Financial Highlights - Eledon had $1402 million in cash, cash equivalents, and short-term investments as of December 31, 2024[6] - The company forecasts sufficient funds to support operations through the end of 2026[6] Tegoprubart Clinical Development - The Phase 2 BESTOW trial of tegoprubart in kidney transplantation has completed enrollment, with top-line data expected in 4Q 2025[8] - Interim data update from the investigator-sponsored Phase 2 trial in islet cell transplantation for Type 1 diabetes is expected in Q4 2025[8] - A Phase 1b kidney transplant trial is ongoing, with an interim data update expected in mid-2025[8] Kidney Transplantation Market - The U S Medicare expenditure for end-stage renal disease and transplant is $50+ billion annually, including kidney transplantation costs of $440,000+ per transplant[23] - The global organ transplant immunosuppressant market size is estimated at $53+ billion[23] - Approximately 60% of organ transplants in the U S are kidney transplants[15] - Over 30-50% of kidney transplants fail within 10 years on the current standard of care immunosuppression[25] Islet Cell Transplantation - Approximately 2 million Americans live with Type 1 diabetes (T1D)[58] - Around 12% of people with T1D experience recurrent severe hypoglycemic events annually[58]

Group 1 - Eledon Pharmaceuticals will host an R&D Day in New York City on July 9, 2025, focusing on its lead investigational candidate, tegoprubart, and its clinical development in organ and cell transplantation [1] - The event will include discussions on unmet needs in solid organ transplantation, the evolution of clinical endpoints, and strategic opportunities in islet cell transplantation and xenotransplantation [1] - A live Q&A session will feature Eledon's management team and invited key opinion leaders [1] Group 2 - Eledon Pharmaceuticals is a clinical stage biotechnology company developing immune-modulating therapies for life-threatening conditions, with tegoprubart as its lead investigational product [3] - Tegoprubart is an anti-CD40L antibody targeting CD40 Ligand, which plays a central role in immune cell activation, making it a promising target for immunomodulatory therapies [3] - The company is conducting preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [3]

Core Viewpoint - Eledon Pharmaceuticals, Inc. (ELDN) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Revisions - The Zacks rating system is primarily based on a company's changing earnings picture, with the Zacks Consensus Estimate tracking EPS estimates from sell-side analysts [2]. - The recent upgrade reflects an 8.4% increase in the Zacks Consensus Estimate for Eledon Pharmaceuticals over the past three months [9]. - For the fiscal year ending December 2025, Eledon is expected to earn -$0.92 per share, representing a year-over-year change of -9100% [9]. Impact of Institutional Investors - Changes in earnings estimates are strongly correlated with near-term stock price movements, largely due to institutional investors who adjust their valuations based on these estimates [5]. - An increase in earnings estimates typically leads to higher fair value calculations for stocks, prompting institutional buying or selling, which influences stock prices [5]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [8]. - The upgrade of Eledon Pharmaceuticals to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating strong potential for market-beating returns in the near term [11].

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]