NEW YORK - BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a developer of stem cell therapies for neurodegenerative diseases, has announced strategic milestones reached in 2024, including securing a Special Protocol Assessment (SPA) with the US Food and Drug Administration (FDA) for a Phase 3b clinical trial of its ALS therapy, NurOwn®. The company's stock, currently trading at $2.80, has seen significant volatility with a 52-week range of $1.69 to $12.54. According to InvestingPro analysis, the stock appears fairly valued based on its proprietary Fair Value model.
The SPA confirms that the trial's design and analysis plan are adequate for regulatory approval, potentially reducing the risk of regulatory challenges. The company also aligned with the FDA on its Chemistry, Manufacturing, and Controls (CMC) plan for NurOwn's trial in June, setting the stage for a consistent manufacturing process.
BrainStorm entered a Memorandum of Understanding with Pluri Inc. to manufacture NurOwn clinically, complementing its Tel Aviv facility and planning to add a U.S.-based center to expand production.
Research data indicates that NurOwn may reduce neurofilament light (NfL) levels, a marker of neurodegeneration in ALS patients, suggesting a possible mitigation of neuronal damage. The company also highlighted potential correlations between NurOwn and biomarkers related to inflammation and neuroprotection.
Despite a setback at a 2023 FDA Advisory Committee meeting, BrainStorm has refined its strategies and continued to align with FDA requirements. The company welcomed Dr. Haro Hartounian as Chief Operating Officer and promoted Bob Dagher, M.D., to Chief Medical (TASE:PMCN) Officer, strengthening its leadership team.
Looking to 2025, BrainStorm will focus on executing the Phase 3b trial for NurOwn, targeting early-stage ALS patients, and advancing its exosome platform for treating neurodegenerative and respiratory diseases. The company's intellectual property was bolstered by a recent Notice of Allowance from the U.S. Patent and Trademark Office.
Despite financial challenges in the biotech sector, BrainStorm has raised approximately $8 million since the ADCOM results and is pursuing additional funding sources to support its Phase 3b trial and exosome platform development. The company's financial position shows an EBITDA of -$13.05 million in the last twelve months, with a levered free cash flow of -$11.35 million. InvestingPro data reveals a Financial Health Score of 1.94, labeled as 'FAIR', with notably low debt levels at just $0.84 million. Subscribers to InvestingPro can access over 30 additional financial metrics and exclusive insights about BrainStorm's financial health.
The FDA's approval of Ryoncil, a mesenchymal stromal cell (MSC)-based therapy, has provided optimism in the cell therapy community, which BrainStorm sees as a positive sign for its MSC-based therapeutic approach with NurOwn. With the next earnings report expected on April 2, 2025, investors can access detailed financial forecasts and analysis through InvestingPro, including earnings projections and comprehensive company health metrics that help evaluate the company's potential in the evolving biotech landscape.
This report is based on a press release statement from BrainStorm Cell Therapeutics Inc.
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