Sesen Bio (Nasdaq: SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of patients with cancer, today announced that it has initiated a
process to review strategic alternatives with the goal of
maximizing shareholder value. Potential strategic alternatives to
be explored and evaluated during the review process may include the
sale of the Company, a merger, acquisition or other business
combination, a strategic partnership with one or more parties, or
the licensing, sale or divestiture of some of the Company’s
proprietary technologies. Pending any decision to undertake any
strategic alternative, the Company is continuing its development
activities in accordance with its existing business strategy.
“Our strong cash position provides us the opportunity to
carefully consider a wide range of potential strategic alternatives
designed to maximize shareholder value,” said Dr. Thomas Cannell,
president and chief executive officer of Sesen Bio. “As we assess
potential external strategic alternatives, we continue to seek to
create value through the development of Vicineum for the treatment
of non-muscle invasive bladder cancer. We plan to request a meeting
with the FDA in the coming weeks to align on the remaining
outstanding items related to an additional Phase 3 clinical
trial.”
As of March 31, 2022, the Company had $169.8 million in cash and
cash equivalents, no outstanding debt and fewer than 0.2 million
outstanding warrants. These amounts are preliminary and are subject
to change upon completion of the Company’s financial statements for
the quarterly period ended March 31, 2022.
About Vicineum™ Vicineum, a locally administered fusion
protein, is Sesen Bio’s lead product candidate being developed for
the treatment of 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 to
the antibody binding fragment until it is internalized by the
cancer cell. This fusion protein design 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 clinical trial in the US for
the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA
accepted the Company’s Biologics License Application (BLA) file for
Vicineum for the treatment of BCG-unresponsive NMIBC, granted
Priority Review for the BLA and set a Prescription Drug User Fee
Act (PDUFA) date of August 18, 2021. On August 13, 2021, the
Company received a Complete Response Letter (CRL) from the FDA
regarding its BLA for Vicineum. After meeting with the FDA, the
Company plans to conduct an additional Phase 3 clinical trial for
Vicineum for the treatment of NMIBC in connection with the
potential resubmission of a BLA. The Company plans to request a
meeting with the FDA in the coming weeks to align on the remaining
outstanding items related to the additional Phase 3 clinical trial.
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 clinical trial for the treatment of
BCG-unresponsive NMIBC. In February 2021, the FDA accepted the
Company’s BLA file for Vicineum for the treatment of
BCG-unresponsive NMIBC, granted Priority Review for the BLA and set
a PDUFA date of August 18, 2021. On August 13, 2021, the Company
received a CRL from the FDA regarding its BLA for Vicineum. After
meeting with the FDA, the Company plans to conduct an additional
Phase 3 clinical trial for Vicineum for the treatment of NMIBC in
connection with the potential resubmission of a BLA. The Company
plans to request a meeting with the FDA in the coming weeks to
align on the remaining outstanding items related to the additional
Phase 3 clinical trial. Sesen Bio retains worldwide rights to
Vicineum with the exception of Greater China, the Middle East and
North Africa (MENA) and Turkey, for which the Company has partnered
with Qilu Pharmaceutical, Hikma Pharmaceuticals and Eczacibasi
Pharmaceuticals Marketing (EIP), 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, which is being
developed for the treatment of 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 the Company. The Company has not
yet experienced any disruptions to its operations as a result of
COVID-19, however, the Company is not able to quantify or predict
with certainty the overall scope of potential impacts to its
business, including, but not limited to, its ability to conduct an
additional Phase 3 clinical trial for Vicineum for the treatment of
NMIBC, its ability to raise capital and, if approved, its ability
to 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,” “expect,” “intend,” “may,” “plan,” “predict,” “target,”
“potential,” “will,” “would,” “should,” “continue,” and similar
expressions, constitute forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995.
For example, statements regarding the Company’s plans to explore
and evaluate potential strategic alternatives, which may include
the sale of the Company, a merger, acquisition or other business
combination, a strategic partnership with one or more parties, or
the licensing, sale or divestiture of some of the Company’s
proprietary technologies, the Company’s plans to continue its
development activities with its existing business strategy, the
Company’s plans to carefully consider a wide range of potential
strategic alternatives designed to maximize shareholder value, the
Company's plans to continue to seek to create value through the
development of Vicineum for the treatment of NMIBC as it assesses
potential external strategic alternatives, the impact of COVID-19
on the Company, including its ability to conduct an additional
Phase 3 clinical trial for Vicineum for the treatment of NMIBC, its
ability to raise capital, and, if approved, its ability to
commercialize Vicineum. Actual results may differ materially from
those indicated by such forward-looking statements as a result of
various important factors, including: the risk that the Company may
not be successful in identifying one or more strategic alternatives
or ultimately pursuing a strategic alternative that delivers the
anticipated benefits or enhances shareholder value, the risk that
the Company’s exploration and evaluation of strategic alternatives
or the public announcement thereof may be disruptive to the
Company’s business operations or cause the Company’s stock price to
fluctuate significantly, the risk that the Company's exploration
and evaluation of strategic alternatives may be time consuming and
involve the dedication of significant resources and may require the
Company to incur significant costs and expenses, the risk that the
Company’s exploration and evaluation of strategic alternatives
could divert the attention of the Company’s management and its
board of directors from the existing business operations,
negatively impact the Company’s ability to attract, retain and
motivate key employees, and expose the Company to potential
litigation in connection with the process of exploring strategic
alternatives or any resulting transaction, the risk that the
Company may not resume its plans to pursue regulatory approval for
Vicineum for the treatment of NMIBC, the risk that the Company may
not be able to align with the FDA on the remaining outstanding
items related to the additional Phase 3 clinical trial for Vicineum
for the treatment of NMIBC, or other issues related to preparing
for the additional Phase 3 clinical trial for Vicineum, including
difficulties with clinical trial site selection and obtaining
clinical trial materials and supplies, the risk that clinical
trials of Vicineum for the treatment of NMIBC, including the
additional clinical trial needed to address issues raised in the
CRL, may fail to demonstrate safety and efficacy to the
satisfaction of the FDA or the European Medicines Agency, or
otherwise produce favorable results, 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/20220503005367/en/
Investors: Erin Clark, Vice
President, Corporate Strategy & Investor Relations
ir@sesenbio.com
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