☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q Commission File Number: 001-36620 ELEDON PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 20-1000967 (State or other juri ...

Updated data from ongoing open-label Phase 1b trial demonstrated a mean 12-month eGFR of approximately 68 mL/min/1.73 m2 post-transplant for patients on tegoprubart Company on track to report topline results from Phase 2 BESTOW trial in kidney transplantation in November 2025 Cash, cash equivalents and short-term investments of $107.6 million as of June 30, 2025 IRVINE, Calif., August 14, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. ("Eledon") (Nasdaq: ELDN) today reported its second quarter 2025 o ...

Updated data from ongoing open-label Phase 1b trial demonstrated a mean 12-month eGFR of approximately 68 mL/min/1.73 m2 post-transplant for patients on tegoprubart Company on track to report topline results from Phase 2 BESTOW trial in kidney transplantation in November 2025 Cash, cash equivalents and short-term investments of $107.6 million as of June 30, 2025 IRVINE, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its second quarter 2025 ope ...

Summary of Eledon Pharmaceuticals (ELDN) Update / Briefing August 06, 2025 Company Overview - **Company**: Eledon Pharmaceuticals (ELDN) - **Focus**: Development of tegoprovart for kidney transplantation Key Industry Insights - **Industry**: Kidney transplantation and immunosuppression therapies - **Event**: Presentation of updated Phase 1b trial results at the World Transplant Congress Core Points and Arguments 1. **Phase 1b Trial Results**: Eledon presented updated results from the Phase 1b trial of tegoprovart, which is being evaluated as a cornerstone immunosuppression therapy in de novo kidney transplantation [3][6][8] 2. **Safety and Efficacy**: The trial demonstrated good safety and tolerability for tegoprovart, with twelve-month eGFR (estimated Glomerular Filtration Rate) results indicating good kidney function [8][26] 3. **Rejection Episodes**: A total of six rejection episodes were reported, with a 19% incidence rate. Most rejections occurred in patients receiving lower doses of ATG (antithymocyte globulin) induction therapy [21][24] 4. **Long-term Predictive Endpoints**: The trial included the abbreviated IBOX score, which is being developed as a surrogate endpoint to predict five-year graft survival. The IBOX score showed strong predictive capabilities [31][35] 5. **Regulatory Considerations**: Eledon is in discussions with regulatory bodies regarding the use of IBOX as a potential endpoint for future clinical trials, with expectations for feedback in the second half of the following year [31][59] Additional Important Content 1. **Patient Demographics**: The study included 32 patients with a mean age of 52.9 years, with 75% being living donors. Notably, 56% of patients had an HLA mismatch of more than five, indicating a higher immunological risk [15][16][94] 2. **Infection Rates**: The trial reported manageable infection rates, with no cases of graft loss. The infections were controllable, and the study aims to explore lower dosing to potentially improve safety outcomes [90][91] 3. **Impact of Improved Graft Survival**: A hypothetical 5% improvement in five-year graft survival could significantly reduce the number of patients dying while waiting for a kidney transplant, potentially allowing for 1,500 additional kidneys to be available each year [41][43] 4. **Future Studies**: Eledon is preparing for the Phase II BISTOLE study, with results expected to be presented in the fourth quarter of the year [44] Conclusion Eledon Pharmaceuticals is making significant strides in the development of tegoprovart for kidney transplantation, with promising Phase 1b trial results indicating good safety and efficacy. The company is focused on regulatory discussions regarding the IBOX score as a predictive endpoint for long-term graft survival, which could have a substantial impact on patient outcomes in the field of kidney transplantation.

IRVINE, Calif., July 17, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that updated clinical data from its ongoing open-label Phase 1b study evaluating tegoprubart for the prevention of rejection in subjects undergoing kidney transplantation will be presented at the World Transplant Congress (WTC) taking place in San Francisco from August 2-6, 2025. The oral presentation will feature updated results from approximately 30 kidney transplant recipients and will ...

Group 1: Eledon Pharmaceuticals, Inc. (ELDN) - Eledon Pharmaceuticals is a clinical stage biotechnology company with a Zacks Rank 1 [1] - The Zacks Consensus Estimate for its current year earnings increased by 23.8% over the last 60 days [1] - Eledon's shares gained 22.2% over the past month, outperforming the S&P 500's advance of 3.8% [1] - The company has a Momentum Score of A [1] Group 2: KDDI Corporation (KDDIY) - KDDI Corporation is a Japanese telecommunications services company with a Zacks Rank 1 [2] - The Zacks Consensus Estimate for its current year earnings increased by 39.7% over the last 60 days [2] - KDDI's shares gained 5.9% over the last six months, slightly outperforming the S&P 500's advance of 5.2% [2] - The company has a Momentum Score of B [2] Group 3: Penguin Solutions, Inc. (PENG) - Penguin Solutions is a designer and developer of enterprise solutions with a Zacks Rank 1 [3] - The Zacks Consensus Estimate for its current year earnings increased by 14.2% over the last 60 days [3] - Penguin's shares gained 41.2% over the last three months, significantly outperforming the S&P 500's advance of 16% [3] - The company has a Momentum Score of A [3]

Summary of Elodon R&D Day Conference Call Company Overview - **Company**: Elodon - **Lead Asset**: Tegoprobart - **Focus**: Solid organ transplantation, particularly kidney, liver, and islet cell transplants, as well as xenotransplantation [1][6][10] Key Industry Insights - **Market Opportunity**: The transplantation market is described as a "proven blockbuster market" with a significant need for innovation, particularly in immunosuppressants [8][12] - **Current Standard of Care**: Calcineurin inhibitors (CNIs), such as tacrolimus, have been the standard for decades but have limitations in long-term graft survival and patient quality of life [12][42] - **Need for New Therapies**: There is a critical need for therapies that can extend the functional life of transplanted organs beyond the current average of about ten years [13][39] Core Scientific Insights - **Mechanism of Action**: Tegoprobart targets the CD40 ligand pathway, which is crucial for modulating immune responses and preventing transplant rejection [17][20] - **Clinical Data**: Preclinical studies indicate that blocking the CD40 ligand is the most effective method for preventing transplant rejection across various organ types [30][32] - **Long-term Outcomes**: The focus is shifting from short-term rejection rates to long-term graft survival, with a need for therapies that minimize side effects associated with current immunosuppressants [55][56] Regulatory Developments - **New Endpoints**: Introduction of the IBOX surrogate endpoint, which combines existing biomarkers to predict long-term graft survival at one year post-transplant [59][60] - **Validation of IBOX**: The IBOX has shown strong predictive capabilities for five-year graft loss, with C statistics ranging from 0.72 to 0.84 across multiple validation datasets [67][68] Financial and Strategic Considerations - **Funding Needs**: The company is seeking non-dilutive financing to advance its programs, particularly in ALS, which is currently on hold [10][11] - **Commercial Potential**: The kidney transplantation market alone is projected to be a large blockbuster opportunity, with unique commercial dynamics due to reimbursement structures [13][14] Additional Insights - **Patient Demographics**: The aging population and rising rates of obesity are expected to increase the number of patients requiring transplants, further highlighting the need for effective therapies [37][38] - **Healthcare Burden**: The financial burden on healthcare systems, particularly Medicare, is significant due to the high costs associated with dialysis and transplant procedures [36][37] Conclusion - Elodon is positioned to address significant unmet needs in the transplantation market through innovative therapies like Tegoprobart, with a focus on improving long-term outcomes and reducing the side effects associated with current treatments. The introduction of new regulatory endpoints like IBOX may facilitate the approval of these therapies and enhance their market potential.

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].