Iovance Biotherapeutics, Inc. · NASDAQ:IOVA

Iovance Biotherapeutics — Corporate Update (November 2018)

30 slides from Iovance Biotherapeutics's corporate update, Nov 9, 2018

  1. Slide 1: Clinical Program Update

    Clinical Program Update November 9. 2018 © 2018, Iovance Biotherapeutics

  2. Slide 2: Forward-looking statements

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

  3. Slide 3: 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

  4. Slide 4: 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

  5. Slide 5: Iovance Accomplishments since 2016

    Iovance Accomplishments since 2016 5 © 2018, Iovance Biotherapeutics Developed a proprietary centralized and commercial CMC process (“Gen 2”) x x Replicated / demonstrated clinical activity using our novel Gen 2 process in melanoma post - checkpoint inhibitors (CPI) x Identified a fast - to - market

  6. Slide 6: Cryopreserved Autologous TIL (lifileucel, LN-144) Manufacturing Process: 22 days

    Excise tumor Clinical s ite to CMO Thaw and infuse LN - 144, followed by IL - 2 administration Fragmentation Expansion ex vivo ex vivo culture IL - 2 + OKT3 Co - culture TIL and feeder cells Rapid Expansion (REP) 11 days Tumor Fragment Culture (Pre - REP) 11 days + IL - 2 Cryopreserved TIL infusion

  7. Slide 7: Iovance company overview

    • 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 ̶ Fast Track ̶ RMAT ̶

  8. Slide 8: Iovance C-144-01 SITC Data Presentation

    Iovance C - 144 - 01 SITC Data Presentation © 2018, Iovance Biotherapeutics 8

  9. Slide 9: Iovance C-144-01 Study Design

    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) Endpoints: • Primary: Efficacy defined as investigator ORR • Secondary: Safety and efficacy Study Updates: • Cohort 2

  10. Slide 10: Iovance C-144-01 Patient Characteristics

    Iovance C - 144 - 01 Patient Characteristics: 10 © 2018, Iovance Biotherapeutics, Inc. Cohort 2 has: • 3.3 mean prior therapies, ranging from 1 - 9 • High tumor burden at baseline: 112 mm mean sum of diameters for the target lesions COHORT 2 CHARACTERISTIC Cohort 2, N= 47 , (%) Gender, n (%) Male 27

  11. Slide 11: Iovance C-144-01 Safety

    * One death was due to intra - abdominal hemorrhage considered possibly related to TIL and one was due to acute respiratory failur e not related to TIL per investigator assessment. Patients with multiple events for a given preferred term are counted only once using the maximum grade under each prefe

  12. Slide 12: Iovance C-144-01 Safety: Adverse Events over Time

    Frequency of AEs over time is reflective of potential benefit of one time treatment with TIL (lifileucel) Iovance C - 144 - 01 Safety: 12 Adverse Events over Time © 2018, Iovance Biotherapeutics, Inc. COHORT 2

  13. Slide 13: Iovance C-144-01 Efficacy

    • Median DOR is 6.4 months • Range of DOR was from 1.3+ to 14+ months * NE due to not reaching first assessment 1 uPRs (4) were not confirmed yet due to not having reached the second assessment as of 25 Oct 2018 Iovance C - 144 - 01 Efficacy © 2018, Iovance Biotherapeutics, Inc. 13 COHORT 2 RESPONSE

  14. Slide 14: Iovance C-144-01 Efficacy: Best Overall Response

    • Mean number of TIL cells infused: 26 x 10 9 • Median number of IL - 2 doses administered was 6.0 • 72% of patients had a reduction in tumor burden • Median study follow up is 6.0 months Four patients who had no disease assessment following autologous TIL (lifileucel, LN - 144) due to cancer - rela

  15. Slide 15: Iovance C-144-01 Efficacy: Time to Response

    (1) BOR is best overall response on prior anti - PD - 1 immunotherapy (2) U: unknown best overall response on prior anti - PD - 1 immunotherapy Iovance C - 144 - 01 Efficacy: 15 Time to Response for Evaluable Patients (PR or Better) © 2018, Iovance Biotherapeutics, Inc. COHORT 2

  16. Slide 16: Efficacy: Percent Change from Baseline in Target Lesions

    Iovance C - 144 - 01 Efficacy: 16 Percent Change from Baseline in Sum of Target Lesion Diameters over Time © 2018, Iovance Biotherapeutics, Inc. COHORT 2

  17. Slide 17: Iovance C-144-01: Conclusions

    • In heavily pretreated metastatic melanoma patients, preliminary efficacy is notable for: • ORR: 38% • Median DOR: 6.4 months, range 1.3+ to 14+ • DCR: 77% • 16/17 had no response to prior anti - PD - 1 Iovance C - 144 - 01: 17 Conclusions © 2018, Iovance Biotherapeutics, Inc. Preliminary data supp

  18. Slide 18: Lifileucel Registration Path

    Lifileucel Registration Path © 2018, Iovance Biotherapeutics 18

  19. Slide 19: Iovance C-144-01 Study Design

    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) Endpoints: • Primary: Efficacy defined as investigator ORR • Secondary: Safety and efficacy Study Updates: • Cohort 2

  20. Slide 20: End-of-Phase FDA Meeting Confirmed Accelerated Single-Arm Path to Approval

    End - of - Phase 2 FDA Meeting has Confirmed Accelerated Single - Arm Path to Approval in Advanced Melanoma © 2018, Iovance Biotherapeutics BICR = Blinded Independent Central Review 20 FDA End - of - Phase 2 Meeting (Sept - 18) • FDA acknowledged acceptability of single - arm data for registration •

  21. Slide 21: RMAT Designation Received for Lifileucel for Advanced Melanoma

    Regenerative Medicine Advanced Therapy (RMAT) Designation Received for Lifileucel for Advanced Melanoma © 2018, Iovance Biotherapeutics FDA’s RMAT Designation • Permits surrogate endpoints can be used for approval • Provides potential for accelerated approval • Increases sponsor access to FDA during

  22. Slide 22: Key Upcoming Melanoma and Manufacturing Milestones

    Key Upcoming Melanoma and Manufacturing Milestones 22 © 2018, Iovance Biotherapeutics 2018 2019 2020 2021 FDA End - of - Phase 2 Meeting (C - 144 - 01 / Melanoma) C - 144 - 01 (Melanoma) Begin new registrational cohort (4) enrollment Clinical Enrollment of Cohort 4 complete C - 144 - 01 (Melanoma) S

  23. Slide 23: LN-145 Program Update

    LN - 145 Program Update © 2018, Iovance Biotherapeutics 23

  24. Slide 24: Baseline Demographics: Cervical and Head & Neck Cancer

    © 2018, Iovance Biotherapeutics BASELINE DEMOGRAPHICS PATIENTS, N= 15 1 n (%) Prior therapies, n (%) Median prior therapies (min, max) 5 (1, 8) Anti - PD - 1 8 (53) Anti - CTLA - 4 2 (13) 24 Cervical Cancer (C - 145 - 04) Baseline Demographics Head & Neck Cancer (C - 145 - 03) Baseline Demographics

  25. Slide 25: Safety: Cervical and Head & Neck Cancer

    TEAE: Treatment emergent adverse event PT: Preferred term © 2018, Iovance Biotherapeutics SAFETY: TEAE (≥40%) BY PT, any grade PATIENTS, N=15 n (%) Chills 11 (73) Pyrexia 8 (53) Anaemia 7 (47) Hypotension 6 (40) Platelet count decreased 6 (40) Vomiting 6 (40) 25 Cervical Cancer (C - 145 - 04) Safety

  26. Slide 26: Clinical Evidence of Efficacy in Cervical and Head & Neck Cancer post-CPI

    Clinical Evidence of Efficacy in Cervical and Head & Neck Cancer post - CPI © 2018, Iovance Biotherapeutics 1 The patients reported are a combination of Gen 1 and Gen 2 manufacturing process 2 uPRs were not confirmed yet due to not having reached the second assessment as of 4 Oct 2018 Note: the comp

  27. Slide 27: Iovance Current and Future 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 + durvalumab 12 Melanoma, Head & Neck, Non - Small Cell Lung Cancer TIL LN - 144 + pembrolizumab TIL LN -

  28. Slide 28: 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

  29. Slide 29: 2019 Goals

    2019 Goals 29 © 2018, Iovance Biotherapeutics Enrollment into Cohort 4 for C - 144 - 01 in support of registration Continue the dialog with FDA for both LN - 144 and LN - 145 in support of registration Initiate building Iovance manufacturing facility Demonstrated activity in other tumor types and li

  30. Slide 30: © 2018, Iovance Biotherapeutics, Inc.

    © 2018, Iovance Biotherapeutics, Inc.

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