Full Press Release Details
Biotherapeutics Reports Fourth Quarter and Full Year 2020
Financial Results and Corporate Updates
Advancing First-in-Class TIL Cell Therapy
CARLOS, Calif., Feb 25, 2021 -- 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 2020 financial results and corporate updates.
Dr. Maria Fardis, Ph.D., President and Chief Executive Officer
of Iovance, stated, "During 2020 we continued to advance our TIL cell therapies in metastatic melanoma, cervical, head and
neck, and non-small cell lung cancers. We believe that the growing body of TIL clinical data across multiple late-stage indications
in cancer, coupled with combination of TIL and checkpoint inhibitors in earlier stages of disease, validate the significant potential
for TIL as a treatment option in multiple solid tumors and stages of cancer. In 2021, our top priority is to continue the dialogue
with FDA regarding our potency assays to support a potential BLA submission for lifileucel. We are excited about many opportunities
to further strengthen the Iovance leadership in development of TIL cell therapy, manufacturing, and potential commercialization."
Full Year 2020 Highlights
and Recent Corporate Updates
Fourth Quarter and Full Year 2020 Financial Results
held $635.0 million in cash, cash equivalents, short-term investments and restricted cash at December 31, 2020 compared
to $312.5 million at December 31, 2019. The current cash position includes net proceeds of $567.0 million from
a common stock public offering in June 2020. The company anticipates that the year-end balance of cash, cash equivalents,
short-term investments and restricted cash will be sufficient into 2023.
Jean-Marc Bellemin, Chief Financial Officer, stated, "I
am confident that Iovance is in a strong position to continue to execute our operating plan and advance our portfolio in 2021.
Our healthy balance sheet will help us deliver on our commitments, both to patients and to our shareholders."
Net loss for the fourth quarter ended December
31, 2020, was $68.4 million, or $0.47 per share, compared to a net loss of $63.6 million, or $0.50 per
share, for the fourth quarter ended December 31, 2019. Net loss for full year ended December 31, 2020, was $259.6
million, or $1.88 per share, compared to a net loss of $197.6 million, or $1.59 per share, for the full
year ended December 31, 2019.
Research and development expenses were $52.4
million for the fourth quarter ended December 31, 2020, a decrease of $1.8 million compared to $54.2 million for
the fourth quarter ended December 31, 2019. Research and development expenses were $201.7 million for the 12 months
ended December 31, 2020, an increase of $35.7 million compared to $166.0 million for the full year ended December
The decrease in research and development
expenses in the fourth quarter 2020 over the prior year period was primarily attributable to a decrease in manufacturing and clinical
costs following the completion of enrollment in the pivotal cohorts for melanoma and cervical cancer. The increase in research
and development expenses in the full year 2020 over the prior full year period was primarily attributable to higher clinical costs,
licensing fees and growth of the internal research and development team.
General and administrative expenses
were $16.1 million for the fourth quarter ended December 31, 2020, an increase of $5.2 million compared
to $10.9 million for the fourth quarter ended December 31, 2019. General and administrative expenses were $60.2
million for the full year ended December 31, 2020, an increase of $19.3 million compared to $40.9 million for
the same period ended December 31, 2019.
The increases in general and administrative
expenses in the fourth quarter and full year of 2020 compared to the prior year periods were primarily attributable to growth of
the internal general and administrative team and higher stock-based compensation expenses.
will host a conference call today at 4:30 p.m. ET to discuss the fourth quarter and year-to-date 2020 financial results
and to provide a corporate update. The conference call dial-in numbers are 1-844-646-4465 (domestic) or 1-615-247-0257 (international).
The conference ID access number for the call is 9075827. The live webcast can be accessed in the Investors section of the company's
website at http://www.iovance.com. The archived webcast will be available for a year in the Investors section
About Iovance Biotherapeutics, Inc.
Biotherapeutics aims to improve patient care by making T cell-based immunotherapies broadly accessible for the treatment of patients
with solid tumors and blood cancers. Tumor infiltrating lymphocyte (TIL) therapy uses a patient's own immune cells to attack
cancer. TIL cells are extracted from a patient's own tumor tissue, expanded through a proprietary process, and infused back
into the patient. Upon infusion, TIL reach tumor tissue, where they attack cancer cells. The company has completed dosing in pivotal
programs in patients with metastatic melanoma and cervical cancer. In addition, the company's TIL therapy is being investigated
in a registration-supporting study for the treatment of patients with locally advanced, recurrent or metastatic non-small cell
lung cancer. Clinical studies are also underway to evaluate TIL in earlier stage cancers in combination with currently approved
treatments, and to investigate Iovance peripheral blood lymphocyte (PBL) T cell therapy for blood cancers. 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; preliminary and interim clinical
results, which may include efficacy and safety results, from ongoing clinical trials may not be reflected in the final analyses
of our ongoing clinical trials or subgroups within these trials; 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 new version of the protocol which further defines
the patient population to include more advanced patients in our cervical cancer trial may have an adverse effect on the results
reported to date; 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; 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 increase our estimated capital requirements; and
other factors, including general economic conditions and regulatory developments, not within our control.
Biotherapeutics, Inc:
Sara Pellegrino, IRC
Vice President, Investor Relations & Public Relations
650-260-7120 ext. 264