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
“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
Fourth Quarter 2025 and Recent Corporate Developments
- 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). - 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. - 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
- 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.
- Report long-term data from Phase 1 and Phase 2 BESTOW studies evaluating tegoprubart in kidney transplantation.
- Receive FDA regulatory guidance on path to market for tegoprubart in islet cell transplantation and xenotransplantation.
- Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients with renal dysfunction receiving an islet cell transplant.
- Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo liver transplant.
- 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
General and administrative expenses for the year ended
Net loss for the year ended
About Eledon Pharmaceuticals and tegoprubart
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Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: our short operating history and shifts in our business strategy; our operating losses since inception; our need for additional funding to develop our lead drug candidate and our ability to secure additional funding on acceptable terms or at all; the impact of issuances of our common stock, including in the possibility of dilution or a decline in our stock price; our ability to successfully develop our product candidates; unfavorable global economic and financial market conditions; the regulatory environment of our business and our ability to obtain required regulatory approvals; results of non-clinical studies and clinical trials, and risks that non-clinical studies or early clinical trials may not be predictive of results of later-stage clinical trials; delays or difficulties in enrollment of patients in clinical trials; our ability to attract and retain our executives and key employees; legislation of the pharmaceutical and healthcare industries; cybersecurity and data privacy risks; the ability of our products to achieve marketing approval; competition in our industry; our ability to obtain insurance coverage; our dependence on contract research organizations; our ability to protect our intellectual property; public health crises; our ability to maintain proper and effective internal control over financial reporting and other risks disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 19, 2026. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ materially from the forward-looking statements contained herein, are discussed in our Annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Contact:
(858) 525 2047
stephen@gilmartinir.com
Media Contact:
CG Life
(212) 253 8881
jurban@cglife.com
Source: Eledon Pharmaceuticals
CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share data) |
||||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 22,808 | $ | 20,549 | ||||
| Short-term investments | 110,528 | 119,629 | ||||||
| Prepaid expenses and other current assets | 2,352 | 3,552 | ||||||
| Total current assets | 135,688 | 143,730 | ||||||
| Operating lease right-of-use asset, net | 613 | 926 | ||||||
| In-process research and development | 32,386 | 32,386 | ||||||
| Other assets | 322 | 363 | ||||||
| Total assets | $ | 169,009 | $ | 177,405 | ||||
| LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,627 | $ | 5,833 | ||||
| Current operating lease liability | 358 | 314 | ||||||
| Accrued expenses and other liabilities | 14,359 | 5,430 | ||||||
| Total current liabilities | 18,344 | 11,577 | ||||||
| Deferred tax liability | 2,187 | 2,183 | ||||||
| Non-current operating lease liability | 283 | 640 | ||||||
| Warrant liabilities | 11,416 | 44,865 | ||||||
| Total liabilities | 32,230 | 59,265 | ||||||
| Commitments and contingencies | ||||||||
| Convertible preferred stock, 5,000,000 shares authorized at |
||||||||
| Series X non-voting convertible preferred stock, |
2,151 | 2,151 | ||||||
| Series X1non-voting convertible preferred stock, |
53,543 | 53,543 | ||||||
| Stockholders’ equity: | ||||||||
| Common stock, |
75 | 60 | ||||||
| Additional paid-in capital | 482,189 | 417,946 | ||||||
| Accumulated other comprehensive income | 24 | 26 | ||||||
| Accumulated deficit | (401,203 | ) | (355,586 | ) | ||||
| Total stockholders’ equity | 81,085 | 62,446 | ||||||
| Total liabilities, convertible preferred stock and stockholders’ equity | $ | 169,009 | $ | 177,405 | ||||
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share data) |
||||||||
| Year Ended |
||||||||
| 2025 | 2024 | |||||||
| Operating expenses | ||||||||
| Research and development | $ | 66,267 | $ | 51,964 | ||||
| General and administrative | 16,984 | 18,613 | ||||||
| Total operating expenses | 83,251 | 70,577 | ||||||
| Other income, net | 4,220 | 3,924 | ||||||
| Change in fair value of warrant liabilities | 33,449 | 30,900 | ||||||
| Loss before income taxes | (45,582 | ) | (35,753 | ) | ||||
| Provision for income taxes | (35 | ) | (431 | ) | ||||
| Net loss | $ | (45,617 | ) | $ | (36,184 | ) | ||
| Other comprehensive loss: | ||||||||
| Unrealized loss on available-for-sale securities, net | (2 | ) | — | |||||
| Comprehensive loss | $ | (45,619 | ) | $ | (36,184 | ) | ||
| Basic and diluted earnings per share of common stock | $ | (0.52 | ) | $ | (0.66 | ) | ||
| Weighted-average common shares outstanding, basic and diluted | 81,836,246 | 48,543,787 | ||||||
| Basic and diluted earnings per share of Series X and Series X1non-voting convertible preferred stock | $ | (28.73 | ) | $ | (36.61 | ) | ||
| Weighted-average shares outstanding of Series X and Series X1non-voting convertible preferred stock, basic and diluted | 114,508 | 114,508 | ||||||
Source: Eledon Pharmaceuticals, Inc.