Core Insights - Eledon Pharmaceuticals is set to present updated clinical data on tegoprubart for kidney transplantation at the World Transplant Congress in August 2025 [1] - The presentation will include results from approximately 30 kidney transplant recipients and will be delivered by Dr. John Gill from the University of British Columbia [1][2] - Eledon will also sponsor a satellite symposium discussing kidney transplant success, featuring notable faculty from various prestigious institutions [3] Presentation Details - The oral presentation titled "Tegoprubart, an Anti-CD40L Antibody, for the Prevention of Rejection in Kidney Transplantation: An Ongoing Phase 1b Study" is scheduled for August 6, 2025, from 10:00 a.m. to 11:15 a.m. PT [2] - A poster session will present new preclinical data on tegoprubart's use in liver transplantation, led by Dr. Andrew Adams from the University of Minnesota [4] Company Overview - Eledon Pharmaceuticals is a clinical-stage biotechnology company focused on developing immune-modulating therapies for severe conditions [4] - The lead product, tegoprubart, is an anti-CD40L antibody targeting CD40 Ligand, which plays a significant role in immune cell activation [4] - The company is conducting studies in kidney transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [4]

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]

Group 1 - Wipro Limited (WIT) has seen a 7.1% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - KNOT Offshore Partners LP (KNOP) has experienced a significant 44.9% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - Penguin Solutions, Inc. (PENG) has recorded a 14.2% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [2] - Eledon Pharmaceuticals, Inc. (ELDN) has seen a 23.8% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [2] - KDDI Corporation (KDDIY) has experienced a 39.7% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [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].

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]