Iovance Biotherapeutics, Inc. · NASDAQ:IOVA

Iovance Biotherapeutics — Investor Presentation (September 2017)

45 slides from Iovance Biotherapeutics's investor presentation, Sep 11, 2017

  1. Slide 1: Corporate Presentation September 2017

    Corporate Presentation September 2017 © 2017, Iovance Biotherapeutics

  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

    © 2017, Iovance Biotherapeutics Corporate Highlights • Clinical - stage biotechnology company focused on the development and commercialization of tumor infiltrating lymphocyte (TIL) therapy for cancer patients in multiple indications • Leveraging and enhancing the utility of TIL therapy as demonstra

  4. Slide 4: TIL Therapy Process

    • EXTRACTION: Patient’s TIL are removed from suppressive tumor microenvironment (via surgical resection of a lesion) • EXPANSION: TIL expanded exponentially ex vivo to yield 10 9 – 10 11 TIL • PREPARATION: Patient receives non - myeloablative lymphodepletion, to eliminate potentially suppressive tum

  5. Slide 5: Iovance Biotherapeutics Pipeline

    Iovance Biotherapeutics Pipeline © 2017, Iovance Biotherapeutics 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 Me

  6. Slide 6: Key Collaborations and Partnerships

    © 2017, Iovance Biotherapeutics 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 therapie

  7. Slide 7: TIL Therapy

    TIL Therapy © 2017, Iovance Biotherapeutics 7

  8. Slide 8: TIL Therapy: 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 mainte

  9. Slide 9: Iovance Manufacturing Process & Logistics

    Iovance Manufacturing Process & Logistics © 2017, Iovance Biotherapeutics 9 Gen 1 Duration: ~5 - 6 Weeks Gen 2 Duration: ~3.5 Weeks Cryopreserved Product Excise tumor Shipment IV infusion post - l ymphodepletion + IL - 2 Dissect tumor into fragments Expansion with IL - 2 Co - culture TIL with feeder

  10. Slide 10: Manufacturing Capacity

    • Iovance’s Manufacturing process is centralized at the following CMO sites: ̶ Lonza, Walkersville ̶ Wuxi AppTech ̶ Moffitt as CMO ̶ PharmaCell (EU) • Iovance developed the Gen 1 process through modification of the NCI’s TIL manufacturing method. Gen 2 and all manufacturing SOPs were developed by Io

  11. Slide 11: Melanoma

    Melanoma © 2017, Iovance Biotherapeutics 11

  12. Slide 12: NCI Study with TIL Therapy in Melanoma

    (1) 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. © 2017, Iovance Biotherapeutics NCI Study with TIL T

  13. Slide 13: NCI Study Treatment-Related Toxicities

    (1) 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. © 2017, Iovance Biotherapeutics NCI Study Treatment -

  14. Slide 14: NCI Study Survival in Melanoma

    NCI Study Survival in Melanoma 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. © 2017, Iovance Biotherape

  15. Slide 15: NCI Study Melanoma Patient

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

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

    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 Immunotherapy. Clinical Cancer Research , 17(13), 4550 - 4557. © 2017, Iovance Biotherapeutics 16 Durable re

  17. Slide 17: Iovance C-144-01 Study Design (June 2017 - ASCO Data)

    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: Iovance C-144-01 Patient Characteristics - Cohort 1

    CHARACTERISTIC N=16, % Gender, n (%) Male 7 (43.8) Female 9 (56.3) Age, n (%) Mean (SD) 54.8 (8.44) Median 54.5 Min, Max 41, 72 Prior therapies, n (%) IL - 2 2 (12.5) anti - CTLA - 4 14 (87.5) anti - PD - 1 16 (100.0) Iovance C - 144 - 01 Patient Characteristics - Cohort 1 © 2017, Iovance Biotherape

  19. Slide 19: Iovance C-144-01 Safety: Treatment Emergent Serious Adverse Events

    Iovance C - 144 - 01 Safety: Treatment Emergent Serious Adverse Events Treatment Emergent SAEs by PT; * not related to therapy event occurred 6 months after treatment. © 2017, Iovance Biotherapeutics 19 PREFERRED TERM 144 - 01 (N=16) ANY GRADE, n (%) GRADE ≥3, n (%) GRADE 5, n (%) Number of subjects

  20. Slide 20: Iovance C-144-01 Efficacy

    • All patients entering the study had received an anti - PD - 1 checkpoint inhibitor • Median number of IL - 2 administrations was 6 * In Efficacy Set 1 of 14 patients was not evaluable due to melanoma - related death prior to first tumor assessment. Iovance C - 144 - 01 Efficacy © 2017, Iovance Bio

  21. Slide 21: Iovance C-144-01 Efficacy

    • ORR is 29% • Tumor reduction was seen in 77% of patients representing those who had tumor reduction in the target lesions • Responses were noted regardless of BRAF mutational status including one long lasting CR (15+ months) * BRAF mutants - Of 14 patients in Efficacy Set, one patient was not eval

  22. Slide 22: Iovance C-144-01 Time to Best Response and Duration

    • Mean time to first response: 1.6 months • Median follow up for this data: 4.1 months Iovance C - 144 - 01 Time to Best Response and Duration © 2017, Iovance Biotherapeutics 22

  23. Slide 23: Iovance C-144-01 Percent Change in Sum of Diameters

    © 2017, Iovance Biotherapeutics Iovance C - 144 - 01 Percent Change in Sum of Diameters 23

  24. Slide 24: Iovance C-144-01 Patient Scan

    Iovance C - 144 - 01 Patient Scan © 2017, Iovance Biotherapeutics 24 Patient is in CR 14 months Post Treatment Pre - Treatment 6 weeks Post - Treatment Iovance C - 144 - 01

  25. Slide 25: Iovance C-144-01 Phase 2 Trial in Metastatic Melanoma

    A Phase 2, Multicenter Study to Assess the Efficacy and Safety 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 prior line of

  26. Slide 26: Cervical Cancer

    Cervical Cancer © 2017, Iovance Biotherapeutics 26

  27. Slide 27: NCI Cervical Cancer and TIL Treatment Data

    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 Cancer, J Clin Oncol , 2014, 23, 5s. Stev

  28. Slide 28: Iovance C-145-04 Phase 2 Trial in Cervical Carcinoma

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

  29. Slide 29: Head & Neck Cancer

    Head & Neck Cancer © 2017, Iovance Biotherapeutics 29

  30. Slide 30: Iovance C-145-03 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 LN - 145

  31. Slide 31: Manufacturing

    Manufacturing © 2017, Iovance Biotherapeutics 31

  32. Slide 32: US Clinical and Commercial Manufacturing Facility

    © 2017, Iovance Biotherapeutics US Clinical and Commercial Manufacturing Facility Philadelphia • The two suites currently being used by Iovance are physically separated • Both are capable of commercial manufacturing 32 Commercial Cell Therapy Center of Excellence Commerce Center 3 • 45,000ft 2 Manuf

  33. Slide 33: Manufacturing Capacity

    © 2017, Iovance Biotherapeutics Manufacturing Capacity • Clinical and commercial manufacturing capabilities are in place in US and EU: ̶ US: WuXi: multiple suites ̶ EU: PharmaCell • All currently planned clinical studies can be supported with available capacity • Commercial capacity at WuXi is scala

  34. Slide 34: TIL Market Opportunity

    TIL Market Opportunity © 2017, Iovance Biotherapeutics 34

  35. Slide 35: Market Opportunity for TIL Therapy in US

    • Iovance’s lead indication for TIL is metastatic melanoma: ̶ Prevalence of melanoma in US (2014) is greater than 1.17 million cases ̶ 74% percent of new cases each year occur in patients 20 - 74 years old (1) ̶ Metastatic (regional and distant) melanoma patients compose 13% of all new cases ~10,000

  36. Slide 36: Competitive Advantages of TILs in Solid Tumors

    © 2017, Iovance Biotherapeutics Competitive Advantages of TILs in Solid Tumors 36 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

  37. Slide 37: Ongoing and Future Directions

    • Continuous improvement in process development: ̶ Shortening of the process further ̶ Automation • Evaluation of biomarkers for response • Selected TILs, modifying the properties may offer benefits: ̶ Selection of more specific TIL (Select for PD - 1, 4 - 1BB Expression) Ongoing and Future Directio

  38. Slide 38: Financials

    Financials © 2017, Iovance Biotherapeutics 38

  39. Slide 39: Financial Summary

    © 2017, Iovance Biotherapeutics Financial Summary 39 As of June 30, 2017 (IN MILLIONS) Common shares outstanding 62.7 Preferred shares 8.8 Warrants/options/RSU’s 13.4 Cash $129 Debt $0

  40. Slide 40: Selected Milestones 2016-2018

    2015 2016 2017 2018 Q2 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Regulatory Manufacturing Clinical Other (corporate or data) Selected Milestones 2016 - 2018 © 2017, Iovance Biotherapeutics 40 Fast Track was granted for LN - 144 in advanced melanoma CTA submissions to EU is initiated FDA interaction to def

  41. Slide 41: Anticipated 2017 Key Milestones

    Anticipated 2017 Key Milestones © 2017, Iovance Biotherapeutics 41 • Evaluate potential opportunistic partnerships in alignment with our core competencies x MD Anderson Cancer Center x Ohio State University Comprehensive Cancer Center x Moffitt Cancer Center PARTNERSHIPS • Define the regulatory path

  42. Slide 42: Thank you

    Thank you © 2017, Iovance Biotherapeutics

  43. Slide 43: MDACC TIL Manufacturing Process

    MDACC TIL Manufacturing Process © 2017, Iovance Biotherapeutics 43 Total Processing Time approx. 5 - 6 weeks Excise tumor IV infusion Post - Lymphodepletion + IL - 2 4 - 1BB antibody Expansion with IL - 2 Co - culture TIL with feeder cells and OKT3 Expand TILs with IL - 2 Prepare infusion bag Dissec

  44. Slide 44: Clinical Regressions in Late-Stage Disease

    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, Iovance Biotherapeutics 44

  45. Slide 45: Compelling Results in Late-Stage Disease

    Compelling Results in Late - Stage Disease Dudley, M. E., et al. (2010, December). CD8 Enriched “Young” Tumor Infiltrating Lymphocytes Can Mediate Regression of Metastatic Melanoma. Clinical Cancer Research, 16(24), 6122 - 6131. © 2017, Iovance Biotherapeutics 45

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