Full Press Release Details
Iovance Biotherapeutics Reports Third Quarter
and Year-to-Date 2022
Financial Results and Corporate Updates
First Biologics License Application (BLA) Submission
Initiated and on Track to Complete in 4Q22
SAN CARLOS, Calif., November 3, 2022 -- Iovance Biotherapeutics,
Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor infiltrating lymphocyte,
TIL, and peripheral-blood lymphocyte, PBL), today reported third quarter and year-to-date 2022 financial results and corporate updates.
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive
Officer of Iovance, stated, "Iovance has made tremendous progress year-to-date. With our rolling BLA submission for lifileucel and
six active clinical trials of TIL therapy underway, we are executing our mission to innovate, develop and deliver TIL therapy for patients
with cancer. We are on track to complete our BLA submission in the fourth quarter. As we prepare for our first potential FDA approval
and commercial launch and advance our pipeline and technology platforms, we believe we have multiple opportunities to create significant
value for patients with cancer as well as for our shareholders."
Third Quarter 2022 Highlights
and Recent Corporate Updates
Regulatory and Clinical Updates for Iovance TIL Therapy (Lifileucel)
in Advanced Melanoma
Manufacturing and Commercial Preparations
Research Programs for Next-Generation TIL Therapies and
Related Technologies
Third Quarter and Year-to-Date 2022 Financial Results
Iovance had $366.6 million in cash,
cash equivalents, investments and restricted cash at September 30, 2022, compared to $602.1 million at December 31, 2021.
The cash position is expected to be sufficient to fund current and planned operations into 2024.
Jean-Marc Bellemin, Chief Financial Officer of Iovance, said, "As
a late-stage oncology company approaching potential commercialization, our cash position continues to support our prudent investments
in commercial launch preparations, internal manufacturing and pipeline expansion into several milestones to create value for patients
Net loss for the third quarter ended September
30, 2022, was $99.6 million, or $0.63 per share, compared to a net loss of $86.1 million, or $0.55 per share,
for the third quarter ended September 30, 2021. Net loss for the nine months ended September 30, 2022, was $290.6 million, or
$1.85 per share, compared to a net loss of $242.9 million, or $1.60 per share, for the same period ended September 30, 2021.
Research and development expenses were $72.5 million for
the third quarter ended September 30, 2022, an increase of $7.1 million compared to $65.4 million for the same
period ended September 30, 2021. Research and development expenses were $214.2 million for the nine months ended September 30, 2022,
an increase of $30.8 million compared to $183.4 million for the same period ended September 30, 2021.
The increases in research and development expenses in the third quarter
and year-to-date 2022 over the prior year periods were primarily attributable to growth of the internal research and development team,
including stock-based compensation expense, as well as facility-related and internal research program costs, which were partially offset
by lower clinical and manufacturing costs driven by completion of enrollment of pivotal clinical trials.
General and administrative expenses were $27.9
million for the third quarter ended September 30, 2022, an increase of $7.0 million compared to $20.9 million for
the same period ended September 30, 2021. General and administrative expenses were $77.6 million for the nine months ended September
30, 2022, an increase of $17.8 million compared to $59.8 million for the same period ended September 30, 2021.
The increase in general and administrative
expenses in the third quarter and year-to-date 2022 compared to the prior year periods were primarily attributable to growth of the internal
general and administrative and commercial teams, including stock-based compensation expense, and facility-related costs associated with
the build-out of the new corporate headquarters, as well as costs associated with pre-commercial activities.
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, please
register at https://register.vevent.com/register/BI4721983fb77a4615b46f4ab97c051712. The live and archived webcast can be accessed
in the Investors section of the Company's website, IR.Iovance.com. The archived webcast will also 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 and maintain U.S. Food and Drug Administration ("FDA") 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 approval; whether clinical trial results from our pivotal studies and cohorts may support registration and approval by
the FDA; 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 enrollment may need to be adjusted for our trials
and cohorts within those trials based on FDA and other regulatory agency input; the changing landscape of care for cervical cancer
patients may impact our clinical trials in this indication; the risk that we may be required to conduct additional clinical trials
or modify ongoing or future clinical trials based on feedback from the FDA or other regulatory authorities; the risk that our
interpretation of the results of our clinical trials or communications with the FDA may differ from the interpretation of such
results or communications by the FDA (including from the recent pre-BLA meeting with the FDA); the risk that the rolling BLA submission
for lifileucel in metastatic melanoma may take longer than expected; the acceptance by
the market of our product candidates and their potential reimbursement by payors, if approved; our ability or inability to
manufacture our therapies using third party manufacturers or our own facility may adversely affect our potential commercial launch;
the results of clinical trials with collaborators using different manufacturing processes may not be reflected in our sponsored
trials; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our