Iovance Biotherapeutics to Present at BTIG Biotechnology Conference 2020
August 07 2020 - 7:30AM
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel T cell-based cancer
immunotherapies, today announced that the company plans to present
at the BTIG Biotechnology Conference 2020 (Virtual) on August 11,
2020 at 2:30pm ET.
A live and archived webcast of the presentation will be
available in the Investors section of the Iovance website at
http://ir.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 advanced 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 our clinical development
activities; the risk that 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 risk that
the results obtained in our ongoing clinical trials may not be
indicative of results obtained in future clinical trials or that
data within these trials may not be supportive of product approval,
including that later developments with the FDA may be inconsistent
with already completed FDA meetings; the risk that the FDA may not
agree with our approach to expand our cervical cancer trial to
include Cohort 2 of the C-145-04 trial; the risk that 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 risk that regulatory authorities may potentially
delay the timing of FDA or other regulatory approval of, or other
action with respect to, our product candidates, or that we may be
required to conduct additional clinical trials or modify ongoing or
future clinical trials based on feedback from the FDA or other
regulatory authorities; the risk that the Company’s interpretation
of the results of its clinical trials or communications with the
FDA may differ from the interpretation of such results or
communications by the FDA; our ability to obtain and maintain
intellectual property rights related to our product pipeline; our
ability to successfully implement our research and development
programs and collaborations; the acceptance by the market of our
product candidates and their potential reimbursement by payors, if
approved; our ability to obtain tax incentives and credits and the
risk that our existing net operating loss carryforwards and
research tax credits may expire or otherwise be limited in use; the
success of our manufacturing, license or development agreements;
risks related to the Company’s ability to maintain and benefit from
accelerated FDA review designations, including breakthrough therapy
designation or regenerative medicine advanced therapy designation,
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 which 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; the results of
clinical trials with collaborators using different manufacturing
processes may not be reflected in the Company’s sponsored trials;
our dependence on additional financing to fund our operations and
complete the development and commercialization of our product
candidates, and the risks that raising such additional capital may
restrict our operations or require us to relinquish rights to our
technologies or product candidates; the risk that additional
expenses may decrease our estimated cash balances and increase our
estimated capital requirements; and other factors, including
general economic conditions and regulatory developments, not within
the Company’s control.
CONTACTS:
Iovance Biotherapeutics, Inc:
Sara Pellegrino, IRC
Vice President, Investor Relations & Public Relations
650-260-7120 ext. 264
Sara.Pellegrino@iovance.com
Solebury Trout:
Annie Chang (investors)
646-378-2972
achang@troutgroup.com
Chad Rubin (investors)
646-378-2947
crubin@troutgroup.com
Rich Allan (media)
646-378-2958
rallan@troutgroup.com
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