Full Press Release Details
Iovance Biotherapeutics Reports Second
Quarter 2020 Financial Results
and Provides a Corporate Update
Enrollment Completed in Pivotal Cohort 1
of C-145-04 Cervical Cancer Study
SAN CARLOS, Calif., August 6, 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 second quarter 2020 financial results and provided a corporate
"During a strong first half of 2020 we completed dosing
and reported early data for our pivotal melanoma program for lifileucel, announced data at AACR for our collaborator Moffitt's
TIL in non-small cell lung cancer, presented updated Cohort 2 data for lifileucel at ASCO, and successfully completed a public
financing," said Maria Fardis, Ph.D., MBA, Iovance President and Chief Executive Officer. "Iovance is now in an excellent
position to execute our planned commercial launch while broadening our pipeline programs. The cumulative set of positive clinical
data for lifileucel continue to support our planned BLA submission for this one-time treatment for metastatic melanoma. We are
also pleased to report that our cervical cancer pivotal program has recently completed enrollment in Cohort 1, and we look forward
to dosing the last few patients in the coming weeks. With the first potential cell therapy in solid tumors and a broadening TIL
platform, we believe Iovance is the leader in development, manufacturing, and commercialization of TIL cell therapy for cancer."
Commercial Launch Planning:
Upcoming Data Presentations:
Second Quarter and First Half 2020 Financial Results
At June 30, 2020, Iovance held $777.4
million in cash, cash equivalents, short-term investments and restricted cash compared to $312.5 million at December
31, 2019. The current cash position includes net proceeds of $567.4 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. The operating expenses in the second half of 2020 are forecasted to be in the same range as the first half of 2020.
Net loss for the second quarter ended June
30, 2020, was $63.0 million, or $0.47 per share, compared to a net loss of $47.6 million, or $0.38 per
share, for the second quarter ended June 30, 2019. Net loss for the six months ended June 30, 2020, was $132.6
million, or $1.02 per share, compared to a net loss of $84.5 million, or $0.68 per share, for the same
period ended June 30, 2019.
Research and development expenses were $49.3
million for the second quarter ended June 30, 2020, an increase of $10.0 million compared to $39.3 million for
the second quarter ended June 30, 2019. Research and development expenses were $106.2 million for the six months
ended June 30, 2020, an increase of $36.0 million compared to $70.2 million for the same period ended June
The increase in research and development
expenses in the second quarter 2020 over the prior year period was primarily attributable to an increase in costs associated with
multiple clinical trials, and growth of the internal research and development team. The increase in research and development expenses
in the first half 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 $14.4 million for the second quarter ended June 30, 2020, an increase of $3.5 million compared to $10.9
million for the second quarter ended June 30, 2019. General and administrative expenses were $28.2 million for
the six months ended June 30, 2020, an increase of $8.3 million compared to $19.9 million for the same
period ended June 30, 2019.
The increases in general and administrative
expenses in the second quarter and first half 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 second quarter 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 7875997. 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 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 investment, restricted cash
balances, and forecasted operating expenses. 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
expect to submit a biologics licensing application ("BLA") to the FDA during 2020), 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 may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials;
the risk that a slower rate of enrollment may delay the Company's clinical trial timelines or otherwise adversely impact