Eledon Pharmaceuticals Conference Call Summary Company Overview - **Company**: Eledon Pharmaceuticals (NasdaqCM:ELDN) - **Focus**: Development of tegoprubart for transplantation, particularly kidney transplants Key Points and Arguments Industry Context - **Transplantation Landscape**: The success in transplantation has been linked to the development of immunosuppressive drugs to prevent organ rejection. However, existing drugs like tacrolimus have limitations, including toxicity and complexity of use [2][5][6]. Tegoprubart Development - **Tegoprubart's Role**: Eledon aims for tegoprubart to be a cornerstone maintenance chronic immunosuppressive medicine across all transplant types, including kidney, islet cell, and potentially xenotransplantation [3][4]. - **Clinical Trials**: The company is conducting multiple studies, including a phase 2 trial (Bistot study) comparing tegoprubart to tacrolimus, the current standard of care [9][10]. Bistot Study Results - **Study Design**: The Bistot trial compared tacrolimus with tegoprubart in kidney transplant patients, focusing on eGFR (estimated Glomerular Filtration Rate) as a primary endpoint [9][10]. - **Efficacy**: Tegoprubart showed a mean eGFR of 69 mL/min compared to 66 mL/min for tacrolimus, indicating numerical superiority but not statistical significance [11][17]. - **Safety Profile**: Tegoprubart demonstrated a favorable safety profile, with significant reductions in side effects commonly associated with tacrolimus, such as new-onset diabetes, tremors, and hypertension [12][28][33]. Unmet Needs in Transplantation - **Current Limitations**: Tacrolimus, while effective, has a narrow therapeutic index and is associated with various toxicities, leading to complications such as kidney injury and increased cardiovascular risk [6][7][8]. - **Need for New Treatments**: There is a pressing need for new immunosuppressive agents that can reduce toxicity and improve long-term outcomes for kidney transplant patients [8][12]. Future Directions - **Phase 3 Study Plans**: Eledon plans to approach the FDA for a phase 3 study design based on the non-inferiority endpoint, with potential for additional superiority claims based on long-term outcomes [42][43]. - **Financial Position**: The company reported $93.4 million in cash, sufficient to fund operations into late 2026, with several upcoming milestones [35][61]. Additional Insights - **Patient Management**: The ability to maintain patients on tegoprubart during rejection episodes without switching to tacrolimus may lead to better long-term kidney function [50][55]. - **KDPI Scores**: The study revealed unexpected findings regarding the quality of donor kidneys, with higher quality kidneys (KDPI < 35) performing better with tacrolimus, raising questions about the long-term implications of drug choice [62]. Conclusion - **Overall Outlook**: Eledon is optimistic about the potential of tegoprubart to improve kidney transplant outcomes and is preparing for further studies to validate its efficacy and safety [34][36].