IRVINE, Calif., Nov. 18, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced preliminary results from an investigator-initiated trial conducted at the University of Chicago Medicine’s Transplant Institute and presented at the Rachmiel Levine-Arthur Riggs Diabetes Research Symposium, held November 14-17, 2025 at City of Hope in Los Angeles, California. The ongoing trial, which has been extended to include a total of 12 subjects, is evaluating tegoprubart, Eledon’s ...

PresentationVamil DivanGuggenheim Securities, LLC, Research Division All right. Thanks, everyone, for joining us here on the Second Annual Guggenheim Healthcare Innovation Conference. I'm Vamil Divan, one of the biopharma analysts here at Guggenheim and joining us in this room next, we have the Eledon Pharmaceutical team. We did have one victim to some of the travel issues who is not able to join us, and that's the CEO DA Gros, but we do have Steve Perrin, President and CSO of the company. So we'll run thr ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36620 ELEDON PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 20-1000967 (State or other ...

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. (“Eled ...

Eledon Pharmaceuticals Conference Call Summary Company Overview - **Company**: Eledon Pharmaceuticals (NasdaqCM:ELDN) - **Focus**: Development of tegoprubart, an anti-CD40 ligand antibody aimed at preventing transplant rejection across various organ types including kidney, heart, and liver [3][4] Core Insights and Arguments - **Current Market Context**: Tacrolimus, a long-standing immunosuppressant, has significant side effects including nephrotoxicity, cardiovascular issues, and metabolic toxicities, which Eledon aims to address with tegoprubart [5][6] - **Clinical Trials**: Eledon is conducting multiple clinical trials, with a primary focus on kidney transplants, which account for approximately 25,000 procedures annually in both the U.S. and Europe [9] - **BESTOW Study**: A phase 2 trial designed to compare tegoprubart against tacrolimus, with a primary endpoint focused on kidney function. The study enrolled 120 patients across various countries [13][14] - **Data Results**: The phase 2 study showed promising results, with tegoprubart demonstrating better kidney function compared to tacrolimus in several subgroups, despite missing the primary endpoint by three points [15][16][18] - **Safety Profile**: Tegoprubart exhibited a significantly better safety profile compared to tacrolimus, with lower incidences of diabetes, hypertension, and neurological issues [19][26] Additional Important Points - **Market Reaction**: Despite positive feedback from the medical community, the investment market reacted negatively, possibly due to a misunderstanding of the study's primary endpoint expectations [24][26] - **Future Steps**: Eledon plans to transition to a phase 3 study for kidney transplants, with regulatory discussions ongoing regarding endpoints and study design [22][41] - **Islet Cell and Xenotransplant Programs**: Eledon is also exploring islet cell transplants and xenotransplantation, with ongoing studies showing promising early results [33][36] - **Competitive Landscape**: Eledon is currently the only company focusing on CD40 ligand inhibition for transplant rejection prevention, while competitors are targeting larger autoimmune indications [39] Financial Position - **Cash Reserves**: As of September, Eledon reported approximately $90 million in cash, with plans to extend the runway to Q1 2027 through an ongoing capital raise [40][41]

Core Points - Eledon Pharmaceuticals announced a public offering of 15,152,485 shares of common stock at a price of $1.65 per share, along with pre-funded warrants for an additional 15,151,515 shares at $1.649 each, aiming for gross proceeds of approximately $50 million [1][2] - The offering is expected to close on or about November 13, 2025, subject to customary closing conditions [1] - The net proceeds will be used to support clinical development of product candidates and advance pipeline programs, as well as for general corporate purposes [2] Offering Details - The offering is made under a registration statement on Form S-3, previously filed with the SEC [3] - A preliminary prospectus supplement was filed with the SEC on November 12, 2025, with a final prospectus supplement to follow [3] Company Overview - Eledon Pharmaceuticals is a clinical stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions [5] - The lead product candidate is tegoprubart, an anti-CD40L antibody targeting CD40 Ligand, which has potential applications in kidney transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [5]

Core Viewpoint - Eledon Pharmaceuticals has initiated an underwritten public offering of its common stock and pre-funded warrants, with the intention to use the proceeds for clinical development and general corporate purposes [1][2]. Group 1: Offering Details - The offering includes common stock and pre-funded warrants, with a 30-day option for underwriters to purchase an additional 15% of the total shares sold [1]. - The offering is subject to market conditions, and there is no assurance regarding its completion or terms [1]. Group 2: Use of Proceeds - Eledon plans to utilize the net proceeds from the offering to support the clinical development of its product candidates and advance its pipeline programs, along with general corporate purposes [2]. Group 3: Company Background - Eledon Pharmaceuticals is a clinical-stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions, with its lead product being tegoprubart, an anti-CD40L antibody [5]. - The company is conducting studies in areas such as kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [5].

Group 1 - Eledon presented Phase II BESTOW data, highlighting the progress in their development of tegoprubart [2][3] - The call included key executives from Eledon, including the CEO, President, CFO, CMO, and Chief Regulatory Officer, indicating a strong leadership presence [2] - Dr. Andrew Adams, a notable figure in transplantation, participated in the presentation, suggesting the significance of the data shared [2]

Core Insights - Eledon Pharmaceuticals, Inc. (NASDAQ:ELDN) stock is experiencing a significant decline following the announcement of Phase 2 trial results for its drug tegoprubart, which is aimed at preventing organ rejection in kidney transplant patients [1][7] Trial Results - The Phase 2 BESTOW trial showed that tegoprubart did not provide significant improvements in estimated glomerular filtration rates (eGFR) compared to the standard immunosuppressant tacrolimus [2][5] - After 12 months, tegoprubart demonstrated an eGFR of 69 mL/min/1.73 m², while tacrolimus had a rate of 66 mL/min/1.73 m² [3] - In living-related donor recipient patients, tegoprubart's eGFR was higher at 72 mL/min/1.73 m², while patients with a high Kidney Donor Profile Index (KDPI > 35) had an eGFR of 62 mL/min/1.73 m² [4] Efficacy and Safety - The composite endpoint of efficacy failure for tegoprubart was non-inferior to tacrolimus, with rates of 22% for tegoprubart compared to 17% for tacrolimus [5] - Delayed graft function was less frequent with tegoprubart, requiring shorter dialysis (14.3% vs. 25.0%; 4.6 days vs. 6.1 days) [6] - Sepsis or bacteremia occurred more frequently in the tacrolimus group (17.2% vs. 4.8%) [6] Future Development - Despite not meeting the primary efficacy endpoint, the company plans to advance tegoprubart into Phase 3 development after discussions with regulators regarding study design and data requirements [6] - Eledon has approximately $93.4 million in cash and short-term investments, which is expected to sustain operations into late 2026 [7]

Eledon Pharmaceuticals Conference Call Summary Company Overview - **Company**: Eledon Pharmaceuticals (NasdaqCM:ELDN) - **Focus**: Development of tegoprubart for transplantation, particularly kidney transplants Key Points and Arguments Industry Context - **Transplantation Landscape**: The success in transplantation has been linked to the development of immunosuppressive drugs to prevent organ rejection. However, existing drugs like tacrolimus have limitations, including toxicity and complexity of use [2][5][6]. Tegoprubart Development - **Tegoprubart's Role**: Eledon aims for tegoprubart to be a cornerstone maintenance chronic immunosuppressive medicine across all transplant types, including kidney, islet cell, and potentially xenotransplantation [3][4]. - **Clinical Trials**: The company is conducting multiple studies, including a phase 2 trial (Bistot study) comparing tegoprubart to tacrolimus, the current standard of care [9][10]. Bistot Study Results - **Study Design**: The Bistot trial compared tacrolimus with tegoprubart in kidney transplant patients, focusing on eGFR (estimated Glomerular Filtration Rate) as a primary endpoint [9][10]. - **Efficacy**: Tegoprubart showed a mean eGFR of 69 mL/min compared to 66 mL/min for tacrolimus, indicating numerical superiority but not statistical significance [11][17]. - **Safety Profile**: Tegoprubart demonstrated a favorable safety profile, with significant reductions in side effects commonly associated with tacrolimus, such as new-onset diabetes, tremors, and hypertension [12][28][33]. Unmet Needs in Transplantation - **Current Limitations**: Tacrolimus, while effective, has a narrow therapeutic index and is associated with various toxicities, leading to complications such as kidney injury and increased cardiovascular risk [6][7][8]. - **Need for New Treatments**: There is a pressing need for new immunosuppressive agents that can reduce toxicity and improve long-term outcomes for kidney transplant patients [8][12]. Future Directions - **Phase 3 Study Plans**: Eledon plans to approach the FDA for a phase 3 study design based on the non-inferiority endpoint, with potential for additional superiority claims based on long-term outcomes [42][43]. - **Financial Position**: The company reported $93.4 million in cash, sufficient to fund operations into late 2026, with several upcoming milestones [35][61]. Additional Insights - **Patient Management**: The ability to maintain patients on tegoprubart during rejection episodes without switching to tacrolimus may lead to better long-term kidney function [50][55]. - **KDPI Scores**: The study revealed unexpected findings regarding the quality of donor kidneys, with higher quality kidneys (KDPI < 35) performing better with tacrolimus, raising questions about the long-term implications of drug choice [62]. Conclusion - **Overall Outlook**: Eledon is optimistic about the potential of tegoprubart to improve kidney transplant outcomes and is preparing for further studies to validate its efficacy and safety [34][36].