Iovance Biotherapeutics, Inc. · NASDAQ:IOVA

Iovance Biotherapeutics — Lion Biotechnologies — Investor Presentation (April 2017)

33 slides from Iovance Biotherapeutics's investor presentation, Apr 21, 2017

  1. Slide 1: Corporate Presentation April 2017

    Corporate Presentation April 2017 © 2017, Lion Biotechnologies

  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: Corporate Highlights

    • Clinical - stage biotechnology company focused on the development and commercialization of novel cancer immunotherapy products • Leveraging and enhancing the power of tumor - infiltrating lymphocyte (TIL) technology to treat solid tumors • Broad pipeline of programs using TIL technology: ̶ Durable

  4. Slide 4: Tumor-Infiltrating Lymphocyte (TIL) Therapy

    Tumor - Infiltrating Lymphocyte (TIL) Therapy • Autologous adoptive cell therapy: ̶ Resect tumor ̶ Isolate and expand TIL ex vivo ̶ Lymphodeplete patients seven days prior to TIL infusion ̶ Infuse TIL followed by one to six doses of IL - 2 © 2017, Lion Biotechnologies 4 Excise tumor Expan d TIL Infu

  5. Slide 5: Lion Biotechnologies' Broad Pipeline

    Lion Biotechnologies’ Broad Pipeline © 2017, Lion Biotechnologies 5 INDICATION REGIMEN N PARTNER PRECLINICAL PHASE 1 PHASE 2 Melanoma Combination TIL ± TBI 101 Melanoma Combination TIL + ipi Melanoma Combination TIL + Keytruda 170 Melanoma Combination TIL + Opdivo 12 Ocular (Uveal) Melanoma TIL 23 M

  6. Slide 6: Key Collaborations and Partnerships

    National Cancer Institute/NIH • Cooperative Research And Development Agreement (CRADA) with Dr. Steve Rosenberg Development of TIL for metastatic melanoma, bladder, lung, breast, and HPV - associated cancers and combination therapies • TIL + PD - 1 combination clinical trial to treat melanoma MedImm

  7. Slide 7: TIL Therapy

    TIL Therapy 7 © 2017, Lion Biotechnologies

  8. Slide 8: 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 one - time treatment: ̶ Potential to establish immunological memory, requiring no additional main

  9. Slide 9: Adoptive Cell Transfer: Maximizes Potency of TILs

    EXTRACTION: Patient’s TILs are removed from suppressive tumor microenvironment (via surgical resection of lesions) EXPANSION: TILs expanded from small tumor fragments using T - cell growth factor interleukin 2 (IL - 2) – TILs are allowed to multiply to large numbers before re - infusing them into pa

  10. Slide 10: Manufacturing Process & Logistics

    Manufacturing Process & Logistics Gen 1 Duration: ~5 - 6 weeks; Gen 2 Duration: ~3.5 weeks 10 Excis e tumor Shipment IV infusion Post - Lymphodepletion + IL - 2 Dissect tumor into fragments Expansion with IL - 2 Co - culture TIL with feeder cells and OKT3 Expand TILs with IL - 2 Prepare infusion bag

  11. Slide 11: Melanoma

    Melanoma 11 © 2017, Lion Biotechnologies

  12. Slide 12: TIL Therapy in Melanoma is Very Promising

    • Data from randomized Phase 2 trial in 101 patients with metastatic melanoma at the NCI confirmed TIL treatment was associated with high, durable objective response rates, including patients that were refractory to checkpoint inhibitors: (1) ̶ CRs have been observed in 24% of patients, 23/24 comple

  13. Slide 13: Treatment-Related Toxicities

    The toxicities of treatment were largely associated with the known side effects of nonmyeloablative chemotherapy (NMA) or total body irradiation (TBI) and administration of high dose IL - 2 (1) 13 Treatment - Related Toxicities (1) Goff, S.L. et al. Randomized, Prospective Evaluation Comparing Inten

  14. Slide 14: Survival in Melanoma

    14 Goff, S.L. et al. Randomized, Prospective Evaluation Comparing Intensity of Lymphodepletion Before Adoptive Transfer of Tumor - Infiltrating Lymphocytes for Patients With Metastatic Melanoma. Journal of Clinical Oncology, 34(20), 2389 - 2397. Survival in Melanoma Overall Survival of patients in T

  15. Slide 15: Melanoma Patient

    Melanoma Patient 15 Rosenberg, et al. Adoptive cell therapy for the treatment of patients with metastatic melanoma Curr Opin Immunol, 21(2), 233 - 240. Pre - Treatment 12+ Days © 2017, Lion Biotechnologies

  16. Slide 16: Survival Benefit in Second and Third Line Patients

    16 Rosenberg, S.A., et al. Durable Complete Responses in Heavily Pretreated Patients with Metastatic Melanoma Using T - Cell Transfer Immunotherapy. Clinical Cancer Research , 17(13), 4550 - 4557. Survival Benefit in Second and Third Line Patients Durable remissions in melanoma regardless of prior t

  17. Slide 17: LN-144 Phase 2 Trial in Metastatic Melanoma

    Phase 2, Multicenter, 3 - Cohort Study to Assess the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes (LN - 144) for Treatment of Patients with Metastatic Melanoma Key Inclusion Criteria: • Measurable metastatic melanoma and ≥ 1 lesion resectable for TIL generation • At least one pri

  18. Slide 18: Cervical Cancer

    Cervical Cancer 18 © 2017, Lion Biotechnologies

  19. Slide 19: Cervical Cancer and TIL Treatment Data

    Cervical Cancer and TIL Treatment Data 19 Stevanovic, et al. Complete Regression of Metastatic Cervical Cancer After Treatment with Human Papillomavirus - Targeted Tumor - Infiltrating T Cells, J Clin Oncol 2015, 33 (15). Hinrichs, et al. HPV - targeted Tumor - Infiltrating Lymphocytes for Cervical

  20. Slide 20: LN-145 Phase 2 Trial in Cervical Carcinoma

    A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety of Adoptive Cell Therapy Using Autologous Tumor Infiltrating Lymphocytes (LN - 145) in Patients with Recurrent, Metastatic or Persistent Cervical Carcinoma N=47; Simon’s two - stage design Key Inclusion Criteria: • Measurable metastati

  21. Slide 21: Head and Neck Cancer

    Head and Neck Cancer 21 © 2017, Lion Biotechnologies

  22. Slide 22: LN-145 Phase 2 Trial in Head and Neck Carcinoma

    A Phase 2 Study to Evaluate the Safety, Tolerability and Efficacy of Cell Transfer Therapy Using Autologous Tumor Infiltrating Lymphocytes (LN - 145) followed by IL - 2 in Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck N=47; Simon’s two - stage design Key Incl

  23. Slide 23: TIL Market Opportunity

    TIL Market Opportunity 23 © 2017, Lion Biotechnologies

  24. Slide 24: Market Opportunity for TIL Therapy

    • 64% percent of new cases per year for patients 20 - 70 years old • Metastatic (regional and distant) melanoma patients compose 13% of all new cases at ~10,000 cases • Prevalence of melanoma in US (2013): >1 million 24 Market Opportunity for TIL Therapy (1) Source: http://seer.cancer.gov/statfacts/

  25. Slide 25: Competitive Advantages of TILs in Solid Tumors

    25 Competitive Advantages of TILs in Solid Tumors CHECKPOINTS TCR CAR TIL Utility in several solid tumors Few solid tumors treated so far No examples of utility in solid tumors Utility in melanoma and HPV cancers Long maintenance period One - time treatment One - time treatment One - time treatment

  26. Slide 26: Future Directions: Next Generation TILs

    • Selected TILs offer many benefits ̶ Selection of more specific TIL (Select for PD - 1, 4 - 1BB Expression) ̶ Shorter duration of manufacturing • COGs • New IP • Genetic engineering of TIL ̶ Modulate exhaustion/inhibitory markers (PD - 1, CTLA - 4, LAG - 3) 26 Future Directions: Next Generation TIL

  27. Slide 27: Leadership and Organization Overview

    Leadership and Organization Overview 27 © 2017, Lion Biotechnologies

  28. Slide 28: Management Team

    Management Team 28 Maria Fardis, Ph.D., MBA President and CEO Michael Lotze, M.D. CSO © 2017, Lion Biotechnologies Gregory Schiffman, MBA CFO

  29. Slide 29: Financial Summary

    Financial Summary 29 AS OF DECEMBER 31, 2016 (IN MILLIONS) Common shares outstanding 62.2 Preferred shares 8.8 Warrants/options/RSU’s 13.4 Cash $166.5 Debt $0 © 2017, Lion Biotechnologies

  30. Slide 30: Anticipated 2017 Key Milestones

    Anticipated 2017 Key Milestones 30 © 2017, Lion Biotechnologies • Evaluate potential opportunistic partnerships in alignment with our core competencies x MDA • Define the regulatory pathway for LN - 144 melanoma drug candidate in U.S. • Initiate regulatory interactions with ex - U.S. health authorit

  31. Slide 31: Thank you

    Thank you © 2017, Lion Biotechnologies

  32. Slide 32: Clinical Regressions in Late-Stage Disease

    32 Clinical Regressions in Late - Stage Disease Rosenberg, S.A. et al. (2009, April). Adoptive Cell Therapy for the Treatment of Patients with Metastatic Melanoma. Current Opinion in Immunology, 21(2), 233 - 240. © 2017, Lion Biotechnologies

  33. Slide 33: Compelling Results in Late-Stage Disease

    33 Dudley, M. E., et al. (2010, December). CD8 Enriched “Young” Tumor Infiltrating Lymphocytes Can Mediate Regression of Metasta tic Melanoma. Clinical Cancer Research, 16(24), 6122 - 6131. Compelling Results in Late - Stage Disease © 2017, Lion Biotechnologies

Lion Biotechnologies — Investor Presentation (April 2017) on 6ix