OvaTure Program On Track to Successfully
Fertilize a Bovine EggPC Cell-Derived Egg
50 Patients Enrolled in OvaPrime Clinical
Trial
Cash Position Expected to Support Operations
into Q12019
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 fourth quarter and year ended December 31,
2016.
“We are entering 2017 with continued confidence in our portfolio
of potentially transformative fertility treatments and a strong
belief in the potential of our EggPC platform to help women and
couples build the families they deserve,” said Michelle Dipp, M.D.,
Ph.D., Executive Chair and Co-Founder of OvaScience.
“In 2016, we achieved criteria indicative of developmental
competence in EggPC cell-derived bovine and human eggs, an
important step in the preclinical development of OvaTure, and we
are on track to successfully fertilize a bovine EggPC cell-derived
egg by year-end,” added Christophe Couturier, Chief Financial
Officer. “We are also pleased to have enrolled the first 50
patients in our company-sponsored trial of OvaPrime, and to have
started performing the first biopsies and reintroductions. With
these milestones in hand, we remain on track to report initial data
on our first 20 patients from this study by year-end. We are
sufficiently funded to support the preclinical development of
OvaTure and clinical development of OvaPrime into the first quarter
of 2019.”
2016 and Recent Business
Highlights:
OvaTureSM Treatment: The Company today
reviewed progress for OvaTure, its 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.
- Progressing toward fertilization of
EggPC cell-derived bovine egg and development of repeatable and
robust process for maturation of EggPC cell-derived human
eggs
There are a choreographed series of events that occur during egg
maturation to prepare an egg for fertilization. Collectively, these
can be described as developmental competence. Together with its
partner, Intrexon Corporation (NYSE: XON), OvaScience has developed
an in vitro cell culture process that has produced bovine and human
eggs derived from EggPC cells that exhibit genetic, morphological
and functional criteria of developmental competence during various
phases of maturation. These criteria include: chromosomal
segregation; an increase in cytoplasmic volume; the appearance of
germinal vesicles, polar bodies and zona pellucida structures; and
a positive brilliant cresyl blue (BCB) test.
Fertilization studies for bovine EggPC-cell derived eggs are
underway and OvaScience and Intrexon expect to successfully
fertilize a bovine EggPC-derived egg by year-end. OvaScience will
continue to work with its clinical partners to develop a repeatable
and robust process for the maturation of eggs derived from 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: The Company announced
milestone achievements for OvaPrime, a potential fertility
treatment that could enable a woman who makes too few or no eggs to
increase her egg reserve.
- Advancing clinical
development
In December 2016, OvaScience announced its decision to continue
the development of OvaPrime. OvaScience is currently evaluating
OvaPrime in a prospective, blinded, randomized and controlled
Company-sponsored trial, which is designed to assess the safety of
OvaPrime and changes in a patient’s hormone levels and follicular
development as measured by ultrasound. The trial will enroll 70
women with either diminished ovarian reserve (DOR) or primary
ovarian insufficiency (POI). To date, the Company has enrolled 50
patients and expects to enroll an additional 20 women by the end of
the first half of 2017.
OvaScience recently completed the first biopsies and
reintroductions in this ongoing clinical trial in Canada. The
Company remains on track to announce initial data from the first 20
patients, including six months of post-EggPC reintroduction safety
data, by year-end.
AUGMENT SM Treatment: The Company
maintained its commercial footprint for AUGMENT, a treatment
designed to improve egg health and with that, IVF success rates, by
using mitochondria from a woman’s own EggPC cells during IVF.
- Revised commercial strategy
In December 2016, the Company announced that it will continue to
make AUGMENT available to patients at clinics in Canada and Japan
and will expand regionally on a limited basis as appropriate.
- Reassessing clinical
strategy
Also announced in December 2016, the Company is reassessing its
clinical development strategy for AUGMENT, including its planned
multi-center clinical trial and the ongoing IVI-sponsored study in
Valencia, Spain.
Separately, OvaScience will meet with the U.S. Food and Drug
Administration (FDA) in the first half of 2017, as part of its
ongoing exploration of potential entry into the U.S. market.
Corporate Highlights:
- In December 2016, OvaScience undertook
a corporate restructuring to extend its cash position into the
first quarter of 2019 and to increase its focus on the development
of OvaTure and OvaPrime. In conjunction with this restructuring,
the Company reduced its workforce by approximately 30 percent.
Total restructuring costs of $6.8 million to $8.2 million are
expected to result from this corporate restructuring, $5.4 million
of which was recorded in 2016.
- In 2016, seven new patents related to
the Company’s treatments were issued, including one in the U.S.
regarding antibody compositions and methods for isolating EggPC
cells, a step common to all OvaScience treatments. In addition, in
2017, nearly 50 new applications covering more than 130 countries
were filed, significantly extending the geographic reach of the
Company’s patent portfolio. The Company now owns or otherwise
controls 58 issued patents in 44 countries and more than 150
applications pending in more than 130 countries.
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 all 70 patients
in the ongoing Canadian study by the end of the first half of the
year
- Complete biopsies in all 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
- AUGMENT:
- Meet with the U.S. FDA to discuss
potential market entry in the first half of the year
Fourth Quarter and Full Year 2016
Financial Results
- Revenue for the quarter ended December
31, 2016 was $121,000, compared to $157,000 in the same period of
2015. Revenues for the full year 2016 were $653,000, compared to
$277,000 in 2015. The Company recognized revenue related to 16
AUGMENT treatments in the fourth quarter of 2016, and related to
107 AUGMENT treatments in the full year 2016, including treatments
offered under various pricing programs. In 2015, OvaScience
recognized revenue from 22 AUGMENT treatments for the full fiscal
year.
- Net loss for the quarter ended December
31, 2016 was $22.6 million, or ($0.64) per share, as compared to
net loss of $20.6 million, or ($0.76) per share, for the same
period in 2015. Net loss for the full year ended December 31, 2016
was $82.3 million or ($2.56) per share, compared to net loss of
$73.2 million or ($2.70) per share for the same period in 2015. The
net loss for the quarter and year ended December 31, 2016 includes
restructuring costs of $5.4 million.
- Research and development expense for
the quarter ended December 31, 2016, excluding restructuring costs,
was $4.7 million, consistent with the same period in 2015. Research
and development expense for the full year ended December 31, 2016,
excluding restructuring costs, was $21.6 million, compared to $18.4
million in the same period in 2015. The year-over-year increase was
primarily driven by a $3.9 million increase in employee
compensation and related benefits driven by the hiring of
additional research and development personnel, a $2.4 million
increase in costs associated with certain ongoing research
agreements, clinical studies and other costs, partially offset by a
$3.3 million decrease in stock-based compensation expense related
to certain mark-to-market adjustments of Founders’ stock, which was
fully vested and expensed in the first quarter of 2015 that did not
recur in 2016, and stock-based compensation expense for certain
senior executives that did not recur in 2016 as a result of
executive leadership changes.
- Selling, general and administrative
expense for the quarter ended December 31, 2016, excluding
restructuring costs, was $10.9 million, compared to $14.6 million
for the same period in 2015. This decrease was primarily driven by
a $3.2 million decrease in stock-based compensation expense related
to certain senior executives that did not recur in 2016 as a result
of executive leadership changes in 2016, a $1.7 million decrease in
costs related to international expansion preparation, including the
establishment of certain international legal entities and
international infrastructure, partially offset by a $1.2 million
increase in costs related to commercialization efforts and overall
business expansion, including increased marketing-related costs.
Selling, general and administrative expense for the full year ended
December 31, 2016 was $49.2 million, compared to $51.6 million in
the same period in 2015. This decrease was primarily driven by a
$7.2 million decrease in stock-based compensation expense related
to certain senior executives that did not recur in 2016 as a result
of executive leadership changes in 2016, as well as certain
mark-to-market adjustments of Founders’ stock, which was fully
vested and expensed in the first quarter of 2015 and did not recur
in 2016, a $4.2 million decrease in costs related to international
expansion preparation, including the establishment of certain
international legal entities and international infrastructure,
partially offset by a $4.7 million increase in costs related to
commercialization efforts and overall business expansion, including
increased marketing-related costs, and a $4.3 million increase in
employee compensation and related benefits driven by the hiring of
additional selling, general and administrative personnel.
At December 31, 2016, OvaScience had cash, cash equivalents and
short-term investments of $114.4 million. OvaScience expects
one-time cash expenditures of approximately $5.7 million to $6.5
million over 2017 and 2018 related to actions resulting from the
corporate restructuring announced in December 2016. The Company may
also incur further restructuring charges related to the
restructuring plan. OvaScience’s operating cash burn for 2017 is
expected to 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, Thursday, March 2, 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 7862456.
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, March 2, 2017 through
11:59 p.m. ET on Thursday, March 9, 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 7862456#.
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 eggs derived from 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; and the Company’s
plans to meet with the U.S. Food and Drug Administration in the
first half of 2017. 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
December 31,2016
December 31,2015
Assets Current assets: Cash and cash equivalents $ 43,930 $
43,224 Short-term investments 70,458 83,438 Prepaid expenses and
other current assets 2,056 3,199 Total current assets 116,444
129,861 Property and equipment, net 5,572 8,313 Investment in joint
venture 65 - Restricted cash 439 439 Other long-term assets 23 -
Total assets $ 122,543 $ 138,613
Liabilities and stockholders’
equity Current liabilities: Accounts payable $ 2,183 $ 3,352
Accrued expenses 11,026 7,891 Total current liabilities 13,209
11,243 Other non-current liabilities 1,116 520 Total liabilities
14,325 11,763 Total stockholders’ equity 108,218 126,850 Total
liabilities and stockholders’ equity $ 122,543 $ 138,613
OvaScience, Inc. Condensed Consolidated Statements of
Operations (Unaudited) (In thousands, except per
share data) Three Months
EndedDecember 31, Year
EndedDecember 31, 2016 2015
2016 2015 Revenues $ 121
$ 157 $ 653 $ 277 Costs and expenses: Costs of
revenues 1,433 1,158 5,401 2,249 Research and development 4,709
4,667 21,641 18,433 Selling, general and administrative 10,947
14,572 49,223 51,594 Restructuring 5,400 -
5,400 - Total operating expenses 22,489
20,397 81,665 72,276 Loss from
operations (21,368) (20,240) (81,012)
(71,999) Interest income (expense), net 162 150 659
436 Other (expense) income, net (82) (51) (164) (20) Loss from
equity method investment (371) (385)
(1,542) (1,561) Loss before income taxes (22,659)
(20,526) (82,059) (73,144) Income tax expense (15)
75 201 75
Net loss $ (22,644) $ (20,601) $
(82,260) $ (73,219) Net loss per share—basic and
diluted $ (0.64) $ (0.76) $ (2.56)
$ (2.70) Weighted average number of shares used in
net loss per share—basic and diluted 35,612 27,280
32,148 27,085
###
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Media and Investor Contact:OvaScience,
Inc.Jennifer Viera, 617-420-8748jviera@ovascience.com
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