The Company believes it remains on track for an
FDA decision on its BLA for Vicineum by August 18, 2021
The Company also believes it remains on track
for potential approval in Europe and key markets in MENA in
2022
Strengthened balance sheet with $151M in cash
and cash equivalents as of June 30, 2021
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
second quarter ended June 30, 2021. The Biologics License
Application (BLA) for the Company’s lead program, Vicineum for the
treatment of BCG-unresponsive non-muscle invasive bladder cancer
(NMIBC), is currently under Priority Review with the US Food and
Drug Administration (FDA) with a target Prescription Drug User Fee
Act (PDUFA) date of August 18, 2021.
“We are excited about the regulatory progress we are making
across our global markets,” said Dr. Thomas Cannell, president and
chief executive officer of Sesen Bio. “We remain focused on
executing a world-class launch in the US if Vicineum is approved,
and we also continue to support our partners outside of the United
States, as part of our commitment to deliver a therapy we believe
can improve patient outcomes globally while reducing overall
healthcare costs for patients.”
US and Outside of the US (OUS) Regulatory Update
US:
- On July 13, 2021, Sesen Bio participated in a productive
Late-Cycle Meeting with the FDA regarding the BLA for Vicineum for
the treatment of BCG-unresponsive NMIBC. In the meeting, the
FDA confirmed that there is no Advisory Committee meeting planned
at this time, and that no post-marketing requirements, including a
confirmatory trial, have been identified at this time. Also in the
meeting, the Company and the FDA discussed remaining questions
related to manufacturing facility inspections, product quality
information requests and additional information related to
chemistry, manufacturing and controls (CMC), and a timeline to
submit additional supporting information was agreed upon. The
Company believes it remains on track for an FDA decision on its BLA
for Vicineum by the target PDUFA date of August 18, 2021.
Europe:
- In Europe, the Company believes it remains on track for
potential approval of Vysyneum™ in 2022. The Company has
received the Day 80 and Day 120 questions from the European
Medicines Agency (EMA) and is responding to inquiries and providing
supporting information as part of the official review process.
China:
- On July 20, 2021, Sesen Bio and Qilu Pharmaceutical, the
Company’s partner in Greater China, announced that the first
patient had been enrolled in China in the clinical trial to assess
the efficacy and safety of Vicineum in patients with
BCG-unresponsive NMIBC. The trial, which plans to enroll
approximately 53 patients with carcinoma in situ (CIS), is being
run at the sole cost of Qilu Pharmaceutical. If the trial is
successful, Qilu Pharmaceutical anticipates submission of the
product market application for Vicineum in China in 2022, with
potential approval expected in 2023.
Middle East and North Africa (MENA):
- The Company continues to work closely with its partner in
MENA, Hikma Pharmaceuticals, to submit marketing authorization
applications for Vicineum in 2021 in seven key markets in the
region: Kingdom of Saudi Arabia, Jordan, Morocco, Egypt, Lebanon,
Kuwait and Algeria. These markets represent a significant
opportunity, with some of the most advanced healthcare systems and
largest economies in the MENA region. The Company believes it is on
track for potential market approvals to begin in the region in
2022.
Business Development Update
- On June 1, 2021, the Company entered into a global supply
agreement with Qilu Pharmaceutical to become part of the
manufacturing network for global commercial supply of Vicineum drug
substance and drug product. This was an expansion of the
initial commercial manufacturing and supply framework agreement
entered into by Sesen Bio and Qilu Pharmaceutical in December 2020,
and sets specific terms such as capacity, forecasts, pricing and
product delivery. Along with existing world-class supply partners,
Sesen Bio expects the global supply agreement with Qilu
Pharmaceutical will enable the Company to meet anticipated
significant global demand for Vicineum.
- On August 5, 2021, Sesen Bio announced it had entered into a
licensing agreement with Eczacibasi Pharmaceuticals Marketing (EIP)
for the registration and commercialization of Vicineum in
Turkey. Under the terms of the licensing agreement, Sesen Bio
will receive an upfront payment of $1.5 million, is eligible to
receive additional regulatory and commercial milestone payments and
is also entitled to receive a 30% royalty on net sales in Turkey.
EIP was granted an exclusive license to register and commercialize
Vicineum for the treatment of BCG-unresponsive NMIBC in Turkey,
where bladder cancer is the sixth most commonly diagnosed cancer
and 11th most common cause of death. This agreement represents the
third OUS partnership that Sesen Bio has entered to date.
Commercial Planning Update
- Sesen Bio completed its commercial build phase in
preparation for the anticipated launch of Vicineum, if approved, in
the US, and has advanced to the implementation phase that will
commence promptly, if approved, and will focus on executing the
Company’s commercial strategy for Vicineum. The Company has
completed the hiring of ~25 talented internal employees to support
the Company cross-functionally, as well as the hiring of 35 sales
representatives as part of the contract sales organization who will
target approximately 2,000 high-prescribers of BCG to drive
awareness, trial and adoption of Vicineum for the treatment of
patients with BCG-unresponsive NMIBC.
In addition to building its sales force, as
part of the Sesen Bio national speaker programs, the Company has
identified and commenced training of 14 key opinion leader (KOL)
speakers to educate their peers on Vicineum for the treatment of
BCG-unresponsive NMIBC, if approved. Upon product availability, the
Company will utilize a two-pronged market access and reimbursement
strategy to ensure maximum coverage for Vicineum.
Promotional efforts will begin immediately
upon the anticipated approval of Vicineum in the US, and the
Company expects Vicineum product to be available to physicians and
patients in the fourth quarter of 2021.
- Results of market research conducted by the Company show
that when given the choice between the product profile of Vicineum,
based on Phase III clinical trial data1, and the product
profile of Keytruda®, physicians will choose Vicineum over 80% of
the time. This data highlights urologists’ preferences that the
Company believes spans clinical, emotional and economic reasons to
prescribe Vicineum. If approved by the FDA, the Company believes
Vicineum could be a best-in-class treatment option for patients,
and a critical step in Sesen Bio realizing its mission to save and
improve the lives of patients with cancer.
[1]The Phase III clinical data are based on the data submitted
in the BLA on December 18, 2020 and are currently under review by
the FDA. Final efficacy and safety data are pending.
Second Quarter 2021 Financial Results
- Cash Position: Cash, cash equivalents and restricted
cash were $151.1 million as of June 30, 2021, compared to $55.4
million as of December 31, 2020.
- R&D Expenses: Research and development expenses for
the second quarter of 2021 were $7.2 million compared to $4.6
million for the same period in 2020. The increase of $2.7 million
was due to increased costs associated with technology transfer and
manufacturing ($1.0 million), professional services in support of
regulatory activity ($0.7 million), employee-related compensation
($0.7 million), and other increases ($0.3 million).
- G&A Expenses: General and administrative expenses
for the second quarter of 2021 were $6.8 million compared to $3.3
million for the same period in 2020. The increase of $3.5 million
was due primarily to increases in sales and marketing expense for
Vicineum pre-commercial launch planning ($1.6 million),
employee-related compensation driven by increased headcount as part
of the commercial build ($1.3 million), and other increases for
commercial launch preparation ($0.6 million).
- Net Loss: Net loss was $25.4 million, or $0.15 per
share, for the second quarter of 2021, compared to net loss of
$26.3 million, or $0.24 per share, for the second quarter of 2020.
The change was attributable to license revenue recognized ($2.2
million), offset by higher operating expenses ($1.3 million).
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 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 registration trial in the US
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 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 the Company’s BLA file 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, 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
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 the
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,” “potential,” “target,” “strategy,” “will,” “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 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, successful
resolution of topics discussed at the Late-Cycle Meeting (including
those related to manufacturing facility inspections, product
quality information requests and additional information related to
CMC), no advisory committee meeting on the BLA being planned at
this time, and no post-marketing requirements being identified at
this time, the Company’s expectations about its ability to execute
a world-class launch of Vicineum in the US, if approved by the FDA,
and its plans to support its OUS partners, the Company’s beliefs
about Vicineum’s ability to be a best-in-class treatment for
patients with BCG-unresponsive NMIBC, if approved, and to improve
patient outcomes while reducing overall healthcare costs, the
timing of approval of the Company’s Marketing Authorization
Application (MAA) for Vysyneum for the treatment of
BCG-unresponsive NMIBC with the EMA if at all, the timing and
results of any clinical trial for Vicineum in China, the timing for
submission and potential approval of the product market application
for Vicineum for the treatment of BCG-unresponsive NMIBC to the
National Medical Products Administration (NMPA) in China if at all,
the timing for submissions and any product market approvals of
Vicineum for the treatment of BCG-unresponsive NMIBC in key markets
in MENA, the ability of the Company’s supply partners to enable the
Company to meet global demand for Vicineum, the timing and receipt
by the Company of any milestone payments or royalties from its OUS
partner in Turkey, the Company’s ability to implement its
commercial strategy for Vicineum, if approved for the treatment of
BCG-unresponsive NMIBC, in the US, the Company’s plans to pursue
certain strategies to increase market access and reimbursement to
maximize coverage of Vicineum for the treatment of BCG-unresponsive
NMIBC, the Company’s expectations regarding the timing for
commercial availability of Vicineum for the treatment of
BCG-unresponsive NMIBC in the US, the Company’s expectations based
on its market research findings regarding preference for the
profile of Vicineum over the profile of Keytruda, 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. 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 FDA may not approve the BLA for Vicineum within the anticipated
timing, or at all, the risk that the EMA may not approve the MAA
for Vysyneum within the anticipated timing, or at all, the risk
that the NMPA may not approve the product market application for
Vicineum within the anticipated timing, or at all, the risk that
the Company may not be able to establish sales, marketing and
distribution capabilities for Vicineum for the treatment of
BCG-unresponsive NMIBC, if approved in the US, the risk that the
Company may not be successful in commercializing Vicineum for the
treatment of BCG-unresponsive NMIBC, if and when it is approved in
the US, the risk that Vicineum may not gain market acceptance among
physicians, patients, third-party payors or the medical community,
the risk that Vicineum may become subject to unfavorable pricing
regulations, third-party coverage or reimbursement practices or
healthcare reform initiatives, 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
(In thousands, except share and per share data)
(Unaudited) June 30, 2021 December 31,
2020 Assets Current assets: Cash and cash equivalents
$
151,036
$
52,389
Accounts receivable
2,303
-
Prepaid expenses and other current assets
21,760
7,478
Restricted cash
-
3,000
Total current assets
175,099
62,867
Non-current assets: Restricted cash
20
20
Property and equipment, net
109
123
Intangible assets
46,400
46,400
Goodwill
13,064
13,064
Long term prepaid expenses
6,150
-
Other assets
205
349
Total non-current assets
65,948
$
59,956
Total Assets
$
241,047
$
122,823
Liabilities and Stockholders’ (Deficit) Equity
Current liabilities: Accounts payable
$
1,228
$
3,102
Accrued expenses
5,301
3,973
Deferred revenue
1,500
1,500
Contingent consideration
10,300
8,985
Other current liabilities
498
489
Total current liabilities
18,827
18,049
Non-current liabilities: Contingent consideration, net of
current portion
160,300
99,855
Deferred tax liability
12,528
12,528
Deferred revenue, net of current portion
-
1,500
Other non-current liabilities
43
118
Total non-current liabilities
172,871
114,001
Total liabilities
191,698
132,050
Stockholders’ Equity ( Deficit): Preferred stock, $0.001 par
value per share; 5,000,000 shares authorized atJune 30, 2021 and
December 31, 2020; no shares issued and outstanding atJune 30, 2021
and December 31, 2020
-
-
Common stock, $0.001 par value per share; 400,000,000 and
200,000,000 shares authorizedat June 30, 2021 and December 31,
2020, respectively; 188,460,951 and 140,449,647 sharesissued and
outstanding at June 30, 2021 and December 31, 2020, respectively
188
140
Additional paid-in capital
446,036
306,554
Accumulated deficit
(396,875
)
(315,921
)
Total Stockholders’ Equity (Deficit)
49,349
(9,227
)
Total Liabilities and Stockholders’ Equity
$
241,047
$
122,823
SESEN BIO, INC. CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE (LOSS) INCOME (In
thousands, except per share data) (Unaudited)
Three Months ended June 30, Six Months ended June 30,
2021
2020
2021
2020
License and related revenue
$
2,234
$
-
$
6,544
$
-
Operating expenses: Research and development
$
7,228
$
4,562
$
13,306
$
13,429
General and administrative
$
6,805
$
3,318
$
12,098
$
6,766
Change in fair value of contingent consideration
$
13,600
$
18,480
$
61,760
$
(35,220
)
Total operating expenses
27,633
$
26,360
$
87,164
(15,025
)
(Loss) Income from Operations
(25,399
)
$
(26,360
)
$
(80,620
)
15,025
Other (expense) income , net
$
(43
)
$
16
$
(46
)
$
195
Net (Loss) Income and Comprehensive (Loss) Income Before Taxes
$
(25,442
)
$
(26,344
)
$
(80,666
)
$
15,220
Provision for income taxes
$
-
$
-
$
(288
)
$
-
Net (Loss) Income and Comprehensive (Loss) Income After Taxes
$
(25,442
)
$
(26,344
)
$
(80,954
)
$
15,220
Net (loss) income attributable to common stockholders -
basic
$
(25,442
)
$
(26,491
)
$
(80,954
)
$
14,751
Net (loss) income attributable to common stockholders - diluted
$
(25,442
)
$
(26,491
)
$
(80,954
)
$
12,600
Net (loss) income per common share - basic
$
(0.15
)
$
(0.24
)
$
(0.49
)
$
0.13
Weighted-average common shares outstanding - basic
175,393
112,569
166,264
111,189
Net (loss) income per common share - diluted
$
(0.15
)
$
(0.24
)
$
(0.49
)
$
0.11
Weighted-average common shares outstanding - diluted
175,393
112,569
166,264
111,203
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210809005157/en/
Erin Clark, Vice President,
Corporate Strategy & Investor Relations
ir@sesenbio.com
Media: Lindsay Rocco at Elixir Health PR
lrocco@elixirhealthpr.com
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