Manufacturing of Vicineum drug substance and
drug product PPQ batches has been completed
Emerging manufacturing data provides strong
support for analytical comparability between clinical and
commercial material
On track to complete BLA submission to the FDA
in December 2020
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
third quarter ended September 30, 2020. The Company’s lead program,
VicineumTM, also known as VB4-845, is currently in the follow-up
stage of a Phase 3 registration trial for the treatment of
high-risk, BCG-unresponsive non-muscle invasive bladder cancer
(NMIBC). In December 2019, the Company initiated the BLA submission
for Vicineum to the FDA under Rolling Review.
“We are rapidly advancing toward the finalization of our BLA in
December as well as a potential MAA submission in Europe in early
2021,” said Dr. Thomas Cannell, president and chief executive
officer of Sesen Bio. “We believe the probability of regulatory
success is high in both the US and Europe due to the strong
clinical profile of Vicineum enabled by the unique dual mechanism
of action. Once approved, we think Vicineum has the potential to be
the best-in-class therapeutic in BCG-unresponsive NMIBC with a
significant global commercial opportunity. We remain laser-focused
towards executing on upcoming key milestones to the benefit of both
patients and shareholders.”
Manufacturing Update
Manufacturing and release testing of the three drug substance
PPQ batches has been completed and all quality acceptance criteria
were met. Manufacturing of the three drug product batches has also
been completed and release testing has been completed for the first
and second batch, with all quality acceptance criteria met. Testing
of the third drug product PPQ batch is expected to be completed in
November 2020. Based on the results obtained thus far, the Company
is confident that the remaining batch will also meet the required
acceptance criteria in support analytical comparability.
As part of the analytical comparability plan submitted to the
FDA, the Company also committed to conduct extensive biophysical
characterization and forced degradation testing on Vicineum
manufactured using the proposed commercial process. These studies
were completed in October 2020, and the Company believes the data
demonstrates that clinical and commercial material are highly
similar, providing strong support for analytical comparability.
EMA Regulatory Process
On October 23, 2020, the Company completed a successful
Pre-Submission meeting with the European Medicines Agency (EMA) for
Vicineum. During the meeting, the EMA provided updated guidance on
various administrative topics, which help to clarify the regulatory
path forward. In addition, earlier in 2020, the EMA provided
written notice of the Company’s eligibility to file a MAA under the
EMA’s centralized procedure. These interactions with the EMA in
2020 confirm the Company’s pathway to a MAA submission for Vicineum
in early 2021 with anticipated approval in early 2022.
Supply Chain
The Company recently announced an exclusive agreement with
Cardinal Health for third-party logistics and specialty
pharmaceutical distribution services related to the commercial
distribution of Vicineum in the United States. The addition of
Cardinal Health completes the selection of major supply chain
partners in support of the commercial distribution of Vicineum in
the United States. All of Sesen Bio’s major supply chain partners,
including Fujifilm, Baxter and Cardinal Health, are recognized
leaders within the industry, which the Company believes will help
to ensure manufacturing and distribution excellence.
OUS Partnership
On July 31, 2020, the Company announced an exclusive license
agreement with Qilu Pharmaceutical for the development and
commercialization of Vicineum in Greater China. On September 29,
2020, the Company received $10.0 million in net proceeds associated
with the $12 million upfront payment due under the license
agreement. Under the terms of the agreement, the Company is also
eligible to receive (i) a 12% royalty, subject to certain
reductions, based upon annual net sales of Vicineum in Greater
China, and (ii) payments totaling up to $23 million upon the
achievement of certain technology transfer, development and
regulatory milestones, the first of which the Company expects to
receive in early 2021.
Third Quarter 2020 Financial Results
- Cash Position: Cash and cash equivalents were $42.0 million as
of September 30, 2020, compared to $48.1 million as of December 31,
2019. This change includes $8.2 million of net proceeds received
during the third quarter of 2020 provided by our ATM offering.
- Revenue: Revenue for the third quarter of 2020 was $11.2
million, which was due to the recognition of revenue from the
Company’s license agreement with Qilu. The Company did not record
any revenue for the third quarter of 2019.
- R&D Expenses: Research and development expenses for the
third quarter of 2020 were $10.2 million compared to $6.6 million
for the same period in 2019. The third quarter increase was due
primarily to costs related to the ongoing technology transfer
process with Fujifilm and Baxter as the Company scales-up for
commercial manufacturing, partially offset by lower clinical
expenses related to the Phase 3 VISTA trial for Vicineum and lower
regulatory consulting fees in support of the Company’s ongoing BLA
submission with the FDA.
- G&A Expenses: General and administrative expenses for the
third quarter of 2020 were $4.1 million compared to $3.2 million
for the same period in 2019. The third quarter increase was due
primarily to increases in investment banking and legal fees related
to the Company’s license agreement with Qilu.
- Net Loss: Net loss was $22.6 million, or $0.19 per basic share
and diluted share, for the three months ended September 30, 2020,
compared to a net loss of $13.1 million, or $0.13 per basic and
diluted share, for the same period in 2019. The change was due
primarily to revenue recognized in the third quarter of 2020
related to the Company’s license agreement with Qilu, offset by
higher technology transfer costs and a non-cash change in fair
value of contingent consideration due to changes in discount
rates.
Conference Call and Webcast Information
Members of the Sesen Bio management team will host a conference
call and webcast today at 8:00 AM ET to review the Company's
financial results and provide a general business update. To
participate in the conference call, please dial (844) 831-3025
(domestic) or (315) 625-6887 (international) and refer to
conference ID 9360749. The webcast can be accessed in the Investor
Relations section of the Company's website at www.sesenbio.com. The
replay of the webcast will be available in the investor section of
the Company’s website at www.sesenbio.com for 60 days following the
call.
About the VISTA Clinical Trial
The VISTA trial is an open-label, multicenter, single-arm Phase
3 clinical trial evaluating the efficacy and tolerability of
VicineumTM as a monotherapy in patients with high-risk, bacillus
Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder
cancer (NMIBC). The primary endpoints of the trial are the complete
response rate and the duration of response in patients with
carcinoma in situ with or without papillary disease. Patients in
the trial received locally administered Vicineum twice a week for
six weeks, followed by once-weekly treatment for another six weeks,
then treatment every other week for up to two years. To learn more
about the Phase 3 VISTA trial, please visit www.clinicaltrials.gov
and search the identifier NCT02449239.
About Vicineum™
Vicineum, a locally administered fusion protein, is Sesen Bio’s
lead product candidate being developed for the treatment of
high-risk 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
conducting the Phase 3 VISTA trial, designed to support the
registration of Vicineum for the treatment of high-risk NMIBC in
patients who have previously received a minimum of two courses of
bacillus Calmette-Guérin (BCG) and whose disease is now
BCG-unresponsive. 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. 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 high-risk, BCG-unresponsive
non-muscle invasive bladder cancer (NMIBC). In December 2019, the
Company initiated the BLA submission for Vicineum to the FDA under
Rolling Review. Sesen Bio retains worldwide rights to Vicineum with
the exception of Greater China, for which the Company has partnered
with Qilu Pharmaceutical 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 high-risk 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 Company’s
ability to successfully develop its product candidates and complete
its planned clinical programs, expectations regarding the
completion of the Company’s PPQ runs; expectations that the
Company’s remaining PPQ batches will meet the required acceptance
criteria in support analytical comparability, expectations that the
Company will complete its BLA submission for Vicineum in December
2020, the Company’s expectations to submit its MAA for Vicineum in
early 2021 with anticipated approval in early 2022, expectations
regarding the timing and amounts of any payments due under the
Company’s license agreement with Qilu, 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 STATEMENTS
OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except
per share data) (Unaudited) Three Months
ended Nine Months ended September 30,
September 30,
2020
2019
2020
2019
License revenue
$
11,236
$
-
$
11,236
$
-
Operating expenses: Research and development
10,196
6,613
23,625
19,243
General and administrative
4,115
3,238
10,882
8,910
Change in change in fair value of contingent consideration
18,400
3,600
(16,820
)
46,600
Total operating expenses
32,711
13,451
17,687
74,753
Loss from operations
(21,475
)
(13,451
)
(6,451
)
(74,753
)
Other income (expense): Other income (expense), net
(1
)
319
195
806
Net Loss and Comprehensive Loss Before Taxes
$
(21,476
)
$
(13,132
)
$
(6,256
)
$
(73,947
)
Provision for income taxes
(1,132
)
-
(1,132
)
-
Net Loss and Comprehensive Loss After Taxes
$
(22,608
)
$
(13,132
)
$
(7,388
)
$
(73,947
)
Deemed dividend
-
-
(147
)
-
Net Loss and Comprehensive Loss Available to Common
Stockholders
$
(22,608
)
$
(13,132
)
$
(7,535
)
$
(73,947
)
Net loss per common share - basic and diluted
$
(0.19
)
$
(0.13
)
$
(0.07
)
$
(0.85
)
Weighted-average common shares outstanding - basic and diluted
117,886
101,266
113,437
86,575
SESEN BIO, INC. CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
(Unaudited) September 30, December 31,
2020
2019
Assets Current assets: Cash and cash equivalents
$
41,969
$
48,121
Prepaid expense and other current assets
7,072
6,326
Total current assets
49,041
54,447
Restricted cash
20
20
Property and equipment, net
154
238
Intangibles
46,400
46,400
Goodwill
13,064
13,064
Other assets
349
196
Total Assets
$
109,028
$
114,365
Liabilities and Stockholders' Deficit Current liabilities:
Accounts payable
$
1,524
$
1,902
Accrued expenses
7,703
6,169
Other current liabilities
481
446
Total current liabilities
9,708
8,517
Contingent consideration
103,200
120,020
Deferred tax liability
12,528
12,528
Other liabilities
145
-
Total Liabilities
125,581
141,065
Commitments and contingencies Stockholders' Deficit: Preferred
stock, $0.001 par value per share; 5,000,000 shares authorized at
September 30, 2020 and December 31, 2019; no shares issued and
outstanding at September 30, 2020 and December 31, 2019 Common
stock. $0.001 par value per share; 200,000,000 shares authorized at
September 30, 2020 and December 31, 2019; 123,645,007 and
106,801,409 shares issued and outstanding at September 30, 2020 and
December 31, 2019, respectively
123
107
Additional paid-in capital
284,236
266,717
Accumulated deficit
(300,912
)
(293,524
)
Total Stockholders' Deficit
(16,553
)
(26,700
)
Total Liabilities and Stockholders' Deficit
$
109,028
$
114,365
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201109005057/en/
Erin Clark, Vice President, Corporate Strategy & Investor
Relations ir@sesenbio.com
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