- 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".
- 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.
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.
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