Eledon Pharmaceuticals, Inc.

Greetings and welcome to the Elladon Pharmaceuticals Second Quarter 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. As a reminder, this conference call is recorded today, August 11, 2022. I now would like to turn the conference over to Paul Little, Chief Financial Officer of Elladon. Please go ahead, sir.

Good afternoon, everyone. and thank you for joining Elladon's second quarter 2022 Operating and Financial Results Conference Call. I am joined on today's call by David Alexander Groh, Chief Executive Officer, and Jeff Forenstein, Chief Medical Officer. Steve Perrin, our President and Chief Scientific Officer, will not be joining today's call because he is attending a funeral. Earlier today, Elladon issued a press release announcing financial results for the second quarter ended June 30th, 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 Eladon. Eladon 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 Eladon's reports filed with the U.S. Securities and Exchange Commission. Now, I would like to pass the call to Eladon CEO, Dr. David Alexander-Grow, DA.

Thank you, Paul, and thank you all for joining the call today. The second quarter marked the beginning of an exciting period for Aladon as we reported the first of four distinct clinical readouts from our Zygoprobarc pipeline with positive Phase IIa results in ALS. This year, we have been focused on execution across the four clinical trials, kidney transplantation, ALS, IgA nephropathy or IGAM, and islet cell transplantation. I'm very encouraged by the progress we have made in each of these areas. In renal transplantation, we recently announced the first patient dose in a Phase 1b open label study of Tegoprobar in Canada, the United Kingdom, and Australia. We look forward to the continued enrollment of this study through the remainder of the year. And based on the timing of our first patient enrolled, we aim to provide initial three- and six-month open-label data across available transplant participants in the first quarter of 2023. Additionally, we announced the FDA has cleared Eladon's investigational new drug application, or IND application, for a larger controlled phase 2A trial of Tegoprabart, for the prevention of organ rejection in patients receiving a kidney transplant, thereby allowing us to expand our development efforts for this important indication into the United States. Jeff will go into the trial design in more detail, but I'll note that this will be a superiority study versus standard of care with calcineurin inhibitors, or CNIs. As I mentioned, We were excited to report positive top line data in a phase two-way study of Tegoprabart in adults with ALS in May. Tegoprabart not only successfully met the primary endpoint of safety and tolerability, but showed dose-dependent target engagement and a level of reduction in pro-inflammatory biomarkers associated with a trend in slowing down of disease progression as measured by ALS-FRS slope. Additionally, We observed a reduction in a number of biomarkers also associated with both IGAN and kidney allograft transplant rejection, which we believe provides significant validation of the goproBART's broad therapeutic potential. With an eye to further progressing ALS clinical development, we will be working with opinion leaders, the patient community, and regulators on potential next steps as well as looking at different approaches to fund a potential future trial. Next, our Phase IIa study of Tegoprabart in adults with a IGAM continues to enroll, and we're expanding the enrollment landscape from our current nine countries with 17 sites into another three additional countries, including the United States and China. Based on enrollment progress to date, we expect to fully enroll the high-dose cohort in the first half of 2023. Our goal is to provide meaningful insights into Tagoprabart's clinical activity after 24 weeks of therapy in this indication, and we thus anticipate reporting initial six-month open-label data from this study in the first quarter of 2023. Turning to olive cell transplantation, in June, Tagoprabart was granted orphan drug designation by the FDA for the prevention of allograft rejection in pancreatic islet cell transplantation. This represents a significant regulatory milestone for this program as we plan to open a clinical site at the University of Chicago in the coming month. We believe that this will be a major catalyst in the enrollment process going forward. With a planned opening of the Chicago clinical site and in order to more efficiently focus our resources we made the decision to close the existing clinical site in Alberta, Canada. We believe the new clinical site in Chicago will be sufficient to enroll the study of up to six participants with type 1 diabetes, and we anticipate reporting initial three-month open label data from this study in the first quarter of 2023. I'll now turn over the call to Jeff Bornstein, our chief medical officer, to provide additional details in our development program.