Brainstorm Cell Therapeutics Inc.

Greetings. Welcome to Brainstorm Cell Therapeutics first quarter 2021 earnings call. At this time, all participants will be in listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. Please note that this conference is being recorded. At this time, I'll now turn the conference over to Michael Wood with LifeSci Advisors. Mr. Wood, you may begin.

Good morning, and thank you, everyone, for joining us. 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 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 2021 and beyond, 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 the 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 Brainstorm undertakes no obligation to publicly update any forward-looking statements. Joining me on the call this morning will be Chaim Liebowitz, President and CEO of Brainstorm, Dr. Stacey Lindborg, Executive VP and Head of Global Clinical Research, Dr. Ralph Kern, President and Chief Medical Officer, Dr. Preetam Shah, Executive VP and Chief Financial Officer, and in addition, Dr. David Setbourn, Executive VP and Chief Operating Officer, will also be on the call and will be available to answer questions during the Q&A session. So now I'd like to turn the call over to Mr. Leibowitz. Please go ahead.

Thank you, Mike. Thanks to all listening and for joining us to discuss our first quarter financial results and corporate highlights. Sorry. On the call today, we will be discussing the current status of our ALS program, the very exciting and recently announced top-line data from our Phase II progressive MS trial our strategic plans for these programs, as well as our quarterly financial results. Starting with our ALS program, I'd first like to say that we remain confident in the strength of our data, the potential of Neuron as a treatment for ALS, and its broad potential as a technology platform in neurodegenerative disease. In parallel to regulatory interactions, we have been in active consultation with various experts, including principal investigators ALS physicians, statisticians, regulatory advisors, as well as the patient advocacy groups in the United States, as well as in other jurisdictions. Dr. Stacey Lindberg, our VP and Head of Global Clinical Research, will provide insight into how we are going about these interactions and gaining feedback on our programs. However, I want to stress that we plan to take all feedback into consideration as we assess the most efficient way to enable ALS patients access to Neuron, including a potential BLA submission and or other regulatory and business options. We are diligently working to define Neuron's path forward and are gaining scientific support. We can assure you this is a top priority. For us, and we intend to update the patient and investor communities as quickly as possible, but we must let additional developments play out before providing a more comprehensive update. Dr. Ralph Kern, our president and chief medical officer, will discuss our progressive MS program in a few minutes, but let me give you some of the highlights. In March, we announced positive top-line data from our open-label Phase II trial. These data showed that the study met its primary endpoint, with neuron being found to be safe and well-tolerated. We also observed consistent improvements in key secondary endpoints, spanning neurologic function, cognition, and biomarkers. Collectively, these promising results further support the utility of the neuron technology platform in neurodegenerative disease and provide additional proof of concept for intracerebral neuron therapy in progressive MS. We are now in consultation with our principal investigator to align our next steps for this program, including design of a face-to-be trial and regulatory pathway. We're also in discussions with potential strategic partners. As part of these efforts, we are also preparing scientific presentations and a peer-reviewed manuscript on our data, which will allow us to gain valuable feedback from the MS community as we work to determine the next steps in our clinical development strategy. Once this strategy is solidified, we'll be sure to provide an update to both investors and the broader MS community. Now, before I hand this off to Stacey, I want to take a moment to acknowledge that all the progress that we will discuss here today has only been possible with the dedication of our patients and caregivers, together with our employees, business partners, and clinical investigators. I'm extremely grateful to all of these individuals for the critical roles they have played in successfully advancing neurons' clinical development. With that, I'll now hand this call over to Stacey, our Executive Vice President, to discuss the status of our ALS program. Stacey.