Iovance Biotherapeutics, Inc 8-K, filed Nov 5, 2026
Iovance Biotherapeutics, Inc. (IOVA)
About this 8-K
Iovance Biotherapeutics, Inc filed this 8-K on November 5, 2026.
Iovance Biotherapeutics raised Full Year 2026 revenue guidance to $410M — $420M from $350M — $370M, reporting 3Q26 revenue of ~$122M and cash of ~$382M. It plans a 2027 Amtagvi supplemental Biologics License Application submission in second-line non-squamous mNSCLC. AI summary
Items reported
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
|
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events.
On November 5, 2026, Iovance Biotherapeutics, Inc. (the “Company”) updated its corporate presentation that it uses for presentations at healthcare conferences and to analysts, current stockholders, and others. A copy of the Company’s presentation that it intends to use at such events is attached as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
|
Description |
99.1 |
|
Iovance Biotherapeutics, Inc., Corporate Presentation – November 2026 |
104 |
|
Cover Page Interactive Data File (embedded as Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
Iovance Biotherapeutics, Inc. |
|
|
|
|
Date: |
November 5, 2026 |
By: |
/s/ Frederick G. Vogt |
|
|
|
Name: Frederick G. Vogt, Ph.D., J.D. |
Corporate Overview November 2026 Exhibit 99.1 Exhibit 99.1
Forward-Looking Statements 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 Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this presentation are made as of the date of this presentation, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events, or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products, including ATC network expansion and new markets; the size of the addressable patient populations for, and the acceptance by the market of, our products and product candidates, if approved, and their potential pricing and/or reimbursement by payors, and whether such acceptance is sufficient to support continued commercialization or development of our products or product candidates; the risk regarding our ability to manufacture our therapies at our iCTC facility, including the risk that our ability to increase manufacturing capacity at our facility may adversely affect our commercial supply or clinical supply; the risks related to our ability to obtain, maintain, and enforce patent and other intellectual property protection for our products and product candidates, including our biomarker-directed strategy; the risk that the successful development or commercialization of our products may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain regulatory authority approval of our product candidates; whether clinical trial results from our clinical studies and cohorts, and meetings with regulatory authorities, may support registrational studies, including biomarker-selected studies, and subsequent approvals by regulatory authorities, and the risk that our clinical trials, including registrational and investigator-sponsored trials, may experience delays in site activation, enrollment, or data readouts, may not meet their primary endpoints, or may not support approval; clinical results, whether preliminary, interim, or final, which may include efficacy and safety results, from clinical trials or cohorts may not be confirmed or reflected in independent review assessments or the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior or future trials or cohorts; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from regulatory authorities; the risk that our interpretation of the results of our clinical trials, including comparisons to other therapies, or communications with regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities or others; the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues, and other factors such as the number of ATCs, may not serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global and domestic geopolitical factors or public health events; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this presentation assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this presentation; and no material fluctuation in exchange rates.
Global Leader in Innovating, Developing and Delivering TIL Therapy for Patients with Cancer 3 Approved Products Commercial Launch Financials >100 Treatment Centers as of 11/05/26 2 >95% © 2026, Iovance Biotherapeutics, Inc. *The midpoint represents an increase of $55 million, or ~15%, over the previous guidance range of $350 to $370 million. 1. Excludes depreciation and amortization 2. Cash, cash equivalents, short-term investments, and restricted cash as of September 30, 2026. >2,000 Patients treated with commercial and clinical Iovance TIL products U.S., Canada & Australia Multiple Markets Globally ~60% Addressable Patients within 200 miles of an ATC Margin from Cost of Sales1 Cash Runway Well into 20292 ~$382M 3Q26 revenue ~$122M Full Year 2026 Revenue Guidance* $410M — $420M
Strong Platform Supports Backbone IO Therapy for Solid Tumors Iovance Retains Global Portfolio and Technology Platform Rights *Advanced Non-squamous NSCLC wild type for EGFR, ALK, ROS1 **Advanced non-squamous NSCLC wild type for EGFR, ALK, ROS1, KRAS, HER2, current or prior smokers. ***UPS & DDLPS Abbreviations: 2L, second line; ccRCC, clear cell renal cell carcinoma; CRC, colorectal cancer; CSCC, cutaneous squamous cell carcinoma; DDLPS, dedifferentiated liposarcoma; ER, estrogen-receptor; FTD, Fast Track Designation; HNSCC, head and neck squamous cell carcinoma; ICI, immune checkpoint inhibitor; IL-2, interleukin 2; IL-12, interleukin 12; IO, immuno-oncology; MCC, Merkel cell carcinoma; NSCLC, non-small cell lung cancer; PD-1, programmed cell death protein-1; TNBC, triple negative breast cancer; UPS, undifferentiated pleomorphic sarcoma Approved Canada EU Australia Switzerland UK U.S. Potential Approval 1Q 2027 Planned 2027 Submission Amtagvi Regimen INDICATION & TREATMENT SETTING PHASE 1 PHASE 2 PHASE 3 Amtagvi Label Expansion Lifileucel + pembrolizumab Frontline advanced melanoma TILVANCE-301 (FTD, Confirmatory) Lifileucel Post-chemo & anti-PD-1 mNSCLC* IOV-LUN-202 Cohorts 1&2 (FTD) Lifileucel Post-chemo & anti-PD-1 mNSCLC (biomarker-enriched)** POSITILITY (LUN-202 Cohort 5) Lifileucel Post-chemo advanced soft tissue sarcomas (DDLPS or UPS) SARATOGA (FTD) Lifileucel Post-chemo & anti-PD-1 serous endometrial cancer ENDURANCE Lifileucel + pembrolizumab Frontline mNSCLC** OPTILISM (Planned 2027 start) Next-Generation Products IOV-4001 (PD-1 Inactivated TIL) Post anti-PD-1 advanced melanoma or NSCLC IOV-GM1-201 IOV-3001 (IL-2 analog) TIL treatment regimen IOV-IL2-101 IOV-5001 (IL-12 tethered TIL) Post-ICI CRC, TNBC/ER Low, HNSCC, NSCLC POTENTIL Brazil Multiple investigator sponsored studies of lifileucel in CSCC, MCC, Uveal, ccRCC, additional soft tissue sarcomas and other solid tumors 2028/2029 Submission mNSCLC* Biomarker-enriched NSCLC** Soft tissue sarcomas*** Clinical & Manufacturing Planned 2027 Submission Advanced Melanoma (2L+) Additional Indications
The Pioneer in One-Time Cell Therapy for Solid Tumors 5 5 © 2026, Iovance Biotherapeutics, Inc. 1. Medina et al, ASCO 2025. Pooled Analysis (n=153), Heavily Pre-Treated Patient Population; 2. Karapetyan L et al. Transplantation & Cell Therapy 2026. Physician-assessed confirmed ORR by RECIST v1.1. All evaluable patients received commercial Amtagvi according to the U.S. prescribing information; 3. Ahn MJ et al. J Clin Onc 2025;43:260-272. 4. Interim data cut as of October 14, 2026 of patients with non-squamous NSCLC with minimum cell dose based on FDA feedback for melanoma. Patients progressed on or after chemotherapy and anti-PD-1 therapy for mNSCLC without EGFR, ROS1 or ALK genomic mutations and received at least one line of FDA-approved targeted therapy if indicated by other actionable tumor mutations; 5. Cash, cash equivalents, short-term investments, and restricted cash as of September 30, 2026; 6. Excludes depreciation and amortization. *Non-squamous mNSCLC without EGFR, ROS1 or ALK genomic mutations. Abbreviations: 2L, second line; ALK, anaplastic lymphoma kinase; APAC, Asia Pacific; COS, cost of sales; mDOR, median duration of response; EGFR, epidermal growth factor receptor; FDA, U.S. Food and Drug Administration; FTD, fast track designation; IO, immuno-oncology; mNSCLC, metastatic non-small cell lung cancer; NSCLC, non-small cell lung cancer; OpEx, operating expenses; ORR, objective response rate; mOS, median overall survival; OS, overall survival; PD-1, programmed cell death protein-1; RECIST, Response Evaluation Criteria in Solid Tumors; ROS1, ROS proto-oncogene 1; sBLA, supplemental Biologics License Application; SOC, standard of care Platform Technology and Robust Pipeline in Blockbuster Solid Tumor Indications $1B+ U.S. Sales Potential in 2L+ Advanced Melanoma First approved treatment in 2L+ advanced melanoma ~80% YoY revenue growth in 3Q26 ~22% QoQ 3Q26 revenue growth 5-year durability: 31.4% ORR; 19.7% OS; mDOR of 36.5 months1 Real-world ~44% ORR; 52% ORR in patients with ≤ 2 prior lines of therapy2 10X U.S. Melanoma Opportunity in mNSCLC Planned sBLA submission in 2027 Additional planned sBLA for biomarker enriched population High unmet need with limited treatment options SOC: 12.8% ORR; 5.6 months mDOR; 12.3 months mOS3 Potential best-in-class clinical profile: 24.6% ORR; 59% ORR in biomarker enriched4 U.S. FDA FTD for Non-squamous NSCLC* Leverages melanoma commercial footprint and manufacturing Operational Excellence Focused on Profitability ~$382M cash, with runway well into 20295 ~60% margin from COS in 3Q26 and 54% YTD6 Ongoing initiatives improving OpEx, cost of sales and gross margin Leading IO pipeline in solid tumors Internal manufacturing 5K+ annual capacity for North America, Europe & APAC >2K commercial & clinical infusions
Significant U.S. Commercial Business Growth and Progress in Global Expansion
Significant Unmet Need in Frontline and Beyond1 Advanced Melanoma Market Opportunity 2L+ Advanced Melanoma Population2,3 U.S.: 8.5K Potential ex-US Markets: 24K+ Overall (1L+): 70K+ BRAF wild-type (prior ICI therapy) ~5 months BRAF mutated (prior ICI and targeted therapy) ~3 months 1. Chesney J, et al. J Immunother Cancer. 2022; 2. National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2026 Estimates. https://seer.cancer.gov (accessed November 2026); World Health Organization International Agency for Research on Cancer (IARC). GLOBOCAN 2022; 3. Data on file as of November 2026. Includes more than 20,000 patients in initial target markets plus additional potential markets; 4. Larkin J, Chiarion-Sileni V, Gonzalez R, et al. NEJM. 5. Robert C, et al.; Lancet 6. Tawbi HA, Schadendorf D, Lipson EJ, et al. NEJM 7. Patrinely JR et al. Cancer. 2020 Abbreviations: 1L, first line; 2L, second line; BRAF, B-Raf proto-oncogene; ICI, immune checkpoint inhibitors; mOS, median overall survival >50% of patients on 1L standard of care progress within 12 months4-6 mOS after Progression on 1L Therapy:7
One Third of Responses Remain Ongoing without Subsequent Treatment 5-Year OS 19.7% mDOR 36.5 Months ORR 31.4% mOS 13.9 Months 1. Medina et al, ASCO 2025. Pooled Analysis (n=153), Heavily Pre-Treated Patient Population Abbreviations: mDOR, median duration of response; ORR, objective response rate; mOS, median overall survival; OS, overall survival Duration of Response Overall Survival Deep and Durable Responses at 5-Year Follow Up1 Median Follow Up 57.8 Months
Best-in-Class Real-World Data Driving Increased Amtagvi Adoption1 1. Karapetyan L et al. Transplantation & Cell Therapy 2026; 2. Three Prior Lines of Therapy (1L-3L): 1L ipilimumab + nivolumab; 2L dabrafenib + trametinib; 3L nivolumab + relatlimab. 86% reduction in target lesions. Response ongoing at 260-day follow up. Photo Credit and Permission: H. Lee Moffitt Cancer Center; 3. For more information, please visit https://www.iovance.com/real-world-data; 4. Ma B, et al, ESMO 2026 Abbreviations: 1L, first line; 2L, second line; 3L, third line; DCR, disease control rate; ORR, objective response rate; OS, overall survival; PD-1, programmed cell death protein-1; PR, partial response Unprecedented Real-World Response Rates of >50% ORR in multiple studies3 Lifileucel may approximately double four-year overall survival (OS) rates compared with standard-of-care therapies in anti-PD-1-resistant advanced melanoma4 44% ORR (18/41) 73% DCR (30/41) Higher response rates with earlier treatment 52% ORR (12/23) OS not reached ≤ 2 prior lines of therapy 33% ORR (6/18) ≥ 3 prior lines of therapy Durable Ongoing Partial Response (PR)2 Significant tumor burden reduction at Week 6 Before Lifileucel Post-Lifileucel (Week 6)
TIL Platform Backbone for Broad Global Solid Tumor Opportunity Melanoma Establishes the Infrastructure for All Future Indications Shared Infrastructure Across Expanding Network of 100+ ATCs Forms Base for Scalable Expansion Medical Oncologists Academic & Community Surgeons Tumor Tissue Procurement Cell Therapists Authorized Treatment Centers $1B 2L+ Melanoma Potential U.S. Peak Revenue NSCLC 10X vs. 2L U.S. mMel Sarcoma 1X vs. 2L U.S. mMel Endometrial ~1X vs. 2L U.S. mMel 1L Melanoma 1X vs. 2L U.S. mMel Additional Indications, Markets & Next Gen Substantial Commercial Growth Opportunity with new tumor types, earlier lines of therapy, geographic expansion and next generation therapies Abbreviations: 1L, first line; 2L, second line; mMel, metastatic melanoma; NSCLC, non-small cell lung cancer
The only scaled, centralized FDA-approved commercial TIL manufacturing process Consistently improving commercial turnaround (~30 days or less) Faster and more reliable than any TIL therapy in development Modular design 5K+ patient annual capacity Optimal utilization, quality & COS U.S. Manufacturing Facility Dedicated to Global Delivery of Commercial and Clinical TIL Cell Therapies Abbreviations: COS, cost of sales Philadelphia, PA Manufacturing facility Current & planned commercial markets Cryopreserved TIL is manufactured in Philadelphia and shipped to commercial and clinical trial sites across North America, South America, Europe, Asia and Australia. Philadelphia Los Angeles Canada Europe South Korea Singapore Australia Brazil
>100 ATCs in U.S., Canada & Australia1,2 1/3 in Community Setting 10K+ ≤100 Population2 1. Not all authorized treatment centers are listed. 2. U.S. Census Bureau, 2024 Annual Estimates. SEER annual estimated death rate from melanoma: 2 deaths per 100K people: https://seer.cancer.gov/ (accessed November 2026) Amtagvi® Authorized Treatment Centers (ATC) Adoption continuing to increase across growing ATC network >1,000 Commercial Patients Treated
Broad Amtagvi U.S. Market and Geographic Access1 1. Data on file as of November 2026. *Plans or policies that cover Amtagvi, including pharmacy benefit managers (PBMs) Abbreviations: ATC, authorized treatment center Lives covered; majority with private coverage* >250M >80% >75% of patients covered by private payers & Medicare of patients within 100 miles of patients within 200 miles BROAD PRIVATE & PUBLIC PAYER COVERAGE PROXIMITY TO ATCs >95% The Vast Majority of Addressable Patients Have Coverage and Local Access to ATCs COMPREHENSIVE PATIENT SUPPORT PROGRAM Reimbursement support Financial assistance Travel & logistics
Tumor Infiltrating Lymphocytes (TIL): Leading Cell Therapy Platform for Solid Tumors 1. Amtagvi USPI Circulation Infused TIL circulate in the blood Migration to Tumor Recognition Lysis TIL expansion T cells grown to the billions1 Tumor collection Tumor resected and shipped Individualized therapy One-time therapy made from a patient’s own cells Billions of TIL recognize multiple patient-specific tumor neoantigens One-time infusion Unique mechanism of action
Deep Pipeline of Registrational Programs
Unprecedented Rate, Depth & Durability in Frontline Melanoma Abbreviations: CR, complete response; DCR, disease control rate; mDOR, median duration of response; ORR, objective response rate; mOS, median overall survival; PD, progressive disease; mPFS, median progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease; SOD, sum of diameters Best Percentage Change from Baseline in Target Lesion SOD Time to Response & Time of Efficacy Assessment for Confirmed Responders (PR or Better) 1A-22 20 0 -20 -40 -60 -80 -100 1A-25 Change from Baseline (%) 1A-26 1A-21 1A-09 1A-02 1A-01 1A-27 1A-16 1A-18 1A-13 1A-03 1A-06 1A-07 1A-20 1A-11 1A-17 1A-14 1A-04 1A-15 1A-12 1A-23a 1A-05 n=2 n=21 Patients Best Overall Response PD SD PR CR CR Start PR Start Ongoing on Study Completed without PD or Death Progression Pembrolizumab Infusion Time (Months) Since TIL Infusion Patients Data Support Rationale for TILVANCE Frontline Study1 62.5% ORR 29.2% CR | 83% DCR via RECIST v1.1 mDOR not reached (median follow-up 26.9 months) mOS not reached (median follow-up 50.9 months) 19.8 months mPFS 1. Furness et al, ESMO 2026; Data on file as of November 2026. IOV-COM-202 Cohort 1A Full Analysis Set includes all patients who received ≥5.58 billion TILs meeting manufacturing product specifications. Each bar is presented for each patient starting from date of TIL infusion up to date of new anti-cancer therapy, end of assessment, death, or data cutoff date, whichever occurs earlier. Patients 1A-03 and 1A-11 withdrew consent during assessment phase while still in response. Patient 1A-12 discontinued from study while still in response to continue pembrolizumab off-study. Patient 1A-14 was in response during assessment phase before moving to long-term follow-up phase due to relocation from the investigative site. aBased on Kaplan-Meier product-limit estimates.
Option to crossover to lifileucel after BIRC-confirmed PD 1:1 Randomization TILVANCE-301 Global Phase 3 and Confirmatory Trial *Pembrolizumab in both arms is started at the same time after randomization. Abbreviations: APAC, Asia Pacific; BIRC, blinded independent review committee; ORR, objective response rate; PD, progressive disease; PD-1, programmed cell death protein-1; PFS, progression free survival Arm A: lifileucel plus pembrolizumab* Long-term follow up Patient Population Unresectable or metastatic melanoma; no prior therapy for metastatic disease N=670 80+ sites in U.S., Canada, Europe, APAC and expanding into new regions Arm B: pembrolizumab alone* Study Design with FDA Agreement Dual primary endpoints: ORR & PFS Interim analysis on ORR Final analysis on PFS Registrational for frontline melanoma Confirmatory for Amtagvi® full approval in post-anti-PD-1 melanoma Ongoing robust enrollment Randomized, Multicenter Study with Optional Crossover to Lifileucel (NCT05727904)
>30K Annual Deaths1 1M+ Global Annual Deaths1 Significant Unmet Need in 2L NSQ NSCLC – Limited durability with SOC Chemo (Docetaxel)3 5.6 mo mDOR 12.3 mo OS 12.8% ORR >90K Annual Deaths1 1. Compared to peak revenue potential in U.S. for 2L+ melanoma. Data on file as of November 2026, includes targeted patient population (Non-squamous advanced NSCLC) in potential future commercial markets. 2. Ever smokers wild type for EGFR, ALK, ROS1, KRAS & HER2, data on file as of November 2026. 3. Ahn MJ et al. J Clin Onc 2025;43:260-272. Abbreviations: 2L, second line; mDOR, median duration of response; mo, month; NSCLC, non-small cell lung cancer; NSQ, Non-squamous; ORR, objective response rate; OS, overall survival; SOC, standard of care >150K Annual Deaths1 >75K Annual Deaths1 Biomarker-enriched group represents about 45% of NSQ NSCLC cases2 Global NSCLC Commercial Opportunity 10X Current Melanoma Opportunity1
IOV-LUN-202 Registrational Trial Design Phase 2 Multicenter Study of Lifileucel in Post-Anti-PD-1 NSCLC (NCT04614103) Abbreviations: ALK, anaplastic lymphoma kinase; APAC, Asia Pacific; sBLA, supplemental Biologics License Application; CR, complete response; DCR, disease control rate; DOR, duration of response; EGFR, epidermal growth factor receptor; HER2, human epidermal growth factor receptor 2; IRC, independent review committee; KRAS, Kirsten rat sarcoma viral oncogene homolog; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival; PD-1, programmed cell death protein-1; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors; ROS1, ROS proto-oncogene 1; TPS, tumor proportion score Iovance TIL Therapy Lifileucel in NSCLC IOV-LUN-202 is designed to enroll patients with advanced NSCLC post anti-PD-1 treatment Endpoints Primary: ORR per RECIST v1.1 by IRC Secondary: CR rate, DOR, DCR, and PFS; OS; safety and tolerability Patient Population Unresectable or metastatic NSCLC, wild type for EGFR, ALK, ROS1, with progression on or after prior anti-PD-1 treatment and chemotherapy 70+ sites in U.S., Canada, Europe, APAC Cohort 1 < 1% or unknown TPS Cohort 2 ≥ 1% TPS POSITILITY Cohort 5 in non-squamous; wild type for EGFR, ALK, ROS1, KRAS, HER2; ever smokers Planned sBLA 2028 (n~80) Planned sBLA 2027 (n~80)
FDA Fast Track Designation in Second-Line Non-squamous mNSCLC Planned sBLA submission to U.S. FDA in 2027 Best Percentage Change From Baseline in Target Lesion by RECIST v1.1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 Patients [61/ 69 Total] Durability of Response1 15 Confirmed Responders + 2 Unconfirmed PRs* 59 51 57 61 38 55 43 60 42 45 49 44 56 47 53 58* 40* 0 6 12 18 24 30 36 42 48 54 Time [Months] since Lifileucel Infusion Data as of 14-Oct-2026 includes partial IRC; Non-squamous NSCLC, infused TVC ≥10 billion; KRAS prior-treatment sensitivity population [n=69]. ORR =17/69 [15 confirmed responses + 2 uPRs]. mSOD = −24.2% across 61 numerical values. Eight patients without numerical SOD remain in the ORR denominator. No imputation. 1Patient numbers match the waterfall. *Patients 40 and 58 : Day 84 uPR; confirmation pending, no confirmed DOR assigned. Patient 40: −31%, Swimmer time is measured from infusion. Abbreviations: sBLA, supplemental Biologics License Application; CR, complete response; DOR, duration of response; IRC, independent review committee; KRAS, Kirsten rat sarcoma viral oncogene homolog; NSCLC, non-small cell lung cancer; mNSCLC, metastatic non-small cell lung cancer; ORR, objective response rate; PD, progressive disease; PR, partial response; uPR, unconfirmed partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease; SOD, sum of diameters; mSOD, mean sum of diameters; TVC, total viable cells Best Overall Response PD SD uPR* PR CR PR Onset uPR Onset Ongoing Progression / Off Study CR Onset -24.2% Mean SOD 24.6% ORR [17/69]
Unmasking the Biology of TIL in NSCLC KRAS Wild-Type Tumors Permissive tumor microenvironment KRAS-Mutant Tumors Suppressive tumor microenvironment Increased IFN-γ IFN-γ TCR–HLA Recognition Lifileucel Non-Squamous NSCLC KRAS Wild-Type More Permissive Cytokine Milieu Active Tumor Killing Reduced IFN-γ IFN-γ TGF-β IL-10 Suppressive Cytokines Immune Suppression Weak Antigen Presentation Lifileucel TCR MDSC Treg Non-Squamous NSCLC KRAS Mutated More effective immune recognition, higher IFN-γ signaling, and active tumor killing in a permissive microenvironment. Reduced antigen presentation, lower IFN-gamma signaling, and increased TGF-β / IL-10 in a suppressive microenvironment limits TIL activity. Less Permissive Cytokine Milieu Limited Tumor Killing TCR Co-mutations and other factors may modify these states. Abbreviations: HLA, human leukocyte antigen; IFN-γ, interferon gamma; IL-10, interleukin 10; MDSC, myeloid-derived suppressor cell; NSCLC, non-small cell lung cancer; TCR, T-cell receptor; TGF-β, transforming growth factor beta; Treg, regulatory T cell.
Best Percentage Change From Baseline in Target Lesion by RECIST v1.1 50 40 30 20 10 0 -10 -20 -30 -40 -50 -60 -70 -80 -90 -100 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 Patients [21 / 22 Total] % Change From Baseline Durability of Response1 12 Confirmed Responders + 1 Unconfirmed PR* 19 14 21 8 16 9 20 11 10 17 13 15 18* 0 6 12 18 24 30 36 42 48 54 Time [Months] since Lifileucel Infusion 59.1% ORR [13/22] -44.4% Mean SOD Potential Best-in-Class Clinical Profile in Biomarker Enriched Population Data as of 14-Oct-2026 includes partial IRC; KRASWT + HER2WT + ever-smoker non-squamous NSCLC, infused TVC ≥10 billion [n=22]. ORR = 13/22 [12 recorded confirmed responses + 1 uPR]. Mean best SOD = -44.4% across 21 numerical values; one patient without numerical SOD remains in the ORR denominator. No imputation. 1Swimmer lane times are approximate, measured from infusion. *Patient 18: Day 84 uPR; confirmation pending response. Abbreviations: ALK, anaplastic lymphoma kinase; CR, complete response; EGFR, epidermal growth factor receptor; HER2, human epidermal growth factor receptor 2; IRC, independent review committee; KRAS, Kirsten rat sarcoma viral oncogene homolog; NSCLC, non-small cell lung cancer; ORR, objective response rate; PD, progressive disease; PR, partial response; uPR, unconfirmed partial response; RECIST, Response Evaluation Criteria in Solid Tumors; ROS1, ROS proto-oncogene 1; SD, stable disease; SOD, sum of diameters; TVC, total viable cells; WT, wild-type. Best Overall Response PD SD uPR* PR CR PR Onset uPR Onset Ongoing Progression / Off Study CR Onset POSITILITY Phase 2 trial enrolling non-squamous ever smokers wild type for EGFR, ALK, ROS1, KRAS & HER2
Note: Non-squamous, KRASWT + ever-smokers: n=7. ORR = [1 CR + 5 PR]/7 = 85.7%. All responses were confirmed and by RECIST v1.1. NE remains in the denominator. Mean SOD = median lowest recorded percentage change from baseline. ORR includes 15/23 non-squamous patients with numeric change. All TVC levels included. Ever-smokers include former and current smokers. Exploratory subgroup analysis. Abbreviations: CR, complete response; EGFR, epidermal growth factor receptor; KRAS, Kirsten rat sarcoma viral oncogene homolog; NE, not evaluable; NSCLC, non-small cell lung cancer; ORR, objective response rate; PD, progressive disease; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease; SOD, sum of diameters; TVC, total viable cells; WT, wild-type Frontline Non-Squamous NSCLC – KRAS Wild-Type + EGFR Wild-Type + Ever Smoker 64.3% ORR [9/14] Frontline Non-Squamous NSCLC – EGFR Wild-Type Only 85.7% ORR [6/7] Best Percentage Change from Baseline in Target Lesion by RECIST v1.1 Patients [6 / 7 Total] Durability of Response: KRAS Wild-Type + Ever Smoker 6 Confirmed Responders: 1 CR + 5 PR 6 5 3 2 1 4 0 6 12 18 24 30 36 42 48 Time [Months] since Lifileucel Infusion Non-Squamous KRAS Wild-Type + Ever Smoker Best Overall Response PD SD PR CR PR Onset Ongoing Progression / Off Study CR Onset Biomarker Enriched Analysis Supports Strategy in Frontline NSCLC OPTILISM Phase 3 Trial to initiate in 2027
1. CancerMPact Patient Metrics for U.S. Soft Tissue Sarcoma (accessed November 2026); 2. Zhou et al. BMC Public Health 2025; 3. CancerMPact Treatment Architecture for Sarcoma for the U.S. & EU5 (May 2025) to inform treatment rates in the U.S. and EU5; 4. Parikh RC, et al. Cancer. 2018. 5. Italiano A, et al. Ann Oncol. 2012; 6. Jones RL et al. Ann Oncol. 2023. Abbreviations: 2L, second line; ATC, authorized treatment center; DDLPS, dedifferentiated liposarcoma; ORR, objective response rate; mOS, median overall survival; mPFS, median progression-free survival; SOC, standard of care; UPS, undifferentiated pleomorphic sarcoma Significant Market Opportunity for Advanced Soft Tissue Sarcomas FDA Fast Track designation in rare, high grade, aggressive refractory UPS & DDLPS >3K >5K U.S. annual cases1 Patients with advanced disease3 Europe annual cases2 >3.5K >8K Patients/yr (U.S. & Europe) Very high unmet need, with devastating prognosis for patients Current 2L SOC has low ORR (<5%) with short durability (mPFS of ~2-3 months, and mOS of ~9-10 months)4-6 Phase 2 SARATOGA registrational trial now recruiting Targeting expedited pathways for registration Exploring additional metastatic soft tissue sarcomas with high unmet need as part of clinical program Existing infrastructure supports fast adoption early in treatment journey Patients highly concentrated at ATCs within existing network Peak revenue opportunity similar to advanced melanoma in the U.S.
Unprecedented Efficacy with Deep, Durable Responses in DDLPS & UPS1 1. Interim data cut as of October 2026 of refractory patients with DDLPS or UPS with minimum cell dose based on FDA feedback in melanoma. 2. Time to response, time on assessment for confirmed responders (PR or better). A bar is presented for each patient starting from date of lifileucel infusion up to date of new anti-cancer therapy, end of assessment, death, or data cutoff date, whichever occurs earlier. *Included under temporary TVC (total viable cell count) lower specifications of 5 billion Abbreviations: CI, confidence interval; CR, complete response; DDLPS, dedifferentiated liposarcoma; ORR, objective response rate; PD, progressive disease; PR, partial response; uPR, unconfirmed partial response; SD, stable disease; UPS, undifferentiated pleomorphic sarcoma Data support rationale for registrational SARATOGA clinical trial Best Percentage Change from Baseline in Target Lesion(s) 1 DDLPS 2 DDLPS 3 UPS 4 DDLPS 5 DDLPS 6 UPS 7 UPS 8 UPS 9 DDLPS 5 8 9 7 6 55.6% ORR [5/9] Strong durability with multiple responses ongoing >1 year >80% received ≥2 prior lines of therapy Change from Baseline (%) Patients Durability of Response2 Time (Months) Since TIL Infusion
SARATOGA (IOV-SAR-201) Registrational Trial Phase 2 Multicenter Study of Lifileucel in Advanced Soft Tissue Sarcomas (NCT07741877) Abbreviations: CR, complete response; DCR, disease control rate; DDLPS, dedifferentiated liposarcoma; DOR, duration of response; IRC, independent review committee; ORR, objective response rate; OS, overall survival; PFS, progression free survival; RECIST, Response Evaluation Criteria in Solid Tumors; UPS, undifferentiated pleomorphic sarcoma Endpoints Primary: ORR per RECIST v1.1 by IRC Secondary: CR rate, DOR, DCR, PFS, OS, safety and tolerability Patient Population Undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) refractory to at least one prior line of anthracycline chemotherapy Cohort 1: UPS Cohort 2: DDLPS Planned sBLA 2028-9 (n~40) Planned sBLA 2028-9 (n~40)
National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2026 Estimates. https://seer.cancer.gov (accessed November 2026); 2. World Health Organization International Agency for Research on Cancer (IARC). GLOBOCAN 2022; 3. NCCN Guidelines Version 2.2024 Endometrial Carcinoma; 4. Kang et al, Nature Portfolio, Scientific Reports, 2022; 5. Makker V, et al. N Engl J Med. 2022; 6. McMeekin S, et al. Gynecol Oncol. 2015. Abbreviations: 2L, second line; DCR, disease control rate; pMMR, proficient DNA mismatch repair; dMMR, deficient DNA mismatch repair; NCCN, National Comprehensive Cancer Network; ORR, objective response rate; PD-1, programmed cell death protein-1; RECIST, Response Evaluation Criteria in Solid Tumors Strong Initial Data for Serous Advanced Endometrial Cancer Biomarker Based Approach in Difficult to Treat Subtype with Very High Unmet Need in 2L+ FDA engagement on expedited pathway and increase in enrollment planned No standard of care for 2L+ post-anti-PD-1 Anti-PD-(L)1 moving into frontline setting, limited data on treatments after anti-PD-(L)13 Mono-chemotherapy after frontline chemo doublet: ~15% ORR5,6 Targeted therapies available only to small subgroups ~13K ~90K U.S. annual endometrial cancer deaths 1 5-yr survival (distant metastases)1 Global deaths2 19.5% Endometrial Cancer Biomarkers4 pMMR: 73% dMMR: 27% >40% of Endometrial Cancer Deaths are Serous 40% ORR via RECIST v1.1 100% DCR via RECIST v1.1 2 Median Prior Lines of Therapy First 5 evaluable patients in ENDURANCE trial all pMMR and progressed on prior chemotherapy and checkpoint inhibitor therapy [2/5] [5/5]
pMMR Subgroup* dMMR Subgroup* Endpoints Primary: ORR per RECIST v1.1 by investigator Secondary: CR rate, DOR, DCR, PFS, OS, safety and tolerability ENDURANCE (IOV-END-201) Phase 2 Trial Endometrial Cancer Patient Population Recurrent, metastatic or primary unresectable disease after chemo and anti-PD-1 therapy ≤3 lines of prior systemic therapy with ≤1 line of chemotherapy *Proof of concept cohorts, enrollment complete Abbreviations: CR, complete response; DCR, disease control rate; DOR, duration of response; dMMR, mismatch repair deficient; pMMR, mismatch repair proficient; MMR, mismatch repair; ORR, objective response rate; OS, overall survival; PD-1, programmed cell death protein-1; PFS, progression free survival; RECIST, Response Evaluation Criteria in Solid Tumors Trial in Patients with Mismatch Repair (MMR) Proficient and Deficient Tumors (NCT06481592) Serous Endometrial Cohort
First-in-class Immuno-Oncology Technologies Target New Indications
30 © 2026, Iovance Biotherapeutics, Inc. IOV-4001: PD-1 Inactivated TIL Therapy 2 T cell PD-1 PD-1 inhibits the ability of T cells to fight cancer: T cells, upon encountering cancer cells, produce PD-1, a checkpoint receptor that is activated by proteins (PD-L1 and PD-L2) found on cancer and other immune cells.1 PD-L2 PD-L1 PD-1 TCR pMHCI PD-L2 PD-L1 Tumor cell Antigen-presenting cell 1. Sharpe AH, Pauken KE, Nat Rev Immunol 2018, 18:153-167 2. Natarajan A et al. AACR 2022 3. Licensed from Cellectis 1 IOV-4001 TCR pMHCI PD-L2 PD-L1 Tumor cell PD-1 Inactivated T Cells Avoid Checkpoint Signals: PD-1 is inactivated using TALEN, restoring the ability of TIL cells to kill cancer cells.2,3 Cognate Antigen Cognate Antigen
Phase 1/2 Open-Label First-in-Human Study: IOV-GM1-201 Endpoints Phase 1: Safety (Complete) Phase 2 Primary: ORR per RECIST v1.1 by investigator Secondary: CR rate, DOR, DCR, PFS, OS, safety and tolerability Genetically Modified, PD-1 Inactivated TIL Therapy IOV-4001 in Previously Treated Metastatic Melanoma and NSCLC (NCT05361174) Cohort 1: Unresectable or metastatic melanoma Post-anti-PD-1/L1, post-BRAF/MEK inhibitor in patients with BRAF mutations (fully enrolled) Cohort 2: Stage III or IV NSCLC Post-anti-PD-1/L1 or post targeted therapy and either chemotherapy or anti-PD-1/L1 Patient Population Adults with unresectable or metastatic melanoma or advanced NSCLC Abbreviations: BRAF, B-Raf proto-oncogene; CR, complete response; DCR, disease control rate; DOR, duration of response; MEK, mitogen-activated protein kinase kinase; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival; PD-1, programmed cell death protein-1; PFS, progression free survival; RECIST, Response Evaluation Criteria in Solid Tumors
32 © 2026, Iovance Biotherapeutics, Inc. IOV-3001: Next Generation IL-2 for TIL Supportive Regimen1,2 Phase 1/2 trial enrolling patients Recombinant fusion protein designed to enhance TIL survival and cellular proliferation A modified copy of the coding sequence for aldesleukin (mdIL-2) is fused to a humanized monoclonal immunoglobulin (Ig)G1κ antibody The mdIL-2 moiety of IOV-3001 binds to the IL-2-receptor (IL-2R) with subsequent phosphorylation of signal transducer and activator of transcription 5 (STAT5), resulting in enhanced performance 1. Mitra S, Leonard WJ, Journal of Leukocyte Biology 2018 103(4): 643-655 2. Simpson-Abelson M et al, ASCO 2024 Gene Expression: Survival Proliferation mdIL-2 IL-2R JAK1 P JAK3 STAT5 dimer Cytosol Nucleus P IOV-3001 IOV-3001 Heavy chain Light chain IOV-3001 Modified IL-2 (mdIL-2) TIL Antibody Preclinical data suggest a better safety profile and less frequent dosing for IOV-3001 compared to Proleukin
IOV-5001: IL-12 Tethered TIL Therapy 1. Zhang L, et al, Clin Cancer Res 2015;21(10):2278–2288; 2. Zhang L, et al, J Immunother Cancer 2020;8:e000210; 3. Kobayashi M, et al, J Exp Med 1989;170:827–845; 4. Zeh HJ, et al, J Immunother 1993;14:155–61; 5. Tugues S, et al, Cell Death and Differentiation 2015;22:237–246; 6. Cao X, et al, Cancer Res 2009;69:8700–9; 7. Steding CE, et al, Immunology 2011;133:221–38 Tethered IL-12 TIL cells can improve efficacy by remodeling the suppressive TME into an immuno-supportive state In advanced melanoma patients, an ORR of 63% (n=16) was observed with prior generation IL-12 secreting TIL product at doses 10- to 100-fold lower than conventional TIL products1 IL-12 shows independent clinical efficacy, with safe delivery to the TME being the primary challenge1,2 Expression of IL-12 on IOV-5001 is induced upon antigen encounter in the TME1,2 IOV-5001’s expressed IL-12 is tethered to the membrane surface of TIL to avoid release into circulation (shedding) 2 Inducible IL-12 expression in the TME and lack of IL-12 shedding expected to allow increased IOV-5001 cell doses and improved TIL efficacy in solid tumor cancers Abbreviations: CD4, cluster of differentiation 4; CD8, cluster of differentiation 8; IFNγ, interferon gamma; IL-12, interleukin 12; IL-12R, interleukin 12 receptor; MDSC, myeloid derived suppressor cell; NK, natural killer cell; NK-T, natural killer T cell; ORR, objective response rate; TCR, T cell receptor; Th1, T helper 1; TME, tumor microenvironment; Treg, regulatory T cell NK and NK-T cell activation and proliferation3 CD8+ T cell activation and proliferation4 CD4+ T cell differentiation to Th15 Treg and MDSC downregulation6,7 33 Direct Action IFNγ Cytosol Nucleus TIL NFAT-TeIL-12 IL-12 IL-12R TCR Antigen © 2026, Iovance Biotherapeutics, Inc. POTENTIL: Phase 1/2 Basket Trial Enrolling in Solid Tumors Representing 100K+ U.S. Deaths Annually
Phase 1/2 First-in-Human Study: POTENTIL (IOV-GE1-201) Endpoints Phase 1: Safety Phase 2 Primary: ORR per RECIST v1.1 by investigator Secondary: CR rate, DOR, DCR, PFS, OS, safety and tolerability Genetically Engineered, IL-12 Tethered TIL Therapy IOV-5001 in Previously Treated Advanced Solid Tumors (NCT07743723) Cohort 1: Stage IV NSCLC without EGFR, ALK, or ROS1 genomic alterations Cohort 2: Unresectable or Stage IV TNBC or ER-low breast cancer Patient Population Adults with previously treated unresectable or metastatic solid tumor cancers Abbreviations: ALK, anaplastic lymphoma kinase; CR, complete response; CRC, colorectal cancer; DCR, disease control rate; DOR, duration of response; EGFR, epidermal growth factor receptor; ER, estrogen-receptor; HNSCC, head and neck squamous cell carcinoma; IL-12, interleukin 12; NSCLC, non small cell lung cancer; ORR, objective response rate; OS, overall survival; PFS, progression free survival; RECIST, Response Evaluation Criteria in Solid Tumors; ROS1, ROS proto-oncogene 1; TNBC, triple negative breast cancer Cohort 3: Stage IV CRC Cohort 4: Stage III or IV HNSCC
Financial Summary
*The midpoint represents an increase of $55 million, or ~15%, over the previous guidance range of $350 to $370 million. Excludes depreciation and amortization Cash, cash equivalents, short-term investments, and restricted cash as of September 30, 2026 Financial Position & Outlook Full Year 2026 Revenue Guidance Raised from $350M — $370M $410M — $420M* 3Q26 Revenue ~$122M ~80% YoY | ~22% QoQ 3Q26 Margin1 ~60% 54% YTD Cash position2 ~$382M As of September 30, 2026 Cash runway well into 2029 Revenue Growth Margin Improvement Cost Control
Thank You