BrainStorm Cell Therapeutics Announces Nasdaq Delisting and Transition to OTCQB

Rhea-AI Summary

BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced its delisting from the Nasdaq Capital Market effective July 18, 2025, due to non-compliance with minimum shareholder equity requirements. The company's shares will transition to the OTCQB Venture Market under the same symbol BCLI.

CEO Chaim Lebovits emphasized that despite this setback, the company remains committed to advancing NurOwn for ALS patients, including preparations for a pivotal Phase 3b trial under an FDA Special Protocol Assessment agreement. The delisting will not affect BrainStorm's business operations, R&D efforts, or SEC compliance obligations.

Positive

• Secured immediate transition to OTCQB market maintaining trading continuity
• Continuing development of NurOwn with FDA-approved Special Protocol Assessment for Phase 3b trial
• Maintaining SEC compliance and shareholder communications

Negative

• Delisting from Nasdaq Capital Market due to insufficient shareholder equity
• Potential reduction in stock visibility and institutional investor access
• Moving to a less prestigious trading venue could impact stock liquidity

Insights

Biotech Financial Analyst

Nasdaq delisting signals financial challenges for BrainStorm, though operations continue as they transition to OTCQB market.

BrainStorm's delisting from Nasdaq due to insufficient shareholder equity represents a significant negative development for the company. This transition to the OTCQB market typically results in reduced liquidity, decreased institutional investment, diminished analyst coverage, and potentially more challenging capital raising conditions.

The delisting stems from non-compliance with Rule 5550(b)(1) regarding minimum shareholder equity requirements, indicating underlying financial weakness that the company has been unable to remedy. While management emphasizes that business operations and R&D efforts will continue uninterrupted, the move to the less prestigious OTCQB market often brings practical consequences for biotechnology companies in development stages.

For investors, this change means their shares will continue trading without interruption, but in a marketplace with typically wider bid-ask spreads and lower trading volumes. The company's emphasis on continuing their NurOwn development program for ALS, particularly the planned Phase 3b trial under an FDA Special Protocol Assessment agreement, suggests they're attempting to maintain momentum despite this setback.

Notably, this delisting occurs at a critical juncture for BrainStorm as they prepare for an important clinical trial. The timing raises questions about the company's ability to fund these expensive late-stage clinical programs without the advantages that come with a Nasdaq listing. Their transition strategy appears organized, with trading expected to continue under the same symbol on the new exchange with minimal disruption.

NEW YORK, July 17, 2025 BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) today announced that it has received a delisting notification from The Nasdaq Stock Market LLC, informing the company that its common stock will be delisted from the Nasdaq Capital Market. Trading of BrainStorm's common stock on Nasdaq will be suspended at the open of trading on July 18, 2025.

The delisting is a result of the company's non-compliance with Nasdaq Listing Rule 5550(b)(1), pertaining to its minimum shareholder equity requirement.

BrainStorm has already secured approval for its common stock to be quoted on the OTCQB Venture Market, a U.S. trading platform operated by OTC Markets Group. The company anticipates its shares will begin trading on the OTCQB under the same symbol, BCLI, beginning at the open of trading on July 18, 2025, or as soon as possible thereafter.

Chaim Lebovits, CEO of BrainStorm Cell Therapeutics, stated, "While this delisting from Nasdaq is a challenging outcome, we want to assure our shareholders and the patient community that it does not alter our core mission or our unwavering commitment to advancing NurOwn for ALS patients. Our pre-arranged transition to OTCQB ensures continuous trading for our shares and allows us to focus entirely on NurOwn's development. We remain fully dedicated to our ongoing scientific and clinical programs, including preparations for our pivotal Phase 3b trial under the Special Protocol Assessment (SPA) agreement with the FDA."

The company confirms that the delisting does not impact its business operations, its ongoing research and development efforts, or its commitment to its shareholders. BrainStorm will continue to provide updates on its progress and financial status in compliance with applicable SEC regulations.

About NurOwn®      
The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc.              
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) is a leading developer of autologous adult stem cell therapies for debilitating neurodegenerative diseases. The company's proprietary NurOwn® platform uses autologous mesenchymal stem cells (MSCs) to produce neurotrophic factor-secreting cells (MSC-NTF cells), designed to deliver targeted biological signals that modulate neuroinflammation and promote neuroprotection.           

NurOwn® is BrainStorm's lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A Phase 3 trial in ALS (NCT03280056) has been completed, and a second Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA. The NurOwn clinical program has generated valuable insights into ALS disease biology, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal time points, and a comprehensive analysis of the "Floor Effect" - a critical challenge in measuring clinical outcomes in advanced ALS. BrainStorm has published its findings in multiple peer-reviewed journals. In addition to ALS, BrainStorm has completed a Phase 2 open-label multicenter trial (NCT03799718) of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society. BrainStorm is also advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic proteins and nucleic acids. The company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering its exosome technology, further strengthening BrainStorm's growing IP portfolio in this emerging area of regenerative medicine. To learn more, visit www.brainstorm-cell.com.

Notice Regarding Forward-Looking Statements 
This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. 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, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other 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

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

Media:
Uri Yablonka, Chief Business Officer
Phone: +1 917-284-2911       
uri@brainstorm-cell.com 

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SOURCE Brainstorm Cell Therapeutics Ltd.

FAQ

Why is BrainStorm Cell Therapeutics (BCLI) being delisted from Nasdaq?

BrainStorm is being delisted due to non-compliance with Nasdaq Listing Rule 5550(b)(1), which pertains to minimum shareholder equity requirements. The delisting takes effect on July 18, 2025.

Where will BCLI stock trade after Nasdaq delisting?

BCLI shares will trade on the OTCQB Venture Market, operated by OTC Markets Group, under the same symbol BCLI, starting July 18, 2025.

How does the Nasdaq delisting affect BrainStorm's NurOwn development?

The delisting does not affect BrainStorm's core operations or its development of NurOwn. The company continues to prepare for its Phase 3b trial under an FDA Special Protocol Assessment agreement.

Will BCLI shareholders be affected by the move to OTCQB?

Shareholders will maintain their ownership, with continuous trading availability on OTCQB. However, the stock may experience reduced liquidity and institutional investor access compared to Nasdaq listing.

What is BrainStorm's plan following the Nasdaq delisting?

BrainStorm will continue its business operations, R&D efforts, and SEC compliance while focusing on advancing NurOwn for ALS patients through clinical development.