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ObsEva Reports Second Quarter 2018 Financial Results and Provides Business Update

ObsEva SA /
ObsEva Reports Second 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.

* Phase 2b EDELWEISS clinical trial of linzagolix (OBE2109) in endometriosis
related pelvic pain achieved primary and secondary endpoints
* Chief Commercial Officer hired as nolasiban moves closer to
commercialization
* Net proceeds of $87 million raised from sale of equity
* Swiss SIX exchange listing completed
Geneva, Switzerland and Boston, MA - August 8, 2018 - ObsEva SA (NASDAQ: OBSV /
SIX: OBSN), 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 June 30, 2018, and provided a business
update outlining recent corporate progress and upcoming milestones.

"Positive EDELWEISS results for linzagolix announced in June was our second
successful major clinical milestone of 2018 following positive IMPLANT2 results
of nolasiban in IVF that were disclosed in February" said Ernest Loumaye, co-
founder and Chief Executive Officer of ObsEva. "We are very pleased with our
clinical development execution and look forward to additional data from both
trials in the fourth quarter of this year".

Recent Highlights
* Positive Phase 3 IMPLANT 2 trial top line results were disclosed in February
2018 for ObsEva's oral oxytocin receptor antagonist nolasiban, demonstrating
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). The
trial follow-up continues to progress through birth and neonatal periods.

* Positive Phase2b EDELWEISS clinical trial results of ObsEva's oral GnRH
receptor antagonist linzagolix in the treatment of endometriosis related
pelvic pain were announced in June 2018. The primary endpoint of the trial
was successfully achieved, with patient response (defined as a 30% or
greater reduction in verbal rating scale, or VRS 0-3 pain score from
baseline) in 61.5% of women at the 75mg dose, 56.4% at 100mg, and 56.3% at
200mg, vs. 34.5% for placebo, respective p values of 0.003, 0.039, and
0.034. In addition, linzagolix treatment was associated with improvement in
secondary trial endpoints, including pelvic pain as measured by a 0-10
numerical rating scale (NRS), dyspareunia and dyschezia pain scores, and
patient well-being as assessed by patient global impression of change
(PGIC), Endometriosis Health Profile-30 score (EHP-30), and patient global
impression of severity (PGIS). Importantly, linzagolix treatment was also
observed to be safe and well tolerated.

* Patient enrollment continued in the PRIMROSE 1 and PRIMROSE 2 Phase 3
clinical trials of linzagolix 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 two doses
being studied, one with hormonal add back therapy (ABT) and one without ABT.

* Patient enrollment continued in Part A of 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. Positive pharmacokinetic (PK) data support moving to
Part B of the trial.

Upcoming Milestones

ObsEva expects to achieve the following clinical and regulatory milestones by
the end of 2018:
* Live birth rate results and 28-day neonatal safety from the Phase 3 IMPLANT2
clinical trial of nolasiban in IVF are expected in Q4 of 2018.

* Initiation of a US nolasiban Phase 3 clinical development program is planned
by the end of 2018. Consistent with nolasiban progress, the Company
announced in late July the hiring of Mr. Wim Souverijns as Chief Commercial
Officer, who will be joining the company in Q4 of 2018 to prepare the
Company for market access and commercialization both in Europe and the U.S.

* 24-week results from the Phase 2b EDELWEISS clinical trial of linzagolix for
the treatment of endometriosis related pelvic pain, including assessment of
bone mineral density (BMD), are expected in early Q4 of 2018. An End-of-
phase 2 meeting with regulatory authorities to discuss the design of the
Phase 3 program for that indication is targeted by the end of 2018.

* Consistent with last quarter's update, completion of patient enrollment in
the Phase 3 PRIMROSE 2 trial of linzagolix for the treatment of uterine
fibroids continues to be targeted for the end of 2018, while PRIMROSE 1
enrollment completion is anticipated in Q1 of 2019.

* Part A of the Phase 2a PROLONG clinical trial of OBE022 in pre-term labor
assessing safety, tolerability and pharmacokinetics in pregnant women is
presently completing, and initial interim efficacy from Part B of the trial
continues to be expected in Q4 of 2018.

Second Quarter 2018 Financial Results

Net loss for the second quarter of 2018 was $18.2 million, or ($0.49) per basic
and diluted share, vs. $17.3 million or ($0.61) per basic and diluted share for
the second quarter of 2017. Research and development expenses were $14.7 million
and general and administrative expenses were $3.5 million for the quarter ended
June 30, 2018, vs.  $14.0 million and $3.9 million, respectively, for the
quarter ended June 30, 2017. Second quarter 2018 net loss included non-cash
expenses of $2.2 million for share-based compensation, which was equivalent to
the prior year period.

As of June 30, 2018, ObsEva had cash and cash equivalents of $166.8 million,
which included net proceeds of approximately $87 million from the sale of equity
securities.

To access the financial reports section of our website, please click here.

Conference Call Information

ObsEva will host a conference call and audio webcast today at 8:00 a.m. Eastern
Time, 2:00 p.m Central European Summer Time, to provide a business update and
discuss second quarter 2018 financial results. To participate in the conference
call, please dial 844-419-1772 (U.S.) or +1 (213) 660-0921 (international) and
refer to conference ID 6749875. 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" and on the SIX Swiss Exchange where it is trading under the
ticker symbol "OBSN". 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.

For further information, please contact:

Media Contact Switzerland and Europe:
Christophe Lamps
Dynamics Group
cla@dynamicsgroup.ch
+41 22 308 6220 Office
+41 79 476 26 87 Mobile

Media Contact U.S.:
Jeanene Timberlake
RooneyPartners LLC
jtimberlake@rooneyco.com
+1 646 770 8858

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
+1 857 972 9347 Office
+1 781 366 5726 Mobile

Consolidated Statements of Comprehensive Loss

      Three-month period   Six-month period ended
 (In USD '000, except per share data) ended June 30, June 30,

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

Operating income other than     3   2   8   8
revenue...................................

OPERATING EXPENSES

Research and development     (14,694)   (14,016)   (31,036)   (27,073)
expenses.................................

General and administrative     (3,501)   (3,855)   (7,150)   (6,600)
expenses.................................
------------ ------------ ------------ -----------
Total operating expenses........     (18,195)   (17,871)   (38,186)   (33,673)


------------ ------------ ------------ -----------
OPERATING LOSS..................     (18,192)   (17,869)   (38,178)   (33,665)
------------ ------------ ------------ -----------


Finance income........................     31   602   186   860

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


------------ ------------ ------------ -----------
NET LOSS BEFORE TAX........     (18,161)   (17,267)   (37,992)   (32,805)
------------ ------------ ------------ -----------


Income tax (expense)...............     (25)   (57)   --   (57)


------------ ------------ ------------ -----------
NET LOSS FOR THE PERIOD..     (18,186)   (17,324)   (37,992)   (32,862)
------------ ------------ ------------ -----------



Net loss per share

Basic.......................................     (0.49)   (0.61)   (1.03)   (1.19)

Diluted....................................     (0.49)   (0.61)   (1.03)   (1.19)

Weighted Average Shares Outstanding      37,617,569   28,469,064   37,004,673   27,582,897
------------ ------------ ------------ -----------



Consolidated Balance Sheet

(In USD '000)     June December
  30,  2018 31, 2017
---------------------
      unaudited audited

ASSETS

Current assets

Cash and cash equivalents.........................     166,835 110,841

Other receivables.......................................     630 783

Prepaid expenses......................................     2,082 1,490
---------------------
Total current assets..................................     169,547 113,114



Non-current assets

Furniture, fixtures and equipment................     305 323

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

Other long-term assets...............................     188 190
---------------------
Total non-current assets...........................     22,101 22,121


---------------------
Total assets..............................................     191,648 135,235
---------------------


LIABILITIES AND SHAREHOLDERS' EQUITY

Current liabilities

Current tax liability.....................................     40 51

Other payables and current liabilities...........     1,446 2,865

Accrued expenses.....................................     10,428 6,514
---------------------
Total current liabilities.............................     11,914 9,430



Non-current liabilities

Post-employment obligations....................     3,034 3,099

Other long-term liabilities...........................     52 55
---------------------
Total non-current liabilities......................     3,086 3,154



Shareholders' equity

Share capital.............................................     3,375 2,864

Share premium..........................................     307,743 219,335

Reserves..................................................     10,189 7,119

Accumulated losses..................................     (144,659) (106,667)
---------------------
Total shareholders' equity........................     176,648 122,651


---------------------
Total liabilities and shareholders' equity..     191,648 135,235
---------------------


###

Press Release:
http://hugin.info/157613/R/2209648/859929.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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