RADNOR, Pa. - NRx Pharmaceuticals, Inc. (NASDAQ:NRXP), a clinical-stage biopharmaceutical company, has reported an improvement in its earnings per share for the fiscal year 2023 and outlined several anticipated milestones for the year ahead. The company announced a narrowed loss of $0.40 per share for the year ended December 31, 2023, compared to a loss of $0.60 per share in the previous year.
The company raised $9.2 million in new capital during FY 2023 and added $7.8 million to its working capital in Q1 2024. It also reduced corporate debt by over 50%, from $11.0 million to approximately $5.4 million through Q1 2024.
NRx Pharmaceuticals has signed development partnerships with Alvogen, Inc., and Lotus Pharmaceuticals, Inc. (1795.TW) for its lead compound NRX-101 in bipolar depression. The partnership includes funding of $330 million in commercial milestones and a double-digit royalty on sales, contingent on successful clinical data and FDA meetings.
The company completed enrollment and the last patient visit in the Phase 2b/3 trial of NRX-101 for Suicidal Bipolar Depression, with top-line data expected in April 2024. Two new Investigational New Drug (IND) applications were accepted by the FDA for Chronic Pain and Complicated Urinary Tract Infection/Pyelonephritis.
NRx Pharmaceuticals initiated the final statistical analysis plan for a 200-person Department of Defense-funded trial in the treatment of chronic pain with D-cycloserine (DCS), with data lock expected next week and top-line data anticipated in April 2024.
The company has also incorporated HOPE Therapeutics, Inc., a specialty pharma company, to distribute intravenous ketamine to qualified clinics. The first manufactured lot of ketamine was released for shipment by Nephron Pharmaceuticals this week.
NRx Pharmaceuticals obtained patient-level data from three efficacy studies of ketamine, which showed a significant reduction in severe depression and acute suicidality. The company plans to file a New Drug Application for the treatment of Acute Suicidality by June 2024, with a PDUFA date anticipated within the same year.
Furthermore, the company has received FDA designations for its NRX-101 treatment for Complicated Urinary Tract Infection and is seeking a clinical phase partner for this indication.
Janet Rehnquist, a nationally recognized attorney, has been elected to the company's Board of Directors. The company is also taking action to restore Nasdaq listing compliance and combat illegal naked shorting of its securities.
NRx Pharmaceuticals will host a conference call on April 1, 2024, to discuss further results and its upcoming filing.
This announcement is based on a press release statement.
InvestingPro Insights
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) has shown resilience and strategic growth through its recent financial and operational developments. A deeper dive into the company's performance using InvestingPro tools reveals several key metrics and analyst insights that may interest investors. The company's Market Cap stands at $48.63 million, reflecting its current valuation in the market.
InvestingPro data indicates that NRXP is experiencing a notable price performance with a 73.88% return over the last month and an impressive 98.06% return over the last six months. This uptrend could signal growing investor confidence in the company's future prospects, especially considering the recent milestones outlined for the year ahead.
An InvestingPro Tip highlights that two analysts have revised their earnings upwards for the upcoming period, suggesting that NRXP's financial outlook might be improving. However, it is important for investors to consider that the company is not expected to be profitable this year, as analysts have noted.
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With the next earnings date set for March 28, 2024, investors will be keen to see if the positive trends continue and how the company's strategic initiatives unfold. The InvestingPro platform offers a detailed fair value estimate, which currently stands at $0.57, providing a benchmark for investors to assess the stock's potential value.
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