Strong balance sheet of $170 million in cash
and cash equivalents as of March 31, 2022, expected to fund current
operating plan into the fourth quarter of 2024
Sesen Bio (Nasdaq: SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of patients with cancer, today reported operating results for the
first quarter ended March 31, 2022. During the quarter, the Company
continued to engage with the US Food and Drug Administration (FDA)
to identify an anticipated regulatory path toward potential
resubmission of a Biologics License Application (BLA) for Vicineum™
for the treatment of non-muscle invasive bladder cancer (NMIBC).
The Company has also initiated a process to review strategic
alternatives with the goal of maximizing shareholder value.
US Regulatory Update
- On March 28, 2022, Sesen Bio participated in a Type C
Meeting with the FDA. During the meeting, the FDA agreed to a
majority of the Company’s proposed protocol and statistical
analysis plan design elements for an additional Phase 3 clinical
trial that it plans to conduct for potential resubmission of a BLA
for Vicineum for the treatment of NMIBC. The Company plans to meet
with the FDA in mid-2022 to align on the remaining outstanding
items related to the additional Phase 3 clinical trial, and intends
to request that meeting in the coming weeks.
In addition to working with the FDA to align
on a study design, the Company has been addressing comments related
to Chemistry, Manufacturing and Controls (CMC) that were included
in the Complete Response Letter (CRL) for the BLA for Vicineum for
the treatment of bacillus Calmette-Guérin (BCG)-unresponsive NMIBC.
The Company has completed technical work on several of the key CMC
comments and is continuing to make progress on the remaining items.
The Company’s responses to the CMC comments will ultimately be
reviewed by the FDA upon a potential BLA resubmission.
Other Business Updates
- On January 6, 2022, Sesen Bio disclosed that it achieved a
$20 million milestone payment pursuant to the Company’s exclusive
license agreement (Roche License Agreement) with Roche for legacy
Interleukin-6 (IL-6) antagonist antibody technology owned by Sesen
Bio. Following this milestone payment, Sesen Bio has
cumulatively received $50 million in upfront and milestone
payments, with an additional $220 million in potential future
milestone payments, as well as royalty payment obligations on
future sales, remaining under the Roche License Agreement. As part
of the Roche License Agreement, Roche also maintains the right to
fully acquire the IL-6 technology.
- On May 3, 2022, Sesen Bio announced that it had 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. The Company is actively working with an
investment bank in this process. Pending any decision to undertake
any strategic alternative, the Company is continuing its
development activities in accordance with its existing business
strategy.
- On June 22, 2022, Sesen Bio will hold its Annual Meeting of
Stockholders, one of the primary purposes of which will be to
approve a proposal for a reverse stock split, which includes a
proportionate reduction in authorized shares of common stock.
The proposed reverse stock split, if approved, should allow the
Company to remain listed on the Nasdaq Global Market, which should
increase the range and attractiveness of strategic alternatives
that the Company is able to consider to maximize shareholder
value.
First Quarter 2022 Financial Results
- Cash Position: Cash, cash equivalents and restricted
cash were $169.8 million as of March 31, 2022, compared to $110.0
million as of March 31, 2021.
- R&D Expenses: Research and development expenses for
the first quarter of 2022 were $4.8 million compared to $6.1
million for the same period in 2021. The decrease of $1.3 million
was primarily due to lower costs associated with technology
transfer and manufacturing ($1.4 million), regulatory and clinical
consulting fees ($0.6 million) and license milestone fees ($0.6
million), which were partially offset by increases in
employee-related compensation, primarily driven by increased
headcount and the retention program implemented in the fourth
quarter of 2021 ($1.2 million), and other R&D expenses ($0.1
million).
- G&A Expenses: General and administrative expenses
for the first quarter of 2022 were $9.0 million compared to $5.3
million for the same period in 2021. The increase of $3.7 million
was due primarily to increases in legal expenses related, in part,
to the independent internal review completed in February 2022 ($3.0
million), employee-related compensation, primarily driven by
increased headcount and the retention program implemented in the
fourth quarter of 2021 ($1.1 million), insurance expense ($0.1
million) and other general expenses ($0.2 million). This was
partially offset by a decrease in consultant fees incurred in
preparation for commercial launch as a result of the subsequent CRL
received in August 2021 ($0.7 million).
- Net Loss: Net loss was $0.8 million, or $0.00 per basic
and per diluted share, for the first quarter of 2022, compared to
net loss of $55.5 million, or $0.35 per basic and diluted share,
for the same period in 2021. The decrease of $54.7 million in net
loss was primarily attributable to the non-cash decrease in fair
value of contingent consideration ($61.1 million), partially offset
by decreased license and related revenue recognized ($4.3
million).
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 anticipated regulatory path
forward for Vicineum for the treatment of NMIBC, the Company’s
plans to conduct an additional Phase 3 clinical trial for potential
resubmission of a BLA for Vicineum for the treatment of NMIBC, the
Company’s plans to meet with the FDA in mid-2022 to align on the
remaining outstanding items related to the additional Phase 3
clinical trial, the Company’s intentions to request such meeting in
the coming weeks, any future payments to the Company pursuant to
the Roche License Agreement including any future milestone payments
and royalty payments, the Company’s plans to review strategic
alternatives with the goal of maximizing shareholder value, 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 in accordance with its
existing business strategy pending any decision to undertake any
strategic alternative, the Company’s plans to hold its Annual
Meeting of Stockholders on June 22, 2022 and request stockholder
approval of a reverse stock split, the Company’s expectations that
such reverse stock split, if approved, should allow the Company to
remain listed on the Nasdaq Global Market, which should increase
the range and attractiveness of strategic alternatives that the
Company is able to consider to maximize shareholder value, 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 resume its plans to pursue regulatory approval
for Vicineum, 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 an 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 otherwise produce
favorable results, the risk that the FDA may not approve a BLA for
Vicineum for the treatment of NMIBC if the Company resubmits a BLA
at a future time, the risk that Vicineum for the treatment of NMIBC
may cause undesirable side effects, serious adverse events or have
other properties that could delay or halt clinical trials, delay or
prevent its regulatory approval by the FDA, limit the commercial
profile of its labeling, if approved, or result in significant
negative consequences following any marketing approval, the
occurrence of any event, change or other circumstances that could
give rise to the termination of the Roche License Agreement, 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, 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.
SESEN BIO, INC. CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited; In thousands, except share and per share data)
March 31, 2022
December 31, 2021
Assets Current assets: Cash and
cash equivalents
$
169,790
$
162,636
Accounts receivable
1,011
21,011
Other receivables
1,041
3,482
Prepaid expenses and other current assets
8,795
18,476
Total current assets
180,637
205,605
Non-current assets: Restricted
cash
20
20
Property and equipment, net
33
43
Intangible assets
14,700
14,700
Goodwill
13,064
13,064
Long term prepaid expenses
17,301
7,192
Other assets
85
123
Total non-current assets
45,203
35,142
Total Assets
$
225,840
$
240,747
Liabilities and Stockholders’ Equity
Current liabilities: Accounts payable
$
666
$
2,853
Accrued expenses
7,278
8,255
Other current liabilities
530
460
Total current liabilities
8,474
11,568
Non-current liabilities:
Contingent consideration
39,100
52,000
Deferred tax liability
3,969
3,969
Deferred revenue
1,500
1,500
Total non-current liabilities
44,569
57,469
Total Liabilities
53,043
69,037
Stockholders’ Equity: Preferred
stock, $0.001 par value per share; 5,000,000 shares authorized at
March 31, 2022 and December 31, 2021 ; no shares issued and
outstanding at March 31, 2022 and December 31, 2021
-
-
Common stock, $0.001 par value per share; 400,000,000 shares
authorized at March 31, 2022 and December 31, 2021; 199,463,645
shares issued and outstanding at March 31, 2022 and December 31,
2021
199
199
Additional paid-in capital
489,662
487,768
Accumulated deficit
(317,064
)
(316,257
)
Total Stockholders’ Equity
172,797
171,710
Total Liabilities and Stockholders’ Equity
$
225,840
$
240,747
SESEN BIO, INC. CONDENSED CONSOLIDATED STATEMENTS OF
INCOME (OPERATIONS) AND COMPREHENSIVE INCOME (LOSS)
(Unaudited; In thousands, except per share data)
Three Months ended March 31,
2022
2021
Revenue: License and related revenue
$
-
$
4,310
Total revenue
$
-
$
4,310
Operating expenses: Research and
development
$
4,760
$
6,078
General and administrative
8,975
5,293
Change in fair value of contingent consideration
(12,900
)
48,160
Total operating expenses
$
835
$
59,531
Loss from Operations
$
(835
)
$
(55,221
)
Other income (expense), net
28
(3
)
Loss Before Taxes
$
(807
)
$
(55,224
)
Provision for income taxes
-
(288
)
Net Loss and Comprehensive Loss After Taxes
$
(807
)
$
(55,512
)
Net loss attributable to common stockholders -
basic and diluted
$
(807
)
$
(55,512
)
Net loss per common share - basic and diluted
$
(0.00
)
$
(0.35
)
Weighted-average common shares outstanding - basic and diluted
199,464
157,033
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220509005287/en/
Investors: Erin Clark, Vice
President, Corporate Strategy & Investor Relations
ir@sesenbio.com
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