NRX Pharmaceuticals, Inc. - NRXP STOCK NEWS

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) has announced the completion of twelve months of stability on the first manufactured commercial scale lot of NRX-100 (Ketamine). This milestone supports the submission of an FDA New Drug Application for the use of intravenous ketamine to treat Suicidal Depression. NRX-100 is the first preservative-free formulation of Ketamine, potentially avoiding toxic side effects of preservatives used in current preparations designed for single dose anesthetic use.

Key points:

• No degradation of the active ingredient was observed during the stability testing
• Projected room temperature shelf stability in excess of three years
• Filing of the NDA for NRX-100 is on track for 2024
• NRX-100 could benefit the 3.8 million people who make a plan to commit suicide in the United States each year

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, was featured in an article on Psychiatrist.com, the home of the Journal of Clinical Psychiatry. The article, titled 'How NRx Could Upend the Fight Against Depression and Suicide,' highlights the company's pipeline products NRX-100 and NRX-101.

NRX-101 is a twice-daily oral combination of D-cycloserine and lurasidone designed to treat suicidal treatment-resistant bipolar depression. Research indicates it may be more effective than lurasidone alone in reducing akathisia and suicidality. NRX-100, a proprietary preservative-free formulation of IV ketamine, is being studied as a treatment for acute suicidal crises in depression.

NRx Pharmaceuticals (Nasdaq: NRXP) and its subsidiary HOPE Therapeutics have announced their participation in the H.C. Wainwright 26th Annual Global Investment Conference, scheduled for September 9-11, 2024. The event will be held at the Lotte New York Palace Hotel and will also offer virtual participation options. Dr. Jonathan Javitt, Chairman and Chief Scientist of NRx and Co-CEO of Hope, will present an overview of the company's business during the conference.

Institutional investors can register for the conference through the provided link. The presentation will be available on-demand starting September 9 at 7:00 A.M. (ET) and can also be accessed through the company's investor relations website.

HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals (Nasdaq: NRXP), has announced potential acquisition and financing agreements for $30 million in currently-operating interventional psychiatry clinics. Key points include:

1. A $30 million Term Sheet from a qualified lender for non-dilutive financing, expected to close within 60 days.
2. A non-binding Term Sheet with initial clinic partners generating over $10 million in annual revenue.
3. Projected annualized revenues of $100 million through continued acquisitions by mid-2025.
4. Focus on treating suicidal depression, treatment-resistant depression (TRD), and PTSD using ketamine therapy, TMS, and digital therapeutics.
5. Planned operations in the United States, France, and the United Kingdom.

NRx Pharmaceuticals (NASDAQ:NRXP) reported Q2 2024 financial results and provided a business update. Key highlights include:

1. Secured $10.8-$16.3 million in convertible-debt funding to support FDA New Drug Applications for NRX-100 (ketamine) and NRX-101.

2. Plans to file NDAs for NRX-100 in suicidal depression and NRX-101 for Accelerated Approval in bipolar depression with akathisia or suicidality.

3. Reduced net loss to $7.9 million in Q2 2024, down from $8.7 million in Q2 2023.

4. Decreased R&D expenses to $2.8 million in Q2 2024 from $3.9 million in Q2 2023.

5. HOPE Therapeutics subsidiary focused on ketamine clinics planned for spinout.

NRx Pharmaceuticals, Inc. (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has announced that it will release its second quarter and year to date 2024 financial results on August 14, 2024, after market close. The results will be available via press release on the company's investor relations website.

Following the release, NRx Pharmaceuticals will host a conference call at 4:30 PM ET on the same day to discuss the financial results and provide a corporate update. Investors can access the call through a live webcast on the company's website or by dialing in using the provided domestic and international phone numbers.

NRx Pharmaceuticals (NASDAQ: NRXP) has secured up to $16 million in convertible debt financing from an institutional investor, Anson Funds. The proceeds will support the 2024 filings for New Drug Applications of NRX-100 (ketamine) and NRX-101, and also aid in launching HOPE Therapeutics. Additionally, a settlement has been reached with Streeterville Capital, who will receive payments from this financing and release all claims.

This financing will come at a significantly lower interest rate and cost of capital compared to previous debts.

NRx Pharmaceuticals (Nasdaq: NRXP) has announced alignment with the FDA on the initial Pediatric Study Plan (iPSP) for NRX-100 (ketamine) in treating suicidal depression. This alignment is important for the upcoming New Drug Application (NDA) filing, scheduled for Q4 2024. Key points include:

1. FDA recognizes the importance of addressing suicidal depression in adolescents aged 9-17.
2. NRx commits to conducting a clinical trial for NRX-100 in this age group post-adult approval.
3. The company remains on track for NDA filing in Q4 2024, with an anticipated PDUFA date in Q2 2025.
4. Additional neurotoxicity studies in juvenile animals will support safety assessments.

The FDA's feedback highlights the growing crisis of youth suicide in the US, with 10% of high school students attempting suicide in the past year.

NRx Pharmaceuticals (Nasdaq: NRXP) announced a significant legal victory as a Utah arbitrator denied Streeterville Capital's petition to block the planned spinoff of HOPE Therapeutics. This decision allows NRx to proceed with its intention to distribute 49% of HOPE Therapeutics shares to current NRx shareholders, subject to regulatory compliance. The arbitrator also rejected Streeterville's attempt to prevent NRx from selling additional shares for operational funding.

HOPE Therapeutics, a wholly-owned subsidiary of NRx, is developing a network of clinics offering ketamine and other therapies for suicidal depression. The spinoff aims to create value for shareholders and potentially list HOPE Therapeutics on a national securities exchange. Prof. Jonathan Javitt, NRx's Founder and Chairman, expressed gratitude for shareholder support as the company moves forward with its plans.