Eledon Pharmaceuticals, Inc.

Good day and welcome to the Elladon Pharmaceuticals third quarter 2022 financial results conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to Paul Little, Chief Financial Officer of Elladon. Mr. Little, please go ahead.

Good afternoon, everyone, and thank you for joining Elladon's third quarter 2022 operating and financial results conference call. Today, I am joined by David Alexander Groh, Chief Executive Officer, Steve Perrin, our President and Chief Scientific Officer, and Jeff Borenstein, our Chief Medical Officer. Earlier today, Elladon issued a press release announcing financial results for the third quarter ended September 30, 2022. You may access the release under the Investors tab on our company's website at eladon.com. 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. Now, I would like to pass the call to Elladon's CEO, Dr. David Alexander Groh, DA.

Thank you, Paul, and thank you all for joining the call today. Following the positive Phase IIa ALS results in the second quarter, we continue to make important progress in our three ongoing clinical trials, evaluating Tegopribart in kidney transplantation, IgA nephropathy, or IGAN, and islet cell transplantation. Before I turn the call over to Steve, I'd like to provide a brief recap on the new developments across our Tegopribart pipeline. In renal transplantation, We successfully dosed our first two subjects in this Phase 1b open-label study of the goproBART. Given our enrollment rate to date, we are on track to provide initial three-month and six-month open-label data across multiple available transplant participants in the first quarter of 2023. Additionally, in the third quarter, we received FDA clearance of our IND application for a phase two trial of Tegoprubart for the prevention of organ rejection in subjects receiving a kidney transplant in the United States. This trial is designed as a superiority study versus standard of care with CNIs and will run in parallel to the ongoing phase one B ex-US trial. The phase two will enroll approximately 120 subjects and we anticipate initiating the study next year. Moving to IGAN, in the third quarter, we received FDA clearance of our IND application, allowing us to evaluate to go probart in IGAN in the United States. Given this clearance, we're now in the process of opening U.S. sites as part of our ongoing global Phase 2A clinical trial. With addition of the U.S., the trial has now received regulatory clearances in 11 countries. Enrollment in the IGAN trial continues with multiple new subjects dose in the high-dose cohort of the study. We remain on track to enroll the full cohort consisting of 21 subjects by the first half of next year and anticipate sharing available six-month open label data from this study in the first quarter of 2023. Turning to islet cell transplantation, After receiving orphan drug designation from the FDA in the second quarter, we opened our first U.S. clinical site at the University of Chicago. The site has been actively engaging with potential participants to evaluate the gopro barton in the phase 2a study for the prevention of allograft rejection in islet cell transplantation. And we continue to expect the first subject to be dosed by year end. We plan to enroll up to six participants with type 1 diabetes at this site, and we anticipate reporting initial three-month open LATA from the first subject in the study in the first quarter of 2023. Finishing with ALS, following our announcement of positive top-line data in our Phase 2a study of Tegoprobar in adults with ALS, We have been working closely with key stakeholders on potential next steps, as well as evaluating a range of approaches to fund a potential future trial. We have been active in sharing our Phase II data with the scientific community across multiple medical conferences, and we look forward to continued engagement with the ALS community as we work to advance this exciting program. I'll now turn the call over to Steve Perrin, our President and Chief Scientific Officer to provide additional details on our development programs.