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]

Drug Development and Clinical Trials - Eledon Pharmaceuticals is focusing on the development of tegoprubart, an anti-CD40L antibody, to prevent organ rejection and treat ALS, with a strategic emphasis on kidney transplantation programs [141][144]. - Interim results from the Phase 1b trial indicated that mean estimated glomerular filtration rate (eGFR) was 70.5 mL/min/1.73m² post-transplant, significantly higher than the historical average of 53 mL/min/1.73m² for standard care [154]. - As of July 2025, 32 patients were enrolled in the Phase 1b study, with eGFR stabilizing around 68 mL/min/1.73m² at 12 months for those on tegoprubart, compared to 63 mL/min/1.73m² in the intention-to-treat population [155]. - The Phase 2 BESTOW trial, which began dosing in August 2023, aims to evaluate tegoprubart against tacrolimus in approximately 120 participants, focusing on graft function and safety [156]. - Safety data from the BESTOW trial indicated that new-onset diabetes occurred in 1 in 47 patients receiving tegoprubart, compared to 1 in 6 for tacrolimus, demonstrating a favorable safety profile [157]. - Tegoprubart showed a significant reduction in tremor incidence (1.6% vs. 25.0%) and cardiovascular effects compared to tacrolimus, suggesting improved tolerability [157]. - Tegoprubart achieved a mean eGFR of approximately 69 mL/min/1.73 m² at 12 months, compared to 66 mL/min/1.73 m² for tacrolimus, indicating strong renal function [158]. - The efficacy failure composite endpoint was 22% in the tegoprubart group versus 17% in the tacrolimus group, demonstrating non-inferiority for tegoprubart [158]. - In a Phase 2 open-label extension study, the first participant was enrolled in October 2023 to evaluate long-term safety and efficacy of tegoprubart [159]. - Tegoprubart has been utilized in four xenotransplantation procedures, with two kidney transplant recipients remaining alive and one maintaining kidney function [162]. - The FDA granted orphan designation to tegoprubart for the prevention of allograft rejection in pancreatic islet cell transplantation in 2022 [167]. - In a pilot study, the first two subjects achieved insulin independence post-transplant, with islet engraftment three to five times higher than those receiving tacrolimus-based immunosuppression [169]. - Tegoprubart demonstrated low anti-drug antibody responses in a Phase 2a study, with no drug-related serious adverse events observed [175]. - The company deprioritized its IgAN program in 2023, discontinuing all clinical development activities related to it [177]. - Eledon acquired Anelixis Therapeutics in September 2020, gaining control over the intellectual property related to tegoprubart [145]. Financial Performance and Funding - The company reported a net loss of $17.46 million for the three months ended September 30, 2025, compared to a net income of $76.97 million in the same period in 2024, a variance of $94.43 million [203]. - For the three months ended September 30, 2025, total operating expenses were $19.07 million, a decrease of $1.44 million compared to $20.51 million in the same period in 2024 [203]. - Research and development expenses for the three months ended September 30, 2025, were $14.97 million, down from $16.52 million in 2024, reflecting a decrease of $1.55 million [203]. - The company has no approved products for commercial sale and has incurred significant net losses since inception, with an accumulated deficit of $390.8 million as of September 30, 2025 [217]. - The company expects to require additional financing to fund operations and advance drug products through clinical development [223]. - For the nine months ended September 30, 2025, the company reported a net cash used in operating activities of $48.3 million, compared to $28.3 million for the same period in 2024, reflecting an increase in net loss from $8.4 million to $35.2 million [225][226][227]. - The company experienced a net cash provided by investing activities of $31.2 million for the nine months ended September 30, 2025, primarily from $123.2 million in proceeds from the maturity of available-for-sale short-term investments [228]. - Financing activities for the nine months ended September 30, 2025, generated only $0.1 million from the exercise of stock options, a significant decrease compared to $53.4 million in net proceeds from the 2024 Private Placement in 2024 [231][232]. - The company entered into an Open Market Sale Agreement on September 20, 2024, to sell shares of common stock with aggregate sales proceeds of up to $75.0 million [188]. - The 2023 Securities Purchase Agreement involved the issuance of 15,151,518 shares of common stock and warrants in a private placement [179]. - The company received gross proceeds of $35.0 million from the initial closing on May 5, 2023, with net proceeds of approximately $33.0 million after expenses [181]. - The second closing on July 8, 2024, generated gross proceeds of $2.1 million, resulting in net proceeds of approximately $2.0 million [182]. - The third closing on September 30 and October 1, 2024, resulted in gross proceeds of $4.0 million, with net proceeds of approximately $3.8 million [183]. - The 2024 Private Placement yielded gross proceeds of $50.0 million, with net proceeds of approximately $48.1 million after offering costs [186]. - The 2024 Underwritten Offering closed on October 30, 2024, generating gross proceeds of $85 million and net proceeds of approximately $79.5 million after expenses [191]. - Total operating expenses for the nine months ended September 30, 2025, increased by $15.886 million to $61.767 million, up from $45.881 million in 2024 [210]. - Net income (loss) for the nine months ended September 30, 2025, was a loss of $35.170 million, compared to a net income of $8.433 million in 2024, reflecting a variance of $43.603 million [210]. - The fair value of warrant liabilities decreased by $22.9 million, from $44.9 million as of December 31, 2024, to $21.9 million as of September 30, 2025 [214]. - Cash and cash equivalents and short-term investments totaled $93.4 million as of September 30, 2025, with working capital of $82.0 million [216]. - Research and development expenses for the nine months ended September 30, 2025, increased by $14.740 million to $48.776 million, compared to $34.036 million in 2024 [211]. - General and administrative expenses increased by $1.146 million to $12.991 million for the nine months ended September 30, 2025, compared to $11.845 million in 2024 [212]. - Other income, net, increased by $1.195 million to $3.680 million for the nine months ended September 30, 2025, compared to $2.485 million in 2024 [210]. Capital Raising and Ownership Dilution - The company may face challenges in raising capital due to potential limitations in financial and credit markets, which could negatively impact its business plans and strategies [224]. - The issuance of shares in various private placements has diluted the ownership interests of existing stockholders, which may continue with future capital raises [224]. - The company is considering the extent of acquiring or in-licensing other product candidates and technologies as part of its future strategy [229].