Brainstorm Cell Therapeutics Inc.

Greetings and welcome to the Brainstorm Cell Therapeutics third quarter 2020 conference call. At this time, all participants are in a listen-only mode. As a reminder, this call is recorded, and I would now like to introduce your host for today's conference, Michael Wood from LifeSci Advisors. Mr. Wood, you may begin.

Thank you, everyone, for joining the Brainstorm Cell Therapeutics earnings call. 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 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 2020 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 its business planning efforts. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond brainstorms control, including the risk and uncertainties described from time to time in the company's SEC filings. Results may differ materially from those projected on today's call. The company undertakes no obligation to publicly update any forward-looking statements. Joining us on the call today will be Chaim Liebowitz, President and CEO of BrainStorm, Dr. Ralph Kern, President and Chief Medical Officer, Dr. Stacey Lindberg, Executive VP and Head of Global Clinical Research, and Preetam Shah, Executive VP and CFO. They will be available to answer your questions during the Q&A session. I'd now like to turn the call over to Mr. Liebowitz. Chaim, please go ahead.

Thanks, Michael. Welcome to BrainStorm's third quarter 2020 earnings. call and thank you everyone for joining us. So far, 2020 has been very productive for Brainstorm as we advanced Neuron on several neurological diseases, continued to build out our operating infrastructure capabilities and expanded our senior management team. We're focused on the upcoming top line readout for the Neuron phase three trial in ALS, which we expect to happen by the end of November. We believe that a successful outcome for this trial will add hope to the ALS community and will be a transformative moment for brainstorm, setting us on a path to filing a BLA and supporting our transition to a commercial stage company. The phase three ALS trial is being conducted at six neurology centers of excellence in the United States. I would like to once again thank all the investigators and their staff at the participating sites for their dedication, especially for enabling this trial to complete on time in the middle of an ongoing COVID-19 pandemic. I also want to express my complete gratitude to the trial participants and their loved ones who fully devoted themselves to the challenges of bringing an investigational therapeutic forward. Joining me on the call today are our President and Chief Medical Officer, Dr. Ralph Kern, who will update you on our clinical program, including our pivotal ALS trial, as well as recent news relating to our progressive MS and Alzheimer's disease programs. I've also asked Dr. Stacey Lindberg, Executive Vice President, Head of Global Clinical Research, to join the call today. She'll talk for a few minutes about the design of the Phase III ALS trial, Our CFO, Dr. Priyam Shah, will then provide updates on our financial results before turning it back to me for concluding remarks and will then address your questions in the Q&A session. For that session, I would like to also invite two recent additions to our senior team. In September, we appointed Dr. Tony Wachlowski as Executive Vice President and Global Head of Regulatory Affairs. Tony is a recognized leader in regulatory affairs and brings years of multinational experience. He spent 35 years at Bristol-Myers Squibb, and his experience expands a broad range of regulatory capabilities across multiple therapeutic areas and geographies. He has a track record in guiding successful FDA interactions and establishing and executing successful global regulatory strategies. We also appointed Bill White as Senior Vice President for Market Access and Pricing. Bill is also a very accomplished senior executive with more than 25 years' experience in leading product commercialization and securing market access for innovative new medicines. His experience will help us develop market access, patient service and distribution strategies that will be important to the timely and efficient market entry of Neuron for ALS, assuming its approval by the FDA. These two most recent appointments are the latest in a series of key senior hires we made throughout 2020. The reason I'm mentioning them now is that they are part of a strategic initiative to build a senior team with proven development and global commercial capabilities as Brainstorm makes the transition to a commercial organization. Other appointments this year that were previously announced included Dr. Stacey Lindberg as Executive Vice President Head of Global Clinical Research, and David Setbaum as Executive Vice President and Chief Operating Officer, and Professor Jacob Renkel, a distinguished economist and banker, joined us as the chairman of our board earlier in the year. In addition to our preparations for the upcoming data readout, we've been busy planning and executing another pre-BL activities. Our clear focus is to expedite this process We want to be able to submit a BLA with the FDA as soon as possible after top line data is available. At the same time, our clinical trial activities and data preparedness is growing. We are advancing our CMC activities in preparation for the BLA and subsequent launch. With respect to the BLA planning, understanding the urgency of ALS, we are in full dialogue with the FDA We're actively exploring with them opportunities to expedite the information flow to the FDA with the ultimate goal of enabling the data review process itself. I'll now turn the call to Dr. Ralph Kern for a clinical and RD update. Ralph?