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 ...

Core Insights - Several small- and mid-cap stocks experienced notable gains in after-hours trading, driven by investor sentiment and sector momentum rather than new company news [1][2][3][4][5] Company Summaries - **Spyre Therapeutics, Inc. (SYRE)**: Closed at $34.71, up $1.65 or 4.99%, leading the list of gainers despite no new updates [1] - **The Oncology Institute, Inc. (TOI)**: Ended at $3.65, up $0.19 or 5.49%, with steady share price increase without new announcements [2] - **Aurora Cannabis Inc. (ACB)**: Closed at $5.70, gaining $0.13 or 2.33%, benefiting from renewed momentum in the cannabis sector [2] - **Solid Biosciences Inc. (SLDB)**: Finished at $5.45, up $0.07 or 1.30%, supported by the recent addition of Duchenne muscular dystrophy to the Recommended Uniform Screening Panel [3] - **EUDA Health Holdings Limited (EUDA)**: Closed at $2.74, gaining $0.12 or 4.58%, attracting buyers in after-hours trading [4] - **Lexeo Therapeutics, Inc. (LXEO)**: Ended at $9.50, up $0.39 or 4.28%, continuing a trend of strength in the biotech sector [4] - **Eledon Pharmaceuticals, Inc. (ELDN)**: Closed at $1.59, up $0.02 or 1.27%, managing a modest gain without new news [5]

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]

Core Viewpoint - Eledon Pharmaceuticals has experienced significant activity recently, with a focus on their developments and data presented at the ASN conference [2]. Group 1: Company Overview - Eledon Pharmaceuticals is represented by Steve Perrin, President and CSO, at the Guggenheim Healthcare Innovation Conference, following the absence of CEO DA Gros due to travel issues [1]. - The company is in a phase of discussing its journey and recent data, indicating a proactive approach to engaging with stakeholders and investors [2]. Group 2: Recent Developments - The discussion will include insights from last week's ASN conference, highlighting key takeaways and future steps for Eledon Pharmaceuticals [2].

Financial Position - As of September 30, 2025, Eledon Pharmaceuticals reported estimated cash, cash equivalents, and short-term investments of approximately $93.4 million[6] Clinical Trials - The company announced results from its Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients[9] - A conference call is scheduled for November 7, 2025, to discuss updated Phase 2 BESTOW clinical data[10]

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]