WILMINGTON, Del., June 12, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", "NRx" or the "Company"), a clinical-stage biopharmaceutical company, and HOPE Therapeutics, Inc., ("HOPE," or the "Company"), a multi-site clinical care delivery organization and wholly-owned subsidiary of NRx, today announced participation in the H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference, scheduled for June 16–17, 2025. HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceut ...

In April 2025, the FDA granted a waiver of the $4.3 million NDA fee under the PDUFA, recognizing both the product's public health value and NRx's qualification under small business provisions. NRX-100 was previously granted Fast Track Designation in a protocol with NRX-101. With regulatory filings underway, patent protection sought through 2045, and a growing body of clinical and technical validation, NRx believes NRX- 100 is well-positioned to become a next-generation standard in both the emerging mental h ...

Financial Performance - For Q1 2025, NRx Pharmaceuticals reported a net loss of $5.5 million, an improvement from a net loss of $6.5 million in Q1 2024, with a loss from operations of $3.8 million compared to $6.0 million in the prior year[21]. - NRx Pharmaceuticals raised $8.9 million in gross proceeds in January 2025 through a convertible debt offering and a registered direct equity offering, strengthening its balance sheet[18]. - Subsequent to Q1, the company signed financing agreements for $10.3 million in acquisition capital that is non-dilutive to shareholders[19]. - As of March 31, 2025, NRx Pharmaceuticals had approximately $5.5 million in cash and cash equivalents, with expectations to support operations through at least the end of 2025[21][22]. Drug Development and Regulatory Plans - The company plans to submit a New Drug Application (NDA) for NRX-100 (preservative-free IV ketamine) in Q2 2025, with an expected PDUFA date in 2025, and has received a $4.3 million NDA submission fee waiver from the FDA[4][8]. - NRX-101 is on track for NDA submission under Accelerated Approval, with anticipated PDUFA date in 2025, supported by strong clinical data and manufacturing stability[13]. - The company has developed a novel formulation, HTX-100, which is expected to undergo clinical testing in 2025/2026 and aims for FDA approval in late 2026[11]. Market Opportunities - NRX-100 targets the over $3 billion market for suicidal depression in the US, while NRX-101 addresses a market estimated at over $2 billion for bipolar depression[12][14]. Strategic Acquisitions - HOPE Therapeutics is acquiring Kadima Neuroscience Institute, Dura Medical, and Neurospa TMS Holdings, expected to generate approximately $15 million in forward-looking pro forma revenues[16]. - The company is negotiating additional clinic acquisitions that could represent ~$20 million in potential pro forma revenue, aiming for a total of $100 million in forward-looking revenue by year-end 2025[17].

NRx Pharmaceuticals (NRXP) Q1 2025 Earnings Call May 15, 2025 04:30 PM ET Company Participants Matthew Duffy - Chief Business Officer & Co-CEO of Hope TherapeuticsJonathan Javitt - Founder, Chairman, Chief Scientist & Co-CEO of Hope TherapeuticsMichael Abrams - CFO Conference Call Participants Thomas Shrader - MD & Healthcare AnalystEdward Woo - Director of Research & Senior Analyst Operator Good afternoon, ladies and gentlemen, and welcome to the NRx Pharmaceuticals First Quarter twenty twenty five Earning ...

NRx Pharmaceuticals (NRXP) Q1 2025 Earnings Call May 15, 2025 04:30 PM ET Speaker0 Good afternoon, ladies and gentlemen, and welcome to the NRx Pharmaceuticals First Quarter twenty twenty five Earnings Call. At this time, all lines are in a listen only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call, you require immediate assistance, please press 0 for the operator. This call is being recorded on Thursday, 05/15/2025. I would now like to turn ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended: March 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38302 NRX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (I.R.S. Em ...

Company has continued to advance its previously announced plan to obtain FDA approval for two new drugs and to develop a network of clinics focused on neuroplastic therapies to treat severe and suicidal depression, PTSD, and related conditions. Clinic acquisition financing is at the HOPE Therapeutics level and non-dilutive to NRXP shareholders In January 2025 completed the third tranche of a convertible note offering and registered direct equity offering to an institutional investor on favorable terms to t ...

Term sheet with Universal Capital, LLC to fund HOPE Therapeutics clinic acquisition strategy Funding tied to already-announced acquisitions, with additional tranches contemplated for further growth, subject to standard due diligence Together with previously announced term sheet with a strategic investor, HOPE funding of $10.3 million is planned in the near term  MIAMI, May 15, 2025 /PRNewswire/ -- HOPE Therapeutics™, Inc. ("HOPE"), a multi-site clinical care delivery organization and wholly-owned subsidiar ...

Kadima Neuropsychiatry Institute in La Jolla, CA expected to serve as clinical model for Hope treatment offerings nationwide Kadima is a leading investigative site for CNS and psychedelic research, having served as the lead site in nearly all major trials in this space Dr. David Feifel, a nationally recognized pioneer in interventional psychiatry to join HOPE as Chief Medical Innovation Officer upon closing Acquisition expected to be accretive to revenue and EBITDA for NRx and HOPE MIAMI, May 13, 2025 /PR ...

MIAMI, May 6, 2025 /PRNewswire/ -- HOPE Therapeutics™, Inc. ("HOPE"), a medical and technology-driven company and wholly-owned subsidiary of NRx Pharmaceuticals, Inc. ("NRx" or the "Company") (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, today announced that it will host an investor event at the Mar-A-Lago Club in Palm Beach, Florida, on Thursday, May 8, 2025, at the invitation of club members. HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.) This discussion is being held to ...