Phase 2 BESTOW Clinical Trial Results November 7, 2025 Forward -Looking Statements This presentation contains forward ‐looking statements that involves substantial risks and uncertainties. Any statements about the company's future expectations, plans and prospects, including statements about its strategy, future operations, development of its product candidates, and other statements containing the words "believes," "anticipates," "plans," "expects," "estimates," "intends," "predicts," "projects," "targets," ...

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Financial Position - As of September 30, 2025, Eledon Pharmaceuticals reported estimated cash, cash equivalents, and short-term investments of approximately $93.4 million[6] Clinical Trials - The company announced results from its Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients[9] - A conference call is scheduled for November 7, 2025, to discuss updated Phase 2 BESTOW clinical data[10]

Core Insights - Eledon Pharmaceuticals announced positive results from its Phase 2 BESTOW trial for tegoprubart, showing its potential as a new standard for preventing kidney transplant rejection [2][3] - Tegoprubart demonstrated a favorable safety profile, significantly reducing common toxicities associated with tacrolimus, including metabolic, neurologic, and cardiovascular issues [3][6] - The company plans to advance tegoprubart into Phase 3 development following discussions with regulators [8] Study Design - The Phase 2 BESTOW trial was a 12-month, randomized, head-to-head study involving 127 kidney transplant recipients, comparing tegoprubart with tacrolimus [4] - All participants received rabbit antithymocyte globulin induction and maintenance therapy with mycophenolate mofetil and corticosteroids [4] Efficacy Results - The primary endpoint was the change in estimated glomerular filtration rate (eGFR) at 12 months post-transplant, with tegoprubart achieving a mean eGFR of 69 mL/min/1.73 m² compared to 66 mL/min/1.73 m² for tacrolimus [12] - The efficacy failure composite endpoint was 22% for tegoprubart versus 17% for tacrolimus, demonstrating non-inferiority for tegoprubart [12] - Subgroup analyses indicated higher eGFRs for tegoprubart in nearly all categories, particularly among living-related donor recipients [12] Safety Results - Tegoprubart showed a significantly lower incidence of new-onset diabetes (1 in 47) compared to tacrolimus (1 in 6) [6] - Neurologic effects such as tremor were markedly lower in the tegoprubart group (1.6% vs. 25.0%) [6] - Cardiovascular issues, including hypertension and heart failure, were also less prevalent in the tegoprubart group [6] Next Steps - Eledon plans to incorporate insights from the Phase 2 data and ongoing studies to optimize the Phase 3 protocol [8] - The company is preparing for discussions with regulators regarding study design and data requirements for the next phase [8] Financial Position - As of September 30, 2025, Eledon reported approximately $93.4 million in cash, cash equivalents, and short-term investments, expected to fund operations until late 2026 [9]

Core Insights - Eledon Pharmaceuticals, Inc. will present at the Guggenheim Second Annual Healthcare Innovation Conference on November 12, 2025, at 10:30 a.m. ET [1] - The company is focused on developing immune-modulating therapies for life-threatening conditions, with its lead product being tegoprubart, an anti-CD40L antibody [2] Company Overview - Eledon Pharmaceuticals is a clinical stage biotechnology company headquartered in Irvine, California [2] - The company is developing therapies targeting CD40 Ligand, which has significant therapeutic potential in various medical conditions [2] - Eledon is conducting preclinical and clinical studies in areas such as kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [2]

Core Insights - Eledon Pharmaceuticals will present topline results from the Phase 2 BESTOW trial for tegoprubart at the American Society of Nephrology's Kidney Week 2025 Annual Meeting [1][2] - The oral presentation is scheduled for November 6, 2025, focusing on the efficacy and safety of tegoprubart in preventing rejection in kidney transplantation [2] - A conference call to discuss the trial results will be held on November 7, 2025, at 8:00 a.m. ET [3] Company Overview - Eledon Pharmaceuticals is a clinical stage biotechnology company developing immune-modulating therapies for life-threatening conditions [4] - The lead investigational product, tegoprubart, is an anti-CD40L antibody targeting CD40 Ligand, which has significant therapeutic potential [4] - The company is conducting studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [4]

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]