Data from the recently completed phase 2b/3 trial of NRX-101 in suicidal bipolar depression(3) at the annual meeting of the American Society of Clinical Psychopharmacology's by Professor Andrew Nierenberg of Harvard Mass General Hospital. These data demonstrated a significantly improved safety profile versus the standard of care, as demonstrated by a clinically significant reduction in akathisia (P=0.025) and time to sustained remission from suicidality (P=0.05). Akathisia is an adverse event seen with antidepressant medications considered by many experts to be a precursor to suicide. Given the vital need for safer medications in this at-risk population, we plan to submit an NDA for Accelerated Approval to the US FDA for treatment of bipolar depression patients with suicidality or akathisia, based on these data as well as additional data from our STABIL-B(4) trial.
Progress with HOPE Therapeutics
HOPE Therapeutics, the Company's wholly owned subsidiary, announced signing of two Letters of Intent to acquire foundational Interventional Psychiatric Clinics and is currently in negotiation with additional clinical networks. These initial acquisitions provide key Clinical and Operational leadership to HOPE, which aims to develop a national network of precision psychiatry clinics that combine treatment with ketamine, Transcranial Magnetic Stimulation, and other therapies to patients with suicidal depression and PTSD.
Unlike the core business of NRx Pharmaceuticals that is focused on biotechnology Research and Development, HOPE is organized around consolidating existing best-in-class precision psychiatry care into a nationwide network. This approach is demonstrating successful results for patients and a profitable operating model at a time when ketamine "medspas" frequently fail and are under increasing regulatory scrutiny. As currently designed, the HOPE acquisition model is likely to be funded as a separate entity, through bond offerings and, thus, to be non-dilutive to NRx shareholders. Over the past quarter, HOPE leadership has identified the clinics that are most likely to participate in the first $100 million consolidation, has completed the audit required for a public listing of HOPE shares, and has identified appropriate underwriters for a future bond offering.
With Hope ownership as an asset of NRx, this will further strengthen the NRx balance sheet and aims to further enhance NRx shareholder value.
NRX-101 for Treatment of Chronic Pain and Urinary Tract Infection $(UTI)$ / Urosepsis
Although the company is currently fully focused on the three opportunities discussed above, Chronic Pain and treatment of UTI with MNRX-101 remain pipeline opportunities, to be pursued following achievement of nearer-term corporate goals.
Funding for FDA filings of NRX-100 and NRX-101
The Company executed a Convertible Debt instrument with Anson Funds of Toronto for $10.8 million in funding designed to retire existing debt and to support FDA New Drug filings of NRX-100 and NRX-101. Terms have been disclosed in 8K filings but are at an interest rate and conversion rate substantially lower than prior corporate indebtedness. This agreement removes impediments to a planned dividend of HOPE Therapeutics shares to NRx shareholders.
Retirement of current debt and settlement of litigation
Concurrent with the Anson investment, the Company has settled its outstanding litigation with Streeterville Capital, LLC at a substantial discount to the amounts claimed in litigation.
Financial Results for the Quarter and Year to Date 2024
For the three months ended September 30, 2024, NRx Pharmaceuticals reduced its operating net loss from $6.1 million in the third quarter of 2023 to $1.6 million in 2024, representing nearly a 75% improvement year over year. For that same period, research and development expenses decreased from $3.3 million in 2023 to $0.6 million in 2024. The $2.7 million decrease is related primarily to a decrease of $2.1 million in clinical trial and development expenses due to the conclusion of the phase 2b/3 study relating to NRX-101 and the Company's cash conservation efforts. Also, in that 3-month period NRx achieved a slight decrease in general and administrative expenses, from $2.5 million in 2023 to $2.4 million in 2024. The decrease of $0.1 million is related primarily to lower insurance expenses.
For the nine months ended September 30, 2024, NRx Pharmaceuticals reduced its net loss to $16.1 million compared to $25.8 million in the prior year. These efficiencies represent an improvement in net loss of $9.7 million year over and a $1.89, or 54%, improvement in net loss per share year over year. Over that nine-month period we recorded $5.2 million of research and development expenses compared to $10.8 million for the same period in 2023 representing a 53% decrease year over year. The decrease of $5.7 million is related primarily to a decrease of $6.1 million in clinical trial and development expenses due to the conclusion of the phase 2b/3 study relating to NRX-101, offset by $1.3 million related to the Alvogen warrants and $0.2 million related to fees paid to regulatory and development consultants. Also, in that nine-month period, we decreased G&A by $1.4 million, from $12.3 million in 2023 to $10.9 million in 2024, representing an 11% decrease year over year.
As of September 30, 2024, we had $1.6 million in cash and cash equivalents. Subsequent to September 30, 2024, we closed tranche two of the Secured Debt Financing from Anson Funds in the amount of $5.4 million. This financing is expected to support filing of New Drug Applications for NRX-100 (ketamine) and NRX-101, general corporate purposes as well as retire historical debt with more favorable terms, and a lower annual interest rate.
NRx continues to implement operational efficiencies to extend cash runway and maintain focus on our path to generating revenue and value for our shareholders.
Please see detailed financials on our Form 10-Q, filed with the SEC and available on our website.
Conference Call and Webcast Details
A live webcast of the conference call will be available on the Company's website at 4:30 p.m. ET Monday November 18, 2024, at https://ir.nrxpharma.com/events. An archive of the webcast will be available on the Company's website for 30 days. Participants that are unable to join the webcast can access the conference call via telephone by dialing domestically 1-800-717-1738 or internationally 1-646-307-1865.
About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals 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. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for NRX-100 (IV ketamine) for 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. NRx 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.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a healthcare delivery company developing a best-in-class network of precision psychiatry clinics that currently offer ketamine transcranial magnetics stimulation $(TMS.AU)$ and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward, " and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the
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