Brainstorm Cell Therapeutics (BCLI) Q2 2026 earnings summary

Executive summary

• Focused on developing autologous cellular therapies for neurodegenerative diseases, with NurOwn® as the lead candidate for ALS, PMS, and AD; advanced preparations for the Phase 3b ENDURANCE trial in ALS, with FDA Special Protocol Assessment granted.

• NurOwn® completed Phase 3 ALS and Phase 2 PMS trials; regulatory pathway for ALS continues after BLA withdrawal in late 2023.

• Recent FDA alignment on Phase 3b trial protocol and CMC aspects for ALS; additional capital needed for further trials and commercialization.

• Appointed Peter J. Pitts, former FDA Associate Commissioner, as Executive Chairman to strengthen regulatory and operational leadership; leadership transitions include Professor Jacob Frenkel moving to Senior Advisor.

• Published a peer-reviewed article advocating for modernized FDA approaches to ALS and rare diseases, highlighting regulatory collaboration.

Financial highlights

• Net loss for Q2 2026 was $3.9M, up from $2.9M in Q2 2025; net loss for H1 2026 was $5.98M, up from $5.77M in H1 2025.

• Operating expenses for H1 2026 were $5.66M, nearly flat year-over-year; R&D expenses decreased, G&A expenses increased due to higher stock-based compensation.

• Cash, cash equivalents, and restricted cash at June 30, 2026, totaled $0.2M, down from $1.03M a year earlier.

• Net cash used in operating activities for H1 2026 was $2.22M; net cash provided by financing activities was $2.15M.

• General and administrative expenses rose to $2.7M in Q2 2026 from $1.5M in Q2 2025; R&D expenses were $1M in Q2 2026, down from $1.1M in Q2 2025.

Outlook and guidance

• Management expects continued losses and negative cash flow from clinical and regulatory activities.

• Additional funding is required to support Phase 3b ALS trial, commercialization, and other pipeline activities.

• Focused on launching the Phase 3b ENDURANCE trial for NurOwn in ALS, aiming to support a new BLA submission.

• Committed to advancing regulatory, operational, and partnership initiatives to support clinical development.

• Uncertainty remains regarding the ability to raise capital on acceptable terms.