Iovance Biotherapeutics, Inc. · NASDAQ:IOVA

Iovance Biotherapeutics — Investor Presentation (January 2021)

51 slides from Iovance Biotherapeutics's investor presentation, Jan 7, 2021

  1. Slide 1: Tumor Infiltrating Lymphocyte Cell Therapy for Treatment of Solid Tumors

    Tumor Infiltrating Lymphocyte Cell Therapy for Treatment of Solid Tumors January 2021 © 2021, Iovance Biotherapeutics, Inc 1

  2. Slide 2: Forward Looking Statements

    Forward Looking Statements 2 Certain matters discussed in this presentation are “forward - looking statements” of Iovance Biotherapeutics, Inc, Inc . (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLR

  3. Slide 3: Iovance: Developing to commercialize TIL Cell Therapy

    Iovance: Developing to commercialize TIL Cell Therapy 3 NASDAQ: IOVA © 2021, Iovance Biotherapeutics, Inc Research Partners Assets • ~$720M cash (9/30/20) • Global rights to all programs, IP and technology • Iovance manufacturing facility ( i CTC ) • Pivotal programs in metastatic melanoma and advan

  4. Slide 4: Investment Highlights

    Leading cell therapy company focused on treatment of solid tumors Investment Highlights • Initial focus in post - checkpoint solid tumors • Expansion into combinations and earlier lines of therapy • Five company - sponsored programs in melanoma, cervical, head & neck, non - small cell lung cancer (N

  5. Slide 5: 2020 Accomplishments; Anticipated 2021 Milestones

    2020 Accomplishments; Anticipated 2021 Milestones 5 Corporate Goals and Updates Clinical Melanoma : early pivotal Cohort 4 data and updated Cohort 2 data Cervical : last patient dosed in cervical pivotal cohort NSCLC : Moffitt TIL data; registration directed study initiated HNSCC : initial data for

  6. Slide 6: Key Highlights for Melanoma Cohort Data

    Key Highlights for Melanoma Cohort 2 Data © 2021, Iovance Biotherapeutics, Inc 6 2019: Melanoma Data update at SITC (1) 36.4% ORR 34.8% ORR as read by independent review committee (IRC) (N=66) by investigator and Melanoma Cohort 2 showed Median DOR still not reached at 28.1 months of median study fo

  7. Slide 7: Tumor Infiltrating Lymphocytes (TIL): Leading Platform for Treatment of Solid Tumors

    Tumor Infiltrating Lymphocytes (TIL): Leading Platform for Treatment of Solid Tumors 7 Remove Tumor Sample Expand & Rejuvenate Patient - specific T Cells Lymphodepletion & Infusion 1 Simpson - Abelson, et. al, Iovance Generation - 2 Tumor - infiltrating Lymphocyte (TIL) Product Is Reinvigorated Duri

  8. Slide 8: TIL Mechanism of Action

    TIL Mechanism of Action Circulation Migration Peptide Antigen Recognition Lysis (Tumor Killing ) 8 Infusion of tumor - infiltrating lymphocytes (TIL) Tumor Peripheral blood Blood vessel Tumor cell TIL TIL Tumor bed TIL Lysing tumor cell T - cell receptor Tumor antigen peptide MHC - I Chemokine recep

  9. Slide 9: Competitive Advantages of TIL in Solid Tumors

    Competitive Advantages of TIL in Solid Tumors Checkpoints TCR CAR - T (Liquid tumors) TIL (Solid tumors) Target multiple tumor antigens Target only single tumor antigen Mainly target only single/ surface tumor antigen Target multiple tumor antigens Long maintenance period One - time treatment One -

  10. Slide 10: Manufacturing Process

    Manufacturing Process © 2021, Iovance Biotherapeutics, Inc 10

  11. Slide 11: Iovance Streamlined GMP Manufacturing Process

    11 Iovance Streamlined 22 - Day GMP Manufacturing Process Gen 2 Process: 22 Days 1 2 Patient Intake Tumor Sample Procurement 3 4 NMA - LD TIL Infusion 5 6 IL - 2 Infusions Recovery/Discharge 4 2 TIL were generated from skin, lymph nodes, liver, lung, peritoneal, musculo - skeletal, breast, and other

  12. Slide 12: Iovance Cell Therapy Center: iCTC

    Iovance Cell Therapy Center: i CTC 12 © 2021, Iovance Biotherapeutics, Inc • Build - to - suit custom facility located in the Navy Yard, Philadelphia, PA • ~136,000 sq. feet, $85 mil investment • First set of clean rooms completed • Commercial GMP production is expected to commence in 2022 • Signifi

  13. Slide 13: First Set of Cleanrooms (Flex Suite) Complete

    First Set of Cleanrooms (Flex Suite) Complete 13 © 2021, Iovance Biotherapeutics, Inc

  14. Slide 14: Clinical, Manufacturing, and Regulatory Registration & Commercialization

    Clinical, Manufacturing, and Regulatory Registration & Commercialization (1) Rosenberg, S. A., et al. Clinical Cancer Research , 2011, 17, 4550 (2) Goff, S. L. et al. Journal of Clinical Oncology , 2016, 34(20), 2389 - 2397 Melanoma: First patient dosed for Gen 1 l ifileucel Gen 2 manufacturing deve

  15. Slide 15: Broad, Iovance-Owned IP Around TIL Therapy

    Broad, Iovance - Owned IP Around TIL Therapy 15 © 2021, Iovance Biotherapeutics, Inc TIL products and compositions: Gen 2, Gen 3, use of co - stimulants, selection of TIL, stable and transient genetic modifications 2 Tumor Sample Procurement 3 4 NMA - LD TIL Infusion 5 IL - 2 Infusions 4 2 TIL from:

  16. Slide 16: Significant Market Potential in Solid Tumors

    (1) https://seer.cancer.gov (December, 2020) Solid Tumor Indication Deaths (1) New Cases (1) Melanoma 6,850 100,350 Cervix Uteri 4,290 13,800 Lung & Bronchus 135,720 228,820 Oral Cavity, Pharynx & Larynx 14,500 65,630 Breast 42,170 276,480 Pancreatic 47,050 57,600 Brain & Other Nervous System 18,020

  17. Slide 17: Current Clinical Pipeline and Select Collaboration Studies

    Select investigator sponsored proof - of - concept studies MDA TIL NCT03610490 Ovarian, colorectal, pancreatic ~54 LN - 145 NCT03449108 Ovarian, sarcomas ~54 Moffitt TIL + nivolumab NCT03215810 Non - small cell lung 20 Regimen Trial Indication N Partner Phase 1 Phase 2 Pivotal Company sponsored stud

  18. Slide 18: Metastatic Melanoma

    Metastatic Melanoma © 2021, Iovance Biotherapeutics, Inc 18

  19. Slide 19: Potential Market for Metastatic Melanoma

    (1) i https://seer.cancer.gov 2019 (2) CheckMate - 37 Trial Results (ICC 10%), Keytruda label (4%). (3) JAMA Oncol . 2019; 5(12):1749 - 1768. doi:10.1001/jamaoncol.2019.2996. (4) Eur J Cancer . 2016; 65:182 - 184. J Clin Oncol . 2018; 36 (suppl: abstr e21588). • Estimated 7,230 (1) U.S. patient deat

  20. Slide 20: C-144-01: Phase 2 Study Design

    Endpoints • Primary: Efficacy defined as IRC ORR Study Updates • Mar 2019: Cohort 4 (pivotal trial) FPI • Jan 2020: last patient dosed • Dec 2020: Cohort 2 median DOR not reached at 28.1 months of median study follow up C - 144 - 01: Phase 2 Study Design © 2021, Iovance Biotherapeutics, Inc 20 Cohor

  21. Slide 21: C-144-01: Cohort 2 Patient Characteristics

    C - 144 - 01: Cohort 2 Patient Characteristics at ASCO 2020 COHORT 2 BY INVESTIGATOR (ASCO 2020) © 2021, Iovance Biotherapeutics, Inc (1) The denominator is the 53 patients who received prior anti - CTLA - 4. CHARACTERISTIC Cohort 2, N=66, (%) Gender, n (%) Female 27 (41) Male 39 (59) Age, years Med

  22. Slide 22: Adverse Events Tend to be Expected, Early and Transient

    Adverse Events Tend to be Expected, Early and Transient *The number of AEs is cumulative and represent the total number of patients dosed. Treatment - Emergent Adverse Events refer to all AEs starting on or after the first dose date of TIL up to 30 days. Patients with multiple events for a given pre

  23. Slide 23: Potentially Efficacious Treatment for Patients with Limited Options

    In heavily pretreated metastatic melanoma patients (3.3 mean prior therapies) • ORR 36% • DCR 80% • Mean TIL cells infused: 27.3 x 10 9 • Median DOR has not been reached at 28.1 months of study follow up (14 Dec 2020 data extract) Potentially Efficacious Treatment for Patients with Limited Options ©

  24. Slide 24: C-144-01 Cohort 2 Efficacy: Time to Response

    ' H D W K 7 L P H P R Q W K V V LQ F H 7 ,/ L Q I X V L R Q 3 D W L H Q W V 2 Q J R L Q J R Q V W X G \ 3 ' 3 5 V W D U W & 5 V W D U W 3 U L R U D Q W L 3 ' % 2 5 R Q 3 U L R U D Q W L 3 ' < H V 3 ' < H V 3 ' < H V 3 ' < H V 3 ' < H V 3 ' < H V 3 ' < H V 3 ' < H V 3 ' < H V 3 5 < H V 3 ' < H V 3 '

  25. Slide 25: C-144-01 Cohort 2 Efficacy: Best Overall Response

    C - 144 - 01 Cohort 2 Efficacy: Best Overall Response © 2021, Iovance Biotherapeutics, Inc 25 81% (50/62) of patients had a reduction in tumor burden & KD Q J H I U R P % D V H O L Q H 3 D W L H Q W 1 R 1 1 3 5 & 5 6 ' 3 ' %H V W 2 Y H U D O O 5 H V S R Q V H • Mean Time to response 1.9 months (rang

  26. Slide 26: C-144-01 Cohort 2 ORR By Subgroup

    C - 144 - 01 Cohort 2 ORR By Subgroup © 2021, Iovance Biotherapeutics, Inc 26 Responses were demonstrated: • Across a wide age range • Even in patients who have progressed on prior anti - CTLA - 4 or prior BRAF • Regardless of the BRAF mutational status • Equally in patients with PD - L1 low or high

  27. Slide 27: C-144-01 Cohort 2 ORR By Subgroup

    C - 144 - 01 Cohort 2 ORR By Subgroup © 2021, Iovance Biotherapeutics, Inc 27 Responses were demonstrated: • In patients with elevated LDH (1 - 2x) • In patients with bulky disease at baseline • Patients with lesions in liver and/or brain • Patients post anti - PD - 1 regardless of duration of time

  28. Slide 28: C-144-01 Cohort 2: Conclusions

    • In heavily pretreated metastatic melanoma patients with high baseline disease burden who progressed on multiple prior therapies, including anti - PD - 1 and BRAF/MEK inhibitors, if BRAFV600 mutant, lifileucel treatment results in: • 36.4% ORR • 80.3% DCR • Median DOR was still not reached at 28.1

  29. Slide 29: Melanoma Post-PD-1 Agents Comparison

    Agent ORR % ( N) Current Development Status Prior Lines of Tx Patient Characteristics Combination with Anti - PD - 1 Checkpoints LAG - 3 + nivo (BMS) 12% (N=61) (1) Multiple 1L studies 1+ All comers, ECOG ≤2 • LAG - 3 expression ≥1% (N=33) ORR=18%; • LAG - 3 expression <1% (N=22) ORR=5% TLR9 agonist

  30. Slide 30: Cervical Cancer

    Cervical Cancer © 2021, Iovance Biotherapeutics, Inc 30

  31. Slide 31: Potential Market for Cervical Cancer

    For PD - L1 + patients, post - chemo receiving Keytruda (3) ORR 14.3% Third line patients: ORR 3.4% ( 6) Available Care for chemotherapy in 2L or 3L metastatic cervical patients 3.4 - 13% (4 - 6) New Cases WW each year (1) 601k 14k Diagnoses in U.S. each year (2) 260k 4k Deaths WW each year (1) Deat

  32. Slide 32: Pivotal Phase Study of TIL Therapy Lifileucel in Cervical Carcinoma

    Pivotal Phase 2 Study of TIL Therapy Lifileucel (Formerly LN - 145) in Recurrent, Metastatic or Persistent Cervical Carcinoma © 2021, Iovance Biotherapeutics, Inc 32 Endpoints • Primary: ORR as determined by IRC • Secondary: safety and efficacy Study Updates • 3Q 2020: Last patient dosed in Cohort 1

  33. Slide 33: Adverse Events Tend to be Early and Transient

    Frequency of AEs over time is reflective of potential benefit of one - time treatment with TIL (lifileucel) Adverse Events Tend to be Early and Transient 33 © 2021, Iovance Biotherapeutics, Inc *The number of AEs is cumulative and represent the total number of patients dosed. Treatment - Emergent Ad

  34. Slide 34: Significant Response Observed in Heavily Pretreated Patients

    Baseline Demographics N= 27 (%) Prior therapies Mean # prior therapies 2.4 Platinum - based 27 (100) Taxane 26 (96) Anti - VEGF 22 (82) PD - 1/PD - L - 1 4 (15%) Target lesions sum of diameter (mm) Mean (SD) 61 (38) Min, Max 10, 165 Histologic Cell Type, n (%) Squamous Cell Carcinoma 12 (44) Adenoca

  35. Slide 35: Responses Observed Early On and Consistent with Melanoma

    Lifileucel time to response and current duration for evaluable patients (partial response or better) Responses Observed Early On and Consistent with Melanoma • Mean time to first response 1.9 months • Mean time to best response 2.4 months © 2021, Iovance Biotherapeutics, Inc 35 C - 145 - 04: Pivotal

  36. Slide 36: Three Complete Responses Observed with Lifileucel

    Lifileucel best overall response rate Three Complete Responses Observed with Lifileucel • 78% of patients had a reduction in tumor burden • Mean time to response 1.9 months • All assessments are by RECIST 1.1 • Responses are deep 36 © 2021, Iovance Biotherapeutics, Inc C - 145 - 04: Pivotal Phase 2

  37. Slide 37: Cervical Cancer Agents Comparison

    Agent ORR % ( N) Current Dev Status Prior Line of Tx Patient Characteristics Antibody - drug conjugate tisotumab vedotin (TV) (Genmab/ Seagen ) 24% (N=101) (1) Phase 2 1+ Recurrent or metastatic cervical cancer that progressed on standard therapy mDOR = 8.3 mons, mOS = 12.1 mons Anti - PD - 1 or com

  38. Slide 38: HNSCC & NSCLC

    HNSCC & NSCLC © 2021, Iovance Biotherapeutics, Inc 38

  39. Slide 39: IOV-COM-202: Global Phase 2 Study of TIL Therapy in Solid Tumors

    © 2021, Iovance Biotherapeutics, Inc 39 1A: Melanoma PD - 1/ PD - L1 Naïve LN - 144 + Pembrolizumab N=12 2A:Head and Neck PD - 1/ PD - L1 Naïve LN - 145 + Pembrolizumab N=19 IOV - COM - 202: Global Phase 2 Study of TIL Therapy in Solid Tumors (NCT03645928) 1B: Melanoma ≥ 1 prior systemic therapies L

  40. Slide 40: Head and Neck Squamous Cell Carcinoma (HNSCC)

    Head and Neck Squamous Cell Carcinoma (HNSCC) © 2021, Iovance Biotherapeutics, Inc 40

  41. Slide 41: Potential Market for HNSCC

    HNSCC Facts Potential Market for Head and Neck Squamous Cell Carcinoma (HNSCC) 41 Abbreviations: ORR, objective response rate; TIL, tumor infiltrating lymphocytes. (1) JAMA Oncol . 2019;5(12):1749 - 1768. doi:10.1001/jamaoncol.2019.2996. (2) https://seer.cancer.gov/statfacts/html/oralcav.html and ht

  42. Slide 42: LN-145 in Anti-PD-1 Naive HNSCC: Cohort 2A

    LN - 145 in Anti - PD - 1 Naive HNSCC: Cohort 2A © 2021, Iovance Biotherapeutics, Inc 42 TEAE consistent with other indications Efficacy (N=9) (1) ORR=44% (11% CR and 33% PR) DCR=89% (1) Jimeno, et. al., Safety and efficacy of tumor infiltrating lymphocyte (TIL; LN - 145) in combination with pembrol

  43. Slide 43: Non-Small Cell Lung Cancer (NSCLC)

    Non - Small Cell Lung Cancer (NSCLC) © 2021, Iovance Biotherapeutics, Inc 43

  44. Slide 44: Potential Market for NSCLC

    9% ORR for docetaxel in 2L NSCLC following progression on chemo (3) New Cases WW each year (1) 2.1M 229k Diagnoses in U.S. each year (2) 1.8M 136k Deaths WW each year (1) Deaths in U.S. each year (2) Available NSCLC care: Checkpoint Inhibitor + Chemo as first line option (1) JAMA Oncol. 2019; 5 (12)

  45. Slide 45: Efficacy Data Post Moffitt TIL Infusion

    Responses N=12 (%) Objective Response Rate 3 (25%) Complete Response 2 (17%) Partial Response 1 (8%) • ORR 25%; • 1 CR is noted in EGFR Δ Ex19 post afatinib , osimertinib , nivolumab • 1 additional uPR may confirm to increase the ORR to 33% • Median DOR not reached; • All 3 responders on TIL were re

  46. Slide 46: Moffitt TIL in Post-Nivolumab NSCLC

    In 12 evaluable patients with advanced NSCLC who received nivolumab and TIL: • Two CRs out to one year • (PD - L1 low=1, EGFR mutation=1) • ORR 25% Nivolumab and Tumor Infiltrating Lymphocytes (TIL) in Advanced Non - Small Cell Lung Cancer (NCT03215810) Moffitt TIL in Post - Nivolumab NSCLC © 2021,

  47. Slide 47: IOV-LUN-202: Phase 2 Study of LN-145 in NSCLC

    Phase 2, multicenter study of LN - 145 in Patients with Metastatic Non - Small - Cell Lung Cancer, IOV - LUN - 202 (NCT04614103) IOV - LUN - 202 47 Endpoints: • Primary: Efficacy defined as ORR by IRC • Secondary: Safety and efficacy Study Updates • Two sites are active 1: NSCLC Patient with < 1% TP

  48. Slide 48: Research Focus into Next Generation TIL

    Select more potent TIL • Iovance PD - 1 positive selected TIL • PD - 1 positive selected TIL also through collaboration with CHUM Expand the TIL platform into new indications/regimens • IOV - 3001 IL - 2 analog licensed from Novartis: IND enabling studies in 2021 Genetically modify to make a more tu

  49. Slide 49: Iovance Global Reach and Scale

    Iovance Global Reach and Scale © 2021, Iovance Biotherapeutics, Inc 49 Iovance Biotherapeutics has ~250 employees • >76% of employees have over 1 year of cell therapy experience • Headquartered in San Carlos, CA • 3 additional offices • Iovance commercial manufacturing facility in Philadelphia, PA S

  50. Slide 50: Well Capitalized in Pursuit of TIL Commercialization

    September 30, 2020 In millions (unaudited) Common shares outstanding 146.6 (1) Preferred shares outstanding 3.6 (2) Options 12.8 Cash, cash equivalents, short - term investments, restricted cash $719.7 (3) Anticipated year - end cash balance >$630 (3) Debt $0 (1) Includes June 2020 offering of 19,47

  51. Slide 51: Thank You

    Thank You © 2021, Iovance Biotherapeutics, Inc 51

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