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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): September 29, 2026
IOVANCE BIOTHERAPEUTICS, INC.
(Exact name of Registrant as Specified in Its
Charter)
| Delaware |
001-36860 |
75-3254381 |
(State
or Other Jurisdiction
of Incorporation) |
(Commission
File Number) |
(IRS
Employer
Identification No.) |
| |
|
|
| 300
Rouse Blvd. |
|
| Philadelphia,
Pennsylvania |
|
19112 |
| (Address
of Principal Executive Offices) |
|
(Zip
Code) |
Registrant’s
Telephone Number, Including Area Code: 650 260-7120
825
Industrial Road, Suite 100
San
Carlos, California 94070
(Former Name or Former Address, if Changed
Since Last Report)
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))
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 |
|
IOVA |
|
The
Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth
company 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. ¨
Item 8.01 Other Events.
On September 29, 2026, Iovance Biotherapeutics, Inc. issued a press
release updating its full year 2026 revenue guidance. A copy of the press release 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 |
|
Press Release of Iovance Biotherapeutics, Inc., dated
September 29, 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. |
| |
|
|
|
| Date: |
September 29, 2026 |
By: |
/s/
Frederick G. Vogt |
| |
|
|
Name: |
Frederick G. Vogt, Ph.D., J.D. |
| |
|
|
Title: |
Interim CEO and President, and General Counsel |
Exhibit 99.1
Iovance Biotherapeutics
Raises Full Year 2026 Revenue Guidance to $410 to $420 Million
New Guidance
Represents an Increase of $55 Million at the Midpoint from the Prior Range of $350 to $370 Million
Strong U.S. Demand
for Amtagvi and Proleukin Drives Increased Outlook
PHILADELPHIA, Pennsylvania, September 29,
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 raised its full year 2026
total revenue guidance range to $410 to $420 million, driven by strong U.S. demand for Amtagvi® (lifileucel) and Proleukin. The midpoint
represents an increase of $55 million, or ~15%, over the previous guidance range of $350 to $370 million and implies nearly 60% annual
growth in total revenue.
“Our record second quarter and
sustained demand for Amtagvi and Proleukin led us to raise our full year 2026 total revenue guidance by $55 million at the midpoint,”
said Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer. “Increasing patient demand and our current
manufacturing schedule provide strong visibility into our third and fourth quarter revenues. In addition, lifileucel continues to advance
across our registrational programs in new solid tumor indications, while continued manufacturing and operating efficiencies accelerate
our progress toward profitability.”
Iovance most recently reported record
second quarter 2026 total product revenue of $99.3 million, has grown its authorized treatment center (ATC) network to ~100 centers,
and remains on track for expansion to at least 110 ATCs by year-end 2026.
Iovance expects to report third quarter
2026 financial results in early November 2026. This update completes the guidance review announced with the Company’s second
quarter 2026 results.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. is
the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid
tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved
in three global markets and available at nearly 100 authorized treatment centers (ATCs). The Iovance TIL platform spans
registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies,
next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly
accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based
manufacturing that is scaled to serve thousands of cancer patients worldwide each year. Headquartered in Pennsylvania with offices and
laboratories in California and Florida, Iovance serves patients at ATCs and clinical sites across almost the entire U.S. and in
many countries around the world. For more information, please visit www.iovance.com.
Amtagvi® and its accompanying design
marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks
of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property
of their respective owners.
Information on Iovance’s broad,
industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com.
Forward-Looking Statements
Certain matters
discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred
to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities
Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,”
“believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,”
“plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,”
“can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty
of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions
and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future
developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date
of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future
events, or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and
other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements,
and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors
that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described
in the sections titled “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our most
recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial
known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our
products; the acceptance by the market of our products and product candidates, if approved, and their potential pricing and/or reimbursement
by payors, and whether such acceptance is sufficient to support continued commercialization or development of our products or product
candidates; the risk regarding our ability to manufacture our therapies at our iCTC facility, including the risk that our ability
to increase manufacturing capacity at our facility may adversely affect our commercial launch; the 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 any of our planned registrational trials 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.
CONTACTS
Investors
IR@iovance.com
650-260-7120 ext. 150
Media
PR@iovance.com
650-260-7120 ext. 150
