Core Insights - NRx Pharmaceuticals is set to launch HOPE Therapeutics clinics in Fall 2025, focusing on treating suicidal depression, PTSD, traumatic brain injury, and cognitive dysfunction through a unique one-week residential program that combines various therapies [1][5] - The program will be the first of its kind in the nation, integrating neuroplastic drugs like ketamine, transcranial magnetic stimulation, and hyperbaric oxygen therapy, along with nutritional therapy and supportive therapy [1][6] - The company recently raised over $8.8 million from biotechnology investors to support its initiatives, with no warrants or variable rate features involved [3][5] Company Overview - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics for central nervous system disorders, including suicidal depression and PTSD [4] - The company is advancing neuroplastic drug development, particularly NRX-100 (intravenous ketamine) and NRX-101 (oral D-cycloserine/lurasidone), with NRX-100 receiving Fast Track Designation for treating suicidal ideation in depression [4] - HOPE Therapeutics, a subsidiary of NRx, aims to create a network of interventional psychiatry clinics offering innovative therapies for patients with suicidal depression and related disorders [6] Key Partnerships and Initiatives - Matthew Rockefeller has joined the advisory board of HOPE Therapeutics, enhancing the company's strategic direction [1][3] - The Global Passion Project, founded by Andrea Cartier Bartzen, emphasizes collaboration and innovation to address global challenges like suicidal depression and PTSD [2]

Core Viewpoint - NRx Pharmaceuticals has announced an expanded access policy for NRX-100, a preservative-free ketamine, following its Fast Track designation by the FDA for treating suicidal ideation in patients with depression, including bipolar depression [1][6]. Group 1: Expanded Access Policy - NRX-100 is now available for expanded access to eligible patients, addressing an unmet need in treating suicidal depression [2][6]. - Physicians can request NRX-100 for patients who are not responsive to or cannot tolerate approved treatment options [3][7]. - The company emphasizes the urgent need for NRX-100 for patients with suicidal depression [3]. Group 2: FDA Designation and Clinical Development - The FDA granted Fast Track designation for NRX-100 based on preliminary data indicating its potential to meet an unmet medical need [2][6]. - NRX Pharmaceuticals is also developing NRX-101, which has received Breakthrough Therapy Designation for treating suicidal bipolar depression [5]. Group 3: Patient Statistics and Clinical Trials - Approximately 13 million adults in the U.S. seriously consider suicide each year, with a suicide occurring every 11 minutes [6]. - NRX has filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application for NRX-100, based on results from well-controlled clinical trials [8].

Financial Data and Key Metrics Changes - For Q2 2025, the company reported a net loss of $17.5 million compared to a net loss of $7.9 million in Q2 2024, primarily due to a $12 million non-cash charge related to fair value accounting measurements [22] - The loss from operations, excluding non-cash impacts, improved to $3.7 million from $7.1 million year-over-year, marking a 47% improvement [22][24] - As of June 30, 2025, the company had approximately $2.9 million in cash and cash equivalents, and a recent direct offering raised net proceeds of approximately $6.5 million [23][24] Business Line Data and Key Metrics Changes - NRx100, an intravenous ketamine product, is undergoing two regulatory approval processes, with a focus on addressing suicidal ideation in depression [13][15] - NRx101, an oral treatment for suicidal bipolar depression, has filed its initial module with the FDA and anticipates a rolling review [18][19] - Hope Therapeutics is progressing towards establishing a network of interventional psychiatry clinics, with plans to finalize the purchase of its first clinics [20][21] Market Data and Key Metrics Changes - The existing market for ketamine is projected at approximately $750 million annually, with NRx100 expected to capture a significant share if approved without toxic preservatives [18][58] - The company aims to address a large unmet medical need, particularly in the context of the public health crisis related to suicidality [15][16] Company Strategy and Development Direction - The company is focused on advancing its drug development initiatives and expanding its clinic acquisitions to build long-term value for shareholders [24] - The strategy includes leveraging the broadened Fast Track designation from the FDA for NRx100, which now encompasses all patients with suicidal ideation in depression [15] - The company aims to create a coherent network of care delivery through Hope Therapeutics, similar to successful models in other healthcare sectors [50] Management's Comments on Operating Environment and Future Outlook - Management highlighted the significant progress made in drug approvals and the establishment of a clinic network, emphasizing the transformative potential for mental health treatment in the U.S. [24] - The management expressed optimism about the upcoming regulatory milestones and the potential for substantial revenue growth from NRx100 and NRx101 [24][60] Other Important Information - The company received a PDUFA fee waiver from the FDA, saving approximately $4.3 million in filing fees, which reflects the agency's support for small business entities [21] - The management noted that the current cash position is expected to support operations well into 2026, allowing for continued advancement of drug development and clinic acquisitions [23][24] Q&A Session Summary Question: Why is the pathway for accelerated approval for NRx101? - Management explained that while the primary endpoint was not superior to an established antidepressant, the focus is on patients with unmet medical needs, allowing for a request for accelerated approval [30][31] Question: What is the expected impact of the citizen petition on benzathonium chloride? - Management indicated that the FDA is required to respond within six months and that the removal of the preservative could significantly enhance NRx's market share in the generic ketamine market [54][58] Question: What is the commercial strategy for NRx100 and NRx101? - The company plans to launch with a small, focused commercial team, leveraging existing mental health facilities and targeting high-prescribing psychiatrists for effective market coverage [68][70]

[Securities Purchase Agreement](index=1&type=section&id=Securities%20Purchase%20Agreement) This agreement details the terms for NRx Pharmaceuticals, Inc. to sell 3,959,999 Common Stock shares to an investor [Introduction and Transaction Overview](index=1&type=section&id=Introduction%20and%20Transaction%20Overview) This section introduces the August 18, 2025 agreement between NRx Pharmaceuticals, Inc. and the investor for Common Stock Party Details | Party | Role | Details | | :--- | :--- | :--- | | **NRx Pharmaceuticals, Inc.** | The Company (Seller) | A Delaware corporation. | | **Investor** | Buyer | As listed on the Schedule of Buyers. | - The transaction involves the purchase and sale of **3,959,999 shares** of Common Stock[4](index=4&type=chunk) - The sale is conducted pursuant to the Company's effective shelf registration statement on Form S-3 (Registration Number 333-265492)[4](index=4&type=chunk) [1. Purchase and Sale of Common Shares](index=1&type=section&id=1.%20PURCHASE%20AND%20SALE%20OF%20COMMON%20SHARES) This section details transaction mechanics, covering share purchase, closing, pricing, payment, and delivery methods Transaction Mechanics | Item | Detail | | :--- | :--- | | **Closing Date** | 10:00 a.m. Los Angeles time, on the 1st Business Day after all conditions are met or waived. | | **Payment Method** | Wire transfer of immediately available funds. | | **Share Delivery** | Credited to the Buyer's DTC balance account via the FAST Program. | [2. Buyer's Representations and Warranties](index=2&type=section&id=2.%20BUYER'S%20REPRESENTATIONS%20AND%20WARRANTIES) The Buyer provides key representations on legal authority, accredited investor status, investment evaluation, and OFAC/KYC - Buyer confirms it is an "**accredited investor**" as defined in Rule 501(a) under the Securities Act[19](index=19&type=chunk) - Buyer represents that it has the knowledge and experience to evaluate the investment's merits and risks and can bear a complete loss of the investment[20](index=20&type=chunk) - Buyer warrants compliance with OFAC regulations, confirming funds are not derived from illegal activities and that it is not a prohibited person or entity[14](index=14&type=chunk)[15](index=15&type=chunk) - Buyer confirms it is not purchasing shares as a result of general solicitation or advertising[21](index=21&type=chunk) [3. Representations and Warranties of the Company](index=5&type=section&id=3.%20REPRESENTATIONS%20AND%20WARRANTIES%20OF%20THE%20COMPANY) The Company provides extensive representations covering corporate organization, transaction authorization, capitalization, securities validity, SEC compliance, and financial accuracy NRx Pharmaceuticals Capitalization (as of Aug 18, 2025) | Security | Authorized | Issued and Outstanding | Reserved for Issuance | | :--- | :--- | :--- | :--- | | **Common Stock** | 500,000,000 | 19,809,902 | 23,144,440 | | **Preferred Stock** | 50,000,000 | 0 | N/A | - The Company confirms the Registration Statement (Form S-3) is effective and available for the issuance of the Common Shares, and it has not received any stop-order notice from the SEC[31](index=31&type=chunk) - The Company represents that its SEC filings over the prior two years were timely and did not contain any untrue statements of a material fact or omit material facts[35](index=35&type=chunk) - The Company agrees to indemnify the Buyer and related parties against losses arising from breaches of the agreement or untrue statements in the registration documents[26](index=26&type=chunk) [4. Covenants](index=14&type=section&id=4.%20COVENANTS) This section outlines ongoing obligations: SEC filings, market listing, transaction disclosure, and a **19.99%** share issuance cap per Nasdaq rules - The Company must file a Current Report on Form 8-K to disclose the material terms of the transaction within the time required by the Exchange Act[55](index=55&type=chunk) - The Company covenants to maintain its listing on an Eligible Market (e.g., Nasdaq, NYSE) and not take any action that would reasonably lead to delisting[53](index=53&type=chunk) - The total number of shares issued to Buyers under the agreement is capped at **19.99%** of the Company's issued and outstanding Common Stock as of the agreement date, per Nasdaq Rule 5635(d)[53](index=53&type=chunk) - The Company will use the net proceeds from the sale for the purposes described in the Prospectus Supplement[59](index=59&type=chunk) [5. Transfer Agent Instructions](index=16&type=section&id=5.%20TRANSFER%20AGENT%20INSTRUCTIONS) The Company must issue irrevocable instructions to its Transfer Agent for prompt, unlegended delivery of Common Shares to Buyer's DTC account - The Company must issue "Irrevocable Transfer Agent Instructions" to credit the purchased shares to the Buyer's DTC account[62](index=62&type=chunk) - The Company warrants that the securities will be **freely transferable** and that certificates or instruments evidencing the shares will **not bear any restrictive legend**[62](index=62&type=chunk)[63](index=63&type=chunk) [6. Conditions to the Company's Obligation to Sell](index=17&type=section&id=6.%20CONDITIONS%20TO%20THE%20COMPANY'S%20OBLIGATION%20TO%20SELL) This section lists conditions for the Company's obligation to sell, including Buyer's document execution, purchase price, and accurate representations - The Buyer must have delivered the **full Purchase Price** via wire transfer[65](index=65&type=chunk) - The Buyer's representations and warranties must be **true and correct in all material respects** as of the Closing Date[66](index=66&type=chunk) [7. Conditions to Buyer's Obligation to Purchase](index=18&type=section&id=7.%20CONDITIONS%20TO%20BUYER'S%20OBLIGATION%20TO%20PURCHASE) This section outlines conditions for Buyer's obligation to purchase, including Company document execution, share delivery, legal opinion, and accurate representations - The Company must have delivered the Common Shares to the Buyer[68](index=68&type=chunk) - The Buyer must have received a **satisfactory legal opinion** from the Company's counsel, Disclosure Law Group[69](index=69&type=chunk) - The Company's representations and warranties must be **true and correct in all material respects** as of the Closing Date[72](index=72&type=chunk) - No law, rule, or injunction from a governmental entity shall prohibit the consummation of the transaction[73](index=73&type=chunk) [8. Governing Law; Miscellaneous](index=19&type=section&id=8.%20GOVERNING%20LAW%3B%20MISCELLANEOUS) This section covers standard legal clauses: Delaware governing law, notice procedures, survival of representations, severability, and entire agreement - The agreement shall be **governed by and construed in accordance with the laws of the State of Delaware**[75](index=75&type=chunk) - All representations, warranties, agreements, and covenants made in the agreement shall **survive the Closing**[85](index=85&type=chunk) - The agreement contains the **entire understanding** between the parties and can only be amended in writing signed by both the Company and the Buyer[79](index=79&type=chunk) [Signatures and Schedules](index=22&type=section&id=Signatures%20and%20Schedules) This section contains signature blocks for the Company and Buyer to execute the agreement, noting omitted schedules and exhibits - The agreement is executed by **Jonathan C. Javitt, MD, MPH, Chairman and CEO** of NRx Pharmaceuticals, Inc[90](index=90&type=chunk) - A signature block is provided for the Buyer to execute the agreement[92](index=92&type=chunk) - The document indicates that all schedules and exhibits have been omitted[94](index=94&type=chunk)

Core Insights - NRx Pharmaceuticals has received an expanded Fast Track Designation from the FDA for NRX-100, allowing it to address an unmet medical need for treating suicidal depression in over 13 million Americans annually, significantly increasing its market potential [4][11][7] - The company is advancing its drug development pipeline, including NRX-100 and NRX-101, with various regulatory filings and applications aimed at accelerating approval processes [8][15][28] - HOPE Therapeutics, a subsidiary of NRx, is establishing a network of interventional psychiatry clinics to provide comprehensive care for mental health conditions, aiming to address a significant public health crisis [20][18][19] Drug Development and Regulatory Activities - NRX-100 is being developed through two paths: a generic approval via an Abbreviated New Drug Application (ANDA) and an innovative drug path via a New Drug Application (NDA) [8][28] - The ANDA market for ketamine is estimated at $750 million, with expectations to enter this market in early 2026 [8] - NRX-101 has received Breakthrough Therapy Designation and is being prepared for a New Drug Application, with over 80,000 pages of supporting material submitted [15][16] Financial Overview - For Q2 2025, the company reported a net loss of $17.6 million, compared to a net loss of $7.9 million in Q2 2024, primarily due to non-cash fair value accounting measurements [24] - The company had approximately $2.9 million in cash and cash equivalents as of June 30, 2025, which is expected to support operations into 2026 [25] HOPE Therapeutics and Market Strategy - HOPE Therapeutics aims to create a national network of clinics to provide integrated care for patients with suicidal depression and related conditions, addressing fragmented mental health treatment [20][18] - The company is negotiating to acquire additional facilities, targeting $100 million in total forward pro-forma revenue by the end of 2025 [23] Toxicology and Safety Considerations - A Citizen's Petition has been filed to remove Benzethonium Chloride from intravenous ketamine products, citing safety concerns and lack of GRAS status [9][10] - The proprietary formulation of NRX-100 is preservative-free, which is expected to be well-received by both physicians and patients, potentially capturing a larger market share [10][9]

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]