Iovance Biotherapeutics, Inc. · NASDAQ:IOVA

Iovance Biotherapeutics — Investor Presentation (January 2023)

43 slides from Iovance Biotherapeutics's investor presentation, Jan 11, 2023

  1. Slide 1: Corporate Overview January 2023

    1 © 2023, Iovance Biotherapeutics, Inc. © 2023, Iovance Biotherapeutics, Inc. Corporate OverviewJanuary 20231

  2. Slide 2: Forward-Looking Statements

    2 © 2023, Iovance Biotherapeutics, Inc. Forward-Looking StatementsCertain matters discussed in this press release 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 Litigation

  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 Active Clinical TrialsPlatformPipelinePeople & AssetsPartners & CollaboratorsAbbreviations: BLA=Biologics License Application; BTD=Breakthrough Therapy Designation;

  4. Slide 4: 2022 Accomplishments

    4 © 2023, Iovance Biotherapeutics, Inc. 2022 Accomplishments REGULATORY•BLA: Commenced rolling BLA submission in August 2022PIPELINE•Advanced melanoma (post-anti-PD-1): Cohort 4 data at SITC 2022 and in JITC•Frontline advanced melanoma: began Phase 3 trial•NSCLC: enrolled additional patients in IOV-

  5. Slide 5: Iovance Solid Tumor Pipeline Highlights

    5 © 2023, Iovance Biotherapeutics, Inc. *Enrollment completeAbbreviations: 1L=first line; 2L=second line; 4L=fourth line; BTD=breakthrough therapy designation; FTD=fast track designation; ipi/nivo=ipilimumab/nivolumab; NSCLC=non-small cell lung cancer; ODD=orphan drug designation; PD-1=programmed ce

  6. Slide 6: Significant Market Potential in Solid Tumors

    6 © 2023, Iovance Biotherapeutics, Inc. Potential market for early lines in combo with standard of care Potential to address unmet need in late lines of treatment1. https://seer.cancer.gov accessed May 2022 Deaths1New Cases1 Melanoma 7,65099,780 Cervical 4,28014,100 Lung & Bronchus 130,180236,740 Or

  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 TumorsTIL –Unique Mechanism of Action•Individualized•Patient’s own immune system amplified and rejuvenated•One-time therapy Remove Tumor Sample Expand & Rejuvenate Patient-specific T

  8. Slide 8: TIL Mechanism of Action

    8 © 2023, Iovance Biotherapeutics, Inc. Tumor TIL Mechanism of Action TILPeripheralbloodBloodvesselTumorcellTILTILTumorbedTIL Lysingtumorcell T-cellreceptorTumorneoantigenpeptidesMHC-I/II ChemokinereceptorCirculationMigrationPeptide Antigen RecognitionLysis(Tumor Killing)Chemokine TIL IFN γ

  9. Slide 9: Iovance Streamlined 22-Day GMP Manufacturing Process

    9 © 2023, Iovance Biotherapeutics, Inc. Iovance Streamlined 22-Day GMP Manufacturing Process 1 2Patient IntakeTumor SampleProcurement 3 4NMA-LDTIL 5 6IL-2Recovery/Discharge 4 2 Gen 2 Process: 22 Days 9 © 2023, Iovance Biotherapeutics, Inc.

  10. Slide 10: Iovance Cell Therapy Center: Leading Cell Therapy Manufacturing Facility

    10 © 2023, Iovance Biotherapeutics, Inc. Iovance Cell Therapy Center: iCTCBuilt-to-suit custom facility in Navy Yard Philadelphia136,000 ft2, $85M investmentLEED gold certification for core and shell buildingHonorable Mention Winner: 2022 ISPE Facility of the Year AwardsClinical supply initiated 3Q2

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

    11 © 2023, Iovance Biotherapeutics, Inc. Iovance Cell Therapy Center (iCTC): Building Annual Capacity for Thousands of Cancer Patients Phase 1 iCTCToday100sof patients/yearBLA Prepin core suites for commercial4separate flex suites for clinical Phase 2iCTC Ongoing Staffing2,000+patients/year12core su

  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.Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, CA Cancer J Clin., May 2021 2.https://seer.cancer.gov accessed May 20223.Clarivate DRG Disease Landscape (2021)4.Keytruda USPI 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%Est. US Incidence of Melanoma(All Stage -2021)1Est. US Incidence of Unresectable or Metastatic Melanoma (2021)2~100K~15K Sta

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

    15 © 2023, Iovance Biotherapeutics, Inc. C-144-01 Phase 2 Study DesignAbbreviations: 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 survival; PD-

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

    16 © 2023, Iovance Biotherapeutics, Inc. 64.4%Cohort 4 (n=87)Disease burden (>3 lesions)40.9%Cohort 2 (n=66)Highlighted Prior Therapy and Baseline Disease Characteristics* *Refer to SITC 2022 presentation for full baseline characteristics1. All patients received prior anti-PD1 therapyAbbreviations:

  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 were count

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

    18 © 2023, Iovance Biotherapeutics, Inc. Objective Response Rate (ORR) of 31.4% by IRC91% Concordance Rate between IRC-and Investigator-assessed ORR *Patient did not have acceptable target lesions and had best overall response of non-CR/non-PD per IRC assessment. †Six patients were nonevaluable for

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

    19 © 2023, Iovance Biotherapeutics, Inc. Tumor Burden Reduction and Best Response to Lifileucel13patients in the full analysis set are not included (9 had no post lifileucel target lesion SOD measurements, and 4 had no acceptable target lesions by IRC).*-100% change from baseline is presented for CR

  20. Slide 20: Time to Response, Duration of Response for Confirmed Responders

    20 © 2023, Iovance Biotherapeutics, Inc. Time to Response, Duration of Response, and Time on Efficacy Assessment for Confirmed Responders (PR or Better)•Median time from lifileucel infusion to best response was 1.5months•Responses deepened over time–7 patients (14.6%) initially assessed as PR were l

  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, months45.133.036.595% CI(44.2, 51.4)(30.4, 35.2)(34.7, 44.2)Median DOR†, monthsNR10.4NR95% CI(NR, NR)(4.1, NR)(8.3, NR)Min, max (months)1.4+, 54.1+1.4+, 34.3+1.4+, 54.1+DOR ≥12 months, n (%)15 (65.

  22. Slide 22: 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)1Iovance TIL Clinical Highlights in Combination with Pembrolizumab in Metastatic Melanoma•8 / 12 patients had a confirmed objective response per RECIST 1

  23. Slide 23: Launch Preparation

    23© 2023, Iovance Biotherapeutics, Inc. 23 LaunchPreparation

  24. Slide 24: iCTC Designed for High-Volume TIL Manufacturing and Flexibility

    24 © 2023, Iovance Biotherapeutics, Inc. •Core suites: TIL commercial manufacturing•Flexible suites: clinical supply, pipeline expansion and advanced manufacturing, including IOV-4001 and Gen 3•Integrated quality control, supply chain and IT systems•100+ employees with additional staffing into launc

  25. Slide 25: Targeting Potential Authorized Treatment Centers (ATCs)

    25 © 2023, Iovance Biotherapeutics, Inc. Targeting Potential Authorized Treatment Centers (ATCs) Potential ATCIovance Clinical Trial Site1 1. ClinicalTrials.govAbbreviations:NCCN=National Comprehensive Cancer Network;KOL=Key Opinion Leaders;BMT=Bone Marrow Transplant Targeting Considerations•Patient

  26. Slide 26: Supporting Providers & Patients: IovanceCares

    26 © 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•Reimbursement

  27. Slide 27: Enabling Market Access

    27 © 2023, Iovance Biotherapeutics, Inc. 55%Commercial29%MedicareMetastatic Melanoma Payer MixAll Treatment Settings and Lines of TherapyEnabling Market Access1. Metastatic Melanoma Insurance Claims Analysis, TIL-eligible patients treated in the ATC setting(1/1/2018 –6/30/2021)Abbreviations: ICD-10

  28. Slide 28: TIL Therapy Clinical Program Highlights

    28© 2023, Iovance Biotherapeutics, Inc. 28 TIL Therapy Clinical Program Highlights

  29. Slide 29: Potential Market for Non-Small Cell Lung Cancer (NSCLC)

    29 © 2023, Iovance Biotherapeutics, Inc. 1.Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, CA Cancer J Clin., May 2021 2.https://seer.cancer.gov accessed May 20223.Brahmer et al., NEJM 2015; Borghaei et al., NEJM 2015; Herbst et

  30. Slide 30: Single-Agent LN-145 Following Progression on Anti-PD-1 Therapy

    30 © 2023, Iovance Biotherapeutics, Inc. Single-Agent LN-145 Following Progression on Anti-PD-1 Therapy (IOV-COM-202 Cohort 3B, N=28)Iovance IOV-COM-202 Efficacy: NSCLC Cohort 3B (post ICI)Best Overall Response for Evaluable Patients (n=24) 60 ― ― ― ― ― ― ― ― ― •All received prior anti-PD-1 / anti-P

  31. Slide 31: Iovance TIL Therapy LN-145 in NSCLC: IOV-LUN-202

    31 © 2023, Iovance Biotherapeutics, Inc. Phase 2, Multicenter Study of LN-145 in Patients with Metastatic NSCLC (NCT04614103)IOV-LUN-202Endpoints •Primary: Efficacy defined as ORR by IRC•Secondary: Safety and efficacyStudy Updates•2Q21: first patients treated•40+ sites are active in U.S., Canada, Eu

  32. Slide 32: IOV-4001 in Previously Treated Metastatic Melanoma and NSCLC

    32 © 2023, Iovance Biotherapeutics, Inc. Phase 1/2 Open-Label First-in-Human Study: IOV-GM1-201Endpoints•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 response (DOR), diseas

  33. Slide 33: Moving TIL Therapy into Relevant Lines of Therapy in NSCLC

    33 © 2023, Iovance Biotherapeutics, Inc. 1L Therapy2L Therapy3L Therapy4L TherapySOCIOVA TrialSOCIOVA TrialSOCIOVA TrialSOCIOVA TrialAnti-PD-1 MonoORR 39-45%1COM-202Cohort 3AChemo DoubletCOM-202Cohort 3CDocetaxel or Docetaxel +RamucirumabORR 9-23%2LUN-202Cohorts 1-3GM1-201Cohort 2*GM1-201Cohort 2*An

  34. Slide 34: Potential Market for Cervical Cancer

    34 © 2023, Iovance Biotherapeutics, Inc. Potential Market for Cervical Cancer1. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, CACancer J Clin., May 2021; 2. https://seer.cancer.gov accessed May 2022; 3. Tewari, et al., NEJM 20

  35. Slide 35: Pivotal Phase 2 Study of Lifileucel in Cervical Carcinoma

    35 © 2023, Iovance Biotherapeutics, Inc. Pivotal Phase 2 Study of Lifileucel (Formerly LN-145) in Recurrent, Metastatic or Persistent Cervical Carcinoma (NCT03108495)Endpoints (Pivotal Cohort 2)•Primary: ORR as determined by IRC•Secondary: safety and efficacyStudy Updates•4Q21: Initial Cohort 3 data

  36. Slide 36: Next Generation Research Programs

    36© 2023, Iovance Biotherapeutics, Inc. 36 Next Generation Research Programs

  37. Slide 37: Next Generation TIL Research: What's Next

    37 © 2023, Iovance Biotherapeutics, Inc. Genetically modify TILDevelop more potent TILOptimize processExpand TIL into new regimensCellectis gene-editing TALEN®collaboration1,2PD-1 and other immune checkpoint targetsDouble knockoutsCytokine tethered TILsPD-1+ selected TILCD39/69 double negative TILs3

  38. Slide 38: Corporate Summary & Milestones

    38© 2023, Iovance Biotherapeutics, Inc. 38 Corporate Summary & Milestones

  39. Slide 39: Well-Capitalized in Pursuit of TIL Commercialization

    39 © 2023, Iovance Biotherapeutics, Inc. September 30, 2022In millions (unaudited)Common sharesoutstanding157.8Preferred shares outstanding2.91Stock options and restricted stock units outstanding17.3Cash, cash equivalents, investments, restricted cash$366.62Anticipated cash runway, inclusive of proc

  40. Slide 40: Broad, Iovance-Owned IP Around TIL Therapy

    40 © 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 1Tumor SampleProcurement 3 4NMA-LDTIL Infusion 5IL-2 Infusions60+ gran

  41. Slide 41: Investment Highlights

    41 © 2023, Iovance Biotherapeutics, Inc. Investment HighlightsPioneering 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 proprietary manufacturing Infrastructure for c

  42. Slide 42: Anticipated 2023 Milestones

    42 © 2023, Iovance Biotherapeutics, Inc. Anticipated 2023 Milestones REGULATORY•BLA: Complete rolling BLA submission in Q1 2023•BLA: FDA approvalPIPELINE•Melanoma: enroll frontline advanced melanoma Phase 3 confirmatory trial•NSCLC: report data and continue to enroll IOV-LUN-202, IOV-COM-202, IOV-GM

  43. Slide 43: Thank You

    43 © 2023, Iovance Biotherapeutics, Inc. © 2023, Iovance Biotherapeutics, Inc. Thank You

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