Phase 2 BESTOW trial data evaluating tegoprubart in kidney transplantation showed favorable efficacy, safety and tolerability, supporting advancement into Phase 3 development Reported positive preliminary results from first six patients with type 1 diabetes treated with tegoprubart following islet transplantation in UChicago Medicine-led study Tegoprubart continues to be used as key component of immunosuppression regimen in xenotransplants, including three transplants of a genetically modified pig kidney in ...

Eledon Pharmaceuticals FY Conference Summary Company Overview - **Company**: Eledon Pharmaceuticals (NasdaqCM:ELDN) - **Focus**: Development of tegoprubart (Tego) for kidney transplantation and other transplant-related therapies Key Points Industry Context - **Transplantation Market**: Approximately 48,000 transplants are performed annually in the U.S., with 60% being kidney transplants [4][5] - **Kidney Transplant Statistics**: About 25,000 to 27,000 kidney transplants occur each year, while around 100,000 Americans are on the waiting list for transplants [5][6] Product Development and Clinical Trials - **Phase 2 BESTOW Data**: Recent results show that Tego's efficacy is not inferior to tacrolimus, the current standard of care, with a strong safety profile [1][2] - **Patient Involvement**: Over 150 patients have used Tego, with more than 100 post-transplant patients included in the study [2] - **Future Milestones**: Plans to approach the FDA regarding the path to market for kidney transplantation and other transplant types, including islet cell and xenotransplantation [3] Financial Position - **Cash Reserves**: Eledon finished the last quarter with over $93 million in cash and completed a $57.5 million financing round, providing sufficient funds until the second quarter of 2027 [2] Comparative Analysis with Tacrolimus - **Market Size**: Tacrolimus represents a $1.5 billion market, despite being over 30 years old [8] - **Safety Concerns**: Tacrolimus is nephrotoxic and associated with diabetes and hypertension, which are leading causes of kidney issues [9] - **Efficacy Metrics**: Mean eGFR (estimated Glomerular Filtration Rate) at 52 weeks was 69 for Tego compared to 66 for tacrolimus, indicating superior kidney function [12] Adverse Events (AEs) Comparison - **Tego vs. Tacrolimus**: Tego showed lower rates of proteinuria, bacteremia, hyperglycemia, and new-onset diabetes compared to tacrolimus [13][14][15][16] - **Psychological Impact**: Patients on tacrolimus may experience longer post-transplant dialysis, which can be psychologically challenging [17] Regulatory and Future Plans - **Phase 3 Trial**: Eledon plans to initiate a Phase 3 trial in the second half of the year, pending FDA discussions [18] - **Patient Enrollment**: Expected enrollment of 200-300 patients per arm for the Phase 3 trial, focusing on achieving non-inferiority in safety and efficacy [19] Market Opportunity - **Concentration of Transplant Centers**: There are about 250 transplant centers in the U.S., with 40 centers performing half of the transplants, indicating a concentrated market [6] Conclusion Eledon Pharmaceuticals is positioned to make significant advancements in the transplantation market with its product Tego, which has demonstrated promising efficacy and safety compared to the current standard of care, tacrolimus. The company is well-funded and has a clear path forward for regulatory approval and further clinical development.

IRVINE, Calif., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that David-Alexandre C. Gros, M.D., Chief Executive Officer will participate in a fireside chat at the upcoming 37th Annual Piper Sandler Healthcare Conference on Thursday, December 4, 2025 at 8:50 a.m. ET (5:50 a.m. PT). To register in advance for the fireside chat webcast, sign up here. A webcast replay will be accessible following the live session on the Company’s website under Events. ...

Core Insights - Eledon Pharmaceuticals announced preliminary results from a trial evaluating tegoprubart, an investigational anti-CD40L antibody, for preventing islet transplant rejection in type 1 diabetes patients [1][2][4] Group 1: Trial Overview - The ongoing trial has been extended to include 12 subjects and focuses on a tacrolimus-free immunosuppression regimen [2] - Preliminary data from the first six subjects show that tegoprubart can prevent rejection of transplanted islet cells, leading to sustained insulin-free management of hemoglobin A1C (HbA1c) levels [2][3] Group 2: Patient Outcomes - All six subjects demonstrated significant improvements in glycemic control, achieving insulin independence after one or two islet transplants [3] - The first three participants have remained insulin-free for over 15 months, with one patient maintaining an HbA1c as low as 4.7% [3] - Two subjects who underwent transplantation in July 2025 achieved insulin independence within approximately four weeks and maintained HbA1c levels below 6% for over three months [3] - A sixth subject, after a second islet infusion, is now insulin-free with an HbA1c of 5.3% [3] Group 3: Safety and Tolerability - Tegoprubart was generally well tolerated, with no serious infections, thromboembolic events, or signs of kidney or neurological toxicity [3] - All six patients have been free of severe hypoglycemic episodes since their transplants [3] Group 4: Future Implications - The results suggest that tegoprubart may offer a safer alternative to traditional calcineurin inhibitors, which are associated with various toxicities [4] - Breakthrough T1D has committed to funding further studies to evaluate tegoprubart in islet transplantation and chronic kidney disease [4] Group 5: Company Background - Eledon Pharmaceuticals is a clinical-stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions [6] - The company's lead product, tegoprubart, targets CD40 Ligand, which has broad therapeutic potential [6]

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]