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- 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
"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
- 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 6-10in 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 ObsEvabelieves 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,
ObsEvabegan the randomized, double blinded, placebo controlled, Part B of the trial this quarter.
- Following recent feedback from regulatory authorities in
Europe, ObsEvaplans 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. ObsEvais planning to submit the European Marketing Authorization Application (MAA) in late 2019, and has commenced commercial planning. Recent feedback received from the FDAdid 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 FDAto 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, ObsEvais 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,
ObsEvawill have an end-of-Phase 2 meeting with the FDAprior 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
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Conference Call Information
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
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Consolidated Statements of Comprehensive Loss
ended September 30,
Ended September 30,
|(in USD ’000, except per share data)||2018||2017||2018||2017|
|Operating income other than revenue||2||3||10||11|
|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||)|
|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|
|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,
|Cash and cash equivalents||156,439||110,841|
|Total current assets||158,804||113,114|
|Furniture, fixtures and equipment||292||323|
|Other long-term assets||273||190|
|Total non-current assets||22,173||22,121|
|LIABILITIES AND SHAREHOLDERS’ EQUITY|
|Current tax liability||17||51|
|Other payables and current liabilities||1,474||2,865|
|Total current liabilities||13,091||9,430|
|Other long-term liabilities||49||55|
|Total non-current liabilities||3,053||3,154|
|Total shareholders’ equity||164,833||122,651|
|Total liabilities and shareholders’ equity||180,977||135,235|