– Initial Safety Data from First 20 Patients in
OvaPrime℠ Clinical Trial Expected by Year-End –
– Granted Exclusive License to IVF Japan Group
to Offer the AUGMENT℠ Treatment in Japan –
– Conference Call Today at 4:30 p.m. ET –
OvaScience℠ (NASDAQ:OVAS), a fertility company focused on the
discovery, development and commercialization of new treatment
options for women, today reported financial results and provided a
business update for the third quarter ended September 30, 2017.
“This quarter we focused on accelerating the pace and efficiency
of our ongoing research and development efforts and on creating
robust and compelling preclinical and clinical data for our
treatments,” said Dr. Christopher Kroeger, Chief Executive Officer
of OvaScience. “We continued to progress our ongoing clinical study
of OvaPrime, and remain on track to report the first in-human
safety data from 20 patients before year-end. We also continued our
efforts with OvaTure, where we are focused on developing robust and
repeatable processes for fertilizing bovine egg precursor
cell-derived eggs and maturing developmentally competent human egg
precursor cells. We look forward to advancing both programs as we
execute on our mission of transforming women’s fertility.”
Third Quarter and Recent Business
Highlights:
OvaPrime℠ Treatment: OvaPrime is a potential fertility
treatment that could help a woman who makes too few or no eggs by
transferring her own concentrated egg precursor (EggPC℠) cells to a
different region in her own ovary, where they may mature into
fertilizable eggs.
- OvaScience continues to progress its
ongoing single center, prospective, blinded and placebo-controlled
study of OvaPrime, which is designed to assess the treatment’s
safety in women with either primary ovarian insufficiency or poor
ovarian response. Additional exploratory endpoints include
OvaPrime’s effect on patients’ anti-mullerian hormone, follicle
stimulating hormone and estradiol levels, as well as follicular
development as measured by ultrasound. The Company plans to use the
results of this study to inform the future clinical development of
OvaPrime.
- OvaScience increased the modified
intent-to-treat (mITT) population in the OvaPrime safety study from
50 to 70 in order to include a greater number of subjects with
primary ovarian insufficiency. As a result, the enrollment for this
study was increased to 95. To date, the Company has enrolled 78
patients. OvaScience expects to complete biopsies in 70 patients
and to announce initial safety data from the first 20 patients by
year-end.
OvaTure℠ Treatment: OvaTure is a potential
fertility treatment that could help a woman produce healthy,
fertilizable eggs without hormone injections by maturing EggPC
cells into eggs in vitro.
- Under the OvaTure collaboration,
OvaScience and Intrexon continued to optimize culture conditions
for the maturation of human and bovine EggPC cells and introduced
new analytical assays into the process to further characterize
maturing eggs that are ideal candidates for future fertilization
studies. In parallel, the companies are exploring additional bovine
fertilization strategies for EggPC cell-derived eggs – in vitro
fertilization (IVF) and intracytoplasmic sperm injection (ICSI).
OvaScience previously communicated a goal of fertilizing a bovine
EggPC cell-derived egg in 2017. While the companies are rigorously
advancing several different experimental approaches that will
read-out by year-end, there is no certainty that these ongoing
efforts will result in a fertilized bovine egg this year.
OvaScience remains firmly committed to advancing the OvaTure
program and will provide regular updates as efforts progress.
- OvaScience continues to work with its
academic partners toward securing authorization to fertilize human
EggPC cell-derived eggs.
AUGMENT℠ Treatment: AUGMENT is a fertility treatment
designed to improve egg fertilization efficiency and IVF success
rates, by using mitochondria from a woman’s own EggPC cells during
IVF.
- In October 2017, OvaScience granted an
exclusive license to IVF Japan Group, a clinic network with
significant AUGMENT experience, to offer the treatment in Japan.
This will enable IVF Japan Group to generate additional outcomes
data and to help inform the target patient profile for the
treatment. Under the terms of the agreement, OvaScience will incur
minimal expense. IVF Japan Group will pay OvaScience a fixed amount
per AUGMENT cycle that will cover all lab operations and personnel
costs. OvaScience will retain worldwide commercialization rights
for AUGMENT outside of Japan and will continue ongoing operations
related to the AUGMENT treatment in North America.
Third Quarter 2017 Financial
Results:
- Research and development expense for
the quarter, excluding restructuring charges, was $4.0 million,
compared to $5.0 million for the same period in 2016. This decrease
was primarily driven by decreased employee related costs, including
stock-based compensation expense mostly due to restructuring
activities.
- Selling, general and administrative
expense for the quarter, excluding restructuring charges, was $5.1
million, compared to $12.6 million for the same period in 2016.
This decrease was driven by reduced employee related costs,
including stock-based compensation expense and commercial related
activities mostly due to restructuring activities.
- Net loss for the quarter was $9.4
million, or $0.26 per share, compared to a net loss of $19.3
million, or $0.54 per share, for the same period in 2016. The net
loss for the quarter includes restructuring charges of $0.4
million.
As of September 30, 2017, OvaScience had cash, cash equivalents
and short-term investments of $75.7 million, compared to $114.4
million as of December 31, 2016.
The cash outlays related to the restructurings in the third
quarter of 2017 were $1.6 million. OvaScience expects to incur
additional cash outlays related to the restructurings of between
$1.0 million and $1.5 million over 2017 and 2018.
OvaScience anticipates that it will have sufficient funds
without additional financing to support its operations into the
first quarter of 2020. This guidance reflects current operating
plans and is subject to change based on the results of ongoing
clinical and preclinical development efforts with OvaPrime and
OvaTure.
Conference CallOvaScience will host a conference call at
4:30 p.m. ET today, Thursday, November 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 9200599.
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, November 2, 2017,
through 11:59 p.m. ET on Thursday, November 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 9200599#.
About OvaScienceOvaScience℠, 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 (EggPC℠) cells – immature
egg cells found inside the protective ovarian lining. OvaScience is
developing OvaPrime℠, which could help women who make too few or no
eggs and OvaTure℠, a potential treatment that could help women
produce healthy, fertilizable eggs without hormone injections.
OvaScience’s AUGMENT℠ treatment, a fertility option designed to
improve IVF success rates, is available in certain IVF clinics in
Canada and Japan. 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 (i) belief that it
will complete of biopsies in 70 patients in the ongoing Canadian
OvaPrime study and have initial data readout from 20 patients in
the Canadian study by the end of 2017, (ii) plans for additional
enrollment in the OvaPrime study, (iii) expectations relating to
its AUGMENT license with IVF Japan, including anticipated data and
anticipated minimal expense to the Company, , (iv) plans for the
bovine and human OvaTure program, and the goal of fertilizing a
bovine Egg PC-cell derived egg and (iv) plans to develop a
repeatable and robust process for the maturation of human EggPC
cells and to pursue authorization to fertilize human EggPC
cell-derived eggs. 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 and
other studies; development risk; risks associated with dependence
on third parties, including our partners; operational risks; 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
September 30,2017
December 31,2016 Assets
Current assets: Cash and cash equivalents $ 24,775 $ 43,930
Short-term investments 50,961 70,458 Prepaid expenses and other
current assets 1,871 2,056 Total current assets
77,607 116,444 Property and equipment, net 3,606 5,572 Investment
in joint venture 0 65 Restricted cash 789 439 Other long-term
assets 24 24 Total assets $ 82,025 $ 122,543
Liabilities and stockholders’ equity Current liabilities:
Accounts payable $ 2,691 $ 2,183 Accrued expenses and other current
liabilities 6,203 11,026 Total current liabilities
8,902 13,209 Other non-current liabilities 834 1,116
Total liabilities 9,736 14,325 Total stockholders’
equity 72,289 108,217 Total liabilities and
stockholders’ equity $ 82,025 $ 122,543
OvaScience, Inc. Condensed Consolidated Statements of
Operations (Unaudited) (In thousands, except per
share data)
Three Months
EndedSeptember 30, Nine Months
EndedSeptember 30, 2017 2016 2017
2016 Revenues $ 56 $ 197 $ 204 $ 532 Costs and
expenses: Cost of revenues 29 1,559 593 3,968 Research and
development 4,016 4,990 14,777 16,932 Selling, general and
administrative 5,056 12,612 22,935 38,276 Restructuring charge
362 0 3,842 0
Total costs and expenses 9,462 19,161
42,148 59,176 Loss from
operations (9,406 ) (18,964 ) (41,944 ) (58,644 ) Interest income,
net (192 ) (162 ) (561 ) (497 ) Other income, net 3 33 37 83 Loss
from equity method investment 140 364
1,015 1,171 Loss before income taxes $
(9,356 ) $ (19,199 ) $ (42,436 ) $ (59,400 ) Income tax expense
11 92 34 217
Net loss (9,367 ) (19,291 ) (42,447 )
(59,617 ) Net loss per share—basic and diluted $ (0.26 ) $
(0.54 ) $ (1.19 ) $ (1.92 ) Weighted average number of shares used
in net loss per share—basic and diluted 35,687
35,568 35,664 30,985
###
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version on businesswire.com: http://www.businesswire.com/news/home/20171102006690/en/
OvaScience, Inc.Jennifer Viera,
617-420-8728jviera@ovascience.com
Ovascience Inc. (delisted) (NASDAQ:OVAS)
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