Full Press Release Details
Iovance Biotherapeutics Highlights Positive
Results, Business Achievements and Corporate
1Q26 Total Revenue of ~$71M Delivers ~45% Year-over-Year
2Q26 Revenue Guidance of $86M to $88M and FY26
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
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
Second Quarter 2026 and Full
Strong Growth in Amtagvi Forecast for 2026
Amtagvi Commercial Business
Strong U.S. Commercial Business to Deliver Strong Growth in 2026
New Data Across Several Pipeline Programs
Anticipated Throughout 2026
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
| 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 |
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