Iovance Biotherapeutics, Inc. · NASDAQ:IOVA

Iovance Biotherapeutics — Investor Presentation (August 2024)

34 slides from Iovance Biotherapeutics's investor presentation, Aug 9, 2024

  1. Slide 1: Corporate Overview August 2024

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

  2. Slide 2: Forward-Looking Statements

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

  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 51 >225M >55 ~$ 450M Cash Position as of 7/24 /24 1 $31.1M First Launch Quarter Revenue (2Q24) ~7 00 Employees

  4. Slide 4: Iovance Solid Tumor Portfolio Highlights

    4 © 2024, Iovance Biotherapeutics, Inc. Iovance Solid Tumor Portfolio Highlights *Enrollment complete Abbreviations: 1L=first line; 2L=second line; 4L=fourth line; FTD=Fast Track Designation; ICI=immune checkpoint inhibitor; IL - 2= interleukin 2; IL - 12=interleukin 12; IND=investigational new drug

  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 U.S. Deaths 1 Gl

  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 one-time, individualized T cell therapy approved by FDA for a solid tumor cancer

    8 © 2024, Iovance Biotherapeutics, Inc. 8 First one - time, individualized T cell therapy approved by FDA 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, Amtag

  11. Slide 11: Amtagvi Durability at 4 Years

    11 © 2024, Iovance Biotherapeutics, Inc. Amtagvi ¯ Durability at 4 - Years Median DOR not reached at 4 - year follow - up 4 - year Follow - up of 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 21.9% of patients were alive at 4 - year

  12. Slide 12: Amtagvi Patient Journey

    12 © 2024, Iovance Biotherapeutics, Inc. Amtagvi ¯ Patient Journey Amtagvi Autologous T Cell Therapy Lymphodepletion Enrollment Process Treatment Regimen Reimbursement Approval ~3 Weeks Manufacturing & Release Testing Time to treatment decreasing over time driven by faster reimbursement and scheduli

  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 ( i CTC): Capacity Expansion Plans i CTC Campus Expansion 10,000+ patients/year i CTC building expansion 3 Automation 14 © 2024, Iovance Biotherapeutics, Inc. Today (as built) up to 2,000 + patients/year 1 12 core suites for commer

  15. Slide 15: Authorized Treatment Centers (ATCs)

    15 © 2024, Iovance Biotherapeutics, Inc. 15 Authorized Treatment Centers (ATCs) 1. Amtagvi.com Note: There are at least 50 authorized treatment centers; Not all authorized treatment centers may be listed on the locator tool (Last accessed August 7, 2024) . Abbreviations: ATC=Authorized Treatment Cen

  16. Slide 16: Broad Market Access

    16 © 2024, Iovance Biotherapeutics, Inc. Broad Market Access Data on file, as of July 31, 2024. Data on file. Abbreviations: NCCN = National Comprehensive Cancer Network Initial payer medical coverage policies consistent with Amtagvi label, clinical trials and NCCN guidelines >225 Million Patient Li

  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 1 • Median PFS not reached at nearly 2 years of median follow - up • mDOR Not Reached (median follow - up 21.7 months) • All response - evaluable patients demonstrated regressi

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

    19 © 2024, Iovance Biotherapeutics, Inc. 1:1 Randomization TILVANCE - 301 Global Phase 3 and Confirmatory Trial LIFILEUCEL + PEMBROLIZUMAB IN FRONTLINE ADVANCED MELANOMA Abbreviations: BIRC=blinded independent review committee; ORR=objective response rate; PD=progressive disease; PD - 1=programmed c

  20. Slide 20: TIL Therapy Pipeline

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

  21. Slide 21: Potential Market for Advanced Non-Small Cell Lung Cancer (NSCLC)

    21 © 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. American Cancer Society, Lung Cancer. https://www.cancer.org/cancer/types/lung - cancer/about.html (accessed

  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) Endpoints • Primary: ORR by IRC • Secondary: Safety † Gen 2 TIL product † † Cohort 3 patients unable to undergo surgical

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

    23 © 2024, Iovance Biotherapeutics, Inc. All responses remain ongoing at time of data cut 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 r

  24. Slide 24: Changing Treatment Landscape for Endometrial Cancer

    24 © 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. NCCN Guidelines Version 2.2024 Endometrial Carcinoma; 3. Kang et al, Nature Portfolio, Scientific Reports,

  25. Slide 25: IOV-END-201 Phase 2 Proof of Concept Study

    25 © 2024, Iovance Biotherapeutics, Inc. IOV - END - 201 Phase 2 Proof of Concept Study Endpoints • Primary : ORR per RECIST v1.1 by investigator • Secondary : CR rate , DOR, DCR, PFS, OS, safety and tolerability • Interim data, including subgroup analyses, specified in the protocol. • Potentially r

  26. Slide 26: IOV-4001 PD-1 Inactivated TIL Therapy

    26 © 2024, Iovance Biotherapeutics, Inc. 26 © 2024, Iovance Biotherapeutics, Inc. IOV - 4001 - PD - 1 Inactivated TIL Therapy APC Tumor cell T cell PD - L1 TCR TCR pMHCI pMHCI CD80 PD - L1 PD - L2 PD - L2 PD1 PD1 • Persistent antigen encounter in the tumor leads to upregulation of PD1 on antigen - s

  27. Slide 27: Phase 1/2 Open-Label First-in-Human Study: IOV-GM1-201

    27 © 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 Cohort 1: Unresectable or metasta

  28. Slide 28: IOV-3001 Next Generation IL-2 for TIL Supportive Regimen

    28 © 2024, Iovance Biotherapeutics, Inc. 28 © 2024, Iovance Biotherapeutics, Inc. IOV - 3001 – Next Generation IL - 2 for TIL Supportive Regimen • IOV - 3001 is a recombinant fusion protein in which a modified copy of the coding sequence for aldesleukin (mdIL - 2) is incorporated into a humanized mo

  29. Slide 29: IOV-5001 IL-12 TIL Therapy to Increase Efficacy

    29 © 2024, Iovance Biotherapeutics, Inc. IOV - 5001 - IL - 12 TIL Therapy to Increase Efficacy • Tethered IL - 12 TILs can improve efficacy by remodeling the suppressive tumor microenvironment into an immuno - supportive state – In advanced melanoma patients, an ORR of 63% (n=16) was observed using

  30. Slide 30: Corporate Summary & Milestones

    30 © 2024, Iovance Biotherapeutics, Inc. 30 Corporate Summary & Milestones

  31. Slide 31: Well-Capitalized in Pursuit of TIL Commercialization

    31 © 2024, Iovance Biotherapeutics, Inc. 31 June 30, 2024 (in millions) Unaudited cash position (July 24, 2024) ~$449.6 1 Common shares outstanding 297.3 Preferred shares outstanding 2.9 2 Stock options and restricted stock units outstanding 30.7 1. Includes net proceeds of approximately $200.0 mill

  32. Slide 32: Anticipated 2024 Milestones

    32 © 2024, Iovance Biotherapeutics, Inc. REGULATORY □ Obtain FDA approval for lifileucel in advanced melanoma (approved on Feb. 16, 2024) □ Submit EMA regulatory dossier (1H24) □ Submit additional ex - U.S. dossiers (2H24) □ Meet with FDA to discuss NSCLC registrational path/frontline study PIPELINE

  33. Slide 33: Corporate Highlights

    33 © 2024, Iovance Biotherapeutics, Inc. Corporate Highlights Pioneering a Transformational Approach to Cure Cancer Large Market Opportunity in High Unmet Need Cancers First FDA Approved T Cell Therapy for a Solid Tumor Cancer Efficient and Scalable Proprietary Manufacturing Facility Fully - Integra

  34. Slide 34: Thank You

    34 © 2024, Iovance Biotherapeutics, Inc. © 2024, Iovance Biotherapeutics, Inc. Thank You

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