–Fertilization of Bovine EggPC Cell-Derived Egg
in OvaTure Program on Track for Year-End–
–OvaPrime Clinical Trial Progressing Toward
Year-End Initial Readout–
–Robust Financial Position Supports Corporate
Strategy into 1Q19–
–Conference Call Today at 4:30 p.m. ET–
OvaScienceSM (NASDAQ: OVAS), a global fertility company focused
on the discovery, development and commercialization of new
treatment options, today reported financial results and provided a
business update for the first quarter ended March 31, 2017.
“During the first quarter, we advanced our portfolio of novel
treatments for female fertility. We progressed our research and
development efforts with OvaTure, and we are on track with patient
enrollment in our ongoing clinical study of OvaPrime. We continue
to expect multiple potential milestones by year-end, including the
successful fertilization of a bovine Egg PC cell-derived egg and an
initial data readout from our ongoing clinical study of OvaPrime,”
said Michelle Dipp, M.D., Ph.D., Executive Chair and Co-Founder of
OvaScience.
“By realigning our organization to increase our focus on OvaTure
and OvaPrime, we have reduced our operational cash spend,” added
Christophe Couturier, Chief Financial Officer of OvaScience. “We
are now positioned to successfully execute on our strategic
priorities, while also achieving our financial plans for 2017.”
First Quarter and Recent Business
Highlights:
OvaTureSM Treatment: OvaTure is a potential
next-generation in vitro fertilization (IVF) treatment that could
help a woman produce healthy, young, fertilizable eggs without
hormone injections by maturing egg precursor (EggPC SM) cells into
eggs in vitro.
- Through its joint venture, OvaXonSM,
OvaScience and Intrexon® (NYSE: XON) continue to progress
fertilization studies for bovine EggPC cell-derived eggs. The
companies remain on track to successfully fertilize a bovine EggPC
cell-derived egg by year-end.
- OvaScience continues to work with its
clinical partners to develop a repeatable and robust process for
the maturation of human EggPC cells and to secure authorization to
fertilize human EggPC cell-derived eggs and embryos by the end of
the first half of 2018.
OvaPrimeSM Treatment: OvaPrime is a
potential fertility treatment that could enable a woman who makes
too few or no eggs to increase her egg reserve, by transferring her
EggPC cells to her own ovary, where they may mature into
fertilizable eggs.
- OvaScience is enrolling patients in its
ongoing, prospective, controlled, blinded and randomized clinical
study of OvaPrime, which is designed to evaluate the treatment’s
safety and effect on patients’ hormone levels and follicular
development as measured by ultrasound. The study is designed to
enroll 70 women with either diminished ovarian reserve (DOR) or
primary ovarian insufficiency (POI). To date, the Company has
enrolled 60 patients and completed reintroductions in 36
patients.
- OvaScience expects to complete
enrollment of 70 patients by the end of the first half of 2017 and
to complete biopsies in 70 patients by year-end. OvaScience also
expects to announce initial data from the first 20 patients,
including six months of post-EggPC reintroduction safety data, by
year-end.
AUGMENT SM Treatment: AUGMENT is a
fertility treatment designed to improve egg health and with that,
IVF success rates, by using mitochondria from a woman’s own EggPC
cells during IVF.
- OvaScience continues to maintain its
footprint for AUGMENT, offering the treatment to patients at
clinics in Canada and Japan. The Company may opportunistically
expand in these countries on a limited basis.
- OvaScience met with the U.S. Food and
Drug Administration (FDA) and will continue to work with the agency
under its available procedures to determine the most appropriate
regulatory pathway for potential entry into the U.S. The Company
will provide an update at the appropriate time in the future.
Upcoming 2017 Milestones
The Company expects to achieve the following milestones in
2017:
- OvaTure:
- Fertilize a bovine EggPC cell-derived
egg by year-end
- OvaPrime:
- Complete enrollment of 70 patients in
the ongoing Canadian study by the end of the first-half
- Complete biopsies in 70 patients in the
ongoing Canadian study by year-end
- Provide initial read-out, including six
months of post-EggPC reintroduction safety data from 20 patients,
by year-end.
First Quarter 2017 Financial
Results
- Revenue for the quarter ended March 31,
2017 was $63,000, compared to $146,000 in the same period of
2016.
- Research and development expense for
the quarter ended March 31, 2017, excluding restructuring charges,
was $5.8 million, compared to $6.0 million for the same period in
2016. This decrease was driven primarily by a $0.8 million decrease
in stock-based compensation expense and a $0.4 million decrease in
costs associated with certain ongoing research agreements,
partially offset by a $1.0 million increase in costs related to the
refocus from commercial expansion to research and development.
- Selling, general and administrative
expense for the quarter ended March 31, 2017, excluding
restructuring charges, was $7.1 million, compared to $14.5 million
for the same period in 2016. This year-over-year decrease of $7.3
million, or 51%, was driven by a $4.2 million decrease in
employee-related costs due to reduced headcount, a $1.8 million
decrease in marketing-related costs, and a $1.3 million decrease in
legal, accounting, tax and other related expenses associated with
international expansion.
- Net loss for the quarter ended March
31, 2017 was $14.9 million, or ($0.42) per share, compared to net
loss of $21.8 million, or ($0.80) per share, for the same period in
2016. The net loss for the quarter ended March 31, 2017 includes
restructuring charges of $1.5 million.
As of March 31, 2017, OvaScience had cash, cash equivalents and
short-term investments of $99.1 million. The cash outlays related
to our restructuring in the first quarter of 2017 represents $2.3
million. We expect the total one-time cash expenditures related to
the restructuring to be between $5.9 million and $6.4 million over
2017 and 2018. The Company may also incur further restructuring
charges related to the restructuring plan. OvaScience continues to
expect that its operating cash burn for 2017 will be between $45
million and $50 million, which excludes these one-time cash
expenditures. OvaScience anticipates that it will have sufficient
funds, without additional financing, to support its operating plan
into the first quarter of 2019.
Conference CallOvaScience will host a conference call at
4:30 p.m. ET today, Tuesday, May 9, 2017, to discuss these
financial results and provide an update on the Company. The
conference call may be accessed by dialing +1-888-424-8151 for U.S.
callers and +1-847-585-4422 for international callers five minutes
prior to the start of the call and providing the passcode 8423996.
Additionally, the live, listen-only webcast of the conference call
can be accessed by visiting the Investors section of the Company’s
website at www.ovascience.com. A replay of the conference call will
be available from 7:00 p.m. ET on Tuesday, May 9, 2017 through
11:59 p.m. ET on Tuesday, May 16, 2017, and may be accessed by
visiting OvaScience’s website or by dialing +1-888-843-7419 for
U.S. callers and +1-630-652-3042 for international callers. The
replay access code is 8423996#.
About OvaScienceOvaScienceSM, Inc. (NASDAQ: OVAS) is a
global fertility company dedicated to improving treatment options
for women around the world. OvaScience is discovering, developing
and commercializing new fertility treatments because it believes
women deserve more options. Each OvaScience treatment is based
on the Company’s proprietary technology platform that leverages the
breakthrough discovery of egg precursor (EggPCSM) cells – immature
egg cells found inside the protective ovarian lining. OvaScience is
developing OvaTureSM, a potential next-generation IVF treatment
that could help a woman produce healthy, young, fertilizable eggs
without hormone injections and OvaPrimeSM, which could increase a
woman’s egg reserve. OvaScience’s AUGMENTSM treatment, a fertility
option designed to improve IVF success rates, is available in
certain IVF clinics in select international regions. OvaScience
treatments are not available in the U.S. For more information,
visit www.ovascience.com.
Forward-Looking StatementsThis press release includes
forward-looking statements about the Company’s plans for the
OvaPrime treatment, OvaTure treatment and AUGMENT treatment,
including statements relating to the Company’s plans to fertilize a
bovine EggPC cell-derived egg by year-end; to complete enrollment
of all 70 patients in the ongoing Canadian study of OvaPrime by the
end of the first half of 2017; to complete biopsies in all patients
in the ongoing Canadian study of OvaPrime by year-end; to present
initial data from 20 OvaPrime patients, including six months of
post-EggPC reintroduction safety data, by year-end; availability of
sufficient funding to support the preclinical development of
OvaTure and clinical development of OvaPrime into the first quarter
of 2019; the Company’s further efforts on human egg maturation; the
Company’s plans to work with its clinical partners in pursuit of
its goals to develop a repeatable and robust process for the
maturation of human EggPC cells and to secure authorization to
fertilize human EggPC cell-derived eggs and embryos by the end of
the first half of 2018; the Company potentially expanding its
AUGMENT footprint in Canada and Japan on a limited basis; and the
Company’s plans to continue ongoing discussions with the U.S. Food
and Drug Administration regarding AUGMENT. Actual results may
differ materially from those indicated by these forward-looking
statements as a result of various important factors, including
risks related to: the science underlying our treatments (including
the OvaPrime, OvaTure and AUGMENT treatments), which is unproven;
our ability to obtain regulatory approval or licenses where
necessary for our treatments; our ability to develop our treatments
on the timelines we expect, if at all; our ability to commercialize
our treatments, on the timelines we expect, if at all; as well as
those risks more fully discussed in the “Risk Factors” section of
our most recently filed Quarterly Report on Form 10-Q and/or Annual
Report on Form 10-K. The forward-looking statements contained in
this press release reflect our current views with respect to future
events. We anticipate that subsequent events and developments will
cause our views to change. However, while we may elect to update
these forward-looking statements in the future, we specifically
disclaim any obligation to do so. These forward-looking statements
should not be relied upon as representing our view as of any date
subsequent to the date hereof.
- Financial Tables to Follow –
OvaScience, Inc.
Condensed Consolidated Balance Sheets (Unaudited)
(In thousands) As of
March 31,
2017
December 31,2016 Assets Current assets: Cash
and cash equivalents $ 25,433 $ 43,930 Short-term investments
73,669 70,458 Prepaid expenses and other current assets 2,048 2,056
Total current assets 101,150 116,444 Property and equipment, net
4,707 5,572 Investment in joint venture - 65 Restricted cash 439
439 Other long-term assets 23 23 Total assets $ 106,319 $ 122,543
Liabilities and stockholders’ equity Current liabilities:
Accounts payable $ 2,384 $ 2,183 Accrued expenses 8,207 11,026
Total current liabilities 10,591 13,209 Other non-current
liabilities 1,006 1,116 Total liabilities 11,597 14,325 Total
stockholders’ equity 94,722 108,218 Total liabilities and
stockholders’ equity $ 106,319 $ 122,543
OvaScience, Inc. Condensed Consolidated Statements of
Operations (Unaudited) (In thousands, except per
share data) Three Months
EndedMarch 31, 2017 2016
Revenues $ 63 $ 146 Costs and expenses: Costs
of revenues 269 1,176 Research and development 5,764 5,955 Selling,
general and administrative 7,129 14,454 Restructuring 1,488
- Total operating expenses 14,650
21,585 Loss from operations (14,587 )
(21,439 ) Interest income, net 182 174 Other expense, net
(60 ) (27 ) Loss from equity method investment (421 )
(391 ) Loss before income taxes (14,886 ) (21,683 ) Income tax
expense (9 ) 75 Net loss $
(14,895 ) $ (21,758 ) Net loss per share—basic and
diluted $ (0.42 ) $ (0.80 ) Weighted average number
of shares used in net loss per share—basic and diluted 35,642
27,301
###
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version on businesswire.com: http://www.businesswire.com/news/home/20170509006651/en/
Media and Investor Contact:OvaScience, Inc.Jennifer
Viera, 617-420-8748jviera@ovascience.com
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