BRAINSTORM CELL THERAPEUTICS INC. Q4 FY2022 earnings call

• The FDA intends to hold an advisory committee meeting to discuss the BLA seeking NurOwn’s approval for ALS. The BLA is under review, and the ADCOM date is unknown but FDA is actively working on it. • Explained the File Over Protest pathway was chosen for the fastest regulatory path to an ADCOM. • Addressed the RTF letter from FDA, with ongoing work to respond to manufacturing items and focus on clinical data in the ADCOM. • Stacy Lindborg discussed the floor effect in the ALSFSR impacting Phase 3 trial results, new analyses at MDA showing NurOwn had significant response in non-floor effect participants. • Highlighted biomarker data collection and ongoing analysis, including partnership with NEALS for sample access to drive ALS research.

As of December 31, 2022, Brainstorm's cash, cash equivalents and short-term bank deposits were approximately $3 million, compared to approximately $22 million on December 31, 2021. Research and development expenditures net in 2022 were $14 million, general and administrative expenses were $10.9 million in 2022 versus $9.3 million in 2021. Net loss for the year ended December 31, 2022, was $24.3 million or $0.66 per share, compared to a net loss of $24.5 million or $0.68 per share in 2021.

• Anticipate receiving the ADCOM date from FDA and clarity on the PDUFA date. • Priority is to advance NurOwn through the regulatory process as expeditiously as possible.

• Uncertainties in the regulatory review process, including potential delays in ADCOM and PDUFA date determination. • Risks associated with interpretation of the floor effect in trial results impacting perception of efficacy.

Q: Can you tell us about the Biomarker response to the trial versus what happened in the Expanded Access Program?

A: Stacy Lindborg said the EAP is completed, final biomarker samples need to be collected from sites, and samples will be sent to labs used in the Phase 3 trial for analysis, with data to be presented in scientific forums.

Q: Have you submitted your Biomarker data to a public academic journal yet?

A: Stacy Lindborg stated the manuscript is fully written and in final stages of review with authors prior to submission.

Q: Regarding the timeline on the PDUFA date and the advisory committee. When did the clock start running for the review timeline?

A: Chaim Lebovits explained the BLA was re-filed on February 7, 2023, making that the date the review timeline became active again.

Q: Has the company been active with its ATM in the last few days? What is the capacity of that ATM?

A: Chaim Lebovits said the company is not active with the ATM currently, and the ATM capacity is $100 million.

Q: Did the floor effect impact the Biomarker changes in the total Phase 3 trial population? Can Biomarkers show impact of NurOwn despite floor effect on ALSFRS?

A: Stacy Lindborg said Biomarker data shows the same biological response with NurOwn across all trial participants, and no changes as expected with placebo participants, providing confidence in the impact of NurOwn.

Q: Can you talk about the safety aspects of an autologous cell therapy and its impact on ADCOM decision?

A: Stacy Lindborg said safety was closely monitored in the trial, with no safety concerns emerging, and safety will be summarized at the ADCOM.

Q: When does the company begin discussions with third-party payers and patient access?

A: David Setboun said the company has been engaged with payers for some time and has market access and pricing expertise in-house.

Q: Is there any intention to unblind trial participants?

A: Stacy Lindborg explained the decision to maintain confidentiality of randomization during regulatory review, as it facilitates discussion of evidence at a treatment group level and is industry best practice.