Eledon Pharmaceuticals — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and short-term investments totaled $69.7 million as of September 30, 2026, down from $133.3 million as of December 31, 2025.
• The Company expects its current cash position to fund operations into Q2 2027.
• Research and development (R&D) expenses for the quarter were $17.8 million, compared to $15.0 million in the same period in 2025.
• General and administrative (G&A) expenses for the quarter were $3.9 million, compared to $4.1 million in the same period in 2025.
• Net loss for the third quarter of 2026 was $3.9 million ($0.03 per basic share), compared to a net loss of $17.5 million ($0.21 per basic share) in the third quarter of 2025.
• The Q3 2026 net loss included a non-cash gain of $17.0 million from changes in the fair value of warrant liabilities; excluding this, the net loss would have been $21.0 million (compared to $18.0 million in Q3 2025 excluding a $0.6 million non-cash gain).
• Total operating expenses for the nine months ended September 30, 2026, were $65.7 million, compared to $61.8 million for the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $74.6 million ($0.63 per basic share), compared to $35.2 million ($0.42 per basic share) in the same period in 2025.

Guidance and Future Outlook:

• The global Phase 3 LEGACY trial of tegoprubart in kidney transplantation is on track to initiate in Q4 2026.
• The LEGACY trial is expected to enroll approximately 600 patients with a primary endpoint of non-inferiority versus tacrolimus at 52 weeks based on a composite of biopsy-proven acute rejection (BPAR), graft loss, and death.
• The Company anticipates initiating a Company-sponsored, registrational path study for tegoprubart in type 1 diabetes (T1D) patients undergoing islet cell transplantation within the next 12 months.
• An investigator-led study evaluating tegoprubart for organ rejection prevention in de novo liver transplant patients is anticipated to initiate within the next 12 months.
• The Company expects to receive FDA regulatory guidance on the path to market for tegoprubart in kidney xenotransplantation within the next 12 months.
• Forward-looking statements note that the ability to achieve milestones depends on securing additional financing on acceptable terms.

Business Segments and Product Lines:

• Kidney Transplantation:
  • FDA granted Fast Track designation to tegoprubart for the prevention of rejection in kidney transplantation.
  • New patient-reported outcomes from the Phase 2 BESTOW program presented at ASN Kidney Week 2026 showed sustained improvements in quality of life and symptom burden for tegoprubart-treated patients compared to tacrolimus.
  • Updated long-term data from the BESTOW extension study presented at TTS 2026 showed tegoprubart-treated patients maintained statistically significantly higher mean estimated glomerular filtration rate (eGFR) at 18, 21, and 24 months, with an approximately 13 mL/min/1.73m² advantage over tacrolimus at month 24 (71 vs. 58 mL/min/1.73m²).
  • No cases of biopsy-proven acute rejection (BPAR) were reported in the tegoprubart arm beyond six months post-transplant, compared to seven BPAR events in the tacrolimus arm.
  • The first highly sensitized kidney transplant patient was dosed under a compassionate-use protocol at Duke University Medical Center.
  • The third patient was treated in an investigator-initiated study at Massachusetts General Hospital (MGH) for kidney transplant tolerance induction.
• Islet Cell Transplantation:
  • The FDA cleared the Investigational New Drug (IND) application for a planned registrational path study in T1D patients undergoing pancreatic islet cell transplantation.
  • The first patients were enrolled in an investigator-initiated trial at the University of Chicago Medicine Transplant Institute for T1D patients with renal dysfunction receiving islet cell transplants.
  • The first islet cell transplant recipient was dosed under a compassionate-use protocol to switch from tacrolimus due to calcineurin inhibitor-related renal dysfunction.
  • The University of Chicago Medicine expanded its investigator-initiated study by enrolling three additional subjects, bringing the total treated to 12 patients.
  • The 12 patients treated to date achieved 100% insulin independence with stable islet graft function through 22 months of follow-up and a favorable tolerability profile.
  • No evidence of nephrotoxicity, hypertension, or neurotoxicity has been observed in the islet cell study patients to date.

Market and Competitive Landscape:

• Tegoprubart is being evaluated against tacrolimus, the current standard of care immunosuppression therapy.
• Highly sensitized kidney transplant patients face a substantial unmet need due to pre-existing antibodies limiting access to compatible donor organs and increasing rejection risks.
• The Company is building upon historical knowledge of anti-CD40L biology for therapeutic intervention in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver transplantation, and amyotrophic lateral sclerosis (ALS).

Risks and Challenges:

• The Company faces risks related to its short operating history, shifts in business strategy, and operating losses since inception.
• There is a need for additional funding to develop the lead drug candidate, with no guarantee of securing additional financing on acceptable terms or at all.
• Risks include the potential for dilution or stock price decline from future issuances of common stock.
• Clinical trial results from non-clinical or early-stage studies may not be predictive of later-stage trial results.
• Potential delays or difficulties in patient enrollment for clinical trials exist.
• Regulatory approval for products is not guaranteed.
• The Company depends on contract research organizations and faces risks regarding intellectual property protection and cybersecurity.

Management Commentary and Tone:

• CEO David-Alexandre C. Gros, M.D., stated the Company continues to execute across key strategic priorities and make meaningful progress in the tegoprubart clinical program.
• Management highlighted that new patient-reported outcomes data strengthened the evidence supporting tegoprubart's differentiated profile compared to standard of care.
• Management noted that investigator-initiated studies and compassionate-use protocols are expanding the understanding of tegoprubart's therapeutic potential in settings with significant unmet needs.

Other Key Points:

• The Company has $69.7 million in cash, cash equivalents, and short-term investments as of September 30, 2026.
• The balance sheet shows total assets of $106.6 million and total liabilities of $36.8 million as of September 30, 2026.
• Warrant liabilities increased to $22.9 million as of September 30, 2026, from $11.4 million as of December 31, 2025.
• Accumulated deficit increased to $475.8 million as of September 30, 2026, from $401.2 million as of December 31, 2025.
• The Company is a clinical stage biotechnology company headquartered in Irvine, California.