Full Press Release Details
Iovance Biotherapeutics Reports Third
Quarter and Year-to-Date 2020
Financial Results and Corporate Updates
Registration-Directed Study Initiated in
Non-Small Cell Lung Cancer
SAN CARLOS, Calif., Nov 5, 2020 -- 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 2020 financial results and provided a corporate
"Subsequent to meeting with FDA, we have moved the BLA
submission date for lifileucel to 2021 in order to reach agreement on the required potency assays to fully define TIL," said
Maria Fardis, PhD, President and CEO of Iovance. "In additional indications, we look forward to starting our registration-directed
study in non-small cell lung cancer, and to presenting initial clinical data of TIL in combination with anti-PD-1 therapy in head
and neck cancer. Our financial strength also allows us to advance our clinical programs and continue our operating plans. Overall,
I believe that Iovance is well-positioned to be the leader in development, manufacturing and commercialization of TIL cell therapy
and Recent Corporate Updates
Head and Neck Cancer at SITC Annual Meeting (November 9-14, 2020):
Third Quarter and September Year-to-Date Financial Results
Iovance held $719.7 million in
cash, cash equivalents, short-term investments and restricted cash at September 30, 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 may be over $630 million.
Net loss for the third quarter ended September
30, 2020, was $58.6 million, or $0.40 per share, compared to a net loss of $49.5 million, or $0.40 per
share, for the third quarter ended September 30, 2019. Net loss for the nine months ended September 30, 2020, was $191.2
million, or $1.41 per share, compared to a net loss of $134.0 million, or $1.08 per share, for the same
period ended September 30, 2019.
Research and development expenses were $43.1
million for the third quarter ended September 30, 2020, an increase of $1.5 million compared to $41.6
million for the third quarter ended September 30, 2019. Research and development expenses were $149.3 million for
the nine months ended September 30, 2020, an increase of $37.5 million compared to $111.8 million for
the same period ended September 30, 2019.
The increase in research and development
expenses in the third quarter 2020 over the prior year period was primarily attributable to growth of the internal research and
development team and higher stock-based compensation, partially offset by a decrease in manufacturing costs. The increase in research
and development expenses in the first nine months of 2020 over the prior year period was primarily attributable to higher patient
enrollment in clinical trials, licensing fees and growth of the internal research and development team.
General and administrative expenses
were $15.9 million for the third quarter ended September 30, 2020, an increase of $5.9 million compared
to $10.0 million for the third quarter ended September 30, 2019. General and administrative expenses were $44.1
million for the nine months ended September 30, 2020, an increase of $14.2 million compared to $30.0 million for
the same period ended September 30, 2019.
The increases in general and administrative
expenses in the third quarter and first nine months 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.
Webcast and Conference Call
Iovance will host a conference call
today at 4:30 p.m. ET to discuss the third 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 1190777. 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 at www.iovance.com.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics ("Iovance" or the
"Company") 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. After infusion, TIL reach tumor tissue, where they attack tumor cells. The Company has completed
dosing in the pivotal study in patients with metastatic melanoma and is currently conducting a pivotal study in patients with
metastatic cervical cancer. In addition, the Company's TIL therapy is being investigated for the treatment of patients with
locally advanced, recurrent or metastatic cancers including head and neck and non-small cell lung cancer. A clinical study to
investigate Iovance T cell therapy for blood cancers called peripheral blood lymphocyte (PBL) therapy is open to enrollment. 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,
filings with the Securities and Exchange Commission ("SEC"),
reports to stockholders and in meetings with investors and analysts, 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. These forward-looking statements include, but are not limited to, statements regarding the
success, timing, projected enrollment, manufacturing and production capabilities, and cost of our ongoing clinical trials and anticipated
clinical trials for our current product candidates (including both Company-sponsored and collaborator-sponsored trials in both
the U.S. and Europe),
such as statements regarding the timing of initiation and completion of these trials; the strength of the Company's product
pipeline; and the guidance provided for the Company's future cash, cash equivalents, short-term investments, restricted cash
balances and forecasted operating expenses, including our statements regarding the sufficiency of our cash reserves to execute
commercial launch and pipeline programs, which assumes no material change in liabilities. These statements involve risks, uncertainties
and other factors 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, including, without limitation, the following
substantial known and unknown risks and uncertainties inherent in the Company's business: the COVID-19 pandemic may have
an adverse effect on the Company and its clinical trials, including potential slower patient recruitment, inability of clinical
trial sites to collect data, inability of the Company or its contract research organizations to monitor patients, as well as U.S.
Food and Drug Administration ("FDA") availability due to competing priorities;
our ability to achieve long-term profitability and successfully commercialize our products alone or with third parties, as well
as our history of operating losses and our expectations that we will continue to incur significant operating losses; our limited
operating history in our current line of business, which makes it difficult to evaluate our prospects, our business plan or the
likelihood of our successfully implementing such business plan; risks related to the timing of and our ability to successfully
develop, submit, obtain and maintain FDA or other regulatory authority approval of, or other action with respect to, our product
candidates (including with respect to lifileucel for the treatment of metastatic melanoma, for which we currently expect to submit
a biologics licensing application ("BLA") to the FDA during 2021), and our ability to successfully commercialize any
product candidates for which we obtain FDA approval; our limited history in conducting clinical trials, on which our future profitability
is substantially dependent, and our need to rely on third parties, including contract research organizations, contract manufacturing
organizations and consultants, in connection with the conduct, supervision and monitoring of our clinical trials for our product
candidates; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing Phase 2 studies