Iovance Biotherapeutics, Inc. · NASDAQ:IOVA

Iovance Biotherapeutics — Investor Presentation (June 2018)

44 slides from Iovance Biotherapeutics's investor presentation, Jun 7, 2018

  1. Slide 1: Corporate Presentation June 2018

    Corporate Presentation June 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: TIL Approach is a Proven Treatment for Solid Tumors

    (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

  4. Slide 4: Clinical development, manufacturing and collaborators summary

    • Clinical Development: ̶ Iovance pipeline of three ongoing and one upcoming company - sponsored trials • Melanoma ̶ C - 144 - 01 Phase 2 trial of LN - 144 ( lifileucel ) in metastatic melanoma with positive responses seen in heavily pre - treated patients (1) • Orphan Drug Designation in malignant

  5. Slide 5: Iovance Clinical Pipeline

    INDICATION REGIMEN N PARTNER PRECLINICAL PHASE 1 PHASE 2 Melanoma TIL 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 Iovance Clinical Pipeline Enrolling Enrolling Enrolling 5 © 2018, Iov

  6. Slide 6: Iovance Collaboration Pipeline

    Iovance Collaboration Pipeline 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 may differ from our clinical trials. As a result, such par

  7. Slide 7: TIL Therapy Overview

    TIL Therapy Overview © 2018, Iovance Biotherapeutics, Inc. 7

  8. Slide 8: TIL Therapy Elicits a Highly Individualized, Specific and Potent Attack

    • 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 maintenan

  9. Slide 9: 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

  10. Slide 10: Competitive Advantages of TIL in Solid Tumors

    © 2018, Iovance Biotherapeutics, Inc. Competitive Advantages of TIL in Solid Tumors 10 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

  11. Slide 11: NCI Study Survival Benefit in Second and Third Line Patients

    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

  12. Slide 12: Manufacturing

    Manufacturing © 2018, Iovance Biotherapeutics, Inc. 12

  13. Slide 13: 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

  14. Slide 14: TIL Therapy Manufacturing

    • Clinical and commercial manufacturing capabilities are in place in the US and EU ̶ US: WuXi (multiple locations), Moffitt ̶ EU: LonzaNL (formerly PharmaCell) • Shorter Generation 2 manufacturing process has been selected for all current and future Iovance studies (all protocols amended) ̶ Shortens

  15. Slide 15: Cell Orchestration Platform (IOVATRAK)

    © 2018, Iovance Biotherapeutics, Inc. Cell Orchestration Platform (IOVATRAK ™ ) Logistics of Each Patient’s Sample and TIL Therapy An automated process integrating scheduling, capacity and logistics throughout the supply chain: Part 11 compliant, improves communication across stakeholders 15 1. EXCI

  16. Slide 16: Melanoma

    Melanoma © 2018, Iovance Biotherapeutics, Inc. 16

  17. Slide 17: Iovance C-144-01 Phase 2 Trial in Metastatic Melanoma

    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

  18. Slide 18: C-144-01 Patient Characteristics: Interim Data

    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

  19. Slide 19: 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 )

  20. Slide 20: 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

  21. Slide 21: Iovance 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

  22. Slide 22: 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. 22 RESPONSE PATIENTS, N=10 n (%) Objec

  23. Slide 23: CT Scan for Patient with PR

    CT Scan for Patient with PR 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. 23 Pre - Treatment 18 wks Pos

  24. Slide 24: Head & Neck Cancer

    Head & Neck Cancer © 2018, Iovance Biotherapeutics, Inc. 24

  25. Slide 25: 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, Mortality, Years of Life Lost , Y ears Lived With Disa

  26. Slide 26: C-145-03 Phase 2 Trial in Head and Neck Cancer

    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

  27. Slide 27: C-145-03: Preliminary Evidence of Efficacy

    BASELINE DEMOGRAPHICS PATIENTS, N= 8 n (%) Prior therapies, n (%) Median prior therapies 4 Anti - PD - 1 8 (100) Anti - CTLA - 4 2 (25) SAFETY: TREATMENT EMERGENT ADVERSE EVENTS (≥30%) BY PREFERRED TERM PATIENTS, N=8 n (%) Pyrexia 7 (88) Chills 6 (75) Hyponatremia 6 (75) Hypotension 6 (75) Abbreviat

  28. Slide 28: Cervical Cancer

    Cervical Cancer © 2018, Iovance Biotherapeutics, Inc. 28

  29. Slide 29: NCI Cervical Cancer and TIL Treatment Data

    Stevanovic , et al. ASCO 2018, Abstract #3004, cervical cancer cohort Stevanovic , et al. Complete Regression of Metastatic Cervical Cancer After Treatment with Human Papillomavirus - Targeted Tumor - Infiltrating T Cells, J Clin Oncol 2015, 33 (14), 1543. Hinrichs, et al. HPV - targeted Tumor - Inf

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

    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

  31. Slide 31: C-145-04: Preliminary Evidence of Response

    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) • First patient dosed in Sep 2017 • Of two evaluable cervical patients, one has a confirmed PR,

  32. Slide 32: Non-Small Cell Lung Cancer

    Non - Small Cell Lung Cancer © 2018, Iovance Biotherapeutics, Inc. 32

  33. Slide 33: Market Opportunity for TIL Therapy in US

    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

  34. Slide 34: Ongoing Collaborations and Partnerships

    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) Iovance sponsored trial in collaboration with MedImmune / AstraZeneca • TIL +/ - anti - PD - L1, durvalumab: • Iovance - sponso

  35. Slide 35: NSCLC Phase 2 Study

    A Phase 2 Study 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) NSCLC Phase 2 Study © 2018, Iova

  36. Slide 36: Collaborations

    Collaborations © 2018, Iovance Biotherapeutics, Inc. 36

  37. Slide 37: MD Anderson Collaboration

    MD Anderson Collaboration • Iovance has a collaboration with MD Anderson involving: ̶ Preclinical research in expanding understanding of TIL ̶ Two clinical studies: • LN - 145 being provided by Iovance ̶ Indications: sarcomas and platinum - resistant ovarian cancer ̶ IND submitted by MDA and cleared

  38. Slide 38: Research

    Research © 2018, Iovance Biotherapeutics, Inc. 38

  39. Slide 39: Iovance Research Focus

    Iovance Research Focus 1. Expand the TIL platform ̶ Evaluate new indications which TIL can be utilized: ex. heme indication (OSU collaboration) 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 • License to uses of

  40. Slide 40: Corporate

    Corporate © 2018, Iovance Biotherapeutics, Inc. 40

  41. Slide 41: Financial Summary

    © 2018, Iovance Biotherapeutics, Inc. Financial Summary March 31, 2018(unaudited) 41 IN MILLIONS Common shares outstanding 90 Preferred shares 8 (1) Warrants/options/RSU’s 13 Cash $297 Debt $0 (1) Preferred shares are shown on an as - converted basis.

  42. Slide 42: Summary of Recent Accomplishments

    © 2018, Iovance Biotherapeutics, Inc. Summary of Recent Accomplishments Investigating Power of TIL Platform for Multiple Indications • Broad Clinical Program: ̶ Updated data in melanoma trial with preliminary results indicating clinically meaningful benefit in patients with relapsed/refractory disea

  43. Slide 43: Partnerships and upcoming milestones

    • Partner with our suppliers and vendors, as well as technology providers x Organizations with technologies for genetic modification • Continue collaborating with new clinical sites and hospitals to assure preparation for commercialization x 50 Clinical sites active across four studies PARTNERSHIPS

  44. Slide 44: Thank you

    Thank you © 2018, Iovance Biotherapeutics, Inc.

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