Tegoprubart

Data from Phase 2 BESTOW trial demonstrated a favorable safety and tolerability profile, substantially reducing the metabolic, neurologic, and cardiovascular toxicities commonly associated with tacrolimus Data supports advancement into Phase 3 development as a potential new standard for the prevention of kidney transplant rejection Strengthened balance sheet with $57.5 million financing to advance transplantation programs IRVINE, Calif. , Nov. 14, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its third quarter 2025 operating and financial results and reviewed recent business highlights. “The results from our Phase 2 BESTOW trial demonstrated tegoprubart’s excellent efficacy and safety, importantly avoiding many of the long-term toxicities commonly seen with current standard-of-care immunosuppressive therapies,” said David-Alexandre C. Gros , M.D., Chief Executive Officer of Eledon. “Further, the proceeds from our recent financing enhance our ability to advance tegoprubart’s programs in kidney transplantation, islet cell transplantation, and xenotransplantation, addressing critical unmet needs in transplant medicine.” Third Quarter 2025 and Business Highlights Presented results from the Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant at the American Society of Nephrology’s Kidney Week 2025 Annual Meeting in Houston, TX. Tegoprubart demonstrated a favorable safety and tolerability profile, substantially reducing the metabolic, neurologic, and cardiovascular toxicities commonly associated with tacrolimus. Kidney function, as measured by estimated glomerular filtration rate (eGFR), was approximately 69 mL/min/1.732 at 12-months for participants in the tegoprubart treatment arm (n=51). Based on the Phase 2 BESTOW results, Eledon plans to advance tegoprubart into Phase 3 development following discussions with regulators on study design and data requirements. Insights from the Phase 2 BESTOW data set and the ongoing long-term extension study will be incorporated to optimize the Phase 3 protocol and strengthen the regulatory package. On November 13, 2025 , Eledon completed an underwritten public offering of common stock and pre-funded warrants, resulting in total gross proceeds of $57.5 million and net proceeds of approximately $53.6 million after deducting underwriting discounts, commissions, and estimated offering expenses. Anticipated Upcoming YE2025 and 2026 Milestones 4Q 2025: Enroll final three patients with Type 1 diabetes in the investigator-led clinical study at UChicago Medicine evaluating tegoprubart in islet cell transplantation. 2026: Receive U.S. Food & Drug Administration (“FDA”) guidance on the Phase 3 trial design for kidney transplantation, and subsequently initiate a Phase 3 trial in kidney transplantation. 2026: Report long-term data from the Phase 1 and Phase 2 BESTOW studies in kidney transplantation. 2026: Report data from nine patients in the investigator-led islet cell transplantation study. 2026: Receive FDA regulatory guidance on path to market for islet cell transplantation & xenotransplantation. Third Quarter 2025 Financial Results Cash, cash equivalents and short-term investments totaled $93.4 million as of September 30, 2025 compared to $140.2 million as of December 31, 2024 . Research and development (R&D) expenses for the third quarter of 2025 were $15.0 million , including $1.1 million of non-cash stock-based compensation expense, compared to $16.5 million , including $0.4 million of non-cash stock-based compensation expense, for the comparable period in 2024. General and administrative expenses for the third quarter of 2025 were $4.1 million , including $1.4 million of non-cash stock-based compensation expense, compared to $4.0 million , including $1.4 million of non-cash stock-based compensation expense, for the comparable period in 2024. Net loss for the third quarter of 2025 was $17.5 million , or $0.21 per basic common share, compared to a net income of $77.0 million , or $1.05 per basic common share, for the comparable period in 2024. Net income in the third quarter of 2024 included a non-cash gain of $96.4 million related to changes in the fair value of warrant liabilities. Excluding this non-cash gain, Eledon would have recorded a net loss of $19.5 million for the third quarter of 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 at www.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: 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 establish and maintain proper and effective internal control over financial reporting and other risks disclosed in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 , filed with the Securities and Exchange Commission on November 14, 2025 . 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 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 Jasper Gilmartin Group (858) 525 2047stephen@gilmartinir.com Media Contact: Jenna Urban CG Life(212) 253 8881jurban@cglife.com Source: Eledon Pharmaceuticals ELEDON PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share data) (Unaudited) ELEDON PHARMACEUTICALS , INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share data) (Unaudited) Source: Eledon Pharmaceuticals, Inc.

IRVINE, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN), today announced the pricing of its underwritten public offering of (i) 15,152,485 shares of its common stock at a public offering price of $1.65 per share and (ii) in lieu of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 15,151,515 shares of common stock at a public offering price of $1.649 per pre-funded warrant. The pre-funded warrants will be immediately exercisable and will have an exercise price of $0.001 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $50 million. In addition, Eledon has granted to the underwriters a 30-day option to purchase up to 4,545,600 additional shares of common stock at the public offering price, less underwriting discounts and commissions. All of the shares of common stock and pre-funded warrants in the offering are to be sold by Eledon. The offering is expected to close on or about November 13, 2025, subject to the satisfaction of customary closing conditions. Leerink Partners, Cantor and LifeSci Capital are acting as joint book-running managers for the offering. Eledon currently intends to use the net proceeds from the offering to support the continued clinical development of its product candidates and advance its pipeline programs as well as for general corporate purposes. The offering is being made pursuant to a registration statement on Form S-3 (File No. 333-282260), previously filed with the Securities and Exchange Commission (the “SEC”) on September 20, 2024 and declared effective on October 2, 2024. The offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC on November 12, 2025 and a final prospectus supplement relating to the offering will be filed with the SEC and available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus, once available, may also be obtained by contacting Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com, or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by email at prospectus@cantor.com. The final terms of the proposed offering will be disclosed in a final prospectus supplement to be filed with the SEC. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. 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. Eledon’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. Eledon is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding Eledon’s expectations on the timing and completion of the offering and the anticipated use of proceeds therefrom. No assurance can be given that the offering will be completed on the terms described. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including market conditions, failure of customary closing conditions and the risk factors and other matters set forth in the preliminary prospectus supplement and final prospectus supplement that will be filed with the SEC and other risks and uncertainties that could cause Eledon’s actual results to differ materially from the forward-looking statements contained herein are discussed in the company’s quarterly 10-Qs, annual 10-K, and other filings with the SEC, 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 Jasper Gilmartin Group (858) 525 2047 stephen@gilmartinir.com Media Contact: Jenna Urban CG Life (212) 253 8881 jurban@cglife.com Source: Eledon Pharmaceuticals Source: Eledon Pharmaceuticals, Inc.