Eledon Pharmaceuticals, Inc.

Greetings and welcome to Elladon Pharmaceuticals' fourth quarter and full year 2021 Operating and Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If you'd like to ask a question, you may press star 1 on your telephone keypad. If anybody should require operator assistance during the conference, please press star 0 on your telephone keypad. As a reminder, this conference is being recorded today, March 24th, 2022. I would now like to turn the conference call over to Paul Little, Chief Financial Officer of Elladon. Please go ahead.

Good afternoon, and thank you for joining Elladon's fourth quarter and full year 2021 Operating and Financial Results Conference Call. I am joined on today's call by David Alexander-Grow, 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 fourth quarter and four-year end of December 31, 2021. You may access the release under the Investors tab on our company's website at elladon.com. Before we begin, I would like to remind everyone that statements made during this conference call relating to Elladon'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 those forecasts due to the impact of many factors beyond the control of Elladon. Elladon expressly disclaimed 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 ELEDON's reports filed with the U.S. Securities and Exchange Commission. It is now my pleasure to pass the call to ELEDON CEO, Dr. David Alexander Groh, DA.

Thank you, Paul, and thank you all for joining the call today. I'm pleased to report on the continued progress here at ELEDON in the fourth quarter of 2021 and into 2022 as we look ahead to a transformative year. We have assembled an exceptional team here, and we are all committed to realizing the broad therapeutic potential of Tegoprobarth, formerly known as AT1501. We recently announced the United States Adopted Names Council assigned Tegoprubart as the unique non-proprietary or generic name for AT1501. This is the name that we will now use going forward. In 2022, we are executing our strategy to explore the breadth of Tegoprubart's potential by evaluating the molecule in up to four open-label clinical trials across three therapeutic areas, neurodegeneration, focusing on ALS, transplantation, focusing on kidney and islet cell transplantation, and autoimmunity, focusing on IgA nephropathy. Before I turn over the call to Steve for additional details on each of these programs, I'll provide a high-level update of our recent progress. In December of last year, we completed enrollment of the fourth and final cohort in our Phase IIa study of Togoprobar in adults with ALS. We recently completed dosing and visits for all subjects in the study, and we thus remain on track to meet our goal and report out top-line data from this study in the second quarter of the year. Turning to transplantation, we received regulatory clearance to initiate a Phase 1B clinical trial in the United Kingdom, evaluating to goproBART as a replacement for tacrolimus as an immunosuppressive regimen component for persons undergoing kidney transplantation. With this clearance, we are working on adding additional sites to the Phase 1B clinical trial, which previously received regulatory clearance in Canada. Also in kidney transplantation, the US FDA requested last year that we conduct a non-human primate study evaluating Tegoprobarth monotherapy in the prevention of allograft rejection. While the trial is still ongoing, we have now transplanted all four animals and are happy to report our preliminary observations showing that to date, monotherapy Tegoprobarth successfully prevented transplant rejection in a manner consistent with both historical anti-CD40 ligand antibodies, as well as with our prior experience with Tegoprobar in a non-human primate islet cell transplantation model. Next, we received ID clearance from the FDA to proceed with a phase two way clinical trial to assess Tegoprobar for the prevention of allograft rejection in patients undergoing islet cell transplantation for the treatment of type 1 diabetes. And finally, we received regulatory clearance in Australia, New Zealand, and Malaysia to initiate a phase 2A clinical trial evaluating to goproBART for the treatment of IgA nephropathy. And we plan to expand the study into up to eight additional countries this year. I'll close by reiterating that 2022 is shaping up to be a transformative year for us, highlighted by multiple clinical trial catalysts, beginning with our ALS trial data readout in the second quarter and followed by initial data readouts from our open label studies in renal transplantation, islet cell transplantation, and IGAN late this year. We look forward to sharing updates on our trials and further demonstrating to goproBART's therapeutic potential. With that, I'll now turn the call over to Steve Perrin, our President and Chief Scientific Officer, to provide more details on our development programs. Steve?