Iovance Biotherapeutics, Inc. · NASDAQ:IOVA

Iovance Biotherapeutics — Investor Presentation (February 2024)

37 slides from Iovance Biotherapeutics's investor presentation, Feb 29, 2024

  1. Slide 1: Corporate Overview February 28, 2024

    1 © 2024, Iovance Biotherapeutics, Inc. © 2024, Iovance Biotherapeutics, Inc. Corporate Overview February 28, 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 Platform Portfolio People & Assets Partners & Collaborators 1. Unaudited cash position which includes net proceeds of approximately $197.1 million from a follow - o

  4. Slide 4: Iovance Solid Tumor Portfolio Highlights

    4 © 2024, Iovance Biotherapeutics, Inc. *Enrollment complete Abbreviations: 1L=first line; 2L=second line; 4L=fourth line; BTD=Breakthrough Therapy Designation; FTD=Fast Track Designatio n; ipi/nivo=ipilimumab/nivolumab; NSCLC=non - small cell lung cancer; ODD=Orphan Drug Designation; PD - 1=program

  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: AMTAGVI (lifileucel): First and only one-time, individualized T cell therapy approved by FDA for a solid tumor cancer

    6 © 2024, Iovance Biotherapeutics, Inc. 6 AMTAGVI ¯ (lifileucel): First and only one - time, individualized T cell therapy approved by FDA for a solid tumor cancer

  7. Slide 7: AMTAGVI USPI

    7 © 2024, Iovance Biotherapeutics, Inc. 1. AMTAGVI USPI

  8. Slide 8: U.S. Unmet Medical Need for Metastatic Melanoma Therapy

    8 © 2024, Iovance Biotherapeutics, Inc. U.S. Unmet Medical Need for Metastatic Melanoma Therapy AMTAGVI is th e First FDA Approved Treatment Option After Progression on ICI (Anti - PD - 1) Therapy and BRAF/MEK inhibitors More than half of patients progress within 12 months on current 1L ICIs , regar

  9. Slide 9: AMTAGVI Delivered Deep and Durable Responses

    9 © 2024, Iovance Biotherapeutics, Inc. AMTAGVI ¯ Delivered Deep and Durable Responses ORR 31.5 % mDOR Not Reached (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. AMTAGVI

  10. Slide 10: AMTAGVI 4-Year Follow Up

    10 © 2024, Iovance Biotherapeutics, Inc. AMTAGVI ¯ C - 144 - 01 4 - year Follow Up 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

  11. Slide 11: AMTAGVI Patient Journey

    11 © 2024, Iovance Biotherapeutics, Inc. AMTAGVI ¯ Patient Journey AMTAGVI Autologous T Cell Therapy ) AMTAGVI starts with a piece of the patient’s tumor tissue • Lymphodepletion • AMTAGVI 䉼 (lifileucel) • Short - Course Proleukin® Scheduling & Tumor Tissue Procurement Treatment Regimen & Monitoring

  12. Slide 12: Iovance Cell Therapy Center: iCTC

    12 © 2024, Iovance Biotherapeutics, Inc. Iovance Cell Therapy Center: i CTC • Built - to - suit custom facility in Navy Yard Philadelphia • Annual capacity for up to several thousand patients as built • Expansion underway for additional capacity within iCTC over next few years • Additional CDMO capa

  13. Slide 13: Iovance Cell Therapy Center (iCTC): Capacity Expansion Plans

    13 © 2024, Iovance Biotherapeutics, Inc. Iovance Cell Therapy Center ( i CTC): Capacity Expansion Plans Pre - Approval (Complete) 100s of patients/year Launch Prep in core suites for commercial 4 separate flex suites for clinical Today (as built) up to 2,000 + patients/year 1 12 core suites for comm

  14. Slide 14: Proleukin (aldesleukin) Strategic Benefits

    14 © 2024, Iovance Biotherapeutics, Inc. Proleukin® (aldesleukin) Strategic Benefits • Significant revenue anticipated with AMTAGVI ¯ launch • IL - 2 supply chain secured for AMTAGVI regimen • Lower clinical trial costs and COGS anticipated £167.7M Upfront investment Short course Proleukin® is admin

  15. Slide 15: Targeting Potential Authorized Treatment Centers (ATCs)

    15 © 2024, Iovance Biotherapeutics, Inc. Targeting Potential Authorized Treatment Centers (ATCs) 1. Amtagvi.com (Last accessed February 28, 2024) Abbreviations : ATC= Authorized Treatment Centers; NCCN=National Comprehensive Cancer Network; KOL=Key Opinion Leaders; BMT=Bone Marrow Transplant Targeti

  16. Slide 16: Market Access: Metastatic Melanoma Payer Mix

    16 © 2024, Iovance Biotherapeutics, Inc. 55% Commercial Medicare IPPS Exempt 4% 17% Medicare Advantage 8% Medicare FFS 7% Medicaid 9% Other Market Access Metastatic Melanoma Payer Mix 1 All Treatment Settings and Lines of Therapy 1. Metastatic Melanoma Insurance Claims Analysis, TIL - eligible patie

  17. Slide 17: Supporting Providers & Patients: IovanceCares

    17 © 2024, Iovance Biotherapeutics, Inc. Supporting Providers & Patients: IovanceCares ¯ Abbreviations: COI=Chain of Identity; COC=Chain of Custody Customer - Centric • Patient management ecosystem • Proprietary COI/COC • Treatment center quality program Patient - Centric • Dedicated case managers •

  18. Slide 18: AMTAGVI Expansion Plans in Advanced Melanoma

    18 © 2024, Iovance Biotherapeutics, Inc. 18 AMTAGVI ¯ Expansion Plans in Advanced Melanoma

  19. Slide 19: Ex-U.S. Unmet Medical Need for Metastatic Melanoma Therapy

    19 © 2024, Iovance Biotherapeutics, Inc. 1. World Health Organization International Agency for Research on Cancer (IARC). GLOBOCAN 2020 2. Clarivate DRG Disease Landscape (2021) Ex - U.S. Unmet Medical Need for Metastatic Melanoma Therapy Expanding AMTAGVI ¯ launch ex - U.S. to double addressable pa

  20. Slide 20: TILVANCE-301 Global Phase 3 and Confirmatory Trial

    20 © 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, programme

  21. Slide 21: Iovance TIL Clinical Highlights in Combination with Pembrolizumab in Metastatic Melanoma

    21 © 2024, Iovance Biotherapeutics, Inc. Lifileucel in combination with anti - PD - 1/PD - L1 therapy in ICI - naïve patients (IOV - COM - 202 Cohort 1A, N=12 ) 1 Iovance TIL Clinical Highlights in Combination with Pembrolizumab in Metastatic Melanoma IOV - COM - 202 COHORT 1A MELANOMA COMBINATION (

  22. Slide 22: TIL Therapy Pipeline

    22 © 2024, Iovance Biotherapeutics, Inc. 22 TIL Therapy Pipeline

  23. Slide 23: Significant Market Potential in Solid Tumors and our Key Programs

    23 © 2024, Iovance Biotherapeutics, Inc. 1. National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2023 Estimates. https://seer.cancer.g ov accessed February 2024 2. World Health Organization International Agency for Research on Cancer (IARC). GLOBOCAN 2020 U.S. Deaths

  24. Slide 24: Potential Market for Advanced Non-Small Cell Lung Cancer (NSCLC)

    24 © 2024, Iovance Biotherapeutics, Inc. 1. National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2023 Estimates. https://seer.cancer.gov acc essed February 2024 2. American Cancer Society, Lung Cancer. https://www.cancer.org/cancer/types/lung - cancer/about.html acces

  25. Slide 25: Iovance TIL Therapy LN-145 in NSCLC: IOV-LUN-202 Trial Design

    25 © 2024, Iovance Biotherapeutics, Inc. IOV - LUN - 202 Trial Design Phase 2 Multicenter Study of LN - 145 † in Patients Post - Anti - PD - 1 NSCLC (NCT04614103)* Endpoints • Primary: ORR by IRC • Secondary: Safety * U.S. FDA placed a partial clinical hold on the IOV - LUN - 202 trial on December 2

  26. Slide 26: Objective Response Rate of 26.1% by RECIST 1.1, Regardless of PD-L1 Status

    26 © 2024, Iovance Biotherapeutics, Inc. Objective Response Rate of 26.1% by RECIST 1.1, Regardless of PD - L1 Status Preliminary Clinical Results for IOV - LUN - 202 Cohorts 1 and 2 IOV - LUN - 202 COHORTS 1 AND 2, POST - ANTI - PD - 1 NSCLC Data cut: July 6, 2023. 21 evaluable patients for respons

  27. Slide 27: All Patients Progressed on or After Anti-PD-1 Therapy and Chemotherapy

    27 © 2024, Iovance Biotherapeutics, Inc. All Patients Progressed on or After Anti - PD - 1 Therapy and Chemotherapy Preliminary Clinical Results for IOV - LUN - 202 Cohorts 1 and 2 1. Data cut: July 6, 2023. Responses were assessed by investigator. 2. Patients who have progressed on or after chemoth

  28. Slide 28: All Responses Remain Ongoing at Time of Data Cut

    28 © 2024, Iovance Biotherapeutics, Inc. All Responses Remain Ongoing at Time of Data Cut Data cut: July 6, 2023. A bar is presented for each patient starting from date of LN - 145 infusion up to date of new anti - cancer therapy, end of assessme nt, death, or data cutoff date, whichever occurs earl

  29. Slide 29: Proof-of-Concept for TIL in ICI-Naïve NSCLC Regardless of PD-L1 Status

    29 © 2024, Iovance Biotherapeutics, Inc. Proof - of - Concept for TIL in ICI - Naïve NSCLC Regardless of PD - L1 Status Cohort 3A Summary IOV - COM - 202 COHORT 3A NSCLC COMBINATION (TIL+PEMBROLIZUMAB ), WCLC ORAL PRESENTATION Cohort 3A Results Support Adding TIL Therapy to Frontline Pembrolizumab +

  30. Slide 30: Frontline NSCLC Registrational Trial: Design Supported by Cohort 3A Data

    30 © 2024, Iovance Biotherapeutics, Inc. Frontline NSCLC Registrational Trial: Design Supported by Cohort 3A Data Long - Term Follow Up ​ SOC Maintenance Treatment +/ - TIL ​ SOC Chemo - IO Treatment* Adding TIL Therapy to Standard - of - Care Therapy TIL Patient Population Treatment naïve metastati

  31. Slide 31: IOV-GM1-201 Phase 1/2 Study of Genetically Modified TIL

    31 © 2024, Iovance Biotherapeutics, Inc. Phase 1/2 Open - Label First - in - Human Study: IOV - GM1 - 201 Endpoints • Phase 1: Safety • Phase 2: Objective Response Rate (ORR) per RECIST v1.1 as assessed by the investigator • Secondary endpoints include complete response (CR) rate, duration of respon

  32. Slide 32: Trailblazing Next-Generation TIL Programs

    32 © 2024, Iovance Biotherapeutics, Inc. Genetically modify TIL Optimize TIL composition Next - generation processes Expand TIL into new regimens Cellectis gene - editing TALEN ® collaboration 1,2 PD - 1 and other immune checkpoint targets (single and multiple knockouts) Cytokine - tethered TILs PD

  33. Slide 33: Corporate Summary & Milestones

    33 © 2024, Iovance Biotherapeutics, Inc. 33 Corporate Summary & Milestones

  34. Slide 34: Well-Capitalized in Pursuit of TIL Commercialization

    34 © 2024, Iovance Biotherapeutics, Inc. February 22, 2024 (in millions) Cash, cash equivalents, investments, restricted cash $485.2 1 Common shares outstanding 279.3 Preferred shares outstanding 2.9 2 Stock options and restricted stock units outstanding 22.0 1. Unaudited cash position which include

  35. Slide 35: Anticipated 2024 Milestones

    35 © 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 - US dossiers (2H24) □ Meet with FDA to discuss NSCLC registrational path/frontline study PIPELINE □

  36. Slide 36: Corporate Highlights

    36 © 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

  37. Slide 37: Thank You

    37 © 2024, Iovance Biotherapeutics, Inc. © 2024, Iovance Biotherapeutics, Inc. Thank You

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