BCLI

• Top priority is advancing NurOwn into Phase IIIb trial (ENDURANCE) for early-stage ALS; FDA granted clearance to initiate in May 2025, preparing for patient enrollment. Secured partnership with Minaris Advanced Therapies for manufacturing, with technology transfer in progress.
• Citizens petition filed with FDA by ALS patients/family; Brainstorm supports exploration of regulatory pathways. Stock transitioned to OTCQB due to NASDAQ noncompliance, but no impact on operations.
• Financials: R&D, G&A, net loss, and cash position discussed by Alla Patlis.

• Intended to initiate Phase IIIb trial but delayed due to funding challenges and citizens petition impact. Actively exploring alternative funding. Regaining NASDAQ compliance and uplifting is a core objective, linked to Phase IIIb trial initiation. Positive FDA outcome on citizens petition could enable funding for the trial.

For the quarter ended June 30, 2025, research and development expenditures net were $1.1 million (compared to $0.9 million in Q2 2024). General and administrative expenses were approximately $1.4 million (compared to $2.1 million in Q2 2024). Net loss was approximately $2.9 million or $0.34 per share (compared to $2.5 million or $0.60 per share in Q2 2024). Cash, cash equivalents and restricted cash were approximately $1 million as of June 30, 2025.

• Uncertainty from citizens petition affecting regulatory dynamics and funding. Delayed nondilutive funding due to submission timeline issues. Dependence on securing funding to initiate trial and meet NASDAQ requirements.

Q: When do you intend to begin the Phase IIIb trial?

A: Made progress to prepare for the trial but delayed due to funding and citizens petition; actively exploring alternative funding and ready to accelerate once funding is secured.

Q: What happened to the nondilutive funding that you shared you would be applying for?

A: Comprehensive application for nondilutive funding was prepared, but due to unexpected submission timeline issues and inability to secure co-funding, couldn't submit; will resubmit once co-funding is secured.

Q: Do you plan to regain compliance and uplift to NASDAQ?

A: Regaining compliance and uplifting is a core strategic objective, linked to Phase IIIb trial initiation; positive FDA outcome on citizens petition could enable funding for trial.

Q: What is the distinction between Citizens petition and broader public support or demand for NurOwn approval?

A: Citizens petition is a regulatory pathway; FDA must respond to it, and Brainstorm's clinical plan remains unchanged with focus on Phase IIIb trial using SPA agreement.

Q: Is the FDA open to looking beyond ALSFRS scores as a gold standard endpoint?

A: ALSFRS remains the primary gold standard endpoint in the trial, though other endpoints are exploratory; FDA reviews will consider relevant data.

Q: Personal story of ALS patient treated with NurOwn?

A: Appreciation for sharing the story, positive impact of NurOwn on the patient, and support for citizens petition to have FDA reevaluate the evidence