Iovance Biotherapeutics, Inc. · NASDAQ:IOVA

Iovance Biotherapeutics — Investor Presentation (June 2024)

40 slides from Iovance Biotherapeutics's investor presentation, Jun 3, 2024

  1. Slide 1: Corporate Overview May 31, 2024

    1 © 2024, Iovance Biotherapeutics, Inc. © 2024, Iovance Biotherapeutics, Inc. Corporate Overview May 31, 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,” “U.S.,” or “our”) within the meaning of the Private Securities Lit

  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 Partners & Collaborators 3 © 2024, Iovance Biotherapeutics, Inc. Commercial Products Abbreviations: BTD=Breakthrough Therapy Designation; FDA=U.S. Food and Drug Adm

  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; BTD=Breakthrough Therapy Designation; FTD=Fast Track Designatio n; ICI=immune checkpoint inhibitor; IL - 2=interleukin 2; IL - 12=interl

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

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

  7. Slide 7: First FDA Approved Treatment after Progression on Anti-PD-1 Therapy & BRAF/MEK Inhibitors

    7 © 2024, Iovance Biotherapeutics, Inc. 1. Amtagvi USPI First FDA Approved Treatment after Progression on Anti - PD - 1 Therapy & BRAF/MEK Inhibitors 1

  8. Slide 8: U.S. Metastatic Melanoma Patient Population

    8 © 2024, Iovance Biotherapeutics, Inc. U.S. Metastatic Melanoma Patient Population More than half of patients progress within 12 months on current 1L ICIs , regardless of BRAF mutation status 3 Amtagvi ¯ is preferred second - line or subsequent therapy in National Comprehensive Cancer Network® (NCC

  9. Slide 9: Amtagvi Delivered Deep and Durable Responses

    9 © 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, Amtagv

  10. Slide 10: Amtagvi Durability at 4 Years

    10 © 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

  11. Slide 11: Amtagvi Patient Journey

    11 © 2024, Iovance Biotherapeutics, Inc. Amtagvi ¯ Patient Journey Amtagvi Autologous T Cell Therapy Lymphodepletion Scheduling & Tumor Tissue Procurement Treatment Regimen Enrollment & Reimbursement Approval Manufacturing & Release Testing Reimbursement approval timelines between ATCs and payers fo

  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 • Supplies commercial and clinical TIL therapy • Annual capacity for up to several thousand patients as built • Expansion underway for additional capacity within

  13. Slide 13: iCTC Capacity Expansion Plans

    13 © 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 13 © 2024, Iovance Biotherapeutics, Inc. Today (as built) up to 2,000 + patients/year 1 12 core suites for commer

  14. Slide 14: Targeting Potential Authorized Treatment Centers (ATCs)

    14 © 2024, Iovance Biotherapeutics, Inc. 14 Targeting Potential 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 May 30, 2024) . Abbreviations: ATC=Author

  15. Slide 15: Broad Market Access and Strong Reimbursement

    15 © 2024, Iovance Biotherapeutics, Inc. 55% Commercial Medicare IPPS Exempt 4% 17% Medicare Advantage 8% Medicare FFS 7% Medicaid 9% Other Broad Market Access Metastatic Melanoma Payer Mix 1 Amtagvi - Eligible Patients Treated in the ATC Setting 1. Metastatic Melanoma Insurance Claims Analysis, TIL

  16. Slide 16: Amtagvi Expansion Plans in Advanced Melanoma

    16 © 2024, Iovance Biotherapeutics, Inc. 16 Amtagvi ¯ Expansion Plans in Advanced Melanoma

  17. Slide 17: Ex-U.S.: Unmet Medical Need for Metastatic Melanoma Therapy

    17 © 2024, Iovance Biotherapeutics, Inc. 1. Germany, U.K., Canada, Italy, Spain, France, Netherlands, World Health Organization International Agency for Research on Cancer (IARC). GLOBOCAN 2022 2. Clarivate DRG Disease Landscape (2021) 3. Germany, U.K., Canada, Italy, Spain, France, Netherlands, Wor

  18. Slide 18: Advanced Frontline Melanoma: ASCO Phase 2 Data Takeaways

    18 © 2024, Iovance Biotherapeutics, Inc. Advanced Frontline Melanoma: ASCO Phase 2 Data Takeaways • ICI - naive patients with advanced melanoma treated with lifileucel plus pembrolizumab had deep and durable responses – Two thirds of patients had a confirmed response by RECIST v1.1 – Almost one thir

  19. Slide 19: Baseline Patient and Disease Characteristics

    19 © 2024, Iovance Biotherapeutics, Inc. Baseline Patient and Disease Characteristics Characteristics N=23 Median age, y (min, max) 51.0 (18 – 68) Male sex, n (%) 15 (65.2) White 23 (100) Melanoma type, n (%) Cutaneous 16 (69.6) Acral 1 (4.3) Mucosal 2 (8.7) Unknown primary 4 (17.4) Metastatic stagi

  20. Slide 20: Safety

    20 © 2024, Iovance Biotherapeutics, Inc. Safety • By Day 30, Grade 3/4 hematologic lab abnormalities resolved to Grade ≤ 2: – Neutropenia: 91.3% – Lymphopenia: 78.3% – Leukopenia: 95.5% – Thrombocytopenia: 95.5% – Anemia: 90.0% • No unexpected AEs • AEs consistent with the lifileucel regimen occurre

  21. Slide 21: All response-evaluable patients demonstrated regression of target lesions

    21 © 2024, Iovance Biotherapeutics, Inc. All response - evaluable patients demonstrated regression of target lesions ORR was 65.2%; CR rate was 30.4% Efficacy Investigator - Assessed Response (RECIST v1.1) N=23 ORR, n (%) (95% CI) 15 (65.2) ( 42.7, 83.6 ) CR 7 (30.4) PR 8 (34.8) SD 6 (26.1) PD 1 (4.

  22. Slide 22: Lifileucel + pembrolizumab demonstrated durable and deepening responses

    22 © 2024, Iovance Biotherapeutics, Inc. Lifileucel + pembrolizumab demonstrated durable and deepening responses Efficacy Percent Change From Baseline in Target Lesion SOD *Target lesion lymph node at baseline is no longer pathological and considered uCR. † The overlapping lines at – 100% represent

  23. Slide 23: Time to Response and Duration of Response

    23 © 2024, Iovance Biotherapeutics, Inc. • Median follow - up was 21.7 months • mDOR was NR • Median time to initial response was 2.6 months • 10 of 15 responders (66.7%) continue on study with ongoing response and 3 additional patients (20%) discontinued follow - up while in response Efficacy Time

  24. Slide 24: TILVANCE-301 Global Phase 3 and Confirmatory Trial

    24 © 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

  25. Slide 25: TIL Therapy Pipeline

    25 © 2024, Iovance Biotherapeutics, Inc. 25 TIL Therapy Pipeline

  26. Slide 26: Significant Market Potential in Solid Tumors and our Key Programs

    26 © 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 G

  27. Slide 27: Potential Market for Advanced Non-Small Cell Lung Cancer (NSCLC)

    27 © 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

  28. Slide 28: IOV-LUN-202 Registrational Trial Design

    28 © 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

  29. Slide 29: Objective Response Rate of 26.1% by RECIST 1.1, Regardless of PD-L1 Status

    29 © 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

  30. Slide 30: All Patients Progressed on or After Anti-PD-1 Therapy and Chemotherapy

    30 © 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

  31. Slide 31: All Responses Remain Ongoing at Time of Data Cut

    31 © 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 Lifileucel infusion up to date of new anti - cancer therapy, end of asse ssment, death, or data cutoff date, whichever occurs ea

  32. Slide 32: Phase 1/2 First-in-Human Study: IOV-GM1-201

    32 © 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

  33. Slide 33: Changing Treatment Landscape for Endometrial Cancer

    33 © 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,

  34. Slide 34: Lifileucel in Advanced Endometrial Cancer Proof of Concept Study

    34 © 2024, Iovance Biotherapeutics, Inc. 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, planned in the protocol. pMMR Subgroup dMMR Subgroup Endom

  35. Slide 35: Trailblazing Next-Generation TIL Programs

    35 © 2024, Iovance Biotherapeutics, Inc. 35 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) IL - 12 and other cytokin

  36. Slide 36: Corporate Summary & Milestones

    36 © 2024, Iovance Biotherapeutics, Inc. 36 Corporate Summary & Milestones

  37. Slide 37: Well-Capitalized in Pursuit of TIL Commercialization

    37 © 2024, Iovance Biotherapeutics, Inc. 37 March 31, 2024 (in millions) Cash, cash equivalents, investments, restricted cash $362.6 Common shares outstanding 279.8 Preferred shares outstanding 2.9 1 Stock options and restricted stock units outstanding 30.8 1. Preferred shares are shown on an as - c

  38. Slide 38: Anticipated 2024 Milestones

    38 © 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

  39. Slide 39: Corporate Highlights

    39 © 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

  40. Slide 40: Thank You

    40 © 2024, Iovance Biotherapeutics, Inc. © 2024, Iovance Biotherapeutics, Inc. Thank You

Iovance Biotherapeutics — Investor Presentation (June 2024) on 6ix