Brainstorm Cell Therapeutics Inc.

Good morning, everyone, and welcome to Brainstorm Cell Therapeutics' fourth quarter 2024 earnings call. At this time, all participants are in a listen-only mode, and if anyone should require operator assistance during this conference, please press star zero on your phone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Michael Wood. Michael, the floor is yours.

Thank you, operator. Good morning, and thank you for joining us. Before passing it off to company management for prepared remarks, I'd like to remind listeners on this conference call that it 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 of the treatment for neurodegenerative disorders such as ALS, the sufficiency 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 their business planning efforts. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond Brainstorm's 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 they undertake no obligation to publicly update any of these forward-looking statements. Joining us on the call today will be Mr. Chaim Liebowitz, President and CEO of Brainstorm, and Ala Patelist, Interim Chief Financial Officer. And in addition, Dr. Haro Hartonian, EVP and Chief Operating Officer, and Dr. Bob Dagger, EVP and Chief Medical Officer, are also on the line, and they will be available for the Q&A. So with that, I'd like to turn the call over to Mr. Liebowitz. Please go ahead.

Thank you, Michael. Good morning, good afternoon to everyone. Thank you for joining us today. We appreciate your continued interest and support in Brainstorm. 2024 was a year of foundational work, positioning us for the critical phase TB trial of Neuron, our investigational treatment for ALS. Our team, in close collaboration with leading ALS experts and regulatory authorities, has carefully designed a trial aimed at confirming neurons potential to significantly slow disease progression in early-stage patients, thus generating the robust data necessary for successful biologic license application. Our primary focus for 2025 is clear and unwavering execution. We're now advancing preparations to initiate the trial and begin patient enrollment driven by our strong belief that neuron, if approved, can make a meaningful difference in the lives of ALS patients. I want to address today three key areas critical to our progress. Regulatory, clinical, and trial execution and manufacturing. Regulatory. We maintain a strong collaborative relationship with the FDA. In 2024, we secured a special protocol assessment significantly de-risking the regulatory pathway. We're also aligned with the FDA on chemistry, manufacturing, and controls, a crucial aspect for a complex cell therapy like Neuron. I want to emphasize that we have been diligently updating and submitting models to our IND. including detailed technical transfer documentation, quality assurance, and quality control processes. While these processes require attention and time, they are essential for regulatory compliance and trial integrity. We anticipate announcing the submission of these models shortly. Clinical. We are in active negotiations for clinical trial agreements with approximately 15 leading clinical centers across the United States, leveraging our established relationship with many of these institutions. The strong interest from renowned ALS clinicians and researchers underscore their belief in Neuron's potential. We will announce these agreements as they are finalized. The trial execution and manufacturing to ensure the efficient execution Of our Phase IIIb trial, we have partnered with Equivia, a leading clinical research organization, specializing in cell and gene therapy trials. Equivia's expertise in ALS trials, regulatory compliance, and comprehensive capabilities will be crucial in managing key aspects of the clinical trial. For the clinical manufacturing of Neuron, we have contracted with Pluri, Inc., leveraging their expertise in GMP-compliant production. This arrangement complements our lease facility at Swarovski Medical Center in Tel Aviv. Furthermore, we're planning to bring an additional U.S.-based manufacturing center online to support broader production needs as we advance through clinical trials. Our financial position and strategic outlook. I want to address the financial realities and strategic direction of Brainstorm directly. We are committed to securing the necessary funding execute the Phase 3B trial, and build a sustainable future. We're actively pursuing multiple funding avenues, including what we announced today, including licensing non-core assets for near-term capital, and exploring non-diluted financing opportunities, such as grant funding. I understand that investors, and even more so the patient community, are eager for rapid progress. we are accurately aware of the urgency. I want to acknowledge the extraordinary dedication of our staff who worked tirelessly under significant financial constraints, including salary reduction, to advance this trial. The time required for regulatory submissions, including the intricate technical transfer and QA-QC processes inherent in a pioneering stem cell therapy, is not indicative of financial delays. I also want to address the expectations regarding immediate financing announcements and trial milestones. We've committed to transparency, but we must adhere to rigorous regulatory processes. We are pioneering in a space where we know there is skepticism, and we must provide robust data to validate neurons efficacy. The Phase 3b trial involves rolling enrollment based on manufacturing capabilities for an autologous stem cell therapy. We anticipate needing approximately $20-30 million annually to see the trial to its conclusion. Given our current market capitalization and the challenging market for non-revenue biotech, raising this amount of cash up front is not practical. But we believe that as we achieve key milestones, IND model submission, FDA clearance to proceed, signing CTAs, and enrolling the first patient, we will see a corresponding increase in our market valuation, especially when combined with strategic partnerships and non-dilutive grants. We are fully committed to this mission. Myself, our chief medical officer, our chief operating officer, our chief business officer, and other senior officers are at times working without remunerations. and most of our other employees have taken significant reductions in compensation. Many of our talented team members have also made sacrifices. They are driven by a shared commitment to proving neurons' potential and ultimately helping ALS patients and for other neurodegenerative diseases. We are deeply grateful for their dedication and want to assure They are recognized and rewarded for their contributions. ALS is a devastating disease. We are committed to providing a therapeutic solution. We are confident in the foundation we have built and the progress we are making. We will continue to provide updates as we advance through the FaceDB trial. We are committed to doing all we can to make this happen. Thank you for your continued support. I'll now turn the call over to Alaa to review the financials.