Phase 2 BESTOW trial data evaluating tegoprubart in kidney transplantation showed favorable efficacy, safety and tolerability, supporting advancement into Phase 3 development Reported positive preliminary results from first six patients with type 1 diabetes treated with tegoprubart following islet transplantation in UChicago Medicine-led study Tegoprubart continues to be used as key component of immunosuppression regimen in xenotransplants, including three transplants of a genetically modified pig kidney in ...

Eledon Pharmaceuticals FY Conference Summary Company Overview - **Company**: Eledon Pharmaceuticals (NasdaqCM:ELDN) - **Focus**: Development of tegoprubart (Tego) for kidney transplantation and other transplant-related therapies Key Points Industry Context - **Transplantation Market**: Approximately 48,000 transplants are performed annually in the U.S., with 60% being kidney transplants [4][5] - **Kidney Transplant Statistics**: About 25,000 to 27,000 kidney transplants occur each year, while around 100,000 Americans are on the waiting list for transplants [5][6] Product Development and Clinical Trials - **Phase 2 BESTOW Data**: Recent results show that Tego's efficacy is not inferior to tacrolimus, the current standard of care, with a strong safety profile [1][2] - **Patient Involvement**: Over 150 patients have used Tego, with more than 100 post-transplant patients included in the study [2] - **Future Milestones**: Plans to approach the FDA regarding the path to market for kidney transplantation and other transplant types, including islet cell and xenotransplantation [3] Financial Position - **Cash Reserves**: Eledon finished the last quarter with over $93 million in cash and completed a $57.5 million financing round, providing sufficient funds until the second quarter of 2027 [2] Comparative Analysis with Tacrolimus - **Market Size**: Tacrolimus represents a $1.5 billion market, despite being over 30 years old [8] - **Safety Concerns**: Tacrolimus is nephrotoxic and associated with diabetes and hypertension, which are leading causes of kidney issues [9] - **Efficacy Metrics**: Mean eGFR (estimated Glomerular Filtration Rate) at 52 weeks was 69 for Tego compared to 66 for tacrolimus, indicating superior kidney function [12] Adverse Events (AEs) Comparison - **Tego vs. Tacrolimus**: Tego showed lower rates of proteinuria, bacteremia, hyperglycemia, and new-onset diabetes compared to tacrolimus [13][14][15][16] - **Psychological Impact**: Patients on tacrolimus may experience longer post-transplant dialysis, which can be psychologically challenging [17] Regulatory and Future Plans - **Phase 3 Trial**: Eledon plans to initiate a Phase 3 trial in the second half of the year, pending FDA discussions [18] - **Patient Enrollment**: Expected enrollment of 200-300 patients per arm for the Phase 3 trial, focusing on achieving non-inferiority in safety and efficacy [19] Market Opportunity - **Concentration of Transplant Centers**: There are about 250 transplant centers in the U.S., with 40 centers performing half of the transplants, indicating a concentrated market [6] Conclusion Eledon Pharmaceuticals is positioned to make significant advancements in the transplantation market with its product Tego, which has demonstrated promising efficacy and safety compared to the current standard of care, tacrolimus. The company is well-funded and has a clear path forward for regulatory approval and further clinical development.

Core Insights - Eledon Pharmaceuticals announced preliminary results from a trial evaluating tegoprubart, an investigational anti-CD40L antibody, for preventing islet transplant rejection in type 1 diabetes patients [1][2][4] Group 1: Trial Overview - The ongoing trial has been extended to include 12 subjects and focuses on a tacrolimus-free immunosuppression regimen [2] - Preliminary data from the first six subjects show that tegoprubart can prevent rejection of transplanted islet cells, leading to sustained insulin-free management of hemoglobin A1C (HbA1c) levels [2][3] Group 2: Patient Outcomes - All six subjects demonstrated significant improvements in glycemic control, achieving insulin independence after one or two islet transplants [3] - The first three participants have remained insulin-free for over 15 months, with one patient maintaining an HbA1c as low as 4.7% [3] - Two subjects who underwent transplantation in July 2025 achieved insulin independence within approximately four weeks and maintained HbA1c levels below 6% for over three months [3] - A sixth subject, after a second islet infusion, is now insulin-free with an HbA1c of 5.3% [3] Group 3: Safety and Tolerability - Tegoprubart was generally well tolerated, with no serious infections, thromboembolic events, or signs of kidney or neurological toxicity [3] - All six patients have been free of severe hypoglycemic episodes since their transplants [3] Group 4: Future Implications - The results suggest that tegoprubart may offer a safer alternative to traditional calcineurin inhibitors, which are associated with various toxicities [4] - Breakthrough T1D has committed to funding further studies to evaluate tegoprubart in islet transplantation and chronic kidney disease [4] Group 5: Company Background - Eledon Pharmaceuticals is a clinical-stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions [6] - The company's lead product, tegoprubart, targets CD40 Ligand, which has broad therapeutic potential [6]

Summary of Eledon Pharmaceuticals (ELDN) Update / Briefing August 06, 2025 Company Overview - **Company**: Eledon Pharmaceuticals (ELDN) - **Focus**: Development of tegoprovart for kidney transplantation Key Industry Insights - **Industry**: Kidney transplantation and immunosuppression therapies - **Event**: Presentation of updated Phase 1b trial results at the World Transplant Congress Core Points and Arguments 1. **Phase 1b Trial Results**: Eledon presented updated results from the Phase 1b trial of tegoprovart, which is being evaluated as a cornerstone immunosuppression therapy in de novo kidney transplantation [3][6][8] 2. **Safety and Efficacy**: The trial demonstrated good safety and tolerability for tegoprovart, with twelve-month eGFR (estimated Glomerular Filtration Rate) results indicating good kidney function [8][26] 3. **Rejection Episodes**: A total of six rejection episodes were reported, with a 19% incidence rate. Most rejections occurred in patients receiving lower doses of ATG (antithymocyte globulin) induction therapy [21][24] 4. **Long-term Predictive Endpoints**: The trial included the abbreviated IBOX score, which is being developed as a surrogate endpoint to predict five-year graft survival. The IBOX score showed strong predictive capabilities [31][35] 5. **Regulatory Considerations**: Eledon is in discussions with regulatory bodies regarding the use of IBOX as a potential endpoint for future clinical trials, with expectations for feedback in the second half of the following year [31][59] Additional Important Content 1. **Patient Demographics**: The study included 32 patients with a mean age of 52.9 years, with 75% being living donors. Notably, 56% of patients had an HLA mismatch of more than five, indicating a higher immunological risk [15][16][94] 2. **Infection Rates**: The trial reported manageable infection rates, with no cases of graft loss. The infections were controllable, and the study aims to explore lower dosing to potentially improve safety outcomes [90][91] 3. **Impact of Improved Graft Survival**: A hypothetical 5% improvement in five-year graft survival could significantly reduce the number of patients dying while waiting for a kidney transplant, potentially allowing for 1,500 additional kidneys to be available each year [41][43] 4. **Future Studies**: Eledon is preparing for the Phase II BISTOLE study, with results expected to be presented in the fourth quarter of the year [44] Conclusion Eledon Pharmaceuticals is making significant strides in the development of tegoprovart for kidney transplantation, with promising Phase 1b trial results indicating good safety and efficacy. The company is focused on regulatory discussions regarding the IBOX score as a predictive endpoint for long-term graft survival, which could have a substantial impact on patient outcomes in the field of kidney transplantation.