Brainstorm Cell Therapeutics Inc.

Greetings and welcome to the Brainstorm Cell Therapeutics third quarter 2023 earnings 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 call, Michael Wood of LifeSci Advisors. Mr. Wood, you may begin.

Good morning and thank you everybody for joining us. Earlier today, Brainstorm issued a press release with its financial results for the third quarter of 2023, including a corporate update. Before passing it off to the company management for prepared remarks, I'd like to remind listeners on this conference call will contain numerous statements, descriptions, forecasts, projections regarding Brainstorm Cell Therapeutics and its potential future business operation and performance, statements regarding the market potential, the treatment of neurodegenerative disorders such as ALS, the sufficiency of the company's existing capital resources for continuing operations in 2023 and beyond, the safety and clinical effectiveness of the neurotechnology platform, clinical trials of neuron and related clinical development programs, as well as the company's ability to develop strategic collaborations and partnerships to support its 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 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 today will be Mr. Chaim Liebowitz, President and CEO of Brainstorm, Dr. Stacey Lindberg, Co-Chief Executive Officer, an Alipatelist Interim Financial Officer. So I'd now like to turn the call over to Mr. Leibowitz. Please go ahead, Ryan.

Thank you, Michael. Thanks to all who have joined us to discuss our Q3 2023 financial results and ongoing progress. We're committed to our goal of making new and available to the ALS community. Our priority now is to work with the FDA and do everything in our power to align on a path forward. As announced previously, we made the decision to withdraw the BLA for Neuron from FDA review. This decision was made following the outcome of the advisory committee that took place to review Neuron in September. This action was coordinated with the FDA and is viewed by the FDA as a withdrawal without prejudice. The next important step will be for us to conduct a meeting with the FDA. We submitted the official request just a few days ago. We will use the opportunity to discuss next steps, including the design for a confirmatory phase 3b study in ALS, which we intend to conduct at such meetings. As part of our regulatory strategy, we intend to seek a special protocol assessment with the FDA before continuing with the planned registration trial. A SPA indicates agreement with the agency on the adequacy and the flexibility of critical elements of the trial design, including items such as patient entry criteria, endpoints, and planned analysis. We believe that having a SPA in place will de-risk the regulatory aspect of our ALS programs. We believe the process will likely take one or two meetings with the FDA, and we'll provide an update once we have clarity on the path forward. In parallel with these regulatory activities, Our management team and board are giving serious thought to how to finance the company and ensure we have the resources to fund the planned safety trial and position ourselves for success in the future. We're actively exploring various options to raise capital, including non-diluted grants, as well as capitalizing on certain non-core assets, such as our exosome technology. In October, we announced a strategic realignment to prioritize and conserve resources. This involves a number of steps, including streamlining our cleanroom operations, as well as a targeted reduction headcount of approximately 30%. Importantly, those positions that are most critical to managing the Plan 360B trial and regulatory submission will be retained. We estimate And overall, the strategic realignment will cut total resource consumption by approximately 50%. Many of us, including all senior management, took a 50% cut in their wages. As for myself, I took over a 90% cut from now. These were difficult but necessary decisions. We are very thankful for the hard work and commitment of all our colleagues at Brainstorm. for their contributions in advancing neuro. I'll now turn the call over to Dr. Stacey Lindberg for additional comments.