Full Press Release Details
Iovance Biotherapeutics Reports Second Quarter
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 (PDUFA) Action Date of November 25, 2023
Preparing for Potential Commercial Launch of
Lifileucel as First Approved TIL Therapy in 2023
Post-Anti-PD-1 Non-Small Cell Lung Cancer TIL
Program Advances into Registrational Development
SAN CARLOS, Calif., August 8, 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 second quarter and first half 2023 financial results
and corporate updates.
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive
Officer of Iovance, stated, "Iovance is making significant progress in executing on our goals. The Priority Review of our BLA for
lifileucel in advanced melanoma remains on track and continues to progress well as we work collaboratively with FDA and approach a potential
approval and launch this year. We acquired Proleukin , which will provide revenue, streamline our supply chain and logistics, reduce
our future cost of goods and lower expenses for IL-2 used with TIL therapies. We are also excited about our NSCLC pipeline, with a registrational
trial and positive preliminary data in post-anti-PD-1 patients and the upcoming full data presentation for TIL therapy in combination
with pembrolizumab in ICI na ve 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 Second Quarter
2023 Highlights and Corporate Updates
Iovance TIL Therapy (Lifileucel) in Advanced Melanoma
Regulatory Highlights
Manufacturing and Commercial
Iovance TIL Therapy Programs in Advanced Non-Small Cell Lung Cancer
Additional Clinical Pipeline Highlights
Research Programs for Next-Generation TIL Therapies and Related
Upcoming Medical Conferences
Second Quarter and First Half 2023 Financial Results
Iovance had $317.3 million in cash, cash equivalents,
investments and restricted cash at June 30, 2023, compared to $478.3 million at December 31, 2022. With the estimated net proceeds
from the common stock public offering of approximately $161.4 million raised in July of 2023, the cash position is expected to be
sufficient to fund current and planned operations into the end of 2024.
Net loss for the second quarter ended June 30,
2023, was $106.5 million, or $0.47 per share, compared to a net loss of $99.3 million, or $0.63 per share, for
the second quarter ended June 30, 2022. Net loss for the six months ended June 30, 2023, was $213.9 million, or $0.98
per share, compared to a net loss of $191.0 million, or $1.21 per share, for the same period ended June 30, 2022.
Revenue for the six months ended June 30, 2023, was $0.2 million,
comprised of product sales following the Proleukin acquisition in May of 2023. There was no revenue for six months ended June 30,
2022. Cost of sales for the six months ended June 30, 2023, was $2.1 million, including $1.9 million of non-cash amortization of
the acquired intangible asset for developed technology during the second quarter. There was no cost of revenues for the six months ended
Research and development expenses were $86.3 million for
the second quarter ended June 30, 2023, an increase of $12.9 million compared to $73.4 million for the same
period ended June 30, 2022. Research and development expenses were $169.1 million for the six months ended June 30, 2023,
an increase of $27.4 million compared to $141.7 million for the same period ended June 30, 2022.
The increases in research and development expenses in the second quarter
and first half of 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, internal research programs and the Phase 3 TILVANCE trial, which were partially offset
by a decrease in stock-based compensation expense.
Selling, general and administrative expenses
were $21.9 million for the second quarter ended June 30, 2023, a decrease of $4.4 million compared to $26.3
million for the same period ended June 30, 2022. Selling, general and administrative expenses were $50.0 million for the
six months ended June 30, 2023, an increase of $0.3 million compared to $49.7 million for the same period ended June 30, 2022.
The decrease in selling, general and administrative expenses in the
second quarter of 2023 compared to the prior year period was primarily attributable to the capitalization of expenses associated with
the Proleukin acquisition upon the transaction close. Decreases in other costs are related to the timing of spend compared to the prior
year period, including marketing, advertising, licensing and insurance costs, partially offset by costs associated with the growth in
the overall business. The increase in selling, general and administrative expenses in the first half of 2023 compared to the prior year
period was primarily attributable to growth of the internal general and administrative and commercial teams, offset by a decrease in legal
fees and other costs.
For additional information, please see the
Company's Selected Condensed Consolidated Balance Sheet and Statement of Operations below.
Webcast and Conference Call
To participate in the conference call and live audio webcast at 5:00
p.m. ET, please register at https://register.vevent.com/register/BI83559f749d674b71bae2cbaeb65d484b. To view the live webcast,
please register at https://edge.media-server.com/mmc/p/nxy3p22t. 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: preliminary
and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts, including but not
limited to our IOV-LUN-202 trial, 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; risks related to the timing of and our ability to
successfully develop, submit, obtain and maintain U.S. Food and Drug Administration ("FDA") or other regulatory authority