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 ...

Eledon Pharmaceuticals, Inc. (NASDAQ: ELDN ) has been at the forefront of the revolutionary pig-to-human organ transplant story, having provided its lead immunosuppressive molecule Tegoprubart for both heart and kidney transplant experiments. It uses its immunology expertiseAbout the TPT serviceThanks for reading. At the Total Pharma Tracker, we offer the following:-Our Android app and website features a set of tools for DIY investors, including a work-in-progress software where you can enter any ticker and ...

Completed enrollment in Phase 2 BESTOW trial assessing tegoprubart in kidney transplantation four months ahead of schedule; on track to report topline results in fourth quarter of 2025 Presented updated data on 13 participants from ongoing Phase 1b trial that continue to support safety and tolerability of tegoprubart for prevention of organ rejection in kidney transplantation Announced positive initial data from first three subjects with type 1 diabetes treated with tegoprubart as part of immunosuppression ...

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, 2024 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 | --- | --- | |-------------------------------------------------------------------------------------------------------- ...