Full Press Release Details
Iovance Biotherapeutics Reports Fourth
Quarter and Full-Year 2019
Financial Results and Provides Corporate
SAN CARLOS, Calif., Feb. 25, 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 fourth quarter and year-end 2019 financial results and provided
"During 2019 we made tremendous progress in advancing
Iovance TIL and PBL products," said Maria Fardis, Ph.D., MBA, Iovance President and Chief Executive Officer. "We conducted
two planned pivotal programs for lifileucel in melanoma and LN-145 in cervical, initiated patient dosing in earlier lines of therapy
and received clearance from FDA on a new IND to proceed to dose patients with our PBL product, IOV-2001. In anticipation for commercialization
of Iovance TIL, we are building our internal manufacturing capability and expanding our commercial team and infrastructure. With
the first potential cell therapy in solid tumors, as well as a broad TIL platform, Iovance is poised to become the leader in development,
manufacturing, and commercialization of TIL cell therapy for solid tumors."
Research and Development
Anticipated 2020 Milestones
Fourth Quarter and Full-Year 2019 Financial Results
Net loss for the fourth quarter ended December
31, 2019, was $63.6 million, or $0.50 per share, compared to a net loss of $32.6 million, or $0.27 per
share, for the fourth quarter ended December 31, 2018. Net loss for the full-year ended December 31, 2019, was $197.6
million, or $1.59 per share, compared to a net loss of $123.6 million, or $1.27 per share, for the full-year
ended December 31, 2018.
Research and development expenses were $54.2
million for the fourth quarter ended December 31, 2019, an increase of $26.8 million compared to $27.4
million for the fourth quarter ended December 31, 2018. Research and development expenses were $166.0 million for
the 12 months ended December 31, 2019, an increase of $66.2 million compared to $99.8 million for the
prior year period. The increases in fourth quarter and full year 2019 over the prior year periods were primarily attributable to
an increase in costs associated with manufacturing activities and capacity, clinical trials due to higher enrollment, and growth
of the internal research and development team.
General and administrative expenses
were $10.9 million for the fourth quarter 2019, an increase of $3.4 million compared to $7.5 million for
the fourth quarter 2018. General and administrative expenses were $40.8 million for the 12 months ended December
31, 2019, an increase of $12.4 million compared to $28.4 million for the full year ended December 31,
2018. The increases in fourth quarter and full year 2019 over the prior year periods were primarily attributable to growth of the
internal general and administrative team, as well as higher intellectual property legal costs and market research activities in
preparation for commercialization.
Cash, cash equivalents, short term
investments and restricted cash
At December 31, 2019, the company
held $312.5 million in cash, cash equivalents, short-term investments and restricted cash compared to $468.5 million at December
Webcast and Conference Call
Iovance will host a conference call
today at 4:30 p.m. ET to discuss fourth quarter and full-year 2019 results and 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 4693108. 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"). We may, in some cases, use terms such as "predicts," "believes," "potential,"
"continue," "estimates," "anticipates," "expects," "plans," "intends,"
"may," "could," "might," "will," "should" or other words that convey
uncertainty of future events or outcomes to identify these forward-looking statements. The forward-looking statements include,
but are not limited to, risks and uncertainties relating to 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 timing of and our ability to successfully submit, obtain and maintain FDA or
other regulatory authority approval of, or other action with respect to, our product candidates, including those product candidates
that have been granted breakthrough therapy designation ("BTD") or regenerative medicine advanced therapy designation
("RMAT") by the FDA and new product candidates in both solid tumor and blood cancers; the strength of the Company's
product pipeline; the successful implementation of the Company's research and development programs and collaborations; the
Company's ability to obtain tax incentives and credits; the guidance provided for the Company's future cash, cash
equivalents, short term investment and restricted cash balances; the success of the Company's manufacturing, license or
development agreements; the acceptance by the market of the Company's product candidates, if approved; and other factors,
including general economic conditions and regulatory developments, not within the Company's control. The factors discussed
herein could cause actual results and developments to be materially different from those expressed in or implied by such statements.
Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Company's
business, including, without limitation: the preliminary clinical results, which may include efficacy and safety results, from
ongoing Phase 2 studies may not be reflected in the final analyses of these trials or subgroups within these trials; a slower
rate of enrollment may impact the Company's clinical trial timelines; enrollment may need to be adjusted for the Company's
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 the Company's cervical cancer trial may have an adverse
effect on the results reported to date; the data within these trials may not be supportive of product approval; changes in patient
populations may result in changes in preliminary clinical results; the Company's ability or inability to address FDA or
other regulatory authority requirements relating to its clinical programs and registrational plans, such requirements including,
but not limited to, clinical, safety, manufacturing and control requirements; the Company's interpretation of communications
with the FDA may differ from the interpretation of such communications by the FDA; risks related to the Company's ability
to maintain and benefit from accelerated FDA review designations, including BTD and RMAT, which may not result in a faster development
process or review of the Company's product candidates (and which may later be rescinded by the FDA), and does not assure
approval of such product candidates by the FDA or the ability of the Company to obtain FDA approval in time to benefit from commercial
opportunities; the ability or inability of the Company to manufacture its therapies using third party manufacturers or its own
facility may adversely affect the Company's potential commercial launch; and additional expenses may decrease our estimated
cash balances and increase our estimated capital requirements. A further list and description of the Company's risks, uncertainties
and other factors can be found in the Company's most recent Annual Report on Form 10-K and the Company's subsequent
filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov
or www.iovance.com. The forward-looking statements are made only as of the
date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect
subsequent events or circumstances.
ASCO 2019 - Safety and efficacy of cryopreserved autologous tumor infiltrating lymphocyte therapy (LN-144, lifileucel)
in advanced metastatic melanoma patients who progressed on multiple prior therapies including anti-PD-1
2Iovance Corporate Overview - https://ir.iovance.com/presentations