Form 8-K

8-K — IOVANCE BIOTHERAPEUTICS, INC.

Accession: 0001104659-26-056782

Filed: 2026-05-07

Period: 2026-05-07

CIK: 0001425205

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

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — tm2613648d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2613648d1_ex99-1.htm)

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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):

May 7, 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 share

IOVA

The

Nasdaq Stock Market LLC

Item 2.02.

Results of Operations and Financial Condition.

On May 7, 2026, Iovance Biotherapeutics, Inc. (the

“Company”) issued a press release announcing its financial results for the first quarter ended March 31, 2026, 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 9.01.

Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

No.

Description

99.1

Press Release of Iovance Biotherapeutics, Inc., dated May 7, 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.

Dated: May 7, 2026

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: tm2613648d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Iovance Biotherapeutics Highlights Positive

First Quarter 2026

Results, Business Achievements and Corporate

Updates

1Q26 Total Revenue of ~$71M Delivers ~45% Year-over-Year

Growth

2Q26 Revenue Guidance of $86M to $88M and FY26

of $350M to $370M

40% Confirmed Objective Response Rate in Metastatic

Serous Endometrial Cancer

SAN CARLOS, Calif., May 7, 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 first quarter 2026 financial results, business achievements, and

corporate updates.

Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive

Officer of Iovance, stated, “We are accelerating the adoption and commercial expansion for Amtagvi after record high demand. Iovance

is well positioned through 2026 for long-term revenue growth, while advancing multiple ongoing and new clinical trials, including our

registrational trial in advanced sarcomas now underway and encouraging initial data reported today for lifileucel in metastatic serous

endometrial cancer. Internal manufacturing efficiencies, operational improvements, and cost reductions will benefit gross margin and

propel future profitability, sustainable growth, and long-term value for patients and shareholders.”

First Quarter 2026 Financial Highlights

Continued Strength in Execution and Cost Discipline

Total

product revenue of ~$71 million increased by ~45% over 1Q25, reflecting significant performance

improvements over the prior annual maintenance period.

o U.S. Amtagvi revenue was ~$60 million.

o Global Proleukin revenue was ~$11 million.

Gross

margin of 41% absorbed one-time costs for the annual maintenance period and the recent internal

facility expansion.

Consistent

with 1Q25, revenue was affected by maintenance of the Iovance Cell Therapy Center (iCTC).

The facility has now been expanded to ensure continuous supply going forward during future

maintenance periods.

Research

and Development (R&D) expenses decreased by 12% compared to 4Q25, driven by operational

efficiencies and marking the third consecutive quarter of improvements.

Successful

centralization of manufacturing at iCTC, significant operational excellence initiatives

focused on Amtagvi production, and R&D optimization should further reduce costs and improve

gross margins in 2026 and 2027.

Second Quarter 2026 and Full

Year 2026 Guidance

Strong Growth in Amtagvi Forecast for 2026

Total

product revenue guidance for 2Q26 is $86 million to $88 million and for FY26 is $350 million

to $370 million.

U.S.

Amtagvi revenue for 2Q26 is expected to be $79 million to $81 million, reflecting an expected

~23% increase over 4Q25 (the quarter prior to iCTC maintenance).

Amtagvi Commercial Business

Strong U.S. Commercial Business to Deliver Strong Growth in 2026

Increasing

Amtagvi demand, catalyzed by real-world data, is driven by adoption and referrals toward

earlier treatment. Recently published real world objective response rates were 52%

in patients with two or fewer prior lines of therapy. Five-year follow-up clinical data

demonstrated deep and durable responses in heavily pretreated patients, with a median duration

of response of 3 years.

Demand

and referral patterns are accelerating across a growing network of more than 90 U.S. and

Canadian academic and community authorized treatment centers (ATCs). By year-end 2026, at

least 110 ATCs will be activated.

Amtagvi

turnaround time is 32 days or less with the first scaled, centralized commercial manufacturing

process for TIL therapy. This is significantly faster than any other TIL therapy in development.

Amtagvi

global expansion is advancing:

o Decisions on marketing authorization application (MAA) approvals are

expected in Australia in the first half of 2026 and in Switzerland in the first half of 2027.

o In the United Kingdom, Iovance withdrew its initial MAA for lifileucel

in May 2026 for procedural reasons. With the full agreement of the Medicines and Healthcare

products Regulatory Agency (MHRA), Iovance will promptly resubmit the MAA with updated

information for an expedited review by the MHRA, which is expected to be completed over the

coming months.

o Iovance is working to resubmit an MAA to the European Medicines Agency

(EMA) in 2026.

o Other regulatory submissions are planned in markets with a high prevalence

of advanced melanoma, non-small cell lung cancer (NSCLC), and soft tissue sarcomas.

Pipeline Updates

New Data Across Several Pipeline Programs

Anticipated Throughout 2026

Registrational

Trials of Lifileucel Treatment in Solid Tumors

o IOV-END-201: Positive initial data in previously treated metastatic

serous endometrial cancer:

§ The

confirmed objective response rate (cORR) by RECIST v1.1 was 40% and disease control rate

was 100% in the first five evaluable patients with a median of 2 prior lines of therapy.

§ All

five patients were mismatch repair proficient and progressed on prior chemotherapy and checkpoint

inhibitor therapy.

§ These

initial responses build on established differentiation of lifileucel from immune checkpoint

inhibitors, including in melanoma, and demonstrate its advantages for solid tumor indications.

§ Serous

endometrial cancer is a difficult to treat subtype accounting for ~40% of the approximately

12,500 annual U.S. endometrial cancer deaths.1 The second line setting represents

an area of unmet medical need, with no therapy approved by FDA specifically for patients

with serous endometrial carcinoma or for patients who have received prior PD-1 blocking antibodies.

§ Engagement

on an expedited approval pathway with the ongoing IOV-END-201 trial is planned with the U.S.

Food and Drug Administration (FDA).

o IOV-LUN-202: initial results in previously treated, metastatic

non-squamous NSCLC supported FDA Fast Track Designation, reflecting the high unmet medical

need in this population. Upcoming milestones include:

§ Updated

data at a major medical meeting in 2026.

§ Completion

of enrollment in 2026 to support a supplemental Biologics License Application (sBLA).

§ Potential

for a U.S. accelerated approval and launch in the second half of 2027.

o IOV-SAR-201: a new registrational trial in undifferentiated pleomorphic

sarcoma (UPS) and dedifferentiated liposarcoma (DDLPS) is now underway, driven by positive

early data with a cORR of 50% in the first six evaluable patients.

§ Site

activation and enrollment are on track to begin in the third quarter of 2026.

§ Iovance

is actively engaging with FDA on a path to expedited approval for lifileucel in UPS and DDLPS.

o TILVANCE-301: A Phase 3 randomized trial of lifileucel and pembrolizumab

in frontline advanced melanoma.

§ Sites

are actively enrolling patients across a broad global footprint.

§ An

early interim analysis based on cORR is intended for a potential sBLA in frontline advanced

melanoma.

§ TILVANCE-301

is also the confirmatory trial to support full approval in second line advanced melanoma.

Generation Pipeline

o An Investigational New Drug (IND) application was submitted to FDA

for a Phase 1/2 basket trial of IOV-5001, a second-generation IL-12 tethered TIL therapy,

to begin enrolling in 2H 2026. Cohorts include advanced colorectal cancer, triple negative

and estrogen receptor low breast cancers, and other highly prevalent solid tumors representing

more than 100,000 U.S. deaths annually.2 IOV-5001 is designed to remodel the suppressive

tumor microenvironment (TME) and activate immunologically cold tumors to support TIL responses.

A first-generation IL-12 secreted TIL therapy showed a cORR of 63% in 16 melanoma patients

at cell doses much lower than used with typical TIL therapies as well as those safely achievable

with IOV-5001.3

o A Phase 1/2 trial, IOV-GM1-201, is enrolling using IOV-4001,

a PD-1 inactivated TIL therapy, in previously treated advanced melanoma and NSCLC. IOV-4001

is engineered to resist inhibitory signals and enhance the ability of TIL therapies to fight

and kill cancer in the TME.

o A Phase 1 safety cohort using IOV-3001 is advancing through multiple

dose levels in the Phase 1/2 trial of our second-generation, modified IL-2 analog for the

TIL treatment regimen. IOV-3001 selectively expands effector T cells while avoiding

activation of regulatory T cells, with the potential for a lower dose IL-2 regimen with reduced

adverse events. IOV-3001 exhibits favorable pharmacokinetics and is expected to be superior

to Proleukin as a component of future TIL regimens.

o Multiple investigator-sponsored clinical trials of lifileucel are

enrolling in cutaneous squamous and Merkel cell carcinomas as well as other new solid tumor

indications.

Corporate Updates

Iovance

currently owns or licenses nearly 400 granted or allowed U.S. and international patents

and patent rights for Amtagvi and other TIL-related technologies, as well as more than

1,000 patent applications worldwide, which are expected to provide exclusivity into 2042

for Amtagvi and beyond for pipeline therapies.

Dr. Friedrich

Graf Finckenstein, Chief Medical Officer, will retire from Iovance in June 2026. The

company thanks Dr. Finckenstein for his service and contributions to the development

of Amtagvi and other pipeline products. A new Chief Medical Officer is expected to be announced

in the near term.

Iovance’s

cash position was ~$319 million on March 31, 2026.4 The current cash position,

bolstered by expense reductions, is expected to fund operations well into 2028.

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/wmx3s4fc. The live and archived webcast can be accessed in the Investors section of the

Company’s website, IR.Iovance.com, for one year.

1.Hamilton, C., Cheung, M., Osann, K. et al. Uterine papillary serous

and clear cell carcinomas predict for poorer survival compared to grade 3 endometrioid corpus cancers. Br J Cancer 94, 642–646

2. Surveillance, Epidemiology, and End Results Program Cancer Stat

Facts (accessed May 2026).

3. Zhang L, Rosenberg SA, et al, Clin Cancer Res 2015;21(10):2278–2288.

4. Cash, cash equivalents, short-term investments, and restricted

cash as of March 31, 2026.

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,” “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 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)

March 31, 2026

(unaudited)

December 31, 2025

Cash, cash equivalents, and investments

$ 313,443

$ 296,980

Restricted cash

$ 5,992

$ 5,980

Total assets

$ 925,665

$ 913,170

Stockholders' equity

$ 721,754

$ 698,583

Condensed Consolidated Statements of Operations

(in thousands, except per share information)

For the Three Months Ended

March 31,

2026

(unaudited)

2025

(unaudited)

Revenue

Product revenue, net

71,430

49,324

Total revenue

71,430

49,324

Costs and expenses*

Cost of sales **

42,498

42,715

Research and development **

62,487

75,965

Selling, general and administrative **

38,949

43,800

Depreciation and amortization

8,539

8,065

Total costs and expenses

152,473

170,545

Loss from operations

(81,043

)

(121,221

)

Other income

Interest and other income, net

1,333

3,220

Net Loss before income taxes

(79,710

)

(118,001

)

Income tax (expense) benefit

665

1,838

Net Loss

(79,045

)

(116,163

)

Net Loss Per Share of Common Stock, Basic and Diluted

(0.19

)

(0.36

)

Weighted-Average Shares of Common Stock Outstanding, Basic and Diluted

418,511

322,868

*Non-cash stock-based compensation included in cost of sales and operating expenses:

Cost of sales

1,019

2,420

Research and development

5,117

9,917

Selling, general and administrative

5,133

10,578

Total stock-based compensation included in costs and expenses

11,269

22,915

** Excludes depreciation and amortization

CONTACTS

Investors

IR@iovance.com

650-260-7120 ext. 150

Media

PR@iovance.com

650-260-7120 ext. 150

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

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

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Title of a 12(b) registered security.

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

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Name of the Exchange on which a security is registered.

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

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

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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

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Trading symbol of an instrument as listed on an exchange.

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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.

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

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