Eledon Pharmaceuticals, Inc.

inhibitors help preserve graft survival, but they are also associated with significant side effects, such as hypertension, dyslipidemia, new onset of diabetes, and tremors. Moreover, research shows that 10-year post-transplant, almost all transplanted kidneys will demonstrate evidence of CNI-induced nephrotoxicity. We believe, based on the evidence generated to date, that tegoprubar has the potential to reduce or even potentially eliminate these side effects, while also providing improved graft function. Turning to the safety results we observed in the study, where among the three participants, Tegoprobar showed good tolerability, especially among a difficult to treat population. None of the participants experienced acute rejection, and there was no evidence of new onset diabetes after transplant or any impact on glucose level levels in two participants without diabetes at baseline. One participant was discontinued from the study on day 55 after developing BK viremia, a common occurrence following a kidney transplant, which occurs in 20% or more of transplant recipients. An additional participant elected to discontinue from the study after 33 weeks, reporting mild alopecia and mild insomnia, which the investigator did not attribute to Tago-Prubart. The adverse events continued once the patient was switched from Tago-Prubart to CNIs. We continue to make progress with this ongoing trial and have since enrolled an additional two participants who both remain on study. We expect to report updated data at a medical conference later this year. Building off our results from the ongoing Phase 1b trial, We remain on track to initiate our randomized open-label Phase II BESTO study to assess the safety and efficacy of tegoprobar compared to tacrolimus and the preservation of allograft function after kidney transplantation. 120 participants will be randomized one-to-one to receive either tegoprobar every 21 days or twice daily oral tacrolimus. The primary endpoint will compare the mean EGFR at 12 months for participants receiving tegopubart versus tacrolimus. Secondary objectives will include safety and tolerability, participant and graft survival, biopsy proof and acute rejection, and the incidence of new onset diabetes mellitus after transplant. I'd like to conclude by briefly covering our IGAN program. We're following our announcement to deprioritize the program at the beginning of the year. we continue to collect safety data from the patients previously enrolled to provide additional insight into Tegoprobar's safety profile. The data we presented at WCN from 16 patients in the high dose cohort of 10 mg per kg every three weeks showed Tegoprobar to be safe and well tolerated with no serious nor severe adverse events reported and no early discontinuations. Four participants had completed at least 24 weeks on treatment, and five others completed at least 12 weeks. We are encouraged by the safety profile TagoProvar continues to display, and to date we have now dosed approximately 100 human subjects across multiple disease indications. Given the deprioritization of the IGAN program, and having now generated key safety insights in this population, We are now winding down all IGAN study activities at our sites, and we anticipate winding down the vast majority of our IGAN activity and spend in the second quarter of 2023. With that, I'd now like to turn the call over to Paul for a financial update.

Thank you, Steve. The company reported a net loss of $10.8 million, or 75 cents per share, for the three months ended March 31st, 2023, compared to a net loss of $9.9 million, or 69 cents per share, for the same period in 2022. Research and development expenses were $8.1 million for the three months ended March 31, 2023, compared to $6.6 million for the comparable period in 2022, an increase of $1.5 million. The increase is primarily due to higher clinical development expenses, primarily with external CROs of $2.1 million, and an increase in personnel costs due to increased headcount. The increase was partially offset by decreases in stock-based compensation, manufacturing, and consulting expenses. General and administrative expenses were $3 million for the three months ended March 31, 2023, compared to $3.2 million for the comparable period in 2022, a decrease of $200,000. The decrease was primarily related to the lower stock-based compensation costs. Earlier this month, we announced the entry into a definitive securities purchase agreement with select healthcare investors that will provide up to $185 million in gross proceeds through a private placement. The purchase agreement included an initial upfront of financing of $35 million and additional aggregate financing up to $105 million, subject to achieving clinical development milestones, volume-weighted share price levels, and trading volume conditions. plus up to $45 million upon the full exercise of warrants being issued in connection with the agreement. The financing was led by BVF partners and Armistice Capital and includes participation from new and existing investors, including the global pharmaceutical company, Sanofi. Elladon ended the first quarter with approximately $46.5 million in cash and cash equivalents. With that financial update, I'll turn the call back over to DA.

Thanks, Paul. I am proud of the progress that Elladon has made in the early part of 2023 and feel we are now well-positioned to make significant strides in our evaluation of Tegoprobar as a potential much-needed replacement for CNIs in kidney transplantation. We are highly encouraged by the data generated to date in our ongoing Phase 1b study and look forward to both its continued enrollment and to providing a clinical update later in the year. Finally, following our financing, we now have a well-capitalized path to launch and execute our phase two bestow trial while we continue to report data from the open-label phase 1b study in parallel. Operator, please begin the Q&A session.