Participated in productive CMC and Clinical
Type A Meetings with the FDA in the fourth quarter
Type C Meeting with the FDA planned for March
28, 2022
Strong balance sheet with $163M in cash and
cash equivalents as of December 31, 2021 expected to fund current
operating plan into 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
fourth quarter and full year ended December 31, 2021. During the
fourth quarter, the Company worked with the US Food and Drug
Administration (FDA) to identify an anticipated regulatory path
toward potential resubmission of a Biologics License Application
(BLA) for the Company’s lead program, Vicineum™ for the treatment
of non-muscle invasive carcinoma in situ (CIS) of the bladder in
patients previously treated with adequate or less than adequate
bacillus Calmette-Guérin (BCG).1
“Our interactions with the FDA during the fourth quarter
provided us further clarity on the steps required to resubmit a BLA
for Vicineum and to bring a therapy to market that we believe has
the potential to save and improve the lives of patients,” said Dr.
Thomas Cannell, president and chief executive officer of Sesen Bio.
“We have bolstered our team’s expertise in order to carry out that
mission, and we look forward to executing our strategic priorities
leading into, and coming out of, our upcoming Type C Meeting in
March.”
US Regulatory Update
- On October 29, 2021, Sesen Bio participated in a productive
Chemistry, Manufacturing and Controls (CMC) Type A Meeting with the
FDA. Following the meeting, the Company believes it has a clear
understanding of what additional information regarding CMC is
required for potential resubmission of a BLA. Other key takeaways
from the meeting include the FDA confirming that:
- Vicineum manufactured using the proposed commercial process is
comparable to Vicineum used in prior clinical trials.
- Sesen Bio can utilize Vicineum manufactured during process
validation for any future clinical trials needed to address issues
raised in the Complete Response Letter (CRL) regarding the BLA for
Vicineum for the treatment of BCG-unresponsive non-muscle invasive
bladder cancer (NMIBC), and that any of these future trials can
proceed while addressing CMC issues raised in the CRL.
- On December 8, 2021, Sesen Bio participated in a productive
Clinical Type A Meeting with the FDA. Following the meeting,
the Company announced that it plans to conduct an additional Phase
3 clinical trial for potential resubmission of a BLA. Other key
takeaways from the meeting include:
- The trial design may include a randomized clinical trial
assessing the safety and efficacy of Vicineum compared to
investigators’ choice of intravesical chemotherapy.
- The trial may include both patients who have received adequate
BCG and patients who have received less than adequate BCG.
The anticipated randomized trial design is aligned with guidance
the Company has received from the European Medicines Agency, which
may help to coordinate the regulatory paths forward for Vicineum in
the US and the European Union. The Company was also encouraged by
the FDA to submit the final results from the Phase 3 VISTA trial
for Vicineum for the treatment of BCG-unresponsive NMIBC with a BLA
resubmission.
- On January 7, 2022, the FDA granted Sesen Bio’s request for
a Type C Meeting to discuss the study protocol for an additional
Phase 3 clinical trial that the Company plans to conduct for
potential resubmission of a BLA for Vicineum for the treatment of
non-muscle invasive carcinoma in situ (CIS) of the bladder in
patients previously treated with adequate or less than adequate
BCG. The Type C Meeting has been scheduled for March 28,
2022.
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 remaining under the Roche License
Agreement.
- On February 25, 2022, the Board of Directors (Board) of
Sesen Bio disclosed the completion of an independent internal
review conducted by outside counsel with the assistance of subject
matter experts (Review). The Review took place over the course
of five months, involved full cooperation from the Company’s
management team, a review of more than 600,000 documents, and 39
interviews of current and former employees and consultants. As a
result of the Review, the Board continues to fully support the
Company’s current management team and believes no changes or
amendments relating to the Company’s prior disclosures to the
Securities and Exchange Commission (SEC) or FDA relating to
Vicineum, the Phase 3 VISTA trial for Vicineum for the treatment of
BCG-unresponsive NMIBC, or the Company’s BLA for Vicineum are
warranted. The Company intends to work cooperatively with the FDA
in preparing for an additional Phase 3 clinical trial for
Vicineum.
Fourth Quarter and Full-Year 2021 Financial Results
- Cash Position: Cash, cash equivalents and restricted
cash were $162.6 million as of December 31, 2021, compared to $55.4
million as of December 31, 2020. The increase of $107.2 million was
due primarily to net proceeds from at-the-market (ATM)
offerings.
- R&D Expenses: Research and development expenses for
the fourth quarter of 2021 were $7.0 million compared to $5.6
million for the same period in 2020. For the year ended December
31, 2021, research and development expenses were $25.3 million
compared to $29.2 million for the same period in 2020. The full
year decrease of $3.9 million was due primarily to lower costs
associated with technology transfer and manufacturing ($7.4
million). This was partially offset by increases in
employee-related compensation driven by increased headcount and the
retention program implemented after receipt of the CRL in August
2021 ($2.1 million), regulatory and clinical consulting fees ($1.0
million) and certain other R&D expenses, none of which were
individually material ($0.5 million).
- G&A Expenses: General and administrative expenses
for the fourth quarter of 2021 were $8.6 million compared to $3.4
million for the same period in 2020. For the year ended December
31, 2021, general and administrative expenses were $29.4 million
compared to $14.3 million for the same period in 2020. The full
year increase of $15.1 million was due primarily to increases in
employee-related compensation ($5.0 million), legal costs ($4.8
million), and marketing and commercial expenses driven by
preparation for the commercial launch prior to receipt of the CRL
($4.1 million). Additionally, accounting services ($0.4 million),
insurance expenses ($0.4 million), information technology expenses
($0.3 million) and other G&A expenses, none of which were
individually material ($0.1 million), contributed to the
increase.
- Restructuring Charge: Restructuring expenses were $5.5
million for the year ended December 31, 2021 compared to no
restructuring expenses for the year ended December 31, 2020. The
increase was due to one-time costs associated with the
Restructuring Plan implemented in response to the CRL for severance
and other employee-related costs ($2.8 million) and the termination
of certain contracts ($2.7 million).
- Non-Cash Related Expenses:
- Intangibles impairment charge for the year ended December 31,
2021 was $31.7 million. In light of the CRL, the Company performed
an interim impairment test for In-Process Research and Development
(IPR&D) assets, which resulted in the decrease in fair value of
Vicineum’s US rights.
- The change in fair value of contingent consideration was a
decrease of $56.8 million for the year ended December 31, 2021
compared to a decrease of $11.2 million for the same period in
2020. This was primarily due to management’s assessment of a lower
probability of regulatory success and a refinement of timelines
given the CRL.
- Income Tax Benefit (Provision): Benefit from income tax
was $8.3 million for the year ended December 31, 2021 compared to
$1.4 million tax expense for the same period in 2020. In connection
with the intangibles impairment charge in the third quarter of
2021, the Company wrote-down the associated deferred tax liability
by $8.6 million as a benefit.
- Net Income (Loss): Net income was $8.9 million, or $0.04
per basic and per diluted share, for the fourth quarter of 2021,
compared to net loss of $15.0 million, or $0.11 per basic and
diluted share, for the same period in 2020. For the year ended
December 31, 2021, net loss was $0.3 million, or $0.00 per share,
compared to net loss of $22.5 million, or $0.19 per share, for the
same period in 2020. The full year decrease of $22.2 million in net
loss was due primarily to the $20 million milestone achieved by
Roche initiating a Phase II clinical study pursuant to the Roche
License Agreement.
1As per the 2018 FDA guidance on NMIBC,
adequate BCG is defined as at least one of the following: (i) at
least five of six doses of an initial induction course plus at
least two of three doses of maintenance therapy or (ii) at least
five of six doses of an initial induction course plus at least two
of six doses of a second induction course.
About Vicineum™
Vicineum, a locally administered fusion protein, is Sesen Bio’s
lead product candidate being developed for the treatment of
non-muscle invasive carcinoma in situ (CIS) of the bladder in
patients previously treated with adequate or less than adequate
BCG. 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 non-muscle invasive bladder
cancer (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 non-muscle invasive CIS of the bladder in patients previously
treated with adequate or less than adequate BCG in connection with
the potential resubmission of a BLA. 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 non-muscle invasive CIS of the bladder in patients
previously treated with adequate or less than adequate BCG in
connection with the potential resubmission of a BLA. 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
non-muscle invasive CIS of the bladder in patients previously
treated with adequate or less than adequate BCG. 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 non-muscle invasive CIS of the
bladder in patients previously treated with adequate or less than
adequate BCG, 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,” “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 non-muscle invasive CIS of the
bladder in patients previously treated with adequate or less than
adequate BCG, the Company’s belief that it has further clarity on
the steps required to resubmit a BLA for Vicineum and to bring a
therapy to market that it believes has the potential to save and
improve the lives of patients, the Company’s belief that it has a
clear understanding of what additional information regarding CMC is
required for potential resubmission of a BLA, the Company’s ability
to use Vicineum manufactured during process validation for any
future clinical trials needed to address issues raised in the CRL
regarding the BLA for Vicineum, the ability for future trials for
Vicineum to proceed while the Company addresses CMC issues raised
in the CRL, the Company’s plans to conduct an additional Phase 3
clinical trial for potential resubmission of a BLA for Vicineum for
the treatment of non-muscle invasive CIS of the bladder in patients
previously treated with adequate or less than adequate BCG, the
Company’s belief that the trial design for an additional Phase 3
clinical trial may include the following elements: a randomized
clinical trial assessing the safety and efficacy of Vicineum
compared to investigators’ choice of intravesical chemotherapy and
inclusion of both patients who have received adequate BCG and
patients who have received less-than-adequate BCG, the Company’s
expectation that the anticipated randomized trial design is aligned
with guidance the Company has received from the European Medicines
Agency (EMA), which may help to coordinate the regulatory paths
forward for Vicineum in the US and the European Union, the
Company’s expectations to hold a Type C Meeting with the FDA to
discuss study protocol for an additional Phase 3 clinical trial,
any future payments to the Company pursuant to the Roche License
Agreement including any future milestone payments and royalty
payments, the Board’s continued support for the Company’s current
management team, the Board’s belief that no changes or amendments
relating to the Company’s prior disclosures to the SEC or FDA
relating to Vicineum, the Phase 3 VISTA trial or the Company’s BLA
for Vicineum are warranted, the Company’s intentions to work
cooperatively with the FDA in preparing for an additional Phase 3
clinical trial for Vicineum, 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 non-muscle invasive CIS of
the bladder in patients previously treated with adequate or less
than adequate BCG, 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 Type C Meeting may not enable the Company to align with the FDA
on the protocol for an additional Phase 3 clinical trial of
Vicineum for the treatment of non-muscle invasive CIS of the
bladder in patients previously treated with adequate or less than
adequate BCG, 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 resume its
plans to pursue regulatory approval for Vicineum in the US or the
European Union, the impact of the completion of the Review,
including any related investigations, reviews or proceedings,
shareholder lawsuits or reputational harm, the risk that the
Company may not be able to reach agreement with the FDA on the
protocol for an additional Phase 3 clinical trial for Vicineum, 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 non-muscle invasive CIS of the bladder in patients
previously treated with adequate or less than adequate BCG,
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 EMA, or otherwise produce
favorable results, the risk that the FDA may not approve a BLA for
Vicineum for the treatment of non-muscle invasive CIS of the
bladder in patients previously treated with adequate or less than
adequate BCG if the Company resubmits a BLA at a future time, the
risk that the European Commission may not approve the marketing
authorization application (MAA) for Vicineum for the treatment of
non-muscle invasive CIS of the bladder in patients previously
treated with adequate or less than adequate BCG if the Company
resubmits a MAA at a future time, the risk that Vicineum for the
treatment of non-muscle invasive CIS of the bladder in patients
previously treated with adequate or less than adequate BCG 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 or the European
Commission, limit the commercial profile of its labeling, if
approved, or result in significant negative consequences following
any marketing approval, 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. CONSOLIDATED BALANCE SHEETS (In
thousands, except share and per share data)
December 31, 2021
December 31, 2020
Assets
Current assets:
Cash and cash equivalents
$
162,636
$
52,389
Accounts receivable
21,011
-
Other receivables
3,482
-
Prepaid expenses and other current assets
18,476
7,478
Restricted cash
-
3,000
Total current assets
205,605
62,867
Non-current assets:
Restricted cash
20
20
Property and equipment, net
43
123
Intangible assets
14,700
46,400
Goodwill
13,064
13,064
Long term prepaid expenses
7,192
-
Other assets
123
349
Total non-current assets
$
35,142
$
59,956
Total Assets
$
240,747
$
122,823
Liabilities and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable
$
2,853
$
3,102
Accrued expenses
8,255
3,973
Deferred revenue
-
1,500
Contingent consideration
-
8,985
Other current liabilities
460
489
Total current liabilities
11,568
18,049
Non-current liabilities:
Contingent consideration, net of current portion
52,000
99,855
Deferred tax liability
3,969
12,528
Deferred revenue, net of current portion
1,500
1,500
Other non-current liabilities
-
118
Total non-current liabilities
57,469
114,001
Total liabilities
69,037
132,050
Stockholders’ Equity ( Deficit):
Preferred stock, $0.001 par value per share; 5,000,000 shares
authorized at December 31, 2021 and 2020; no shares issued and
outstanding at December 31, 2021 and 2020
-
-
Common stock, $0.001 par value per share; 400,000,000 and
200,000,000 shares authorized at December 31, 2021 and 2020;
199,463,645 and 140,449,647 shares issued and outstanding at
December 31, 2021 and 2020, respectively
199
140
Additional paid-in capital
487,768
306,554
Accumulated deficit
(316,257)
(315,921)
Total Stockholders’ Equity (Deficit)
171,710
(9,227)
Total Liabilities and Stockholders’ Equity
$
240,747
$
122,823
SESEN BIO, INC. CONSOLIDATED STATEMENTS OF
INCOME (OPERATIONS) AND COMPREHENSIVE INCOME (LOSS)
(In thousands, except per share data)
Three Months ended December
31,
Twelve Months ended December
31,
2021
2020
2021
2020
Revenue:
License and related revenue
$
20,000
$
-
$
26,544
$
11,236
Total revenue
20,000
-
26,544
11,236
Operating expenses:
Research and development
7,039
5,566
25,312
29,191
General and administrative
8,597
3,421
29,393
14,302
Restructuring charge
6
-
5,528
-
Intangibles impairment charge
-
31,700
-
Change in fair value of contingent consideration
(4,600)
5,640
(56,840)
(11,180)
Total operating expenses
11,042
14,627
35,093
32,313
Income (Loss) from Operations
8,958
(14,627)
(8,549)
(21,077)
Other income (expense), net
(15)
(69)
(60)
125
Income (Loss) Before Taxes
8,944
(14,696)
(8,609)
(20,952)
Benefit (provision) for income taxes
-
(313)
8,273
(1,445)
Net Income (Loss) and Comprehensive Income (Loss) After Taxes
$
8,944
$
(15,009)
$
(336)
$
(22,397)
Deemed dividend on adjustment of exercise price of certain warrants
$
-
$
-
$
-
$
(147)
Net income (loss) attributable to common stockholders - basic
$
8,944
$
(15,009)
$
(336)
$
(22,544)
Net income (loss) attributable to common stockholders - diluted
$
8,944
$
(15,009)
$
(336)
$
(22,544)
Net income (loss) per common share - basic
$
0.04
$
(0.11)
$
(0.00)
$
(0.19)
Weighted-average common shares outstanding - basic
199,464
131,522
182,323
118,221
Net income (loss) per common share - diluted
$
0.04
$
(0.11)
$
(0.00)
$
(0.19)
Weighted-average common shares outstanding - diluted
199,464
131,522
182,323
118,221
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220228005267/en/
Investors: Zane Goodwin,
Senior Director, Corporate Development ir@sesenbio.com
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