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]

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].

Phase 2 BESTOW Clinical Trial Results November 7, 2025 Forward -Looking Statements This presentation contains forward ‐looking statements that involves substantial risks and uncertainties. Any statements about the company's future expectations, plans and prospects, including statements about its strategy, future operations, development of its product candidates, and other statements containing the words "believes," "anticipates," "plans," "expects," "estimates," "intends," "predicts," "projects," "targets," ...

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Core Insights - Eledon Pharmaceuticals announced positive results from its Phase 2 BESTOW trial for tegoprubart, showing its potential as a new standard for preventing kidney transplant rejection [2][3] - Tegoprubart demonstrated a favorable safety profile, significantly reducing common toxicities associated with tacrolimus, including metabolic, neurologic, and cardiovascular issues [3][6] - The company plans to advance tegoprubart into Phase 3 development following discussions with regulators [8] Study Design - The Phase 2 BESTOW trial was a 12-month, randomized, head-to-head study involving 127 kidney transplant recipients, comparing tegoprubart with tacrolimus [4] - All participants received rabbit antithymocyte globulin induction and maintenance therapy with mycophenolate mofetil and corticosteroids [4] Efficacy Results - The primary endpoint was the change in estimated glomerular filtration rate (eGFR) at 12 months post-transplant, with tegoprubart achieving a mean eGFR of 69 mL/min/1.73 m² compared to 66 mL/min/1.73 m² for tacrolimus [12] - The efficacy failure composite endpoint was 22% for tegoprubart versus 17% for tacrolimus, demonstrating non-inferiority for tegoprubart [12] - Subgroup analyses indicated higher eGFRs for tegoprubart in nearly all categories, particularly among living-related donor recipients [12] Safety Results - Tegoprubart showed a significantly lower incidence of new-onset diabetes (1 in 47) compared to tacrolimus (1 in 6) [6] - Neurologic effects such as tremor were markedly lower in the tegoprubart group (1.6% vs. 25.0%) [6] - Cardiovascular issues, including hypertension and heart failure, were also less prevalent in the tegoprubart group [6] Next Steps - Eledon plans to incorporate insights from the Phase 2 data and ongoing studies to optimize the Phase 3 protocol [8] - The company is preparing for discussions with regulators regarding study design and data requirements for the next phase [8] Financial Position - As of September 30, 2025, Eledon reported approximately $93.4 million in cash, cash equivalents, and short-term investments, expected to fund operations until late 2026 [9]

Core Insights - Eledon Pharmaceuticals, Inc. will present at the Guggenheim Second Annual Healthcare Innovation Conference on November 12, 2025, at 10:30 a.m. ET [1] - The company is focused on developing immune-modulating therapies for life-threatening conditions, with its lead product being tegoprubart, an anti-CD40L antibody [2] Company Overview - Eledon Pharmaceuticals is a clinical stage biotechnology company headquartered in Irvine, California [2] - The company is developing therapies targeting CD40 Ligand, which has significant therapeutic potential in various medical conditions [2] - Eledon is conducting preclinical and clinical studies in areas such as kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [2]

Core Insights - Eledon Pharmaceuticals will present topline results from the Phase 2 BESTOW trial for tegoprubart at the American Society of Nephrology's Kidney Week 2025 Annual Meeting [1][2] - The oral presentation is scheduled for November 6, 2025, focusing on the efficacy and safety of tegoprubart in preventing rejection in kidney transplantation [2] - A conference call to discuss the trial results will be held on November 7, 2025, at 8:00 a.m. ET [3] Company Overview - Eledon Pharmaceuticals is a clinical stage biotechnology company developing immune-modulating therapies for life-threatening conditions [4] - The lead investigational product, tegoprubart, is an anti-CD40L antibody targeting CD40 Ligand, which has significant therapeutic potential [4] - The company is conducting studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [4]