BrainStorm Cell Therapeutics Granted Compliance Extension from Nasdaq

Rhea-AI Summary

BrainStorm Cell Therapeutics (NASDAQ: BCLI) has received an extension from the Nasdaq Hearings Panel until June 30, 2025 to regain compliance with certain continued listing standards of The Nasdaq Capital Market. The extension was granted following the company's presentation at a panel hearing on February 25, 2025.

The biotechnology company, focused on developing autologous cellular therapies for neurodegenerative diseases, is implementing a compliance plan that includes:

• Launching a Phase 3b ALS study for NurOwn®
• Reducing overall debt balance
• Pursuing strategic partnerships to enhance pipeline

CEO Chaim Lebovits emphasized the company's commitment to meeting the requirements within the specified timeframe while focusing on strengthening their financial position and advancing clinical programs.

Positive

• Granted requested Nasdaq compliance extension until June 30, 2025
• Moving forward with Phase 3b ALS study for NurOwn®
• Actively pursuing strategic partnerships to enhance pipeline

Negative

• Company faces potential Nasdaq delisting risk if compliance requirements are not met by June 2025
• Current debt balance requires reduction as part of compliance plan
• Company needs to improve financial standing to maintain listing

Insights

Financial Regulatory Expert

BrainStorm's Nasdaq compliance extension represents a critical regulatory reprieve that temporarily addresses what appears to be a serious listing challenge. Examining their $8.2 million market cap and $1.44 share price suggests they may be struggling with Nasdaq's continued listing requirements around minimum market value or equity standards.

This extension provides essential breathing room, but doesn't resolve underlying structural challenges. The panel's willingness to grant the full requested extension through June 30 indicates they found BrainStorm's compliance plan credible, which is marginally positive. However, the need for such an extension inherently signals financial distress that investors should carefully evaluate.

Management's acknowledgment of debt reduction as a key compliance strategy confirms financial restructuring is likely needed. The relatively short three-month window for remediation underscores the urgency of their situation - companies usually receive 180 days plus a potential additional 180-day extension for bid price issues, suggesting BrainStorm may have already exhausted initial grace periods.

While avoiding immediate delisting maintains market access and liquidity for existing shareholders, the company now faces significant pressure to rapidly execute multiple strategic initiatives simultaneously, including advancing clinical programs while improving their balance sheet. This regulatory development creates a definitive timeline against which investors can evaluate management's execution capacity.

Biotech Investment Strategist

BrainStorm's compliance extension creates a defined execution window that intertwines their regulatory challenges with clinical development milestones. The plan's emphasis on launching the Phase 3b ALS study for NurOwn® suggests management views clinical advancement as a potential catalyst for improving their financial metrics and market perception.

This strategy merits cautious analysis. The company must now balance resource allocation between compliance requirements and clinical progress, potentially creating competing priorities. ALS therapeutics development carries significant execution risk, and the compliance timeline could potentially rush certain development decisions or create suboptimal capital allocation.

Their mention of pursuing strategic partnerships is particularly noteworthy. For small neuroscience companies with challenging financial positions, partnership structures often involve significant value concessions. Any partnerships announced in this three-month window should be scrutinized for unfavorable terms that might signal desperation rather than strategic optimization.

The explicit linking of clinical programs to shareholder value in the CEO's statement suggests they're counting on positive NurOwn momentum to drive investor sentiment. This creates a precarious situation where clinical milestones now carry dual significance - both for therapeutic advancement and for maintaining market listing compliance. The compressed timeline increases execution pressure on a management team that must simultaneously address financial restructuring, clinical development, and potential partnership negotiations.

NEW YORK, March 26, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading biotechnology company committed to the development and commercialization of best-in-class autologous cellular therapies for the treatment of neurodegenerative diseases, today announced that it has been granted the exact compliance extension it requested from the Nasdaq Hearings Panel through June 30, 2025, to regain compliance with certain continued listing standards of The Nasdaq Capital Market.

BrainStorm presented its request for continued listing on The Nasdaq Capital Market and the relevant compliance plan to the Nasdaq Hearings Panel at the panel hearing held on February 25, 2025. As a result of the hearing, the Nasdaq Hearings Panel granted BrainStorm an extension until June 30, 2025 to regain compliance with certain continued listing standards. The grant of such exception reflects BrainStorm's commitment to executing its compliance plan to meet the applicable requirements within the specified time frame.

Chaim Lebovits, President and Chief Executive Officer of BrainStorm Cell Therapeutics, commented: "We take our compliance plan extremely seriously, and we are fully committed to implementing the necessary measures to meet the requirements within the given time frame. This effort is fully aligned with our ongoing work plan, which includes launching the Phase 3b ALS study for NurOwn®, reducing our overall debt balance, and actively pursuing strategic partnerships to enhance our pipeline. We remain focused on strengthening our financial position and advancing our clinical programs to deliver value to both patients and shareholders."

The company is actively pursuing a range of initiatives aimed at enhancing shareholder value and improving its financial standing. BrainStorm remains dedicated to maintaining transparency throughout this process and will continue to provide updates as warranted.

About BrainStorm Cell Therapeutics Inc.              
BrainStorm Cell Therapeutics Inc. is a leading developer of innovative therapies for debilitating neurodegenerative diseases, leveraging both autologous and allogeneic platforms. The Company holds exclusive worldwide licensing rights for the NurOwn® technology platform, which produces autologous MSC-NTF cells. These cells have received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for amyotrophic lateral sclerosis (ALS). BrainStorm is currently planning the launch of a confirmatory Phase 3b trial in ALS with NurOwn to further evaluate its safety and efficacy. BrainStorm's exosome technology, derived from MSC-NTF cells, represents an allogeneic therapeutic platform, providing customizable, nano-carrier-based solutions for targeted delivery of bioactive molecules. These exosomes exhibit unique immunomodulatory properties and are designed to address critical pathways in neurodegenerative and respiratory diseases. The Company has completed a Phase 3 trial assessing NurOwn in ALS and advanced clinical studies of NurOwn in progressive multiple sclerosis (MS), supported by grants from the California Institute for Regenerative Medicine (CIRM) and the National MS Society (NMSS).

Notice Regarding Forward-Looking Statements  
This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding the expectation of continued listing of BrainStorm's common stock on The Nasdaq Capital Market, execution of its compliance plan, launch of the Phase 3b ALS study for NurOwn®, reduction of its overall debt balance, and active pursuit of strategic partnerships to enhance its pipeline. 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 BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, the factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

CONTACTS

IR:
Michael Wood
Phone: +1 646-597-6983
mwood@lifesciadvisors.com

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SOURCE BrainStorm Cell Therapeutics Inc.

FAQ

What is the deadline given to BrainStorm Cell Therapeutics (BCLI) to regain Nasdaq compliance?

BrainStorm Cell Therapeutics has until June 30, 2025 to regain compliance with Nasdaq's continued listing standards.

What are the key components of BCLI's compliance plan announced in March 2025?

The plan includes launching Phase 3b ALS study for NurOwn®, reducing debt balance, and pursuing strategic partnerships.

When did BCLI present their compliance plan to the Nasdaq Hearings Panel?

BrainStorm presented their compliance plan at the Nasdaq Hearings Panel on February 25, 2025.

What is BrainStorm Cell Therapeutics (BCLI) developing NurOwn® for?

BCLI is developing NurOwn® as an autologous cellular therapy for the treatment of neurodegenerative diseases, including ALS.