Eledon Pharmaceuticals, Inc. (ELDN), a clinical-stage biotechnology company, reported its full-year 2025 financial results reflecting wider net loss and highlighted operational updates from its fourth quarter. In addition, the firm provided expected milestones ahead for its lead candidate, Tegoprubart.
Company Profile
Eledon Pharma develops therapies for transplanted organs to prevent rejection and to treat amyotrophic lateral sclerosis (ALS), leveraging its immunology expertise.
The company's lead compound in development is Tegoprubart, an IgG1 anti-CD40L antibody with therapeutic potential, currently under clinical research in kidney transplantation and xenotransplantation.
FY'25 Results
Net loss for the full year 2025 expanded to $45.6 million or $0.52 per share from $36.2 million, or $0.66 per share in the prior year.
As of December 31, 2025, the firm reported cash and cash equivalents of $22.81 million and total assets of $169.01 million.
Q4 Operational Updates
During the quarter, the lead drug candidate Tegoprubart received an Orphan Drug designation from the FDA for the prevention of allograft rejection in liver transplantation.
The firm presented 24-month follow-up data from eight patients enrolled in a Phase 1b long-term extension trial evaluating Tegoprubart in kidney transplantation at the American Society of Transplant Surgeons Winter Symposium.
According to the firm, the data continued to support the favourable 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.
In addition, it reported updated results from an investigator-initiated trial of 12 patients with type 1 diabetes (T1D) treated with Tegoprubart as the core immunosuppressant following islet transplantation.
As stated by the firm, all 10 patients who were more than 4 weeks post-transplant achieved 100% insulin independence, and the most recent haemoglobin A1c (HbA1c) was below 6.0%, with a mean HbA1c across the 10 patients of approximately 5.35%.
The firm noted that the study continues to generate significant patient demand with inquiries received from several hundred T1D patients.
Expected Upcoming Milestones
- Receive FDA guidance on the Phase 3 trial design of Tegoprubart in kidney transplantation, followed by initiation of the Phase 3 trial pending regulatory alignment.
- Report long-term data from Phase 1 and Phase 2 BESTOW studies evaluating Tegoprubart in kidney transplantation.
- Receive FDA regulatory guidance on the path to market for Tegoprubart in islet cell transplantation and xenotransplantation.
-Initiate investigator-led studies evaluating Tegoprubart for the prevention of organ rejection in patients with renal dysfunction receiving an islet cell transplant, a de novo liver transplant, and also for kidney transplant tolerance induction.
Conclusion
"Looking ahead, we anticipate multiple important milestones this year ", said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon.
ELDN has traded between $1.35 and $4.60 in the last year. The stock closed Thursday's trade at $2.85, down 5%.
In the overnight market, ELDN is down 0.35% at $2.84.
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