BrainStorm Secures Premium Funding for High-Stakes ALS Trial

NEW YORK, NY – February 20, 2026 – BrainStorm Cell Therapeutics announced today it has secured $1 million in strategic financing at a premium to its market price, a move the company hails as a "powerful vote of confidence" as it prepares for a pivotal new clinical trial for its amyotrophic lateral sclerosis (ALS) therapy, NurOwn®.

The deal, structured as a private placement with an accredited investor, comes at a critical juncture for the biotech firm. BrainStorm is finalizing preparations for a Phase 3b trial under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA), following a significant regulatory setback in 2023. The new capital is earmarked for these regulatory initiatives, prepayments for the upcoming trial, and general corporate purposes.

A Vote of Confidence or a Financial Lifeline?

The terms of the financing are designed to signal strong investor belief in BrainStorm's long-term prospects. The common stock was priced at $0.60 per share, a notable premium to the $0.54 closing price on February 9, the date the transaction was finalized. Perhaps more telling is the inclusion of warrants, which give the investor the right to purchase additional shares in the future. The deal includes 120% warrant coverage with an exercise price of $1.00 per share, nearly double the company's recent stock price.

"Securing this financing at a premium to the current market is a powerful vote of confidence in the trajectory of Brainstorm," said Chaim Lebovits, President and CEO, in a statement. "The $1.00 warrant strike price, in particular, serves as a clear indicator of where we believe this company is headed."

However, this infusion of capital must be viewed against the company's challenging financial backdrop. According to its most recent financial filings for the third quarter of 2025, BrainStorm reported a net loss of nearly $7.9 million for the quarter. Publicly available data also indicates the company's short-term obligations currently exceed its liquid assets.

In this context, the $1 million, which will be delivered in two $500,000 tranches, is not sufficient to fully fund a late-stage clinical trial, which can often cost tens or even hundreds of millions of dollars. Instead, the financing appears to be a crucial bridge, providing the necessary runway to advance immediate regulatory goals and make key prepayments for the Phase 3b study while the company seeks more substantial, long-term funding.

Navigating a Difficult Regulatory Path

The path forward for NurOwn® is paved with both promise and past disappointment. The therapy faced a major hurdle in September 2023 when an FDA advisory committee voted against approving its Biologics License Application (BLA). The committee cited a lack of substantial evidence of effectiveness after the company's first Phase 3 trial failed to meet its primary endpoint of significantly slowing disease progression across the entire study population, although some positive signals were observed in a subgroup of patients with less advanced disease.

This history makes the design of the upcoming Phase 3b trial critically important. BrainStorm has secured a Special Protocol Assessment (SPA) agreement with the FDA for this new study. An SPA is a declaration from the FDA that the clinical trial's design, endpoints, and statistical analysis are adequate to support a future BLA submission, provided the trial meets its objectives. This agreement significantly de-risks the regulatory process by ensuring the company and the agency are aligned on the study's framework before it begins. The new trial is expected to enroll approximately 200 participants in a 24-week placebo-controlled study.

In addition to the SPA-guided trial, the company mentioned it is engaged in "high-level discussions regarding the pending Citizens Petition for Accelerated Approval." A Citizens Petition is a formal mechanism that allows individuals or organizations to request action from the FDA. While it represents another potential avenue to engage with regulators, the process can be lengthy and its outcome is never guaranteed. This multi-pronged strategy underscores the company's determination to find a viable path to market for NurOwn®.

The Science and the Crowded Field of ALS Research

NurOwn® represents a personalized approach to treating neurodegenerative disease. The platform uses a patient's own bone marrow-derived mesenchymal stem cells (MSCs), which are expanded and engineered ex vivo to secrete high levels of neurotrophic factors (NTFs). These NTF-secreting cells are then injected back into the patient's spinal canal, where they are designed to protect neurons from damage and modulate the neuroinflammatory processes that drive ALS progression.

BrainStorm's therapy is entering a field marked by both heartbreaking failures and hard-won victories. The recent decision by Amylyx Pharmaceuticals to withdraw its approved drug, Relyvrio, from the market after a follow-up trial failed to confirm its benefit served as a stark reminder of the complexities of treating ALS.

At the same time, the landscape offers glimmers of hope. The 2023 approval of Qalsody (tofersen) provided a powerful, targeted treatment for patients with a rare genetic form of ALS caused by mutations in the SOD1 gene. While it benefits only a small subset of the ALS population, its success has energized the field's focus on precision medicine.

The pipeline of potential ALS treatments remains active, with dozens of therapies in clinical development. These range from small molecules and antibody-based drugs to advanced genetic therapies being tested in large-scale initiatives like the HEALEY ALS Platform Trial. NurOwn's cell-based, immunomodulatory approach offers a distinct mechanism of action compared to many of these competitors. The success of its upcoming Phase 3b trial will be paramount in determining whether this unique scientific strategy can translate into a meaningful clinical benefit for the broader ALS community, which remains in desperate need of effective new treatments.