Eledon Pharmaceuticals Inc.
03/19/2026 | Press release | Distributed by Public on 03/19/2026 15:02
Eledon Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Operating and Financial Results (Form 8-K)
Eledon Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Operating and Financial Results
Reported updated results from 12 patients with type 1 diabetes treated with tegoprubart following islet transplantation in UChicago Medicine-led study
Presented 24-month follow-up data from Phase 1b long-term extension study which continues to support the favorable safety and tolerability profile of tegoprubart
Tegoprubart granted Orphan Drug designation by the FDA for the prevention of allograft rejection in liver transplantation
IRVINE, Calif., March 19, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. ("Eledon") (Nasdaq: ELDN) today reported its fourth quarter and full year 2025 operating and financial results and reviewed recent business highlights.
"Over the past year, Eledon has made significant progress advancing tegoprubart, our anti-CD40L antibody, as a potential next-generation immunosuppressive therapy across multiple transplantation settings," said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. "The over 100 patients treated across our transplantation programs to date provide a growing body of evidence that reinforces our conviction that tegoprubart can address key safety and efficacy issues with current standard-of-care transplant immunosuppression. Looking ahead, we anticipate multiple important milestones this year, including regulatory engagement to support advancement into Phase 3 development in kidney transplantation, initiation of an additional islet transplantation trial in type 1 diabetes, and the start of a clinical trial in liver transplantation."
Fourth Quarter 2025 and Recent Corporate Developments
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Announced that tegoprubart has been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA) for the prevention of allograft rejection in liver transplantation. Tegoprubart previously received Orphan Drug designation from the FDA for the prevention of allograft rejection in pancreatic islet cell transplantation and for the treatment of amyotrophic lateral sclerosis (ALS).
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Presented 24-month follow-up data from eight patients enrolled in the Phase 1b long-term extension trial evaluating tegoprubart in kidney transplantation at the American Society of Transplant Surgeons Winter Symposium. The data continue to support the favorable safety and tolerability profile of tegoprubart with no episodes of biopsy-proven acute rejection, graft loss, death, new-onset diabetes mellitus, or de novo donor-specific antibody formation reported during the study period. Mean estimated glomerular filtration rate (eGFR) increased over the measurement period, from 67.0 mL/min/1.73 m² at 12 months to 74.2 mL/min/1.73 m² at 24 months.
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Reported updated results from 12 patients with type 1 diabetes treated with tegoprubart as the core immunosuppressant following islet transplantation in an investigator-initiated trial conducted at the University of Chicago Medicine Transplant Institute. All 10 patients who were more than four weeks post-transplant achieved 100% insulin independence and a most recent hemoglobin A1C (HbA1c) below 6.0%, with a mean most recent HbA1c across the 10 patients of approximately 5.35%. Tegoprubart-based immunosuppression was generally well tolerated with reported post-transplant immunosuppression-related adverse events successfully treated by lowering the mycophenolic acid dose, if necessary. There were no rejection episodes, and no patients developed de novo donor-specific HLA antibodies. Additionally, no evidence of nephrotoxicity, hypertension or neurotoxicity, which are commonly associated with tacrolimus-based immunosuppression regimens, was observed. The study continues to generate significant patient demand with inquiries received from several hundred T1D patients.
Anticipated Upcoming Milestones
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Receive FDA guidance on the Phase 3 trial design assessing tegoprubart in kidney transplantation, followed by initiation of the Phase 3 trial pending regulatory alignment.
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Report long-term data from Phase 1 and Phase 2 BESTOW studies evaluating tegoprubart in kidney transplantation.
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Receive FDA regulatory guidance on path to market for tegoprubart in islet cell transplantation and xenotransplantation.
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Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients with renal dysfunction receiving an islet cell transplant.
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Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo liver transplant.
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Initiate an investigator-led study evaluating tegoprubart for kidney transplant tolerance induction.
Full Year 2025 Financial Results
Research and development (R&D) expenses for the year ended December 31, 2025 were $66.3 million, including $4.2 million of non-cash stock-based compensation expense, compared to $52.0 million, including $4.3 million of non-cash stock-based compensation expense, for the comparable period in 2024. The increase was primarily driven by continued advancement of the tegoprubart clinical development programs, including expanded clinical trial activity and manufacturing scale-up, as well as increased personnel to support these efforts.
General and administrative expenses for the year ended December 31, 2025 were $17.0 million, including $6.2 million of non-cash stock-based compensation expense, compared to $18.6 million, including $8.8 million of non-cash stock-based compensation expense, for the comparable period
in 2024. The decrease was primarily driven by lower stock-based compensation expense, partially offset by higher professional services and personnel-related costs.
Net loss for the year ended December 31, 2025 was $45.6 million, or $0.52 per basic share of common stock, compared to a net loss of $36.2 million, or $0.66 per basic share of common stock, for the comparable period in 2024. The 2025 net loss included a non-cash gain of $33.4 million from changes in the fair value of warrant liabilities, while the 2024 net loss included a non-cash gain of $30.9 million from such changes. Excluding the non-cash items related to changes in the fair value of warrant liabilities, Eledon would have recorded a net loss of $79.1 million for the year ended December 31, 2025 and $67.1 million for the year ended December 31, 2024.
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company's lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver transplantation and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company's website at www.eledon.com.
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