Full Press Release Details
Iovance Biotherapeutics Reports First Quarter
Financial Results and Corporate Updates
Strong Momentum for Amtagvi (Lifileucel)
Following U.S. Food and Drug Administration
100+ Amtagvi Patients Enrolled Across More
Than 40 Current Authorized Treatment Centers
(ATCs), with ~50 Total ATCs On Track by End of May and 70+ Total ATCs by Year-End 2024
Amtagvi Regulatory Submissions on Track in
the European Union (EU),
United Kingdom (UK), and Canada in 2024
SAN CARLOS, Calif., May 9, 2024
-- 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 2024 financial results and corporate updates.
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive
Officer of Iovance, stated, "The first quarter of 2024 was transformative for Iovance following our first FDA approval and our
strong start for the U.S. commercial launch of Amtagvi for patients with advanced melanoma. Immediate demand for Amtagvi is very
high and continues to significantly increase across initial ATCs. As of today, more than 100 patients have already enrolled for Amtagvi
therapy. We have successfully manufactured and delivered Amtagvi to many ATCs where commercial patients are being treated. We expect
our launch momentum to remain strong and continue to build as we ramp up the U.S. launch throughout 2024 with the authorization of additional
ATCs. We also continue to execute across our broad clinical pipeline. As a fully integrated company, Iovance is well positioned
to remain the global leader in innovating, developing, and delivering TIL cell therapy for patients with cancer."
Recent and First Quarter
2024 Highlights and Corporate Updates
Amtagvi (Lifileucel) U.S. Approval and Launch Highlights
in Advanced Melanoma
Lifileucel Launch Expansion into New Markets
Iovance TIL Cell Therapy Pipeline Highlights
Upcoming ASCO 2024 Highlights for Iovance
First quarter 2024 Financial Results
Net loss for the first quarter ended March 31,
2024, was $113.0 million, or $0.42 per share, compared to a net loss of $107.4 million, or $0.50 per share, for the first quarter ended
March 31, 2023. The net loss for the first quarter 2024 includes amortization of intangible assets acquired as part of the Proleukin
Revenue for the first quarter ended March 31,
2024, was $0.7 million from sales of Proleukin in licensed markets outside of the U.S. Cost of sales was $7.3 million, primarily
related to inventoriable costs associated with sales of Proleukin and non-cash amortization expense for the acquired intangible asset
for developed technology during the first quarter of 2024. No revenue or cost of sales were incurred for the first quarter ended March 31,
Research and development expenses were $79.8
million for the first quarter ended March 31, 2024, a decrease of $2.9 million compared to $82.7 million for the first quarter of
2023. The decrease was primarily attributable to the transition to commercial Amtagvi manufacturing in the most recent quarter, partially
offset by increased costs associated with the purchases of raw materials, clinical trials driven primarily by the Phase 3 TILVANCE-301
clinical trial, and the planned EU regulatory submissions for lifileucel.
Selling, general and administrative expenses
were $31.4 million for the first quarter ended March 31, 2024, an increase of $3.3 million compared to $28.1 million for the first
quarter of 2023. The increase was primarily attributable to increases in headcount and related costs, including stock-based compensation,
to support the growth in the overall business and related corporate infrastructure, as well as costs incurred to support the commercialization
of Amtagvi and Proleukin, partially offset by a decrease in legal costs.
For additional information, please see the
Company's Selected Condensed Consolidated Balance Sheet and Statement of Operations below.
To listen to the live or archived audio
webcast, please register at https://edge.media-server.com/mmc/p/m4tigan7. The live and archived webcast can be accessed in
the Investors section of the Company's website, IR.Iovance.com for one year.
1. National Cancer Institute Surveillance,
Epidemiology and End Results (SEER) Program. 2024 Estimates. https://seer.cancer.gov
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.
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," "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, including Amtagvi, for which we have obtained
U.S. Food and Drug Administration ("FDA") approval, and Proleukin, for which we have obtained FDA and European Medicines
Agency ("EMA") approval; the risk that the EMA or other ex-U.S. regulatory authorities may not approve or may delay approval
for our marketing authorization application submission for lifileucel in metastatic melanoma; the acceptance by the market of our products,
including Amtagvi and Proleukin, and their potential pricing and/or reimbursement by payors, if approved (in the case of our product
candidates), in the U.S. and other international markets and whether such acceptance is sufficient to support continued commercialization
or development of our products, including Amtagvi and Proleukin, or product candidates, respectively; the risk whether the number of
patients treated and/or ATCs is an appropriate measure of commercial success and/or recognized revenue; future competitive or other market
factors may adversely affect the commercial potential for Amtagvi or Proleukin; the risk regarding our ability or inability to manufacture
our therapies using third party manufacturers or at our own facility, including our ability to increase manufacturing capacity at such
third party manufacturers and our own facility, may adversely affect our commercial launch; the results of clinical trials with collaborators
using different manufacturing processes may not be reflected in our sponsored trials; the risk regarding the successful integration of
the recent Proleukin acquisition; the risk that the successful development or commercialization of our products, including Amtagvi and
Proleukin, 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 FDA, EMA, or other regulatory authority
approval of, or other action with respect to, our product candidates; whether clinical trial results from our pivotal studies and cohorts,
and meetings with the FDA, EMA, or other regulatory authorities may support registrational studies and subsequent approvals by the FDA,