Brainstorm Cell Therapeutics Inc.

Greetings and welcome to the Brainstorm Cell Therapeutics Second Quarter 2025 Conference Call. At this time, all participants are in a listen-only mode. As a reminder, this call is being recorded. And I would now like to introduce your host for today's call, Michael Wood of LifeSci Advisors. Mr. Wood, you may begin.

Thank you, Kelly. Good morning, everyone, and thank you for joining us this morning. before passing it off to company management for prepared remarks. I would like to remind listeners that this conference call will contain numerous statements, descriptions, forecasts, and projections regarding Brainstorm Cell Therapeutics and its potential future business operations and performance, statements regarding the market potential for the treatment of neurodegenerative disorders such as ALS, the sufficiency of the company's existing capital resources for continuing operations in 2025 and beyond, the safety and clinical effectiveness of the Neuron technology platform, clinical trials of Neuron and related clinical development programs, and the company's ability to develop strategic collaborations and partnerships to support its business planning efforts. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond brainstorm control, including the risks and uncertainties described from time to time in the company's SEC filings. The company's results may differ materially from those projected on today's call, and the company undertakes no obligation to publicly update any forward-looking statements. Joining us on the call this morning will be Haim Leibowitz, President and CEO of Brainstorm, Dr. Bob Dagger, Executive Vice President and Chief Medical Officer, Haro Hartonian, Executive Vice President and Chief Operating Officer, and Ala Patlis, Interim Chief Financial Officer. So I'd now like to turn the call over to Mr. Liebowitz. Please go ahead.

Thank you, Mike. Good morning, everyone. Thank you for joining us today. We appreciate your continued interest and support in Brainstorm. I want to reaffirm that our top priority is advancing Neuron into our planned Phase IIIb clinical trial. This trial called Endurance is designed to confirm its therapeutic benefit in patients with early stage ALS. As we previously disclosed, we reached a key milestone in May this year with the US FDA granting clearance to initiate this pivotal trial. This allows us to move forward with patient enrollment and we are preparing to begin that process. The trial for Endurance has been reviewed and agreed upon with the FDA under a special protocol assessment, or SPA, which confirms that the study's endpoints and statistical methods will be appropriate to support a future BLA. Assuming the data meets expectations, the SPA provides us with regulatory clarity and a strong foundation, and we believe it de-risks this program. An important part of the trial preparations is to ensure we have a robust manufacturing network to supply product for the trial. We announced during the second quarter that we secured a partnership with Minaris Advanced Therapies, a global contract development and manufacturing organization that specializes in cell and gene therapies. We have initiated the technology transfer and preparation for clinical trial manufacturing at Minaris State of the Art facility in Allendale, New Jersey. This partnership enhances Brainstorm's U.S.-based manufacturing capabilities and will complement our previously announced collaboration with Pluri Inc. in Israel, which will also contribute to the production of clinical trial materials. I want to spend a few minutes talking about a recent important regulatory development, and that is the filing of the citizen's petition with the FDA requesting a de novo review of the data-supporting neurons. This petition was filed by a coalition of ALS patients and family members. As a reminder, a citizen petition filed under the Federal Food, Drug, and Cosmetic Act is a formal process allowing any interested party to request FDA action, and this includes reviewing data or issuing new guidance. Although Brainstorm was not directly involved in drafting or submitting this petition or its contents, We, of course, welcome the FDA's willingness to reevaluate existing data. We have consistently stood by the integrity and scientific validity of the neuron data, and we support exploration of potential regulatory pathways that may allow appropriate access to this potentially valuable treatment for patients with ALS. We believe a comprehensive review of all evidence is essential, and this is even more important today as the regulatory landscape for rare disease with unmet needs continues to evolve. The Citizen's Petition is a 309-page document that incorporates a decade of data, including the results completed, neurons, trials, as well as extensive real-world evidence, such as new findings from the Expanded Access Program. The new evidence is supported by testimony from top ALS neurologists who served as principal investigators in the prior Phase III trials. Brainstorm is committed to continuing alignment with the FDA and we intend to proceed the Phase 3B endurance trial as I explained earlier. As previously announced, Brainstorm's common stock recently transitioned from the NASDAQ capital market to the OTCQB. The listing is a result of the company's non-compliance with NASDAQ listing rule 550B1 pertaining to its minimum shareholder equity requirement. While this was a challenging outcome, I want to be clear that it has no impact on our business operations, our ongoing R&D programs, or our commitments to execute on our strategic priorities. We remain fully committed to advancing Neuron for patients living with ALS and to progressing our clinical initiatives, including the planned Phase 3b trial. Our vision for the company and focus have not changed. The work being conducted by our team continues, and our dedication to serving both our patients and our shareholders remains steadfast. Brainstorm remains a reporting company under the Securities Exchange Act of 1934 and will continue to provide regular updates on our operational progress and financial position in full compliance with applicable SSU regulations. We intend to keep stockholders informed of all material developments as we assess our options for relisting on the NASDAQ. Hala?