Brainstorm Posts 43% EPS Gain in Q2

Brainstorm Cell Therapeutics (BCLI -2.90%), a biotechnology developer focused on neurodegenerative diseases, released its second quarter 2025 results on August 14, 2025. The headline news was a GAAP earnings per share was $0.34, beating analyst expectations of $(0.37) and improving from a loss of $0.60 in the prior year period. However, the company again posted no revenue as it remains pre-commercial. Most importantly, Brainstorm won clearance from the U.S. Food and Drug Administration (FDA) to begin a pivotal Phase 3b trial for its lead therapy, NurOwn, in amyotrophic lateral sclerosis (ALS). While the quarter showed progress on key clinical, regulatory, and operational fronts, a razor-thin cash balance and rising expenses put the company’s future plans at significant risk without near-term financing.

Source: Analyst estimates for the quarter provided by FactSet.

Company Overview and Recent Focus

Brainstorm Cell Therapeutics is a clinical-stage biotechnology company developing cell therapies to treat neurodegenerative conditions. Its core platform, NurOwn, is a cell therapy product targeting diseases like ALS and progressive multiple sclerosis (PMS).

The company’s efforts over the past year have centered on advancing NurOwn through the late-stage regulatory process. After setbacks with previous FDA submissions, Brainstorm gained important clearance this quarter to start a new pivotal clinical trial with a Special Protocol Assessment in place. The outcome of this study will help determine whether NurOwn can reach commercial approval. Alongside clinical execution, the company is expanding its manufacturing partnerships and protecting its intellectual property portfolio, which it views as critical for long-term growth.

Quarter Highlights: Financial, Clinical, and Strategic Updates

Brainstorm’s financial results reflected both operational discipline and growth in research spending. The GAAP earnings per share loss improved year over year, due largely to lower general and administrative (G&A) costs. G&A expenses (GAAP) dropped to $1.4 million from $2.1 million in the prior year, as the company trimmed non-core expenses. At the same time, research and development (R&D) costs, which include spending on clinical trials and scientific validation, rose to $1.1 million from $0.9 million (GAAP). This uptick highlights renewed clinical activity tied to the upcoming Phase 3b ALS trial.

The company reported no revenue, as it remains firmly in the clinical trial stage without commercial products. Brainstorm did, however, receive significant regulatory news during the period: the FDA cleared the start of its pivotal Phase 3b “ENDURANCE” study of NurOwn in ALS. This randomized, double-blind trial is designed for about 200 participants, with a primary endpoint measuring changes on the ALS Functional Rating Scale. The clearance came after a Special Protocol Assessment agreement was reached with the FDA, giving Brainstorm detailed guidance and confidence on their trial design framework.

Clinical data were another highlight. New survival results from the Expanded Access Program showed that all participants (10 out of 10) treated with NurOwn lived beyond five years from ALS symptom onset—a result substantially ahead of published estimates for this disease, which suggest approximately 10% survival beyond five years. The company notes that this small group started treatment earlier in their disease course, so the results should be interpreted cautiously, but separately presented biomarker and genetic data have also brought peer recognition. NurOwn research was featured as “breakthrough science” at the International Society for Cell & Gene Therapy 2025 annual meeting, emphasizing ongoing scientific validation.

The company also moved forward on manufacturing partnerships and operational readiness. Letters of intent and collaborations with contract manufacturing organizations, such as Minaris, will help ensure clinical trial supply. Brainstorm continues to grow its intellectual property footprint, with around 30 patents pending or granted worldwide across cell therapy and exosome-based platforms.

Financial Position and Risk Profile

Despite cost control on general expenses and progress on key operational initiatives, the company’s financial position is precarious. Brainstorm ended the quarter with $1.03 million in cash, while quarterly expenses exceeded $2.5 million. Net loss (GAAP) was $2.9 million, compared to $2.54 million in the prior year. The balance sheet shows negative equity, with total liabilities of $8.6 million and a stockholders’ deficit of $6.1 million as of June 30, 2025 (GAAP).

This situation puts enormous pressure on the company to raise new capital quickly. Management is pursuing non-dilutive grants and strategic partnerships, targeting a $15 million grant as its top priority for funding the new clinical trial. Brainstorm’s pipeline includes NurOwn for ALS, a Phase 2 program for progressive multiple sclerosis, and a proprietary exosome-based platform. The ability to start and sustain the planned pivotal trial depends entirely on fresh capital, with management stating, “securing proper funding is an essential to commence the trial.”

Looking Ahead: Outlook and Investor Considerations

For the remainder of fiscal 2025, Brainstorm did not provide any formal financial or operational guidance. The absence of product revenue and low cash holdings place all future plans in flux until the company secures new funding sources. The primary focus will be initiating patient enrollment in the new Phase 3b ALS trial.

Investors should watch for developments on the funding front, progress with clinical trial enrollment, and additional regulatory updates as the most critical drivers for the company’s trajectory. Events like new grant awards, strategic collaborations, or changes in manufacturing capacity could quickly shift the outlook. BCLI does not currently pay a dividend.

Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.