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ObsEva Reports Third Quarter 2017 Financial Results and Provides Business Update

ObsEva SA /
ObsEva Reports Third Quarter 2017 Financial Results and Provides Business Update
. Processed and transmitted by Nasdaq Corporate Solutions.
The issuer is solely responsible for the content of this announcement.

- All Three Development Compounds Progressing with Key Clinical Milestones Over
the Next 12 Months -

Geneva, Switzerland and Boston, MA - November 14, 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 third quarter ended September 30, 2017 and provided a business update
outlining recent corporate progress and upcoming milestones.

"We are very proud of the progress that we are making in each of our development
programs, and continue to deliver upon our objectives and timelines that were
outlined at our IPO in January. Our team has been able to navigate the
complexities of executing on global trials and the robust patient recruitment in
our IMPLANT 2 and EDELWEISS clinical trials demonstrates the severe unmet
medical need that exists and demonstrates the potential of our therapeutics to
greatly improve patient care." said Ernest Loumaye, Chief Executive Officer of
ObsEva. "With our recent successful financing, we are now positioned to achieve
several clinical milestones in 2018-19."

Pipeline Progress Achieved in Third Quarter of 2017
* Patient recruitment was completed in August for the Phase 3 IMPLANT 2 trial
of nolasiban, ObsEva's oral oxytocin receptor antagonist designed to improve
clinical pregnancy and live birth rates in women undergoing in-vitro
fertilization (IVF). Approximately 760 patients have now been randomized in
this European trial.
* Patient recruitment was completed in November, 2017 for ObsEva's EDELWEISS
Phase 2b clinical trial of OBE2109, its oral GnRH receptor antagonist for
the treatment of endometriosis. Enrollment is targeted at 330 patients
globally.
* The Phase 3 PRIMROSE 1 and 2 trials of OBE2109 for the treatment of uterine
fibroids randomized its first patients to active therapy following screening
that began earlier this year. Enrollment is targeted at approximately 1,000
women in total. The primary endpoint of these trials is the reduction of
heavy menstrual bleeding.
* Clinical trial protocol was finalized and regulatory applications submitted
to begin the PROLONG trial, a 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 pipeline milestones over
the remainder of 2017 and 2018:
* Announcement of primary endpoint results from the 760 patient Phase 3
IMPLANT 2 clinical trial of nolasiban in assisted reproductive technology
(ART) in the first quarter of 2018.
* Announcement of primary endpoint results from the 330 patient Phase 2b
EDELWEISS trial of OBE2109 for the treatment of endometriosis in mid-2018.
* Commencement of the Phase 2a PROLONG clinical trial of OBE022 in pre-term
labor in the fourth quarter of 2017, with preliminary results in
approximately 60 patients expected in late 2018.
* Completion of patient enrollment of the Phase 3 PRIMROSE 1 and 2 trials of
OBE2109 for the treatment of uterine fibroids in late 2018.

Third Quarter 2017 Financial Results
Net loss for the third quarter of 2017 was $17.0 million, or $0.59 per basic and
diluted share. Research and development expenses were $13.9 million and general
and administrative expenses were $3.0 million for the quarter ended September
30, 2017. As of September 30, 2017, ObsEva had cash and cash equivalents of
$68.4 million, which does not include net proceeds of approximately $56 million
raised in the private equity financing that was announced on October 10, 2017.

Conference Call Information
ObsEva will host a conference call and audio webcast today at 8:00 a.m. Eastern
Time to provide a business update and discuss third 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
2197575. 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 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 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, 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@spectrumscience.com
+1 202-955-6222 x2526

Company Contact:
CEO Office contact
Delphine Renaud
delphine.renaud@obseva.ch
+41 22-552-1550

Investor Contact
Mario Corso
Senior Director, Investor Relations
mario.corso@obseva.com
+1 781-366-5726


Consolidated Statements of Comprehensive Loss

      Three-month period   Nine-month period
 (in USD '000, except per share data) ended September ended September 30,
30,

      2017   2016   2017   2016
-------------------- --------------------
      unaudited   unaudited



Other operating income...........................     3   7   11   37



OPERATING EXPENSES

Research and development expenses........     (13,910)   (5,978)   (40,983)   (15,544)

General and administrative expenses.........     (3,001)   (1,946)   (9,601)   (3,321)
---------- --------- ---------- ---------
Total operating expenses.........................     (16,911)   (7,924)   (50,584)   (18,865)


---------- --------- ---------- ---------
OPERATING LOSS...................................     (16,908)   (7,917)   (50,573)   (18,828)
---------- --------- ---------- ---------


Finance income.........................................     (106)   7   754   34

Finance expense.......................................     (1)   (36)   (1)   (267)


---------- --------- ---------- ---------
NET LOSS BEFORE TAX.........................     (17,015)   (7,946)   (49,820)   (19,061)
---------- --------- ---------- ---------


Income tax benefit / (expense....................     21   -   (36)   -


---------- --------- ---------- ---------
NET LOSS FOR THE PERIOD...................     (16,994)   (7,946)   (49,856)   (19,061)
---------- --------- ---------- ---------


Net loss per share

Basic........................................................     (0.59)   (0.37)   (1.78)   (0.89)

Diluted.....................................................     (0.59)   (0.37)   (1.78)   (0.89)




OTHER COMPREHENSIVE INCOME


---------- --------- ---------- ---------
Currency translation differences.................     -   554   -   1,956
---------- --------- ---------- ---------


TOTAL OTHER COMPREHENSIVE
INCOME................................................... - 554 -   1,956


---------- --------- ---------- ---------
TOTAL COMPREHENSIVE LOSS FOR THE     (16,994)   (7,392)   (49,856)   (17,105)
PERIOD............................................
---------- --------- ---------- ---------





Consolidated Balance Sheet

(in USD '000)     September December
  30, 31,
2017 2016
--------------------
      unaudited audited

ASSETS

Current assets

Cash and cash equivalents.................................     68,358 25,508

Other receivables...............................................     683 783

Prepaid expenses and deferred costs.................     1,679 2,415
--------------------
Total current assets..........................................     70,720 28,706



Non-current assets

Furniture, fixtures and equipment........................     339 121

Intangible assets................................................     21,608 16,608

Other long-term assets.......................................     190 90
--------------------
Total non-current assets...................................     22,137 16,819


--------------------
Total assets......................................................     92,857 45,525
--------------------


LIABILITIES AND SHAREHOLDERS' EQUITY

Current liabilities

Current tax liability..............................................     36 -

Other payables and current liabilities...................     2,662 2,383

Accrued expenses.............................................     5,752 4,269
--------------------
Total current liabilities......................................     8,450 6,652



Non-current liabilities

Post-employment obligations.............................     2,840 2,832
--------------------
Total non-current liabilities...............................     2,840 2,832



Shareholders' equity

Share capital......................................................     2,265 1,740

Share premium...................................................     162,982 71,966

Reserves...........................................................     5,775 1,934

Accumulated losses...........................................     (89,455) (39,599)
--------------------
Total shareholders' equity................................     81,567 36,041


--------------------
Total liabilities and shareholders' equity..........     92,857 45,525
--------------------


###

Press release:
http://hugin.info/157613/R/2149397/824880.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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