Full Press Release Details
Iovance Biotherapeutics Reports Second
Quarter 2019 Financial Results and Provides Corporate Update
- Regulatory submission for LN-145 in advanced
cervical cancer expected in the second half of 2020 -
- Company to host conference call at 4:30
SAN CARLOS, Calif., Aug. 1, 2019 -- Iovance
Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating
lymphocyte (TIL) technology, today reported financial results from second quarter and first six
months of 2019 and provided a corporate update.
"We have had a highly
productive second quarter at Iovance," commented Maria Fardis, Ph.D., MBA, president
and chief executive officer of Iovance Biotherapeutics. "We presented data for both
melanoma and cervical programs at ASCO, met with the FDA to define our registration path for LN-145, received Breakthrough Therapy
Designation for LN-145, and broke ground for our commercial manufacturing facility. Based on FDA feedback, we expect to
submit a Biologics License Application (BLA) for LN-145 for advanced cervical cancer in late 2020. This time frame potentially
overlaps with the expected timing of a submission in the advanced melanoma indication. In addition, we continue to expand the Iovance
team and build our corporate infrastructure in anticipation of making TIL therapy broadly accessible to all patients that may
benefit from this treatment approach."
and Upcoming Milestones
Second Quarter 2019 Financial Results
Net loss for the second quarter ended
June 30, 2019, was $47.6 million, or $0.38 per share, compared to net loss of $30.7 million, or $0.34 per share for the second
quarter ended June 30, 2018.
Research and development expenses were
$39.3 million for the second quarter of 2019, an increase of $14.7 million compared to $24.6 million for the second quarter of
2018. The increase in research and development expenses was primarily attributable to costs associated with the transfer of the
manufacturing process to additional facilities to increase our manufacturing capacity, an increase in total patients in our clinical
studies which in turn resulted in higher study costs, and an increase in research and development employees.
General and administrative expenses
were $10.9 million for the second quarter of 2019, an increase of $4.1 million compared to $6.8 million for the second quarter
of 2018. The increase was primarily attributable to new general and administrative employees and higher stock-based compensation,
legal expenses related to the intellectual property portfolio and real estate and external market research costs as we prepare
for commercialization.
Six Months Ended June 30, 2019 Financial Results
Net loss for the six months ended June
30, 2019, was $84.5 million, or $0.68 per share, compared to net loss of $57.2 million, or $0.65 per share for the same period
ended June 30, 2018.
Research and development expenses were
$70.2 million for the six months ended June 30, 2019, an increase of $25.7 million compared to $44.5 million for the same period
ended June 30, 2018. The increase in research and development expenses was primarily attributable to costs associated with the
transfer of the manufacturing process to additional facilities to increase our manufacturing capacity, higher costs for drugs used
in the clinical studies, an increase in total patients in our clinical studies which in turn resulted in higher study costs, and
an increase in the number of research and development employees.
General and administrative expenses
were $19.9 million for the six months ended June 30, 2019, an increase of $6.1 million compared to $13.8 million for the same period
ended June 30, 2018. The increase was primarily attributable to the addition of general and administrative employees and higher
stock-based compensation, legal expenses related to intellectual property, and external market research expenses.
Cash, Cash Equivalents, Short-Term
Investments and Restricted Cash
At June 30, 2019, the company held
$409.6 million in cash, cash equivalents, short-term investments and restricted cash as compared to $440.0 million at March 31,
2019. During the second quarter the company used $33.8 million for operating activities. The company anticipates that the year-end
balance of cash, cash equivalents, short-term investments and restricted cash may be between $310 and $320 million.
Webcast and Conference Call
Iovance will host a conference call and live audio webcast to
discuss financial results and provide a corporate update today at 4:30 p.m. EDT.
To participate in the conference call, please dial 1-844-646-4465
(domestic) or 1-615-247-0257 (international) and reference the access code 7574927. A live and archived webcast can be accessed
in the Investors section of the company's website at www.iovance.com.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics intends to commercialize autologous
cell therapy products for solid tumors and blood cancers. Tumor infiltrating lymphocyte (TIL) therapy uses a patient's own
cancer-fighting immune cells to attack solid tumors. TIL are extracted from tumor cells, and once expanded through a proprietary
process are infused back into the patient. After infusion, TIL enter tumor tissue, where they recognize, attack, and destroy the
tumor. The company is currently conducting pivotal studies in patients with metastatic melanoma and advanced cervical cancer.
In addition, the company's TIL therapies are being investigated for the treatment of patients with locally advanced, recurrent
or metastatic cancers including head and neck and non-small cell lung cancer. Iovance has also developed a T cell therapy for
blood cancers called peripheral blood lymphocyte (PBL) and intends to bring that product to clinic to investigate utility of PBL
in chronic lymphocytic leukemia. 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
equivalent, and short term investment positions; 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; the 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; the Company's ability 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;
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