Brainstorm Cell Therapeutics Inc.

Greetings and welcome to the Brainstorm Cell Therapeutics fiscal year end 2020 earnings call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to introduce your host, Mr. Michael Wood of LifeSci Advisors. Mr. Wood, you may begin.

Thank you, and good morning, everyone. Thank you for joining the Brainstorm Cell Therapeutics call. Before we begin the 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 disorders, such as ALS and MS, sufficiency of the company's existing capital resources for continuing operations in 2021 and beyond, the findings to date regarding the tolerability and clinical potential 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 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 presented on today's call. The company undertakes no obligation to publicly update any of these forward-looking statements. Joining me on the call this morning is Hyde Leibowitz, President and CEO of Brainstorm, Dr. Ralph Kern, President and Chief Medical Officer, Dr. Preetam Shah, Executive VP and CFO. In addition, Dr. Stacey Lindbergh, Executive VP and Head of Global Clinical Research 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. Leibowitz. If I can please go ahead.

Thank you, Michael. Welcome to BrainStone's fourth quarter and year-end 2020 earnings call. Thank you everyone for joining us. On the call today, I want to discuss our plans for the year ahead. The past year was a challenging year for all of us as we navigated through the COVID-19 global pandemic. Our commitment as a company is to make Neuron available to patients with ALS as well as to patients with other neurodegenerative disease through our progressive MS and Alzheimer's diseases trial. I'm incredibly proud of our employees the business partners and clinical investigators for their commitment and collaboration in working together to advance our clinical programs. I would also like to acknowledge our patients and caregivers who showed great dedication to our clinical trial despite the pandemic. 2020 was truly a year of great learnings and community building. Our number one priority right now is to seek a path forward for potential regulatory approval of Neuron and ALS. We have met with the FDA and have put forward a compelling set of data. The FDA is now reviewing the data we shared. We are waiting for their feedback. You will appreciate that this is a sensitive period that we are in and we need to let conversations play out between Brainstorm and the FDA before we can report a detailed plan. I will say that the FDA has been very collaborative and willing to review and discuss the phase three data with us. We will try to respond to the questions from investor while respecting the FDA and the process. Therefore, at this time, we cannot speculate on the timing of that feedback or the likely outcome of the ongoing FDA discussions. Since the phase three readout, our whole team has been laser focused on gaining a sound understanding of the data. The process of meeting with the FDA and other important partners has generated even greater understanding, confidence, and support from the ALS community. We have proactively provided the FDA with data and analysis that were discussed in our review of the study. Since our last investor's call, we have continued to learn from the BCT-002 Phase III trial, and with each step, our confidence in the study results has continued to increase. Please know we're operating with great urgency. We have tremendous support from leading ALS physicians and statisticians as we have sought to gain objectivity around the evidence generated. We continue to have high conviction in the efficacy of Neuron and our single greatest motivation as a company is to make Neuron available to patients with ALS. In addition to our clinical data review, we're also in active dialogue with the FDA around the chemistry, manufacturing, and controls portion of Neuron's regulatory review. We recently conducted a Type C meeting with the agency to discuss future CMC plans for Neuron in support of a commercial ramp-up and sought guidance on the requirements necessary to move forward with our plans for converting to a semi-automated manufacturing process. We will provide a further update on the topic in the near future. We have initiated an expanded access program to provide neuron treatments for ALS patients who completed the phase three trial and meet specific eligibility requirements. This EAP was developed in partnership with the FDA and will take place at the six clinical centers of excellence that participated in the trial. Initiating the expanded access program immediately after the phase three trial completion speaks to the promise of neurons phase three clinical data the urgent unmet medical need for ALS patients, and our unwavering commitment to patients. The ALS physician advocacy and patient community feedback on the EAP has been extremely positive. At this point, I would like to invite Dr. Ralph Kern, our Chief Medical Officer, and Dr. Stacy Lidmark, our Head of Global Clinical Research, to comment on the ALS program. Ralph?