Iovance Biotherapeutics (IOVA) grows 2025 revenue to $263.5M and secures Fast Track
Rhea-AI Filing Summary
Iovance Biotherapeutics reported strong topline growth for the fourth quarter and full year 2025 while remaining loss-making as it scales commercialization of Amtagvi. Fourth-quarter product revenue reached
Positive
- Strong topline growth and guidance achievement: Full-year 2025 revenue rose to approximately
$263.5M from$164.1M in 2024, with about30% quarterly revenue growth in Q4 and annual revenue within the stated$250M–$300M guidance range. - Improving profitability metrics: Q4 2025 gross margin increased to
50% , indicating early operating leverage from the Amtagvi launch and ongoing cost-optimization initiatives. - Strengthened regulatory and pipeline position: Lifileucel received U.S. FDA Fast Track designation in second-line advanced non-small cell lung cancer, complementing an expanding TIL pipeline with multiple registrational and proof-of-concept studies in solid tumors.
- Solid liquidity and stated runway: Cash, cash equivalents and investments of
$297.0M plus restricted cash as of December 31, 2025 support the company’s indication of cash runway intoQ3 2027 , reducing near-term financing risk.
Negative
- Large ongoing net losses: Total 2025 costs and expenses of
$666.9M resulted in a full-year net loss of$391.0M , or$(1.09) per share, highlighting that the business is still far from break-even despite revenue growth. - High operating expense burden: Research and development expenses of
$300.3M and selling, general and administrative expenses of$152.3M in 2025, plus cost of sales of$173.2M , underscore the substantial spending required to commercialize Amtagvi and advance the pipeline.
Insights
Revenue growth and margin gains are encouraging, but losses remain large.
Iovance Biotherapeutics delivered about
Despite this progress, 2025 total costs and expenses reached
The pipeline update adds strategic upside: lifileucel received U.S. FDA Fast Track designation in second-line advanced non-small cell lung cancer, and the company is running registrational or proof-of-concept trials in melanoma, NSCLC, sarcoma and endometrial cancer. Future company filings and data readouts will clarify how quickly revenue can catch up with the current expense base.
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| Item 2.02 | Results of Operations and Financial Condition. |
On February 24, 2026, Iovance Biotherapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the fourth quarter and fiscal year ended December 31, 2025, and an update on recent developments. A copy of that press release is furnished as Exhibit 99.1.
The information furnished under this Item 2.02, including the accompanying Exhibit 99.1, shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of such section, nor shall such information be deemed to be incorporated by reference in any subsequent filing by the Company under the Securities Act of 1933, as amended, or the Exchange Act, regardless of the general incorporation language of such filing, except as specifically stated in such filing.
| Item 8.01 | Other Events. |
On February 24, 2026, 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 99.2 and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Press Release of Iovance Biotherapeutics, Inc., dated February 24, 2026. | |
| 99.2 | Iovance Biotherapeutics, Inc., Corporate Presentation - February 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.
| Dated: February 24, 2026 | Iovance Biotherapeutics, Inc. | ||
| By: | /s/ Frederick G. Vogt | ||
| Name: | Frederick G. Vogt, Ph.D., J.D. | ||
| Title: | Interim CEO and President, and General Counsel | ||
Exhibit 99.1
Iovance Biotherapeutics Highlights Strong Fourth Quarter and Full Year 2025
Results, Business Achievements and Corporate Updates
~30% Quarterly Revenue Growth Driven by Amtagvi Demand
Gross Margin Increased to 50%
FY25 Revenue of $264M Achieved Annual Guidance
U.S. FDA Fast Track Designation Granted for Lifileucel in
Second-Line Advanced Non-Small Cell Lung Cancer
SAN CARLOS, Calif., February 24, 2026 -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today reported fourth quarter and full year 2025 financial results, business achievements and corporate updates.
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “Iovance delivered approximately 30 percent quarterly revenue growth and achieved our 2025 guidance range in the first full calendar year of launch. Growth was driven by increasing demand for Amtagvi. After ongoing improvements in our operations and gross margin, we are well positioned for future profitability. Iovance is poised to create substantial value for patients and shareholders as we increase revenue while advancing our registrational trial in non-small cell lung cancer and best-in-class TIL pipeline in solid tumors.”
Fourth Quarter and Full Year 2025 Financial Highlights
Topline Growth, Significant Margin Improvement, and Cost Optimization
| · | Fourth quarter 2025 total product revenue of ~$87 million with strong growth of ~30% over the prior quarter, including: |
| o | U.S. Amtagvi revenue of ~$65 million. |
| o | Global Proleukin revenue of ~$22 million. |
| · | Fourth quarter 2025 gross margin from cost of sales was ~50%, reflecting increasing benefits from solid execution and cost optimization. |
| · | Full year 2025 total product revenue of ~$264 million achieved the guidance range of $250 million to $300 million in the first full year of launch, including: |
| o | U.S. Amtagvi revenue of ~$220 million. |
| o | Global Proleukin revenue of ~$44 million. |
| · | The cash position as of December 31, 2025 of ~$303 million1 is expected to fund operations into the third quarter of 2027. |
| · | Operational excellence initiatives, including internalization of all lifileucel manufacturing and optimization of research and development activities, are expected to drive significant additional improvements in operating expenses, cost of sales and gross margin in 2026 and 2027. |
Amtagvi Commercial Launch
Strong U.S. Commercial Growth and Execution with Approvals Pending in New Global Markets
| · | Best-in-class Amtagvi real-world response rates are increasing adoption and strengthening referral trends toward earlier treatment. |
| o | An oral presentation at the 2026 Tandem Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT®) and the Center for International Blood and Marrow Transplant Research (CIBMTR®) reported: |
| o | An unprecedented overall objective response rate (ORR) of ~44%. |
| o | Higher ORR of 52% after two or fewer prior lines of therapy, highlighting the importance of early treatment. |
| · | A continuously growing and maturing network of U.S. authorized treatment centers (ATCs) expanded patient access in 2025, with further acceleration anticipated in 2026. |
| o | Academic ATCs are contributing to growth as new centers onboard and experienced centers treat more patients. |
| o | The first community ATCs began treating patients in late 2025 and are expected to drive additional demand in 2026. |
| o | A specialty pharmacy distribution channel was introduced as another option for ATCs to purchase Amtagvi. |
| · | Five-year analysis of the C-144-01 trial of Amtagvi demonstrated ~31% ORR, median duration of response (mDOR) of 36+ months, and ~20% five-year overall survival, highlighting the unprecedented long-term benefits of this first-in-class therapy. |
| · | Manufacturing turnaround improved to 32 days or less from inbound to return shipment to ATCs. |
| · | Global expansion of Amtagvi is underway in several markets outside the U.S. |
| o | Amtagvi was approved in Canada in August 2025. |
| o | Regulatory submissions are under review with potential approvals in the United Kingdom and Australia in the first half of 2026, and Switzerland in the first half of 2027. |
| o | Iovance is working with the European Medicines Agency (EMA) to resubmit a marketing authorization application (MAA) in 2026. |
Lifileucel in Previously Treated Advanced NSCLC: IOV-LUN-202 Registrational Trial
Clinical and Regulatory Momentum Building Towards Potential 2H27 Launch
| · | The U.S. FDA granted Fast Track Designation (FTD) for lifileucel for the treatment of adults with metastatic nonsquamous (NSQ) NSCLC that has progressed on or after chemo- and anti-PD-1 therapies and at least one line of FDA-approved targeted therapy, if indicated, for actionable tumor mutations excluding ALK, ROS1 and EGFR. |
| · | Positive interim data demonstrated a potential best-in-class profile in NSQ advanced NSCLC patients. |
| o | The ORR was 26% and mDOR was not reached at 25+ months of follow up following one-time lifileucel monotherapy. |
| o | Standard of care docetaxel has shown 12.8% ORR, 5.6 months mDOR, and 12.3 months overall survival, highlighting a significant unmet medical need.2 |
| · | Anticipated milestones: |
| o | Present updated data at a major medical meeting in 2026. |
| o | Complete enrollment in 2026. |
| o | Support a supplemental Biologics License Application for U.S. accelerated approval with a potential launch in the second half of 2027. |
Pipeline Updates
New Data Across Several Pipeline Programs Anticipated Throughout 2026
| · | Iovance announced positive early data for one-time lifileucel treatment in patients with advanced undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) who were refractory to at least one prior line of systemic therapy: |
| o | Among the first six evaluable patients, the confirmed RECIST v1.1 ORR was 50%. |
| o | Iovance plans to commence a single arm registrational trial in previously treated advanced UPS and DDLPS in the second quarter of 2026 and engage with the FDA on a path to expedited approval. |
| · | The Phase 3 TILVANCE-301 trial of lifileucel and pembrolizumab in frontline advanced melanoma made significant progress, with enrollment accelerating across a broad and expanding global footprint. The U.S. FDA previously granted FTD in frontline advanced melanoma for lifileucel in combination with pembrolizumab. The TILVANCE-301 trial is designed with FDA and EMA input to show contribution of components for lifileucel in combination with pembrolizumab compared to pembrolizumab alone. |
| · | Two of Iovance’s Phase 2 trials, IOV-END-201 and IOV-MEL-202, are investigating lifileucel in previously treated patients with advanced endometrial cancer and melanoma, respectively. |
| · | A Phase 1/2 trial is investigating IOV-4001, a PD-1 inactivated TIL therapy, in previously treated advanced melanoma and NSCLC. |
| · | A Phase 1/2 trial is investigating IOV-3001, a second-generation, modified IL-2 analog for use in the TIL treatment regimen. |
| · | An Investigational New Drug (IND) submission is planned in the first half of 2026 to begin clinical development of IOV-5001, a genetically engineered, inducible, and tethered interleukin-12 TIL therapy, in a Phase 1/2 basket trial. |
| · | Multiple investigator-sponsored clinical trials are exploring new solid tumor indications for Iovance TIL therapies and next generation approaches. |
Webcast and Conference Call
Management will host a conference call and live audio webcast to discuss these results and provide a corporate update today at 8:30 a.m. ET. To listen to the live or archived audio webcast, please register at https://edge.media-server.com/mmc/p/5rbo34au. The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.Iovance.com, for one year.
1. Cash, cash equivalents, short-term investments, and restricted cash as of December 31, 2025
2. Ahn MJ et al. J Clin Onc 2024;43:260-272.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com.
Amtagvi ® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.
Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com.
Forward-Looking Statements
Certain 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 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 press release are made as of the date of this press release, 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; 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 launch; 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 pivotal studies and cohorts, and meetings with regulatory authorities may support registrational studies and subsequent approvals by regulatory authorities, including the risk that the planned registrational trial in advanced sarcomas may not support approval; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior 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 or communications with regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities; 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 press release 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 press release; and no material fluctuation in exchange rates.
IOVANCE BIOTHERAPEUTICS, INC.
Selected Condensed Consolidated Balance Sheets
(in thousands)
| December 31, 2025 | December 31, 2024 | |||||||
| Cash, cash equivalents, and investments | $ | 296,980 | $ | 323,781 | ||||
| Restricted cash | $ | 5,980 | $ | 6,359 | ||||
| Total assets | $ | 913,170 | $ | 910,426 | ||||
| Stockholders' equity | $ | 698,583 | $ | 710,405 | ||||
Condensed Consolidated Statements of Operations
(in thousands, except per share information)
| For the Three Months Ended December 31, | For the Twelve Months Ended December 31, | |||||||||||||||
| 2025 (unaudited) | 2024 (unaudited) | 2025 | 2024 | |||||||||||||
| Revenue | ||||||||||||||||
| Product revenue, net | $ | 86,771 | $ | 73,694 | $ | 263,502 | $ | 164,070 | ||||||||
| Total revenue | 86,711 | 73,694 | 263,502 | 164,070 | ||||||||||||
| Costs and expenses* | ||||||||||||||||
| Cost of sales** | $ | 43,112 | $ | 37,789 | $ | 173,184 | $ | 93,248 | ||||||||
| Research and development** | 71,202 | 71,007 | 300,270 | 276,228 | ||||||||||||
| Selling, general and administrative** | 36,400 | 42,321 | 152,322 | 152,269 | ||||||||||||
| Depreciation and amortization | 9,517 | 9,153 | 35,939 | 37,603 | ||||||||||||
| Restructuring charges | — | — | 5,143 | — | ||||||||||||
| Total costs and expenses | 160,231 | 160,270 | 666,858 | 559,348 | ||||||||||||
| Loss from operations | (73,460 | ) | (86,576 | ) | (403,356 | ) | (395,278 | ) | ||||||||
| Other income | ||||||||||||||||
| Interest and other income, net | 1,740 | 9,575 | 10,307 | 20,273 | ||||||||||||
| Net Loss before income taxes | (71,720 | ) | (77,001 | ) | (393,049 | ) | (375,005 | ) | ||||||||
| Income tax (expense) benefit | (184 | ) | (1,558 | ) | 2,071 | 2,828 | ||||||||||
| Net Loss | $ | (71,904 | ) | $ | (78,559 | ) | $ | (390,978 | ) | $ | (372,177 | ) | ||||
| Net Loss Per Share of Common Stock, Basic and Diluted | $ | (0.18 | ) | $ | (0.26 | ) | $ | (1.09 | ) | $ | (1.28 | ) | ||||
| Weighted-Average Shares of Common Stock Outstanding, Basic and Diluted | 406,966 | 304,890 | 357,345 | 289,877 | ||||||||||||
| *Non-cash stock-based compensation included in cost of sales and operating expenses: | ||||||||||||||||
| Cost of sales | $ | 1,309 | $ | 3,192 | $ | 7,286 | $ | 8,554 | ||||||||
| Research and development | 5,672 | 13,445 | 26,959 | 49,270 | ||||||||||||
| Selling, general and administrative | 4,836 | 14,336 | 27,330 | 51,799 | ||||||||||||
| Total stock-based compensation included in costs and expenses | $ | 11,817 | $ | 30,973 | $ | 61,575 | $ | 109,623 | ||||||||
** Excludes depreciation and amortization
CONTACTS
Investors
IR@iovance.com
650-260-7120 ext. 150
Media
PR@iovance.com
650-260-7120 ext. 150
Exhibit 99.2
1 © 2026, Iovance Biotherapeutics, Inc. © 2026, Iovance Biotherapeutics, Inc. Corporate Overview February 2026 1
2 © 2026, Iovance Biotherapeutics, Inc. 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,” “outl ook ,” “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. For ward - looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, ex pected 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 , p erformance, 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 filing s 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, th e following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products; the acc eptance 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 t o support continued commercialization or development of our products or product candidates; the risk regarding our ability to manufacture our therapies at our i CTC facility, including the risk that our ability to increase manufacturing capacity at our facility may adversely affect our commercial launch; the risk that the successful development o r c ommercialization 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 relat ed 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 fro m our pivotal studies and cohorts, and meetings with regulatory authorities may support registrational studies and subsequent approvals by regulatory authorities, including the r isk that the planned registrational trial in advanced sarcomas may not support approval; preliminary and interim clinical results, which may include efficacy and safety results, f rom ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or c oho rts; 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 int erpretation of the results of our clinical trials or communications with regulatory authorities may differ from the interpretation of such results or communications by such regul ato ry authorities; 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 a ut horization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital require men ts; 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 ef fec ts of global and domestic geopolitical factors or public health events; and other factors, including general economic conditions and regulatory developments, not within our co ntr ol. Any financial guidance provided in this presentation assumes the following: no material change in our ability to manufacture our products; no material change in payo r c overage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this presentation; a nd no material fluctuation in exchange rates.
3 © 2026, Iovance Biotherapeutics, Inc. Global Leadership in Innovating, Developing and Delivering TIL Therapy for Patients with Cancer 3 Approved Products Commercial Launch Financials >85 ~$303M Cash as of 12/31/25 Treatment Centers as of 12/31/25* 2 ~95% 50% Gross Margin (Q4 2025) © 2026, Iovance Biotherapeutics, Inc. *Includes center s in final stages of readiness or soon to be authorized. Abbreviations: FDA, U.S. Food and Drug Administration >1,500 Patients treated with commercial and clinical Iovance TIL products U.S. & Canada Multiple Markets Globally ~30% Full Year 2025 Revenue $264M (Guidance of $250M - $300M Achieved) Addressable Patients within 200 miles of an ATC Q4 2025 Quarterly Revenue Growth
4 © 2026, Iovance Biotherapeutics, Inc. The Pioneer in One - Time Cell Therapy for Solid Tumors 4 4 © 2026, Iovance Biotherapeutics, Inc. 1. Medina et al, ASCO 2025. Pooled Analysis (n=153), Heavily Pre - Treated Patient Population; 2. Karapetyan et al, Tandem Meeting 2026. Physician - assessed confirmed ORR by RECIST v1.1. All evaluable patients received commercial Amtagvi according to the U.S. prescribing information; 3. Interim data cut as of October 10, 2025 of patients with nonsquamous NSCLC with minimum cell dose based on FDA feedback for melnaoma . 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 indica ted by other actionable tumor mutations; 4. As of December 31 , 2025 *Nonsquamous mNSCLC without EGFR, ROS1 or ALK genomic mutations Abbreviations: 2L, second line; FTD, fast track designation; mDOR, median duration of response; mNSCLC, metastatic non - small cel l lung cancer; OpEx , operating expenses; ORR, objective response rate; mOS, median overall survival; SOC, standard of care Platform technology and robust pipeline in blockbuster solid tumor indications Operational Excellence Focused on Profitability ~7X U.S. Melanoma Opportunity in 2L mNSCLC* $1B+ U.S. Sales Potential in 2L+ Advanced Melanoma • $303M cash 4 runway into 3Q27 • 50% gross margin (4Q25) • 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 • 1.5K+ commercial and clinical patients treated • High unmet need with limited treatment options • SOC: ~13% ORR; ~8 months mDOR; ~13 months mOS • Potential best - in - class lifileucel clinical profile: ~26% ORR; mDOR not reached at 25+ months follow up 3 • FTD for NSCLC from U.S. FDA • Potential launch in 2H27 • Leverages melanoma commercial footprint and manufacturing • First and only approved treatment in 2L+ advanced melanoma • ~30% quarterly growth in 4Q25 • ~$264M total revenue in first calendar year of launch • 5 - year durability : 34% ORR; ~20% OS; mDOR of >36 months 1 • Real - world ~44% ORR ; 52% ORR in patients with ≤ 2 prior lines of therapy 2
5 © 2026, Iovance Biotherapeutics, Inc. Strong Platform Supports Backbone IO Therapy for Solid Tumors Iovance Retains Global Portfolio and Technology Platform Rights Approved Amtagvi Treatment R egimen Canada EU: Updated Submission Planned Australia 1H26 Switzerland 1H27 UK 1H26 U.S. Under Review Additional Clinical & Commercial Use Canada U.S. * Planned to commence in 2026 Abbreviations: 2L, second line; 4L, fourth line; DDLPS, dedifferentiated liposarcoma; FTD, Fast Track Designation; IO, immuno - on cology; IL - 2, interleukin 2; IL - 12, interleukin 12; NSCLC , non - small cell lung cancer; PD - 1, programmed cell death protein - 1; UPS, undifferentiated pleomorphic sarcoma PHASE 3 PHASE 2 PHASE 1 INDICATION & TREATMENT SETTING TILVANCE - 301 (FTD, Confirmatory) Frontline advanced melanoma Lifileucel + pembrolizumab Registration - Directed IOV - LUN - 202 (FTD) Post - chemo & anti - PD - 1 advanced NSCLC Lifileucel IOV - SAR - 201* Post - chemo advanced soft tissue sarcomas (DDLPS or UPS) Lifleucel IOV - MEL - 202 Post anti - PD - 1 advanced melanoma Lifileucel Lifileucel Pipeline IOV - END - 201 Post - chemo & anti - PD - 1 endometrial cancer Lifileucel IOV - GM1 - 201 Post anti - PD - 1 advanced melanoma or NSCLC PD - 1 Inactivated TIL (IOV - 4001) Next - Generation Products IOV - IL2 - 101 TIL treatment regimen IL - 2 analog (IOV - 3001) IOV - GE1 - 201* Basket trial IL - 12 tethered TIL (IOV - 5001)
6 © 2026, Iovance Biotherapeutics, Inc. Tumor Infiltrating Lymphocytes (TIL): Leading Cell Therapy Platform for Solid Tumors Unique Mechanism of Action • Individualized • One - time therapy • Patient’s T cells fight cancer Tumor Tissue Collection Patient - specific T Cells Grown into the Billions 1 TIL Treatment Regimen 1. Amtagvi USPI
7 © 2026, Iovance Biotherapeutics, Inc. Global Deaths 2 U.S. Deaths 1 59K 8K Melanoma 1.8M 125K Lung & Bronchus 50K 5K Soft Tissue Sarcomas 97K 13K Endometrial 1. National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2025 Estimates. https://seer.cancer.g ov (accessed February 2026) 2. World Health Organization International Agency for Research on Cancer (IARC). GLOBOCAN 2022; Zhou et al. BMC Public Health 20 25 91% of all cancer cases are solid tumors 1 Market Expansion Opportunity in Solid Tumors 1 New indications: 2 Additional markets: Amtagvi® Approved Markets Planned Markets
8 © 2026, Iovance Biotherapeutics, Inc. 8 First FDA - approved One - time, Individualized T cell Therapy for a Solid Tumor Cancer
9 © 2026, Iovance Biotherapeutics, Inc. Significant unmet need in frontline and beyond 1 Advanced Melanoma Market Opportunity 2L+ Advanced Melanoma Population 2,3 US: 8K Potential ex - US Markets: 22 K Overall (1L+): 7 0K 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. 2025 Estimates. https:/ /s eer.cancer.gov (accessed August 2025); World Health Organization International Agency for Research on Cancer (IARC). GLOBOCAN 2022;3. Data on file as of July 2025. Includes more than 20,000 patients initial target markets plus additional pote nti al 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; ICI, immune checkpoint inhibitors; mOS, median overall survival; mPFS, median progression - free su rvival; PD - (L)1, programmed death receptor - 1 or programmed death - ligand >50% of patients on 1L standard of care progress within 12 months 4 - 6 mOS after Progression on 1L Therapy: 7
10 © 2026, Iovance Biotherapeutics, Inc. 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; mOS, media overall survival; NR, not reached; ORR, objective response rate Duration of Response Overall Survival Deep and Durable Responses at 5 - Year Follow Up 1 AMTAGVI® IN PREVIOUSLY TREATED ADVANCED MELANOMA Median Follow Up 57.8 Months
11 © 2026, Iovance Biotherapeutics, Inc. 52 % ORR (12/23) Best - in - class real - world data driving increased Amtagvi adoption 1 AMTAGVI® IN PREVIOUSLY TREATED ADVANCED MELANOMA 1. Karapetyan L et al. Tandem Meetings 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 Abbreviations: DCR, disease control rate; ORR, objective response rate 44 % ORR (18/41) 33% ORR (6/18) Before Lifileucel Post - Lifileucel (Week 6) Durable Ongoing Partial Response (PR) 2 Significant tumor burden reduction at Week 6 ≤ 2 prior lines of therapy ≥ 3 prior lines of therapy Unprecedented Real - World Response Rates Presented at 2026 Tandem Meetings 73% DCR ( 30/41) Higher Respon se Rates with Earlier Treatment
12 © 2026, Iovance Biotherapeutics, Inc. 12 © 2026, Iovance Biotherapeutics, Inc. Lymphodepletion Reimbursement ~3 Weeks Manufacturing, Release & Shipment Short - Course Proleukin® Scheduling Goal: <2 weeks Primary Oncologist ATC Medical Oncologist Follow - Up & Return to Primary Oncologist ~ 32 DAYS Community Practice Amtagvi® Patient Journey AMTAGVI® IN PREVIOUSLY TREATED ADVANCED MELANOMA Amtagvi® Broad payer coverage consistent with Amtagvi label, clinical trials and NCCN guidelines
13 © 2026, Iovance Biotherapeutics, Inc. • Modular design • Global supply and logistics • C apacity for up to 5K patients/year • Optimal utilization , quality & COS Manufacturing Facility Dedicated to Commercial and Clinical TIL Cell Therapies COS = cost of sales Philadelphia, PA
14 © 2026, Iovance Biotherapeutics, Inc. Amtagvi ® Authorized Treatment Centers (ATC) AMTAGVI® IN PREVIOUSLY TREATED ADVANCED MELANOMA 10K+ ≤ 100 Population 2 1. Not all authorized treatment centers are listed, Includes onboarded ATCs as well as in - process ATCs. 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 April 2025) 3. Internal data
15 © 2026, Iovance Biotherapeutics, Inc. Broad Market Access Data on file as of July 2025. *Plans or policies that cover Amtagvi, including pharmacy benefit managers (PBMs) Abbreviations: NCCN, National Comprehensive Cancer Network Payer medical coverage policies consistent with Amtagvi label, clinical trials and NCCN guidelines Patient lives covered; Majority of patients have private coverage* Typical time to financial clearance 250+ Million ~ 3 Weeks > 75% of Amtagvi patients covered by private payers
16 © 2026, Iovance Biotherapeutics, Inc. 16 Amtagvi® Expansion Plans in Advanced Melanoma
17 © 2026, Iovance Biotherapeutics, Inc. Unprecedented Rate, Depth & Durability of Responses in Frontline Advanced Melanoma • Median PFS and median DOR not reached at nearly 2 years of median follow - up (median follow - up 21.7 months) • All response - evaluable patients demonstrated regression of target lesions • Safety consistent with underlying disease and known safety profiles of pembrolizumab, NMA - LD, lifileucel, and IL - 2 • Late AEs consistent with anti - PD - 1 monotherapy, differentiated from ICI combination therapies LIFILEUCEL + PEMBROLIZUMAB IN FRONTLINE ADVANCED MELANOMA: IOV - COM - 202 COHORT 1A 1. Thomas et al, ASCO 2024; Data on file as of May 31, 2024. *Unconfirmed CRs, confirmed following data cut. a One patient without a postdose tumor response assessment was not included. b Target lesion lymph node at baseline decreased by 50% is no longer pathological, and thus is shown here as - 100% representing uCR. Abbreviations: CI, confidence interval; CR, complete response; DOR, duration of response; ICI, immune checkpoint inhibitor; O RR, objective response rate; PD, progressive disease; PFS, progression free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tu mors; SD, stable disease; SOD, sum of diameters; AE, adverse event; IL - 2, interleukin - 2; NMA - LD, nonmyeloablative lymphodepletion Data support rationale for TILVANCE frontline study: 1 65.2% ORR via RECIST v 1.1 30.4% CR 64.7% PFS at 6 & 12 months Best Percentage Change from Baseline in Target Lesion SOD Time to Response and Time of Efficacy Assessment for Confirmed Responders (PR or Better)
18 © 2026, Iovance Biotherapeutics, Inc. Option to crossover to lifileucel after BIRC - confirmed PD 1:1 Randomization TILVANCE - 301 Global Phase 3 and Confirmatory Trial LIFILEUCEL + PEMBROLIZUMAB IN FRONTLINE ADVANCED MELANOMA *Pembrolizumab in both arms is started at the same time after randomization. Abbreviations: BIRC, blinded independent review committee; ORR, objective response rate; PD, progressive disease; PD - 1, program med 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 75+ sites in U.S., Canada, Europe, APAC 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 full approval of Amtagvi ® in post - anti - PD - 1 melanoma • Enrollment on track with internal projections Randomized, multicenter study with optional crossover to Iifileucel (NCT05727904)
19 © 2026, Iovance Biotherapeutics, Inc. 19 TIL Therapy Pipeline
20 © 2026, Iovance Biotherapeutics, Inc. 1M+ Global Annual Deaths 1 Significant Unmet Need in 2L Nonsquamous NSCLC – Limited durability with SOC Chemo (Docetaxel) 2 5.6 mo mDOR 12.3 mo OS 12.8% ORR >90K Annual Deaths 1 1. Data on file as of November 2025, includes targeted patient population in potential future commercial markets. 2. Ahn MJ et al. J Clin Onc 2024;43:260 - 272. Abbreviations: APAC, Asia Pacific; mDOR, median duration of response; mo , month; NSCLC, non - small - cell lung cancer; ORR, objective response rate; OS, overall survival; SOC, standard of care >150K Annual Deaths 1 >75K Annual Deaths 1 TIL Experience is Growing at Leading Cancer Centers across North America, Europe & APAC Global NSCLC Commercial Opportunity ~7X Current Melanoma Opportunity 1
21 © 2026, Iovance Biotherapeutics, Inc. IOV - LUN - 202 Registrational Trial Design Phase 2 Multicenter Study of Lifileucel in Post - Anti - PD - 1 NSCLC (NCT04614103) Abbreviations: Anti - PD - 1, anti - programmed cell death inhibitor; IRC, independent review committee; NSCLC, non - small cell lung ca ncer; ORR, objective response rate; 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 by IRC • Secondary: Safety Patient Population Unresectable or metastatic NSCLC with progression on or after prior anti - PD - 1 treatment and chemotherapy 65+ sites in U.S., Canada, Europe, APAC Cohort 1: < 1% or unknown TPS Cohort 2: ≥ 1% TPS Registrational Cohorts
22 © 2026, Iovance Biotherapeutics, Inc. Fast Track Designation in Second - Line Nonsquamous mNSCLC IOV - LUN - 202 COHORTS 1 & 2 POST - ANTI - PD - 1 ADVANCED NSCLC 1. Interim data cut as of October 10, 2025 of patients with nonsquamous NSCLC with minimum cell dose based on FDA feedback in me lan oma. 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 mutatio ns. 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. *Patient 23 in ongoing follow up to confirm PR. Abbreviations: CR, complete response; mNSCLC, metastatic non - small cell lung cancer; ORR, objective response rate; PD, progressi ve disease; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease; uPR , unconfirmed partial response One - Time Therapy with Unprecedented Durability and Potential Best - in - Class Clinical Profile 1 25.6% ORR (n=39; RECIST 1.1) mDOR Not Reached (Median follow up: 25.4 months) Patients Time (months) Since Lifileucel Infusion % Change From Baseline Durability of Response 2 Patients Best Percentage Change from Baseline in Target Lesion(s)
23 © 2026, Iovance Biotherapeutics, Inc. Cohort 3A Results Support Adding TIL Therapy to Frontline NSCLC 1 IOV - COM - 202 COHORT 3A, ICI - NAÏVE NSCLC % Change from Baseline Time (Months) Since TIL Infusion PD - L1 negative, EGFR WT subgroup has a high unmet need 2 Best Percentage Change from Baseline in Target Lesion SOD 64.3% ORR EGFR WT Time to Response for Confirmed Responders (PR or Better, EGFR WT Patients) mDOR not reached (median follow - up 26.5 months) • Safety consistent with Iovance TIL combination studies • Supports adding TIL therapy to pembrolizumab plus chemotherapy for frontline NSCLC in IOV - COM - 202 cohorts 3D/3E 1. Creelan et al,SITC 2024 2 . KEYTRUDA USPI; OPDIVO USPI *PR response based on target lesion reduction of 100% with the persistence of nontarget lesions. Abbreviations: CR, complete response; EGFR, epidermal growth factor receptor; ICI, immune checkpoint inhibitor; 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 diameter; TPS, tumor proportion score; WT, wild - type 54.5% ORR EGFR WT PD - L1 Negative by RECIST 1.1 Anti - PD - 1 ORR Benchmarks 2 27% (TPS ≥ 1%); 39 - 45% (TPS ≥ 50%) Treatment - naïve (mono) 18 - 20% Post - chemotherapy (mono) 48 - 58% Frontline (anti - PD - 1 + chemo) 2 Patients 60 40 20 0 – 20 – 40 – 60 – 80 – 100 a 3A - 03 3A - 16 3A - 08 3A - 22 3A - 15 3A - 09 3A - 04 3A - 02 3A - PD - L1 TPS <1 <1 <1 <1 ≥ 50 <1 <1 <1 <1 3A - 10 ≥ 50 3A - 17 ≥ 50 3A - 11 <1 3A - 13 <1 8 0 10 0 PD SD PR CR
24 © 2026, Iovance Biotherapeutics, Inc. 1.. CancerMPact Patient Metrics for US Soft Tissue Sarcoma (accessed February 2026); 2. Zhou et al. BMC Public Health 2025; 3. CancerMPact Treatment Architecture for Sarcoma for the US & EU5 (May 2025) to inform treatment rates in the US 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; DDLPS, dedifferentiated liposarcoma; DCR, disease control rate; ICI, immune checkpoint inhibitor; ORR, objective response rat e; RECIST, Response Evaluation Criteria in Solid Tumors; SOD, sum of diameter (in millimeters); UPS, undifferentiated pleomorphic sarcoma Significant Market Opportunity for Advanced Tissue Sarcomas LIFILEUCEL IN ADVANCED SOFT TISSUE SARCOMAS Practice - changing potential in rare, high grade, aggressive refractory UPS & DDLPS with very high unmet need Deep responses improved over time • All evaluable patients had significant disease burden • Safety consistent with lifileucel in other indications Current 2L SOC has low ORR (<5%) with short durability 4 - 6 • No approved ICI options Phase 2 registrational trial to commence in 2Q 2026 • Targeting expedited pathways for registration • Plan to explore additional high grade soft tissue sarcoma subtypes >3 K >5K US annual cases 1 Patients with advanced disease 3 Europe annual cases 2 >3.5K >8K Patients/yr (US & Europe) 50% ORR via RECIST v1.1 2.33 Mean Prior Lines of Therapy 117 mm Baseline Mean SOD
25 © 2026, Iovance Biotherapeutics, Inc. 1. National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2025 Estimates. https://seer.cancer.gov (accessed August 2025); 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: Anti - PD - 1, anti - programmed cell death inhibitor; pMMR , proficient DNA mismatch repair; dMMR , deficient DNA mismatch repair; SOC, standard of care; TMB - H, tumor mutational burden high; ORR, objective response rate Potential Market for Advanced Endometrial Cancer LIFILEUCEL IN ADVANCED ENDOMETRIAL CANCER Immunosensitive Tumor Type with Significant Unmet Need in 2L+ Anti - PD - (L)1 moving into front - line therapy setting 3 No standard of care for 2L+ post - anti - PD - 1 • Molecularly defined subgroups with available targeted therapies are small • ORR with mono - chemotherapy after front - line chemo doublet: ~15% 5,6 • Limited data on treatments after anti - PD - (L)1 ~14K ~98K US annual uterine cancer deaths 1 5 - yr survival ( distant metastases ) 1 Global deaths 2 19.5% Endometrial Cancer Biomarkers 4 dMMR : 27% pMMR : 73% >90% of Uterine Cancers are Endometrial
26 © 2026, Iovance Biotherapeutics, Inc. pMMR Subgroup dMMR Subgroup Endpoints • Primary : ORR per RECIST v1.1 by investigator • Secondary : CR rate , DOR, DCR, PFS, OS, safety and tolerability • Subgroup analyses specified in protocol • Potential to expand / convert to registrational trial • First patient enrolled Q4 2024 IOV - END - 201 Phase 2 Proof of Concept Study Endometrial Cancer Patient Population * Recurrent, metastatic or primary unresectable disease after chemo and anti - PD - 1 therapy ≤ 3 lines of prior systemic therapy with no more than 1 line of chemotherapy *Sample size and study population of registrational ph2 study will be determined after PoC final analysis Abbreviations: Anti - PD - 1, anti - programmed cell death inhibitor; CR, complete response; dMMR, mismatch repair deficient; pMMR, mi smatch repair proficient; DCR, disease control rate; DOR, duration of response; ORR, objective response rate; OS, overall survival; PFS, progression free survival LIFILEUCEL IN ADVANCED ENDOMETRIAL CANCER Proof - of - Concept Trial in Patients with Mismatch Repair (MMR) Proficient and Deficient Tumors (NCT06481592)
27 © 2026, Iovance Biotherapeutics, Inc. 27 © 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
28 © 2026, Iovance Biotherapeutics, Inc. 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 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 N=53 NEXT - GENERATION TIL THERAPY: IOV - 4001 Abbreviations: Anti - PD - 1, anti - programmed cell death inhibitor; CR, complete response;; DCR, disease control rate; DOR, duration of response; NSCLC, non - small cell lung cancer; ORR, objective response rate; OS, overall survival; PFS, progression free survival
29 © 2026, Iovance Biotherapeutics, Inc. 29 © 2026, Iovance Biotherapeutics, Inc. IOV - 3001: Next Generation IL - 2 for TIL Supportive Regimen 1,2 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)G1 κ 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 IOV - 3001 may have a better safety profile and require less frequent dosing compared to Proleukin
30 © 2026, Iovance Biotherapeutics, Inc. IOV - 5001: IL - 12 TIL Therapy to Increase Efficacy 1. Zhang L, Rosenberg SA, et al, Clin Cancer Res 2015;21(10):2278 – 2288 2. Zhang L, Davis JS, et al, J Immunother Cancer 2020;8:e000210 3. Kobayashi M, Fitz L, et al, J Exp Med 1989;170:827 – 845. 4. Zeh HJ, Hurd S et al, J Immunother 1993;14:155 – 61. 5. Tugues S, Burkhard SH, et al, Cell Death and Differentiation 2015;22:237 – 246. 6. Cao X, Leonard K, et al, Cancer Res 2009;69:8700 – 9. 7. Steding CE, Wu S, 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 products 1 • IL - 12 shows independent clinical efficacy, with safe delivery to the TME being the primary challenge 1,2 • Expression of IL - 12 on IOV - 5001 is induced upon antigen encounter in the TME 1,2 • 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 are expected to allow increased IOV - 5001 cell doses and improved TIL efficacy in solid tumor cancers Abbreviations: IL - 12, interleukin 12; MDSC, myeloid derived suppressor cell; NK, natural killer cell; NKT, natural killer T cel l; ORR, objective response rate; TME, tumor microenvironment; Treg, regulatory T cell NK and NK - T cell activation and proliferation 3 CD8 + T cell activation and proliferation 4 CD4 + T cell differentiation to Th1 5 T reg and MDSC downregulation 6,7 30 Direct Action IFN γ Cytosol Nucleus TIL NFAT - TeIL - 12 IL - 12 IL - 12R TCR Antigen © 2026, Iovance Biotherapeutics, Inc.
31 © 2026, Iovance Biotherapeutics, Inc. 31 Corporate Summary
32 © 2026, Iovance Biotherapeutics, Inc. 1. Includes anticipated revenue from Amtagvi® and Proleukin® and anticipated savings from strategic restructuring announced on Aug ust 7, 2025 2. Preferred shares are shown on an as - converted basis . Financial Position & Outlook Cash runway into Q3 2027 1 2025 Revenue (First Full Year of Launch) ~$264M FY25 Guidance of $250M - $300M Achieved Revenue Growth Margin Improvement Cost Control Cash position (12/31/25) $303M
33 © 2026, Iovance Biotherapeutics, Inc. © 2026, Iovance Biotherapeutics, Inc. Thank You
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