Sesen Bio Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
June 18 2021 - 8:00AM
Business Wire
Sesen Bio (Nasdaq: SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of patients with cancer, today reported the grant of a
non-statutory stock option to one new employee in connection with
the employee’s commencement of employment with Sesen Bio. The
addition of this new team member represents a continuation of the
buildout of the Sesen Bio team in support of its transformation
into a commercial-stage company ahead of the target Prescription
Drug User Fee Act (PDUFA) date of August 18, 2021 for Vicineum™ for
the treatment of BCG-unresponsive non-muscle invasive bladder
cancer.
Under the grant of the non-statutory stock option, up to 52,500
shares of Sesen Bio common stock are purchasable upon vesting of
the stock option within the ten-year term. The stock option vests
over a four-year period, with one quarter of the underlying shares
vesting on the first anniversary of the date of grant, and an
additional 6.25% of the underlying shares vesting at the end of
each successive three-month period following the one-year
anniversary of the date of grant, subject in each case to the
employee’s continued service with Sesen Bio.
The non-statutory stock option was granted on June 14, 2021 at
an exercise price of $4.25, based on the closing price of common
stock on the date of the grant, and was granted outside of the
Company’s 2014 Stock Incentive Plan. The option was granted as a
material inducement to employment in accordance with Nasdaq Listing
Rule 5635(c)(4).
About Vicineum™
Vicineum, a locally administered fusion protein, is Sesen Bio’s
lead product candidate being developed for the treatment of
BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
Vicineum is comprised of a recombinant fusion protein that targets
epithelial cell adhesion molecule (EpCAM) antigens on the surface
of tumor cells to deliver a potent protein payload, Pseudomonas
Exotoxin A. Vicineum is constructed with a stable, genetically
engineered peptide tether to ensure the payload remains attached
until it is internalized by the cancer cell, which is believed to
decrease the risk of toxicity to healthy tissues, thereby improving
its safety. In prior clinical trials conducted by Sesen Bio, EpCAM
has been shown to be overexpressed in NMIBC cells with minimal to
no EpCAM expression observed on normal bladder cells. Sesen Bio is
currently in the follow-up stage of a Phase 3 registration trial in
the US for the treatment of BCG-unresponsive NMIBC. In February
2021, the FDA accepted for filing the Company’s BLA for Vicineum
for the treatment of BCG-unresponsive NMIBC and granted the
application Priority Review with a target PDUFA date of August 18,
2021. Additionally, Sesen Bio believes that cancer cell-killing
properties of Vicineum promote an anti-tumor immune response that
may potentially combine well with immuno-oncology drugs, such as
checkpoint inhibitors. For this reason, the activity of Vicineum in
BCG-unresponsive NMIBC is also being explored at the US National
Cancer Institute in combination with AstraZeneca’s immune
checkpoint inhibitor durvalumab.
About Sesen Bio
Sesen Bio, Inc. is a late-stage clinical company advancing
targeted fusion protein therapeutics for the treatment of patients
with cancer. The Company’s lead program, Vicineum™, also known as
oportuzumab monatox, is currently in the follow-up stage of a Phase
3 registration trial for the treatment of BCG-unresponsive
non-muscle invasive bladder cancer (NMIBC). In February 2021, the
FDA accepted for filing the Company’s BLA for Vicineum for the
treatment of BCG-unresponsive NMIBC and granted the application
Priority Review with a target PDUFA date of August 18, 2021. Sesen
Bio retains worldwide rights to Vicineum with the exception of
Greater China and the Middle East and North Africa (MENA), for
which the Company has partnered with Qilu Pharmaceutical and Hikma
Pharmaceuticals, respectively, for commercialization. Vicineum is a
locally administered targeted fusion protein composed of an
anti-EpCAM antibody fragment tethered to a truncated form of
Pseudomonas Exotoxin A for the treatment of BCG-unresponsive NMIBC.
For more information, please visit the Company’s website at
www.sesenbio.com.
COVID-19 Pandemic Potential Impact
Sesen Bio continues to monitor the rapidly evolving environment
regarding the potential impact of the COVID-19 pandemic on our
Company. The Company has not yet experienced any disruptions to our
operations as a result of COVID-19, however, we are not able to
quantify or predict with certainty the overall scope of potential
impacts to our business, including, but not limited to, our ability
to raise capital and, if approved, commercialize Vicineum. Sesen
Bio remains committed to the health and safety of patients,
caregivers and employees.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for the Company, the Company’s strategy, future
operations, and other statements containing the words “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “target,” “potential,” “will,” “would,”
“could,” “should,” “continue,” and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including: the timing for
the FDA’s decision on the Company’s BLA for Vicineum for the
treatment of BCG-unresponsive NMIBC based on the FDA granting the
BLA Priority Review, the target PDUFA date of August 18, 2021, the
impact of COVID-19 on the Company, including its ability to raise
capital, and, if approved, its ability to commercialize Vicineum
for the treatment of BCG-unresponsive NMIBC, and other factors
discussed in the “Risk Factors” section of the Company’s Annual
Report on Form 10-K, Quarterly Reports on Form 10-Q and other
reports filed with the Securities and Exchange Commission. In
addition, the forward-looking statements included in this press
release represent the Company’s views as of the date hereof. The
Company anticipates that subsequent events and developments will
cause the Company’s views to change. However, while the Company may
elect to update these forward-looking statements at some point in
the future, the Company specifically disclaims any obligation to do
so. These forward-looking statements should not be relied upon as
representing the Company’s views as of any date subsequent to the
date hereof.
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version on businesswire.com: https://www.businesswire.com/news/home/20210618005011/en/
Erin Clark, Vice President, Corporate Strategy & Investor
Relations ir@sesenbio.com
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