ObsEva Reports First Quarter 2017 Financial Results and Business Update
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ObsEva SA /
ObsEva Reports First Quarter 2017 Financial Results and Business Update
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- Phase 3 Programs Underway in Uterine Fibroids and Assisted Reproduction
Technology (ART) -
Geneva, Switzerland and Boston, MA - May 18, 2017 - ObsEva SA (NASDAQ: OBSV), a
clinical-stage biopharmaceutical company focused on the development and
commercialization of novel therapeutics for serious conditions that compromise a
woman's reproductive health and pregnancy, today reported financial results for
the first quarter ended March 31, 2017 and provided a business update outlining
recent corporate progress.
"The first quarter was a transformational time for ObsEva, as we set our sights
on becoming a leader in women's health medicine. In addition to completing our
initial public offering we have made substantial progress within all three of
our clinical programs," said Ernest Loumaye, Chief Executive Officer of ObsEva.
"We are currently enrolling patients for the EDELWEISS trial, the PRIMROSE
trials, and the IMPLANT 2 trial, and look forward to completing the enrollment
for both the EDELWEISS trial and the IMPLANT 2 trial later in the year. In
addition, we announced today the completion of a Phase 1 drug-drug interaction
study with OBE022 and standard of care drugs used for treatment of preterm
labor. We are continuing to build our team and capabilities and look forward to
expanding our presence in our new Boston office."
Commencement of Phase 3 programs and Early Stage Study Progress
* In April, the Company began enrollment of the PRIMROSE 1 and 2 studies of
OBE2109, its oral GnRH receptor antagonist for the treatment of uterine
fibroids. This Phase 3 program will enroll a total of approximately 1,000
women, with the goal of reducing heavy menstrual bleeding.
* In March, ObsEva began enrollment of the IMPLANT 2 study of nolasiban
(OBE001), its oral oxytocin antagonist for use in ART. This Phase 3 trial
will enroll 760 patients in Europe with the goal of increasing live birth
rates following in vitro fertilization (IVF).
* Also in March, the Company presented data at the Society for Reproductive
Investigation's 64th Annual Scientific Meeting on its first-in-class, once
daily, oral and selective prostaglandin F2alpha (PGF2alpha) receptor
antagonist, OBE022. The study demonstrated statistically significant delays
in RU486-induced preterm labor in an animal model, including a clear
synergistic effect with standard of care nifedipine.
* In February 2017, the Company completed a Phase 1 clinical trial assessing
the safety, tolerability and PK profile of OBE022 in healthy post-menopausal
female volunteers. OBE022 was observed to have a favorable PK profile, no
clinically significant food effect, a favorable safety profile and to be
well-tolerated at the highest doses tested.
Corporate Highlights
* On January 25, 2017 the Company raised gross proceeds of $96.8 million on
the NASDAQ Global Select Market.
* Opening ObsEva USA Inc. in Boston. In January 2017, Tim Adams joined ObsEva
as Chief Financial Officer and is leading the company's Boston office. The
ObsEva Boston office will house finance, IR, and Clinical Operations teams.
Upcoming Milestones
ObsEva expects consistent flow of clinical and pipeline milestones over the
reminder of 2017, including:
* Final PK/PD study results for OBE2109 in combination with add back therapy
(ABT) in 2Q:17;
* Commencement of Phase 2a clinical trial of OBE022 in pre-term labor in
2H:17;
* Completion of enrollment of Phase 3 IMPLANT2 trial of nolasiban for assisted
reproduction by the end of 2017, with data release planned 1H:18; and
* Completion of enrollment of Phase 2b EDELWEISS trial of OBE2109 for the
treatment of endometriosis by the end of 2017, with data release planned
1H:18.
First Quarter 2017 Financial Results
Net loss for the first quarter of 2017 was $15.5 million, or $0.58 per basic and
diluted share. Research and development expenses were $13.1 million and general
and administrative expenses were $2.7 million for the quarter ended March
31, 2017. As of March 31, 2017, ObsEva had cash and cash equivalents of $104.2
million.
Conference Call Information
ObsEva will host a conference call and audio webcast today at 08:00 a.m. Eastern
Time to provide a business update and discuss first quarter 2017 financial
results. To participate in the conference call, please dial 844-419-1772
(domestic) or (213) 660-0921 (international) and refer to conference ID
21002537. The webcast can be accessed under the Investor Relations section of
the company's website www.obseva.com
About ObsEva
ObsEva is a clinical-stage biopharmaceutical company focused on the clinical
development and commercialization of novel therapeutics for serious conditions
that compromise a woman's reproductive health and pregnancy. Through strategic
in-licensing and disciplined drug development, ObsEva has established a late-
stage clinical pipeline with development programs focused on treating
endometriosis, uterine fibroids, preterm labor and improving ART outcomes.
ObsEva is listed on The NASDAQ Global Select Market and is trading under the
ticker symbol "OBSV". For more information, please visit www.ObsEva.com.
Cautionary Note Regarding Forward Looking Statements
Any statements contained in this press release that do not describe historical
facts may constitute forward-looking statements as that term is defined in the
Private Securities Litigation Reform Act of 1995. These statements may be
identified by words such as "believe", "expect", "may", "plan," "potential,"
"will," and similar expressions, and are based on ObsEva's current beliefs and
expectations. These forward-looking statements include expectations regarding
the clinical development of ObsEva's pipeline. These statements involve risks
and uncertainties that could cause actual results to differ materially from
those reflected in such statements. Risks and uncertainties that may cause
actual results to differ materially include uncertainties inherent in the
conduct of clinical trials, ObsEva's reliance on third parties over which it may
not always have full control, and other risks and uncertainties that are
described in the Risk Factors section of ObsEva's Annual Report on Form 20-F for
the year ended December 31, 2016, and other filings ObsEva makes with the SEC.
These documents are available on the Investors page of ObsEva's website at
http://www.obseva.com. Any forward-looking statements speak only as of the date
of this press release and are based on information available to ObsEva as of the
date of this release, and ObsEva assumes no obligation to, and does not intend
to, update any forward-looking statements, whether as a result of new
information, future events or otherwise.
Media Contact:
Liz Bryan
Spectrum Science
lbryan(at)spectrumscience.com
202-955-6222 x2526
Company Contact:
CEO Office Contact
Delphine Renaud
delphine.renaud(at)obseva.ch
+41 22 552 1550
Investor Contact
Mario Corso
Senior Director, Investor Relations
mario.corso(at)obseva.com
781-366-5726
Consolidated Statement of Comprehensive Loss
(in USD '000, except per share data)
Three-month period ended March
31,
2017 2016
-------------------------------
unaudited
Other operating income 6 3
OPERATING EXPENSES
Research and development expenses (13,057) (3,815)
General and administrative expenses (2,745) (659)
---------- --------------------
Total operating expenses (15,802) (4,474)
---------- --------------------
OPERATING LOSS (15,796) (4,471)
---------- --------------------
Finance income 258 14
Finance expense - (224)
---------- --------------------
NET LOSS BEFORE TAX (15,538) (4,681)
---------- --------------------
Income tax expense - -
---------- --------------------
NET LOSS FOR THE PERIOD (15,538) (4,681)
---------- --------------------
Net loss per share
Basic (0.58) (0.22)
Diluted (0.58) (0.22)
OTHER COMPREHENSIVE INCOME
Items that will not be reclassified to profit
and loss
---------- --------------------
Remeasurements on post-retirement benefit
plans - -
Items that may be reclassified to profit or
loss
Currency translation differences - 2,403
---------- --------------------
TOTAL OTHER COMPREHENSIVE INCOME - 2,403
---------- --------------------
TOTAL COMPREHENSIVE LOSS FOR THE PERIOD (15,538) (2,278)
---------- --------------------
Consolidated Balance Sheet
(in USD '000) As at December
As at March 31, 2017 31, 2016
---------------------------------------------
unaudited audited
ASSETS
Current assets
Cash and cash equivalents 104,158 25,508
Other receivables 988 783
Prepaid expenses and 1,047 2,415
deferred costs
---------------------------------------------
Total current assets 106,193 28,706
Non-current assets
Plant and equipment 118 121
Intangible assets 16,608 16,608
Other long-term assets 171 90
---------------------------------------------
Total non-current assets 16,897 16,819
---------------------------------------------
Total assets 123,090 45,525
---------------------------------------------
LIABILITIES AND SHAREHOLDERS EQUITY
Current liabilities
Other payables and current 1,836 2,383
liabilities
Accrued expenses 6,912 4,269
---------------------------------------------
Total current liabilities 8,748 6,652
Non-current liabilities
Post-employment obligations 2,859 2,832
---------------------------------------------
Total non-current 2,859 2,832
liabilities
Shareholders' equity
Share capital 2,240 1,740
Share premium 160,260 71,966
Reserves 4,120 1,934
Accumulated losses (55,137) (39,599)
---------------------------------------------
Total shareholders' equity 111,483 36,041
---------------------------------------------
Total liabilities and 123,090 45,525
shareholders' equity
---------------------------------------------
###
Press Release:
http://hugin.info/157613/R/2105907/799355.pdf
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The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: ObsEva SA via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 18.05.2017 - 13:00 Uhr
Sprache: Deutsch
News-ID 543767
Anzahl Zeichen: 15608
contact information:
Town:
Plan-les-Ouates
Kategorie:
Business News
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