Full Press Release Details
Iovance Biotherapeutics
Reports Fourth Quarter and Full Year 2022
Financial Results and Corporate Updates
First Biologics License Application (BLA) Submission
on Track to Complete in 1Q23
SAN CARLOS, Calif., February 28, 2023 -- 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 fourth quarter and full year 2022 financial results and corporate updates.
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive
Officer of Iovance, stated, "During 2022, we made considerable progress initiating our first BLA for lifileucel in advanced melanoma,
preparing for launch, and advancing our immuno-oncology pipeline. As we prepare for commercialization and expand our pipeline, our planned
acquisition of Proleukin will provide an immediate source of revenue, streamline our supply chain and logistics, reduce our future
cost of goods and lower expenses for IL-2 used with TIL therapies in commercial and clinical settings. Our top priorities in 2023 are
to complete the BLA submission in the first quarter, receive FDA approval, then successfully launch lifileucel. We also continue to develop
our pipeline in multiple solid tumor indications and look forward to presenting new data."
Recent and Full Year 2022
Highlights and Corporate Updates
Acquisition of Proleukin
Iovance TIL Therapy (Lifileucel) in Advanced Melanoma
Manufacturing and Commercial Preparations
Research Programs for Next-Generation TIL Therapies and
Related Technologies
Fourth Quarter and Full Year 2022 Financial Results
Iovance had $478.3 million in cash, cash equivalents, investments
and restricted cash at December 31, 2022, compared to $602.1 million at December 31, 2021. With the net proceeds from the
ATM equity financing facility of approximately $450.0 million raised during the fourth quarter of 2022 and first quarter of 2023 to date,
the cash position is expected to be sufficient to fund current and planned operations into the second half of 2024.
Jean-Marc Bellemin, Chief Financial Officer of Iovance, said, "Our
cash position, including proceeds from our ATM facility, is expected to support our planned acquisition of Proleukin as well as commercial
launch preparations, internal manufacturing and clinical pipeline expansion into several milestones to create value for patients and shareholders."
Net loss for the fourth quarter ended December
31, 2022, was $105.3 million, or $0.64 per share, compared to a net loss of $99.3 million, or $0.63 per share,
for the fourth quarter ended December 31, 2021. Net loss for the full year period ended December 31, 2022, was $395.9 million,
or $2.49 per share, compared to a net loss of $342.3 million, or $2.23 per share, for the same period ended December 31, 2021.
Research and development expenses were $80.6 million for
the fourth quarter ended December 31, 2022, an increase of $5.0 million compared to $75.6 million for the same
period ended December 31, 2021. Research and development expenses were $294.8 million for the full year period ended December 31,
2022, an increase of $35.8 million compared to $259.0 million for the same period ended December 31, 2021.
The increases in research and development expenses in the fourth 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 $26.5
million for the fourth quarter ended December 31, 2022, an increase of $2.7 million compared to $23.8 million for
the same period ended December 31, 2021. General and administrative expenses were $104.1 million for the full year period ended December
31, 2022, an increase of $20.4 million compared to $83.7 million for the same period ended December 31, 2021.
The increase in general and administrative
expenses in the fourth 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
in the conference call, please register at https://edge.media-server.com/mmc/p/vku8d4ww.
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, and meetings with the FDA, may support registrational studies and subsequent approvals 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 the acquisition of
Proleukin may not be completed in a timely manner or at all; the failure to satisfy the closing conditions to the consummation of