NRx Pharmaceuticals (Nasdaq: NRXP)

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Trial Endpoint Reached for First Suicidal Bipolar Depression, Chronic Pain and PTSD Drug; Agreement with Partners Can Provide up to $329 Million and Royalties: NRx Pharmaceuticals (Nasdaq: NRXP)
For more information on $NRXP visit: https://www.nrxpharma.com/ and https://axecapitalusa.com/nrxp/

Developing Therapeutics for the Treatment of CNS Disorders, Specifically Suicidal Bipolar Depression, Chronic Pain and PTSD.
Reached Last Patient, Last Visit in Phase 2b/3 Trial of NRX-101 for Suicidal Treatment Resistant Bipolar Depression.  
Study Maintained 95% Concordance Rate Between Study Sites and Central Raters on Primary Endpoint. No Unexpected Serious Adverse Events Reported.
Positive Sata and FDA Comment Triggers next $4 Million Payment from Partners Alvogen and Lotus and their Assumption of Development Costs with up to $329 Million in Milestone Payments and a Royalty on Net Sales in the Mid-Teens.
Launch of HOPE Therapeutics, Inc. at the BIO CEO & Investor Conference 2024, Plus Planned Share Dividend to Existing NRXP Shareholders.
Completed Initial Manufacture of IV Infusion and Plans to File FDA New Drug Application for Acute Suicidality Upon Demonstration of 2-ear Shelf Stability.
Already Received $5 Million Milestone Payment from Partners Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd. (1975.TW)
NRXP Eligible for Additional $320 Million in Development & Sales Milestones, Plus Double-Digit Royalties Upon Approval and Commercialization of NRX-101.
Completing Enrollment for Phase 2b/3 Trial in Suicidal Treatment-Resistant Bipolar Depression in Cooperation with Lotus Pharmaceutical.
Incorporation of HOPE Therapeutics Dedicated to NRX-100 (IV Ketamine) for Suicidal Depression to Patients.
HOPE Therapeutics to be Initially Owned by NXRP and current NXRP Shareholders via a Planned Tax-Free Dividend.

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. NRXP is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRXP has partnered with Alvogen Pharmaceuticals around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.

NRXP has recently announced plans to submit a New Drug Application for NRX-100 (IV ketamine) in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRXP was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.

NRXP Announces Last Patient, Last Visit in its Phase 2b/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depression 

On March 4^th NRXP announced that the 74^th and last evaluable patient has completed their day 42 visit in its Phase 2b/3 study of NRX-101, the Company’s patented combination of the NMDA antagonist D-cycloserine and lurasidone, in Suicidal Treatment Resistant Bipolar Depression.  The NRXP database is being cleaned, finalized, and locked; statistical analysis will then be performed, with top-line data to follow shortly thereafter.  As previously disclosed, positive data from this trial triggers a milestone payment from Alvogen to NRXP. Alvogen will then be responsible for further development and commercialization costs for this program. 

The NRXP NRX-101 treatment has been awarded Breakthrough Therapy Designation, Fast Track Designation, a Biomarker Letter of Support, and a Special Protocol Agreement by the FDA for treatment of suicidal bipolar depression. It is the only oral medication to have demonstrated reduced suicidal ideation in patients with bipolar depression, a lethal disease that claims the lives of one in five who live with it.  

The Phase 2b/3 NRXP trial (www.clinicaltrials.gov NCT 03395392) is a randomized, prospective, multicenter, double-blind study comparing NRX-101 to lurasidone over six weeks. The Principal Investigator is Prof. Andrew Nierenberg of Harvard Massachusetts General Hospital. The primary efficacy endpoint is reduction in depression as measured on the MADRS scale and the secondary endpoint is reduction of suicidal ideation as measured by the Clinical Global Impression Suicidality Scale (CGI-SS).  As previously disclosed, treatment compliance and concordance of local raters to central raters scores was in excess of 94%, well above the industry standard that is normally seen in CNS trials.

NRXP to Launch HOPE Therapeutics, Inc. at the BIO CEO & Investor Conference 2024, Plus Planned Share Dividend to Existing NRXP Shareholders

On February 20^th NRXP announced that Dr. Jonathan Javitt, its Chairman and Chief Scient, would present a corporate overview at the BIO CEO & Investor Conference, held February 26-27, 2024 in New York City. Presenting with him would be Matthew Duffy, the newly-appointed co-CEO of HOPE Therapeutics.

Concurrent with the presentation, NRXP pland to file a proxy statement, subject to board approval, for NRXP shareholders outlining the share structure and seeking a shareholder advisory vote to support the planned share dividend for HOPE Therapeutics. NRXP has received consistent advice from public shareholders that the planned share dividend and royalty coupon be distributed only to shareholders and warrant-holders who execute a covenant not to participate in short sales of the Company’s stock.

$5 Million Milestone Payment from Partners Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd. (1975.TW)

On February 12^th NRXP announced the advance of the first $5 million milestone payment based on the Company’s partnership agreement with Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd. (1975.TW).

NRXP will immediately receive $5 million of the first milestone, which the Company will use to fund development of NRX-101 through the phase 2 meeting with FDA. As compensation for advancing the milestone, Alvogen and Lotus will receive 4.1 million warrants to purchase NRXP common stock, at a strike price of $0.40 with a three (3) year term.  The second portion of the milestone will be $4 million and, as before, be triggered by a positive response to the Company’s planned end of phase 2 meeting with FDA. 

NRXP then remains eligible to receive up to $320 million in future development and sales milestones, as well as royalty payments escalating to mid-teen percentages on Net Sales, subject to achievement of certain sales volumes.  Additionally, Alvogen and Lotus will be responsible for future development and commercialization costs for the NRXP NRX-101 in treatment of bipolar depression with suicidality.

Comments by Strategic Partner Lotus Pharmaceutical Co. Ltd. (1975.TW) in Recent Financial Report

On February 9^th NRXP announced that its Asia Pacific strategic partner Lotus Pharmaceutical Co. Ltd (1975.TW) identified enrollment completion of the NRXP clinical trial in bipolar depression as a material event in is February 7 financial filing. Lotus provides the Asia Pacific component of the NRXP global partnership with Alvogen, Inc.

Lotus reported in the accompanying press release that “Lotus Pharmaceutical’s strategic partner, NRXP, has achieved a significant milestone by completing enrollment for its phase 2b/3 trial of NRX-101 in suicidal treatment-resistant bipolar depression. The readout for this trial is anticipated in Q2 of this year.”

Incorporation of HOPE Therapeutics & Planned Share Dividend/Royalty Coupon

On February 5^th NRXP announced the incorporation of HOPE Therapeutics™, a biotechnology company dedicated to bringing NRX-100 (IV Ketamine), which will be re-designated HTX-100, a potentially lifesaving treatment option for patients with Suicidal Depression. The company will initially be owned by NRXP and its current shareholders, who will receive their shares in the form of a dividend with an accompanying royalty coupon tied to future sales of HTX-100, subject to Board approval. This is designed with counsel to not be a taxable event for NRXP shareholders.

HOPE is dedicated to providing an FDA-approved presentation of IV Ketamine, manufactured to current federal standards, in a diversion- and abuse-deterrent presentation. A New Drug Application (NDA) is planned for the first half of 2024, based on more than 1,000 patients treated in well-controlled trials of ketamine in Suicidal Depression together with HOPE’s expertise in sterile products formulation. Importantly, NRXP intends to provide state-of-the-art patient and reimbursement support for all of its patients and their clinics. Access to insurance coverage is critical for providing treatment to this vulnerable population and can only be achieved through development of an FDA-approved product. Additionally, providing an approved, compliant product for patients allows clinics to deliver state-of-the-art care to people suffering from suicidality without fear of legal and regulatory actions. 

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