Full Press Release Details
Updated data from ongoing open-label Phase 1b trial demonstrated a mean 12-month eGFR of approximately 68 mL/min/1.73 m2post-transplant for patients on tegoprubart
Company on track to report topline results from Phase 2 BESTOW trial in kidney transplantation in November 2025
Cash, cash equivalents and short-term investments of $107.6 million as of June 30, 2025
IRVINE, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its second quarter 2025 operating and financial results and reviewed recent business highlights.
“We are proud to enter the second half of the year with strong momentum as we have achieved all of our key milestones to date including advancing tegoprubart in kidney, islet cell (type 1 diabetes), and liver allotransplantation, as well as in xenotransplantation. The positive data we recently presented at the World Transplant Congress reinforce the potential of tegoprubart to improve long-term transplant outcomes while reducing the toxic side effects often associated with the current standard of care,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “With these encouraging results in hand, we look forward to sharing topline data later this year from our Phase 2 BESTOW trial in kidney transplantation and to continuing to explore tegoprubart’s broad potential in other transplant indications.”
Year-to-Date 2025 Business Highlights
Anticipated Upcoming Milestones for 2H 2025
Second Quarter 2025 Financial Results
Cash, cash equivalents and short-term investmentstotaled $107.6 million as of June 30, 2025 compared to $140.2 million as of December 31, 2024. The company expects current cash, cash equivalents and short-term investments to fund operations to the end of 2026.
Research and development (R&D) expensesfor the second quarter of 2025 were $20.3 million, including $1.1 million of non-cash stock-based compensation expense, compared to $10.1 million, including $0.8 million of non-cash stock-based compensation expense, for the comparable period in 2024.
General and administrative expensesfor the second quarter of 2025 were $4.5 million, including $1.6 million of non-cash stock-based compensation expense, compared to $4.4 million, including $2.2 million of non-cash stock-based compensation expense, for the comparable period in 2024.
Net lossfor the second quarter of 2025 was $11.2 million, or $0.13 per basic common share, compared to a net loss of $44.9 million, or $0.92 per basic common share, for the comparable period in 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, liver allograft transplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website atwww.eledon.com.
Follow Eledon Pharmaceuticals on social media:LinkedIn;Twitter
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: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. 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 significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, 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:
Stephen JasperGilmartin Group(858) 525 2047stephen@gilmartinir.com
Media Contact:
Jenna UrbanCG Life(212) 253 8881jurban@cglife.com
Source: Eledon Pharmaceuticals
| ELEDON PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(In thousands, except share data)(Unaudited) | ||||||||
| June 30,2025 | December 31,2024 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 5,741 | $ | 20,549 | ||||
| Short-term investments | 101,829 | 119,629 | ||||||
| Prepaid expenses and other current assets | 3,834 | 3,552 | ||||||
| Total current assets | 111,404 | 143,730 | ||||||
| Operating lease asset, net | 773 | 926 | ||||||
| In-process research and development | 32,386 | 32,386 | ||||||
| Other assets | 346 | 363 | ||||||
| Total assets | $ | 144,909 | $ | 177,405 | ||||
| LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,831 | $ | 5,833 | ||||
| Current operating lease liabilities | 336 | 314 | ||||||
| Accrued expenses and other liabilities | 7,552 | 5,430 | ||||||
| Total current liabilities | 13,719 | 11,577 | ||||||
| Deferred tax liabilities | 2,183 | 2,183 | ||||||
| Non-current operating lease liabilities | 467 | 640 | ||||||
| Warrant liabilities | 22,512 | 44,865 | ||||||
| Total liabilities | 38,881 | 59,265 | ||||||
| Commitments and contingencies | — | — | ||||||
| Convertible preferred stock, 5,000,000 shares authorized at June 30, 2025 and December 31, 2024: | ||||||||
| Series X1non-voting convertible preferred stock, $0.001 par value, 515,000 shares designated; 110,086 shares issued and outstanding at June 30, 2025 and December 31, 2024 | 53,543 | 53,543 | ||||||
| Series X non-voting convertible preferred stock, $0.001 par value, 10,000 shares designated; 4,422 shares issued and outstanding at June 30, 2025 and December 31, 2024 | 2,151 | 2,151 | ||||||
| Stockholders’ equity: | ||||||||
| Common stock, $0.001 par value, 300,000,000 shares authorized at June 30, 2025 and 200,000,000 at December 31, 2024; 59,881,775 and 59,789,275 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively | 60 | 60 | ||||||
| Additional paid-in capital | 423,619 | 417,946 | ||||||
| Accumulated other comprehensive income (loss) | (48 | ) | 26 | |||||
| Accumulated deficit | (373,297 | ) | (355,586 | ) | ||||
| Total stockholders’ equity | 50,334 | 62,446 | ||||||
| Total liabilities, convertible preferred stock and stockholders’ equity | $ | 144,909 | $ | 177,405 |
| ELEDON PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(In thousands, except share and per share data)(Unaudited) | ||||||||||||||||
| For the Three MonthsEnded June 30, | For the Six MonthsEnded June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 20,276 | $ | 10,106 | $ | 33,807 | $ | 17,516 | ||||||||
| General and administrative | 4,457 | 4,396 | 8,890 | 7,855 | ||||||||||||
| Total operating expenses | 24,733 | 14,502 | 42,697 | 25,371 | ||||||||||||
| Loss from operations | (24,733 | ) | (14,502 | ) | (42,697 | ) | (25,371 | ) | ||||||||
| Other income, net | 1,224 | 869 | 2,633 | 1,443 | ||||||||||||
| Change in fair value of warrant liabilities | 12,293 | (31,274 | ) | 22,353 | (44,610 | ) | ||||||||||
| Net loss | $ | (11,216 | ) | $ | (44,907 | ) | $ | (17,711 | ) | $ | (68,538 | ) | ||||
| Other comprehensive loss: | ||||||||||||||||
| Unrealized loss on available-for-sale securities, net | (30 | ) | — | (74 | ) | — | ||||||||||
| Comprehensive loss | $ | (11,246 | ) | $ | (44,907 | ) | $ | (17,785 | ) | $ | (68,538 | ) | ||||
| Basic and diluted earnings per share of common stock (2024 As Restated) | $ | (0.13 | ) | $ | (0.92 | ) | $ | (0.21 | ) | $ | (1.61 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 77,156,068 | 42,278,411 | 77,141,196 | 36,133,906 | ||||||||||||
| Basic and diluted earnings per share of Series X and Series X1non-voting convertible preferred stock (2024 As Restated) | $ | (7.46 | ) | $ | (51.29 | ) | $ | (11.78 | ) | $ | (89.60 | ) | ||||
| Weighted-average shares outstanding of Series X and Series X1non-voting convertible preferred stock, basic and diluted (2024 As Restated) | 114,508 | 114,508 | 114,508 | 114,508 | ||||||||||||