Iovance (NASDAQ: IOVA) gains Australian Amtagvi approval as shareholders back larger share pool
Rhea-AI Filing Summary
Iovance Biotherapeutics reported that stockholders approved all seven proposals at its Annual Meeting, including an amendment to the 2020 Employee Stock Purchase Plan adding 1,000,000 shares and an increase in authorized common stock from 500,000,000 to 650,000,000 shares. Directors were re-elected, executive compensation received advisory approval, and Ernst & Young LLP was ratified as auditor.
The company also received marketing authorization from Australia’s Therapeutic Goods Administration for Amtagvi (lifileucel) to treat previously treated advanced melanoma. Amtagvi is described as the first T cell therapy for a solid tumor cancer and the first option in Australia for advanced melanoma after anti-PD-1 and targeted therapy.
Positive
- Australian marketing authorization for Amtagvi: The Therapeutic Goods Administration approved Amtagvi (lifileucel) for previously treated advanced melanoma, adding a new geographic market and described as the first T cell therapy for a solid tumor and the first post–anti-PD-1 option in Australia.
Negative
- None.
Insights
Australian approval for Amtagvi adds a new market while shareholders back expanded share capacity.
Iovance secured strong shareholder support for all Annual Meeting proposals, including expanding authorized common stock to 650,000,000 shares and adding 1,000,000 shares to the 2020 Employee Stock Purchase Plan. These changes increase the company’s flexibility for future equity-based plans and financing.
The Therapeutic Goods Administration of Australia granted marketing authorization, with conditions, for Amtagvi (lifileucel) in previously treated advanced melanoma after PD-1 and targeted therapy. Australia has a high melanoma incidence, and this is described as the first T cell therapy for a solid tumor and first post–anti-PD-1 option there.
TGA approval was based on the global Phase 2 C-144-01 trial, where efficacy was evaluated using objective response rate and duration of response under RECIST 1.1. Future disclosures, including uptake in Australian treatment centers and ongoing trials such as TILVANCE-301, will help clarify the commercial impact.
8-K Event Classification
Key Figures
Key Terms
Therapeutic Goods Administration (TGA) regulatory
tumor infiltrating lymphocyte (TIL) therapies medical
objective response rate (ORR) medical
duration of response (DOR) medical
RECIST version 1.1 medical
Phase 2 study medical
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
Current Report
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (date of earliest event reported):
(Exact Name of Registrant as Specified in Charter)
| (State of Incorporation) | ||
| Commission File Number | (I.R.S. Employer Identification No.) | |
| (Address of Principal Executive Offices) | (Zip Code) | |
| ( | ||
| (Registrant’s Telephone Number, Including Area Code) | ||
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| 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
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading
Symbol(s) |
Name
of each exchange on which registered |
| 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 | ||
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