Core Insights - Eledon Pharmaceuticals reported positive data from an ongoing Phase 1b trial of tegoprubart, showing a mean 12-month estimated glomerular filtration rate (eGFR) of approximately 68 mL/min/1.73 m for kidney transplant patients, significantly higher than the historical mean of 53 mL/min/1.73 m with standard care [1][3] - The company is on track to release topline results from the Phase 2 BESTOW trial in kidney transplantation in November 2025 [1][10] - Eledon has a cash position of $107.6 million as of June 30, 2025, which is expected to fund operations through the end of 2026 [1][5] Business Highlights - Eledon achieved key milestones in advancing tegoprubart for kidney, islet cell, and liver transplantation, as well as xenotransplantation [2] - Updated data presented at the World Transplant Congress indicated that tegoprubart was well tolerated with no severe adverse events reported [3] - The company announced the first three islet cell transplant recipients treated with tegoprubart at the University of Chicago, achieving insulin independence [3] Financial Results - Research and development expenses for Q2 2025 were $20.3 million, up from $10.1 million in Q2 2024 [6] - General and administrative expenses for Q2 2025 were $4.5 million, slightly higher than $4.4 million in Q2 2024 [7] - The net loss for Q2 2025 was $11.2 million, a significant reduction from a net loss of $44.9 million in Q2 2024 [7][16] Upcoming Milestones - The company plans to report topline results from the Phase 2 BESTOW trial in November 2025 [10] - Eledon will launch an investigator-initiated trial at Massachusetts General Hospital to evaluate tegoprubart for inducing donor-specific immune tolerance [10]

Core Insights - Eledon Pharmaceuticals is set to present updated clinical data on tegoprubart for kidney transplantation at the World Transplant Congress in August 2025 [1] - The presentation will include results from approximately 30 kidney transplant recipients and will be delivered by Dr. John Gill from the University of British Columbia [1][2] - Eledon will also sponsor a satellite symposium discussing kidney transplant success, featuring notable faculty from various prestigious institutions [3] Presentation Details - The oral presentation titled "Tegoprubart, an Anti-CD40L Antibody, for the Prevention of Rejection in Kidney Transplantation: An Ongoing Phase 1b Study" is scheduled for August 6, 2025, from 10:00 a.m. to 11:15 a.m. PT [2] - A poster session will present new preclinical data on tegoprubart's use in liver transplantation, led by Dr. Andrew Adams from the University of Minnesota [4] Company Overview - Eledon Pharmaceuticals is a clinical-stage biotechnology company focused on developing immune-modulating therapies for severe conditions [4] - The lead product, tegoprubart, is an anti-CD40L antibody targeting CD40 Ligand, which plays a significant role in immune cell activation [4] - The company is conducting studies in kidney transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [4]

Core Viewpoint - Sernova Biotherapeutics has entered into a Collaborative Research Agreement with Eledon Pharmaceuticals to utilize Eledon's immunosuppressive agent, tegoprubart, in Sernova's Phase 1/2 clinical trial for its Cell Pouch Bio-hybrid Organ aimed at treating patients with Type 1 Diabetes (T1D) [1][2]. Group 1: Collaboration and Clinical Trial Details - Eledon will supply tegoprubart, an investigational anti-CD40L antibody, to replace tacrolimus in Cohort C of the clinical trial, addressing the limitations of tacrolimus in islet cell therapy for T1D [2][3]. - The trial led by Dr. Piotr Witkowski showed that T1D patients receiving islet transplants with tegoprubart achieved normal blood sugar levels and insulin independence, with islet engraftment rates three to five times higher than those receiving tacrolimus [3]. Group 2: Company Statements and Future Outlook - Sernova's CEO expressed optimism about the combination of their Cell Pouch technology with tegoprubart, suggesting it could lead to faster insulin independence with reduced toxicity to islet cells [4]. - Eledon's CEO highlighted the potential of tegoprubart to protect transplanted cells without the toxicities associated with standard immunosuppressive treatments, aiming to transform the treatment landscape for T1D [4]. Group 3: Company Background - Sernova Biotherapeutics is focused on developing regenerative medicine therapeutics that integrate its Cell Pouch with human donor cells or stem-cell derived islet-like clusters to create bio-hybrid organs for treating T1D and other chronic diseases [5].

Core Insights - Eledon Pharmaceuticals is progressing towards reporting topline results from the Phase 2 BESTOW trial in kidney transplantation, expected in the fourth quarter of 2025 [1][2] - The company is focusing on tegoprubart as a novel immunosuppression therapy, with significant updates anticipated in the second half of 2025 [2] Business Highlights - Tegoprubart was used in the second transplant of a genetically modified pig kidney into a human at Massachusetts General Hospital, marking a significant milestone in xenotransplantation [3] - The patient involved in the transplant was discharged without the need for dialysis for the first time in over two years, showcasing the potential effectiveness of the treatment [3] Financial Results - As of March 31, 2025, the company reported cash, cash equivalents, and short-term investments totaling $124.9 million, a decrease from $140.2 million as of December 31, 2024 [5] - Research and development expenses for Q1 2025 were $13.5 million, up from $7.4 million in the same period of 2024 [6] - General and administrative expenses increased to $4.4 million in Q1 2025 from $3.5 million in Q1 2024 [7] - The net loss for Q1 2025 was $6.5 million, or $0.08 per share, a significant improvement compared to a net loss of $23.6 million, or $0.79 per share, in Q1 2024 [8][16] Upcoming Milestones - The company plans to report updated interim clinical data from the ongoing Phase 1b open-label trial in August 2025 and topline results from the Phase 2 BESTOW trial in Q4 2025 [10]

Group 1 - Eledon Pharmaceuticals is a small cap, development-stage biotech company focused on its lead candidate, tegoprubart, which inhibits CD40 ligand binding of T-cells with CD40 receptors on B-cells and dendritic cells [1] - The mechanism of action for tegoprubart serves to reduce T-cell mediated immune responses, indicating potential therapeutic applications [1]