Company Expects to Report Six-Month Update from
VISTA Trial in December 2018; On-Track to Report 12-Month VISTA
Trial Data in Mid-2019
Sesen Bio, Inc. (Nasdaq: SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of people with cancer, today reported operating results for the
third quarter ended September 30, 2018 and recent highlights from
its development program for Vicinium® for patients with high-grade
non-muscle invasive bladder cancer (NMIBC).
“2018 has been a year of focused execution for Sesen Bio, led by
the advancement of the Phase 3 program for Vicinium for patients
with NMIBC,” said Dr. Thomas Cannell, president and chief executive
officer of Sesen Bio. “NMIBC is a devastating disease and there
remains just one recommendation for patients who do not respond or
become refractory to today’s standard-of-care treatment: complete
bladder removal. Our goal is to help save this essential organ and
provide a meaningful treatment option for patients with
BCG-unresponsive NMIBC. Our Phase 3 registration clinical trial is
well-designed and preliminary data reported earlier this year
suggest that Vicinium is active and has a favorable safety profile,
consistent with our Phase 2 experience. We look forward to
assessing six-month data from the trial next month and twelve-month
data in mid-2019. If the VISTA Trial is successful, we believe
Vicinium could change the treatment outlook for patients with
NMIBC, bringing us closer to achieving our mission of saving and
renewing the lives of patients with cancer.”
Recent Highlights
- In September 2018, at the Global
Congress on Bladder Cancer 2018, Sesen Bio presented a biomarker
update from its Phase 3 VISTA Trial data showing that all screened
patient samples expressed EpCAM, the molecular target of
Vicinium.
- In October 2018, the company entered
into an agreement with FUJIFILM Diosynth Biotechnologies U.S.A.,
Inc. to provide supply services in support of the manufacturing of
Vicinium for the treatment of high-grade NMIBC. The Agreement
facilitates a transfer of manufacturing technology from Sesen Bio
to Fujifilm.
Upcoming Events
- Sesen Bio anticipates reporting
six-month data from the ongoing Phase 3 VISTA Trial in December
2018. A conference call will be held to review the data, with
details to follow.
Third Quarter 2018 Financial Results
- Cash Position: Cash and cash
equivalents were $57.9 million as of September 30, 2018, compared
to $11.3 million as of September 30, 2017.
- Revenue: There was no revenue
for the three-month periods ended September 30, 2018 and 2017,
respectively, as no revenue triggering milestones were achieved
during either period under the company’s license agreement with F.
Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche).
- R&D Expenses: Research and
development expenses were $3.4 million for the three months ended
September 30, 2018, compared to $3.6 million for the same period in
2017. The decrease was due primarily to a reduction in
Vicinium-related development expenses.
- G&A Expenses: General and
administrative expenses were $3.8 million for the three months
ended September 30, 2018, compared to $1.6 million for the same
period in 2017. The increase was due primarily to an increase in
professional fees as well as higher personnel-related
expenses.
- Net Loss: Net loss was $14.0
million, or $0.18 per share, for the three months ended September
30, 2018, compared to net loss of $9.1 million, or $0.37 per share,
for the same period in 2017. The increase was due primarily to the
change in the fair value of contingent consideration and increased
general and administrative expenses.
- Financial Guidance: Based on
current operating plans, Sesen Bio believes it will have capital
sufficient to fund its current operating plans into 2020.
About Sesen BioSesen Bio, Inc. is a late-stage clinical
company advancing targeted fusion protein therapeutics for the
treatment of people with cancer. The company’s lead program,
Vicinium®, also known as VB4-845, is currently in a Phase 3
registration trial, the VISTA Trial, for the treatment of
high-grade non-muscle invasive bladder cancer. Twelve-month data
from the trial are anticipated in mid-2019. Vicinium incorporates a
tumor-targeting antibody fragment and a protein cytotoxic payload
into a single protein molecule designed to selectively and
effectively kill cancer cells, while minimizing toxicity to
non-cancerous bladder cells. For more information, please visit the
company’s website at www.sesenbio.com.
Cautionary Note on Forward-Looking StatementsAny
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
uncertainties inherent in the initiation and conduct of clinical
trials, the possibility that the three-month or six-month data of
the Phase 3 VISTA Trial are not indicative of final clinical
results and final clinical trial results may not be positive with
regard to the safety or efficacy of Vicinium®, our ability to
successfully develop our product candidates and complete our
planned clinical programs, our ability to obtain marketing
approvals for our product candidates, expectations regarding our
ongoing clinical trials, availability and timing of data from
clinical trials, whether interim results from a clinical trial will
be predictive of the final results of the trial or results of early
clinical studies will be indicative of the results of future
studies, the adequacy of any clinical models, expectations
regarding regulatory approvals, expectations regarding the adequacy
of our existing capital resources to fund our operations into 2020
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)
September 30,
December 31, 2018 2017 Assets
Current assets: Cash and cash equivalents $ 57,856 $ 14,680 Prepaid
expenses and other current assets 1,529 301
Total current assets
59,385 14,981
Property and equipment, net
365 522 Restricted cash 20 10 Intangible assets 46,400 46,400
Goodwill 13,064 13,064 Other assets 61 120
Total assets $ 119,295 $ 75,097
Liabilities and stockholders' equity Current liabilities:
Accounts payable $ 1,391 $ 907 Accrued expenses 5,170
3,813
Total current liabilities
6,561 4,720 Other liabilities 311 215 Deferred tax liability 12,528
12,528 Contingent consideration 49,500 39,600 Stockholders'
equity: Common stock 77 35 Additional paid-in capital 229,585
170,330 Accumulated deficit (179,267 ) (152,331 )
Total stockholders' equity 50,395 18,034
Total liabilities and stockholders' equity $ 119,295
$ 75,097
SESEN BIO, INC.CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS(unaudited)(in thousands, except per share
data)
Three Months Ended September 30, Nine Months Ended
September 30,
2018
2017
2018
2017
Total revenue $ - $ - $ - $ 425 Operating expenses: Research
and development 3,372 3,619 9,406 9,402 General and administrative
3,825 1,631 8,128 6,085 Loss from change in fair value of
contingent consideration 7,200 3,900
9,900 7,600
Total operating expenses
14,397 9,150 27,434
23,087 Loss from operations (14,397 ) (9,150 )
(27,434 ) (22,662 ) Other income, net 382 45
498 180 Net loss and
comprehensive loss $ (14,015 ) $ (9,105 ) $ (26,936 ) $ (22,482 )
Net loss per share —basic and diluted $ (0.18 ) $ (0.37 ) $ (0.48 )
$ (0.91 )
Weighted-average number of common shares
used in net loss per share —basic and diluted
77,030 24,691 56,526
24,663
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version on businesswire.com: https://www.businesswire.com/news/home/20181108005175/en/
THRUST Strategic CommunicationsMonique Allaire,
781-631-0759monique@thrustsc.comorAlicia Davis,
910-620-3302alicia@thrustsc.com
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