Eledon Pharmaceuticals, Inc.

Greetings and welcome to the Elladon Pharmaceuticals fourth quarter and full year 2022 financial results conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the forum presentation. As a reminder, this conference is being recorded today, March 30th, 2023. At this time, I would now like to turn the conference call over to Paul Little, Chief Financial Officer of Elladon. Please go ahead, sir.

Good afternoon, everyone, and thank you for joining Elladon's fourth quarter and full year 2022 operating and financial results conference call. I'm joined on today's call by David Alexander Groh, Chief Executive Officer, and Steve Perrin, our President and Chief Scientific Officer. Jeff Borenstein, our Chief Medical Officer, is not present today as he is traveling to the World Congress of Nephrology. Earlier today, Elladon issued a press release announcing financial results for the fourth quarter and full year ended December 31st, 2022. You may access the release under the investors tab on our company's website at elladon.com. 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 these forecasts due to the impact of many factors beyond the control of ELEDON. ELEDON 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, followed with the U.S. Securities and Exchange Commission. Now, it is my pleasure 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. We made the strategic decision as we entered 2023 to primarily focus our financial and organizational resources are in our kidney transplantation program to continue to seek non-dilutive financing for our LS program and to de-prioritize our IgA nephropathy and islet cell transplant programs. Our rationale was based on the significant existing preclinical data from both Tegopubarc, our anti-CD40 ligand antibody, and historical anti-CD40 ligand antibodies demonstrating the class's potential in organ transplantation. Combined with the large potential size of the transplant market, a clear regulatory path that also provides for potential upside using kidney function or another predictive endpoint, and the concentration of organ transplantation in the United States across a relatively limited number of hospitals, thus making it possible for smaller-sized biotech to tackle from a sales and marketing perspective. Tomorrow, at the World Congress of Nephrology, we will release open-label data from our Phase 1b trial, evaluating to gopubart in kidney transplantation. We will present the kidney function data of three kidney transplant recipients that were treated with to gopubart, replacing tacrolimus, as the cornerstone chronic anti-rejection therapy. Steve will go into further details about this open label data later in the call, but I do want to point out one significant data point that at available time points between 4 and 31 weeks, the average EGFR achieved by this cohort was consistently above 70 mL per minute per 1.73 meters squared. These data demonstrate that the goproBART is successfully protecting the kidney after transplant in that there was no rejection and that the observed mean EGFR is notably higher than the mean EGFR using current standard of care, which is commonly reported in the 50s. A novel drug that could prevent rejection while also significantly improving short- and long-term graft function would benefit transplant patients and fill an unmet need in a market where the standard of care has changed little in decades. When looked at together with the results we reported last year in ALS, these kidney transplant data further demonstrate the Gopubar activity. In our Phase II ALS trial, we demonstrated dose-dependent target engagement and how that target engagement resulted in a broad dose-dependent decrease in pro-inflammatory biomarkers. We are now demonstrating that this broad anti-inflammatory effect results in a clinical benefit in the prevention of rejection and the protection of kidneys after transplantation. At the World Congress of Nephrology, we will also release safety data from our Phase II trial evaluating Togopubart in IgA nephropathy, where in 16 patients going out up to 42 weeks, there were no severe adverse events and only two related drug adverse events. This IGAN data continues to demonstrate that the goproBART is safe and well-tolerated and adds to the goproBART's robust and growing safety database, which now includes about 100 human subjects across various disease indications. Last year, We made significant progress in the development of Tegoprobar for use in kidney transplantation and expect to continue that momentum this year. We received IND clearance from the US FDA for BESTO, our planned phase 2 trial, evaluating Tegoprobar versus the standard of care, tacrolimus, for the prevention of rejection in persons receiving a de novo kidney transplant. The trial is planned to enroll 120 subjects and includes a long-term extension allowing for the collection of longer-term efficacy and safety from both this Phase 2 as well as the ongoing Phase 1b trial. We remain on track to initiate this trial in the middle of the year. The shortage of transplantable organs and cells for patients who need them is a global issue. And over the past decades, the number of patients that have required transplant has continued to grow faster than the number of potential organs available. Xenotransplantation, or the use of animal organs in humans, provides a potential solution to close the organ gap. In January of this year, we announced a collaboration for the use of Tegoprobar in preclinical xenotransplantation studies with eGenesis. Under this agreement, Tegopribart will be administered as a component of eGenesis' immunosuppression regimen for the prevention of xenotransplant rejection in non-human primate studies. We believe this is a key first step that establishes a framework for expanded collaborations, including the potential use of Tegopribart for preclinical xeno studies across eGenesis kidney, heart, and islet cell programs. With that, I'll hand the call over to Steve Perrin, our President and Chief Scientific Officer, to provide additional details on our development programs.