Eledon Pharmaceuticals, Inc.

Greetings. Welcome to the Elladon Pharmaceuticals report second quarter 2021 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 anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note that this conference is being recorded. I will now turn the conference over to your host, Paul Little, Chief Financial Officer. You may begin.

Good afternoon. And thank you for joining Elladon Pharmaceuticals' second quarter 2021 financial results conference call. Joining me today is David Alexandra Groh, Chief Executive Officer, Steven Perrin, President and Chief Scientific Officer, and Jeff Bornstein, Chief Medical Officer. Earlier today, Elladon issued a press release announcing financial results for the second quarter ended June 30th, 2021. You may access the release under the investors tab on our company website, elladon.com. Before we begin, I would like to remind everyone that statements made today during this call related 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 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 directed to the risk factors set forth in Elladon's reports file with the SEC on our website under the Investor tab. We encourage you to review these documents carefully. It is now my pleasure to pass the call over to our CEO, Dr. David Alexandra Groh.

Thank you, Paul, and good afternoon, everyone. We continue to make significant progress during the second quarter advancing our lead molecule, AT1501. I'm excited by the promise offered to us by AT1501 as a potential therapeutic for organ or cellular transplantation, ALS, and serious immunological diseases where patients face limited treatment options. We plan to advance AT1501 in up to four clinical trials, 1, ALS, 2, the prevention of kidney allograft transplant rejection, 3, autoimmune nephritis starting with IgA nephropathy or IGAN, and 4, the prevention of islet cell allograft transplant rejection for the treatment of type 1 diabetes. We selected these indications based on preclinical data that was generated with both our molecule as well as historical anti-CD40 ligand molecules. Steve will give more details about each of these, but at a high level, our recent progress is as follows. In the ALS Phase II biomarker study, our trial is progressing according to plan. We are completing enrollment of our third of four cohorts, and top-line data is expected in the first half of 2022. In renal transplantation, We previously communicated that the US FDA requested that we provide AT1501 specific renal transplant data in non-human primates prior to initiating a clinical trial in renal transplantation in the United States. And that as a result, we would both look to complete the FDA requirements as quickly as possible, as well as look to initiate a clinical trial outside of the United States. In terms of our U.S. regulatory requirements, we reached alignment with the FDA to conduct a preclinical renal transplant study evaluating AT1501 as monotherapy in four nonhuman primates. We anticipate initiating this nonhuman primate study in collaboration with an academic collaborator with vast transplant experience next quarter with completion of the study in mid-2022. With regards to our XUS clinical trial, we received a no objection letter from Health Canada in response to our clinical trial application proposing to evaluate AT1501 replacing tacrolimus as an immunosuppressive regimen component in patients undergoing kidney transplantation. The trial is expected to be initiated in the last quarter of 2021 with interim data readouts expected to begin in late 2022. In autoimmune nephritis, we will be targeting IgA nephropathy. There is a long history of preclinical and clinical data demonstrating that blocking CD40 ligand signaling ameliorates disease progression, modifies biomarkers of disease, and improves renal function in autoimmune diseases of the kidney, such as IgA. We selected IGAN because of the unique approach that an anti-CD40 ligand brings in going after both the cellular and the antibody-mediated portions of disease pathophysiology. In islet transplantation for type 1 diabetes, earlier this year, we initiated a phase 2 clinical trial of AT1501 as a replacement for tacrolimus. As we announced previously, we learned in early January that our study site in Canada voluntarily stopped performing islet cell transplants on a temporary basis because of COVID-19 before allowing for the resumption of these procedures. Unfortunately, until late June, vaccination rates in Canada remained far behind those in the United States, and the number of islet cell transplant procedures performed remained much lower than pre-COVID. As a result, we are still waiting for our first patient to be enrolled. Steve will discuss the steps we're taking to address the pace of this study, including making it easier for patients to enroll and looking at additional geographies where islet cell transplants are performed. Steve will also provide an update on AT1501 in non-human primate islet cell data that was presented at the American Transplant Congress in June. I will now turn over the call to Steve Perrin, our President and Chief Scientific Officer, to discuss our clinical programs. Afterwards, Paul Little will provide a financial update. Steve, please go ahead.