Iovance Biotherapeutics, Inc. · NASDAQ:IOVA

Iovance Biotherapeutics — Investor Presentation (October 2020)

46 slides from Iovance Biotherapeutics's investor presentation, Oct 5, 2020

  1. Slide 1: Investigating the Power of Tumor Infiltrating Lymphocytes for Treatment of Cancer

    Investigating the Power of Tumor Infiltrating Lymphocytes for Treatment of Cancer October 2020

  2. Slide 2: 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 Litigation Reform Act of 1995 (the “PSLRA”). All such written or oral stat

  3. Slide 3: 2020 Recent Updates

    2020 Recent Updates © 2020, Iovance Biotherapeutics 3 2020 Updates Data flow: Updated Cohort 2 at ASCO Early pivotal Cohort 4 data in melanoma by investigator Data showing effect of Moffitt TIL in NSCLC presented at AACR 2020 FDA Type B Meeting held, Agreement on clinical follow up for Cohort 4 reac

  4. Slide 4: TIL: Leading Platform for Treatment of Solid Tumors

    • Highly personalized therapy • Our own immune system amplified and rejuvenated Tumor - Infiltrating Lymphocytes (TIL) – Unique Mechanism in Immuno - oncology © 2020, Iovance Biotherapeutics 4 Excise Tumor Culture & Expand with IL - 2 Reinfuse Post - Lymphodepletion TIL: Leading Platform for Treatme

  5. Slide 5: Proprietary Centralized, Scalable GMP Manufacturing

    © 2020, Iovance Biotherapeutics 5 Iovance Proprietary Centralized, Scalable, and Efficient GMP Manufacturing Gen 2 Process Time: 22 Days 1 2 Patient Intake Surgical Resection 3 4 NMA - LD TIL Infusion 5 6 IL - 2 Infusions Recovery/Discharge 4 2 TIL were generated from skin, lymph nodes, liver, lung,

  6. Slide 6: TIL Mechanism of Action

    TIL Mechanism of Action Circulation Migration Recognition Lysis © 2020, Iovance Biotherapeutics 6 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 recept

  7. Slide 7: Development milestones and history

    Manufacturing Development, Clinical Program Establishment Pre - 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 FDA Orphan Drug Designation for l ifileucel in malignant melanoma 2

  8. Slide 8: Key Highlights for Melanoma Cohort Data

    Key Highlights for Melanoma Cohort 2 Data © 2020, Iovance Biotherapeutics 8 2019: Melanoma Data update at SITC (8 Nov 2019) (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 not reached at 18.7 months of median study

  9. Slide 9: 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

  10. Slide 10: Highly Individualized, Specific & Potent Attack Against Cancer

    Leverages and enhances the body’s natural defense against cancer using a patient’s own Tumor Infiltrating Lymphocytes, or TIL • Polyclonal: Can recognize multiple neoantigens • Effective in heterogeneous solid tumors • Data in melanoma, cervical, head & neck, and lung cancers • Individualized: TIL o

  11. Slide 11: 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 -

  12. Slide 12: Broad, Iovance-Owned IP Around TIL Therapy

    Manufacturing Twelve granted U.S. patents for compositions and methods of treatment in a broad range of cancers relating to Gen 2 manufacturing process including combinations with PD - 1 antibodies Advanced Technologies Patent applications filed for a wide range of TIL technologies including: • Marr

  13. Slide 13: Iovance Cell Therapy Center (iCTC)

    Iovance Cell Therapy Center ( i CTC) © 2020, Iovance Biotherapeutics 13 • Build - to - suit custom facility located in the Navy Yard, Philadelphia, PA • ~136,000 sq. feet, $85 mil investment • Clean room build initiated April 2020 • Commercial GMP production is expected to commence in 2022 • Signifi

  14. Slide 14: Significant Market Potential in Solid Tumors

    (1) https://seer.cancer.gov Solid Tumor Indication Deaths (1) New Cases (1) Melanoma 7,230 96,480 Cervix Uteri 4,250 13,170 Lung & Bronchus 142,670 228,150 Oral Cavity, Pharynx & Larynx 10,860 53,000 Breast 41,760 268,600 Pancreatic 45,750 56,770 Brain & Other Nervous System 17,760 23,820 90% of all

  15. Slide 15: Current Clinical Pipeline and Select Collaboration Studies

    Regimen Trial Indication N Partner Phase 1 Phase 2 Pivotal Company sponsored studies Lifileucel C - 144 - 01 Melanoma 178 — Lifileucel C - 145 - 04 Cervical cancer 138 — LN - 145/ LN - 145 - S1 C - 145 - 03 Head & neck cancer 55 — Lifileucel + pembrolizumab LN - 145 - S1 LN - 145 + pembrolizumab LN

  16. Slide 16: Metastatic Melanoma

    Metastatic Melanoma © 2020, Iovance Biotherapeutics 16

  17. Slide 17: Potential Market for Metastatic Melanoma

    (1) in 2019, https://seer.cancer.gov ; (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 d

  18. Slide 18: C-144-01: Phase 2 Study Design

    Endpoints • Primary: Efficacy defined as IRC ORR Study Updates • Mar 2019: Cohort 4 (pivotal trial) FPI • Jun 2019: Full Cohort 2 data on 66 patients presented at ASCO • Nov 2019: IRC Cohort 2 data presented at SITC • Nov 2019: Investigator read of Cohort 2 sub - analysis for primary refractory to P

  19. Slide 19: Cohort Patient Characteristics at ASCO 2020

    C - 144 - 01: Cohort 2 Patient Characteristics at ASCO 2020 COHORT 2 BY INVESTIGATOR (ASCO 2020) © 2020, Iovance Biotherapeutics 19 (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 Median

  20. Slide 20: 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 pref

  21. Slide 21: Potentially Efficacious Treatment for Patients with Limited Options

    In heavily pretreated metastatic melanoma patients (3.3 mean prior therapies) • ORR 36% • DCR 80% • Median DOR has not been reached at 18.7 mons of study follow up • Mean TIL cells infused: 27.3 x 10 9 • Median number of IL - 2 doses: 5.5 Potentially Efficacious Treatment for Patients with Limited O

  22. Slide 22: ' H D W K         

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  23. Slide 23: Cohort Efficacy: Best Overall Response

    C - 144 - 01 Cohort 2 Efficacy: Best Overall Response © 2020, Iovance Biotherapeutics 23 Three subjects had no post TIL disease assessment due to early death, and one due to start of new anti - cancer therapy. 81% (50/62) of patients had a reduction in tumor burden               & KD

  24. Slide 24: Cohort ORR By Subgroup

    C - 144 - 01 Cohort 2 ORR By Subgroup © 2020, Iovance Biotherapeutics 24 CI, Confidence interval. 95% CI is calculated using the Clopper - Pearson Exact test. Responses were demonstrated: • Across a wide age range • Even in patients who have progressed on prior anti - CTLA - 4 or prior BRAF • Regard

  25. Slide 25: Cohort ORR By Subgroup

    C - 144 - 01 Cohort 2 ORR By Subgroup © 2020, Iovance Biotherapeutics 25 ULN, Upper Limit Normal; CI , Confidence interval. 95% CI is calculated using the Clopper - Pearson Exact test. Responses were demonstrated: • In patients with elevated LDH (1 - 2x) • In patients with bulky disease at baseline

  26. Slide 26: 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 18.7

  27. Slide 27: Late Stage (2L/3L) Melanoma Treatment Development Efforts

    2L/3L melanoma treatment has no current standard of care Late Stage (2L/3L) Melanoma Treatment Development Efforts (1) Ascierto P et al., ESMO 2017; (2) Diab, et al., ESMO 2020; (3) Milhem M et al., SITC 2019; (4) Fernandez et al., ESMO 2020, LBA44; (5) Ramalingam et al., AACR 2019; (6) Buchbinder E

  28. Slide 28: Cervical Cancer

    Cervical Cancer © 2020, Iovance Biotherapeutics 28

  29. Slide 29: Potential Market for Cervical Cancer

    For PD - L1 + patients, post - chemo receiving Keytruda (3) ORR 14.3% Available Care for chemotherapy in 2L metastatic cervical patients 4.5 - 13% (4)(5) New Cases WW each year (1) 601k 13k Diagnoses in U.S. each year (2) 260k 4k Deaths WW each year (1) Deaths in U.S. each year (2) Available care: C

  30. Slide 30: C-145-04: Pivotal Phase 2 Trial in Cervical Cancer

    Phase 2, multicenter study to evaluate the efficacy and safety of autologous TIL (lifileucel, formerly LN - 145) in patients with recurrent, metastatic or persistent cervical carcinoma (NCT03108495) C - 145 - 04: Pivotal Phase 2 Trial in Cervical Cancer © 2020, Iovance Biotherapeutics 30 Endpoints •

  31. Slide 31: Lifileucel in Cervical Cancer Interim Update at ASCO 2019

    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

  32. Slide 32: 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 © 2020, Iovance Biotherapeutics 32 *The number of AEs is cumulative and represent the total number of patients dosed Treatment - Emergent Adverse

  33. Slide 33: Significant Response Observed in Patients with Limited Options

    Responses N=27 (%) Objective Response Rate 12 (44%) Complete Response 3 (11%) Partial Response 9 (33%) Stable Disease 11 (41%) Progressive Disease 4 (15%) Non - Evaluable 0 Disease Control Rate 23 ( 85%) In heavily pretreated cervical cancer patients (2.4 mean prior therapies) • CR 11% • ORR 44% • D

  34. Slide 34: 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 © 2020, Iovance Biotherapeutics 34

  35. Slide 35: 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 with majority of responders are over 30% 35 © 2020, Iovance Biotherape

  36. Slide 36: Development Efforts in Recurrent, Metastatic or Persistent Cervical Carcinoma

    Recurrent, metastatic, or persistent cervical carcinoma has no current standard of care Development Efforts in Recurrent, Metastatic or Persistent Cervical Carcinoma Agent ORR % ( N) Current Dev Status Prior Line of Tx Patient Characteristics Antibody - drug conjugate tisotumab vedotin (TV) ( Genmab

  37. Slide 37: Additional Solid Tumor Studies

    Additional Solid Tumor Studies © 2020, Iovance Biotherapeutics 37

  38. Slide 38: Non-Small Cell Lung Cancer (NSCLC)

    Non - Small Cell Lung Cancer (NSCLC) © 2020, Iovance Biotherapeutics 38

  39. Slide 39: 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

  40. Slide 40: Moffitt TIL in Post-Nivolumab NSCLC

    Nivolumab and Tumor Infiltrating Lymphocytes (TIL) in Advanced Non - Small Cell Lung Cancer (NCT03215810) Moffitt TIL in Post - Nivolumab NSCLC © 2020, Iovance Biotherapeutics 40 (1) Creelan, et. al., Durable complete responses to adoptive cell transfer using tumor infiltrating lymphocytes (TIL) in

  41. Slide 41: TIL in Earlier Lines of Therapy in Combination with SOC

    A prospective, open - label, multi - cohort, non - randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN - 144 (Lifileucel)/LN - 145 in combination with pembrolizumab or TIL LN - 145/LN - 145 - S1 as a single therapy (NCT03645928) TIL in Earlier Lines of Therapy in

  42. Slide 42: Research Focus into Next Generation TIL

    Select more potent TIL • PD - 1 positive selected TIL by Iovance • PD - 1 positive selected TIL also through collaboration with CHUM Expand the TIL platform into new indications/regimens • First patient dosed in Phase 1/2 study for PBL in CLL • IOV - 3001 IL - 2 analog licensed from Novartis Genetic

  43. Slide 43: Global Reach and Scale

    Iovance Biotherapeutics Global Reach and Scale © 2020, Iovance Biotherapeutics 43 Iovance Biotherapeutics has >200 employees • Headquartered in San Carlos, CA • 3 additional offices • Iovance commercial manufacturing facility in Philadelphia, PA (under construction) San Carlos, CA New York City, NY

  44. Slide 44: Well Capitalized in Pursuit of TIL Commercialization

    June 30, 2020 In millions (unaudited) Common shares outstanding 146 (1) Preferred shares 4 (2) Options 12 Cash, cash equivalents, short - term investments, restricted cash $777.4 (3) Anticipated year - end cash balance >$630 (3) Debt $0 (1) Includes May 2020 offering of 19,475,806 shares of common s

  45. Slide 45: Milestones 2020-2021

    Last patient dosed in Cohort 4 for lifileucel in support of registration in melanoma Last patient dosed in pivotal program of lifileucel for cervical cancer Hold a pre - BLA meeting with FDA Milestones 2020 - 2021 Submit BLA for lifileucel © 2020, Iovance Biotherapeutics 45 x Data presentation at AS

  46. Slide 46: Thank You

    TOVANCE BIOTHERAPEUTICS ADVANCING IMMUNO-ONCOLOGY Thank You NX

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