Company Overview - Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions [2] - The company's lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, which has broad therapeutic potential [2] - Eledon is conducting preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [2] Upcoming Event - Steve Perrin, Ph.D., President and Chief Scientific Officer of Eledon, will participate in a plenary session at the 18 Congress of the International Xenotransplantation Association (IXA) from September 30–October 3, 2025, in Geneva, Switzerland [1] - The plenary session will focus on immunosuppression, immune monitoring, and anti-CD154 pathway blockade, with a specific lecture titled "201.2 Anti-CD154 Pathway Blockade" scheduled for October 1, 2025, from 10:30 a.m. to 12:00 p.m. CET [1]

Group 1: Company Overview - Eledon Pharmaceuticals (ELDN) is a clinical-stage biotech company focused on immunology, particularly in immunomodulation for transplantation and some work in autoimmune and neurodegenerative diseases [2] - Eledon was included in the Russell 3000 and Russell 2000 indices in June, increasing its visibility as it approaches multiple clinical catalysts [2] Group 2: Financial Performance - Eledon is currently valued at $154.5 million, with its stock having dipped 37% year-to-date but surged 114% over the last two years [3] - As of Q2, Eledon ended with $107.6 million in cash, cash equivalents, and short-term investments, which is expected to fund operations through the end of 2026 [5] Group 3: Product Development - Eledon's lead asset, tegoprubart, is an investigational anti-CD40L antibody aimed at preventing organ transplant rejection and curing autoimmune illnesses by regulating the CD40-CD40L immunological pathway [4] - Positive findings from ongoing trials of tegoprubart were presented at the World Transplant Congress in August 2025, showing no reports of mortality, graft loss, or drug-related complications among trial participants [5] - The company plans to present topline results of its Phase 2 BESTOW kidney transplantation study in November, which could establish tegoprubart as a cornerstone in transplant immunosuppression if successful [6] Group 4: Market Potential - Tegoprubart holds significant therapeutic potential in solid organ transplantation, cell transplantation, xenotransplantation, and autoimmune illnesses such as amyotrophic lateral sclerosis (ALS) [7]

Summary of Eledon Pharmaceuticals (ELDN) Conference Call Company Overview - **Company**: Eledon Pharmaceuticals - **Focus**: Development of tegoprubart for kidney transplant rejection prevention Industry Context - **Industry**: Biotech, specifically in transplant medicine - **Current Standard of Care**: Calcineurin inhibitors, primarily tacrolimus, which has been in use since 1994 Key Points and Arguments Unmet Need in Kidney Transplantation - Tacrolimus has significant limitations including nephrotoxicity, hypertension, and beta cell toxicity leading to hyperglycemia and insulin-dependent diabetes [4][5] - The average survival of transplanted kidneys is between 10 to 15 years, with patients often requiring multiple transplants due to organ scarcity [5][6] Tegoprubart Development - Tegoprubart is being evaluated in Phase 1B and Phase 2 trials as an alternative to tacrolimus [3] - The goal is to improve patient quality of life and organ survival by reducing adverse effects associated with tacrolimus [5] Clinical Trial Design and Endpoints - **Phase 1B Study**: Focused on safety and tolerability, with endpoints including rejection rates and kidney function measured by eGFR [14][15] - **Phase 2 Study (BESTOW)**: Designed to demonstrate superiority over tacrolimus, with a primary endpoint of kidney function at 12 months, aiming for an eight-point difference in eGFR [15][34] iBOX Score as a New Endpoint - iBOX is a composite endpoint that includes eGFR, DSA, proteinuria, and time since transplant, which is a better predictor of long-term graft survival than traditional biopsy-proven rejection [7][19] - Eledon reported an iBOX score of negative 4.1 in the on-treatment group, significantly better than the average CNI iBOX score of negative 2.9 [18][22] Rejection Rates and Safety Profile - The rejection rate in the Phase 1B study was reported at 18%, comparable to BALADA sub-studies in the low 20s, while standard care is in the high single digits [23][24] - The safety profile showed no significant adverse events typically associated with tacrolimus, such as graft loss or sepsis [45] Market Opportunity - Approximately 48,000 transplants occur annually in the U.S., with nearly 30,000 being kidney transplants [48] - The U.S. transplant immunosuppressant market is substantial, with tacrolimus generating nearly $1.5 billion in annual revenues [48] Future Expectations - Eledon anticipates presenting data from the Phase 2 study in Q4 and expects to launch Phase 3 trials in the second half of the following year [54][58] - The company is also exploring islet cell transplantation and xenotransplantation, with ongoing studies expected to yield more data [58] Additional Important Insights - The FDA is considering new approval endpoints that may allow for superiority claims based on iBOX scores [11][12] - The concentrated nature of the transplant market, with only 40 centers performing half of the transplants, presents a unique opportunity for Eledon to leverage existing relationships [48][51] This summary encapsulates the critical insights from the conference call, highlighting Eledon's strategic focus on addressing unmet needs in kidney transplantation through innovative therapies and the potential market impact.

Company Overview - Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions [2] - The lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, which has broad therapeutic potential [2] - The company is conducting preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [2] Upcoming Events - David-Alexandre C. Gros, M.D., CEO of Eledon, will participate in a fireside chat at the Cantor Global Healthcare Conference on September 5, 2025, at 9:10 a.m. ET [1] - A webcast replay of the fireside chat will be available on the company's website following the live session [1]

Company Overview - Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions [2] - The lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, which has broad therapeutic potential [2] - The company is conducting preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [2] Upcoming Events - David-Alexandre C. Gros, M.D., CEO of Eledon, will participate in a fireside chat at the Cantor Global Healthcare Conference on September 5, 2025, at 9:10 a.m. ET [1] - A webcast replay of the fireside chat will be available on the company's website following the live session [1]

Core Insights - Eledon Pharmaceuticals reported positive data from an ongoing Phase 1b trial of tegoprubart, showing a mean 12-month estimated glomerular filtration rate (eGFR) of approximately 68 mL/min/1.73 m for kidney transplant patients, significantly higher than the historical mean of 53 mL/min/1.73 m with standard care [1][3] - The company is on track to release topline results from the Phase 2 BESTOW trial in kidney transplantation in November 2025 [1][10] - Eledon has a cash position of $107.6 million as of June 30, 2025, which is expected to fund operations through the end of 2026 [1][5] Business Highlights - Eledon achieved key milestones in advancing tegoprubart for kidney, islet cell, and liver transplantation, as well as xenotransplantation [2] - Updated data presented at the World Transplant Congress indicated that tegoprubart was well tolerated with no severe adverse events reported [3] - The company announced the first three islet cell transplant recipients treated with tegoprubart at the University of Chicago, achieving insulin independence [3] Financial Results - Research and development expenses for Q2 2025 were $20.3 million, up from $10.1 million in Q2 2024 [6] - General and administrative expenses for Q2 2025 were $4.5 million, slightly higher than $4.4 million in Q2 2024 [7] - The net loss for Q2 2025 was $11.2 million, a significant reduction from a net loss of $44.9 million in Q2 2024 [7][16] Upcoming Milestones - The company plans to report topline results from the Phase 2 BESTOW trial in November 2025 [10] - Eledon will launch an investigator-initiated trial at Massachusetts General Hospital to evaluate tegoprubart for inducing donor-specific immune tolerance [10]

Core Viewpoint - Eledon Pharmaceuticals is set to present updated clinical data on tegoprubart for kidney transplantation at the World Transplant Congress on August 6, 2025, with a conference call scheduled for the same day [1]. Group 1: Company Overview - Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions [3]. - The lead investigational product, tegoprubart, is an anti-CD40L antibody targeting the CD40 Ligand, which has significant therapeutic potential [3]. - The company is conducting studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [3]. Group 2: Clinical Study Details - The ongoing open-label Phase 1b study evaluates tegoprubart for preventing rejection in approximately 30 kidney transplant recipients [1]. - The updated clinical data will be presented at the World Transplant Congress in San Francisco, CA [1]. Group 3: Conference Call Information - A conference call and webcast will take place on August 6, 2025, at 4:30 p.m. ET to discuss the updated clinical data [1]. - Domestic callers can join by dialing 1-800-717-1738, while international callers can use 1-646-307-1865, with the conference ID being 34575 [2].

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]

Core Viewpoint - Sernova Biotherapeutics has entered into a Collaborative Research Agreement with Eledon Pharmaceuticals to utilize Eledon's immunosuppressive agent, tegoprubart, in Sernova's Phase 1/2 clinical trial for its Cell Pouch Bio-hybrid Organ aimed at treating patients with Type 1 Diabetes (T1D) [1][2]. Group 1: Collaboration and Clinical Trial Details - Eledon will supply tegoprubart, an investigational anti-CD40L antibody, to replace tacrolimus in Cohort C of the clinical trial, addressing the limitations of tacrolimus in islet cell therapy for T1D [2][3]. - The trial led by Dr. Piotr Witkowski showed that T1D patients receiving islet transplants with tegoprubart achieved normal blood sugar levels and insulin independence, with islet engraftment rates three to five times higher than those receiving tacrolimus [3]. Group 2: Company Statements and Future Outlook - Sernova's CEO expressed optimism about the combination of their Cell Pouch technology with tegoprubart, suggesting it could lead to faster insulin independence with reduced toxicity to islet cells [4]. - Eledon's CEO highlighted the potential of tegoprubart to protect transplanted cells without the toxicities associated with standard immunosuppressive treatments, aiming to transform the treatment landscape for T1D [4]. Group 3: Company Background - Sernova Biotherapeutics is focused on developing regenerative medicine therapeutics that integrate its Cell Pouch with human donor cells or stem-cell derived islet-like clusters to create bio-hybrid organs for treating T1D and other chronic diseases [5].

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]