel formulation [5] Events and Collaborations - The CEO and Chairman of NRx Pharmaceuticals will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on July 29-30, 2025, discussing neuroplasticity in CNS disorder treatments [1][2] - The discussion will include insights from Prof. Samuel Wilkinson, a pioneer in the understanding of ketamine and other neuroplastic drugs for treating depression and PTSD [2] Subsidiary Information - HOPE Therapeutics, Inc., 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 [6]

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].

Core Points - NRx Pharmaceuticals has filed for the FDA's newly announced Commissioner's National Priority Voucher program for its NRX-100, a preservative-free formulation of ketamine for intravenous use [1][7] - The FDA's new approval pathway aims to expedite the review process for drugs addressing national health priorities, reducing the review time from approximately 10-12 months to 1-2 months [2][3] - The FDA has identified suicidal depression and PTSD as national health crises, aligning with NRx's focus on innovative treatments for these conditions [5][9] Company Developments - NRx has already submitted the chemistry, manufacturing, and controls (CMC) portion of the application for NRX-100 and received FDA feedback [3][6] - The company is preparing a citizen petition to withdraw preservative-containing forms of ketamine due to toxicity concerns, which could enhance its market position in the $750 million generic ketamine market projected to reach $3-5 billion annually by 2033 [9][11] - NRx has received Fast Track Designation from the FDA for NRX-100, indicating its potential to address unmet medical needs [5][11] Market Context - The FDA plans to issue a limited number of vouchers in the first year of the CNPV program to companies that align with U.S. national health priorities [3][4] - NRx's innovative manufacturing approach aims to reduce reliance on foreign sources for ketamine supply, enhancing domestic drug manufacturing as a national security issue [4][8] - The company anticipates decisions on drug approval by year-end 2025, consistent with the timelines announced for the CNPV program [7][9]

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]