BrainStorm partners with Minaris for ALS therapy trial

NEW YORK - BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a micro-cap biotechnology company with a market value of $8.54 million focused on developing stem cell therapies for neurodegenerative diseases, has entered into a strategic partnership with Minaris Advanced Therapies to manufacture NurOwn® for an upcoming Phase 3b clinical trial. According to InvestingPro analysis, the company’s stock has fallen significantly over the past year, with shares down 86.6%. The Letter of Intent (LOI) signifies the commencement of technology transfer to Minaris’ facilities in New Jersey, bolstering BrainStorm’s U.S. manufacturing capabilities.

The collaboration aims to ensure the highest standards in clinical trial manufacturing and expedite the movement towards commercial production. Minaris will leverage its expertise in cell therapy manufacturing to support BrainStorm’s multicenter trial in the United States. With an InvestingPro Financial Health Score of 1.66 (labeled as WEAK) and current ratio of 0.21, this partnership comes at a crucial time for the company. InvestingPro subscribers can access 8 additional key insights about BCLI’s financial position and future prospects through the comprehensive Pro Research Report. This partnership complements a recent alliance with Pluri Inc. in Israel, further strengthening the production network for NurOwn®.

NurOwn® utilizes autologous mesenchymal stem cells (MSCs) that are differentiated into neurotrophic factor-secreting cells (MSC-NTF cells), which are intended to deliver targeted biological signals to modulate neuroinflammation and promote neuroprotection in neurodegenerative disorders, particularly amyotrophic lateral sclerosis (ALS).

BrainStorm’s President and CEO, Chaim Lebovits, expressed the company’s commitment to the ALS community and the potential impact of NurOwn® on patients’ lives. The company faces significant financial challenges, with an EBITDA of -$12.07 million in the last twelve months, according to InvestingPro data. Discover detailed analysis and more than 30 financial metrics with an InvestingPro subscription. The technology platform has been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The company has previously completed a Phase 3 trial in ALS and is preparing for the Phase 3b trial under a Special Protocol Assessment (SPA) with the FDA. BrainStorm has also explored the therapy’s application in progressive multiple sclerosis (MS) and is developing an exosome-based platform for regenerative medicine.

The information in this article is based on a press release statement from BrainStorm Cell Therapeutics Inc.

In other recent news, BrainStorm Cell Therapeutics has announced significant developments during its Q1 2025 earnings call, primarily focusing on its NurOwn therapy for ALS. The company is advancing its Phase 3b trial, which aims to confirm the therapeutic benefits of NurOwn for patients in the early stages of ALS. Despite facing financial challenges, BrainStorm is actively pursuing a $15 million non-dilutive grant and negotiating strategic partnerships to improve its financial standing. The U.S. FDA has cleared the company to initiate the trial, marking a crucial milestone in its clinical development efforts.

Additionally, the company plans to expand its manufacturing capabilities, including a technology transfer to Pluri and a forthcoming letter of intent with a U.S.-based facility. The company is also progressing with its exosome program, showing promising preclinical data for respiratory and inflammatory diseases. Analyst discussions during the earnings call emphasized the importance of securing additional financial resources and highlighted the potential impact of genetic factors on treatment efficacy. These developments reflect BrainStorm’s commitment to advancing its ALS treatment options while navigating financial constraints.

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