Iovance Biotherapeutics, Inc. · NASDAQ:IOVA

Iovance Biotherapeutics — Investor Presentation (August 2022)

37 slides from Iovance Biotherapeutics's investor presentation, Aug 29, 2022

  1. Slide 1: Corporate Overview August 25, 2022

    1 © 2022, Iovance Biotherapeutics, Inc. © 2022, Iovance Biotherapeutics, Inc. Corporate Overview August 25, 2022 1

  2. Slide 2: Forward-Looking Statements

    2 © 2022, 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 © 2022, Iovance Biotherapeutics, Inc. Global Leadership in Innovating, Developing and Delivering TIL Therapy for Patients with Cancer Active Clinical Trials Platform Pipeline People & Assets Partners & Collaborators Abbreviations: BTD: Breakthrough Therapy Designation; RMAT: Regenerative Medicine

  4. Slide 4: Product candidates by indication and phase

    4 © 2022, Iovance Biotherapeutics, Inc. PRODUCT CANDIDATE INDICATION(S) IND - ENABLING PHASE 1 PHASE 2 PIVOTAL TIL Lifileucel/LN - 144 Melanoma (post - anti - PD - 1) Lifileucel Cervical cancer ( post - chemo & post - anti - PD - 1 ) LN - 145 NSCLC (2L post - chemo & post - anti - PD - 1) LN - 145 N

  5. Slide 5: Significant Market Potential in Solid Tumors

    5 © 2022, Iovance Biotherapeutics, Inc. Potential market for early lines in combo with standard of care Potential to address unmet need in late lines of treatment 1. https://seer.cancer.gov accessed May 2022 Deaths 1 New Cases 1 Melanoma 7,650 99,780 Cervical 4,280 14,100 Lung & Bronchus 130,180 236

  6. Slide 6: Tumor Infiltrating Lymphocytes (TIL): Leading Platform for Treatment of Solid Tumors

    6 © 2022, Iovance Biotherapeutics, Inc. Tumor Infiltrating Lymphocytes (TIL): Leading Platform for Treatment of Solid Tumors TIL – Unique Mechanism of Action • Highly personalized • One - time therapy • Patient’s own immune system amplified and rejuvenated Remove Tumor Sample Expand & Rejuvenate Pat

  7. Slide 7: TIL Mechanism of Action

    7 © 2022, Iovance Biotherapeutics, Inc. Tumor TIL Mechanism of Action Infusion of tumor infiltrating lymphocytes (TIL) Peripheral blood Blood vessel Tumor cell TIL TIL Tumor bed TIL Lysing tumor cell T - cell receptor Tumor neoantigen peptides MHC - I/II Chemokine receptor Circulation Migration Pept

  8. Slide 8: Iovance Streamlined 22-Day GMP Manufacturing Process

    8 © 2022, Iovance Biotherapeutics, Inc. Iovance Streamlined 22 - Day GMP Manufacturing Process 1 2 Patient Intake Tumor Sample Procurement 3 4 NMA - LD TIL 5 6 IL - 2 Recovery/Discharge 4 2 Gen 2 Process: 22 Days 8 © 2022, Iovance Biotherapeutics, Inc.

  9. Slide 9: Leading Cell Therapy Manufacturing Facility: iCTC

    9 © 2022, Iovance Biotherapeutics, Inc. Iovance Cell Therapy Center: iCTC Built - to - suit custom facility in Navy Yard Philadelphia 136,000 ft 2 , $85M investment LEED gold certification for core and shell building Honorable Mention Winner: 2022 ISPE Facility of the Year Awards Clinical supply ini

  10. Slide 10: Broad, Iovance-Owned IP Around TIL Therapy

    10 © 2022, Iovance Biotherapeutics, Inc. Broad, Iovance - Owned IP Around TIL Therapy TIL products and compositions: Gen 2, Gen 3, use of co - stimulants, selection of TIL, stable and transient genetic modifications, cryopreservation 1 Tumor Sample Procurement 3 4 NMA - LD TIL Infusion 5 IL - 2 Infu

  11. Slide 11: Clinical Data Highlights

    11 © 2022, Iovance Biotherapeutics, Inc. 11 Clinical Data Highlights

  12. Slide 12: Potential Market for Metastatic Melanoma

    12 © 2022, Iovance Biotherapeutics, Inc. 1. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, CA Cancer J Clin., May 2021 2. https://seer.cancer.gov accessed May 2022 3. Keytruda USPI accessed Mar 2022 4. Keytruda USPI accessed Ma

  13. Slide 13: C-144-01 Phase 2 Study Design

    13 © 2022, Iovance Biotherapeutics, Inc. Endpoints • Primary: Efficacy defined as ORR assessed by IRC Study Updates • Mar 2019: Cohort 4 (pivotal trial) first patient enrolled • Jan 2020: last patient dosed (Cohort 4) • May 2021: Cohort 2 publication in Journal of Clinical Oncology 1 • June 2021: Co

  14. Slide 14: Lifileucel C-144-01 Cohort 2 Clinical Data Highlights in Melanoma

    14 © 2022, Iovance Biotherapeutics, Inc. Lifileucel C - 144 - 01 Cohort 2 Clinical Data Highlights in Melanoma 1. As assessed by investigator using RECIST 1.1 (data extraction: April 22, 2021). Larkin, et. al. ASCO 2021. Abstract #9505. Abbreviations: CR, complete response; DOR, duration of response

  15. Slide 15: C-144-01 Cohort 2 and 4 Topline Data Release

    15 © 2022, Iovance Biotherapeutics, Inc. C - 144 - 01 COHORT 2 AND COHORT 4 TOPLINE DATA RELEASE ASSESSED BY IRC USING RECIST 1.1 Cohort 2+4 (N=153) Cohort 4 (N=87 1 ) C - 144 - 01 Primary Analysis Supports Expected Approval 29 % ORR (IRC) • Cohort 2 patients had about half the cumulative duration o

  16. Slide 16: C-144-01 Cohort 4 Topline Data Release

    16 © 2022, Iovance Biotherapeutics, Inc. C - 144 - 01 COHORT 4 TOPLINE DATA RELEASE ASSESSED BY IRC USING REC IST 1.1 44% of Responders DOR ≥ 12 mo. Prior anti - CTLA - 4 in combination with anti - PD - 1 26.3 Months Longest Ongoing Response C - 144 - 01 Cohort 4 Data Highlights: DOR at Data Cutoff

  17. Slide 17: Iovance TIL Clinical Highlights in Combination with Pembrolizumab in Metastatic Melanoma

    17 © 2022, 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 • 8 / 12 patients had a confirmed objective resp

  18. Slide 18: Potential Market for Non-Small Cell Lung Cancer (NSCLC)

    18 © 2022, Iovance Biotherapeutics, Inc. 1. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, CA Ca nce r J Clin., May 2021 2. https://seer.cancer.gov accessed May 2022 3. Brahmer et al., NEJM 2015; Borghaei et al., NEJM 2015; Her

  19. Slide 19: Iovance TIL Clinical Data Highlights in NSCLC

    19 © 2022, Iovance Biotherapeutics, Inc. Single - Agent LN - 145 Following Progression on Anti - PD - 1 T herapy (IOV - COM - 202 Cohort 3B, N=28) 1 Iovance TIL Clinical Data Highlights in NSCLC Best Overall Response for Evaluable Patients (n=24) 60 ― 40 ― 20 ― 0 ― - 20 ― - 40 ― - 60 ― - 80 ― - 100

  20. Slide 20: Iovance TIL Therapy LN-145 in NSCLC: IOV-LUN-202

    20 © 2022, Iovance Biotherapeutics, Inc. Phase 2, Multicenter Study of LN - 145 in Patients with Metastatic Non - Small - Cell Lung Cancer, IOV - LUN - 202 (NCT04614103) IOV - LUN - 202 Endpoints • Primary: Efficacy defined as ORR by IRC • Secondary: Safety and efficacy Study Updates • 2Q21: first p

  21. Slide 21: IOV-4001 First-in-Human Study: IOV-GM1-201

    21 © 2022, Iovance Biotherapeutics, Inc. IOV - 4001 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 response (DOR), di

  22. Slide 22: Launch Preparation

    22 © 2022, Iovance Biotherapeutics, Inc. 22 Launch Preparation

  23. Slide 23: Preparing to Launch First-to-Market TIL in Advanced Melanoma

    23 © 2022, Iovance Biotherapeutics, Inc. 1. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, CA Ca nce r J Clin., May 2021 2. https://seer.cancer.gov accessed May 2022 3. Clarivate DRG Disease Landscape (2021) Abbreviations: EU5=

  24. Slide 24: Best-in-Class Manufacturing

    24 © 2022, Iovance Biotherapeutics, Inc. Best - in - Class Manufacturing Continuous improvement of cost, quality & efficiency Reduce material costs Consistent success rates Redundant & reliable suppliers Increase throughput Reduce overhead costs

  25. Slide 25: iCTC Designed for High-Volume TIL Manufacturing and Flexibility

    25 © 2022, Iovance Biotherapeutics, Inc. • Core suites: TIL commercial manufacturing • Flexible suites: clinical supply, pipeline expansion and advanced manufacturing, including IOV - 4001 and Gen 3 • Integrated quality control, supply chain and IT systems • 100+ employees with additional staffing i

  26. Slide 26: Building Capacity to Treat Thousands of Cancer Patients Annually

    26 © 2022, Iovance Biotherapeutics, Inc. Building Capacity to Treat Thousands of Cancer Patients Annually Phase 1 i CTC ( Today ): 100s of patients/year BLA Prep in c ore suites for commercial Phase 2 i CTC: 2,000+ patients/year core suites for commercial separate flex suites for clinical Phase 3 i

  27. Slide 27: Targeting Potential Authorized Treatment Centers (ATCs)

    27 © 2022, Iovance Biotherapeutics, Inc. Targeting Potential Authorized Treatment Centers (ATCs) Potential ATC Iovance Clinical Trial Site 1 1. ClinicalTrials.gov Targeting Considerations • Patient volume • NCCN status, KOLs • Existing cell therapy / BMT • Iovance clinical trial(s) Drive Demand • To

  28. Slide 28: Supporting Providers & Patients: IovanceCares

    28 © 2022, 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

  29. Slide 29: Enabling Market Access

    29 © 2022, Iovance Biotherapeutics, Inc. 55% Commercial 29% Medicare Metastatic Melanoma Payer Mix All Treatment Settings and Lines of Therapy Enabling Market Access 1. Metastatic Melanoma Insurance Claims Analysis, TIL - eligible patients treated in the ATC setting (1/1/2018 – 6/30/2021) Abbreviati

  30. Slide 30: Research Pipeline

    30 © 2022, Iovance Biotherapeutics, Inc. 30 Research Pipeline

  31. Slide 31: What's Next: Genetically Modified TIL

    31 © 2022, Iovance Biotherapeutics, Inc. Genetically mod TIL Develop more potent TIL Optimize process Expand TIL into new regimens Cellectis gene - editing TALEN ® collaboration 1,2 PD - 1 and other immune checkpoint targets PD - 1+ selected TIL CD39/69 double negative TILs 3 Gen 3 (16 - day) proces

  32. Slide 32: Advancing Genetically-Modified TIL Toward the Clinic

    32 © 2022, Iovance Biotherapeutics, Inc. Advancing Genetically - Modified TIL Toward the Clinic Additional immune checkpoint targets, including double inactivation Additional transient and stable gene insertion and inactivation Cytokine tethered TILs PD - 1 Inactivated TIL (IOV - 4001) Clinical Stud

  33. Slide 33: Financial Summary & Milestones

    33 © 2022, Iovance Biotherapeutics, Inc. 33 Financial Summary & Milestones

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

    34 © 2022, Iovance Biotherapeutics, Inc. June 30, 2022 In millions (unaudited) Common shares outstanding 157.8 Preferred shares outstanding 2.9 1 Stock options and restricted stock units outstanding 17.2 Cash, cash equivalents, investments, restricted cash $430.9 2 Anticipated cash runway sufficient

  35. Slide 35: 2021 Accomplishments and Anticipated 2022 Milestones

    35 © 2022, Iovance Biotherapeutics, Inc. 2021 Accomplishments Anticipated 2022 Milestones REGULATORY • BLA: FDA feedback received for potency assays; additional assay data submission & interactions 2H21 • BLA: Commence rolling BLA submission in August 2022 • BLA: Complete rolling BLA submission in Q

  36. Slide 36: Investment Highlights

    36 © 2022, Iovance Biotherapeutics, Inc. Investment Highlights Pioneering a Transformational Approach to Cure Cancer Large market opportunity & strong unmet need Potential to be first one - time cell therapy approved for solid tumors Efficient & scalable proprietary manufacturing Infrastructure for

  37. Slide 37: Thank You

    37 © 2022, Iovance Biotherapeutics, Inc. © 2022, Iovance Biotherapeutics, Inc. Thank You

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