Iovance Biotherapeutics, Inc. · NASDAQ:IOVA

Iovance Biotherapeutics — Investor Presentation (May 2022)

32 slides from Iovance Biotherapeutics's investor presentation, May 13, 2022

  1. Slide 1: Corporate Overview May 2022

    1 © 2022, Iovance Biotherapeutics, Inc. Corporate Overview May 2022 1

  2. Slide 2: Forward-Looking Statements

    2 Forward - Looking Statements © 2022, Iovance Biotherapeutics, Inc. Certain matters discussed in this presentation are “forward - looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litiga

  3. Slide 3: Global Leadership in Innovating, Developing and Delivering TIL Therapy for Patients with Cancer

    3 Global Leadership in Innovating, Developing and Delivering TIL Therapy for Patients with Cancer Active Clinical Trials Platform Pipeline Partners & C o l l a b o r a t o r s BTD: Breakthrough Therapy Designation; RMAT: Regenerative Medicine Advanced Therapy Designation 22 - day Proprietary Manufac

  4. Slide 4: Iovance Immuno-Oncology Pipeline

    4 Iovance Immuno - Oncology Pipeline IND=investigational new drug; ipi/nivo=ipilimumab/nivolumab; NSCLC=non - small cell lung cancer; PBL=peripheral blood lymphocytes; RMAT=Regenerative Medicines Advanced Therapy; TIL=tumor infiltrating lymphocytes © 2022, Iovance Biotherapeutics, Inc. PRODUCT CANDI

  5. Slide 5: Significant Market Potential in Solid Tumors

    5 Potential market for early lines in combo with standard of care Potential to address unmet need in late lines of treatment 1. https://seer.cancer.gov accessed February 2022 Melanoma Cervical Lung & Bronchus Oral Cavity, Pharynx & Larynx Breast Pancreatic Brain & Other Nervous System Deaths 1 7,180

  6. Slide 6: Tumor Infiltrating Lymphocytes (TIL): Leading Platform for Treatment of Solid Tumors

    6 Tumor Infiltrating Lymphocytes (TIL): Leading Platform for Treatment of Solid Tumors TIL – Unique Mechanism of Action • Highly personalized • One - time therapy • Patient’s own immune system amplified and rejuvenated Remove Tumor Sample Expand & Rejuvenate Patient - specific T Cells 1 L y m p h o

  7. Slide 7: TIL Mechanism of Action

    7 T u m o r TIL Mechanism of Action Infusion of tumor infiltrating lymphocytes (TIL) P e ri p h e r a l blood Blood v e s s e l T u m o r cell T I L T I L T u m o r bed T I L L y s i n g t u m o r cell T - cell Tumor MHC - I/II receptor neoantigen peptides C h e m ok i n e receptor Circulation Migra

  8. Slide 8: Iovance Streamlined 22-Day GMP Manufacturing Process

    8 Iovance Streamlined 22 - Day GMP Manufacturing Process 1 Patient Intake 2 Tumor Sample Procurement 3 4 N M A - L D T I L 5 6 I L - 2 Recovery/Discharge 4 2 Gen 2 Process: 22 Days © 2022, Iovance Biotherapeutics, Inc. © 2022, Iovance Biotherapeutics, Inc.

  9. Slide 9: Iovance Cell Therapy Center: iCTC

    9 Iovance Cell Therapy Center: i CTC Built - to - suit custom facility in Navy Yard Philadelphia 136,000 ft 2 , $85M investment LEED gold certification for core and shell building First set of clean rooms occupied Clinical supply initiated 3Q21 Commercial manufacturing expected with BLA approval Sig

  10. Slide 10: Broad, Iovance-Owned IP Around TIL Therapy

    1 0 Broad, Iovance - Owned IP Around TIL Therapy TIL products and compositions: Gen 2, Gen 3, use of co - stimulants, selection of TIL, stable and transient genetic modifications, cryopreservation 4 2 TIL from: • Tumor • Marrow infiltrating lymphocytes • Peripheral blood lymphocytes • Frozen tumor t

  11. Slide 11: Clinical Data Highlights

    1 1 © 2022, Iovance Biotherapeutics, Inc. Clinical Data Highlights

  12. Slide 12: Potential Market for Metastatic Melanoma

    1 2 © 2022, Iovance Biotherapeutics, Inc . 1. Global Burden of Disease Cancer Collaboration, JAMA Oncol 2019 2. https://seer.cancer.gov accessed February 2022 3.Keytruda USPI accessed Mar 2021 4. Keytruda USPI accessed Mar 2021 (4%) and Weber et al., Lancet Oncol 2015 (ICC 10%) 5. Kirchburger et al.

  13. Slide 13: Iovance TIL Clinical Data Highlights in Melanoma

    1 3 1. As assessed by investigator using RECIST 1.1 (data extraction: April 22, 2021). Larkin, et. al. ASCO 2021. Abstract #9505. Abbreviations: CR, complete response; DOR, duration of response; ORR, overall response rate; PR, partial response; SD, stable disease Best Overall Response Time to Respon

  14. Slide 14: Potential Market for Non-Small Cell Lung Cancer

    1 4 1. Global Burden of Disease Cancer Collaboration, JAMA Oncol 2019 2. https://seer.cancer.gov accessed February 2022 3. Brahmer et al., NEJM 2015; Borghaei et al., NEJM 2015; Herbst et al., Lancet 2016; Rittmeyer et al., Lancet 2017 Potential Market for Non - Small Cell Lung Cancer (NSCLC) in Sec

  15. Slide 15: Iovance TIL Clinical Data Highlights in NSCLC

    1 5 Single - Agent LN - 145 Following Progression on Anti - PD - 1 Therapy (IOV - COM - 202 Cohort 3B, N=28) 1 Iovance TIL Clinical Data Highlights in NSCLC Best Overall Response for Evaluable Patients 1 (n=24) Time to Response for Confirmed Responders 1 (PR or Better; n=6) Heavily Pre - Treated Pat

  16. Slide 16: TIL for Solid Tumors in Earlier Treatment Settings

    1 6 TIL for Solid Tumors in Earlier Treatment Settings 1. Robert C, et al. N Engl J Med 2015; 372:2521 - 2532 2. Burtness B, et al. Lancet 2019; 394:1915 - 1928 3. KEYTRUDA (pembrolizumab) USPI Abbreviations: HNSCC, head and neck squamous cell carcinoma; ORR, objective response rate; TIL, tumor infi

  17. Slide 17: Best Overall Response for Iovance TIL+Pembro in 3 Solid Tumors

    1 7 S I T C 2 0 2 1 Best Overall Response for Iovance TIL+Pembro in 3 Solid Tumors Consistent Reductions in Tumor Burden Compared to Pembro Alone in Melanoma, Cervical and HNSCC 1 COM - 202 Cohort 1A Melanoma COM - 202 Cohort 2A HNSCC C - 145 - 04 Cohort 3 Cervical • Melanoma, 60.0% (including 3 CRs

  18. Slide 18: Time to Response (PR or Better) in Solid Tumors

    1 8 Time to Response (PR or Better) in 3 Solid Tumors 1 Ongoing responses at data cutoff: • Melanoma, 66.7% (4/6) • HNSCC, 50.0% (3/6) • Cervical, 71.4% (5/7) Median study follow - up (months): † • Melanoma, 11.5 • HNSCC, 7.8 • Cervical, 7.6 Prior Therapy Type PD - L1 Status ‡ Pt ID COM - 202 Cohort

  19. Slide 19: Best Overall Response (by Investigator) – April 2022 Update

    1 9 CR: complete response, PR: partial response, SD: stable disease, PD: progressive disease, NE: non - evaluable Best Overall Response (by Investigator) – April 2022 Update IOV - COM - 202 Cohort 1A, Melanoma (N=12) Objective Response Rate, n (%) 8 (66.7) (95% CI) (34.9, 90.1) Disease Control Rate,

  20. Slide 20: Efficacy: Best Overall Response and Time to Response – April 2022 Update

    2 0 Efficacy: Best Overall Response and Time to Response for Evaluable Patients (by Investigator) – April 2022 Update I O V - C O M - 2 0 2 C o h o r t 1 A M e la n o m a C o m b i n a t i o n ( T I L + P e m b r o l i z u m a b ) - D a t a C u t o f f : J a n u a r y 2 0 , 2 0 2 2 Best Overall Resp

  21. Slide 21: Launch Preparation

    2 1 © 2022, Iovance Biotherapeutics, Inc. Launch P r e p a r a t i o n

  22. Slide 22: Best-in-Class Manufacturing

    2 2 Best - in - Class Manufacturing Continuous cost, quality & efficiency improvement Reduce m a t e r i a l costs C o n s i s t e n t success rates R e d u n d a n t & reliable suppliers Increase t h r o u g h p u t Reduce o v e r h e a d costs © 2022, Iovance Biotherapeutics, Inc.

  23. Slide 23: Targeting Potential Authorized Treatment Centers (ATCs)

    2 3 Targeting Potential Authorized Treatment Centers (ATCs) Potential ATC Iovance Clinical Trial Site 1 1. ClinicalTrials.gov Targeting C o n s i d e r a t i o n s • Patient volume • NCCN status, KOLs • Existing cell therapy / BMT • Iovance clinical trial(s) Drive Demand • Top account prioritization

  24. Slide 24: Supporting Providers & Patients: IovanceCares

    2 4 Supporting Providers & Patients: IovanceCares Œ Abbreviations: COI, Chain of Identity; COC, Chain of Custody Customer - Centric • Patient management ecosystem • Proprietary COI/COC • Treatment center quality program Patient - Centric • Dedicated case managers • Reimbursement support • Patient su

  25. Slide 25: Research Pipeline

    2 5 © 2022, Iovance Biotherapeutics, Inc. Research Pipeline

  26. Slide 26: Research Pipeline: What's Next

    2 6 Cellectis TALEN ® collaboration agreement to support clinical programs 1 IOV - 4001 IND allowance PD - 1+ selected TIL CD39/69 double negative TILs 2 Gen 3 (16 - day) process (COM - 202) Core biopsy (LUN - 202 study) IOV - 3001 IL - 2 analog licensed from Novartis: IND enabling studies in 2022 W

  27. Slide 27: Advancing Genetically-Modified TIL Toward the Clinic

    2 7 Advancing Genetically - Modified TIL Toward the Clinic Additional immune c h e ck p o i n t targets Additional transient and stable gene insertion and inactivation Cytokine tethered TILs IND Allowance for PD - 1 Inactivated TIL (IOV - 4001) to Enter Clinical Study in 2022 © 2022, Iovance Biother

  28. Slide 28: Financial Summary & Milestones

    2 8 © 2022, Iovance Biotherapeutics, Inc. Financial Summary & Milestones

  29. Slide 29: Well-Capitalized in Pursuit of TIL Commercialization

    2 9 March 31, 2022 Common shares outstanding In millions (unaudited) 1 5 7 . 2 Preferred shares outstanding 2 . 9 1 Stock options and restricted stock units outstanding 1 7 . 2 Cash, cash equivalents, investments, restricted cash $ 5 1 6 . 0 2 Anticipated cash runway sufficient into 2024 © 2022, Iov

  30. Slide 30: 2021 Accomplishments and Anticipated 2022 Milestones

    3 0 2021 Accomplishments Anticipated 2022 Milestones R E G U L A T O R Y • BLA: FDA feedback received for potency assays; additional assay data submission & interactions 2H21 • BLA: on track for August 2022 BLA submission P I P E L I N E • Melanoma and Cervical: TIL + pembrolizumab data at ASCO and

  31. Slide 31: Investment Highlights

    3 1 Investment Highlights © 2022, Iovance Biotherapeutics, Inc. © 2022, Iovance Biotherapeutics, Inc. Pioneering a Transformational Approach to Cure Cancer Large market opportunity & strong unmet need Potential to be first one - time cell therapy approved for solid tumors Efficient & scalable propri

  32. Slide 32: Thank You

    3 2 Thank You © 2022, Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics — Investor Presentation (May 2022) on 6ix