– Fertilization of Bovine EggPC Cell-Derived
Egg in OvaTure Program on Track for Year-End –
– Completed Target Enrollment in OvaPrime
Clinical Safety Study; Expect to Announce Initial Safety Data in
First 20 Patients by Year-End –
– Sufficiently Funded to Support Operations
into 1Q 2020, Enabling Key Milestones –
– Conference Call Today at 4:30 p.m. ET –
OvaScienceSM (NASDAQ:OVAS), a fertility company focused on the
discovery, development and commercialization of new treatment
options, today reported financial results and provided a business
update for the second quarter ended June 30, 2017.
Second 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 (EggPCSM) cells into
eggs in vitro.
- At the Midwest Reproductive Symposium
International (MRSi) in June 2017, and the 50th Annual Meeting of
the Society for the Study of Reproduction (SSR) in July 2017,
OvaScience presented pre-clinical data which it believes
demonstrate that bovine and human EggPC cell-derived eggs are
similar to endogenous eggs with respect to key morphologic, genetic
and functional criteria indicative of developmental competence.
This suggests that bovine and human EggPC cells can be developed in
vitro into eggs that exhibit key hallmarks of maturation.
- OvaScience and Intrexon® (NYSE:XON)
continue to progress fertilization studies for bovine EggPC-cell
derived eggs. Starting in August 2017, Intrexon will perform
pre-clinical bovine EggPC work for OvaScience under the OvaTure
collaboration rather than under the OvaXonSM joint venture. Based
on project plans provided by Intrexon, OvaScience continues to
expect to fertilize a bovine EggPC cell-derived egg by the end of
2017 and is in discussions with Intrexon regarding the future of
the OvaXon joint venture.
- OvaScience continues to work with its
clinical partners toward its goals of developing a repeatable and
robust process for the maturation of human EggPC cells. The Company
is also working toward securing authorization to fertilize human
EggPC cell-derived eggs and characterizing the resulting 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.
- In June 2017, OvaScience announced that
it has completed target enrollment of 70 patients in its ongoing
prospective, controlled, blinded and randomized study of OvaPrime,
which is designed to assess the treatment’s safety in women with
either primary ovarian insufficiency (POI) or poor ovarian response
(POR). Secondary endpoints include OvaPrime’s effect on patients’
anti-mullerian (AMH), follicle stimulating (FSH), and estradiol
(E2) hormone levels, as well as follicular development, as measured
by ultrasound. OvaScience expects to complete biopsies in 70
patients and to announce initial safety data from the first 20
patients by year-end.
AUGMENTSM 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.
- In June 2017, OvaScience announced that
it will continue to pursue business development opportunities for
AUGMENT, while discontinuing its ongoing operations related to the
AUGMENT treatment outside of North America. The Company is
committed to minimizing the impact of this decision on women and
families in affected areas.
Corporate Highlights:
- In June 2017, OvaScience announced the
appointment of Christopher Kroeger, M.D., M.B.A., as Chief
Executive Officer, effective September 1, 2017. Dr. Kroeger brings
substantial experience driving drug development and innovation in
the life sciences and medical industries, and a strong clinical and
research background as a physician and scientist. Upon Dr.
Kroeger’s transition to OvaScience, Michelle Dipp, M.D., Ph.D.,
Co-Founder and Executive Chairman, will step down from the Board of
Directors and serve in an advisory role. Richard Aldrich,
Co-Founder of OvaScience and Partner of Longwood Fund, will
continue to serve as lead independent director of the Board of
Directors.
- Also in June 2017, OvaScience undertook
a corporate restructuring to align with its strategic focus on
advancing OvaTure and OvaPrime and to extend its cash position into
the first quarter of 2020. In conjunction with this restructuring,
OvaScience reduced its workforce by approximately 50 percent.
Upcoming 2017
Milestones:
The Company expects to achieve the following milestones by
year-end 2017:
- OvaTure:
- Fertilize a bovine EggPC cell-derived
egg
- OvaPrime:
- Complete biopsies in 70 patients in the
ongoing Canadian study
- Provide initial data readout, including
six months of post-EggPC reintroduction safety data from 20
patients
Second Quarter 2017 Financial
Results:
- Revenue for the quarter ended June 30,
2017 was $84,000, compared to $189,000 for the same period in
2016.
- Research and development expense for
the quarter ended June 30, 2017, excluding restructuring charges,
was $5.0 million, compared to $6.0 million for the same period in
2016. This decrease was primarily driven by a $0.5 million decrease
in employee related costs and stock-based compensation and a $0.5
million decrease in certain research agreements, both resulting
from restructuring activities.
- Selling, general and administrative
expense for the quarter ended June 30, 2017, excluding
restructuring charges, was $10.8 million, compared to $11.2 million
for the same period in 2016. The decrease was driven by decreases
of $1.4 million in employee related costs due to the Company’s
reduced headcount, a $1.2 million decrease in marketing and
commercial related costs, a $0.8 million decrease in travel,
facilities and other costs primarily resulting from the Company’s
restructuring activities. These decreases were offset by a $2.9
million increase in non-cash stock-based compensation, primarily
driven by the modification of awards granted to an executive
resulting in accelerated compensation expense. Of the $2.9 million
increase, $2.3 million related to the June 2014 and December 2014
option grants. The Advisory Agreement has subsequently been amended
to permit the accelerated vesting of those grants prior to December
31, 2018 only in the event of a future termination “without cause”
or resignation for “good reason.”
- Net loss for the quarter ended June 30,
2017 was $18.2 million, or ($0.51) per share, compared to a net
loss of $18.6 million, or ($0.62) per share, for the same period in
2016. The net loss for the quarter ended June 30, 2017 includes
restructuring charges of $2.0 million.
As of June 30, 2017, OvaScience had cash, cash equivalents and
short-term investments of $86.6 million, compared to $114.4 million
as of December 31, 2016. The cash outlays related to the
restructurings in the first half of 2017 represent $4.1 million.
OvaScience has incurred $8.9 million dollars of restructuring
expenses to-date and expect total one-time cash expenditures
resulting from the two restructurings to be between $8 and $9
million over 2017 and 2018. The Company may also incur further
restructuring charges related to the restructuring plans.
OvaScience anticipates that it will have sufficient funds, without
additional financing, to support its operating plan into the first
quarter of 2020.
Conference CallOvaScience will host a conference call at
4:30 p.m. ET today, Thursday, August 3, 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 6428711.
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 Thursday, August 3, 2017, through
11:59 p.m. ET on Thursday, August 17, 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 6428711#.
About OvaScienceOvaScienceSM, Inc. (NASDAQ:OVAS) is a
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 Canada. 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
OvaPrimeSM treatment, OvaTureSM treatment and AUGMENTSM treatment,
including statements relating to the Company’s (i) belief that it
is sufficiently funded, without additional financing, to support
operations into the first quarter of 2020, (ii) discussions with
Intrexon® relating to the future of the OvaXonSM joint venture,
(iii) expectation that it will achieve its upcoming 2017
milestones, including the fertilization of a bovine EggPC cell
derived egg, completion of biopsies in 70 patients in the ongoing
Canadian study and initial data readout from 20 patients in the
Canadian study, (iv) plans 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 by the end
of the first half of 2018, (v) plans to discontinue efforts
relating to AUGMENT outside of North America and explore
partnership opportunities for AUGMENT, (vi) expected one-time cash
expenditures and potential restructuring charges resulting from
restructurings. 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; risks associated with clinical
studies; development risk; risks associated with dependence on and
discussions with third parties; operational risks; risks associated
with pursuing partnership opportunities with third parties; 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 June 30,2017
December 31,2016 Assets Current assets: Cash
and cash equivalents $ 22,937 $ 43,930 Short-term investments
63,622 70,458 Prepaid expenses and other current assets
2,535 2,056 Total current assets 89,094 116,444 Property and
equipment, net 3,956 5,572 Investment in joint venture - 65
Restricted cash 812 439 Other long-term assets 23 23
Total assets $ 93,885 $ 122,543
Liabilities and stockholders’
equity Current liabilities: Accounts payable $ 3,275 $ 2,183
Accrued expenses and other current liabilities 8,544
11,026 Total current liabilities 11,819 13,209 Other non-current
liabilities 925 1,116 Total liabilities 12,744
14,325 Total stockholders’ equity 81,141
108,218 Total liabilities and stockholders’ equity $ 93,885 $
122,543
OvaScience, Inc. Condensed
Consolidated Statements of Operations (Unaudited) (In
thousands, except per share data)
Three Months EndedJune 30,
Six Months EndedJune 30, 2017
2016 2017 2016 Revenues $ 84 $ 189 $
147 $ 335 Costs and expenses: Costs of revenues 274 1,233 543 2,409
Research and development 4,997 5,987 10,761 11,942 Selling, general
and administrative 10,751 11,210 18,371 25,664 Restructuring charge
1,992 - 3,480 -
Total costs and expenses 18,014 18,430
33,155 40,015 Loss from
operations (17,930 ) (18,241 ) (33,008 ) (39,680 ) Interest income,
net 186 161 368 335 Other income, net 25 (22 ) (35 ) (49 ) Loss
from equity method investment (454 ) (416 )
(875 ) (807 ) Loss before income taxes $ (18,173 ) $ (18,518
) (33,550 ) $ (40,201 ) Income tax expense 13
50 22 125 Net loss
(18,186 ) (18,568 ) (33,572 ) (40,326 )
Net loss per share—basic and diluted $ (0.51 ) $ (0.62 ) $ (0.94 )
$ (1.41 ) Weighted average number of shares used in net loss
per share—basic and diluted 35,664 30,036
35,653 28,668
###
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Media and Investor ContactOvaScience, Inc.Jennifer
Viera, 617-420-8728jviera@ovascience.com
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