Iovance Biotherapeutics, Inc. · NASDAQ:IOVA

Iovance Biotherapeutics — Investor Presentation (January 2024)

54 slides from Iovance Biotherapeutics's investor presentation, Jan 26, 2024

  1. Slide 1: Corporate Overview January 25, 2024

    1 © 2024, Iovance Biotherapeutics, Inc. © 2024, Iovance Biotherapeutics, Inc. Corporate Overview January 25, 2024 1

  2. Slide 2: Forward-Looking Statements

    2 © 2024, 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 © 2024, 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; LCM=late - cycle

  4. Slide 4: Iovance Solid Tumor Pipeline Highlights

    4 © 2024, 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=program

  5. Slide 5: Significant Market Potential in Solid Tumors and our Key Programs

    5 © 2024, 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. World Health Organization International Agency for Research on Cancer (IARC). GLOBOCAN 2020 U.S. Deaths 1 Glob

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

    6 © 2024, 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

  7. Slide 7: TIL Mechanism of Action

    7 © 2024, 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)

  8. Slide 8: Iovance Streamlined GMP Manufacturing Process

    8 © 2024, 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 8 © 2024, Iovance Biotherapeutics, Inc. Abbreviations: GMP= good manufacturing practice

  9. Slide 9: Leading Cell Therapy Manufacturing Facility

    9 © 2024, 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 Clinical supply initiated 3Q21 Successfully completed FDA Pre - License Inspection

  10. Slide 10: Iovance Cell Therapy Center: Building Annual Capacity for Thousands of Cancer Patients

    10 © 2024, 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 Launch Prep in core suites for commercial 4 separate flex suites for clinical Phase 2 iCTC Ongoing Staffing 2,000+ patient

  11. Slide 11: Iovance TIL Therapy in Advanced Melanoma

    11 © 2024, Iovance Biotherapeutics, Inc. 11 Iovance TIL Therapy in Advanced Melanoma

  12. Slide 12: U.S. Unmet Medical Need for Metastatic Melanoma Therapy

    12 © 2024, Iovance Biotherapeutics, Inc. U.S. Unmet Medical Need for Metastatic Melanoma Therapy No FDA Approved Treatment Options After Progression on ICI (Anti - PD - 1) Therapy and BRAF/MEK inhibitors BRAF/MEK inhibitors if BRAF mutation + Chemotherapy ORR 4 - 10% 5 mOS ~7 - 8 months 6 Anti - PD

  13. Slide 13: Ex-U.S. Unmet Medical Need for Metastatic Melanoma Therapy

    13 © 2024, Iovance Biotherapeutics, Inc. 1. World Health Organization International Agency for Research on Cancer (IARC). GLOBOCAN 2020 2. Clarivate DRG Disease Landscape (2021) Ex - U.S. Unmet Medical Need for Metastatic Melanoma Therapy Opportunity to double addressable patient population with ex

  14. Slide 14: C-144-01 Phase 2 Study Design

    14 © 2024, 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

  15. Slide 15: Highlighted Prior Therapy and Baseline Disease Characteristics

    15 © 2024, 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

  16. Slide 16: Safety: Non-Hematologic TEAEs in ≥30% of Patients

    16 © 2024, 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

  17. Slide 17: Objective Response Rate (ORR) of 31.4% by IRC

    17 © 2024, 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

  18. Slide 18: Tumor Burden Reduction and Best Response to Lifileucel

    18 © 2024, 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

  19. Slide 19: Time to Response, Duration of Response, and Time on Efficacy Assessment

    19 © 2024, 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

  20. Slide 20: Duration of Response

    20 © 2024, 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

  21. Slide 21: Iovance TIL Clinical Highlights in Combination with Pembrolizumab in Metastatic Melanoma

    21 © 2024, 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 (

  22. Slide 22: TILVANCE-301 Global Phase 3 Confirmatory Trial

    22 © 2024, 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

  23. Slide 23: Proleukin Transaction Strategic Benefits

    23 © 2024, 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 re

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

    24 © 2024, 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 © 2024, 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 Phase 2 Trial Design of LN-145 in Post-Anti-PD-1 NSCLC

    26 © 2024, 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 * U.S. FDA placed a clinical hold on the IOV - LUN - 202 trial on December 22, 2023

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

    27 © 2024, 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 © 2024, 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 © 2024, 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: Proof-of-Concept for TIL in ICI-Naïve NSCLC Regardless of PD-L1 Status

    30 © 2024, Iovance Biotherapeutics, Inc. Proof - of - Concept for TIL in ICI - Naïve NSCLC Regardless of PD - L1 Status Cohort 3A Summary IOV - COM - 202 COHORT 3A NSCLC COMBINATION (TIL+PEMBROLIZUMAB ), WCLC ORAL PRESENTATION (JUNE 26, 2023 DATA CUT) Cohort 3A Results Support Adding TIL Therapy to

  31. Slide 31: TIL Activity Across ICI Naïve Subgroups and TPS Scores

    31 © 2024, Iovance Biotherapeutics, Inc. TIL Activity Across ICI Naïve Subgroups and TPS Scores, Including 58.3% ORR in Patients with EGFR WT Disease Best Response and Percent Change in Target Lesion SOD IOV - COM - 202 COHORT 3A NSCLC COMBINATION (TIL+PEMBROLIZUMAB ), WCLC ORAL PRESENTATION (JUNE 2

  32. Slide 32: Time on Study for Confirmed EGFR WT Responders

    32 © 2024, Iovance Biotherapeutics, Inc. Time on Study for Confirmed EGFR WT Responders (n=7) IOV - COM - 202 COHORT 3A NSCLC COMBINATION (TIL+PEMBROLIZUMAB ), WCLC ORAL PRESENTATION (JUNE 26, 2023 DATA CUT) Durable Responses Include 3 Ongoing Responders with EGFR WT Disease at a Median Study Follow

  33. Slide 33: Deepening of Responses Over Time

    33 © 2024, Iovance Biotherapeutics, Inc. Deepening of Responses Over Time are Characteristic of One - Time Immunotherapy Change in Target Lesion SOD in EGFR WT Patients (n=11) IOV - COM - 202 COHORT 3A NSCLC COMBINATION (TIL+PEMBROLIZUMAB ), WCLC ORAL PRESENTATION (JUNE 26, 2023 DATA CUT) Abbreviati

  34. Slide 34: Frontline NSCLC Registrational Trial Design

    34 © 2024, Iovance Biotherapeutics, Inc. Frontline NSCLC Registrational Trial: Design Supported by Cohort 3A Data Long - Term Follow Up ​ SOC Maintenance Treatment +/ - TIL ​ SOC Chemo - IO Treatment* Adding TIL Therapy to Standard - of - Care Therapy TIL Patient Population Treatment naïve metastati

  35. Slide 35: Moving TIL Therapy into Relevant Lines of Therapy in NSCLC

    35 © 2024, 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

  36. Slide 36: Launch Preparation

    36 © 2024, Iovance Biotherapeutics, Inc. 36 Launch Preparation

  37. Slide 37: iCTC Designed for High-Volume TIL Manufacturing and Flexibility

    37 © 2024, 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

  38. Slide 38: Targeting Potential Authorized Treatment Centers (ATCs)

    38 © 2024, Iovance Biotherapeutics, Inc. Targeting Potential Authorized Treatment Centers (ATCs) Potential ATC Iovance Clinical Trial Site 1 1. ClinicalTrials.gov Abbreviations: ATC=Authorized Treatment Centers; NCCN=National Comprehensive Cancer Network; KOL=Key Opinion Leaders; BMT=Bone Marrow Tra

  39. Slide 39: Enabling Market Access: Metastatic Melanoma Payer Mix

    39 © 2024, Iovance Biotherapeutics, Inc. 55% Commercial Medicare IPPS Exempt 4% 17% Medicare Advantage 8% 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 - eligi

  40. Slide 40: Supporting Providers & Patients: IovanceCares

    40 © 2024, 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 •

  41. Slide 41: Hospital Bed Capacity Supports Broad Lifileucel Adoption at ATCs

    41 © 2024, 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

  42. Slide 42: Other TIL Therapy Clinical Program Highlights

    42 © 2024, Iovance Biotherapeutics, Inc. 42 Other TIL Therapy Clinical Program Highlights

  43. Slide 43: IOV-4001 in Previously Treated Metastatic Melanoma and NSCLC

    43 © 2024, 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

  44. Slide 44: Potential Market for Cervical Cancer

    44 © 2024, 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

  45. Slide 45: Pivotal Phase 2 Trial of Lifileucel in Cervical Carcinoma

    45 © 2024, 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

  46. Slide 46: Next-Generation Research Programs

    46 © 2024, Iovance Biotherapeutics, Inc. 46 Next - Generation Research Programs

  47. Slide 47: Trailblazing Next-Generation TIL Programs

    47 © 2024, 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

  48. Slide 48: Corporate Summary & Milestones

    48 © 2024, Iovance Biotherapeutics, Inc. 48 Corporate Summary & Milestones

  49. Slide 49: Well-Capitalized in Pursuit of TIL Commercialization

    49 © 2024, Iovance Biotherapeutics, Inc. September 30, 2023 (in millions) Cash, cash equivalents, investments, restricted cash $427.8 1 Common shares outstanding 255.8 Preferred shares outstanding 2.9 2 Stock options and restricted stock units outstanding 23.1 1. Includes Restricted Cash of $66.4 mi

  50. Slide 50: Broad, Iovance-Owned IP Around TIL Therapy

    50 © 2024, 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

  51. Slide 51: Corporate Highlights

    51 © 2024, 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

  52. Slide 52: 2023 Milestones

    52 © 2024, Iovance Biotherapeutics, Inc. REGULATORY □ BLA: Complete rolling BLA submission for lifileucel in post - anti - PD - 1 advanced melanoma in Q1 2023; late cycle meeting completed and BLA on track toward PDUFA date □ Ex - U.S. regulatory submissions: Initiate preparation of submissions in e

  53. Slide 53: Anticipated 2024 Milestones

    53 © 2024, Iovance Biotherapeutics, Inc. REGULATORY □ Obtain FDA approval for lifileucel in advanced melanoma (PDUFA date: February 24, 2024) □ Submit EMA regulatory submission in 1 st half of 2024 □ Submit additional ex - US submissions in 2 nd half of 2024 □ Meet with FDA to discuss NSCLC registra

  54. Slide 54: Thank You

    54 © 2024, Iovance Biotherapeutics, Inc. © 2024, Iovance Biotherapeutics, Inc. Thank You

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