Brainstorm Cell Therapeutics Inc.

And welcome to the Brainstorm Cell Therapeutics Second Quarter 2023 Earnings Call. At this time, all 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 call, Mr. Michael Wood of LifeSite Advisors. Mr. Wood, you may begin.

Good morning, and thank you for joining us this morning. Earlier today, Brainstorm issued a press release with its financial results for the second quarter of 2023, including a corporate update. Before passing it off to the company for prepared remarks, I'd 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 diseases such as ALS, the sufficiency of the company's existing capital resources for continued operations in 2023 and beyond, the safety and clinical effectiveness of 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 its business planning efforts. Forelooking 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 the company undertakes no obligation to publicly update any forward-looking statements. Joining us on the call this morning will be Karin Leibowitz, President and CEO of Brainstorm, Dr. Stacey Lindberg, Co-Chief Executive Officer, and Ala Patlis, Interim Chief Financial Officer. In addition, Brainstorm's Executive VP and Chief Medical Officer, Dr. Kirk Taylor, is also on the call and will be available to answer questions during the Q&A session. So I'd like to turn the call now to Mr. Leibowitz. Please go ahead.

Thank you, Michael. Thank you all who have joined us to discuss our Q2 2023 financial results and recent progress. Our main priorities right now are to prepare for the forthcoming advisory committee for Neuron, our investigational therapy for the treatment of ALS, and to make sure the company is prepared to make Neuron available to patients. As announced in June, the FDA will convene a meeting of the Cellular Tissue and Gene Therapies Advisory Committee to review our BLA for Neuron on September 27. In addition, the BLA has been assigned a PDUFA action date of December 8, 2023. Neuron's regulatory process, as we have mentioned previously, will be the same as it is for any other investigational therapy that is subject of a filed BLA. The upcoming outcome will be guided by an agenda that includes detailed presentations by Brainstorm and the FDA, which will allow our team and the agency to discuss the clinical evidence supporting neurons' safety and efficacy as an ALS therapy. Other key stakeholders, including independent medical experts, statisticians, and patient advocates, will then have the opportunity to provide their own unique perspective on neurons' clinical data set as well as the unmet needs of people living with ALS. Members of the outcome will then have the opportunity to vote on the response to the question set forth by the FDA. The agency will take the results of this vote, or these votes, as well as the preceding discussions at the meeting, under advisement when coming to a decision on the BLA, which will be made by the December 8th PDUFA date. Given the strength of the clinical evidence we have generated on Neuron, we remain confident in our ability to achieve a successful outcome from the outcome and are preparing for success to ensure we can make Neuron available to patients as quickly as possible if approved later this year. Our team is focused on being fully prepared in advance of the upcoming outcome. These preparations began months ago and continue today as we work with our expert consultants to ensure we can present and respond to all questions that the FDA and ATCA members might raise. We are grateful to the FDA for its cooperation throughout the review process and recognize that the agency is taking our application very seriously. I'll now turn the call over to my colleague, Dr. Stacey Klimberg, for additional comments. Stacey?