Brainstorm Cell Therapeutics Inc.

Good day, ladies and gentlemen, and welcome to the Brainstorm Cell Therapeutics third quarter 2021 earnings call. At this time, all participants have been placed on a listen-only mode, and the floor will be open for questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, Michael Wood of LifeSci Advisors. Sir, the floor is yours.

Good morning, and thank you for joining us. Before we begin the opening remarks, I'd like to remind listeners that this conference call contains 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 diseases such as ALS and MS, the sufficiency of the company's existing capital resources for continuing operations in 2021 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 the 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 filings with the SEC. 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 me on the call today will be Haim Leibowitz, President and CEO of Brainstorm, Ala Patlis, Interim Chief Financial Officer, and in addition, Dr. Stacey Lindberg, Executive VP and Chief Development Officer, Dr. Ralph Curran, President and Chief Medical Officer, and Dr. David Setburn, Executive VP and Chief Operating Officer, will also be on the call and will be available to answer questions during the Q&A session. So I'd now like to turn the call over to Mr. Leibowitz. Please go ahead.

Thanks, Michael. Thanks to all listening for joining us to discuss our third quarter financial results and corporate highlights. There are updates on our own in both the ALS and Progressive MS programs that I want to cover today, as well as some important additions to our management team. First, With regard to our lead program, Neuron and ALS, we remain committed to advancing this program and pursuing the best and most expeditious path forward to enable patient access. Patients and advocates are changing the landscape of ALS to match the urgency of their disease. Given the important changes, we are in active dialogue with regulators around our regulatory plan and we will share this as soon as it is appropriate. We recently presented important new biomarker data from our Phase III trial in ALS in a poster session at the Northeast ALS Consortium for NILS in October. The presenter was Dr. James Berry, the Principal Investigator of Neuron Trial and the Director of the Massachusetts General Hospital Multidisciplinary ALS Clinic. Biomarker analysis, as a reminder, were pre-specified in the statistical analysis plan and was completed and submitted to the FDA prior to unblinding of the tract. These involved collecting PSF samples from all participants and measuring pre-specified biomarkers at seven time points from baseline through week 20. The results of these analysis showed that neural treatment resulted in significant changes across many biomarkers pertaining to neurodegeneration, neuroinflammation, and neuroprotection, while levels of these biomarkers remained stable and unchanged following treatment with placebo. Another important analysis that was pre-specified was designed to help us understand how the observed changes in biomarkers with neuron related to clinical response observed in the trial. As shared in Daniil's presentation, Dr. Berry presented results from a stepwise regression model which identified a set of biomarkers spanning the pathways of neuroprotection, neuroinflammation, and neurodegeneration biomarkers that accurately predicted clinical response in the trial with over 80% accuracy. And not only did we observe significant changes in biomarkers important for ALS with neurons, but they are meaningful in helping us understand who responded to treatment in the studies. The results further our understanding of neurons' mechanism of action in ALS, which targets multiple pathways and provides additional evidence linking the mechanism of action to neurons' impact on ALS disease progression. In the future, this information will also help future studies that use CSF biomarkers to advance ALS science. We do, of course, plan to share them with the FDA and other regulatory authorities. A hyperlink to this poster was included in the press release, which is available on the publication section of the Brainstorm website. I would encourage investors to review it. Turning now to our Progressive Multiple Fetorosis Program. The results from our Phase II study of Luron in Progressive MS were featured in an oral presentation at the 37th Congress of the European Committee of Treatment and Research in Multiple Fetorosis, or ACTRAN. We announced positive top-line results from the study in March of this year, and this was our first opportunity to share the results with the broader neurology community at a major international MS meeting. The presentation was given by Dr. Jeffrey Cohen, the director of experimental therapeutics at the Cleveland Clinic Mellon Center for MS and Principal Investigating the Neuron MS Phase II Trial. Dr. Cohen shared that the study achieved its primary endpoint of safety and vulnerability. In addition, we demonstrated a reduction of neuroinflammatory biomarkers and an increase in neuroprotective biomarkers in CSF. In addition, we observed consistent improvement across MS-functional outcome measures, including walking, upper extremity function, vision, and cognition. Brainstorm was the main sponsor for this study, but we had additional financial support for the biomarker analysis from the National Multiple Sclerosis Society's Best Forward Program.