NRx Pharmaceuticals (Nasdaq: NRXP) Demonstrates Compliance with Nasdaq MVLS Standard

Rhea-AI Summary

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) has announced plans to achieve compliance with Nasdaq market requirements related to minimum bid price and total Market Value of Listed Securities. The company aims to present its full compliance plan to Nasdaq on January 4, 2024, based on achieving clinical and regulatory milestones. NRx has demonstrated compliance with the $35 million MVLS since Dec 18, 2023, and aims to maintain compliance with this requirement going forward, rendering NRXP eligible for a second 180-day compliance period to reach a bid price of $1.

Positive

• NRx Pharmaceuticals has demonstrated compliance with the $35 million MVLS since Dec 18, 2023, rendering NRXP eligible for a second 180-day compliance period to reach a bid price of $1.

Negative

• The company may need to effect a reverse stock split if needed to achieve bid price compliance by the end of the second 180 period that occurs on April 15, 2024, which could potentially affect shareholder value.

Insights

Financial Analyst

The announcement by NRx Pharmaceuticals regarding its compliance strategy with Nasdaq requirements is a critical development with implications for investor confidence and the company's financial stability. The ability to maintain the minimum Market Value of Listed Securities (MVLS) and the bid price is essential for the company's continued listing on the exchange, which can affect liquidity and access to capital. The strategic decision to request a move to the Nasdaq Capital Market, which has a lower MVLS threshold, indicates a tactical approach to compliance while the company works on improving its financial metrics.

Moreover, the potential reverse stock split is a significant signal to the market. While such corporate actions are often viewed unfavorably because they can indicate distress, the company's framing of this as a contingency plan shows proactive governance. Investors should closely monitor the upcoming shareholder vote on this matter, as it will determine the company's ability to execute the reverse split if necessary. The outcome of this vote and the subsequent price movements will be pivotal in assessing NRx's financial health.

Medical Research Analyst

NRx Pharmaceuticals' pipeline of near-term drug approval opportunities is a cornerstone of its strategy to regain compliance with Nasdaq's requirements. The focus on NRX-100, an intravenous ketamine product, is particularly noteworthy given recent setbacks in the development of nasal ketamine by other companies. If successful, NRX-100 could become a significant player in the market for treatments for acute suicidal ideation in depression. The establishment of HOPE Therapeutics to commercialize NRX-100 could also streamline the path to market and provide a focused investment opportunity.

NRX-101's diverse applications in treatment-resistant bipolar depression, chronic pain and complicated urinary tract infections (cUTI) demonstrate the company's strategic approach to leveraging its research across multiple large-market opportunities. The partnership with Alvogen and the pursuit of NIH HEAL funding are positive indicators of NRx's commitment to advancing its clinical programs and securing external support, which can mitigate development costs and risks. The potential FDA Qualified Infectious Disease Product status for its cUTI indication could also offer market exclusivity benefits, enhancing the drug's commercial prospects.

Market Research Analyst

The clinical and regulatory milestones outlined by NRx Pharmaceuticals are not only crucial for the company's Nasdaq compliance but also for its market positioning. The pharmaceutical industry is highly competitive and the ability to bring new drugs to market can significantly alter a company's trajectory. NRx's strategic decision to spin out certain assets, such as HOPE Therapeutics for NRX-100, could attract focused investment and potentially unlock shareholder value.

Investors should be aware of the sizeable market opportunities referenced, such as the $70 billion market for nociceptive pain treatments. The company's progress in these areas, including the expected data from the Phase 2b/3 trial for NRX-101 in treatment-resistant bipolar depression and the Department of Defense-funded study for chronic pain, will be key drivers of investor sentiment. Positive outcomes could lead to substantial royalty income and milestone payments, as seen with the Alvogen partnership. However, the inherent risks of clinical development mean that setbacks could have a negative impact on the company's financial position and stock price.

• Company to present full compliance plan, based on achieving clinical milestones, to Nasdaq on January 4, 2024

RADNOR, Pa., Jan. 2, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company today announced an update on plans to achieve compliance with Nasdaq market requirements related to minimum bid price and total Market Value of Listed Securities (MVLS).  As has been previously disclosed, Nasdaq presented NRx with two deficiency notices, one related to failure to maintain the minimum $1 bid price and the other related to failure to maintain the minimum MVLS for the Nasdaq Global Market (i.e., and MVLS of $50 million). Because there were two simultaneous deficiencies, the Company did not qualify for a second automatic 180-day compliance period on the bid price deficiency.

As was shared by the Company's CEO at the annual meeting of shareholders held on December 19, 2023, NRx has requested that Nasdaq move its listing to the Nasdaq Capital Market, where the MVLS is set at $35 million.  The Company is pleased to announce that it has demonstrated compliance with the $35 million MVLS since Dec 18, 2023, and aim to maintain compliance with this requirement going forward. Achieving compliance with the Nasdaq Capital Markets MVLS threshold renders NRXP eligible for a second 180-day compliance period to reach a bid price of $1.

The Company will present its going-forward compliance plan to Nasdaq on January 4, 2024. That compliance plan is largely based on achieving clinical and regulatory milestones as outlined previously and summarized below. As part of that compliance plan, we are required to demonstrate a capacity to effect a reverse stock split if needed to achieve bid price compliance by the end of the second 180 period that occurs on April 15, 2024. Accordingly, we filed a Form 14A preliminary proxy statement on December 29, 2023 announcing a meeting of shareholders to be held on February 7, 2024, at which shareholders are asked to vote to authorize the Board of Directors to effect a reverse split, in the event that the Company does not reach compliance with the $1/share bid price by April 15, 2024.  This is required by the Nasdaq committee to demonstrate the Company's commitment to regaining compliance. Based on the forward momentum that has been achieved, the Company does not anticipate a need to effect a reverse split.  Should bid price compliance be reached prior to February 7, the shareholder meeting will be cancelled.

NRx currently has four (4) near-term drug approval opportunities with meaningful commercial and/or monetization prospects:

NRX-100 – Intravenous Ketamine

With recent failures in attempts to develop nasal ketamine, NRx has the only potential near-term path through the FDA for a labeled ketamine product that will address the needs of acutely suicidal patients with both bipolar and unipolar depression. In March 2024, we aim to submit a New Drug Application based on data from two well-controlled, randomized trials together with GMP manufacturing data, aiming for two-year stability at launch.  NRx has incorporated HOPE Therapeutics (HTX) as a vehicle for taking NRX-100 to market. We are developing this as a spinout that will focus on current income for investors in a market that could be accessed by the end of 2024.

NRX-101 – Treatment-Resistant Bipolar Depression

Phase 2b/3 trial enrollment is nearing completion with data expected in early 2024. NRx has partnered this program with Alvogen for $330 million in potential milestones a ~15% royalty, including a $10 million milestone payment on successful readout and FDA comment; Alvogen is responsible for all development and commercialization costs, following receipt of positive data and FDA response.

NRX-101 – Chronic Pain

D-cycloserine (DCS) has been shown to reduce nociceptive pain (~$70b market opportunity) while demonstrating no potential for addiction and potentially reducing opioid craving. Expecting imminent readout from U.S. DoD-funded study evaluating DCS in chronic, refractory low back pain and have submitted NRX-101 for HEAL funding from NIH.

NRX-101 – Complicated Urinary Tract Infection

While 90% of organisms show resistance to common antibiotics, data show that DCS is effective against many of these pathogens and is highly concentrated in the urine. NRx has an open IND for cUTI and is eligible for FDA Qualified Infectious Disease Product status. Exploring spin-out or licensing opportunities.

About NRx Pharmaceuticals

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 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.

NRx has recently announced plans to submit a New Drug Application for 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. 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.

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SOURCE NRx Pharmaceuticals, Inc.

FAQ

What is NRx Pharmaceuticals, Inc.'s plan to achieve compliance with Nasdaq market requirements?

NRx Pharmaceuticals, Inc. aims to present its full compliance plan to Nasdaq on January 4, 2024, based on achieving clinical and regulatory milestones.

What is the current status of NRx Pharmaceuticals, Inc.'s compliance with the $35 million MVLS?

NRx has demonstrated compliance with the $35 million MVLS since Dec 18, 2023, rendering NRXP eligible for a second 180-day compliance period to reach a bid price of $1.

What are the near-term drug approval opportunities for NRx Pharmaceuticals, Inc.?

NRx currently has four near-term drug approval opportunities, including NRX-100, NRX-101 for treatment-resistant bipolar depression, chronic pain, and complicated urinary tract infection.

What are the potential commercial and monetization prospects for NRx Pharmaceuticals, Inc.'s drug NRX-100?

NRx aims to submit a New Drug Application for NRX-100 in March 2024, with the potential to address the needs of acutely suicidal patients with both bipolar and unipolar depression.

What partnership does NRx Pharmaceuticals, Inc. have for the program NRX-101 for treatment-resistant bipolar depression?

NRx has partnered this program with Alvogen for $330 million in potential milestones and a ~15% royalty.

What is the status of NRx Pharmaceuticals, Inc.'s drug NRX-101 for chronic pain?

NRx is expecting imminent readout from a U.S. DoD-funded study evaluating DCS in chronic, refractory low back pain and has submitted NRX-101 for HEAL funding from NIH.

What is the market opportunity for NRx Pharmaceuticals, Inc.'s drug NRX-101 for complicated urinary tract infection?

NRx has an open IND for cUTI and is eligible for FDA Qualified Infectious Disease Product status, exploring spin-out or licensing opportunities.