Eledon Pharmaceuticals Reports Second Quarter 2026 Financial Results and Recent Business Highlights
Successful End-of-Phase 2 meeting with FDA supports advancement of tegoprubart into a global Phase 3 kidney transplantation trial, on track to initiate in late 2026
Long-term Phase 2 BESTOW data presented at ATC 2026 demonstrated sustained higher kidney function and improved patient-reported outcomes with tegoprubart compared with tacrolimus
Updated islet cell transplantation data presented at
Cash, cash equivalents and short-term investments of
“During the first half of the year, we made meaningful progress establishing the regulatory framework for our planned Phase 3 kidney transplantation program, which we expect to initiate later this year,” said
Second Quarter 2026 Business Highlights
Kidney Transplantation
- Completed a successful End-of-Phase 2 meeting with the
U.S. Food and Drug Administration , establishing the regulatory framework for the planned Phase 3 trial of tegoprubart in kidney transplantation. The global trial is on track to initiate in late 2026 and 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. - Presented new long-term data from the Phase 2 BESTOW clinical program at the
American Transplant Congress (ATC) inJune 2026 , demonstrating sustained higher kidney function in kidney transplant patients treated with tegoprubart compared with tacrolimus, the current standard-of-care immunosuppression therapy. At 18 months, the eGFR curves showed a statistically significant separation (p<0.05), with mean eGFR approximately 12 mL/min/1.73 m² higher for tegoprubart compared with tacrolimus (approximately 74 vs. 61 mL/min/1.73 m²). No BPAR events were observed in tegoprubart-treated patients after the first six months post-transplant, compared with seven BPAR events (9.4% of tacrolimus-treated patients) reported in the tacrolimus arm. Patient-reported outcomes at 52 weeks favored tegoprubart, with statistically significant improvements versus tacrolimus on two validated measures of symptom burden. Long-term data from the BESTOW extension trial also demonstrated favorable long-term safety and tolerability. - Treated the first two patients in an investigator-initiated study of kidney transplant tolerance induction at
Massachusetts General Hospital . - Entered into a strategic partnership with Natera, Inc., a global leader in cell-free DNA testing and precision medicine, to incorporate Natera’s Prospera kidney transplant assessment test as the exclusive donor-derived cell-free DNA (dd-cfDNA) monitoring assay in Eledon’s planned Phase 3 kidney transplantation trial.
Islet Cell Transplantation
- Presented updated data from the
University of Chicago Medicine investigator-initiated islet cell transplantation study atADA 2026. All 12 patients with T1D achieved insulin independence and HbA1c below 6.5%, with a mean most recent HbA1c of approximately 5.4% and no severe hypoglycemic episodes post-transplant. Tegoprubart demonstrated stable islet graft function through a maximum follow-up of 22 months and was generally well tolerated, with no evidence of nephrotoxicity, hypertension or neurotoxicity.
Anticipated Upcoming Milestones
The Company anticipates the following milestones in 2026 and over the next 12 months:
- Initiate Phase 3 clinical trial evaluating tegoprubart in kidney transplantation in late 2026.
- Support the initiation of an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients with renal dysfunction receiving an islet cell transplant in 2026.
- Initiate company-sponsored, registration path study evaluating tegoprubart in islet cell transplantation.
- Support the initiation of an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo liver transplant.
- Receive FDA regulatory guidance on the path to market for tegoprubart in xenotransplantation.
Second Quarter 2026 Financial Results
Cash, cash equivalents and short-term investments totaled
Research and development (R&D) expenses for the second quarter of 2026 were
General and administrative (G&A) expenses for the second quarter of 2026 were
Net loss for the second quarter of 2026 was
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-CD40L 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.
Follow Eledon Pharmaceuticals on social media: LinkedIn; X
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 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 Report on Form 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 as 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:
Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com
Media Contact:
Jenna Urban
CG Life
(212) 253 8881
jurban@cglife.com
CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share data) (Unaudited) |
||||||||
2026 |
2025 |
|||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 6,803 | $ | 22,808 | ||||
| Short-term investments | 81,953 | 110,528 | ||||||
| Prepaid expenses and other current assets | 4,335 | 2,352 | ||||||
| Total current assets | 93,091 | 135,688 | ||||||
| Operating lease asset, net | 445 | 613 | ||||||
| In-process research and development | 32,386 | 32,386 | ||||||
| Other assets | 172 | 322 | ||||||
| Total assets | $ | 126,094 | $ | 169,009 | ||||
| LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,214 | $ | 3,627 | ||||
| Current operating lease liabilities | 381 | 358 | ||||||
| Accrued expenses and other liabilities | 8,194 | 14,359 | ||||||
| Total current liabilities | 11,789 | 18,344 | ||||||
| Deferred tax liabilities | 2,187 | 2,187 | ||||||
| Non-current operating lease liabilities | 86 | 283 | ||||||
| Warrant liabilities | 40,001 | 11,416 | ||||||
| Total liabilities | 54,063 | 32,230 | ||||||
| Commitments and contingencies | ||||||||
| Convertible preferred stock, 5,000,000 shares authorized at |
||||||||
| Series X non-voting convertible preferred stock, |
2,151 | 2,151 | ||||||
| Series X1 non-voting convertible preferred stock, |
36,867 | 53,543 | ||||||
| Stockholders’ equity: | ||||||||
| Common stock, |
81 | 75 | ||||||
| Additional paid-in capital | 504,904 | 482,189 | ||||||
| Accumulated other comprehensive income (loss) | (114 | ) | 24 | |||||
| Accumulated deficit | (471,858 | ) | (401,203 | ) | ||||
| Total stockholders’ equity | 33,013 | 81,085 | ||||||
| Total liabilities, convertible preferred stock and stockholders’ equity | $ | 126,094 | $ | 169,009 | ||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share data) (Unaudited) |
||||||||||||||||
| For the Three Months Ended |
For the Six Months Ended |
|||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 18,230 | $ | 20,276 | $ | 35,427 | $ | 33,807 | ||||||||
| General and administrative | 4,639 | 4,457 | 8,623 | 8,890 | ||||||||||||
| Total operating expenses | 22,869 | 24,733 | 44,050 | 42,697 | ||||||||||||
| Loss from operations | (22,869 | ) | (24,733 | ) | (44,050 | ) | (42,697 | ) | ||||||||
| Other income, net | 862 | 1,224 | 1,980 | 2,633 | ||||||||||||
| Change in fair value of warrant liabilities | (9,623 | ) | 12,293 | (28,585 | ) | 22,353 | ||||||||||
| Net loss | $ | (31,630 | ) | $ | (11,216 | ) | $ | (70,655 | ) | $ | (17,711 | ) | ||||
| Other comprehensive loss: | ||||||||||||||||
| Unrealized loss on available-for-sale securities, net | (42 | ) | (30 | ) | (138 | ) | (74 | ) | ||||||||
| Comprehensive loss | $ | (31,672 | ) | $ | (11,246 | ) | $ | (70,793 | ) | $ | (17,785 | ) | ||||
| Basic and diluted earnings per share of common stock | $ | (0.27 | ) | $ | (0.13 | ) | $ | (0.59 | ) | $ | (0.21 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 113,631,565 | 77,156,068 | 113,031,223 | 77,141,196 | ||||||||||||
| Basic and diluted earnings per share of Series X and Series X1non-voting convertible preferred stock | $ | (14.79 | ) | $ | (7.46 | ) | $ | (33.04 | ) | $ | (11.78 | ) | ||||
| Weighted-average shares outstanding of Series X and Series X1non-voting convertible preferred stock, basic and diluted | 93,876 | 114,508 | 104,135 | 114,508 | ||||||||||||
Source: Eledon Pharmaceuticals, Inc.