Full Press Release Details
Iovance Biotherapeutics Reports Third Quarter
and Year-to-Date 2023
Financial Results and Corporate Updates
FDA Priority Review of Biologics License Application
(BLA) on Track for Lifileucel in Advanced Melanoma with Prescription Drug User Fee Act Action (PDUFA) Date of February 24, 2023
Positive Regulatory Feedback Supports Lifileucel
Regulatory Submissions in Europe and Canada in 2024
Onboarding Completed at Approximately 30 Authorized
Treatment Centers (ATCs) in Preparation for Potential U.S. Commercial Launch of Lifileucel as First Approved TIL Therapy
SAN CARLOS, Calif., November 7, 2023 -- Iovance Biotherapeutics,
Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte
(TIL) therapies for patients with cancer, today reported third quarter and year-to-date 2023 financial results and corporate updates.
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive
Officer of Iovance, stated, "Iovance continues to make significant progress toward commercialization while pursuing opportunities
for our TIL therapies in additional geographies and solid tumor cancers. The Priority Review of our BLA for lifileucel in advanced melanoma
remains on track. We are prepared to rapidly serve the U.S. melanoma community immediately following an FDA approval, with additional
regulatory submissions commencing in the first half of next year to expand into Europe and other geographies. We are also excited about
our lung cancer development strategy, including positive momentum for our registrational IOV-LUN-202 trial in advanced non-small cell
lung cancer patients. We are well positioned to execute on our regulatory, pipeline, manufacturing, and commercial launch activities to
advance our mission to be the global leader in TIL therapy."
Recent and Third Quarter 2023
Highlights and Corporate Updates
Lifileucel in Advanced Melanoma
Regulatory Highlights
Manufacturing and Commercial
Iovance TIL Therapy in Advanced Non-Small Cell Lung Cancer
Iovance TIL Therapy in Endometrial Cancer
Additional Pipeline Highlights
Third Quarter and Year-to-Date Financial Results
Iovance had $427.8 million in cash, cash equivalents,
investments and restricted cash at September 30, 2023, compared to $478.3 million at December 31, 2022. The combined net proceeds in the
third quarter of 2023 from the Company's public offering in July 2023 and the at-the market (ATM) equity financing facility were
approximately $203.2 million. The current cash position and anticipated revenue in 2024 from lifileucel and Proleukin is expected
to be sufficient to fund current and planned operations into 2025.
Net loss for the third quarter ended September
30, 2023, was $113.8 million, or $0.46 per share, compared to a net loss of $99.6 million, or $0.63 per share, for
the third quarter ended September 30, 2022. Net loss for the nine months ended September 30, 2023, was $327.7 million, or $1.44
per share, compared to a net loss of $290.6 million, or $1.85 per share, for the same period ended September 30, 2022.
Revenue for the third quarter and nine months ended September 30, 2023,
was $0.5 million and $0.7 million, respectively, and comprised of product sales following the Proleukin acquisition in May 2023.
There was no revenue for the third quarter and nine months ended September 30, 2022. Cost of sales for the third quarter and nine months
ended September 30, 2023, was $4.3 million and $6.4 million, respectively, and comprised of cost of inventory associated with sales of
Proleukin as well as $4.0 million and $5.9 million, respectively, of non-cash amortization expenses of the acquired intangible asset
for developed technology. There was no cost of revenues for the third quarter and nine months ended September 30, 2022.
Research and development expenses were $87.5 million for
the third quarter ended September 30, 2023, an increase of $15.0 million compared to $72.5 million for the same
period ended September 30, 2022. Research and development expenses were $256.6 million for the nine months ended September 30, 2023,
an increase of $42.4 million compared to $214.2 million for the same period ended September 30, 2022.
American Cancer Statistics. Key Statistics for Endometrial Cancer, https://www.cancer.org/cancer/endometrial-cancer/about/key-statistics.html.
The increases in research and development expenses in the third quarter
and the nine months ended September 30, 2023, over the prior year periods were primarily attributable to growth of the internal research
and development team, as well as higher costs related to facilities and the initiation of new clinical trials, including the Phase 3 TILVANCE
trial, which were partially offset by a decrease in stock-based compensation expense.
Selling, general and administrative expenses
were $27.0 million for the third quarter ended September 30, 2023, a decrease of $0.9 million compared to $27.9
million for the same period ended September 30, 2022. Selling, general and administrative expenses were $77.0 million for the
nine months ended September 30, 2023, a decrease of $0.6 million compared to $77.6 million for the same period ended September 30, 2022.
The decrease in selling, general and administrative
expenses in the third quarter and the nine months ended September 30, 2023, compared to prior year periods was primarily attributable
to the decrease in stock-based compensation expense and other costs related to the timing of spend compared to the prior year period,
including marketing, advertising, and legal costs, partially offset by costs associated with the growth in the overall business. For
additional information, please see the Company's Selected Condensed Consolidated Balance Sheet and Statement of Operations below.
Webcast and Conference Call
in the conference call Q&A and live audio webcast, please register at https://register.vevent.com/register/BIfd1787749ef747f19a491cb371d60fab.
To listen to the live or archived webcast, please register at https://edge.media-server.com/mmc/p/n9gmq93h.
The live and archived webcast can be accessed in the Investors section of the
Company's website, IR.Iovance.com. The archived webcast will be available for one year.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics 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. Our lead late-stage TIL product candidate, lifileucel for metastatic melanoma, has the potential
to become the first approved one-time cell therapy for a solid tumor cancer. The Iovance TIL platform
has demonstrated promising clinical data across multiple solid tumors. 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.
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").
All such written or oral statements made in this press release, other than statements of historical fact, are forward-looking statements
and are intended to be covered by the safe harbor for forward-looking statements provided by 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 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 effects of the COVID-19 pandemic; risks related to the timing
of and our ability to successfully develop, submit, obtain, or maintain U.S. Food and Drug Administration ("FDA"), European
Medicines Agency ("EMA"), or other regulatory authority approval of, or other action with respect to, our product candidates,
and our ability to successfully commercialize any product candidates for which we obtain FDA, EMA, or other regulatory authority approval;
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, EMA, or other regulatory authorities, including the risk that the