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 ...

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]

Market Overview - U.S. stocks experienced a decline, with the Dow Jones index dropping over 200 points, closing down 0.47% at 46,693.85, NASDAQ fell 1.42% to 22,725.49, and S&P 500 decreased 0.82% to 6,664.90 [1] - European shares also fell, with the eurozone's STOXX 600 down 0.55%, Spain's IBEX 35 Index down 1.3%, and London's FTSE 100 down 0.55% [5] - Asian markets closed lower, with Japan's Nikkei 225 down 1.19%, Hong Kong's Hang Seng down 0.92%, and China's Shanghai Composite down 0.25% [6] Company Performance - Fluor Corporation's shares fell 2% after reporting third-quarter results, with adjusted earnings per share at 68 cents, exceeding the 45-cent estimate, but revenue fell 18% to $3.37 billion, below the $4.20 billion consensus [2] - Motorsport Games Inc saw a significant increase in shares, rising 84% to $4.02 due to a year-over-year increase in third-quarter sales [8] - BIO-Key International Inc shares surged 66% to $1.06 following the announcement of significant biometric and IAM deployment in the Middle East [8] - Gulf Island Fabrication Inc shares increased by 50% to $11.76 after IES agreed to acquire the company for $12 per share in cash [8] - Eledon Pharmaceuticals Inc shares dropped 54% to $1.88 after announcing results from its Phase 2 BESTOW trial [8] - Energys Group Ltd shares fell 46% to $2.14, and Functional Brands shares decreased by 47% to $0.68 [8] Economic Indicators - The University of Michigan's consumer sentiment index declined to 50.3 in November from 53.6 in the previous month, below market expectations of 53.2 [10] - Median inflation expectations in the U.S. eased to 3.2% for the one-year horizon in October, down from 3.4% in September [10]

Market Overview - U.S. stocks experienced a decline, with the Dow Jones index dropping over 200 points, down 0.47% to 46,693.85, NASDAQ falling 1.42% to 22,725.49, and S&P 500 decreasing 0.82% to 6,664.90 [1] - European shares also fell, with the eurozone's STOXX 600 down 0.55%, Spain's IBEX 35 Index down 1.3%, and other major indices in London, Germany, and France also declining [5] - Asian markets closed lower, with Japan's Nikkei 225 down 1.19%, Hong Kong's Hang Seng down 0.92%, and China's Shanghai Composite down 0.25% [6] Company Performance - Fluor Corporation's shares fell 2% after reporting third-quarter results, with adjusted earnings per share at 68 cents, exceeding the 45-cent estimate, but revenue fell 18% to $3.37 billion, below the $4.20 billion consensus [2] - Motorsport Games Inc saw a significant increase in shares, rising 84% to $4.02 due to a year-over-year increase in third-quarter sales [8] - BIO-Key International Inc shares surged 66% to $1.06 following the announcement of significant biometric and IAM deployment in the Middle East [8] - Gulf Island Fabrication Inc shares increased by 50% to $11.76 after IES agreed to acquire the company for $12 per share in cash [8] - Eledon Pharmaceuticals Inc shares dropped 54% to $1.88 after announcing results from its Phase 2 BESTOW trial [8] - Energys Group Ltd shares fell 46% to $2.14, and Functional Brands shares decreased by 47% to $0.68 [8] Economic Indicators - The University of Michigan's consumer sentiment index declined to 50.3 in November from 53.6 in the previous month, below market expectations of 53.2 [10] - Median inflation expectations in the U.S. eased to 3.2% for the one-year horizon in October, down from 3.4% in September [10]

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].