Summary of Eledon Pharmaceuticals Conference Call Company Overview - **Company**: Eledon Pharmaceuticals (NasdaqCM:ELDN) - **Focus**: Development of immunosuppressive therapies for organ transplantation, particularly kidney and islet cell transplants Key Points from the Conference Call Phase 2 BESTOW Study Results - The Phase 2 BESTOW study showed promising outcomes, achieving a non-inferiority margin for a composite endpoint, which is crucial for Phase 3 approval [1] - Although the primary endpoint of kidney function was not met, the data indicated that the treatment outperformed standard care in various aspects [1][2] - Safety profile was significantly better, with a ninefold reduction in tremors and a sevenfold reduction in infection rates compared to standard care [3] Market Perception and Data Interpretation - The market may have underestimated the implications of missing the kidney function endpoint, as the approvable endpoint for kidney transplant studies is a composite endpoint unrelated to kidney function [4] - Acute rejection rates were higher in the tegoprubart arm (20%) compared to the tacrolimus arm (14%), but all rejections in the tegoprubart group occurred within the first six months [5] Phase 3 Study Planning - Eledon plans to request an end-of-phase 2 meeting with the FDA in late Q1 or early Q2 2026 to discuss the Phase 3 study design [10] - The primary endpoint for the Phase 3 study will focus on patient and graft survival, with a non-inferiority design [15][17] Long-term Data and Quality of Life Measures - Long-term follow-up data from a Phase 1b study showed no acute rejections and 100% survival, indicating potential for better long-term outcomes compared to standard care [7][8] - The Phase 3 study will include patient-reported outcomes to assess quality of life and toxicities associated with standard care [21] Commercial Opportunity - Eledon believes tegoprubart could become the new standard of care in transplantation, with potential applications in both allotransplant and xenotransplant settings [28] - The company aims to address the limitations of current therapies and believes that the infrastructure for drug administration has improved since previous launches [27] Islet Cell Program - The islet cell transplant program has shown promising results, with several patients achieving independence from insulin [31][32] - Eledon plans to transition this program into a sponsored study, with an IND filing expected by the end of 2026 [33][35] Xenotransplantation Developments - Eledon is collaborating on xenotransplantation studies, showing significant progress with genetically modified pig organs [41][42] - The company plans to supply tegoprubart as part of the immunosuppressive regimen for xenotransplantation, leveraging safety and efficacy data from ongoing studies [43] Financial Position and Future Milestones - Eledon has sufficient cash to fund operations through Q2 2027, with key milestones including the opening of INDs for kidney and islet cell transplant studies [50][51] - The company is committed to supporting ongoing research in xenotransplantation and other transplant-related studies [52] Additional Insights - The discussion highlighted the importance of managing immunosuppression protocols in clinical trials to ensure balanced treatment across study arms [23][24] - The potential for xenotransplantation to alleviate organ shortages presents a significant commercial opportunity, as many patients remain on waiting lists without receiving transplants [44]

IRVINE, Calif., Feb. 05, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that Steven Perrin, Ph.D., President and Chief Scientific Officer will participate in a fireside chat at the upcoming Guggenheim Emerging Outlook: Biotech Summit 2026 on Thursday, February 12, 2026, at 10:00 a.m. ET (7:00 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 und ...

Core Insights - Eledon Pharmaceuticals announced positive 24-month follow-up data from a Phase 1b trial of tegoprubart in kidney transplantation, showing an increase in mean estimated glomerular filtration rate (eGFR) from 67.0 mL/min/1.73 m² at 12 months to 74.2 mL/min/1.73 m² at 24 months [1][2] Company Overview - 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 [3] - The company aims to leverage its expertise in anti-CD40 Ligand biology to conduct studies in various transplantation fields, including kidney allograft transplantation and amyotrophic lateral sclerosis (ALS) [3]

Core Insights - Eledon Pharmaceuticals has made significant progress in 2025, particularly with the tegoprubart clinical programs in kidney allotransplantation, islet transplantation, and xenotransplantation, showing promising results in safety and efficacy [2][3] Group 1: Clinical Trial Results - The Phase 2 BESTOW trial demonstrated tegoprubart's favorable safety and tolerability profile, reducing toxicities associated with tacrolimus, with a kidney function eGFR of 69 mL/min/1.73 m² at 12 months, the highest reported in larger trials [3] - The efficacy failure composite endpoint for tegoprubart was 22.2% compared to 17.2% for tacrolimus, indicating non-inferiority [3] - Preliminary results from six type 1 diabetes patients treated with tegoprubart post-islet transplantation showed all achieved insulin independence, with three remaining insulin-free for over a year [3] Group 2: Regulatory and Development Plans - The company plans to engage with regulatory authorities, including the FDA, to advance tegoprubart into Phase 3 development, aiming to provide a safer alternative to tacrolimus-based immunosuppression [2][4] - Anticipated milestones for 2026 include presenting 24-month data from a Phase 1 extension study at the American Society of Transplant Surgeons Winter Symposium [4][7] Group 3: Financial Developments - Eledon completed a $57.5 million financing, expected to support operations into the second quarter of 2027 [3][4]

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.

Core Viewpoint - Eledon Pharmaceuticals is actively participating in the healthcare sector by presenting at the Piper Sandler Healthcare Conference, highlighting its commitment to engaging with investors and stakeholders [1]. Group 1: Company Overview - Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions [2]. - The company's lead investigational product is tegoprubart, an anti-CD40L antibody that targets the CD40 Ligand, which has significant therapeutic potential [2]. - Eledon is conducting preclinical and clinical studies in areas such as kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [2]. Group 2: Upcoming Events - David-Alexandre C. Gros, M.D., the CEO of Eledon, will participate in a fireside chat at the 37th Annual Piper Sandler Healthcare Conference on December 4, 2025, at 8:50 a.m. ET [1]. - A webcast replay of the fireside chat will be available on the company's website following the live session [1].

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]