EX-99.2 3 eldn-ex99_2.htm EX-99.2

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Phase 1b Trial Update: Evaluating Tegoprubart For The Prevention of Rejection In Patients Undergoing Kidney Transplantation November 2, 2023 EXHIBIT 99.2


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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,” “could,” “may,” and similar expressions, constitute forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, although not all forward‐looking statements include such identifying words. Forward‐looking statements include, but are not limited to statements regarding: expectations regarding the timing for the commencement and completion of product development or clinical trials; the rate and degree of market acceptance and clinical utility of the company’s products; the company’s commercialization, marketing and manufacturing capabilities and strategy; the company’s intellectual property position and strategy; the company’s ability to identify additional products or product candidates with significant commercial potential; the company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; developments relating to the company’s competitors and industry; and the impact of government laws and regulations. Actual results may differ materially from those indicated by such forward‐looking statements as a result of various important factors, including: the ability to develop commercially viable product formulations; the sufficiency of the company’s cash resources; the ability to obtain necessary regulatory and ethics approvals to commence additional clinical trials; whether data from early clinical trials will be indicative of the data that will be obtained from future clinical trials; whether the results of clinical trials will warrant submission for regulatory approval of any investigational product; whether any such submission will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies and, if we are able to obtain such approval for an investigational product, whether it will be successfully distributed and marketed. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward‐looking statements contained herein, are discussed in our annual report on Form 10‐K for the year ended December 31, 2022, and other filings with the SEC which can be found at www.sec.gov. Any forward‐looking statements contained in this presentation speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward‐looking statements, whether as a result of new information, future events or otherwise. Photo: Gertrude “Trudy” Elion, inventor of azathioprine and recipient of Nobel Prize in Medicine in 1988.


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Tegoprubart: Transplantation Focused Pipeline in a Product Opportunity Note: As of September 22, 2023. Development plans and timelines may change, including based on US and global regulatory interactions. Indications DEVELOPMENT STAGE Pre-clinical Phase 1 / Early Human Trials Phase 2 Phase 3 Kidney Transplantation Phase 2 BESTOW and ex-US Phase 1b enrolling Sub-cutaneous formulation completed non-human primate study Xenotransplantation Cardiac xenotransplantation performed at University of Maryland eGenesis & academic collaborations Liver Transplantation Academic collaboration Amyotrophic Lateral Sclerosis (ALS) Seeking non-equity dilutive financing to advance program to Phase 3


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Kidney Transplantation Immunosuppression Market Represents a Multi-Billion Dollar Commercial Opportunity Large Patient Population Sources: NIDDK; USRDS; DHHS OPTN; Milliman 2020; Statista 2021; Astellas; Novartis; Precision Reports 2023. End Stage Renal Disease & Transplant Medicare covers cost of immunosuppressive transplant drugs, regardless of patient age, if patient does not have other insurance Global organ transplant immunosuppressant market size estimated $5.3+ billion Astellas reported tacrolimus global revenues ~$1.5B in FY2022 (Prograf, first FDA approval 1994) Heavy Economic Burden Early graft failure of transplanted kidneys $50+ Billion annual U.S. Medicare expenditure including Kidney Transplantation costs of $420,000+ / transplant People living with a functioning kidney transplant 255,000+ 188,000+ Many patients require repeat transplants Average age transplant U.S. 50 years old Average organ only functions 10-15 years $150,000+ average incremental U.S., medical costs / patient year after graft failure Re-transplants deplete an already inadequate donor organ pool Patients returning to dialysis: ▼ quality of life < 50% 5-year survival rate 25,000+ 21,000+ Kidney Transplants Annually 90,000+ Americans on transplant waiting list 5,000 Americans per year die waiting for a kidney transplant ~15% of U.S. adults on waitlist are waiting for repeat transplants


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Mechanism Overview of CD40L Inflammatory Signaling Interaction of CD40 with CD40L on immune cells mediates activation of the co-stimulatory immune pathway, controlling "cross talk” between the adaptive and innate immune systems Maximal activation of inflammatory system is a 3-step process requiring co-stimulatory signaling Step 1: Major histocompatibility complexes (MHC) and CD3/TCR engagement Step 2: CD40 and CD40L binding resulting in cell division and clonal expansion Step 3: Pro-inflammatory response by polarized T cells expressing inflammatory chemokines and cytokines Blocking CD40L shifts polarization away from pro-inflammatory signaling to T cell anergy, apoptosis, and polarization to a Treg environment Blocking CD40L thus does not generally result in lymphopenia often seen with immunosuppressive agents Source: Adapted from Kant, 2022. T cell B cell CD40L CD40 CD40L CD40 tegoprubart tegoprubart Antigen Presenting Cell CD40/CD40L Pathway and Tegoprubart Site of Action


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Removing CNIs May Stop the Cycle of Transplantation and Subsequent CNI Related Graft Failure Source: Nankivell 2003; ATC 2018; NIDDK; USRDS; DHHS OPTN; Milliman 2020; Statista 2021; Astellas; Novartis; Precision Reports 2023; UCSF.. CNI side effects are a leading cause of kidney graft failure over time…. ….and can lead to a cycle of transplantation and graft failure Transplant $440,000+ avg. cost per U.S. patient Dialysis & Kidney Wait List ~15% of adults on waitlist are for repeat transplants ~15% to 20% mortality rate in 1st year of dialysis Graft Failure $150,000+ avg. incremental medical costs per patient post graft failure CNI Associated Kidney Damage Nephrotoxicity Hypertension Diabetes


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Distribution of eGFRs Using Standard of Care Post Transplant: Median ~51 mL/min/1.73m2 in First Year Source: Am J Kidney Dis. 2011 Mar; 57(3):466-75.


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Kidney Allograft Function is an Early Predictor of Future Graft Failure eGFR at 12 months is associated with subsequent death-censored graft failure Source: Am J Kidney Dis. 2011 Mar; 57(3):466-75. Graft function measured using eGFR at 12 months post transplant is associated independently with subsequent graft failure Of multiple covariates,12-month eGFR is the strongest predictor of graft failure


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Phase 1b and Phase 2 Kidney Transplantation Studies are Running in Parallel Note: Development plans may change, including based on US and global regulatory interactions. Phase 1b Up to 12 participants undergoing kidney transplantation Canada, UK and Australia 52-week, open label, single arm study Phase 2 “BESTOW” ~120 participants (60/arm) undergoing kidney transplantation U.S. and other countries ATG induction therapy plus CNI-free maintenance therapy with tegoprubart  (as a replacement for tacrolimus) as part of a maintenance immunosuppressive regimen including mycophenolate and a corticosteroid taper ATG induction therapy plus CNI-free maintenance therapy with tegoprubart or tacrolimus as part of a maintenance immunosuppressive regimen including mycophenolate and a corticosteroid taper 52-week, head-to-head, superiority study Primary endpoints: Safety & tolerability Secondary endpoints: Graft function (eGFR) Participant and graft survival Biopsy proven acute rejection (BPAR) Immune cell infiltrate of graft biopsy Biomarker measures of kidney injury and rejection risk Primary endpoints: Graft function (eGFR) Safety & tolerability Secondary endpoints: Participant and graft survival Biopsy proven acute rejection (BPAR) Immune cell infiltrate of graft biopsy Rate of new onset diabetes mellitus (NODAT) Biomarker measures of kidney injury and rejection risk


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Phase 1b Kidney Transplantation: Demographics & Disposition Source: ASN, November 2, 2023.


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Phase 1b Kidney Transplantation: Treatment Emergent Adverse Events Source: ASN, November 2, 2023. 1 participant experienced a T cell mediated rejection (Banff score 1a). The patient was treated and remains in the study 1 patient experienced a surgical related acute tubular necrosis on day 0 (prior to administration of study drug) which impacted their kidney function. The patient continues to be in the study No cases of hyperglycemia, new onset diabetes, tremor, or cytomegalovirus infection


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Phase 1b Kidney Transplantation: Mean eGFR Over Time Pro-Inflammatory CD40L Target Engagement Note: Estimated glomerular filtration rate (eGFR) as of October 19, 2023, calculated using the chronic kidney disease epidemiology collaboration (CKD-EPI) creatinine equation. N is the number of participants at that time contributing data to mean eGFR calculation. Source: ASN, November 2, 2023. Aggregate mean eGFR was above 70 mL/min/1.73m2 at all reported time points after day 90 One participant completed the 12-month study with an eGFR of 91 on day 374, and is now enrolled in a Phase 2 open-label extension study N =


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Phase 1b Kidney Transplantation: Summary Conclusions Data from 11 participants demonstrates tegoprubart successfully prevented kidney transplant rejection and was generally safe and well-tolerated Aggregate mean eGFR was above 70 mL/min/1.73m2 at all reported time points after day 90, supporting tegoprubart’s potential to better protect organ function than with regimens using calcineurin inhibitors, the current standard of care Eledon next plans to report updated data from the Phase 1b trial mid-2024 Source: ASN, November 2, 2023.


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Q&A 14


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