Brainstorm Cell Therapeutics Inc.

The next presenting company is Brainstorm Cell Therapeutics from New York, New York, United States. Brainstorm Cell Therapeutics is focused on CNS neurological gene cell therapy inflammation. Presenting for Brainstorm Cell Therapeutics are their CEO, Haim Lebovitz, and co-CEO, Dr. Stacey Lindbergh.

Good morning. Dr. Stacy Lindberg is my co-CEO as of late week or so. And so we don't want to change the presentation or send someone else to present me. So we can do this together. This is a very exciting moment for us. And I'm sure many of you know that late in the week, we're having a meeting with the FDA type A meeting. But for now, we'll be focusing and explaining our narrative of our data, why we think approvals warranted here. And just will Stacey please take this forward and move the slides, and I will jump in different slides, right?

Sure. Thank you. It's a pleasure to see everybody here. We have our forward-looking statements. And we've presented quite regularly here and on our own are very excited about the evidence we've generated. We'll be focusing, as Haim said, on the Phase III ALS data. but wanted to offer a little bit of background and perspective. Neuron is an autologous treatment. It's consistent, reliable, and convenient. And by nature of not using animal proteins, antibiotics, or any genetic modifications, and with Culture Rescue, we have the ability to effectively make this an off-the-shelf product. With one bone marrow harvest, we can produce several years of treatment. And we have successfully completed tech transfer of manufacturing to our commercial manufacturing organization, Catalan, which was done in 2021, and really have had great success and have superb manufacturing quality across all the transfers for production and academic centers and our clinical trials, demonstrating really robustness with our manufacturing process. You look at our pipeline, ALS is the furthest progressed. We have been studying ALS, and I'll show you in just a few minutes, have completed four clinical trials. The phase three trial was published in Muscle and Nerve. It appeared in print in January of 2022. But even more importantly, we started with a number of animal models preclinically, which really gave us a foundation and understanding of Neuron. and an ability to really understand the mechanism of action and the breadth across different neurological diseases. We've completed clinical trials in two different diseases. So we have a progressive MS study that was completed and also was published in a peer-reviewed journal, generating a lot of excitement at ECTRIMS and also amongst the MS community. It was published in a multiple sclerosis journal in September of last year. We also have new technologies coming. So as you see on the bottom, we have an Exosome platform. We have published data from ARDS and really are looking forward to sharing in the future different diseases that we believe really are incredibly promising, and this would enable growth beyond the neuron technology.