BRAINSTORM CELL THERAPEUTICS INC. Q3 FY2023 earnings call

• Regulatory: Withdrew BLA for NurOwn from FDA review, submitted request for meeting with FDA to discuss Phase 3b trial design and seek Special Protocol Assessment (SPA).
• Strategic realignment: Streamlined clean room operations, 30% headcount reduction, senior management took wage cuts (e.g., CEO took over 90% cut), estimated to cut total resource consumption by ~50%.
• Financials: Provided Q3 2023 financial results including cash, expenses, and net loss compared to prior year.

No detailed product segment financial performance provided. Overall, cash, cash equivalents, and short-term bank deposits were approximately $1.4 million as of September 30, 2023 compared to $3 million as of December 31, 2022. Research and development expenses for Q3 2023 were approximately $3.3 million vs. $3.8 million in Q3 2022. General and administrative expenses for Q3 2023 were approximately $2.7 million vs. $3.1 million in Q3 2022. Net loss for Q3 2023 was approximately $1.2 million or $0.03 per share compared to a net loss of approximately $6.9 million or $0.19 per share in Q3 2022.

• Intend to seek SPA with FDA to align on Phase 3b trial design.
• Actively exploring funding options including non-dilutive grants, partnerships, and capitalizing on non-core assets like exosome technology.
• Plan to start Phase 3b trial in stages, not waiting for full funding to commence.

• Regulatory uncertainties with FDA regarding trial design and approval.
• Dependence on successful fundraising to fund trial and ongoing operations.
• Uncertainty in biotech modality adoption which may affect partnership opportunities.

Q: Is it possible that even with the ADCOM decision around NurOwn, the FDA could grant limited approval for early stage ALS patients where there has been an observable positive response?

A: Stacy Lindborg stated that generating additional data via Phase 3b trial is the only path to gain regulatory approval for NurOwn, and they wouldn't have withdrawn the BLA if they thought current data alone would suffice.

Q: How long before you know more about your funding plans? And when are you hoping to start the Phase 3b? And are you waiting for funding or grants to come in before you can commence the study?

A: Chaim Lebovits said they're working with banks and exploring various funding avenues including partnerships and grants, expect to raise funds for the trial in stages, and won't wait to start the trial until full funding is secured.

Q: Are you working on the new trial parameters with the FDA?

A: Stacy Lindborg said they requested an expedited face-to-face meeting with FDA to discuss next steps including Phase 3b trial design and seek SPA.

Q: Why don't you partner with big pharma?

A: Chaim Lebovits said they're seeking partnerships, cell therapy is an emerging modality, but they have a derisked Phase 3 asset with attractive upside and will pursue partnerships as a promising avenue.

Q: Why is this time going to be different?

A: Chaim Lebovits mentioned FDA proposed expedited SPA, they'll work to align on trial design and listen to inputs from organizations and advocates, and the expedited SPA process may lead to different treatment path.

Q: On manufacturing, comment on BrainStorm's ability to manufacture and clean room management?

A: Chaim Lebovits said they'll balance academic and commercial sites, start with academic centers for cheaper operation and have commercial site ready for trial success.

Q: Comment on exosome technology?

A: Stacy Lindborg said exosome technology allows exploration of different diseases with cargo-carrying ability and potential for effective administration options.