BrainStorm Secures Key Manufacturing Partnership with Minaris for Upcoming NurOwn® Phase 3b ALS Clinical Trials

Rhea-AI Summary

BrainStorm Cell Therapeutics (NASDAQ: BCLI) has signed a Letter of Intent with Minaris Advanced Therapies for manufacturing NurOwn®, its adult stem cell therapy for ALS treatment. The partnership will facilitate technology transfer and clinical trial manufacturing at Minaris' Allendale, New Jersey facility in preparation for BrainStorm's planned Phase 3b clinical trial.

This U.S.-based manufacturing collaboration complements BrainStorm's recent partnership with Pluri Inc. (Nasdaq: PLUR) in Israel, establishing a robust manufacturing network for NurOwn®. The strategic relationship aims to advance the clinical development of this therapy for ALS patients through a multicenter Phase 3b trial.

Positive

• None.

Negative

• Manufacturing partnerships still in early stages with only Letter of Intent signed
• Technology transfer process yet to begin, which could impact trial timeline

Insights

Biotechnology & Clinical Trials Expert

BrainStorm's manufacturing partnership with Minaris strengthens NurOwn's Phase 3b trial infrastructure, but doesn't yet guarantee clinical success.

This manufacturing partnership between BrainStorm and Minaris represents a critical infrastructure development for NurOwn's upcoming Phase 3b ALS trial. The agreement addresses one of the key challenges in cell therapy development - establishing reliable, compliant manufacturing capacity that can scale from clinical trials to potential commercialization.

The Letter of Intent initiates technology transfer to Minaris' Allendale facility, creating a dual manufacturing strategy alongside BrainStorm's previously announced partnership with Pluri in Israel. This redundancy is strategically sound, providing geographic diversification and manufacturing flexibility for a complex cellular therapy.

For context, NurOwn is an autologous mesenchymal stem cell therapy where cells are harvested from patients, expanded and differentiated to secrete neurotrophic factors, then reintroduced to potentially slow ALS progression. This requires sophisticated manufacturing capabilities under strict regulatory oversight.

What's particularly notable is BrainStorm's deliberate effort to establish manufacturing relationships before initiating their Phase 3b trial, suggesting they're applying lessons from previous development challenges. The addition of Minaris, with specific expertise in cell therapies, indicates BrainStorm is preparing not just for the trial but potentially positioning for commercial readiness should results prove positive.

However, investors should recognize this remains a preparatory step rather than clinical progress itself. The therapy must still demonstrate efficacy in the Phase 3b trial, which follows previous studies with mixed results. Manufacturing partnerships are necessary but insufficient conditions for ultimate regulatory approval.

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NEW YORK, May 27, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that it has signed a Letter of Intent (LOI) with Minaris Advanced Therapies, a global contract development and manufacturing organization (CDMO) specializing in cell and gene therapies, to manufacture NurOwn^® for its upcoming clinical trial.

The LOI marks the beginning of a strategic collaboration between BrainStorm and Minaris to initiate the technology transfer of NurOwn^® in preparation for clinical trial manufacturing at Minaris' state-of-the-art facility in Allendale, New Jersey. This partnership supports BrainStorm's readiness for its planned Phase 3b clinical trial.

"We are excited to support BrainStorm in the next phase of NurOwn development," said Eytan Abraham, Ph.D., Chief Commercial and Technology Officer at Minaris Advanced Therapies. "Our team looks forward to applying our expertise in cell therapy manufacturing to enable BrainStorm to conduct its clinical trial to the highest standards and move efficiently to commercial manufacturing."

This partnership enhances BrainStorm's U.S. based manufacturing capabilities and supports its multicenter Phase 3b clinical trial in the United States. It complements BrainStorm's recently announced collaboration with Pluri Inc. (Nasdaq: PLUR) in Israel, which will also contribute to the production of clinical trial material. Together, these strategic relationships reinforce BrainStorm's commitment to building a robust and flexible manufacturing network to advance the clinical development of NurOwn^®.

Chaim Lebovits, President and Chief Executive Officer of BrainStorm Cell Therapeutics, commented, "This partnership reflects our ongoing commitment to the ALS community and to advancing a therapy with the potential to meaningfully impact patients' lives. NurOwn^® represents a scientifically advanced and differentiated approach to treating ALS, and by joining forces with Minaris Advanced Therapies, we are ensuring that our clinical and manufacturing strategies are tightly aligned to support a successful Phase 3b trial and beyond,"

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

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

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SOURCE BrainStorm Cell Therapeutics Inc.

FAQ

What is the purpose of BrainStorm's (BCLI) partnership with Minaris Advanced Therapies?

The partnership is for manufacturing NurOwn®, BrainStorm's adult stem cell therapy, for its upcoming Phase 3b clinical trials in ALS treatment at Minaris' facility in Allendale, New Jersey.

Where will BCLI manufacture NurOwn® for its Phase 3b clinical trial?

NurOwn® will be manufactured at two locations: Minaris' facility in Allendale, New Jersey, USA, and through Pluri Inc. in Israel.

What stage is BrainStorm's (BCLI) manufacturing agreement with Minaris?

BrainStorm has signed a Letter of Intent (LOI) with Minaris and is initiating the technology transfer process for NurOwn® manufacturing.

What is NurOwn® being developed for by BrainStorm (BCLI)?

NurOwn® is being developed as an adult stem cell therapy for treating neurodegenerative diseases, specifically ALS (Amyotrophic Lateral Sclerosis).