BRAINSTORM CELL THERAPEUTICS INC. Q1 FY2023 earnings call

• FDA notified of an advisory committee to discuss the BLA for NurOwn; no firm date yet.
• Thorough analysis of NurOwn Phase 3 data shows clinically meaningful effectiveness in pre-specified less advanced disease subgroup.
• Additional focused analyses provide insights into trial outcomes, showing statistically significant treatment difference in a pre-specified subgroup on a secondary endpoint.
• Strong and consistent biomarker data supporting NurOwn's mechanism of action.
• Appointed Dr. Kirk Taylor as EVP and CMO, plus other key hires in regulatory and clinical operations.
• FDA granted accelerated approval to another ALS drug, and Brainstorm is watching developments.

Brainstorm's cash, cash equivalents, and short-term bank deposits were approximately $2.2 million as of March 31, 2023, down from $3 million on December 31, 2022. Research and development expenditures for Q1 2023 were $2.9 million, compared to $2.6 million in Q1 2022. General and administrative expenses were $2.2 million in Q1 2023, down from $2.9 million in Q1 2022. Net loss for Q1 2023 was $5.1 million or $0.14 per share, compared to a net loss of $5.4 million or $0.15 per share in Q1 2022.

• Planning for anticipated growth by expanding medical, regulatory, and advocacy teams.
• Awaiting advisory committee meeting to discuss BLA for NurOwn.

• Uncertainty around the timing and outcome of the advisory committee.
• Financial risk related to cash levels, but company has institutional support and a $100 million facility.
• Regulatory risks associated with BLA approval process.

Q: Do you have a firm date for the upcoming advisory committee?

A: No, we don't yet have a firm date. Once we have, we will share it.

Q: Why did BrainStorm design the Phase 3 to allow participants with advanced ALS unless the inability to measure their progress during the study?

A: Explained about floor effect in ALS functional rating scale not being well understood in 2016-2017, and current trials accounting for this.

Q: Does BrainStorm believe it must have a biomarker analyses published to be successful at the ADCOM?

A: No, but publishing more data informs the community; manuscript is in final review before submission.

Q: Are you willing to partner with large cap biopharmaceutical companies to accelerate clinical trials?

A: Always willing to entertain partnerships in the best interest of the company.

Q: Motivated to join BrainStorm?

A: Unmet medical need and possibility of bringing new treatment to ALS community, plus joining world-class team.

Q: Lead times for FDA advisory committee meeting?

A: FDA gives lead time, but exact date not set yet, expected in next few months.

Q: Strategy for advancing NurOwn in other jurisdictions?

A: Focused on ADCOM, but will look at other jurisdictions with new hires.

Q: Finances with $2.2 million cash?

A: Have institutional support, $100 million facility, no debt.

Q: Next generation drugs?

A: R&D team working on next gen drugs for ALS, MS, Parkinson's, Huntington's, etc.