Brainstorm Cell Therapeutics (BCLI) Status Update summary

Regulatory and clinical trial progress

• Achieved alignment with the FDA on CMC aspects for the phase III-B ALS trial after a productive Type C meeting, following an SPA agreement outlining trial design and endpoints.

• Engaged a leading CRO with ALS and cell therapy expertise to support trial execution, with clinical sites already lined up and first patient dosing targeted before year-end.

• Trial entry criteria focus on early-stage ALS patients, with a shortened screening period and higher baseline ALSFRS scores to optimize for treatment response.

• Biomarker and potency release criteria for NurOwn have been agreed upon with the FDA, supporting both clinical trial and future commercialization readiness.

• Fast enrollment is anticipated due to increased trial sites and strong patient interest.

Financing and shareholder value

• Raised $4 million through a stock and warrant sale to fund near-term milestones, with additional financing options, including non-dilutive grants, actively being explored.

• Strategic fundraising aims to initiate the trial and achieve key milestones, with the expectation that positive trial progress will enhance company valuation and future financing terms.

• Focus on long-term shareholder value and milestone achievement to avoid a reverse stock split.

Manufacturing and operational updates

• Secured a commercial manufacturing partner to ensure BLA readiness and reduce time to market if the trial is successful.

• New COO, Dr. Haro Hartounian, brings extensive cell and gene therapy experience, overseeing CMC and commercialization.

• Manufacturing process is well-defined, with robust plans for identity, sterility, potency, and biomarker release criteria.