Form 8-K

8-K — IOVANCE BIOTHERAPEUTICS, INC.

Accession: 0001104659-26-072408

Filed: 2026-06-10

Period: 2026-06-04

CIK: 0001425205

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

Item: Submission of Matters to a Vote of Security Holders

Item: Other Events

Item: Financial Statements and Exhibits

Documents

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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):

June 4, 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 5.07

Submission of Matters to a Vote of Security Holders.

Annual Meeting of Stockholders

On June 10, 2026, Iovance

Biotherapeutics, Inc. (the “Company”) held its Annual Meeting of Stockholders (the “Annual Meeting”) virtually,

via live webcast. At the Annual Meeting, the Company’s stockholders voted on seven proposals, each of which is described in more

detail in the Company’s definitive proxy statement on Schedule 14A filed with the U.S. Securities and Exchange Commission on April

28, 2026. At the Annual Meeting, 329,492,680 shares, or approximately 74% of all shares of the Company’s common stock outstanding

as of the record date, were represented either in person or by proxy. The following is a brief description of each matter voted upon and

the certified results, including the number of votes cast for and against each matter and, if applicable, the number of abstentions and

broker non-votes with respect to each matter:

Proposal 1: a proposal to elect Iain Dukes, D. Phil., Athena Countouriotis, M.D., Ryan Maynard, Wayne P. Rothbaum, Frederick G. Vogt, Ph.D., J.D., and Michael Weiser, M.D., Ph.D. to the Board of Directors (the “Board”) to serve as directors until the Company’s 2027 Annual Meeting of Stockholders;

Proposal 2: a proposal to approve, on a non-binding advisory basis, the compensation of the Company’s named executive officers;

Proposal 3: a proposal to approve, on a non-binding advisory basis, the frequency of the Company’s future votes on the compensation of the Company’s named executive officers;

Proposal 4: a proposal to ratify the appointment of Ernst & Young LLP as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2026;

Proposal 5: a proposal to approve an amendment to the 2020 Employee Stock Purchase Plan to increase the number of shares available for grant by 1,000,000 shares;

Proposal 6: a proposal to approve an amendment to the Company’s Certificate of Incorporation, as amended, to increase the number of authorized shares of the Company’s common stock from 500,000,000 shares to 650,000,000 shares; and

Proposal 7: a proposal to approve an adjournment of the Annual Meeting, if necessary, to solicit additional proxies if there are not sufficient votes at the time of the Annual Meeting to approval Proposal 6.

Voting Results

Proposal 1: The voting results for the election

of the director nominees were as follows:

For

Withheld

Broker Non-Vote

Dr. Dukes

182,990,471

16,322,922

130,179,287

Dr. Countouriotis

186,590,407

12,722,986

130,179,287

Mr. Maynard

186,379,215

12,934,178

130,179,287

Mr. Rothbaum

183,881,242

15,432,151

130,179,287

Dr. Vogt

181,341,958

17,971,435

130,179,287

Dr. Weiser

185,454,684

13,858,709

130,179,287

Each of the above nominees

was elected as a director of the Company.

Proposal 2: This proposal

was approved with 160,497,888 “FOR” votes, 36,117,764 “AGAINST” votes and 2,697,741 “ABSTAIN” votes.

There were 130,179,287 broker non-votes in connection with this proposal.

Proposal 3: This proposal

was approved as follows: 188,106,776 “1 YEAR” votes, 3,404,958 “2 YEARS” votes, 3,558,800 “3 YEARS”

votes, and 4,242,859 “ABSTAIN” votes. There were 0 broker non-votes in connection with this proposal.

Proposal 4: This proposal

was approved with 317,671,584 “FOR” votes, 6,433,002 “AGAINST” votes and 5,388,094 “ABSTAIN” votes.

There were 0 broker non-votes in connection with this proposal.

Proposal 5: This proposal

was approved with 178,677,284 “FOR” votes, 18,961,472 “AGAINST” votes and 1,674,637 “ABSTAIN” votes.

There were 130,179,287 broker non-votes in connection with this proposal.

Proposal 6: This proposal

was approved with 254,976,692 “FOR” votes, 71,438,492 “AGAINST” votes and 3,077,496 “ABSTAIN” votes.

There were 0 broker non-votes in connection with this proposal.

Proposal 7: This proposal

was approved with 267,867,310 “FOR” votes, 56,350,642 “AGAINST” votes and 5,274,728 “ABSTAIN” votes.

There were 0 broker non-votes in connection with this proposal.

Item 8.01

Other Events.

On June 4, 2026, the Company received marketing authorization from

the Therapeutic Goods Administration of Australia for Amtagvi® for previously treated advanced (metastatic or unresectable) melanoma.

The full text of the press release announcing the approval is attached hereto as Exhibit 99.1 and 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 June 3, 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: June 10, 2026

IOVANCE BIOTHERAPEUTICS, INC.

By:

/s/ Frederick G. Vogt

Frederick G. Vogt, Ph.D., J.D., 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’s Amtagvi® (lifileucel)

Granted Approval for

the Treatment of Advanced Melanoma in Australia

First T cell therapy for a solid tumor cancer

and first treatment option approved

in Australia for advanced melanoma after anti-PD-1

and targeted therapy

SAN CARLOS, Calif., June 3, 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 announced that the Therapeutic Goods Administration (TGA)

of Australia granted approval with conditions of Amtagvi® (lifileucel), a tumor-derived autologous T cell immunotherapy, for previously

treated advanced (metastatic or unresectable) melanoma. Amtagvi is indicated for the treatment of adult patients with unresectable or

metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without

a MEK inhibitor.

“This approval in Australia is our third marketing authorization

for Amtagvi and marks a significant step forward for Iovance in the country with the highest rate of melanoma globally,” said Frederick

Vogt, Ph.D., J.D., Interim Chief Executive Officer and President of Iovance. “We are in the process of authorizing our first Australian

treatment center as we advance our expansion strategy for Amtagvi in additional markets with a high prevalence of advanced melanoma.”

Australia has the highest rate of melanoma globally, with an estimated

17,000 new cases diagnosed each year and more than 1,500 deaths annually.1,2 Similar to the U.S. and other global markets,

there is a significant need for new therapies for patients with advanced melanoma.

TGA granted approval based on safety

and efficacy results from the global, multicenter C-144-01 trial investigating Amtagvi in patients with advanced melanoma previously treated

with anti-PD-1 therapy and targeted therapy, if applicable.

About the C-144-01 Clinical Trial

C-144-01 is a global, multicenter Phase

2 study in which patients received lifileucel monotherapy. The study enrolled patients with metastatic melanoma who were previously treated

with at least one systemic therapy, including a PD-1 blocking antibody, and, if BRAF V600 mutation positive, a BRAF inhibitor or

a BRAF inhibitor with a MEK inhibitor. Efficacy was established on the basis of objective response rate (ORR) and duration of response

(DOR) by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The detailed results

of C-144-01 were published in the Journal for ImmunoTherapy of Cancer in 2022. A five-year analysis of C-144-01 was published in the Journal

of Clinical Oncology in 2025.

Iovance is investigating Amtagvi in

frontline advanced melanoma in the Phase 3 trial, TILVANCE-301 (NCT05727904), as well as in additional solid tumor

types.

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.

1. Cancer Australia, Melanoma of the Skin Statistics, https://www.canceraustralia.gov.au/cancer-types/melanoma-skin/melanoma-skin-statistics

(Accessed March 2026)

2. Melanoma Institute Australia, Melanoma Facts, https://melanoma.org.au/about-melanoma/melanoma-facts/

(Accessed March 2026)

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 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 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 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.

CONTACTS

Investors

IR@iovance.com

650-260-7120 ext.

150

Media

PR@iovance.com

650-260-7120 ext.

150

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