Form 8-K

8-K — IOVANCE BIOTHERAPEUTICS, INC.

Accession: 0001104659-26-092145

Filed: 2026-08-06

Period: 2026-08-06

CIK: 0001425205

SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tm2622463d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2622463d1_ex99-1.htm)

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8-K — FORM 8-K

8-K (Primary)

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2026-08-06

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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):

August 6, 2026

IOVANCE BIOTHERAPEUTICS, INC.

(Exact Name of Registrant as Specified in Charter)

Delaware

(State of Incorporation)

001-36860

75-3254381

Commission File Number

(I.R.S. Employer Identification No.)

825

Industrial Road, Suite 100

San

Carlos, California

94070

(Address of Principal Executive Offices)

(Zip Code)

(650)

260-7120

(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:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425).

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12).

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)).

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)).

Indicate

by check mark whether the registrant is an emerging growth company as defined in 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 ¨

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. ¨

Securities registered pursuant to Section 12(b) of the Act:

Title

of each class

Trading

Symbol(s)

Name

of each exchange on which

registered

Common stock, par value $0.000041666 per value

IOVA

The

Nasdaq Stock Market, LLC

Item 8.01

Other Events.

On August 6, 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

No.

Description

99.1

Iovance Biotherapeutics, Inc., Corporate Presentation – August 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.

Date: August 6, 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

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2622463d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Corporate Overview

August 2026

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,”

“achievable,” “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; 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 Iovance Cell Therapy Center facility, including the risk that our ability to increase manufacturing capacity at our facility may adversely affect our commercial launch; the

risks related to our ability to obtain, maintain and enforce patent and other intellectual property protection for our products and product candidates; 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 authorized treatment centers, 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

Approved

Products

Commercial Launch Financials

>95 Treatment Centers

as of 08/05/26*

>95%

Margin from Cost of Sales1

56%

*Includes centers in final stages of readiness or soon to be authorized.

1. Excludes depreciation and amortization 2. Cash, cash equivalents, short-term investments, and restricted cash as of June 30, 2026.

Abbreviations: FDA, U.S. Food and Drug Administration

~2,000 Patients treated with commercial and

clinical Iovance TIL products

U.S., Canada & Australia

Multiple Markets Globally ~66%

Addressable Patients

within 200 miles of an ATC

Year-Over-Year Quarterly

Revenue Growth

Cash Runway into 2H282

~$304M

2Q26 revenue >10% above 2Q26 guidance

~$99M

The Pioneer in One-Time Cell Therapy for Solid Tumors

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 2024;43:260-272. 4. Interim data cut as of October 10, 2025 of patients with nonsquamous 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 June 30, 2026; 6. Excludes depreciation and amortization

*Nonsquamous mNSCLC without EGFR, ROS1 or ALK genomic mutations

Abbreviations: 2L, second line; COS, cost of sales; FTD, fast track designation; mDOR, median duration of response; mNSCLC, metastatic non-small cell 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

$1B+

U.S. Sales Potential in

2L+ Advanced Melanoma

~7X U.S. Melanoma

Opportunity

in 2L mNSCLC*

Operational Excellence

Focused on Profitability

• First and only approved treatment in

2L+ advanced melanoma

• ~66% YoY revenue growth in 2Q26

• 2Q26 revenue >10% above 2Q26

guidance

• 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

• High unmet need with limited

treatment options

• SOC: 12.8% ORR; 5.6 months mDOR;

12.3 months mOS3

• Potential best-in-class lifileucel

clinical profile: 25.6% ORR; mDOR

not reached at 25.4 months follow up4

• FTD for NSCLC from U.S. FDA

• Potential launch in 2H27

• Leverages melanoma commercial

footprint and manufacturing

• ~$304M cash, with runway into

second half 20285

• ~56% gross margin from COS in

2Q26 and 50% 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

Strong Platform Supports Backbone IO Therapy for Solid Tumors

Iovance Retains Global Portfolio and Technology Platform Rights

Abbreviations: 2L, second line; 4L, fourth line; CRC, colorectal cancer; DDLPS, dedifferentiated liposarcoma; ER, estrogen-receptor; FTD, Fast Track Designation; IO, immuno-oncology; HNSCC, head and neck squamous

cell carcinoma; IL-2, interleukin 2; IL-12, interleukin 12; NSCLC, non-small cell lung cancer; PD-1, programmed cell death protein-1; TNBC, triple negative breast cancer; UPS, undifferentiated pleomorphic sarcoma

Approved Amtagvi

Treatment

U.S. Australia Canada UK (2H 2026) Switzerland(1H 2027) EU Regimen

Additional

Clinical &

Commercial Use

Under Review Pending

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 advanced NSCLC IOV-LUN-202 (FTD)

Lifileucel Post-chemo advanced soft tissue sarcomas (DDLPS or UPS) SARATOGA (FTD)

Lifileucel Post-chemo & anti-PD-1 endometrial cancer IOV-END-201

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 IOV-GE1-201

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

US:

8.5K

Potential

ex-US Markets:

22K

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 June 2026); World Health Organization International Agency for Research on Cancer (IARC).

GLOBOCAN 2022;3. Data on file as of August 2026. Includes more than 20,000 patients 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; ICI, immune checkpoint inhibitors; mOS, median overall survival; mPFS, median progression-free survival; PD-(L)1, programmed death receptor-1 or programmed death-ligand

>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; mOS, median overall survival; NR, not reached; ORR, objective response rate

Duration of Response

Overall Survival

Deep and Durable Responses at 5-Year Follow Up1

Median Follow Up

57.8 Months

52% ORR(12/23)

OS Not Reached

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/scientific-publications-presentations/

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

Significanttumor burden reduction at Week 6

≤ 2 prior lines of therapy

≥ 3 prior lines of therapy

Unprecedented Real-World Response Rates of >50% ORR in multiple studies3

73% DCR

(30/41)

Higher Response Rates with Earlier Treatment

One Shared Infrastructure with Scalable Expansion

Melanoma

Medical Oncologist

Currently Treating

NSCLC

Medical Oncologist

Educating

Sarcoma

Medical Oncologist

Educating

Endometrial

Medical Oncologist

Educating

One-Time Treatment

Patient

Identification

Tumor Tissue

Procurement

Centralized

Manufacturing

Administration

E x i s t i n g I n s t i t u t i o n a l G r o u n d w o r k S u p p o r t s L a b e l E x p a n s i o n

Surgeons

Tumor Tissue Procurement · Trained once,

serve every indication

Cell Therapists

Authorized Treatment Centers · Trained once,

serve every indication

• The only scaled, centralized

FDA-approved commercial TIL

manufacturing process

• Continually improving end-to-end commercial turnaround

(~31 days)

• Modular design

• 5K+ patient annual capacity

• Optimal utilization, quality &

COS

Manufacturing Facility Dedicated

to Global Delivery of Commercial and

Clinical TIL Cell Therapies

COS = cost of sales

Philadelphia, PA

Manufacturing facility Countries with clinical trial sites

Cryopreserved TIL is manufactured in Philadelphia and shipped to

commercial and clinical trial sites across North America, Europe,

Asia-Pacific and Australia.

Philadelphia

Los Angeles

Canada

Europe

South Korea

Singapore

Australia

>95

ATCs in North America1,2

1/3

in Community Setting

≤100 10K+

Population2

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 August 2026)

Amtagvi® Authorized Treatment Centers (ATC)

Broad Amtagvi U.S. Market and Geographic Access

Data on file as of August 2026.

*Plans or policies that cover Amtagvi, including pharmacy benefit managers (PBMs)

Abbreviations: NCCN, National Comprehensive Cancer Network

Lives covered;

majority with

private coverage*

>250M >75% >80%

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

Unique mechanism of action One-time infusion

Deep Pipeline of Registrational Programs

Unprecedented Rate, Depth &

Durability of Responses in

Frontline Advanced Melanoma

• mPFS and mDOR not reached at ~2 years of 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

1. Thomas et al, ASCO 2024; Data on file as of May 31, 2024.

*Unconfirmed CRs, confirmed following data cut.

aOne patient without a postdose tumor response assessment was not included.

bTarget 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; M, median; ORR, objective

response rate; PD, progressive disease; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; 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%

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)

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: 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 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

• Enrollment on track with internal

projections

Randomized, Multicenter Study with Optional Crossover to Lifileucel (NCT05727904)

1M+

Global

Annual Deaths1

Significant Unmet Need in 2L Nonsquamous NSCLC

– Limited durability with SOC Chemo (Docetaxel)2

12.8% ORR 5.6 mo mDOR 12.3 mo OS

>90K

Annual Deaths1

1. Data on file as of August 2026, includes targeted patient population (nonsquamous advanced NSCLC) 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 Deaths1

>75K

Annual Deaths1

TIL Experience is Growing at Leading Cancer Centers across North America, Europe & APAC

Global NSCLC Commercial Opportunity

~7X Current Melanoma Opportunity1

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 cancer; 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 per RECIST v1.1

by IRC

• Secondary: CR rate, DOR,

DCR, and PFS; OS; safety and

tolerability

Patient

Population

Unresectable or

metastatic NSCLC

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

Registrational Cohorts

FDA Fast Track Designation in Second-Line Nonsquamous mNSCLC

1.Interim data cut as of October 10, 2025 of patients with nonsquamous NSCLC with minimum cell dose based on FDA feedback in 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. 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, progressive 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 Profile1

25.6% ORR

(n=39; RECIST v1.1)

mDOR Not Reached

(Median follow up: 25.4 months)

Patients

Time (months) Since Lifileucel Infusion

% Change From Baseline

Durability of Response2

Patients

Best Percentage Change from Baseline in Target Lesion(s)

Cohort 3A Results Support Adding TIL Therapy to Frontline NSCLC1

% Change from Baseline

Time (Months) Since TIL Infusion

PD-L1 Negative, EGFRWT Subgroup has a High Unmet Need2

Best Percentage Change from Baseline in Target Lesion SOD

64.3% ORR EGFRWT

Time to Response for Confirmed Responders (PR or Better, EGFRWT 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

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 EGFRWT PD-L1 Negative

by RECIST v1.1

Anti-PD-1 ORR Benchmarks2

Treatment-naïve

(mono)

27% (TPS ≥ 1%);

39 - 45% (TPS ≥ 50%)

Post-chemotherapy

(mono)

18 - 20%

Frontline

(anti-PD-1 + chemo)

48-58%

Patients

–20

–40

–60

–80

–100

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

3A-13

100 PD SD PR CR

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 rate; RECIST, Response Evaluation Criteria in Solid Tumors; SOD, sum of diameter (in

millimeters); UPS, undifferentiated pleomorphic sarcoma

Significant Market Opportunity for Advanced Soft Tissue Sarcomas

FDA Fast Track Designation in Rare, High Grade, Aggressive RefractoryUPS & DDLPS with Very HighUnmet 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 durability4-6

• No approved ICI options

• Patients concentrated at centers of excellence

Phase 2 SARATOGA registrational trial commenced in 2Q 2026

• Targeting expedited pathways for registration

• Plan to explore additional high grade soft tissue sarcoma subtypes

>3K

>5K

U.S. annual cases1

Patients with

advanced disease3

Europe annual

cases2

>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

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; DOR, duration of response; IRC, independent review committee; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival; PFS,

progression free survival; RECIST, Response Evaluation Criteria in Solid Tumors

Endpoints

Primary:

ORR per RECIST v1.1 by IRC

Secondary:

CR rate, DOR, DCR, PFS, OS, safety

and tolerability

Patient

Population

Patients with

undifferentiated

pleomorphic sarcoma

(UPS) or

dedifferentiated

liposarcoma

(DDLPS) who have

received 1-3 prior

systemic treatments

Cohort 1:

UPS

Cohort 2:

DDLPS

1. National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2026 Estimates. https://seer.cancer.gov (accessed June 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: 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

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 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 front-line chemo doublet: ~15% ORR5,6

• Targeted therapies available only to small subgroups

~13K

~90K

US annual

endometrial

cancer deaths 1

5-yr survival

(distant metastases)

Global deaths2

19.5%

Endometrial

Cancer

Biomarkers4

pMMR: 73%

dMMR: 27%

>40%

of Endometrial Cancer

Deaths are Serous

40%

Confirmed ORR via

RECIST v1.1

100%

DCR via RECIST v1.1

Median Prior Lines

of Therapy

First 5 evaluable patients all mismatch repair proficient and progressedon prior

chemotherapy and checkpoint inhibitor therapy

pMMR

Subgroup*

dMMR

Subgroup*

Endpoints

• Primary: ORR per RECIST v1.1 by

investigator

• Secondary: CR rate, DOR, DCR, PFS,

OS, safety and tolerability

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 ≤1 line of

chemotherapy

*Proof of concept cohorts, enrollment complete

**Planned

Abbreviations: Anti-PD-1, anti-programmed cell death inhibitor; CR, complete response; dMMR, mismatch repair deficient; pMMR, mismatch repair proficient; DCR, disease control rate; DOR, duration of response; ORR,

objective response rate; OS, overall survival; PFS, progression free survival

Proof-of-Concept Trial in Patients with Mismatch Repair (MMR) Proficient and Deficient Tumors (NCT06481592)

Serous

Endometrial

Cohort**

First-in-class Immuno-Oncology Technologies Target

New Indications

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-L1 PD-L2

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

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: 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;

RECIST, Response Evaluation Criteria in Solid Tumors

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

JAK3

STAT5

dimer

Cytosol

Nucleus

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: IL-12, interleukin 12; IND, investigational new drug application; MDSC, myeloid derived suppressor cell; NK, natural killer cell; NKT, natural killer T cell; ORR, objective response rate; 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

Direct Action

IFNγ

Cytosol

Nucleus

TIL

NFAT-TeIL-12

IL-12 IL-12R

TCR

Antigen

IND-Cleared: Phase 1/2 Basket Trial Enrolling in Solid

Tumors Representing 100K+ U.S. Deaths Annually

Phase 1/2 Open-Label First-in-Human Study: 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: Anti-PD-1, anti-programmed cell death inhibitor; CR, complete response; CRC, colorectal cancer; DCR, disease control rate; DOR, duration of response; ER, estrogen receptor; HNSCC, head and neck squamous cell carcinoma; NSCLC, non small cell lung cancer; ORR,

objective response rate; OS, overall survival; PFS, progression free survival; RECIST, Response Evaluation Criteria in Solid Tumors ; TNBC, triple negative breast cancer

Cohort 3: Stage IV CRC

Cohort 4: Stage III or IV HNSCC

Financial Summary

1. Excludes depreciation and amortization

2. Cash, cash equivalents, short-term investments, and restricted cash as of June 30, 2026

Financial Position & Outlook

Cash runway into

2H 2028

Revenue Growth | Margin Improvement | Cost Control

Cash position2

~$304M

2Q26 Margin1

56%

2Q26 Revenue >10% Above 2Q26 Guidance

~$99M

Thank You

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Aug. 06, 2026

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IOVANCE BIOTHERAPEUTICS, INC.

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825

Industrial Road

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dei_SecurityExchangeName

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

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- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

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dei_TradingSymbol

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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