Iovance Biotherapeutics, Inc. · NASDAQ:IOVA

Iovance Biotherapeutics — Investor Presentation (August 2023)

50 slides from Iovance Biotherapeutics's investor presentation, Aug 18, 2023

  1. Slide 1: Corporate Overview

    1 © 2023, Iovance Biotherapeutics, Inc. © 2023, Iovance Biotherapeutics, Inc. Corporate Overview August 16, 2023 1

  2. Slide 2: Forward-Looking Statements

    2 © 2023, Iovance Biotherapeutics, Inc. Forward - Looking Statements Certain matters discussed in this press release are “forward - looking statements” of Iovance Biotherapeutics, Inc. (hereinafter r eferred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Liti

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

    3 © 2023, Iovance Biotherapeutics, Inc. Global Leadership in Innovating, Developing and Delivering TIL Therapy for Patients with Cancer Platform Pipeline People & Assets Partners & Collaborators Abbreviations: BLA=Biologics License Application; BTD=Breakthrough Therapy Designation; RMAT=Regenerative

  4. Slide 4: Proleukin Transaction Strategic Benefits

    4 © 2023, Iovance Biotherapeutics, Inc. Proleukin ® Transaction Strategic Benefits • Global rights to Proleukin ® ( aldesleukin , human recombinant IL - 2) and associated revenue • Secure IL - 2 supply chain for lifileucel regimen • Lower clinical trial costs and future COGS • Significant additional

  5. Slide 5: Iovance Solid Tumor Pipeline Highlights

    5 © 2023, Iovance Biotherapeutics, Inc. *Enrollment complete Abbreviations: 1L=first line; 2L=second line; 4L=fourth line; BTD=Breakthrough Therapy Designation; FTD=Fast Track Designatio n; ipi / nivo =ipilimumab/nivolumab; NSCLC=non - small cell lung cancer; ODD=Orphan Drug Designation; PD - 1=prog

  6. Slide 6: Significant Market Potential in Solid Tumors and our Key Programs

    6 © 2023, Iovance Biotherapeutics, Inc. 1. National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2023 Estimates. https://seer.cancer.g ov accessed May 2023 Deaths 1 New Cases 1 Melanoma 8K 98K Cervical 4K 14K Lung & Bronchus 127K 238K 91% of all cancer cases are solid

  7. Slide 7: Tumor Infiltrating Lymphocytes (TIL): Leading Platform for Treatment of Solid Tumors

    7 © 2023, Iovance Biotherapeutics, Inc. Tumor Infiltrating Lymphocytes (TIL): Leading Platform for Treatment of Solid Tumors TIL – Unique Mechanism of Action • Individualized • Patient’s own immune system amplified and rejuvenated • One - time therapy Remove Tumor Sample Expand & Rejuvenate Patient

  8. Slide 8: TIL Mechanism of Action

    8 © 2023, Iovance Biotherapeutics, Inc. Tumor TIL Mechanism of Action TIL Peripheral blood Blood vessel Tumor cell TIL TIL Tumor bed TIL Lysing tumor cell T - cell receptor Tumor neoantigen peptides MHC - I/II Chemokine receptor Circulation Migration Peptide Antigen Recognition Lysis (Tumor Killing)

  9. Slide 9: Iovance Streamlined GMP Manufacturing Process

    9 © 2023, Iovance Biotherapeutics, Inc. Iovance Streamlined 22 - Day GMP Manufacturing Process 1 2 Patient Intake Tumor Sample Procurement 3 4 NMA - LD TIL 5 6 IL - 2 Recovery/Discharge 4 2 Gen 2 Process: 22 Days 9 © 2023, Iovance Biotherapeutics, Inc.

  10. Slide 10: Leading Cell Therapy Manufacturing Facility

    10 © 2023, Iovance Biotherapeutics, Inc. 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 Honorable Mention Winner: 2022 ISPE Facility of the Year Awards Clinical supply i

  11. Slide 11: Iovance Cell Therapy Center: Building Annual Capacity for Thousands of Cancer Patients

    11 © 2023, Iovance Biotherapeutics, Inc. Iovance Cell Therapy Center ( i CTC ): Building Annual Capacity for Thousands of Cancer Patients Phase 1 iCTC Today 100s of patients/year BLA Prep in core suites for commercial 4 separate flex suites for clinical Phase 2 iCTC Ongoing Staffing 2,000+ patients/

  12. Slide 12: Iovance TIL Therapy in Advanced Melanoma

    12 © 2023, Iovance Biotherapeutics, Inc. 12 Iovance TIL Therapy in Advanced Melanoma

  13. Slide 13: Unmet Medical Need for Metastatic Melanoma Therapy

    13 © 2023, Iovance Biotherapeutics, Inc. 1. Estimate of US incidence (2021) of unresectable or metastatic melanoma based on secondary and primary market research 2. National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2023 Estimates. https://seer.cancer.gov accessed M

  14. Slide 14: Estimated incidence of unresectable or metastatic melanoma by initial disease stage

    14 © 2023, Iovance Biotherapeutics, Inc. Estimated total incidence and incidence of unresectable or metastatic melanoma by initial disease stage (US) 5% 34% 4% 24% 4% 5% 14% 16% 73% 21% ~100,000 ~15,000 Stage I Stage II Stage III - unresectable Stage III - resectable Stage IV 1. Estimate of US incid

  15. Slide 15: C-144-01 Phase 2 Study Design

    15 © 2023, Iovance Biotherapeutics, Inc. C - 144 - 01 Phase 2 Study Design Abbreviations: DOR=duration of response; ECOG=Eastern Cooperative Oncology Group; IL - 2=interleukin 2; IRC=Independent Review Committee; NMA - LD= nonmyeloablative lymphodepletion; ORR=objective response rate; OS=overall sur

  16. Slide 16: Highlighted Prior Therapy and Baseline Disease Characteristics

    16 © 2023, Iovance Biotherapeutics, Inc. Highlighted Prior Therapy and Baseline Disease Characteristics* *Refer to SITC 2022 presentation for full baseline characteristics 1. All patients received prior anti - PD1 therapy Abbreviations: CTLA - 4=cytotoxic T - lymphocyte antigen 4; ICI=immune checkpo

  17. Slide 17: Safety: Non-Hematologic TEAEs in ≥30% of Patients

    17 © 2023, Iovance Biotherapeutics, Inc. Safety Non - Hematologic TEAEs in ≥ 30% of Patients* , † *Per CTCAE v4.03; Safety Analysis Set (N=156). † Grade 5 TEAEs included pneumonia (n=1), acute respiratory failure (n=1), arrhythmia (n=1), and intra - abdominal hemorrhage (n=1). All occurrences of AEs

  18. Slide 18: Objective Response Rate (ORR) of 31.4% by IRC

    18 © 2023, Iovance Biotherapeutics, Inc. Objective Response Rate (ORR) of 31.4% by IRC SITC 2022 C - 144 - 01 COHORTS 2 + 4 POOLED ANALYSIS ASSESSED BY IRC USING RECIST 1.1 91% Concordance Rate between IRC - and Investigator - assessed ORR *Patient did not have acceptable target lesions and had best

  19. Slide 19: Tumor Burden Reduction and Best Response to Lifileucel

    19 © 2023, Iovance Biotherapeutics, Inc. Tumor Burden Reduction and Best Response to Lifileucel SITC 2022 C - 144 - 01 COHORTS 2 + 4 POOLED ANALYSIS ASSESSED BY IRC USING RECIST 1.1 13 patients in the full analysis set are not included (9 had no post lifileucel target lesion SOD measurements, and 4

  20. Slide 20: Time to Response, Duration of Response, and Time on Efficacy Assessment

    20 © 2023, Iovance Biotherapeutics, Inc. Time to Response, Duration of Response, and Time on Efficacy Assessment for Confirmed Responders (PR or Better) SITC 2022 C - 144 - 01 COHORTS 2 + 4 POOLED ANALYSIS ASSESSED BY IRC USING RECIST 1.1 • Median time from lifileucel infusion to best response was 1

  21. Slide 21: Duration of Response

    21 © 2023, Iovance Biotherapeutics, Inc. Cohort 2 (n=23) Cohort 4 (n=25) Cohort 2+4 (N=48) Median follow - up, months 45.1 33.0 36.5 95% CI (44.2, 51.4) (30.4, 35.2) (34.7, 44.2) Median DOR † , months NR 10.4 NR 95% CI (NR, NR) (4.1, NR) (8.3, NR) Min, max (months) 1.4+, 54.1+ 1.4+, 34.3+ 1.4+, 54.1

  22. Slide 22: Iovance TIL Clinical Highlights in Combination with Pembrolizumab in Metastatic Melanoma

    22 © 2023, Iovance Biotherapeutics, Inc. Lifileucel in combination with anti - PD - 1/PD - L1 therapy in ICI - naïve patients (IOV - COM - 202 Cohort 1A, N=12 ) 1 Iovance TIL Clinical Highlights in Combination with Pembrolizumab in Metastatic Melanoma IOV - COM - 202 COHORT 1A MELANOMA COMBINATION (

  23. Slide 23: TILVANCE-301: Global Phase 3 Confirmatory Trial

    23 © 2023, Iovance Biotherapeutics, Inc. 1:1 Randomization TILVANCE - 301 Global Phase 3 and Confirmatory Trial LIFILEUCEL + PEMBROLIZUMAB IN FRONTLINE ADVANCED MELANOMA Abbreviations: BIRC, blinded independent review committee; ORR=objective response rate; PD=progressive disease; PD - 1, programme

  24. Slide 24: Iovance TIL Therapy in Non-Small Cell Lung Cancer

    24 © 2023, Iovance Biotherapeutics, Inc. 24 Iovance TIL Therapy in Non - Small Cell Lung Cancer

  25. Slide 25: Potential Market for Advanced Non-Small Cell Lung Cancer (NSCLC)

    25 © 2023, Iovance Biotherapeutics, Inc. 1. National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2023 Estimates. https://seer.cancer.gov acc essed May 2023 2. American Cancer Society, Lung Cancer. https://www.cancer.org/cancer/types/lung - cancer/about.html accessed J

  26. Slide 26: IOV-LUN-202 Trial Design

    26 © 2023, Iovance Biotherapeutics, Inc. IOV - LUN - 202 Trial Design Phase 2 Multicenter Study of LN - 145 † in Patients Post - Anti - PD - 1 NSCLC (NCT04614103) Endpoints • Primary: ORR by IRC • Secondary: Safety * Cohort 3 patients unable to undergo surgical harvest, TIL grown from core biopsy. †

  27. Slide 27: Preliminary Clinical Results for IOV-LUN-202 Cohorts 1 and 2

    27 © 2023, Iovance Biotherapeutics, Inc. All Patients Progressed on or After Anti - PD - 1 Therapy and Chemotherapy Preliminary Clinical Results for IOV - LUN - 202 Cohorts 1 and 2 1. Data cut: July 6, 2023. Responses were assessed by investigator. 2. Patients who have progressed on or after chemoth

  28. Slide 28: Objective Response Rate of 26.1% by RECIST 1.1, Regardless of PD-L1 Status

    28 © 2023, Iovance Biotherapeutics, Inc. Objective Response Rate of 26.1% by RECIST 1.1, Regardless of PD - L1 Status Preliminary Clinical Results for IOV - LUN - 202 Cohorts 1 and 2 IOV - LUN - 202 COHORTS 1 AND 2, POST - ANTI - PD - 1 NSCLC, JULY 6, 2023 Data cut: July 6, 2023. 21 evaluable patien

  29. Slide 29: All Responses Remain Ongoing at Time of Data Cut

    29 © 2023, Iovance Biotherapeutics, Inc. All Responses Remain Ongoing at Time of Data Cut Data cut: July 6, 2023. A bar is presented for each patient starting from date of LN - 145 infusion up to date of new anti - cancer therapy, end of assessme nt, death, or data cutoff date, whichever occurs earl

  30. Slide 30: Preliminary Clinical Results in ICI Naïve NSCLC

    30 © 2023, Iovance Biotherapeutics, Inc. Preliminary Clinical Results in ICI Naïve NSCLC Clinical Activity • 8/17 patients had a confirmed objective response per RECIST 1.1 (2 CRs and 6 PRs) • Responses observed regardless of PD - L1 status • Safety consistent with Iovance TIL combination studies •

  31. Slide 31: Durable Responses Observed in EGFR WT Disease

    31 © 2023, Iovance Biotherapeutics, Inc. Durable Responses Observed, Including 3 Ongoing Responders with EGFR WT Disease, at a Median Study Follow up of 18.2 Months Time to Response for Confirmed Responders (n=8) IOV - COM - 202 COHORT 3A NSCLC COMBINATION (TIL+PEMBROLIZUMAB ), WCLC ORAL PRESENTATIO

  32. Slide 32: Moving TIL Therapy into Relevant Lines of Therapy in NSCLC

    32 © 2023, Iovance Biotherapeutics, Inc. 1L Therapy 2L Therapy 3L Therapy 4L Therapy SOC IOVA Trial SOC IOVA Trial SOC IOVA Trial SOC IOVA Trial Anti - PD - 1 Mono ORR 39 - 45% 1 COM - 202 Cohort 3A Chemo Doublet COM - 202 Cohort 3C Docetaxel or Docetaxel + Ramucirumab ORR 9 - 23% 2 LUN - 202 Cohort

  33. Slide 33: IOV-GM1-201 Phase 1/2 First-in-Human Study

    33 © 2023, Iovance Biotherapeutics, Inc. Phase 1/2 Open - Label First - in - Human Study: IOV - GM1 - 201 Endpoints • Phase 1: Safety • Phase 2: Objective Response Rate (ORR) per RECIST v1.1 as assessed by the investigator • Secondary endpoints include complete response (CR) rate, duration of respon

  34. Slide 34: Launch Preparation

    34 © 2023, Iovance Biotherapeutics, Inc. 34 Launch Preparation

  35. Slide 35: iCTC Designed for High-Volume TIL Manufacturing and Flexibility

    35 © 2023, Iovance Biotherapeutics, Inc. i CTC Designed for High - Volume TIL Manufacturing and Flexibility • Core suites: TIL commercial manufacturing • Flexible suites: clinical supply, pipeline expansion and advanced manufacturing • Integrated quality control, supply chain and IT systems • 100+ e

  36. Slide 36: Targeting Potential Authorized Treatment Centers (ATCs)

    36 © 2023, Iovance Biotherapeutics, Inc. Targeting Potential Authorized Treatment Centers (ATCs) Potential ATC Iovance Clinical Trial Site 1 1. ClinicalTrials.gov Abbreviations: NCCN=National Comprehensive Cancer Network; KOL=Key Opinion Leaders; BMT=Bone Marrow Transplant Targeting Considerations •

  37. Slide 37: Hospital Bed Capacity Supports Broad Lifileucel Adoption at ATCs

    37 © 2023, Iovance Biotherapeutics, Inc. Hospital Bed Capacity • HHS data reinforce sufficient overall bed availability at target ATCs 1 ̶ Average of ~ 91 available beds per target ATC • Target ATCs report sufficient oncology bed availability for anticipated lifileucel demand 2 ̶ Average of ~25 avai

  38. Slide 38: Supporting Providers & Patients: IovanceCares

    38 © 2023, Iovance Biotherapeutics, Inc. Supporting Providers & Patients: IovanceCares ¯ 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 •

  39. Slide 39: Enabling Market Access

    39 © 2023, Iovance Biotherapeutics, Inc. 55% Commercial 17% Medicare Advantage 12% Medicare FFS 7% Medicaid 9% Other Enabling Market Access Metastatic Melanoma Payer Mix 1 All Treatment Settings and Lines of Therapy 1. Metastatic Melanoma Insurance Claims Analysis, TIL - eligible patients treated in

  40. Slide 40: Other TIL Therapy Clinical Program Highlights

    40 © 2023, Iovance Biotherapeutics, Inc. 40 Other TIL Therapy Clinical Program Highlights

  41. Slide 41: Potential Market for Cervical Cancer

    41 © 2023, Iovance Biotherapeutics, Inc. Potential Market for Cervical Cancer 1. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, CA Ca ncer J Clin., May 2021; 2. National Cancer Institute Surveillance, Epidemiology and End Resul

  42. Slide 42: Pivotal Phase 2 Trial of Lifileucel in Cervical Carcinoma

    42 © 2023, Iovance Biotherapeutics, Inc. Pivotal Phase 2 Trial of Lifileucel in Recurrent, Metastatic or Persistent Cervical Carcinoma (NCT03108495) Endpoints (Pivotal Cohort 2) • Primary: ORR as determined by IRC • Secondary: safety and efficacy Study Updates • 4Q21: initial Cohort 3 data at SITC 1

  43. Slide 43: Next-Generation Research Programs

    43 © 2023, Iovance Biotherapeutics, Inc. 43 Next - Generation Research Programs

  44. Slide 44: Trailblazing Next-Generation TIL Programs

    44 © 2023, Iovance Biotherapeutics, Inc. Genetically modify TIL Optimize TIL composition Next - generation processes Expand TIL into new regimens Cellectis gene - editing TALEN ® collaboration 1,2 PD - 1 and other immune checkpoint targets (single and multiple knockouts) Cytokine - tethered TILs PD

  45. Slide 45: Corporate Summary & Milestones

    45 © 2023, Iovance Biotherapeutics, Inc. 45 Corporate Summary & Milestones

  46. Slide 46: Well-Capitalized in Pursuit of TIL Commercialization

    46 © 2023, Iovance Biotherapeutics, Inc. June 30, 2023 (in millions) Cash, cash equivalents, investments, restricted cash $317.3 1 Common shares outstanding 224.7 Preferred shares outstanding 2.9 2 Stock options and restricted stock units outstanding 23.6 1. Includes Restricted Cash of $6.4 million

  47. Slide 47: Broad, Iovance-Owned IP Around TIL Therapy

    47 © 2023, Iovance Biotherapeutics, Inc. 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 1 Tumor Sample Procurement 3 4 NMA - LD TIL Infusion 5 IL - 2 Infu

  48. Slide 48: Corporate Highlights

    48 © 2023, Iovance Biotherapeutics, Inc. Corporate Highlights Pioneering a Transformational Approach to Cure Cancer Large Market Opportunity in High Unmet Need Cancers Potential for First Cell Therapy Approved for Solid Tumors Efficient and Scalable Proprietary Manufacturing Facility Infrastructure

  49. Slide 49: Anticipated 2023 Milestones

    49 © 2023, Iovance Biotherapeutics, Inc. Anticipated 2023 Milestones REGULATORY • BLA: Complete rolling BLA submission for lifileucel in post - anti - PD - 1 advanced melanoma in Q1 2023 • BLA: Obtain FDA approval PIPELINE • Melanoma: enroll patients in frontline advanced melanoma Phase 3 confirmato

  50. Slide 50: Thank You

    50 © 2023, Iovance Biotherapeutics, Inc. © 2023, Iovance Biotherapeutics, Inc. Thank You

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