Sesen Bio Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
March 22 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 grants of non-statutory
stock options to three new employees in connection with the
commencement of their employment with Sesen Bio. The addition of
these new team members represents the beginning of the anticipated
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 grants of non-statutory stock options, up to 160,000
shares of Sesen Bio common stock are purchasable upon vesting of
the stock options within the ten-year term. Each of the stock
options vest 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.
Each of the non-statutory stock options was granted on March 16,
2021 at an exercise price of $3.02 per share, which was equal to
the closing price of common stock on the date of grant and was
granted outside of the Company’s 2014 Stock Incentive Plan. Each of
the options 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 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
VB4-845, 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 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
anticipated buildout of the Company’s team to support its
anticipated transformation into a commercial-stage company, 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 PDUFA date of August 18, 2021 and the
need for an advisory meeting on the BLA, 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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210322005393/en/
Erin Clark, Vice President,
Corporate Strategy & Investor Relations
ir@sesenbio.com
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