NeuroSense Regains Compliance with Nasdaq's Minimum Equity Requirement

Rhea-AI Summary

NeuroSense Therapeutics (Nasdaq: NRSN) has announced regaining compliance with Nasdaq's stockholders' equity requirement, ensuring continued listing on The Nasdaq Capital Market. The company successfully improved its balance sheet by raising new equity and reducing liabilities, exceeding the required $2.5 million threshold.

Key developments include a $5 million financing completed in December 2024, following a Nasdaq hearing on August 1, 2024. The company is preparing to transition into a pivotal Phase 3 study for PrimeC, following promising Phase 2b PARADIGM study results.

NeuroSense will be subject to a mandatory panel monitor for one year from January 3, 2025. If the company fails to maintain compliance during this period, it will not receive additional time but can request a new hearing before any delisting action.

Positive

• Successfully raised $5 million in financing (December 2024)
• Regained Nasdaq compliance, maintaining stock listing
• Advancing to Phase 3 study for PrimeC following positive Phase 2b results

Negative

• Subject to one-year mandatory monitoring period
• Risk of immediate delisting if equity requirement not maintained during monitoring period

Insights

Financial Analyst

This regulatory compliance achievement represents a critical financial turning point for NeuroSense. The <money>$5 million</money> December financing not only helped meet Nasdaq's <money>$2.5 million</money> equity requirement but also provides essential working capital for their upcoming Phase 3 study. The micro-cap company's market value of <money>$27.9 million</money> reflects the speculative nature of early-stage biotech investments.

The one-year monitoring period starting January 3, 2025, poses ongoing compliance risks. With biotech burn rates typically ranging from <money>$500,000</money> to <money>$2 million</money> monthly for clinical trials, maintaining the equity threshold will likely require additional capital raises. This could lead to further dilution for existing shareholders. The binding term sheet for PrimeC development suggests potential partnership revenue, but careful monitoring of cash runway remains crucial.

Biotech Research Analyst

The transition to Phase 3 trials for PrimeC following positive Phase 2b PARADIGM results marks a pivotal inflection point. Late-stage ALS drug development historically has a success rate below 20%, making each advancement significant. The binding term sheet suggests external validation of PrimeC's potential, though specifics of the development agreement will be crucial.

For context, ALS drug development typically requires substantial investment in Phase 3 trials, often exceeding <money>$30 million</money>. The recent financing provides initial runway, but successful completion of Phase 3 will likely require additional strategic partnerships or capital infusion. The regulatory compliance achievement removes an immediate obstacle, allowing management to focus on clinical development milestones.

• NeuroSense in Compliance with all Nasdaq Listing Requirements

CAMBRIDGE, Mass., Jan. 6, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-stage clinical biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that the Company received formal written notice from The Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with Nasdaq's stockholders' equity requirement ("Equity Requirement") set forth in Nasdaq Listing Rule 5550(b)(1). The Company's Ordinary Shares will continue to be listed and trade on The Nasdaq Capital Market under the symbol "NRSN".

This confirmation follows the Company's successful efforts to improve its balance sheet by raising new equity and reducing outstanding liabilities. As a result, NeuroSense shareholders' equity now exceeds Nasdaq's Equity Requirement of at least $2.5 million.

Since the Nasdaq hearing on August 1, 2024, NeuroSense has taken several important steps, including the closing of a $5 million financing in December 2024.

These steps demonstrate NeuroSense's strong momentum as it prepares to transition into a pivotal Phase 3 study for PrimeC, following the promising results of the Phase 2b PARADIGM study.

Alon Ben-Noon, CEO of NeuroSense, said: "Regaining Nasdaq compliance is a significant milestone that reflects our dedicated efforts to strengthen the Company's financial position and ensure continued growth. This achievement underscores the confidence in our strategic direction and sets a solid foundation as we advance our pipeline. Our recent developments, including the binding term sheet to develop PrimeC, further highlight the progress we are making in addressing the unmet needs of ALS patients."

As part of the compliance confirmation, NeuroSense will be subject to a mandatory panel monitor for a year from the date the letter was received, January 3, 2025. If, within that one-year monitoring period, the Company fails to comply with the Equity Requirement, the Company will not be permitted additional time to regain compliance with the Equity Requirement. However, the Company will have an opportunity to request a new hearing with the Nasdaq Listing Qualifications Hearing Panel prior to a delisting of the Company's securities from Nasdaq.

About ALS

Amyotrophic lateral sclerosis ("ALS") is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

About PARADIGM

PARADIGM is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b (NCT05357950) clinical trial of PrimeC in ALS. The trial included 68 participants living with ALS in Canada, Italy, and Israel.

During the first 6 months of the trial, 45 participants were randomized to receive PrimeC, and 23 participants were randomized to receive placebo. This was followed by a 12-month open-label extension with all participants receiving PrimeC in a blinded manner, where neither the participants nor the clinical staff were aware of the initial treatment allocation.

Most patients enrolled in both the active and placebo arms of the trial were concurrently treated with Riluzole, the ALS standard of care medication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA approved ALS drug.   

About PrimeC

PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation to potentially inhibit the progression of ALS. NeuroSense completed a Phase 2a clinical trial which met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC's biological activity. PrimeC was granted Orphan Drug Designation by the U.S. Food and Drug Administration and the European Medicines Agency.

About NeuroSense

NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.

Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics' current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the Company's growth and the advancement of its pipeline. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the risk of a failure to continue to comply with the Nasdaq Listing Rules, the risk that the Company will not grow or advance its pipeline as anticipated, a delay in commencement of enrollment for the Phase 3 trial, if any, or a delay in regulatory submissions with the FDA, the risk that the trial will not be completed, meet regulatory expectations or provide sufficient data for drug approval, unexpected changes in trial design, delay in submission by the Company of its regulatory dossier, that regulatory approvals for PrimeC will be delayed or not obtained in the U.S., Canada or elsewhere; unsuccessful results of the Phase 3 trial, unexpected R&D costs or operating expenses, insufficient capital to complete development of PrimeC, a delay in the reporting of additional results from PARADIGM clinical trial, the timing of expected regulatory and business milestones, risks associated with meeting with the FDA and Health Canada to determine the best path forward following the results from PARADIGM clinical trial, including a delay in any such meeting; the potential for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; the development and commercial potential of any product candidates of Neurosense; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense's filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading "Risk Factors" in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 4, 2024 and NeuroSense's subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

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SOURCE NeuroSense

FAQ

What was the amount of financing NeuroSense (NRSN) raised in December 2024?

NeuroSense raised $5 million in financing in December 2024.

What is the minimum stockholders' equity requirement for NRSN to maintain Nasdaq listing?

NRSN must maintain a minimum stockholders' equity of $2.5 million to comply with Nasdaq's listing requirements.

When does NRSN's Nasdaq compliance monitoring period end?

The monitoring period ends on January 3, 2026, one year from the date of the compliance notice.

What happens if NRSN fails to meet Nasdaq requirements during the monitoring period?

If NRSN fails to comply during the monitoring period, it won't receive additional time to regain compliance but can request a new hearing before delisting.

What is the next clinical trial phase for NRSN's PrimeC?

NRSN is preparing to transition into a pivotal Phase 3 study for PrimeC following the Phase 2b PARADIGM study.