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ObsEva Reports First Quarter 2018 Financial Results and Provides Business Update

ObsEva SA /
ObsEva Reports First Quarter 2018 Financial Results and Provides Business Update
. Processed and transmitted by Nasdaq Corporate Solutions.
The issuer is solely responsible for the content of this announcement.

-Key First Quarter 2018 Clinical Milestones Achieved
* Patient randomization completed in Phase 2b EDELWEISS trial of OBE2109 in
Endometriosis, results expected by the end of Q2:18, and

* Primary endpoint achieved in Phase 3 IMPLANT2 trial of nolasiban in IVF,
Live Birth Rate data expected in Q4:18

Geneva, Switzerland and Boston, MA - May 16, 2018 - 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 quarter ended March 31, 2018, and provided a business update outlining
recent corporate progress and upcoming milestones.

"2018 is off to a very good start for ObsEva, with the first quarter
announcement of positive IMPLANT2 phase 3 results for nolasiban in IVF" said
Ernest Loumaye, co-founder and Chief Executive Officer of ObsEva. "Along with
our GnRH antagonist OBE2109, we now believe that we have two late clinical-stage
compounds with the potential to significantly improve the treatment of important
medical conditions that impact the lives of millions of women globally".

Recent Pipeline Highlights
* Positive Phase 3 IMPLANT 2 trial top line results were disclosed in February
2018 for ObsEva's oral oxytocin receptor antagonist nolasiban, given as a
single dose, 4 hours prior to a single embryo transfer (ET) and designed to
improve clinical pregnancy and live birth rates in women undergoing in-vitro
fertilization (IVF).  The primary endpoint was achieved, with a 10-week
ongoing pregnancy rate of 35.6% for nolasiban treated patients vs. 28.5% for
placebo treated patients, a 25% relative increase (p= 0.031).  In the ET Day
5 subgroup, the relative increase was 32% and the absolute increase was
11.2% in favor of nolasiban (nolasiban 45.9% and placebo 34.7%, p = 0.034).
In addition, nolasiban treatment was safe and well tolerated with no
difference in rates of discontinuation from treatment emergent adverse
events (TEAE's) nor the incidence of serious adverse events (SAE's) as
compared to placebo.

* Patient randomization was completed in the first quarter of 2018 for the
EDELWEISS Phase 2b clinical trial of OBE2109, ObsEva's oral GnRH receptor
antagonist for the treatment of endometriosis.  The trial enrolled nearly
330 patients combined in Europe and the U.S., and is comparing 4 different
doses of OBE2109 to placebo, with the goal of identifying dosages that can
alleviate pain symptoms utilizing either partial or full estrogen
suppression to offer  potential alternatives both with and without hormonal
add back therapy (ABT).

* Patient enrollment continued in the PRIMROSE 1 and PRIMROSE 2 Phase 3
clinical trials of OBE2109 for the treatment of uterine fibroids, with a
target enrollment of approximately 1,000 women in total (US and Europe).
These trials  are designed to reduce heavy menstrual bleeding (HMB)
associated with uterine fibroids, with efficacy and safety of  2 doses being
studied, one with ABT and one without ABT.

* First patients were enrolled in the PROLONG Phase 2a clinical trial of
OBE022, ObsEva's oral prostaglandin F2 alpha receptor antagonist for the
treatment of pre-term labor in pregnant women between 24 and 34 weeks of
gestation.

Upcoming Milestones
ObsEva expects to achieve the following clinical and regulatory milestones
during 2018:
* 12-week results from the Phase 2b EDELWEISS clinical trial of OBE2109 for
the treatment of endometriosis, by the end of Q2:18 and readout of 24-week
treatment data, including bone mineral density measurement in Q4:18. End-of-
phase 2 meeting with regulatory authorities to discuss the design of the
phase 3 program for that indication is expected by the end of 2018.

* Given current trends, completion of patient enrollment in the Phase 3
PRIMROSE 2 trial of OBE2109 for the treatment of uterine fibroids continues
to be targeted for the end of 2018, while PRIMROSE 1 enrollment completion
is anticipated in Q1:19

* Results of live birth rate and 28-day neonatal safety from the Phase 3
IMPLANT2 clinical trial of nolasiban in IVF in Q4:18. Post consultation with
regulatory authorities, initiation of a US Phase 3 clinical development
program is planned for Q4:18.

* Safety, tolerability and pharmacokinetics in pregnant women, and interim
efficacy from the Phase 2a PROLONG clinical trial of OBE022 in pre-term
labor in Q4:18.
First Quarter 2018 Financial Results
Net loss for the first quarter of 2018 was $19.8 million, or ($0.54) per basic
and diluted share, vs. $15.5 million or ($0.58) per basic and diluted share for
the first quarter of 2017. Research and development expenses were $16.3 million
and general and administrative expenses were $3.6 million for the quarter ended
March 31, 2018, vs.  $13.1 million and $2.7 million, respectively, for the
quarter ended March 31, 2017. Our first quarter 2018 net loss included non-cash
expenses of $2.4 million for share-based compensation, vs.  $2.3 million in the
first quarter of 2017.
As of March 31, 2018, ObsEva had cash and cash equivalents of $95.4 million.

Conference Call Information
ObsEva will host a conference call and audio webcast today at 8:00 a.m. Eastern
Time, 2 p.m Central European Time, to provide a business update and discuss
first quarter 2018 financial results. To participate in the conference call,
please dial 844-419-1772 (U.S.) or (213) 660-0921 (international) and refer to
conference ID 5663506. The webcast can be accessed under the "Investors" section
of ObsEva'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 IVF 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 product candidates and the timing of
enrollment in and data from clinical trials. 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, 2017, 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:
Marion Janic
RooneyPartners LLC
mjanic@rooneyco.com
212-223-4017

CEO Office Contact:
Shauna Dillon
Shauna.dillon@obseva.ch
+41 22 552 1550

Investor Contact:
Mario Corso
Senior Director, Investor Relations
mario.corso@obseva.com
857-972-9347 office
781-366-5726 mobile

Consolidated Statements of Comprehensive Loss

      Three-month period ended March
 (in USD '000, except per share data) 31,

      2018   2017
--------------------------------
      Unaudited



Other operating income.........     5   6



OPERATING EXPENSES

Research and development expenses....      (16,342)   (13,057)

General and administrative expenses....     (3,649)   (2,745)
------------ -------------------
Total operating expenses........     (19,991)   (15,802)


------------ -------------------
OPERATING LOSS..........     (19,986)   (15,796)
------------ -------------------


Finance income.............     155   258

Finance expense.............     -   -


------------ -------------------
NET LOSS BEFORE TAX.......     (19,831)   (15,538)
------------ -------------------


Income tax benefit...........     25   -


------------ -------------------
NET LOSS FOR THE PERIOD......     (19,806)   (15,538)
------------ -------------------



Net loss per share

Basic................     (0.54)   (0.58)

Diluted................     (0.54)   (0.58)

Weighted Average Shares outstanding     36,389,578   26,623,553


Consolidated Balance Sheets

(in USD '000)
  March 31, 2018 December 31, 2017
----------------------------------
      unaudited audited

ASSETS

Current assets

Cash and cash     95,435 110,841
equivalents..............

Other receivables.................     791 783

Prepaid expenses and deferred     1,786 1,490
costs..........
----------------------------------
Total current assets..............     98,012 113,114



Non-current assets

Furniture, fixtures and     310 323
equipment.........

Intangible assets.................     21,608 21,608

Other long-term assets.............     192 190
----------------------------------
Total non-current assets.............     22,110 22,121


----------------------------------
Total assets.................     120,122 135,235
----------------------------------


LIABILITIES AND SHAREHOLDERS' EQUITY

Current liabilities

Current tax liability..............     27 51

Other payables and current     1,613 2,865
liabilities........

Accrued expenses.................     10,106 6,514
----------------------------------
Total current liabilities..............     11,746 9,430



Non-current liabilities

Post-employment obligations..........     3,063 3.099

Other long-term     53 55
liabilities............
----------------------------------
Total non-current     3,116 3,154
liabilities..........



Shareholders' equity

Share capital...................     2,871 2,864

Share premium...................     220,141 219,335

Reserves....................     8,721 7,119

Accumulated losses...............     (126,473) (106,667)
----------------------------------
Total shareholders' equity...........     105,260 122,651


----------------------------------
Total liabilities and shareholders'     120,122 135,235
equity....
----------------------------------

###

Pdf file:
http://hugin.info/157613/R/2193069/849309.pdf



This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
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



 
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