Iovance Biotherapeutics, Inc. · NASDAQ:IOVA

Iovance Biotherapeutics — Investor Presentation (November 2024)

35 slides from Iovance Biotherapeutics's investor presentation, Nov 8, 2024

  1. Slide 1: Corporate Overview November 2024

    1 © 2024, Iovance Biotherapeutics, Inc. © 2024, Iovance Biotherapeutics, Inc. Corporate Overview November 2024 1

  2. Slide 2: Forward-Looking Statements

    2 © 2024, Iovance Biotherapeutics, Inc. Forward - Looking Statements Certain matters discussed in this presentation are “forward - looking statements” of Iovance Biotherapeutics, Inc. (hereinafter re ferred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litig

  3. Slide 3: Global Leadership in Innovating, Developing and Delivering TIL Therapy for Patients with Cancer

    3 © 2024, Iovance Biotherapeutics, Inc. Global Leadership in Innovating, Developing and Delivering TIL Therapy for Patients with Cancer 3 Approved Products Commercial Launch People & Assets 56 >250M >140 ~$ 404M Cash as of 9/30/24 $58.6M 3Q24 Revenue >750 Employees 3 1 1 DESIGNATIONS: Fast Track BTD

  4. Slide 4: Iovance Solid Tumor Portfolio Highlights

    4 © 2024, Iovance Biotherapeutics, Inc. Iovance Solid Tumor Portfolio Highlights *Enrollment complete in Cohort 3B; Cohorts 1A and 3D are new planned cohorts Abbreviations: 1L=first line; 2L=second line; 4L=fourth line; FTD=Fast Track Designation; ICI=immune checkpoint inhibitor; IL - 2= interleukin

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

    5 © 2024, Iovance Biotherapeutics, Inc. Tumor Infiltrating Lymphocytes (TIL): Leading Cell Therapy Platform for Solid Tumors TIL – Unique Proposed Mechanism of Action • Individualized • One - time therapy • Deploys the patient’s own T cells to fight cancer Tumor Tissue Collection Patient - specific

  6. Slide 6: Significant Market Potential in Solid Tumors and our Key Programs

    6 © 2024, Iovance Biotherapeutics, Inc. 1. National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2024 Estimates. https://seer.cancer.g ov (accessed May 2024) 2. World Health Organization International Agency for Research on Cancer (IARC). GLOBOCAN 2022 Global Deaths 2

  7. Slide 7: Significant Opportunity to Expand Advanced Melanoma Market

    7 © 2024, Iovance Biotherapeutics, Inc. 1. National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2024 Estimates. https://seer.cancer.gov (accessed May 2024) 2. World Health Organization International Agency for Research on Cancer (IARC). GLOBOCAN 2022 3. Data on file a

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

    8 © 2024, Iovance Biotherapeutics, Inc. 8 First FDA - approved One - time, Individualized T cell Therapy for a Solid Tumor Cancer

  9. Slide 9: Preferred second-line+ therapy in NCCN guidelines

    9 © 2024, Iovance Biotherapeutics, Inc. 1. National Comprehensive Cancer Network® Guidelines, Melanoma: Cutaneous, Version 2.24 Preferred second - line+ therapy in NCCN guidelines 1

  10. Slide 10: Amtagvi Delivered Deep and Durable Responses

    10 © 2024, Iovance Biotherapeutics, Inc. Amtagvi Delivered Deep and Durable Responses (95% CI: 21.1, 43.4) mDOR Not Reached ORR 31.4 % (95% CI: 24.1, 39.4) (Range: 1.4+, 45.0+) (Range: 1.4+, 26.3+; 95% CI: 4.1, NR) 18.6 months follow up 21.5 months follow up 2 1. C - 144 - 01 Clinical Trial, Amtagvi

  11. Slide 11: Amtagvi Durability at 4 Years Follow Up

    11 © 2024, Iovance Biotherapeutics, Inc. Amtagvi Durability at 4 - Years Follow Up (Pooled Analysis, n=153) 31.4% (95% CI: 24.1, 39.4) ORR Not Reached (95% CI: 8.3, NR) mDOR 48.1 months follow - up 1. Medina et al, ESMO IO 2023 Abbreviations: CI=confidence interval; mDOR = median duration of respons

  12. Slide 12: 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 12 © 2024, Iovance Biotherapeutics, Inc. Amtagvi Patient Journey Lymphodepletion Reimbursement Approval ~3 Weeks Manufacturing,

  13. Slide 13: Iovance Cell Therapy Center: iCTC

    13 © 2024, Iovance Biotherapeutics, Inc. Iovance Cell Therapy Center: i CTC • Built - to - suit custom facility in Navy Yard Philadelphia • Commercial and clinical TIL therapy supply • Expanding headcount in alignment with expected growth in demand • Control to optimize capacity, quality & COGS FDA

  14. Slide 14: Iovance Cell Therapy Center (iCTC): Capacity Expansion Plans

    14 © 2024, Iovance Biotherapeutics, Inc. Iovance Cell Therapy Center (iCTC): Capacity Expansion Plans i CTC Campus Expansion 10,000+ patients/year i CTC building expansion 3 Automation Today (As built) up to 2,000 + patients/year 1 12 core suites for commercial 4 separate flex suites for clinical Si

  15. Slide 15: Amtagvi Authorized Treatment Centers (ATCs)

    15 © 2024, Iovance Biotherapeutics, Inc. 15 Amtagvi Authorized Treatment Centers (ATCs) 1 1. Amtagvi.com Note: Not all authorized treatment centers may be listed on the locator tool (Last accessed November 2024) . Abbreviations: ATC=Authorized Treatment Centers Goal to ensure patients have geographi

  16. Slide 16: Broad Market Access

    16 © 2024, Iovance Biotherapeutics, Inc. Broad Market Access Data on file as of October 31, 2024. *Plans or policies that cover Amtagvi, including pharmacy benefit managers (PBMs) Abbreviations: NCCN = National Comprehensive Cancer Network Payer medical coverage policies consistent with Amtagvi labe

  17. Slide 17: Amtagvi Expansion Plans in Advanced Melanoma

    17 © 2024, Iovance Biotherapeutics, Inc. 17 Amtagvi Expansion Plans in Advanced Melanoma

  18. Slide 18: Unprecedented Rate, Depth & Durability of Responses in Frontline Advanced Melanoma

    18 © 2024, 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

  19. Slide 19: TILVANCE-301 Global Phase 3 and Confirmatory Trial

    19 © 2024, Iovance Biotherapeutics, Inc. Option to crossover to lifileucel after BIRC - confirmed PD 1:1 Randomization TILVANCE - 301 Global Phase 3 and Confirmatory Trial LIFILEUCEL + PEMBROLIZUMAB IN FRONTLINE ADVANCED MELANOMA *Pembrolizumab in both arms is started at the same time after randomiz

  20. Slide 20: TIL Therapy Pipeline

    20 © 2024, Iovance Biotherapeutics, Inc. 20 TIL Therapy Pipeline

  21. Slide 21: Large Domestic and Global Addressable Market in Non-Small Cell Lung Cancer (NSCLC)

    21 © 2024, Iovance Biotherapeutics, Inc. Cohorts investigating multiple treatment regimens and patient populations in 3 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. Data

  22. Slide 22: IOV-LUN-202 Registrational Trial Design

    22 © 2024, 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:

  23. Slide 23: Strong Preliminary Clinical Results in Second-Line mNSCLC

    23 © 2024, Iovance Biotherapeutics, Inc. Strong Preliminary Clinical Results in Second - Line mNSCLC IOV - LUN - 202 COHORTS 1 AND 2, POST - ANTI - PD - 1 NSCLC % Change from Baseline (n=23) Patients *Data cut: July 6, 2023. 21 evaluable patients for response. Responses were assessed by investigator

  24. Slide 24: Cohort 3A Results Support Adding TIL Therapy to Frontline NSCLC

    24 © 2024, Iovance Biotherapeutics, Inc. Cohort 3A Results Support Adding TIL Therapy to Frontline NSCLC 1 IOV - COM - 202 COHORT 3A, ICI - NAÏVE NSCLC % Change from Baseline Time (Months) Since TIL Infusion Patients PD - L1 negative, EGFR WT subgroup has a high unmet need 2 Best Percentage Change f

  25. Slide 25: Potential Market for Advanced Endometrial Cancer

    25 © 2024, Iovance Biotherapeutics, Inc. 1. National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2024 Estimates. https://seer.cancer.gov (ac cessed May 2024); 2. World Health Organization International Agency for Research on Cancer (IARC). GLOBOCAN 2022 3. NCCN Guidel

  26. Slide 26: IOV-END-201 Phase 2 Proof of Concept Study Endometrial Cancer

    26 © 2024, 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

  27. Slide 27: IOV-4001: PD-1 Inactivated TIL Therapy

    27 © 2024, Iovance Biotherapeutics, Inc. 27 © 2024, 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 pro

  28. Slide 28: Phase 1/2 Open-Label First-in-Human Study: IOV-GM1-201

    28 © 2024, 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 Inac

  29. Slide 29: IOV-3001: Next Generation IL-2 for TIL Supportive Regimen

    29 © 2024, Iovance Biotherapeutics, Inc. 29 © 2024, Iovance Biotherapeutics, Inc. IOV - 3001: Next Generation IL - 2 for TIL Supportive Regimen Recombinant fusion protein designed to enhance TIL survival and cellular proliferation • A modified copy of the coding sequence for aldesleukin (mdIL - 2) i

  30. Slide 30: IOV-5001: IL-12 TIL Therapy to Increase Efficacy

    30 © 2024, 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 H

  31. Slide 31: Corporate Summary & Milestones

    31 © 2024, Iovance Biotherapeutics, Inc. 31 Corporate Summary & Milestones

  32. Slide 32: Strong Financial Position for Launch Success and Pipeline Growth

    32 © 2024, Iovance Biotherapeutics, Inc. (in millions) September 30, 2024 $403.8 1 Cash position 304.6 Common shares outstanding 2.9 2 Preferred shares outstanding 28.8 Stock options and restricted stock units outstanding 1. Includes net proceeds of approximately $200.0 million raised from an at - t

  33. Slide 33: 2024 Milestones

    33 © 2024, Iovance Biotherapeutics, Inc. □ Obtain FDA approval for lifileucel in advanced melanoma (approved on Feb. 16, 2024) □ Submit EMA regulatory dossier (1H24) (Validated by EMA) □ Submit additional ex - U.S. dossiers (2H24) (UK complete, Canada underway) □ Present data for NSCLC frontline and

  34. Slide 34: Corporate Highlights: Pioneering a Transformational Approach to Cure Cancer

    34 © 2024, Iovance Biotherapeutics, Inc. Corporate Highlights Pioneering a Transformational Approach to Cure Cancer 34 © 2024, Iovance Biotherapeutics, Inc. Abbreviations: FTD, fast track designation; ICI, immune checkpoint inhibitor; NSCLC, non - small cell lung cancer; PD - 1, programme d cell dea

  35. Slide 35: Thank You

    35 © 2024, Iovance Biotherapeutics, Inc. © 2024, Iovance Biotherapeutics, Inc. Thank You

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