Bullish indicating open at $55-$60, IPO prices at $37
NEW YORK - BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a biotech company focused on stem cell therapies for neurodegenerative diseases, has received FDA approval to start a Phase 3b clinical trial for its ALS treatment, NurOwn®. The FDA’s clearance, announced today, permits the company to begin patient enrollment in the study. The company’s stock, currently trading at $1.32, has shown strong momentum with an 8.2% gain over the past week, though it remains significantly below its 52-week high of $10.05. According to InvestingPro analysis, the company appears slightly undervalued at its current market capitalization of $8.61 million.
The trial will assess the efficacy of NurOwn® (autologous MSC-NTF cells) in treating amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease. This decision follows a Special Protocol Assessment (SPA) agreement with the FDA, which affirmed that the trial’s design, endpoints, and statistical methods are suitable for supporting a future Biologics License Application (BLA). InvestingPro data reveals the company operates with a moderate debt level, with a total debt to capital ratio of 0.17, though its current ratio of 0.21 indicates potential liquidity challenges.
President and CEO of BrainStorm, Chaim Lebovits, expressed the significance of the FDA clearance as a "defining milestone" for both the company and the ALS community. BrainStorm plans to activate clinical sites in phases and is exploring funding options, including non-dilutive grants, to ensure the study’s success.
The upcoming Phase 3b trial aims to enroll about 200 participants across various academic medical centers. It includes a 24-week randomized, double-blind, placebo-controlled phase, followed by a 24-week open-label extension where all participants will receive the investigational therapy. The primary measure of effectiveness will be the change from baseline in the ALS Functional Rating Scale-Revised (ALSFRS-R) at week 24.
BrainStorm’s management will provide further details and discuss the development in a corporate update conference call and webcast scheduled for today. With analyst price targets ranging from $6.00 to $24.35, investors seeking deeper insights can access the comprehensive Pro Research Report and additional financial metrics through InvestingPro, which offers exclusive analysis of over 1,400 US stocks, including detailed health scores and future growth projections.
The company’s proprietary NurOwn® platform involves the use of mesenchymal stem cells (MSCs) that have been modified to secrete neurotrophic factors (MSC-NTF cells), which aim to reduce neuroinflammation and promote neuroprotection. NurOwn® has already completed a Phase 3 trial and is now progressing to the Phase 3b trial under the SPA with the FDA. BrainStorm has shared insights from its clinical program in peer-reviewed journals and is also developing an exosome-based platform for delivering therapeutic proteins and nucleic acids.
This news article is based on a press release statement from BrainStorm Cell Therapeutics Inc.
In other recent news, Brainstorm Cell Therapeutics has reported its financial results for the fourth quarter of 2024, highlighting a reduction in research and development expenses from $10.7 million in 2023 to $4.7 million in 2024. The company also announced a net loss of $11.6 million for 2024, which is an improvement from the $17.2 million loss in 2023. Cash reserves have decreased to $400,000 by the end of 2024, down from $1.5 million in the previous year. Brainstorm Cell Therapeutics is advancing its Phase 3b clinical trial for its ALS treatment, NurOwn, having submitted an Investigational New Drug amendment to the U.S. FDA. This trial is under a Special Protocol Assessment agreement, potentially expediting the regulatory review process. Additionally, the company has amended its bylaws to lower the quorum requirement for shareholder meetings, facilitating easier conduct of such meetings. These developments reflect Brainstorm’s strategic focus on advancing its ALS therapy amid financial and operational challenges.
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