Brainstorm Cell Therapeutics Inc.

Greetings and welcome to the Brainstorm Cell Therapeutics first quarter 2025 conference call. At this time, all participants are in a listen-only mode. As a reminder, this call is being recorded. I would now like to introduce your host for today's call, Joyce Lonergan of LifeSci Advisors. Joyce, you may begin.

Thank you, Holly. Good morning and thank you for joining us today. Before passing the call 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 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 its SEC filings. The company's results may differ materially from those projected on today's call. The company undertakes no obligation to publicly update any forward-looking statements. Joining us on the call today will be Chaim Leibovitz, President and Chief Executive Officer of Brainstorm, Dr. Hara Hartounian, Executive Vice President and Chief Operating Officer, Dr. Bob Dagger, Executive Vice President and Chief Medical Officer, and Dr. Netra Plontanshraga, Senior Vice President of Research and Development. I would now like to turn the call over to Mr. Leibowitz. Please go ahead.

Thank you, Joyce. Good morning or good afternoon, everyone. Thank you for joining us today. We appreciate your continued interest and support in Brainstorm. We published our Q1 2025 earnings release after the market closed last Thursday, and my colleagues and I are pleased to provide a corporate update today. Our unwavering primary focus remains the execution of the clinical development plan for Neuron and the initiation of our pivotal Phase 3b trial designed to confirm its therapeutic benefit for individuals in the early stages of ALS. Hopefully, you will have seen the press release we released this morning announcing that US FDA has cleared us to initiate the trial. This follows the amendments we submitted to our investigational new drug application, which included comprehensive technical transfer documentation, robust quality assurance, and stringent quality control processes. This regulatory clearance marks a significant milestone, bringing us closer to commencing patient enrollment. As previously disclosed, the trial design has been carefully agreed upon with the FDA under a special protocol assessment, or SPA. This SPA is a crucial element as we believe it substantially de-risks the regulatory pathway for Neuron. It provides confirmation that the trial's endpoints and our statistical analysis plan are deemed appropriate for the FDA to potentially support approval, contingent, upon the trial meeting its pre-specified expectations. We also announced previously that in a face-to-face type C meeting, we had achieved alignment with the FDA and CMC, a particularly vital aspect for an advanced cell therapy like Neuron. Our CMC team is always advancing its development and continues to work as regulatory guidance directs. To provide further detail on our operational readiness for the upcoming trial, I'd like to turn the call over to our Chief Operating Officer, Dr. Jairo Artunio. Jairo?