Full Press Release Details
Iovance Biotherapeutics Reports Third
Quarter and September Year-to-Date 2019 Financial Results
- Late-breaking abstract at Society
for Immunotherapy of Cancer (SITC) meeting to feature Independent Review Committee (IRC) read results from Cohort 2 of C-144-01
- Investigational New Drug (IND)
application cleared for newly developed peripheral blood lymphocyte (PBL) therapy, IOV-2001 -
- Company to host conference call at 4:30
SAN CARLOS, Calif., Nov. 4, 2019 -- Iovance
Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies,
today reported financial results from the third quarter and nine months ending September 30, 2019, and provided a corporate update.
"We continue making great
progress in developing tumor infiltrating lymphocyte (TIL) therapy, which could become the first approved cell therapy product
for solid tumor indications," commented Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics.
"Our pivotal studies in metastatic melanoma and advanced cervical cancer are
on track to complete enrollment in early 2020. We expect to submit for regulatory approval for
TIL therapies lifileucel and LN-145 in late 2020. These therapies have the potential to impact the lives of thousands of
patients in the U.S. with melanoma or cervical cancer that have exhausted current treatment options. Furthermore, we are very
pleased to have a new IND active in order to investigate
the polyclonal blood-based T cell, or PBL therapy
(IOV-2001), in chronic lymphocytic leukemia (CLL). This candidate was developed based
on Iovance research efforts focused on the generation of novel cell therapy products. We anticipate the initiation of IOV-CLL-01,
an Iovance-sponsored trial with IOV-2001 PBL product, before the end of 2019."
and Upcoming Milestones
SITC Late-Breaking Abstract Information
Third Quarter 2019 Financial Results
Net loss for the third quarter ended September
30, 2019, was $49.5 million, or $0.40 per share, compared to a net loss of $33.8 million, or $0.36 per
share, for the third quarter ended September 30, 2018.
Research and development expenses were $41.6
million for the third quarter ended September 30, 2019, an increase of $13.7 million compared to $27.9
million for the third quarter ended September 30, 2018. The increase was primarily attributable to higher manufacturing
costs resulting from increased capacity added to support enrollment in the pivotal and other clinical trials. In addition the increase
is also due to higher personnel costs including stock-based compensation resulting from an increase in headcount as compared to
the third quarter in 2018.
General and administrative expenses
were $10.0 million for the third quarter 2019, an increase of $2.9 million compared to $7.1 million for
the third quarter 2018. The increase was primarily attributable to increased personnel costs due to additional employees added
in 2019 and additional legal fees to support the growing patent portfolio.
Nine Months Ended September
30, 2019, Financial Results
Net loss for the nine months ended September
30, 2019, was $134.0 million, or $1.08 per share, compared to a net loss of $91.0 million, or $1.01 per
share, for the same period ended September 30, 2018.
Research and development expenses were $111.8
million for the nine months ended September 30, 2019, an increase of $39.4 million compared to $72.4 million for
the same period ended September 30, 2018. The increase was primarily attributable to additional manufacturing and clinical
trial costs resulting from higher enrollment in the clinical trials and increased personnel costs due to an increase in employees
as compared to the same period in 2018.
General and administrative expenses
were $30.0 million for the nine months ended September 30, 2019, an increase of $9.1 million compared
to $20.9 million for the same period ended September 30, 2018. The increase was primarily attributable to higher
personnel costs including stock-based compensation resulting from an increase in the number of employees and additional legal fees
to support the patent portfolio.
Cash, cash equivalents, short term
investments and restricted cash
At September 30, 2019, the company
held $367.3 million in cash, cash equivalents, short-term investments and restricted cash compared to $468.5 million at December
31, 2018. 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
today at 4:30 p.m. ET to discuss these third quarter 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 3482317. The live webcast can be accessed in the Investors section of the company's website at http://www.iovance.com.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics intends 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
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. Clinical studies of T cell therapy for blood cancers called peripheral blood lymphocyte
(PBL) therapy are being planned. 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; 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