Brainstorm Cell Therapeutics Inc.

Greetings, ladies and gentlemen, and welcome to the Brainstorm Cell Therapeutics Second Quarter 2022 Conference Call. At this time, 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 conference, Mr. Tom Galassi of LifeSciAdvisors. Mr. Galassi, you may begin.

Good morning, and thank you for joining us. Before we begin the opening remarks, we would 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 performance, statements regarding the market potential for the treatment of neurodegenerative disorders such as ALS and MS, the sufficiency of the company's existing capital resources for continuing operations in 2022 and beyond, the safety and clinical effectiveness of the Neurone 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 filing. 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 Chaim Leibovitz, Chief Executive Officer of Brainstorm, Dr. Stacey Lindberg, Executive Vice President and Chief Development Officer, Dr. Ralph Kern, President and Chief Medical Officer, and Alaa Patlas, Interim Chief Financial Officer. In addition, Dr. David Zeppelin, Executive Vice President and Chief Operating Officer, is also on the call and will be available to answer your questions during the Q&A session. Now, I would like to turn the call over to Mr. Leibovitz. Please go ahead.

Thanks, Tom, and thank you to all listening for joining us to discuss our second quarter financial results and corporate highlights. I expect most of you have read our press release by now, and you will be able to see that we have been working very hard behind the scenes. We've been extremely disciplined by remaining quiet until today about our intentions to submit a BLA for Neuron. We are very excited to have this Q2 earnings call and to provide you with an update. Before I share my prepared remarks, the right thing to do is to start by expressing my thanks. Some of you might not understand all that is required to prepare a regulatory dossier, especially the first DLA for brainstorm. We have been working diligently towards this goal for over a year. And this is a very important moment for us as a company. I want to thank each and every employee at Brainstorm. Many who have dedicated their entire careers to our mission to help ALS patients. Every person in our company has contributed to this moment. But I would be remiss if I didn't specifically highlight the leadership of a few people. I'll start with Yosef Levy, our Vice President of Manufacturing. but has been accountable for every product that has been manufactured. It serves as the basis for our application. Under his leadership, we have launched a new manufacturing site with our commercial partner, Catalent, a great partner, by the way, in preparation for commercial launch, and authored the CMC sections of the BLA. Next, I want to thank Stacy Lindbergh, Executive Vice President and Chief Development Officer, for her leadership in clinical development and as the overall leader for the entire BLA process. Stacey has not only been the key driver of analytics and insights we have gained from phase three, but has also authored key non-clinical and clinical modules of the FBLA. Of course, I would like to thank our president, the chief medical officer, Ralph Kern, and the entire medical affairs team. This is also an appropriate time to thank the California Institute for Regenerative Medicine for being our substantial financial partner for this trial, as well as IMALS and ALS Association for funding part of the biomarker study. There are a number of important items to cover on today's call, including an update regarding the published results from Neuron's Phase III ALS trial and our decision to submit a BLA to the FDA for Neuron. In addition, Ralph will be speaking about our progressive MS program, and reviewing some of the recent presentations we made to the medical community. As is our usual practice, we'll follow our prepared remarks by addressing questions we received from investors in advance, as well as taking live questions from those of you listening on the call today. Beginning with our Phase III results, which you may recall were peer-reviewed and published in the journal Muscle & Nerve in December 2021 and in print in March 2022. While performing routine quality control checks and preparations for upcoming BLA filing, we discovered an error in the statistical model utilized by a vendor in the analysis of a key secondary endpoint. This is now being corrected, and last Friday, Muscle and Nerve published an errata sheet to the original article. Though correcting the error resulted in a change that was relatively small numerically, it does have meaningful positive implications that reinforces and strengthens the conclusions of the Phase III study. With the correction, the Phase III data are stronger than originally thought as we have achieved statistical significance on a key, important secondary endpoint for multiple subgroups, including the trial's pre-specified efficacy subgroup. The endpoint I'm referring to is average change from baseline to week 28 in ALS-FRS-R score and the pre-specified subgroup in trial participants with baseline ALS-FRS-R scores of at least 35, which is indicative of patients with less disease progression. Let me be clear about the context of the trial. The underlying data has not changed. The primary and secondary endpoints for the overall trial are still not significant. And it's productive to also clarify that the RATM relates only to the pre-specified subgroup on the secondary endpoint, as mentioned in addition to sensitivity analysis with additional thresholds summarized in the original manuscript. Given Stacey's extensive expertise and experience, as an industry leader and relevant to this discussion, Stacey is specifically also a globally recognized medical statistician It's far more appropriate that I ask Stacey to lay out in more detail this data. Stacey.