Eledon Pharmaceuticals, Inc.

Hello, and welcome to the Elladon Pharmaceuticals third quarter 2021 earnings calling webcast. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to CFO Paul Little. Please go ahead.

Good afternoon, and thank you for joining Elladon's third quarter 2021 financial results conference call. Joining me today is David Alexandre Gros, Chief Executive Officer, Steve Perrin, President and Chief Scientific Officer, and Jeff Bornstein, Chief Medical Officer. Earlier today, Elladon issued a press release announcing financial results for the third quarter ended September 30th, 2021. You may access the release under the investors tab on our company's website at eladon.com. Before we begin, I would like to remind everyone that statements made during this conference call relating to Eladon's expected future performance, future business prospects, or future events or plans may include forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. All such forward-looking statements are intended to be subject to the safe harbor protection provided by the Reform Act. Actual outcomes and results could differ materially from these forecasts due to the impact of many factors beyond the control of Elladon. Elladon expressly disclaims any duty to provide updates to its forward-looking statements, whether as a result of new information, future events, or otherwise. Participants are directed to the risk factors set forth in Elladon's reports filed with the U.S. Securities and Exchange Commission. It is now my pleasure to pass a call to Elladon's CEO, Dr. David-Alexandra Groh, DA.

Thank you, Paul, and thank you all for joining us this afternoon. We formed what is now Elladon just one year ago when we acquired Analixis and concurrently executed a financing with leading life science investors. Since then, we have built a world-class team and strove towards initiating clinical trials in three therapeutic areas, transplantation, focusing on kidney and islet cell transplantation, autoimmunity, focusing on IJ nephropathy, and neurodegeneration, focusing on ALS. I'm proud of the progress our team has made over the past year, and especially the past months, underscoring our focus on operational execution. Specifically, We are nearing completion of enrollment in our phase two trial of AT1501 in adults with ALS with 16 of 18 subjects enrolled in the fourth and final cohort. We received a no objection letter from Health Canada allowing us to initiate our open label clinical trial evaluating AT1501 in kidney transplantation and we are in the process of opening our first site in Canada. We received IND clearance from the FDA to proceed with a clinical trial to assess the safety and efficacy of AT1501 in the prevention of rejection in patients undergoing islet cell transplantation for the treatment of type 1 diabetes. We initiated an AT1501 monotherapy kidney transplantation study in non-human primates as requested by the FDA in advance of a potential IND application for AT1501 in kidney transplantation in the United States. We announced a research collaboration with CareDx, a world leader in transplant diagnostics and services, and we recently announced IGAN as the next indication for development of AT1501 and remain on track to begin opening sites for the Phase II study by the end of this year. And finally, we presented additional data at the International Pancreas and Islet Transplantation World Congress from our non-human primate islet transplantation study, focusing on the potential benefit of using AT1501 in transplantation versus traditional immunosuppression, including calcineurin inhibitors. Before Steve and Paul dive into last quarter in more detail, I'd like to talk about the importance of our upcoming work with CareDx, as well as share some thoughts about 2022, since the new year is quickly approaching. We recently announced a research collaboration with CareDx in October. This multi-year and multi-trial collaboration enhances our capabilities for our upcoming and potential future clinical trials, of AT1501 in kidney transplantation for a number of reasons. First, it gives us access to CareDx's kidney care suite, including AlloSure, a non-invasive cell-free assay that looks for donor-derived double-stranded DNA in the blood as an indicator of graft rejection. Second, it gives us access to algorithms, including iBox, a predictive algorithm that provides a prognostic indication of allograft survival. When possible, we plan on integrating biomarkers and algorithms such as these into our renal transplant studies as exploratory endpoints to allow us to better characterize AT1501's performance and its differentiation from current standard of care and potentially allow us to do so at earlier time points than was historically possible. Finally, as we plan and execute our trials, we will benefit from CareDx's large footprint, experience with kidney transplantation clinical trials, and its established relationship with both key medical institutions and opinion leaders. I'll end by talking about 2022. With our ALS Phase II study enrollment nearly completed, enrollment in other trials expected to begin in the near term. Starting with ALS in the first half of 2022, we are approaching a very busy year of sequential clinical data readouts from ALS, renal transplantation, IGAN, and islet cell transplantation. With that, I'll turn the call over to Steve Perrin, our President and Chief Scientific Officer, to review our lead asset and clinical indications. Steve?