Financial Performance - NRx Pharmaceuticals reported a reduction in operational loss by approximately $2.0 million to $2.4 million for Q4 2024, a nearly 45% improvement compared to Q4 2023[23]. - For the year ended December 31, 2024, the company reduced its loss from operations by approximately $9.3 million, or 33.5%, to $18.5 million from $27.8 million in 2023[24]. - NRx Pharmaceuticals has completed financing agreements totaling $10.9 million in 2024 and $8.5 million in January 2025 to support ongoing operations and clinic expansions[20][25]. - Management forecasts potential profitability on a forward-looking run-rate basis by year-end 2025, although no assurances can be given[3]. Research and Development - Research and development expenses decreased by approximately $1.5 million to $1.0 million in Q4 2024, down from $2.5 million in Q4 2023, primarily due to the conclusion of the phase 2b/3 study for NRX-101[23]. - NRx has initiated a New Drug Application filing for NRX-100 (IV ketamine) for the treatment of suicidal depression[30]. - NRx was awarded Fast Track Designation by the US FDA for the development of ketamine (NRX-100) to treat patients with acute suicidality[30]. Product Development and Licensing - The anticipated PDUFA date for the NDA filing of NRX-100 is prior to December 31, 2025, targeting the $3 billion Suicidal Depression market in the US[6][7]. - The company has accepted non-binding terms for licensing NRX-100, which includes over $300 million in potential milestones plus tiered double-digit royalties based on net sales[3][7]. - NRx Pharmaceuticals plans to file an ANDA for preservative-free ketamine in Q2 2025, aiming to address all currently indicated human and veterinary applications[9]. Strategic Growth and Acquisitions - The company aims to acquire 15-20 psychiatry clinics in Florida by year-end 2025, with each clinic currently generating approximately $5 million in revenue[19][18]. - The company is negotiating terms with a strategic investor for capital to support further HOPE clinic acquisitions, enhancing its interventional psychiatry services[3][21]. - HOPE Therapeutics aims to develop a network of interventional psychiatry clinics offering ketamine TMS and other therapies for suicidal depression[31]. - HOPE Therapeutics is focused on acquiring providers for its national network and raising adequate capital for these acquisitions[32]. - The company intends to spin-off HOPE Therapeutics as part of its growth strategy[32]. Risks and Forward-Looking Statements - The company acknowledges risks and uncertainties that may affect future financial performance and operational results[32]. - Investors are encouraged to review the company's most recent Annual Report on Form 10-K for detailed risk factors[32]. - The company does not assume any obligation to update forward-looking statements unless required by law[32]. Management - Matthew Duffy serves as Chief Business Officer of NRx Pharmaceuticals and Co-Chief Executive Officer of HOPE Therapeutics[33].

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Q4 2024 Earnings Conference Call March 17, 2025 8:30 AM ET Company Participants Matthew Duffy - Chief Business Officer Jonathan Javitt - Founder, Chairman and Chief Scientist Michael Abrams - Chief Financial Officer Conference Call Participants Jason Kolbert - D. Boral Capital Thomas Shrader - BTIG Vernon Bernardino - H.C. Wainwright Ed Woo - Ascendiant Capital Operator Good morning, ladies and gentlemen, and welcome to the NRx Pharmaceuticals 4Q and Full Year 2024 Ea ...

NRx Pharmaceuticals (NRXP) Q4 2024 Earnings Call March 17, 2025 08:30 AM ET Company Participants Matthew Duffy - Chief Business Officer & Co-CEO of Hope TherapeuticsJonathan Javitt - Founder, Chairman, and CEOMichael Abrams - CFOJason Kolbert - Managing DirectorVernon Bernardino - Managing Director Conference Call Participants Thomas Shrader - Equity Research AnalystEdward Woo - Director of Research & Senior Analyst Operator Good morning, ladies and gentlemen, and welcome to the NRx Pharmaceuticals 4Q and F ...

Core Insights - NRx Pharmaceuticals has made significant advancements in its drug development and business strategy, including the filing of a New Drug Application (NDA) for NRX-100, aimed at treating Suicidal Depression, and progress towards NDA for NRX-101 for bipolar depression [1][4][28] - The company has successfully reduced operational losses and improved financial metrics, indicating a positive trend in cost management and operational efficiency [22][23] Financial Results - For Q4 2024, the company reduced its loss from operations by approximately $2.0 million to $2.4 million, a nearly 45% improvement compared to Q4 2023, primarily due to lower research and development costs [22] - For the full year 2024, the loss from operations decreased by approximately $9.3 million, or 33.5%, to $18.5 million, driven by a significant reduction in research and development expenses [23] - As of December 31, 2024, the company had approximately $1.4 million in cash and cash equivalents, with additional financing completed in January 2025 totaling approximately $8.5 million [24][19] Research and Development Activities - The company has initiated the NDA filing for NRX-100, a preservative-free IV ketamine formulation for Suicidal Depression, with an anticipated PDUFA date prior to December 31, 2025 [3][4] - NRX-101 is also moving towards NDA submission for Accelerated Approval, targeting bipolar depression in patients at risk of akathisia, with a similar PDUFA timeline [11][12] - The company is developing a novel pH neutral formulation of ketamine (HTX-100) for both intravenous and subcutaneous administration, expected to undergo clinical testing in 2025/2026 [8] Strategic Initiatives - NRx Pharmaceuticals is negotiating potential licensing agreements for NRX-100 that could yield over $300 million in milestones and tiered royalties [5][4] - The company is actively pursuing acquisitions to expand its HOPE Therapeutics network, aiming to establish a national network of interventional psychiatry clinics [15][17] - A leading regulatory law firm has been retained to file a citizen's petition to remove toxic preservatives from ketamine formulations, aligning with evolving federal policies [9][6] Market Potential - The market for Suicidal Depression in the US is estimated to exceed $3 billion, while the bipolar depression market could exceed $5 billion [5][12] - The company believes that the preservative-free feature of NRX-100 will be beneficial to patients and is consistent with federal policy changes regarding toxic substances in drug formulations [7][9]

Financing and Capital Structure - NRx Pharmaceuticals closed $10.87 million in debt capital financing in 2024 and an additional $8.5 million in January 2025, totaling $16.3 million from institutional investors[472]. - The Company secured $8.5 million in new financing subsequent to December 31, 2024, to support working capital requirements through the end of fiscal year 2025[498]. - The Company entered into a securities purchase agreement on January 27, 2025, for the sale of 1,215,278 shares at a purchase price of $2.88 per share, generating gross proceeds of approximately $3.5 million[499][500]. - The Company executed an agreement on August 12, 2024, to sell and issue $16.3 million of Notes and Warrants, with proceeds used to settle outstanding amounts owed and for working capital needs[532]. - The Company completed the February 2024 Public Offering with gross proceeds of approximately $1.7 million, selling shares at a public offering price of $3.00 each, while underwriters purchased at $2.76 per share[537]. - The February 2024 Private Placement raised approximately $1.0 million by issuing 270,000 shares at a price of $3.80 per share, representing a 26.7% premium to the public offering price[539]. - Financing activities provided $7.485 million in cash during 2024, primarily from the issuance of common stock and warrants, offset by $7.9 million in repayments of convertible notes[545]. Research and Development - The company initiated a New Drug Application (NDA) for NRX-101 in Q4 2024, with an anticipated FDA decision date by June 30, 2025[474]. - NRX-101 received Qualified Infectious Disease Product designation and Fast Track designation for treating Complicated Urinary Tract Infection[479]. - The company is developing HTX-100, a novel pH neutral formulation of ketamine, expected to begin clinical testing by 2026[477]. - For the year ended December 31, 2024, the company recorded $6.2 million in research and development expenses, a decrease of $7.2 million from $13.4 million in 2023, primarily due to the conclusion of the phase 2 study related to NRX-101[519]. - The Company has a contractual obligation to pay milestone payments of $0.3 million upon completion of phase 3 trials for NRX-101, along with ongoing royalties of 1% to 2.5% of gross sales[548]. Financial Performance - For the years ended December 31, 2024 and 2023, NRx Pharmaceuticals reported net losses of $25.1 million and $30.2 million, respectively[506]. - The company reported a net loss of $25.1 million for the year ended December 31, 2024, an improvement of $5.0 million from a net loss of $30.2 million in 2023[518]. - The net cash used in operating activities for the year ended December 31, 2024, was approximately $10.6 million, resulting from a net loss of $25.1 million[542]. - The Company reported a net cash decrease of $3.152 million for the year ended December 31, 2024, compared to a decrease of $15.459 million in 2023[542]. - The Company has generated no revenues and expects to continue incurring significant operating losses, relying on equity and/or debt financing to continue operations[527]. - The Company has no revenues and has suffered operating losses since inception, raising substantial doubt about its ability to continue as a going concern[569]. Assets and Liabilities - As of December 31, 2024, NRx Pharmaceuticals had an accumulated deficit of $278.3 million and a stockholders' deficit of $23.5 million[506]. - As of December 31, 2024, the Company reported total assets of $3.651 million, a decrease from $7.315 million in 2023, and total liabilities increased to $26.874 million from $19.048 million[542]. - The Company incurred a working capital deficit of $18.8 million as of December 31, 2024[506]. - The Company reported a working capital deficit as of December 31, 2024[569]. Compliance and Regulatory Matters - The Nasdaq Stock Market notified the Company on July 20, 2023, regarding non-compliance with the minimum market value of listed securities requirement of $50 million[510]. - The company received a written notification from Nasdaq on August 6, 2024, indicating non-compliance with the minimum market value of listed securities requirement of $35 million for 33 consecutive business days[512]. - The Company transferred its listing from the Nasdaq Global Market to the Nasdaq Capital Market on January 19, 2024, after receiving an exception to the Nasdaq Listing Rules[511]. Strategic Initiatives - A non-binding offer was accepted for licensing NRX-100, which includes potential milestones of $325 million and royalties ranging from 11% to 16% of sales[474]. - NRx is negotiating to acquire three precision psychiatry centers and six additional centers to expand its HOPE network[477]. - The company anticipates expanding its treatment offerings to include PTSD by year-end 2025, contingent on successful acquisitions[477]. - NRx engaged BTIG to identify additional clinic candidates to meet projected revenue targets by the end of 2025[477]. - The Company is negotiating with a publicly-traded entity for acquisition capital to support the expansion of HOPE, aiming to finance less than 50% of the proposed acquisition costs[504]. Operational Expenses - General and administrative expenses for the year ended December 31, 2024, were $13.5 million, down from $14.2 million in 2023, reflecting a decrease of $0.7 million[520]. - The total operating expenses for the year ended December 31, 2024, were $18.5 million, a reduction of $9.3 million compared to $27.8 million in 2023[518]. Other Financial Matters - The Company recorded a default penalty of $0.8 million for the year ended December 31, 2024, due to alleged default in connection with the Streeterville convertible note[523]. - The fair value of the convertible note was estimated using a Monte Carlo simulation model, which is complex and subjective[575][576]. - The valuation of the convertible note as of December 31, 2024, was identified as a critical audit matter[576]. - Management's estimate of the fair value of the convertible note was agreed upon after independent testing of data and assumptions[577].

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 been designated as an investigational Breakthrough Therapy by the FDA for suicidal treatment-resistant bipolar depression and chronic pain [3] - NRx Pharmaceuticals plans to file a New Drug Application (NDA) for Accelerated Approval for NRX-101 targeting patients with bipolar depression and suicidality or akathisia [3] Recent Developments - NRx has initiated a New Drug Application filing for NRX-100 (IV ketamine) aimed at treating suicidal depression, based on results from well-controlled clinical trials and new data from French health authorities [4] - The company has received Fast Track Designation from the US FDA for the development of ketamine (NRX-100) to treat patients with acute suicidality [4] Upcoming Events - NRx Pharmaceuticals will release its fourth quarter and full year 2024 financial results on March 17, 2025, before the market opens [1] - A conference call will be held at 8:30am ET on the same day to discuss the financial results and provide a corporate update [1][2]

Core Viewpoint - NRx Pharmaceuticals is expected to report a loss per share of 20 cents for the fourth quarter of 2024, with no revenues anticipated due to the absence of marketed products [1][2]. Financial Performance - The Zacks Consensus Estimate for NRx Pharmaceuticals' 2024 loss per share has remained constant at $1.75, while the 2025 forecast is at 8 cents [2]. - NRx Pharmaceuticals has shown encouraging performance over the last three quarters, with an average earnings surprise of 39.15%, including a notable 81.48% surprise in the last reported quarter [3][4]. Earnings Expectations - The company currently has an Earnings ESP of -0.20% and a Zacks Rank of 3 (Hold), indicating that the odds of an earnings beat are not favorable this time [5]. - The upcoming earnings call is expected to provide updates on the clinical-stage pipeline programs, particularly focusing on novel candidates for central nervous system disorders [6][10]. Drug Development Pipeline - NRx Pharmaceuticals is developing two lead drug candidates: NRX-101 for suicidal bipolar depression, chronic pain, and PTSD, and NRX-100 (IV ketamine) for suicidal depression [8]. - The company submitted an initial section of the NDA for NRX-100 to the FDA in December 2024, with the final efficacy data expected in the first quarter of 2025 [9]. Market Performance - NRx Pharmaceuticals' stock has increased by 86.1% over the past three months, outperforming the industry and the S&P 500, which saw a decline of 5.4% [11][12]. Competitive Landscape - The company faces competition in the market for treatments for schizophrenia and bipolar disorders, with notable products like J&J's Spravato and Alkermes' Lybalvi already approved [16][17].

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 received FDA designation as an investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain [4] - NRx Pharmaceuticals has initiated a New Drug Application filing for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on clinical trial results and data from French health authorities [5] HOPE Therapeutics - HOPE Therapeutics, Inc. is a wholly-owned subsidiary of NRx Pharmaceuticals, aiming to create a network of interventional psychiatry clinics offering ketamine transcranial magnetic stimulation (TMS) and other therapies for suicidal depression [6] - The company plans to integrate a digital therapeutic-enabled platform to enhance the clinical benefits of NMDA-targeted drug therapy [6] Upcoming Events - NRx Pharmaceuticals will present a company update at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 12, 2025, from 9:20 to 9:50 AM EST [2] - Management will also be available for one-on-one meetings in New York from February 10th to 12th, 2025, during the BIO CEO & Investor Conference [3]

Core Insights - HOPE Therapeutics, Inc. has engaged BTIG for advisory services to evaluate strategic and financing options, including potential acquisitions for its network of clinics [1][2][3] - The company has secured $27 million in funding for clinic acquisitions and plans to leverage this investment with bank debt for the rollup of Interventional Psychiatry Clinics [2][5] - The partnership with BTIG aims to accelerate the establishment of a global network of Interventional Psychiatry Clinics to address mental health issues [3][5] Company Overview - HOPE Therapeutics, Inc. is focused on developing a network of interventional psychiatry clinics that will offer treatments such as ketamine therapy and transcranial magnetic stimulation for patients with severe depression and PTSD [5][6] - NRx Pharmaceuticals, the parent company, is a clinical-stage biopharmaceutical firm developing therapeutics for central nervous system disorders, including suicidal bipolar depression and chronic pain [7][8] - NRx is advancing its investigational drug NRX-101, which has received FDA Breakthrough Therapy designation for treating suicidal treatment-resistant bipolar depression [7][8] Financial and Strategic Developments - The engagement with BTIG includes identifying and evaluating potential clinical partners and financing initiatives to support the company's growth strategy [2][5] - The first tranche of the $27 million funding is expected to close soon, enabling the company to initiate its acquisition strategy [2][9] - BTIG's expertise in investment banking and related services is seen as crucial for HOPE's goal of becoming a leading provider of mental health care [3][4]

Core Viewpoint - HOPE Therapeutics, Inc. has signed a Stock Purchase Agreement with Smith & Sauer, LLC for a $27 million financing aimed at acquiring HOPE clinics to address severe mental health issues such as suicidal depression and PTSD [1][2][3] Financing Details - The agreement includes an immediate funding of $2 million in NRx common stock and a commitment for an additional $25 million in Series A Preferred Stock, with the first tranche of $6.75 million due by February 7, 2025, and the full amount by April 1, 2025 [1][5] - The investment is expected to be leveraged with bank debt to initiate a nationwide rollup of Interventional Psychiatry Clinics, targeting projected revenues of approximately $100 million by the end of 2025 [2][3] Strategic Goals - HOPE aims to create a nationwide chain of clinics that combine ketamine treatment, Transcranial Magnetic Stimulation (TMS), and FDA-approved Digital Therapeutics to provide comprehensive care for patients with life-threatening mental health conditions [2][3][8] - The company has initiated a financial advisory relationship with a leading investment bank to raise an additional $400 million for expanding its national and international presence [3] Market Focus - The partnership with Smith & Sauer emphasizes addressing mental health challenges, particularly within military and veteran communities, highlighting the importance of innovative and accessible mental health solutions [4][7] - HOPE Therapeutics is positioned to serve the 16 million Americans who contemplate suicide annually and the 45 million who suffer from depression and PTSD [3][4] Company Background - HOPE Therapeutics is a development stage healthcare delivery company focused on establishing a network of interventional psychiatry clinics [8] - NRx Pharmaceuticals, the parent company, is a clinical-stage biopharmaceutical firm developing therapeutics for central nervous system disorders, including suicidal bipolar depression and PTSD [9][10]