Iovance Biotherapeutics, Inc. · NASDAQ:IOVA

Iovance Biotherapeutics — Investor Presentation (August 2025)

32 slides from Iovance Biotherapeutics's investor presentation, Aug 29, 2025

  1. Slide 1: Corporate Overview August 2025

    1 © 2025, Iovance Biotherapeutics, Inc. © 2025, Iovance Biotherapeutics, Inc. Corporate Overview August 2025 1

  2. Slide 2: Forward-Looking Statements

    2 © 2025, Iovance Biotherapeutics, Inc. Forward-Looking Statements Certain matters discussed in this presentation are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation

  3. Slide 3: Global Leadership in Innovating, Developing and Delivering TIL Therapy

    3 © 2025, Iovance Biotherapeutics, Inc. Global Leadership in Innovating, Developing and Delivering TIL Therapy for Patients with Cancer Approved Products Commercial Launch People & Assets >80 >250M ~$307 Cash as of 6/30/25 M ~1K Employees 3 1 1 FDA Designations Fast Track BTD RMAT Treatment Centers

  4. Slide 4: Iovance Solid Tumor Portfolio Highlights

    4 © 2025, Iovance Biotherapeutics, Inc. Iovance Solid Tumor Portfolio Highlights *Enrollment complete in IOV-COM-202 Cohorts 1A, 3A & 3B; Enrollment paused in Cohorts 3D & 3E. Abbreviations: 1L=first line; 2L=second line; 4L=fourth line; FTD=Fast Track Designation; ICI=immune checkpoint inhibitor; I

  5. Slide 5: Tumor Infiltrating Lymphocytes (TIL): Leading Cell Therapy Platform for Solid Tumors

    5 © 2025, Iovance Biotherapeutics, Inc. Tumor Infiltrating Lymphocytes (TIL): Leading Cell Therapy Platform for Solid Tumors TIL –Unique Mechanism of Action • Individualized • One-time therapy • Deploys the patient’s own T cells to fight cancer Tumor Tissue Collection Patient-specific T Cells Grown

  6. Slide 6: Significant Market Potential in Solid Tumors

    6 © 2025, Iovance Biotherapeutics, Inc. U.S. Deaths1 Global Deaths2 Melanoma 8K 59K Lung & Bronchus 125K 1.8M Endometrial 13K 97K 1. National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2025 Estimates. https://seer.cancer.gov (accessed August 2025) 2. World Health Org

  7. Slide 7: Opportunity to Expand Advanced Melanoma Market

    7 © 2025, Iovance Biotherapeutics, Inc. Significant unmet need in frontline and beyond1 Opportunity to Expand Advanced Melanoma Market 2L+ Advanced Melanoma Patient Population2,3 US: 8K Potential ex-US Markets: 22K Overall (1L+): 70K Prognosis for patients who progress on front-line PD-1 therapy7 BR

  8. Slide 8: First FDA-approved One-time, Individualized T cell Therapy for a Solid Tumor Cancer

    8 © 2025, Iovance Biotherapeutics, Inc. First FDA-approved One-time, Individualized T cell Therapy for a Solid Tumor Cancer

  9. Slide 9: Amtagvi Addresses High Unmet Need for Patients Who Progress After Immune Checkpoint Inhibitors

    9 © 2025, Iovance Biotherapeutics, Inc. Amtagvi Addresses High Unmet Need for Patients Who Progress After Immune Checkpoint Inhibitors1 Preferred second-line+ therapy in NCCN guidelines2 Deep & durable responses at 5-year follow up1 1. Medina et al, ASCO 2025. Pooled Analysis (n=153), Heavily Pre-Tr

  10. Slide 10: Physician-assessed responses reinforce Amtagvi clinical benefit

    10 © 2025, Iovance Biotherapeutics, Inc. Higher response rates observed in third-line or earlier patients Physician-assessed responses reinforce Amtagvi clinical benefit 60.9% ORR (14/23) Nearly Half of Patients Responded to Amtagvi in Real-World Analysis1 1. All evaluable patients received commerci

  11. Slide 11: Amtagvi Patient Journey

    *Earlier time to treatment driven by faster reimbursement and scheduling, earlier lymphodepletion, and shorter turnaround for manufacturing/release as the launch continues 11 © 2025, Iovance Biotherapeutics, Inc. Amtagvi® Patient Journey Lymphodepletion Reimbursement Approval ~3 Weeks Manufacturing,

  12. Slide 12: FDA-Approved Cell Therapy Manufacturing Facility

    12 © 2025, Iovance Biotherapeutics, Inc. Philadelphia, PA • Flex facility with capacity for up to 5K patients/year • Supplies commercial and clinical TIL cell therapies globally • Control to optimize capacity, quality & COGS FDA-Approved Cell Therapy Manufacturing Facility Dedicated to Commercial an

  13. Slide 13: Amtagvi Authorized Treatment Centers

    13 © 2025, Iovance Biotherapeutics, Inc. Amtagvi® Authorized Treatment Centers (ATC) >90% of Addressable Patients within 200 miles of ATCs1,2 ≤100 10K+ Population2 1. Not all authorized treatment centers are listed, Includes onboarded ATCs as well as in-process ATCs. 2. U.S. Census Bureau, 2024 Annu

  14. Slide 14: Broad Market Access

    14 © 2025, Iovance Biotherapeutics, Inc. Broad Market Access Data on file as of July 2025. *Plans or policies that cover Amtagvi, including pharmacy benefit managers (PBMs) Abbreviations: NCCN = National Comprehensive Cancer Network Payer medical coverage policies consistent with Amtagvi label, clin

  15. Slide 15: Amtagvi Expansion Plans in Advanced Melanoma

    15 © 2025, Iovance Biotherapeutics, Inc. Amtagvi® Expansion Plans in Advanced Melanoma

  16. Slide 16: Unprecedented Rate, Depth & Durability of Responses in Frontline Advanced Melanoma

    16 © 2025, Iovance Biotherapeutics, Inc. Unprecedented Rate, Depth & Durability of Responses in Frontline Advanced Melanoma • Median PFS and median DOR not reached at nearly 2 years of median follow-up (median follow-up 21.7 months) • All response-evaluable patients demonstrated regression of target

  17. Slide 17: TILVANCE-301 Global Phase 3 and Confirmatory Trial

    17 © 2025, Iovance Biotherapeutics, Inc. Option to crossover to lifileucel after BIRC-confirmed PD 1:1 Randomization TILVANCE-301 Global Phase 3 and Confirmatory Trial L I F I L E U C E L + P E M B R O L I Z U M A B I N F R O N T L I N E A D V A N C E D M E L A N O M A *Pembrolizumab in both arms is

  18. Slide 18: TIL Therapy Pipeline

    18 © 2025, Iovance Biotherapeutics, Inc. TIL Therapy Pipeline

  19. Slide 19: Large Domestic and Global Addressable Market in NSCLC

    19 © 2025, Iovance Biotherapeutics, Inc. Cohorts investigating multiple treatment regimens and patient populations in three Iovance clinical trials Large Domestic and Global Addressable Market in Non-Small Cell Lung Cancer (NSCLC) 1. Clarivate DRG Disease Landscape (2021), figures approximate 2. Dat

  20. Slide 20: IOV-LUN-202 Registrational Trial Design

    20 © 2025, Iovance Biotherapeutics, Inc. IOV-LUN-202 Registrational Trial Design Phase 2 Multicenter Study of Lifileucel† in Patients Post-Anti-PD-1 NSCLC (NCT04614103) †Gen 2 TIL product † † Cohort 3 patients unable to undergo surgical harvest, TIL grown from core biopsy Abbreviations: Anti-PD-1=an

  21. Slide 21: Strong Preliminary Clinical Results in Second-Line mNSCLC

    21 © 2025, Iovance Biotherapeutics, Inc. Strong Preliminary Clinical Results in Second-Line mNSCLC I O V- L U N- 2 0 2 C O H O R T S 1 A N D 2 , P O S T -A N T I-P D-1 N S C L C % Change from Baseline (n=23) Patients *Data cut: July 6, 2023. 21 evaluable patients for response. Responses were assesse

  22. Slide 22: Cohort 3A Results Support Adding TIL Therapy to Frontline NSCLC

    22 © 2025, Iovance Biotherapeutics, Inc. Cohort 3A Results Support Adding TIL Therapy to Frontline NSCLC1 I O V- C O M- 2 0 2 C O H O R T 3 A , I C I- N A Ï V E N S C L C % Change from Baseline Time (Months) Since TIL Infusion Patients PD-L1 negative, EGFRWT subgroup has a high unmet need2 Best Perc

  23. Slide 23: Potential Market for Advanced Endometrial Cancer

    23 © 2025, Iovance Biotherapeutics, Inc. 1. National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2025 Estimates. https://seer.cancer.gov (accessed August 2025); 2. World Health Organization International Agency for Research on Cancer (IARC). GLOBOCAN 2022 3. NCCN Guid

  24. Slide 24: IOV-END-201 Phase 2 Proof of Concept Study Endometrial Cancer

    24 © 2025, Iovance Biotherapeutics, Inc. pMMR Subgroup dMMR Subgroup Endpoints • Primary: ORR per RECIST v1.1 by investigator • Secondary: CR rate, DOR, DCR, PFS, OS, safety and tolerability • Subgroup analyses specified in protocol • Potential to expand / convert to registrational trial • First pat

  25. Slide 25: IOV-4001: PD-1 Inactivated TIL Therapy

    25 © 2025, Iovance Biotherapeutics, Inc. © 2025, Iovance Biotherapeutics, Inc. IOV-4001: PD-1 Inactivated TIL Therapy 2 T cell PD-1 PD-1 inhibits the ability of T cells to fight cancer: T cells, upon encountering cancer cells, produce PD-1, a checkpoint receptor that is activated by proteins (PD-L1

  26. Slide 26: IOV-4001 Phase 1/2 First-in-Human Study IOV-GM1-201

    26 © 2025, Iovance Biotherapeutics, Inc. Phase 1/2 Open-Label First-in-Human Study: IOV-GM1-201 Endpoints • Phase 1: Safety (Complete) • Phase 2 Primary: ORR per RECIST v1.1 by investigator • Secondary: CR rate, DOR, DCR, PFS, OS, safety and tolerability Genetically Modified, PD-1 Inactivated TIL Th

  27. Slide 27: IOV-3001: Next Generation IL-2 for TIL Supportive Regimen

    27 © 2025, Iovance Biotherapeutics, Inc. © 2025, Iovance Biotherapeutics, Inc. IOV-3001: Next Generation IL-2 for TIL Supportive Regimen1,2 Phase 1/2 trial enrolling patients Recombinant fusion protein designed to enhance TIL survival and cellular proliferation • A modified copy of the coding sequen

  28. Slide 28: IOV-5001: IL-12 TIL Therapy to Increase Efficacy

    28 © 2025, Iovance Biotherapeutics, Inc. IOV-5001: IL-12 TIL Therapy to Increase Efficacy 1. Zhang L, Rosenberg SA, et al, Clin Cancer Res 2015;21(10):2278–2288 2. Zhang L, Davis JS, et al, J Immunother Cancer 2020;8:e000210 3. Kobayashi M, Fitz L, et al, J Exp Med 1989;170:827–845. 4. Zeh HJ, Hurd

  29. Slide 29: Corporate Summary & Milestones

    29 © 2025, Iovance Biotherapeutics, Inc. Corporate Summary & Milestones

  30. Slide 30: Financial Position & Outlook

    30 © 2025, Iovance Biotherapeutics, Inc. 1. Includes anticipated revenue from Amtagvi and Proleukin® and anticipated savings from strategic restructuring announced on August 7, 2025 2. Iovance is implementing a strategic restructuring to optimize business performance, resulting in more than $100 mil

  31. Slide 31: Corporate Highlights: Pioneering a Transformational Approach to Cure Cancer

    31 © 2025, Iovance Biotherapeutics, Inc. Corporate Highlights Pioneering a Transformational Approach to Cure Cancer Abbreviations: FTD, fast track designation; ICI, immune checkpoint inhibitor; NSCLC, non-small cell lung cancer; PD-1, programmed cell death protein-1 Large Market Opportunity in High

  32. Slide 32: Thank You

    32 © 2025, Iovance Biotherapeutics, Inc. © 2025, Iovance Biotherapeutics, Inc. Thank You

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