Iovance Biotherapeutics, Inc. · NASDAQ:IOVA

Iovance Biotherapeutics — Investor Presentation (July 2019)

39 slides from Iovance Biotherapeutics's investor presentation, Jul 2, 2019

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

    July 2019 © 2019, Iovance Biotherapeutics, Inc. Investigating the Power of Tumor Infiltrating Lymphocytes for Treatment of Solid Tumors

  2. Slide 2: Forward-looking statements

    This presentation contains “forward - looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Compan y,” “we,” “us,” or “our”). We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “int

  3. Slide 3: Leveraging Tumor Infiltrating Lymphocyte (TIL) to Address Unmet Need

    Manufacturing Development, Clinical Program Establishment 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 2015 Fi

  4. Slide 4: Leveraging Tumor Infiltrating Lymphocyte (TIL) to Address Unmet Need

    Manufacturing Development, Clinical Program Establishment 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 2015 Fi

  5. Slide 5: Investment Highlights

    © 2019, Iovance Biotherapeutics, Inc. Leading cell therapy company focused on treatment of solid tumors Investment Highlights 5 Large market opportunity and strong unmet need Potential to be the first cell therapy approved for solid tumors in melanoma and cervical Efficient and scalable proprietary

  6. Slide 6: Highly Individualized, Specific, and 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 solid tumors which are heterogeneous • Available data in melanoma, cervical, head & neck, and lung cancers •

  7. Slide 7: Competitive Advantages of TIL in Solid Tumors

    © 2019, Iovance Biotherapeutics , Inc. Competitive Advantages of TIL in Solid Tumors 7 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 maint

  8. Slide 8: Developed Centralized, Scalable, and Efficient GMP Manufacturing

    EXCISE: Patient’s tumor is removed via surgical resection of a lesion EXTRACT: Tumor is fragmented and placed in media for TIL to leave the tumor and enter media EXPAND: TIL expanded via IL - 2 + OKT3 exponentially ex vivo to yield 10 9 – 10 11 TIL PREPARE & INFUSE : Patient receives non - myeloabla

  9. Slide 9: Broad, Iovance-Owned IP Around TIL Therapy

    Manufacturing Multiple layers of patent applications filed for Gen 2 TIL products • Iovance is pursuing claims covering cryopreserved TIL products, manufacturing processes and methods of treatment • Includes three recently granted U.S. patents for methods of treatment in a broad range of cancers, in

  10. Slide 10: Iovance Commercial Manufacturing Facility

    • Build - to - suit custom facility located in the Navy Yard, Philadelphia, PA • ~136,000 sq. feet • GMP production is expected to commence in 2022 • IOVA investing $75M over 3 years • Significant reduction in COGS expected © 2019, Iovance Biotherapeutics, Inc. Iovance Commercial Manufacturing Facil

  11. Slide 11: Significant Market Potential in Solid Tumors

    (1) https://seer.cancer.gov Solid Tumor Indication Deaths (1) New Cases (1) Melanoma 9,320 91,270 Cervix Uteri 4,170 13,240 Oral Cavity, Pharynx & Larynx 13,740 64,690 Lung & Bronchus 154,050 234,030 Bladder 17,240 81,190 Breast 41,400 268,670 Pancreatic 44,330 55,440 Brain & Other Nervous System 16

  12. Slide 12: Current Clinical Pipeline and Select Collaboration Studies

    Company sponsored studies Select investigator sponsored proof - of - concept studies Lifileucel innovaTIL - 01 Melanoma 164 — LN - 145 innovaTIL - 04 Cervical cancer 59 — LN - 145 C - 145 - 03 Head & neck cancer 47 — Lifileucel + pembrolizumab LN - 145 + pembrolizumab LN - 145 IOV - COM - 202 Melano

  13. Slide 13: Metastatic Melanoma

    © 2019, Iovance Biotherapeutics, Inc. Metastatic Melanoma

  14. Slide 14: Potential Market for Metastatic Melanoma

    (1) https://seer.cancer.gov (2) Decision Resources Group – Disease Landscape and Forecast for Malignant Melanoma - Reprinted with permission. ©2018 DR/Decision Resources, LLC (3) Keynote - 37 Trial Results (4) Global Burden of Disease Cancer Collaboration, Global, Regional, and National Cancer Incid

  15. Slide 15: InnovaTIL-01: Phase 2 Study Design

    Phase 2, multicenter study to assess the efficacy and safety of autologous Tumor Infiltrating Lymphocytes (lifileucel) for treatment of patients with metastatic melanoma (NCT02360579) Endpoints: • Primary: Efficacy defined as investigator ORR • Secondary: Safety and efficacy Study Updates: • October

  16. Slide 16: InnovaTIL-01: Cohort 2 Update at ASCO 2019

    Baseline Demographics N= 66 (%) Prior therapies Mean # prior therapies 3.3 Anti - PD - 1 66 (100) Anti - CTLA - 4 53 (80) BRAF/MEK 15 (23) Target lesions sum of diameter (mm) Mean (SD) 106 (71) Min, Max 11, 343 Baseline LDH (U/L) Median 244 1 - 2 times ULN 19 (29) > 2 times ULN 8 (12) Number of targ

  17. Slide 17: Adverse Events Tend to be Early and Transient

    © 2019, Iovance Biotherapeutics , Inc. Frequency of AEs over time is reflective of potential benefit of one time treatment with lifileucel Adverse Events Tend to be Early and Transient 17 **Treatment - Emergent Adverse Events refer to all AEs starting on or after the first dose date of TIL up to 30

  18. Slide 18: Potentially Efficacious Treatment for Patients with Limited Options

    Responses N=66 (%) Objective Response Rate 25 (38%) Complete Response 2 (3%) Partial Response 23 (35%) Stable Disease 28 (42%) Progressive Disease 9 (14%) Non - Evaluable 4 (6%) Disease Control Rate 53 ( 80%) • In heavily pretreated metastatic melanoma patients (3.3 mean prior therapies) • ORR 38% •

  19. Slide 19: Responders Previously Progressed on Checkpoint Inhibitors

    Responders Previously Progressed on Checkpoint Inhibitors © 2019, Iovance Biotherapeutics, Inc. 19 COHORT 2 BOR is best overall response on prior anti - PD - 1 immunotherapy Lifileucel time to response and current duration of for evaluable patients (partial response or better)

  20. Slide 20: TIL Therapy Provides Deep Responses

    © 2019, Iovance Biotherapeutics , Inc. 20 TIL Therapy Provides Deep Responses COHORT 2 Lifileucel best overall response rate (1) • 81% of patients had a reduction in tumor burden • Mean Time to response 1.9 months (range 1.3 - 5.6 ) • All assessments are by RECIST 1.1 • Responses are deep – nearly a

  21. Slide 21: Cohort 4 is a Pivotal Single-Arm Registrational Trial

    © 2019, Iovance Biotherapeutics , Inc. 21 Cohort 4 is a Pivotal Single - Arm Registrational Trial Cohort 4 (Pivotal): Cryopreserved TIL product (Gen 2) N=75 Per FDA interaction COHORT 4 Key inclusion criteria: • Measurable metastatic melanoma and ≥ 1 lesion resectable for TIL generation • Progressio

  22. Slide 22: Late Stage (2L/3L) Melanoma Treatment Development Efforts

    © 2019, Iovance Biotherapeutics , Inc. 2L/3L melanoma treatment has no current standard of care Late Stage (2L/3L) Melanoma Treatment Development Efforts 22 (1) Ascierto P et al ., ESMO 2017 (2) Idera Pharmaceuticals Results Dec 14, 2018 (3) Milhem M et al., AACR 2018 (4) DVAX Corp Pres, Jan 10, 201

  23. Slide 23: Cervical Cancer

    © 2019, Iovance Biotherapeutics, Inc. Cervical Cancer

  24. Slide 24: Cervical Cancer Market and Available Care

    (1) Global Burden of Disease Cancer Collaboration, Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability - Adjusted Life - years for 29 Cancer Groups, 1990 to 2016: A Systematic Analysis for the Global Burden of Disease Study. JAM

  25. Slide 25: InnovaTIL-04: Phase 2 Trial in Cervical Cancer

    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) © 2019, Iovance Biotherapeutics , Inc. 25 InnovaTIL - 04: Phase 2 Trial in Cervical Cancer Endp

  26. Slide 26: InnovaTIL-04: LN-145 in Cervical Cancer

    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

  27. Slide 27: Adverse Events Tend to be Early and Transient

    © 2019, Iovance Biotherapeutics , Inc. Frequency of AEs over time is reflective of potential benefit of one time treatment with TIL (LN - 145) Adverse Events Tend to be Early and Transient 27 **Treatment - Emergent Adverse Events refer to all AEs starting on or after the first dose date of TIL up to

  28. Slide 28: 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% •

  29. Slide 29: Responses Observed Early On and Consistent with Melanoma

    © 2019, Iovance Biotherapeutics , Inc. LN - 145 time to response and current duration of for evaluable patients (partial response or better) Responses Observed Early On and Consistent with Melanoma 29 • Mean time to first response 1.9 months • Mean time to best response 2.4 months

  30. Slide 30: Three Complete Responses Observed with LN-145

    © 2019, Iovance Biotherapeutics , Inc. 30 Three Complete Responses Observed with LN - 145 LN - 145 best overall response rate • 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 – majority of responders are ove

  31. Slide 31: Development Efforts in Recurrent, Metastatic or Persistent Cervical Carcinoma

    © 2019, Iovance Biotherapeutics , Inc. Recurrent, metastatic or persistent cervical carcinoma has no current standard of care Development Efforts in Recurrent, Metastatic or Persistent Cervical Carcinoma 31 (4) D’Souza et al. SGO 2019 (5) Yan, et al . Cancer Metastasis Rev . 2015 Agent ORR % ( N) Cu

  32. Slide 32: TIL in Earlier Lines of Therapy in Combination with SOC

    Melanoma PD - 1/PDL - 1 Naïve Melanoma Head & Neck Cohort 1: TIL+ Pembro N=12 Cohort 2: TIL+ Pembro N=12 Relapsed Refractory NSCLC NSCLC Cohort 3: TIL N=12 PD - 1/PDL - 1 Naïve Head & Neck Endpoints: • Primary: ORR and safety • Secondary: CR rate Study updates: • 16+ sites are activated globally • S

  33. Slide 33: Hematologic Malignancies

    © 2019, Iovance Biotherapeutics, Inc. Hematologic Malignancies

  34. Slide 34: Peripheral Blood Lymphocytes (PBL) for Hematological Indications

    © 2019, Iovance Biotherapeutics, Inc. Peripheral Blood Lymphocytes (PBL) for Hematological Indications 34 Expand the TIL platform into new indications • IOV - 2001 for post - ibrutinib CLL patients • IOV - 2001 is a non - genetically modified, polyclonal T cell product • IOV - 2001 shows cytotoxicit

  35. Slide 35: Research Focus into Next Generation TIL

    © 2019, Iovance Biotherapeutics , Inc. Research Focus into Next Generation TIL 35 Prepare or select more potent TIL • Use anti - 4 - 1BB, anti - OX40, or other co - stimulants in cocktails in ex vivo growth of TIL • License to uses of 4 - 1BB agonists obtained from Moffitt Cancer Center • Select mor

  36. Slide 36: Iovance Biotherapeutics Global Reach and Scale

    © 2019, Iovance Biotherapeutics , Inc. Iovance Biotherapeutics Global Reach and Scale 36 Iovance Biotherapeutics has ~120 employees • Headquartered in San Carlos, CA • 4 additional offices • Iovance commercial manufacturing facility in Philadelphia, PA (under construction) San Carlos, CA New York Ci

  37. Slide 37: Well Capitalized in Pursuit of TIL Commercialization

    March 31, 2019 In millions Common shares outstanding 123 Preferred shares 6 (1) Options 9 Cash, cash equivalents, short - term investments $440 Debt 0 (1) Preferred shares are shown on an as - converted basis © 2019, Iovance Biotherapeutics , Inc. Well Capitalized in Pursuit of TIL Commercialization

  38. Slide 38: Achieved and Upcoming Milestones

    Demonstrate consistent, scalable, rapid proprietary manufacturing method Demonstrate activity in melanoma post - checkpoint inhibitor (difficult to treat patients) Align on registration pathway for melanoma with FDA Demonstrate activity in post - CPI cervical, head & neck tumors Secure new IP around

  39. Slide 39: Thank you

    © 2019, Iovance Biotherapeutics, Inc. Thank you

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