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]

Core Viewpoint - NRx Pharmaceuticals has entered into a binding agreement for a registered direct offering of common stock and senior secured convertible promissory notes, aiming to raise a total of $8.9 million to support its drug development and operational funding [1][7]. Financing Details - The registered direct offering is expected to generate gross proceeds of $3.5 million, with approximately 1.2 million shares being issued at $2.88 per share [1][3]. - The company plans to issue senior secured convertible promissory notes with expected gross proceeds of $5.4 million, which will have an original discount of 8% and an interest rate of 6% per annum [1][4]. Use of Proceeds - The net proceeds from the financing will be utilized for filing New Drug Applications for NRX-100 and NRX-101, launching HOPE Therapeutics, and potentially acquiring new products for the pipeline [1][2][7]. - The funding is anticipated to support operations into 2026, alongside projected product sales and potential non-dilutive funding [1][7]. Product Development - NRx Pharmaceuticals is developing NRX-100 (IV ketamine) and NRX-101, both aimed at treating suicidal depression and PTSD, with plans to file for FDA approval [9][10]. - NRX-101 has been designated as an investigational Breakthrough Therapy by the FDA for treatment-resistant bipolar depression and chronic pain [9]. Strategic Partnerships - The company has received support from Anson Funds, which has expressed confidence in NRx's mission and its potential to transform the lives of patients with suicidal depression [2].

Compliance with Nasdaq Listing Requirements - The company regained compliance with the Nasdaq Capital Market's minimum market value of listed securities (MVLS) requirement, which mandates a MVLS of at least $35 million for 10 consecutive trading days [1][2] - The company's MVLS was at least $35 million for 10 consecutive trading days, meeting the requirement on January 16, 2025 [2] - The Nasdaq Listing Qualifications Staff confirmed the matter is now closed [1][6] Company Overview and Pipeline - 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's lead product, NRX-101, is an FDA-designated Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain, with potential as a non-opioid treatment for chronic pain and complicated UTI [3] - NRx is preparing to file a New Drug Application (NDA) for Accelerated Approval of NRX-101 for bipolar depression and suicidality or akathisia [3] Recent Developments in Drug Development - NRx announced the initiation of filing a New Drug Application for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on clinical trial results from the US National Institutes of Health and data from French health authorities [4] - The US FDA granted Fast Track Designation for the development of ketamine (NRX-100) as part of a protocol to treat patients with acute suicidality [4] Contact Information - Matthew Duffy, Chief Business Officer of NRx Pharmaceuticals and Co-Chief Executive Officer of HOPE Therapeutics, is the contact for further information [8]

Core Insights - NRx Pharmaceuticals and its subsidiary HOPE Therapeutics have appointed Mr. Michael Taylor and Ms. Anita Nunes to their Board of Directors, enhancing their leadership team [1][2][4]. Group 1: Leadership Appointments - Mr. Michael Taylor has over 25 years of experience in global credit markets, focusing on special situations and capital formation, and has held significant positions at various financial institutions [2][3]. - Ms. Anita Nunes, CEO and Co-Founder of Smith & Sauer, LLC, has more than 20 years of experience in driving transformative growth and has led a recent $27 million investment in Hope Therapeutics and NRx Pharmaceuticals [4][6]. Group 2: Company Overview - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics for central nervous system disorders, including suicidal bipolar depression, chronic pain, and PTSD, with NRX-101 designated as a Breakthrough Therapy by the FDA [7]. - HOPE Therapeutics aims to establish a network of interventional psychiatry clinics offering innovative therapies, including ketamine and transcranial magnetic stimulation (TMS), to treat suicidal depression and related disorders [9][10].

Company Overview - HOPE Therapeutics Inc is a development stage healthcare delivery company focused on creating a network of interventional psychiatry clinics offering ketamine transcranial magnetic stimulation (TMS) and other therapies for suicidal depression and related disorders [1] - The company is developing a digital therapeutic-enabled platform to enhance the clinical benefits of NMDA-targeted drug therapy [1] - HOPE Therapeutics is a wholly-owned subsidiary of NRx Pharmaceuticals Inc [5] Key Developments - NRx Pharmaceuticals has initiated filing a New Drug Application for NRX-100 (IV ketamine) for treating suicidal depression based on clinical trial results from US National Institutes of Health and French health authorities data [2] - NRX-100 received Fast Track Designation from the US FDA for treating acute suicidality [2] - HOPE Therapeutics plans to acquire Kadima Neuropsychiatry Institute as its flagship clinic [3][5] - Dr David Feifel, founder of Kadima and a global leader in interventional psychiatry, is expected to join HOPE as Chief Medical Innovation Officer [3][6] Industry Insights - Ketamine treatment requires appropriate psychiatric supervision in controlled settings, as emphasized by Dr Feifel and supported by HOPE Therapeutics [7] - The recent death of Mathew Perry highlights the need for psychiatric centers of excellence providing ketamine and advanced treatments for depression [8] - Dr Feifel plans to bring his successful ketamine treatment methods from Kadima to the HOPE network [8] Parent Company Information - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing NMDA platform-based therapeutics for central nervous system disorders [9] - The company is developing NRX-101, an FDA-designated Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain [9] - NRx plans to file an NDA for Accelerated Approval of NRX-101 for bipolar depression with suicidality or akathisia [9] - NRX-101 has potential as a non-opioid treatment for chronic pain and complicated UTI [9]