Drug Development and Clinical Trials - Eledon Pharmaceuticals is focusing on the development of tegoprubart, an anti-CD40L antibody, for preventing organ rejection and treating ALS [128]. - In January 2023, the company announced plans to prioritize kidney transplantation programs, discontinuing the islet cell transplantation and IgAN programs [131]. - The ongoing Phase 1b trial of tegoprubart reported a mean estimated eGFR of 70.5 mL/min/1.73m² after day 30 post-transplant, compared to historical averages of approximately 53 mL/min/1.73m² [142]. - As of June 2024, interim results indicated that tegoprubart is generally safe and well tolerated, with no cases of hyperglycemia or graft loss reported [142]. - The BESTOW trial, a Phase 2 study comparing tegoprubart to tacrolimus, aims to enroll approximately 120 participants and assess graft function at 12 months post-transplant [143]. - Eledon received regulatory approvals for the Phase 1b trial in the U.S., Canada, the U.K., and Australia, with the first subject dosed in July 2022 [139]. - The company entered a collaborative research agreement with eGenesis in January 2023 to explore tegoprubart in xenotransplantation studies [146]. - Tegoprubart has received orphan designation from the FDA for preventing allograft rejection in pancreatic islet cell transplantation [150]. - The company aims to address the challenges of current immunosuppressive therapies, potentially improving long-term graft survival and reducing the need for repeat transplants [138]. - Eledon acquired Anelixis Therapeutics in September 2020, gaining control over the intellectual property related to tegoprubart [132]. - Tegoprubart is being utilized in a pilot study at the University of Chicago Medicine to assess safety in achieving calcineurin inhibitor-free immunosuppression in T1D patients undergoing islet cell transplantation [151]. - Positive data from the study indicated that the first two subjects achieved insulin independence and normal HbA1c levels, while the third subject reduced insulin use by over 60% within three days post-transplant [152]. - Islet engraftment in subjects treated with tegoprubart was three to five times higher than in those receiving tacrolimus-based immunosuppression, suggesting improved graft survival and function [152]. - The Phase 2a study of tegoprubart for ALS enrolled 54 subjects, with 50 completing all infusions and no serious drug-related adverse events observed [157]. - Tegoprubart demonstrated target engagement in all dose cohorts, with a dose-dependent reduction in inflammatory biomarkers in 20 of 32 pro-inflammatory proteins [157]. Financial Performance and Funding - The 2023 Securities Purchase Agreement resulted in gross proceeds of $35.0 million, with net proceeds of approximately $33.0 million after expenses [163]. - The 2024 Private Placement generated gross proceeds of $50.0 million, with net proceeds of approximately $48.1 million after deducting offering costs [168]. - The 2024 Underwritten Offering closed with gross proceeds of $85 million, resulting in net proceeds of approximately $79.5 million after underwriting discounts and commissions [172]. - The company deprioritized its IgAN program and discontinued all related clinical development activities in 2023 [159]. - The FDA granted orphan drug designation to tegoprubart for ALS in 2018, with ongoing efforts to secure additional financing for further clinical development [156][158]. - Research and development expenses increased by $6.1 million to $13.5 million for the three months ended March 31, 2025, compared to $7.4 million in the same period of 2024 [182]. - General and administrative expenses rose by $1.0 million to $4.4 million for the three months ended March 31, 2025, compared to $3.5 million in 2024 [184]. - The net loss for the three months ended March 31, 2025, was $6.5 million, a decrease of $17.1 million compared to a net loss of $23.6 million in the same period of 2024 [182]. - The fair value of warrant liabilities decreased by $23.4 million to $10.1 million for the three months ended March 31, 2025, compared to a $13.3 million increase in the same period of 2024 [186]. - As of March 31, 2025, the company had cash and cash equivalents and short-term investments totaling $124.9 million, with working capital of $118.5 million [187]. - The company has incurred significant net losses since inception and does not expect to generate revenue from product sales until regulatory approval is obtained [188]. - The company anticipates ongoing increases in expenses as it expands its clinical programs and seeks marketing approval for its product candidates [193]. - The company will require additional financing to advance its drug products through clinical development and to fund operations for the foreseeable future [194]. - The increase in other income, net, was primarily due to a rise in interest income, totaling $1.4 million for the three months ended March 31, 2025, compared to $0.6 million in 2024 [185]. - The company does not have any approved products for commercial sale and has no committed sources of capital, relying primarily on proceeds from stock sales and warrants [188]. - For the three months ended March 31, 2025, the company reported a net cash used in operating activities of $16.1 million, compared to $8.7 million for the same period in 2024, reflecting a significant increase in cash outflow [198][199][200]. - The net loss for the three months ended March 31, 2025, was $6.5 million, a decrease from the net loss of $23.6 million in the same period of 2024 [199][200]. - Net cash provided by investing activities for the three months ended March 31, 2025, was $3.9 million, down from $9.8 million in the same period of 2024 [201][202]. - The company experienced a decrease in accounts payable and accrued expenses by $2.4 million for the three months ended March 31, 2025 [199]. - The company raised capital through private placements and underwritten offerings, which diluted existing stockholders' ownership interests [197]. - The company reported $35.7 million in proceeds from the maturity of available-for-sale short-term investments for the three months ended March 31, 2025 [201]. - The company incurred costs associated with being a public company, which may impact its financial performance [197]. Operational Focus and Future Outlook - The company is focused on the development of tegoprubart, with ongoing clinical trials that may be affected by global macroeconomic conditions [196]. - The company is evaluating the scope of indications for tegoprubart development, which may influence future revenue streams [196]. - The company is actively working on enhancing operational systems and attracting qualified personnel to support its development efforts [196].

Financial Performance - Eledon Pharmaceuticals reported cash, cash equivalents, and short-term investments of $124.9 million as of March 31, 2025, down from $140.2 million as of December 31, 2024[6]. - The net loss for Q1 2025 was $6.5 million, or $0.08 per share, significantly improved from a net loss of $23.6 million, or $0.79 per share, in Q1 2024[9]. - Total operating expenses for Q1 2025 were $18.0 million, compared to $10.9 million in Q1 2024, indicating a 65% increase[16]. - The company expects its current cash and investments to fund operations through the end of 2026[6]. Research and Development - Research and development expenses for Q1 2025 were $13.5 million, a 82% increase from $7.4 million in Q1 2024[7]. - General and administrative expenses for Q1 2025 were $4.4 million, compared to $3.5 million in Q1 2024, reflecting a 26% increase[8]. - Eledon is on track to report topline results from the Phase 2 BESTOW trial in kidney transplantation in Q4 2025[2]. - The company plans to report updated interim clinical data from the ongoing Phase 1b open-label trial in August 2025[5]. - Eledon anticipates reporting updated interim clinical data from a trial with UChicago Medicine in late 2025[5]. - Tegoprubart was used in the second transplant of a genetically modified pig kidney into a human, marking a significant milestone in the company's research[3].

Core Insights - Eledon Pharmaceuticals is progressing towards reporting topline results from the Phase 2 BESTOW trial in kidney transplantation, expected in the fourth quarter of 2025 [1][2] - The company is focusing on tegoprubart as a novel immunosuppression therapy, with significant updates anticipated in the second half of 2025 [2] Business Highlights - Tegoprubart was used in the second transplant of a genetically modified pig kidney into a human at Massachusetts General Hospital, marking a significant milestone in xenotransplantation [3] - The patient involved in the transplant was discharged without the need for dialysis for the first time in over two years, showcasing the potential effectiveness of the treatment [3] Financial Results - As of March 31, 2025, the company reported cash, cash equivalents, and short-term investments totaling $124.9 million, a decrease from $140.2 million as of December 31, 2024 [5] - Research and development expenses for Q1 2025 were $13.5 million, up from $7.4 million in the same period of 2024 [6] - General and administrative expenses increased to $4.4 million in Q1 2025 from $3.5 million in Q1 2024 [7] - The net loss for Q1 2025 was $6.5 million, or $0.08 per share, a significant improvement compared to a net loss of $23.6 million, or $0.79 per share, in Q1 2024 [8][16] Upcoming Milestones - The company plans to report updated interim clinical data from the ongoing Phase 1b open-label trial in August 2025 and topline results from the Phase 2 BESTOW trial in Q4 2025 [10]

Group 1 - Eledon Pharmaceuticals is a small cap, development-stage biotech company focused on its lead candidate, tegoprubart, which inhibits CD40 ligand binding of T-cells with CD40 receptors on B-cells and dendritic cells [1] - The mechanism of action for tegoprubart serves to reduce T-cell mediated immune responses, indicating potential therapeutic applications [1]

Financial Position and Liquidity - As of December 31, 2024, there were 59,789,275 shares of common stock outstanding and warrants to purchase 33,052,744 shares, indicating potential significant dilution for current stockholders [150]. - The company currently lacks sufficient liquidity to fund continued clinical development of tegoprubart for ALS without additional financing [157]. - The ongoing global economic volatility, including inflation and conflicts, could negatively impact the company's ability to secure necessary financing [157]. - The company has diversified its cash deposits following the failure of Silicon Valley Bank, reducing cash in FDIC insured accounts to less than 3% of total cash and cash equivalents [160]. - The company does not expect to pay any cash dividends in the foreseeable future, focusing on retaining earnings for business development [246]. Drug Development and Regulatory Risks - The company has invested substantially all resources in the development of its lead drug candidate, tegoprubart, with no products currently having gained regulatory approval [151]. - The company does not expect to generate product revenues for several years, if at all, heavily relying on the successful development and commercialization of drug candidates [151]. - Drug development involves lengthy and expensive processes with high risks of failure, particularly in demonstrating safety and efficacy to regulatory authorities [161]. - The company may experience delays in clinical trials due to various unforeseen events, impacting the ability to receive marketing approval [162]. - Additional clinical trials or testing may be required, increasing product development costs and potentially delaying commercialization [164]. - Delays in patient enrollment for clinical trials may lead to increased development costs and a decline in the company's value [166]. - The company has not received marketing approval for any of its product candidates, which could materially impair revenue generation [174]. - Regulatory approval processes are expensive and can take several years, with no guarantee of success [174]. - The ongoing conflict in Ukraine and the Middle East may disrupt clinical trial activities in affected regions [169]. Competition and Market Dynamics - The competitive landscape is intense, with major pharmaceutical and biotechnology companies potentially developing similar products before the company [203]. - The company faces significant competition from larger firms such as Novartis, Sanofi, and Amgen, which have greater resources for drug development [204]. - Tegoprubart is expected to compete with several FDA-approved therapeutics for transplant rejection prevention, including PROGRAF and NULOJIX [205]. - The company anticipates competition in the ALS treatment market from established products like RADICAVA and riluzole, as well as various biotechnology firms [206]. - The commercial opportunity may be diminished if competitors develop safer, more effective, or less expensive products [207]. Operational and Compliance Challenges - The company currently lacks a marketing and sales force, which may hinder its ability to effectively commercialize approved product candidates [202]. - The company relies on third-party manufacturers for drug production, which poses risks related to quality and supply chain disruptions [216]. - The ability to commercialize products may be adversely affected by reliance on third-party contractors for clinical testing and regulatory submissions [224]. - The company is subject to various healthcare laws, which could expose it to significant penalties, including civil and criminal sanctions, if found in violation [187]. - Compliance with healthcare laws and regulations may involve substantial costs, potentially impacting the company's financial performance [188]. Intellectual Property and Legal Risks - The company may need to license certain intellectual property from third parties, and failure to obtain such licenses could materially harm its business [236]. - The company may become involved in lawsuits to protect its intellectual property, which could be expensive and time-consuming [233]. - The company faces risks related to potential infringement claims from third parties, which could require obtaining licenses on unfavorable terms [234]. - The company has previously disclosed a material weakness in internal control over financial reporting, which could lead to significant remediation costs if not effectively managed [243]. - The company may be subject to claims of misappropriation of trade secrets, which could result in litigation and loss of valuable intellectual property rights [238]. Cybersecurity and Data Protection - The company relies on information systems that are vulnerable to cybersecurity incidents, which could disrupt operations and adversely affect its financial condition [192]. - The company may incur significant costs to mitigate cybersecurity threats and ensure compliance with data privacy obligations [195]. - The company must navigate complex data protection regulations, particularly in the European Economic Area, which could result in substantial fines for non-compliance [196]. - Loss of clinical trial data could delay regulatory approval efforts and significantly increase recovery costs [193]. Financial Performance and Market Expectations - The company expects its stock price to be volatile, influenced by factors such as regulatory approvals, clinical trial results, and market conditions [239]. - The company identified and remediated a material weakness in internal control over financial reporting, concluding that as of December 31, 2024, its internal control was effective [243]. - The company faces pricing pressures due to the availability of generic products and increasing healthcare cost containment efforts [212]. - There is uncertainty regarding insurance coverage and reimbursement for newly approved products, which could limit marketability and revenue generation [210]. - The Inflation Reduction Act of 2022 may reduce the prices and reimbursement for the company's products, impacting profitability [182].

Clinical Developments - Tegoprubart was used as a key component in the second transplant of a genetically modified pig kidney into a human, with the patient discharged without the need for dialysis for the first time in over two years[3]. - Initial positive data from the first three subjects with type 1 diabetes treated with tegoprubart showed potential insulin independence without the use of tacrolimus[4]. - Anticipated milestones include topline results from the Phase 2 BESTOW trial in Q4 2025 and updated interim clinical data from ongoing trials in 2025[10]. Financial Performance - Cash, cash equivalents, and short-term investments totaled $140.2 million as of December 31, 2024, compared to $78.2 million at September 30, 2024, extending the cash runway to the end of 2026[6]. - Research and development expenses for Q4 2024 were $17.9 million, up from $7.1 million in Q4 2023, driven by increased clinical development expenses[7]. - General and administrative expenses for Q4 2024 were $6.8 million, compared to $3.3 million in Q4 2023, reflecting higher stock-based compensation and professional services[8]. - Net loss for Q4 2024 was $44.6 million, or $0.64 per basic share, compared to a net loss of $30.1 million, or $1.00 per basic share, in Q4 2023[9]. - Full year 2024 net loss was $36.2 million, or $0.75 per basic share, significantly improved from a net loss of $116.5 million, or $4.73 per basic share, in 2023[13]. - The company completed an oversubscribed offering for total gross proceeds of $85 million, with net proceeds of approximately $79.5 million after expenses[4]. - Total assets increased to $177.4 million as of December 31, 2024, compared to $89.1 million in 2023, reflecting strong balance sheet growth[19].

Core Insights - Eledon Pharmaceuticals has made significant advancements in organ transplantation, particularly with the use of tegoprubart as a key immunosuppression component in recent transplants, including a genetically modified pig kidney and islet transplants for type 1 diabetes patients [2][6] - The company reported positive initial data from its trials, indicating the potential of tegoprubart to protect transplanted organs and cells across various transplant types [2][6] - Eledon is well-positioned financially, with an oversubscribed offering raising $85 million, extending its cash runway to the end of 2026 [5][6] Recent Business Highlights - Tegoprubart was utilized in the second transplant of a genetically modified pig kidney into a human, with the patient discharged without the need for dialysis for the first time in over two years [6] - Initial data from three islet transplant recipients showed promising results, potentially achieving insulin independence without the use of tacrolimus [6] - The company completed an underwritten offering, raising approximately $79.5 million after expenses, with participation from both new and existing investors [6] Financial Results - As of December 31, 2024, cash, cash equivalents, and short-term investments totaled $140.2 million, up from $78.2 million at September 30, 2024 [5] - Research and development expenses for Q4 2024 were $17.9 million, compared to $7.1 million in Q4 2023, reflecting increased clinical development activities [7] - The net loss for Q4 2024 was $44.6 million, or $0.64 per share, compared to a net loss of $30.1 million, or $1.00 per share, in Q4 2023 [9] Anticipated Upcoming Milestones - Updated interim clinical data from the ongoing Phase 1b trial for kidney transplant patients is expected in Summer 2025 [6] - Topline results from the Phase 2 BESTOW trial of tegoprubart in kidney transplantation are anticipated in Q4 2025 [6] Full Year Financial Overview - For the year ended December 31, 2024, total operating expenses were $70.6 million, compared to $43.0 million in 2023, driven by increased R&D and administrative costs [19] - The net loss for 2024 was $36.2 million, or $0.75 per share, significantly reduced from a net loss of $116.5 million, or $4.73 per share, in 2023 [12][19]

IRVINE, Calif., March 04, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that Steve Perrin, Ph.D., Chief Scientific Officer and President, will participate in a fireside chat at the upcoming Leerink Partners Global Healthcare Conference on Tuesday, March 11, 2025, at 2:20 p.m. ET (11:20 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 Eve ...

Patient treated in procedure, conducted at Mass General Transplant Center and in collaboration with partner eGenesis, was recently released from hospital Investigational therapy tegoprubart targets CD40 ligand (CD40L) with potential to improve both safety and efficacy compared to standard of care immunosuppression regimens IRVINE, Calif., Feb. 07, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. ("Eledon") (NASDAQ:ELDN) today announced that tegoprubart, the company's investigational anti-CD40L antibody ...

IRVINE, Calif., Jan. 29, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that David-Alexandre C. Gros, M.D., Chief Executive Officer, and Steve Perrin, Ph.D., Chief Scientific Officer and President, will participate in a fireside chat at the upcoming Guggenheim Securities SMID Cap Biotech Conference on Wednesday, February 5, 2025, at 1:00 p.m. ET (10:00 a.m. PT). To register in advance for the presentation webcast, sign up here. A webcast replay will be access ...