Brainstorm Cell Therapeutics Inc.

Thank you for holding, ladies and gentlemen, and please remain on the line. The brainstorm conference event will begin momentarily. Thank you for your patience. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Greetings, and welcome to the Brainstorm Cell Therapeutics Third Quarter 2022 Conference Call. At this time, participants are in a listen-only mode. As a reminder, this conference call is being recorded. And now, I would like to introduce your host for today's conference, Michael Wood of LifeSci Advisors. Mr. Wood, you may begin.

Good morning, and thank you for joining us. Before we begin the call and opening remarks, we'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 2022 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 brain surface 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 takes no obligation to publicly update any forward-looking statements. Joining us on the call today will be Harry Leibowitz, President and CEO of Brainstorm, Dr. Stacey Lindberg, Executive Vice President and Chief Development Officer, Dr. Ralph Kern, President and Chief Medical Officer, and Ala Patlis, Interim Chief Financial Officer. In addition, Dr. David Setborn, 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. So now I'd like to turn the call over to Mr. Liebowitz. Please go ahead.

Thanks, Michael, and thank you to everyone for joining us this morning. As is our usual practice, we'll follow our prepared remarks by addressing questions we receive from investors in advance, as well as taking live questions from those of you listening on the call today. The main topic we want to cover this morning is the FDA's issuance of a refusal to file letter for the Neuron BLA submission. The letter we received from the FDA contained two topics that led to the issuance of the refusal to file letter. The first is clinical and statistics, and the second is CMC, or chemistry manufacturing and controls. On the first topic, clinical and statistics, the letter basically summarizes what was known prior to the filing, that the trial missed the primary endpoint. On the second topic, the letter itemizes CMC items that we expect to be able to fully remediate. Returning to the first and arguably the most important topic in the letter, it is clear that the FDA still seeks substantial evidence defined by statistically significant results on the clinical outcomes measured by the primary endpoint. And anything short of this, in their view, is insufficient evidence for a filing. We obviously have a different view on the value of the evidence that has been generated from the Phase III trial. We continue to believe that the totality of evidence from the Phase III trial is sufficient to support an approval and represents a significant contribution to ALS therapy. We also believe there needs to be urgency and flexibility in the review and approval of treatments for individuals with ALS who have no time to waste. ALS remains a uniformly fatal illness where death occurs typically within two to five years from diagnosis. The limited number of available treatments have only modest impacts on disease progression. We will pursue a type A meeting to progress this application. And as part of this meeting, we will discuss with FDA a path to an FDA Advisory Committee meeting, an outcome. We believe that it is more than reasonable to expect that the FDA will allow a fair hearing in an open and transparent setting as an FDA Advisory Committee meeting. And ADCOM provides an open and fair hearing in a public venue in which the FDA can frame their review of the evidence and all the other relevant stakeholders can also express their view and also hear how medical experts, statisticians, patients, and other members of the ALS community view our data. This forum would also allow patients physicians, and the broader advocacy community to express their views relevant to an approval. At this point, I will turn the call over to Dr. Stacey Lindberg, our Executive Vice President and Chief Development Officer, for some additional comments and to provide our view of data share through recent medical conference presentations. Stacey?