Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) ("Iovance" or the
“Company”), a biotechnology company focused on innovating,
developing, and delivering novel polyclonal tumor infiltrating
lymphocyte (“TIL”) therapies for patients with cancer, today
announced that on August 15, 2024 (the “Date of Grant”), the
Company approved the grant of inducement stock options and
restricted stock units covering an aggregate of 289,710 shares of
Iovance’s common stock to twenty-four new, non-executive employees.
The awards were granted under Iovance’s 2021 Inducement Plan,
which was adopted on September 22, 2021 and amended on January 12,
2022, March 13, 2023, and February 26, 2024 and provides for the
granting of equity awards to new employees of Iovance by the
Company’s compensation committee in accordance with Nasdaq Listing
Rule 5635(c)(4). Each of the stock options granted as referenced in
this press release has an exercise price of $10.67, the closing
price of Iovance’s common stock on the Date of Grant. Each stock
option and restricted stock unit vests over a three-year period,
with one-third of the shares vesting on the first anniversary of
the employee’s start date (the “First Vesting Date”), and the
remaining shares vesting in eight quarterly installments over the
next two years, commencing with the first quarter following the
First Vesting Date, subject to continued employment with the
Company through the applicable vesting dates.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. aims to be the global leader in
innovating, developing, and delivering tumor infiltrating
lymphocyte (“TIL”) therapies for patients with cancer. We are
pioneering a transformational approach to cure cancer by harnessing
the human immune system’s ability to recognize and destroy diverse
cancer cells in each patient. The Iovance TIL platform has
demonstrated promising clinical data across multiple solid tumors.
Iovance’s Amtagvi™ is the first FDA-approved T cell therapy for a
solid tumor indication. We are committed to continuous innovation
in cell therapy, including gene-edited cell therapy, that may
extend and improve life for patients with cancer. For more
information, please visit www.iovance.com.
Amtagvi™ and its accompanying design marks, Proleukin®,
Iovance®, and IovanceCares™ are trademarks and registered
trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries.
All other trademarks and registered trademarks are the property of
their respective owners.
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”). 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,” “can,”
“could,” “might,” “will,” “should,” or other words that convey
uncertainty of future events or outcomes and are intended to
identify forward-looking statements. Forward-looking statements are
based on assumptions and assessments made in light of management’s
experience and perception of historical trends, current conditions,
expected future developments, and other factors believed to be
appropriate. Forward-looking statements in this press release are
made as of the date of this press release, and we undertake no duty
to update or revise any such statements, whether as a result of new
information, future events, or otherwise. Forward-looking
statements are not guarantees of future performance and are subject
to risks, uncertainties, and other factors, many of which are
outside of our control, 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. Important factors that could cause
actual results, developments, and business decisions to differ
materially from forward-looking statements are described in the
sections titled "Risk Factors" in our filings with the U.S.
Securities and Exchange Commission, including our most recent
Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and
include, but are not limited to, the following substantial known
and unknown risks and uncertainties inherent in our business: the
risks related to our ability to successfully commercialize our
products, including Amtagvi, for which we have obtained U.S. Food
and Drug Administration (“FDA”) approval, and Proleukin, for which
we have obtained FDA and European Medicines Agency (“EMA”)
approval; the risk that the EMA or other ex-U.S. regulatory
authorities may not approve or may delay approval for our marketing
authorization application submission for lifileucel in metastatic
melanoma; the acceptance by the market of our products, including
Amtagvi and Proleukin, and their potential pricing and/or
reimbursement by payors, if approved (in the case of our product
candidates), in the U.S. and other international markets and
whether such acceptance is sufficient to support continued
commercialization or development of our products, including Amtagvi
and Proleukin, or product candidates, respectively; future
competitive or other market factors may adversely affect the
commercial potential for Amtagvi or Proleukin; the risk regarding
our ability or inability to manufacture our therapies using third
party manufacturers or at our own facility, including our ability
to increase manufacturing capacity at such third party
manufacturers and our own facility, may adversely affect our
commercial launch; the results of clinical trials with
collaborators using different manufacturing processes may not be
reflected in our sponsored trials; the risk regarding the
successful integration of the recent Proleukin acquisition; the
risk that the successful development or commercialization of our
products, including Amtagvi and Proleukin, may not generate
sufficient revenue from product sales, and we may not become
profitable in the near term, or at all; the risks related to the
timing of and our ability to successfully develop, submit, obtain,
or maintain FDA, EMA, or other regulatory authority approval of, or
other action with respect to, our product candidates; whether
clinical trial results from our pivotal studies and cohorts, and
meetings with the FDA, EMA, or other regulatory authorities may
support registrational studies and subsequent approvals by the FDA,
EMA, or other regulatory authorities, including the risk that the
planned single arm Phase 2 IOV-LUN-202 trial may not support
registration; preliminary and interim clinical results, which may
include efficacy and safety results, from ongoing clinical trials
or cohorts may not be reflected in the final analyses of our
ongoing clinical trials or subgroups within these trials or in
other prior trials or cohorts; the risk that enrollment may need to
be adjusted for our trials and cohorts within those trials based on
FDA and other regulatory agency input; the risk that the changing
landscape of care for cervical cancer patients may impact our
clinical trials in this indication; the risk that we may be
required to conduct additional clinical trials or modify ongoing or
future clinical trials based on feedback from the FDA, EMA, or
other regulatory authorities; the risk that our interpretation of
the results of our clinical trials or communications with the FDA,
EMA, or other regulatory authorities may differ from the
interpretation of such results or communications by such regulatory
authorities (including from our prior meetings with the FDA
regarding our non-small cell lung cancer clinical trials); the risk
that clinical data from ongoing clinical trials of Amtagvi will not
continue or be repeated in ongoing or planned clinical trials or
may not support regulatory approval or renewal of authorization;
the risk that unanticipated expenses may decrease our estimated
cash balances and forecasts and increase our estimated capital
requirements; the risk that we may not be able to recognize revenue
for our products; the risk that Proleukin revenues may not continue
to serve as a leading indicator for Amtagvi revenues; the risks
regarding our anticipated operating and financial performance,
including our financial guidance and projections; the effects of
global pandemic; the effects of global and domestic geopolitical
factors; and other factors, including general economic conditions
and regulatory developments, not within our control.
CONTACTS
Iovance Biotherapeutics, Inc:
Sara Pellegrino, IRC
Senior Vice President, Investor Relations & Corporate Communications
650-260-7120 ext. 264
Sara.Pellegrino@iovance.com
Jen Saunders
Senior Director, Investor Relations & Corporate Communications
267-485-3119
Jen.Saunders@iovance.com
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