Core Viewpoint - NRx Pharmaceuticals, Inc. (NRXP) has experienced a recent decline in share price, but the formation of a hammer chart pattern suggests a potential trend reversal due to increased buying interest and bullish sentiment among analysts [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottoming out, with reduced selling pressure and a shift in control from bears to bulls [2][5]. - This pattern is characterized by a small candle body with a long lower wick, signifying that despite a downtrend, buying interest has emerged to push the stock price up towards the opening price [4][5]. Fundamental Analysis - There has been a significant upward trend in earnings estimate revisions for NRXP, with a 25% increase in the consensus EPS estimate over the last 30 days, indicating improved earnings expectations from analysts [7][8]. - The strong agreement among Wall Street analysts regarding the company's earnings prospects enhances the bullish case for NRXP [2][7]. Zacks Rank - NRXP currently holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [9]. - A Zacks Rank of 2 serves as a strong indicator of a potential trend reversal, suggesting that the company's prospects are improving [9].

Neurospa currently operates six interventional psychiatry clinics on Florida's Gulf Coast HOPE to acquire majority interest in Neurospa for a combination of cash and equity Neurospa clinics deliver a full range of interventional psychiatry services, including Ketamine, Spravato® and Transcranial Magnetic Stimulation (TMS) to patients with severe depression and related conditions Acquisition to be accretive to HOPE revenue projections for 2025 MIAMI, March 24, 2025 /PRNewswire/ -- HOPE Therapeutics, Inc., ( ...

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 ...

Financial Data and Key Metrics Changes - For the year ended December 31, 2024, NRx Pharmaceuticals reduced its loss from operations by approximately $9.3 million or 33.5% to $18.5 million from $27.8 million for the year ended December 31, 2023 [30] - Research and development expense decreased by approximately $7.2 million or 53.6% to $6.2 million compared to $13.4 million for the year ended December 31, 2023 [30] - General administrative expense for the year ended December 31, 2024, decreased by approximately $7.7 million to $13.5 million compared to $14.2 million for the year ended December 31, 2023 [31] Business Line Data and Key Metrics Changes - NRx is advancing its drug development pipeline with the NDA filing for NRX100, a preservative-free intravenous ketamine, and anticipates an accelerated NDA filing for NRX101, a fixed-dose combination of desexeserin and lurasidone [7][19] - The company has proven manufacturing capacity to supply more than 1,000,000 doses of NRX100 per month upon FDA approval [7] - Hope Therapeutics is focused on delivering clinical care and has signed non-binding letters of intent to acquire three profitable interventional psychiatry clinics [9][10] Market Data and Key Metrics Changes - The market for intranasal esketamine is approximately $1 billion, with NRX100 expected to expand access to ketamine treatments for a broader patient population [18] - The estimated market for NRX101, targeting bipolar depression, is over $2 billion, with the broader bipolar market potentially exceeding $5 billion [24] Company Strategy and Development Direction - NRx aims to transition from a research-focused company to a healthcare provider capable of generating revenue and achieving profitability by the end of 2025 [5][6] - The company plans to build a national network of interventional psychiatry centers through Hope Therapeutics, combining various treatment modalities [25][27] - NRx is focused on addressing the unmet needs in the treatment of suicidality, depression, and PTSD, leveraging new drug applications and clinic acquisitions [10][11] Management's Comments on Operating Environment and Future Outlook - Management highlighted the increased commitment from the U.S. government to treat mental health conditions, which aligns with NRx's mission [6] - The company is optimistic about its path to profitability, supported by reduced operating expenses and anticipated revenue from Hope Therapeutics [28] - Management expressed confidence in the potential for significant market opportunities with the upcoming drug approvals and clinic acquisitions [28][66] Other Important Information - NRx has raised nearly $20 million in financing and is exploring additional funding options for Hope Therapeutics [28] - The company is filing a citizen's petition with the FDA to remove ketamine preparations containing benzatholium chloride from the market until safety can be demonstrated for repeated use [15] Q&A Session Summary Question: How does removing the preservative from ketamine change the formulation? - Management explained that the preservative was originally included for multi-use vials, but with single-use vials, it is unnecessary [35][36] Question: Can you discuss the acquisition strategy for clinics? - Management indicated that Florida is a focus area, with plans to acquire clinics that effectively combine ketamine treatment with other therapies [41][42] Question: What is the status of the potential ketamine deal? - Management confirmed interest from commercial partners and expressed hope for a deal announcement in the near future [46][56] Question: How will the ANDA and NDA submissions be handled at the FDA? - Management clarified that the NDA is for adding depression indications to the ketamine label, while the ANDA is for a preservative-free version of the existing drug [52][53] Question: What are the expected revenues from the clinics being acquired? - Management confirmed that the clinics targeted for acquisition are expected to have run rates of about $5 million or larger [59]

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]