Brainstorm Cell Therapeutics Inc. Q2 FY2024 earnings call

• Progress in preparations for Phase 3b trial for NurOwn in ALS, with NurOwn as a derisked asset having secured FDA SPA and alignment on CMC aspects. - Selected leading CRO and building network of clinical centers. - Actively pursuing non-dilutive funding, including a $15M grant application. - Addressing NASDAQ listing requirements, scheduling earlier shareholder meeting to seek approval for reverse split authorization if needed. - Financials overview by Alla Patlis on cash, expenses, and net loss.

Cash, cash equivalents and restricted cash were approximately $3.65 million as of June 30, 2024 compared to $0.75 million as of June 30, 2023. Research and development expenses for the three months ended June 30, 2024 and 2023 were approximately $0.9 million and $2.8 million respectively. General and administrative expenses for the three months ended June 30, 2024 and 2023 were approximately $2 million and $2.7 million respectively. Net loss for the three months ended June 30, 2024, was approximately $2.5 million as compared to a net loss of approximately $5.3 million for the three months ended June 30, 2023. Net loss per share for the three months ended June 30, 2024 and 2023 was $4.13 respectively.

• Aim to initiate Phase 3b trial for NurOwn in ALS by end of 2024 or first quarter of 2025. - Focus on non-dilutive funding sources. - Key near-term milestones include securing trial side agreements, obtaining non-diluted funding, and initiating the trial.

• NASDAQ delisting risk if not maintaining $1 share price for 10 consecutive trading days by October 28 and $35 million market cap. - Potential dilution concern but emphasis on non-dilutive funding strategies to minimize dilution.

Q: Can you please elaborate on the key milestones that investors should be looking forward to in the near term?

A: Securing first few trial side agreements, pursuing additional non-diluted funding, and trial initiation.

Q: With the proposed increase in authorized shares, what is your plan for equity raises over the next several quarters?

A: Increase in authorized shares is for flexibility to pursue strategic opportunities without dilutive financing, focusing on non-dilutive funding sources.

Q: With the CMC alignment, does the company need to implement any new actions or adjustments?

A: Reached alignment to initialize the trial.

Q: Regarding the ALS FRS entry criteria changes, how do they impact the Phase 3b trial?

A: Entry criteria refined to focus on earlier disease course patients for higher likelihood of showing benefits from NurOwn.

Q: Regarding the Phase 3 trial structure, could the BLA be filed immediately after double-blind portion?

A: Yes, BLA could be filed after the first half of the double-blinded period.

Q: Color on trial cost and production cost?

A: Still finalizing contracts, previous trial cost ~$50M for 200 patients, working on reducing production costs through technological innovations.