ObsEva Reports Third Quarter 2018 Financial Results and Provides Business Update
08 Noviembre 2018 - 12:15AM
ObsEva Reports Third Quarter 2018 Financial Results and Provides
Business Update
- IMPLANT 4 trial of nolasiban in IVF starting in Q4
2018, European MAA filing expected late 2019
- 24-week data from Phase 2b EDELWEISS clinical trial of
linzagolix in endometriosis supports 75mg without ABT and 200mg
with low dose ABT for Phase 3 trials planned for
2019
- Phase 3 PRIMROSE 1 and 2 trials in uterine fibroids
continue enrolling, 6-month results anticipated 2H
2019
Geneva, Switzerland and Boston, MA –
November 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 September 30,
2018, and provided a business update outlining recent corporate
progress and upcoming milestones.
"We continued to make significant progress this
quarter with two positive data readouts; the live birth rate
results from the IMPLANT 2 trial of nolasiban in IVF, and 24-week
data from the Phase2b EDELWEISS trial of linzagolix in
endometriosis,” said Ernest Loumaye, co-founder and Chief Executive
Officer of ObsEva. “With recent regulatory feedback on nolasiban,
we plan to initiate IMPLANT 4 before year end and, assuming
positive data, intend to file an MAA in late 2019. We are excited
by the progress of this program and have begun preparation for
commercialization in Europe.”
Recent Highlights
- Additional positive Phase 3 IMPLANT 2 trial results were
announced in October 2018. Live birth rate, reflecting the
ultimate goal of IVF procedures, taking home a baby, showed a 34.8%
vs. 27.7% statistically and clinically significant benefit in favor
of patients receiving nolasiban, a 26% relative improvement,
p=0.025. For patients undergoing Day 5 ET, the live birth
rate benefit was even more pronounced for nolasiban, 44.8% vs.
33.2%, a 35% relative improvement, p=0.025. In addition, IMPLANT 2
trial results were presented at the Annual Meeting of the American
Society for Reproductive Medicine (ASRM), October 6-10 in Denver
Colorado, and received the 2018 Prize Paper Award from the Society
for Assisted Reproductive Technologies (SART).
- Additional 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 September
2018. The 24-week data showed an improvement in patient response
rate (defined as a 30% or greater reduction in verbal rating scale,
or VRS 0-3 pain score from baseline) at 24 weeks vs. 12 weeks for
key doses, 70.8% of women vs. 61.5% with 75mg once daily, and 77.3%
of women vs. 56.3% with 200mg once daily. The key safety
endpoint of mean change in bone mineral density (BMD) at the lumbar
spine (site of greatest bone loss) was -0.8% at the 75mg once daily
dose and -2.6% at the 200mg once daily dose, which ObsEva believes
supports its expectation to further develop the once daily 75mg
dose without low dose hormonal add-back therapy (ABT) and the once
daily 200mg dose with low dose ABT.
- Patient enrollment is continuing 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, 200mg with ABT
and 100mg without ABT.
- Enrollment of 8 patients was completed in the open label 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. Given the positive pharmacokinetic (PK) and safety data,
ObsEva began the randomized, double blinded, placebo controlled,
Part B of the trial this quarter.
Upcoming Milestones
ObsEva expects to achieve the following clinical
and regulatory milestones in 2018 and 2019:
- Following recent feedback from regulatory authorities in
Europe, ObsEva plans to begin a Phase 3 trial prior to the end of
2018, or the IMPLANT 4 trial, primarily in European, Canadian and
CIS or Russian centers. ObsEva is planning to submit the European
Marketing Authorization Application (MAA) in late 2019, and has
commenced commercial planning. Recent feedback received from the
FDA did not provide the clarity that we were hoping to see on the
design of pivotal clinical trials to support an IVF indication in
the US. We are working with the FDA to get agreement on certain
elements, e.g. time of patient randomization, primary and secondary
endpoints and potential stratification by patient age. Upon
agreement with the FDA, which we hope will be achieved in 2019,
ObsEva is planning to pursue its clinical trial program in the
United States.
- Enrollment completion for the PRIMROSE 2 trial of linzagolix
for the treatment of uterine fibroids continues to be targeted for
Q4 of 2018, while PRIMROSE 1 enrollment completion is anticipated
in Q1 of 2019. Six-month primary endpoint data from both
trials are expected in H2 of 2019.
- For linzagolix in endometriosis, ObsEva will have an
end-of-Phase 2 meeting with the FDA prior to the end of 2018, and
plans to begin Phase 3 clinical trials in Q1 of 2019.
- Part B of the Phase 2a PROLONG clinical trial of OBE022 in
pre-term labor has commenced, and depending upon the rate of
enrollment, initial interim efficacy results from the trial in 30
patients is expected in Q1 of 2019.
Third Quarter 2018 Financial Results
Net loss for the third quarter of 2018 was $18.6
million, or ($0.42) per basic and diluted share, vs. $17.0 million
or ($0.59) per basic and diluted share for the third quarter of
2017. Research and development expenses were $15.9 million and
general and administrative expenses were $3.1 million for the
quarter ended September 30, 2018, vs. $13.9 million and $3.0
million, respectively, for the quarter ended September 30,
2017. Third quarter 2018 net loss included non-cash expenses
of $2.0 million for share-based compensation, as compared to $2.3
million in the prior period.
As of September 30, 2018, ObsEva had cash and
cash equivalents of $156.4 million.
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, 2p.m Central European
Time, to provide a business update and discuss third 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 3178666. 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, the timing of enrollment in and
data from clinical trials and the results of interactions with
regulatory authorities. 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, clinical
development and related interactions with regulators, 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 LampsDynamics Groupcla@dynamicsgroup.ch
+41 22 308 6220 Office+41 79 476 26 87 Mobile
Media Contact U.S.:Marion
JanicRooneyPartners LLCmjanic@rooneyco.com+1 212 223 4017 Office+1
646 537 5649 Mobile
CEO Office Contact:Shauna
DillonShauna.dillon@obseva.ch+41 22 552 1550
Investor Contact:Mario
CorsoSenior Director, Investor Relationsmario.corso@obseva.com+1
857 972 9347 Office+1 781 366 5726 Mobile
Consolidated Statements of Comprehensive
Loss
|
|
Three-month periodended
September 30, |
|
|
Nine-Month PeriodEnded
September 30, |
|
(in USD
’000, except per share data) |
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
|
|
unaudited |
|
|
unaudited |
|
Operating income other than revenue |
|
|
2 |
|
|
|
3 |
|
|
|
10 |
|
|
|
11 |
|
OPERATING EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses |
|
|
(15,909 |
) |
|
|
(13,910 |
) |
|
|
(46,945 |
) |
|
|
(40,983 |
) |
General and
administrative expenses |
|
|
(3,137 |
) |
|
|
(3,001 |
) |
|
|
(10,287 |
) |
|
|
(9,601 |
) |
Total
operating expenses |
|
|
(19,046 |
) |
|
|
(16,911 |
) |
|
|
(57,231 |
) |
|
|
(50,584 |
) |
OPERATING LOSS |
|
|
(19,043 |
) |
|
|
(16,908 |
) |
|
|
(57,221 |
) |
|
|
(50,573 |
) |
Finance
income |
|
|
430 |
|
|
|
(106 |
) |
|
|
616 |
|
|
|
754 |
|
Finance
expense |
|
|
— |
|
|
|
(1 |
) |
|
|
— |
|
|
|
(1 |
) |
NET LOSS
BEFORE TAX |
|
|
(18,613 |
) |
|
|
(17,015 |
) |
|
|
(56,605 |
) |
|
|
(49,820 |
) |
Income tax
expense |
|
|
23 |
|
|
|
21 |
|
|
|
23 |
|
|
|
(36 |
) |
NET LOSS
FOR THE PERIOD |
|
|
(18,590 |
) |
|
|
(16,994 |
) |
|
|
(56,582 |
) |
|
|
(49,856 |
) |
Net loss
per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
(0.42 |
) |
|
|
(0.59 |
) |
|
|
(1.45 |
) |
|
|
(1.78 |
) |
Diluted |
|
|
(0.42 |
) |
|
|
(0.59 |
) |
|
|
(1.45 |
) |
|
|
(1.78 |
) |
Weighted Average
Number of Shares Outstanding |
|
|
43,196,686 |
|
|
|
28,627,148 |
|
|
|
39,092,256 |
|
|
|
28,047,694 |
|
Consolidated Balance Sheets
(in USD
’000) |
|
September 30,2018 |
|
|
December 31,2017 |
|
|
|
unaudited |
|
|
audited |
|
ASSETS |
|
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
|
Cash and cash
equivalents |
|
|
156,439 |
|
|
|
110,841 |
|
Other
receivables |
|
|
695 |
|
|
|
783 |
|
Prepaid
expenses |
|
|
1,670 |
|
|
|
1,490 |
|
Total
current assets |
|
|
158,804 |
|
|
|
113,114 |
|
Non-current assets |
|
|
|
|
|
|
|
|
Furniture,
fixtures and equipment |
|
|
292 |
|
|
|
323 |
|
Intangible
assets |
|
|
21,608 |
|
|
|
21,608 |
|
Other long-term
assets |
|
|
273 |
|
|
|
190 |
|
Total
non-current assets |
|
|
22,173 |
|
|
|
22,121 |
|
Total
assets |
|
|
180,977 |
|
|
|
135,235 |
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
|
Current tax
liability |
|
|
17 |
|
|
|
51 |
|
Other payables
and current liabilities |
|
|
1,474 |
|
|
|
2,865 |
|
Accrued
expenses |
|
|
11,600 |
|
|
|
6,514 |
|
Total
current liabilities |
|
|
13,091 |
|
|
|
9,430 |
|
Non-current liabilities |
|
|
|
|
|
|
|
|
Post-employment
obligations |
|
|
3,004 |
|
|
|
3,099 |
|
Other long-term
liabilities |
|
|
49 |
|
|
|
55 |
|
Total
non-current liabilities |
|
|
3,053 |
|
|
|
3,154 |
|
Shareholders’ equity |
|
|
|
|
|
|
|
|
Share
capital |
|
|
3,413 |
|
|
|
2,864 |
|
Share
premium |
|
|
313,628 |
|
|
|
219,335 |
|
Reserves |
|
|
11,041 |
|
|
|
7,119 |
|
Accumulated
losses |
|
|
(163,249 |
) |
|
|
(106,667 |
) |
Total
shareholders’ equity |
|
|
164,833 |
|
|
|
122,651 |
|
Total
liabilities and shareholders’ equity |
|
|
180,977 |
|
|
|
135,235 |
|
###