Slide 1: Phase 2 BESTOW Clinical Trial Results
Phase 2 BESTOW Clinical Trial Results November 7, 2025
Slide 2: Forward-Looking Statements
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 cand
Slide 3: Tegoprubart is a Pipeline in a Product Opportunity
Tegoprubart is a Pipeline in a Product Opportunity DEVELOPMENT STAGE Early Human Trials/ INDICATIONS PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 NOTES ALLOTRANSPLANTATION • Phase 2 BESTOW completed. Phase 1b & Kidney Long-Term Extension trials ongoing • U. Chicago investigator sponsored trial Islet Cell •
Slide 4: Life-long Maintenance Immunosuppression is Necessary to Protect Transplanted Organs
Life-long Maintenance Immunosuppression is Necessary to Protect Transplanted Organs Without immunosuppression, the host sees donor kidney as “foreign” and attacks (i.e., rejects) it Induction immunosuppression (e.g. ATG) is given at the time of transplant to rapidly suppress the graft recipient’s im
Slide 5: Unmet Need in Kidney Transplantation
Unmet Need in Kidney Transplantation CNI, calcineurin inhibitor. 1. Poggio E et al. Am J Transplantation 2021;21:2824–32. 2. Fitzsimmons WE, Naesens M. Transplantation 2024;108:593–7. 3. Leas BF et al. Comparative Effectiveness Reviews, No. 166. Rockville, MD: Agency for Healthcare Research and Qual
Slide 6: BESTOW Overview
BESTOW Overview 6
Slide 7: BESTOW Trial Overview
BESTOW Trial Overview Deceased donor for first 10 Tegoprubart infusion (1h IV) on Days 1, 3, 7, patients enrolled; living or 14, 21, 28, then every 21±3 days thereafter (to • BESTOW is the first-ever clinical deceased donor thereafter M12) trial comparing head-to-head tacrolimus to CD40L antibody Sc
Slide 8: BESTOW Key Efficacy Endpoints
BESTOW Key Efficacy Endpoints Secondary Endpoints Include Primary Endpoint of eGFR as a Proxy Historical Approvable Endpoint of of Potential Long-Term Graft Function Non-Inferiority • Since the 1990’s the primary US FDA approvable endpoint has been non-inferiority based on a composite of efficacy fa
Slide 9: BESTOW Conclusions
BESTOW Conclusions 1. Observed composite endpoint (death, graft loss, BPAR, LTFU) failure rate in BESTOW was within the range reported in previous late-phase trials of approved immunosuppressive agents and demonstrated non-inferiority for tegoprubart vs. tacrolimus, using a 20% non- inferiority marg
Slide 10: Participant Flow
Participant Flow Enrolled in BESTOW Tegoprubart (n=127) Tacrolimus Randomized, received transplant Randomized, received transplant and study treatment and study treatment (n=63; 100%) (n=64; 100%) Early study discontinuation (n=2; 3.2%) Early study discontinuation (n=4; 6.3%) • Death (n=1; 1.6%) • D
Slide 11: Donor, Recipient and Immunosuppression Characteristics
Donor Recipient Additional Characteristics Characteristics Immunosuppression Mean (SD), unless TEGO TAC Mean (SD), unless TEGO TAC Mean (SD), unless TEGO TAC stated otherwise N=63 N=64 stated otherwise N=63 N=64 stated otherwise N=63 N=64 Donor age, years 43.5 (15.3) 43.0 (14.64) Recipient age, year
Slide 12: BESTOW Efficacy
BESTOW Efficacy 12
Slide 13: Mean eGFR Over 52 Weeks in Patients Who Completed Treatment
Mean eGFR Over 52 Weeks in Patients Who Completed Treatment Note: Patients who completed treatment were those patients who completed 52 weeks of the study and received all planned doses of the randomized study drug. CI, confidence interval; eGFR, estimated glomerular filtration rate; SEM, standard e
Slide 14: Subgroup Analysis of eGFR at 12 Month in Patients Who Completed Treatment
Subgroup Analysis of eGFR at 12 Month in Patients Who Completed Treatment Mean Difference (Tego-Tac) Mean (SE) in eGFR(mL/min/1.73m2)±SE Tegoprubart Tacrolimus Overall 69 (2.8) 66 (3.1) Donor Type Deceased 68 (3.3) 68 (3.8) KDPI<35 78 (5.8) 80 (4.0) KDPI≥35 62 (2.9) 53 (5.0) Living 72 (5.6) 62 (5.7)
Slide 15: Mean eGFR by Donor Type in Patients Who Completed Treatment
Mean eGFR by Donor Type in Patients Who Completed Treatment Note: Patients who completed treatment were those patients who completed 52 weeks of the study and received all planned doses of the randomized study drug. Rejection was determined by BPAR. BPAR, Biopsy Proven Acute Rejection; eGFR, estimat
Slide 16: Mean eGFR by KDPI Score in Deceased Donor Recipients Who Completed Treatment
Mean eGFR by KDPI Score in Deceased Donor Recipients Who Completed Treatment Note: Patients who completed treatment were those patients who completed 52 weeks of the study and received all planned doses of the randomized study drug. Rejection was determined by BPAR. BPAR, Biopsy Proven Acute Rejecti
Slide 17: Mean eGFR at 12-months for Living Donor or KDPI ≥ 35 Kidney Recipients
Mean eGFR at 12-months for Subjects Who Received a Living Donor Kidney or a Deceased Donor Kidney With KDPI ≥ 35 Note: Patients who completed treatment were those patients who completed 52 weeks of the study and received all planned doses of the randomized study drug. 17
Slide 18: Comparative Abbreviated iBox Scores at 12 Months
Comparative Abbreviated iBox Scores at 12 Months CNI, calcineurin inhibitor; ITT, intent to treat; mTOR, mammalian target of rapamycin; mTOR, mTORi, mammalian target of rapamycin inhibitor; OT, on treatment. 1. Klein A et al. Am J Transplant 2023;23:1496–506. 2. European Medicines Agency (EMA) Scien
Slide 19: BPAR Based on All Biopsies Through 12 Months
BPAR Based on ALL BIOPSIES Through 12 Months Tegoprubart 20 Tacrolimus Acute mg/kg (N=64) BPAR-Free Time on-Treatment Parameters (N=63) n (%) n (%) 1.0 Total biopsies 58 (92.1) 51 (79.7) Survival Probability 0.8 Acute Rejection 13 (20.6) 9 (14.1) Acute AMR 2 (3.2) 1 (1.6) 0.6 Acute TCMR 13 (20.6) 8
Slide 20: Mean eGFR by Tegoprubart Treatment Completion in Patients Who Experienced Rejection
Mean eGFR by Tegoprubart Treatment Completion in Patients Who Experienced Rejection Note: Patients who completed treatment were those patients who completed 52 weeks of the study and received all planned doses of the randomized study drug. Rejection was determined by BPAR (biopsy proven acute reject
Slide 21: Composite Efficacy Failure & Donor-Specific Antibodies
Composite Efficacy Failure & Donor-Specific Antibodies Tegoprubart Tacrolimus Difference (Tegoprubart – All biopsy, (N=63) (N=64) Tacrolimus) aAMR+aTCMR n (%) n (%) % (95% CI) BPAR 13 (20.6) 9 (14.1) 6.6 (-7.0, 20.3) Graft loss 1 (1.6) 1 (1.6) 0 Death 1 (1.6) 1 (1.6) 0 LTFU 0 0 0 EF rate through 12
Slide 22: BESTOW Safety
BESTOW Safety 22
Slide 23: Overall Summary of Treatment-Emergent Adverse Events
Overall Summary of Treatment-Emergent Adverse Events Tegoprubart (N=63) Tacrolimus (N=64) Risk Difference n (%) n (%) (95% CI)1 Any AE 61 (96.8) 64 (100) -3.2 (-11.1, 2.9) AE by Max Severity2 G1: Mild 5 (7.9) 8 (12.5) G2: Moderate 20 (31.7) 23 (35.9) G3: Severe 31 (49.2) 28 (43.8) G4: Life-threateni
Slide 24: AEs ≥5% with ≥2 Times Risk Observed with a Therapy
AEs ≥5% with ≥2 Times Risk Observed with a Therapy Tegoprubart (N=63) Tacrolimus (N=64) Relative n (%) n (%) Difference Opportunistic Bacteremia 1 (1.6) 7 (10.9) 6.8x 6.8x Infections Sepsis 2 (3.2) 5 (7.8) 2.4x 2.4x Renal Proteinuria 10 (15.9) 1 (1.6) 9.9x 9.9x Hyperglycemia 6 (9.5) 14 (21.9) 2.3x 2
Slide 25: Opportunistic Infections
Opportunistic Infections Tegoprubart (N=63) Tacrolimus (N=64) Risk Difference n (%) n (%) (95% CI)1 Opportunistic Infections 43 (68.3) 44 (68.8) -0.5 (-17.2, 15.8) Viral Infections 33 (52.4) 31 (48.4) 3.9 (-13.8, 21.6) CMV 25 (39.7) 23 (35.9) 3.7 (-13.3, 20.7) CMV disease 1 (1.6) 3 (4.7) -3.1 (-11.7
Slide 26: AEs ≥5%: Renal & Metabolic
AEs ≥5%: Renal & Metabolic Tegoprubart (N=63) Tacrolimus (N=64) Risk Difference n (%) n (%) (95% CI)1 Renal Delayed Graft Function 9 (14.3) 16 (25.0) -10.7 (-25.0, 3.4) Mean Days on Dialysis for DGF (SD) 4.6 (4.19) 6.1 (7.71) Oliguria 0 5 (7.8) -7.8 (-17.3, -1.4) Proteinuria 10 (15.9) 1 (1.6) 14.3 (
Slide 27: AEs ≥5%: CNS and Cardiovascular
AEs ≥5%: CNS and Cardiovascular Tegoprubart (N=63) Tacrolimus (N=64) Risk Difference n (%) n (%) (95% CI)1 CNS Tremors 1 (1.6) 16 (25.0) -23.4 (-35.8, -11.5) Muscle Spasms 3 (4.8) 10 (15.6) -10.9 (-22.7, 0.1) Neurocognitive & Psychiatric Disorders 14 (22.2) 22 (34.4) -12.2 (-27.9, 3.8) Headache 7 (1
Slide 28: AEs ≥5%: Blood, Cancer & Gastro-Intestinal
AEs ≥5%: Blood, Cancer & Gastro-Intestinal Tegoprubart (N=63) Tacrolimus (N=64) Risk Difference n (%) n (%) (95% CI)1 Blood Anemia 20 (31.7) 19 (29.7) 2.1 (-14.2, 18.8) Leukopenia 26 (41.3) 15 (23.4) 17.8 (1.4, 33.9) Lymphopenia 4 (6.3) 10 (15.6) -9.3 (-21.4, 2.0) Neutropenia 9 (14.3) 10 (15.6) -1.3
Slide 29: Conclusion
Conclusion 29 COMPANY CONFIDENTIAL & PROPRIETARY INFORMATION. MAY CONTAIN TRADE SECRETS. DO NOT DUPLICATE, DETAIL, DISTRIBUTE, TRANSMIT, FORWARD, OR USE IN ANY PROMOTIONAL MANNER.
Slide 30: BESTOW Conclusions
BESTOW Conclusions 1. Observed composite endpoint (death, graft loss, BPAR, LTFU) failure rate in BESTOW was within the range reported in previous late-phase trials of approved immunosuppressive agents and demonstrated non-inferiority for tegoprubart vs. tacrolimus, using a 20% non- inferiority marg
Slide 31: Eledon Financial Profile and Expected Milestones
Eledon Financial Profile and Expected Milestones Strong • $93.4M* in cash, cash equivalents and short-term investments as of Financial September 30, 2025 Profile • Forecasted sufficient to fund operations to late 2026 • Guidance from FDA on Phase 3 design / path to market for kidney transplantation
Slide 32: Eledon Pharmaceuticals
Eledon Pharmaceuticals 19800 MacArthur Blvd., Suite 250 Irvine, California 92612, USA info@eledon.com +1 949-238-8090 32