Iovance Biotherapeutics, Inc. · NASDAQ:IOVA

Iovance Biotherapeutics — Investor Presentation (September 2018)

43 slides from Iovance Biotherapeutics's investor presentation, Sep 5, 2018

  1. Slide 1: Corporate Presentation September 2018

    Corporate Presentation September 2018 © 2018, Iovance Biotherapeutics, Inc.

  2. Slide 2: Forward-looking statements

    This presentation contains forward - looking statements reflecting management’s current beliefs and expectations . These forward looking statements can be identified with words such as “expects”, “plans”, “projects”, “potential”, “suggests”, “may”, or similar expressions . Such forward - looking sta

  3. Slide 3: Iovance Corporate Highlights

    • Developing and commercializing tumor infiltrating lymphocyte (TIL) therapies as a platform for treatment of cancers • Robust Clinical Development Pipeline: ̶ Iovance pipeline of 5 company - sponsored Phase 2 trials • Metastatic melanoma C - 144 - 01 ̶ Orphan Drug Designation: malignant melanoma st

  4. Slide 4: History of TIL: From NCI to Iovance

    (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. (3) https://seer.cancer.gov/statfacts/html/all.html Data from third parties may not be representative of Iovance’s data. © 2018, Iovance Biotherapeut

  5. Slide 5: TIL Therapy Overview

    TIL Therapy Overview © 2018, Iovance Biotherapeutics, Inc. 5

  6. Slide 6: TIL Therapy Elicits a Highly Individualized, Specific and Potent Attack Against Solid Tumors

    • Leverages and enhances the body’s natural defense against cancer using a patient’s own TIL • Polyclonal and can recognize multiple neoantigens ̶ Solid tumors are heterogeneous • Durable response with single treatment • Potential to establish immunological memory, requiring no additional maintenanc

  7. Slide 7: TIL Therapy Process

    1. EXCISE 2. EXTRACT 3. EXPAND 4. PREPARE & INFUSE • EXCISION: Patient’s TIL are removed from suppressive tumor microenvironment (via surgical resection of a lesion) • EXTRACTION: Tumor is fragmented and placed in media for TIL to leave the tumor and enter media • EXPANSION: TIL expanded exponential

  8. Slide 8: Competitive Advantages of TIL in Solid Tumors

    © 2018, Iovance Biotherapeutics, Inc. Competitive Advantages of TIL in Solid Tumors 8 CHECKPOINTS TCR CAR - T (LIQUID TUMORS) TIL (SOLID TUMORS) Utility in several solid tumors Few solid tumors treated so far No examples of successful utility in solid tumors Available data in melanoma, head & neck,

  9. Slide 9: Durable remissions in melanoma regardless of prior therapies

    19/20 CR were ongoing at more than 3 to 7 years Durable remissions in melanoma regardless of prior therapies NCI Study Survival Benefit in Second and Third Line Patients Rosenberg, S.A., et al. Durable Complete Responses in Heavily Pretreated Patients with Metastatic Melanoma Using T - Cell Transfer

  10. Slide 10: Iovance Clinical Pipeline

    INDICATION REGIMEN N PARTNER PRECLINICAL PHASE 1 PHASE 2 Melanoma lifileucel 85 — Cervical Cancer TIL LN - 145 47 — Head & Neck Cancer TIL LN - 145 47 — Non - Small Cell Lung Cancer TIL LN - 145 vs TIL LN - 145 + durvalumab 24 Melanoma, Head & Neck, Non - Small Cell Lung Cancer TIL LN - 144 + pembro

  11. Slide 11: Iovance Collaboration Pipeline

    Iovance Collaboration Pipeline Chandran, S. S et al., Lancet Oncol 2017; 18: 792 - 802. For the studies listed in our collaboration pipeline table, the partner listed above is the sponsor of the clinical trial. Su ch partner may not use our Gen 2 manufacturing process and/or the therapeutic dosing m

  12. Slide 12: Melanoma

    Melanoma © 2018, Iovance Biotherapeutics, Inc. 12

  13. Slide 13: Iovance Phase 2 Trial in Metastatic Melanoma (C-144-01)

    Phase 2, multicenter study to assess the efficacy and safety of autologous Tumor Infiltrating Lymphocytes LN - 144 for treatment of patients with metastatic melanoma (NCT02360579) Key Inclusion Criteria: • Measurable metastatic melanoma and ≥ 1 lesion resectable for TIL generation • Progression on a

  14. Slide 14: C-144-01 Patient Characteristics: Interim Data as of Dec. 2017

    CHARACTERISTIC Cohort 2 N= 17 , (%) Gender, n (%) Male 8 (47) Female 9 (53) Age Median 54 Min, Max 35, 66 Prior therapies, n (%) Mean # prior systemic therapies 3.6 Anti - CTLA - 4 15 (88) Anti - PD - 1 16 (94) Target Lesion Sum of Diameter (mm) Mean (SD) 140 (93) Min, Max 38, 342 CHARACTERISTIC Coh

  15. Slide 15: C-144-01 Safety: Treatment Emergent Adverse Events

    Notes: Patients with multiple events for a given preferred term are counted only once using the maximum grade under each pref err ed term. Treatment - Emergent Adverse Events refer to all AEs starting on or after the first dose date of pre - treatment chemotherapy (Fludarabine and Cyclophosphamide )

  16. Slide 16: Time to Response for Evaluable Patients

    Of 10 patients in Efficacy Set, one patient (Patient 10) is not evaluable (NE) due to melanoma - related death prior to first tumor assessment not represented on figure. © 2018, Iovance Biotherapeutics, Inc. Time to Response for Evaluable Patients (SD or Better) • DCR is: 80% • Time to response is s

  17. Slide 17: C-144-01 Efficacy

    • Mean number of TIL cells infused: 34 x 10 9 • Median number of IL - 2 doses administered was 4.5 • Patients with BRAF mutation responded as well as patients with wild type BRAF One patient (Patient 10) had passed away prior to the first assessment (still considered in the Efficacy Set). * Refers t

  18. Slide 18: C-144-01 Efficacy: Evaluable Patient Data

    • All efficacy - evaluable patients had received an anti - PD - 1 and anti - CTLA - 4 checkpoint inhibitor 1 Dec 2017 Data Cut * NE due to not reaching first assessment. Iovance C - 144 - 01 Efficacy: Evaluable Patient Data © 2018, Iovance Biotherapeutics, Inc. 18 RESPONSE PATIENTS, N=10 n (%) Objec

  19. Slide 19: CT Scan for Patient with PR

    CT Scan for Patient with PR in C - 144 - 01 Study TL1: Lt low. quad. abdom. - BL: 8.8 cm / 18 wk: 3.7 cm TL2: Lt uppr quad abdom. - BL: 5.2 cm / 18 wk: 0 cm TL3: Lt renal – BL: 4.1 cm / 18 wk: 2.1 cm TL5: Rt femoral LN - 4 cm (short axis) / 18 wk: 2.3 cm © 2018, Iovance Biotherapeutics, Inc. 19 Pre

  20. Slide 20: Head & Neck Cancer

    Head & Neck Cancer © 2018, Iovance Biotherapeutics, Inc. 20

  21. Slide 21: HNSCC Cancer Facts

    Head and Neck Squamous Cell Carcinoma (HNSCC) Abbreviations: HPV, human papillomavirus infection; OPC, oropharyngeal cancer; ORR, objective response rate; TIL, tumor infil tra ting lymphocytes. (1) Global Burden of Disease Cancer Collaboration, Global, Regional, and National Cancer Incidence, Mortal

  22. Slide 22: Phase 2 Trial in Recurrent/Metastatic SCCHN (C-145-03)

    Phase 2 study to evaluate the efficacy and safety of autologous Tumor Infiltrating Lymphocytes (LN - 145) for the treatment of patients with recurrent metastatic squamous cell carcinoma of the head and neck (NCT03083873) Key Inclusion Criteria: • Measurable metastatic disease and ≥ 1 lesion resectab

  23. Slide 23: C-145-03: Preliminary Evidence of Efficacy

    Iovance C - 145 - 03 Phase 2 Trial in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck: Preliminary Evidence of Efficacy Abbreviations: ORR, objective response rate; PR, partial response. 23 © 2018, Iovance Biotherapeutics, Inc. BASELINE DEMOGRAPHICS PATIENTS, N= 8 n (%) Prio

  24. Slide 24: Cervical Cancer

    Cervical Cancer © 2018, Iovance Biotherapeutics, Inc. 24

  25. Slide 25: Cervical Cancer Facts

    Abbreviations: HPV, human papillomavirus infection; ORR, objective response rate; TIL, tumor infiltrating lymphocytes. (1) Global Burden of Disease Cancer Collaboration, Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost , Y ears Lived With Disability, and Disability - Ad

  26. Slide 26: NCI Cervical Cancer and TIL Treatment Data

    Stevanovic , et al., Treatment of Metastatic Human Papiliomavirus - Associated Epithelial Cancers with Adoptive Transfer of Tumor - Infiltrating T Cells, ASCO 2018, Abstract #3004 This type of response may not be representative of all patients. NCI Cervical Cancer and TIL Treatment Data © 2018, Iova

  27. Slide 27: Phase 2 Trial in Cervical Carcinoma (C-145-04)

    Phase 2, multicenter study to evaluate the efficacy and safety of autologous Tumor Infiltrating Lymphocytes (LN - 145) in patients with recurrent, metastatic or persistent cervical carcinoma (NCT03108495) Key Inclusion Criteria: • Measurable recurrent, persistent, or metastatic disease and ≥ 1 lesio

  28. Slide 28: Non-Small Cell Lung Cancer

    Non - Small Cell Lung Cancer © 2018, Iovance Biotherapeutics, Inc. 28

  29. Slide 29: Lung Cancer Has the Highest Mortality Rate Among Solid Tumors in the U.S.

    INDICATION NEW CASES (1) DEATHS (1) Melanoma 87,110 9,730 Cervix Uteri 12,820 4,210 Oral Cavity, Pharynx & Larynx 63,030 13,360 Lung & Bronchus 222,500 155,870 Bladder 79,030 16,870 Breast 2 52,710 40,610 Pancreatic 53,670 4 3,090 Brain & Other Nervous System 23,800 16,700 (1) https://seer.cancer.go

  30. Slide 30: Two Ongoing Trials in Non-Small Cell Lung Cancer

    Moffitt Cancer Center sponsored trial • TIL + anti - PD - 1, nivolumab ( Opdivo ® ) • An Investigator Initiated Trial (IIT), Phase 1 study in 18 advanced NSCLC patients (1) • Early results to be presented at World Lung on September 24 in Toronto, Safety and Clinical Activity of Adoptive Cell Transfe

  31. Slide 31: Moffitt Phase 1 NSCLC Study

    Phase I clinical trial combining nivolumab and Tumor Infiltrating Lymphocytes (TIL) for patients with advanced Non - Small Cell Lung Cancer (NCT03215810) • N=18 • First patient harvested in 4Q 2017 Key Inclusion Criteria: • PD - 1/PD - L1 naïve • Confirmed or suspected diagnosis of stage IV or recur

  32. Slide 32: Iovance-Sponsored NSCLC Phase 2 Study

    A Phase 2 study (IOV - LUN - 201) to assess the efficacy and safety of autologous Tumor Infiltrating Lymphocytes (LN - 145) alone and in combination with anti - PD - L1 inhibitor durvalumab (MEDI4736) in patients with locally advanced or metastatic Non - Small Cell Lung Cancer (NSCLC) (NCT03419559)

  33. Slide 33: TIL in Combination with Standard of Care Earlier Line of Therapy

    TIL in Combination with Standard of Care Earlier Line of Therapy © 2018, Iovance Biotherapeutics, Inc. 33

  34. Slide 34: IOV-COM-202: Co-Administration of TIL and Pembrolizumab

    A Phase 2, multicenter study of autologous Tumor Infiltrating Lymphocytes (LN - 144/LN - 145) in patients with solid tumors (NCT0364592) Key Inclusion Criteria: • Histologically confirmed diagnosis of unresectable or metastatic melanoma, recurrent or metastatic squamous cell carcinoma of the head an

  35. Slide 35: Research

    Research 35 © 2018, Iovance Biotherapeutics, Inc.

  36. Slide 36: Iovance TIL Research Focus

    Iovance TIL Research Focus 1. Expand the TIL platform into new indications ̶ Heme indication (OSU collaboration) ̶ Bladder cancer (Roswell Park Cancer Institute) 2. Prepare or select more potent TIL ̶ Use anti - 4 - 1BB, anti - OX40, or IL - 2/ IL - 15/ IL - 21 cocktails in ex vivo growth of TIL • L

  37. Slide 37: Manufacturing

    Manufacturing © 2018, Iovance Biotherapeutics, Inc. 37

  38. Slide 38: Iovance Cryopreserved 22 Day TIL Manufacturing Process

    Excise tumor Express courier from clinical s ite to CMO Express courier in cryoshipper from CMO to clinical s ite Thaw and i nfuse. Follow by IL - 2 administration Cut into fragments Expansion ex vivo scale up ex vivo culture IL - 2 + OKT3 Co - culture TIL and feeder cells Rapid Expansion (REP) 11 d

  39. Slide 39: Corporate

    Corporate 39 © 2018, Iovance Biotherapeutics, Inc.

  40. Slide 40: Financial Summary June 30, 2018

    © 2018, Iovance Biotherapeutics, Inc. Financial Summary June 30, 2018 (unaudited) 40 IN MILLIONS Common shares outstanding 93 Preferred shares 7 (1) Warrants/options/RSU’s 10 Cash, cash equivalents, short - term investments $276 Debt $0 (1) Preferred shares are shown on an as - converted basis.

  41. Slide 41: Summary of Recent Accomplishments

    © 2018, Iovance Biotherapeutics, Inc. Summary of Recent Accomplishments • Built a broad TIL clinical development program - entered new indications and announced new collaborations ̶ 70 clinical sites now active across five IOVA studies ̶ Data in melanoma trial with preliminary results indicating cli

  42. Slide 42: Milestones and Partnerships

    x Partner with our suppliers and vendors, as well as technology providers x Organizations with technologies for genetic modification x Continue collaborating with new clinical sites and hospitals to assure preparation for commercialization x 70 Clinical sites active across four studies x Roswell Par

  43. Slide 43: Thank you

    Thank you © 2018, Iovance Biotherapeutics, Inc.

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