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- Phase 3 Programs Underway in Uterine Fibroids and Assisted Reproduction Technology (ART) -
"The first quarter was a transformational time for
Commencement of Phase 3 programs and Early Stage Study Progress
- In April, the Company began enrollment of the PRIMROSE 1 and 2 studies of OBE2109, its oral GnRH receptor antagonist for the treatment of uterine fibroids. This Phase 3 program will enroll a total of approximately 1,000 women, with the goal of reducing heavy menstrual bleeding.
- In March,
ObsEvabegan enrollment of the IMPLANT 2 study of nolasiban (OBE001), its oral oxytocin antagonist for use in ART. This Phase 3 trial will enroll 760 patients in Europewith the goal of increasing live birth rates following in vitro fertilization (IVF).
- Also in March, the Company presented data at the
Society for Reproductive Investigation's64th Annual Scientific Meeting on its first-in-class, once daily, oral and selective prostaglandin F2alpha (PGF2alpha) receptor antagonist, OBE022. The study demonstrated statistically significant delays in RU486-induced preterm labor in an animal model, including a clear synergistic effect with standard of care nifedipine.
February 2017, the Company completed a Phase 1 clinical trial assessing the safety, tolerability and PK profile of OBE022 in healthy post-menopausal female volunteers. OBE022 was observed to have a favorable PK profile, no clinically significant food effect, a favorable safety profile and to be well-tolerated at the highest doses tested.
January 25, 2017the Company raised gross proceeds of $96.8 millionon the NASDAQ Global Select Market.
- Opening ObsEva USA Inc. in
Boston. In January 2017, Tim Adamsjoined ObsEvaas Chief Financial Officer and is leading the company's Bostonoffice. The ObsEva Boston office will house finance, IR, and Clinical Operations teams.
- Final PK/PD study results for OBE2109 in combination with add back therapy (ABT) in 2Q:17;
- Commencement of Phase 2a clinical trial of OBE022 in pre-term labor in 2H:17;
- Completion of enrollment of Phase 3 IMPLANT2 trial of nolasiban for assisted reproduction by the end of 2017, with data release planned 1H:18; and
- Completion of enrollment of Phase 2b EDELWEISS trial of OBE2109 for the treatment of endometriosis by the end of 2017, with data release planned 1H:18.
First Quarter 2017 Financial Results
Net loss for the first quarter of 2017 was
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
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Consolidated Statement of Comprehensive Loss
(in USD '000, except per share data)
|Three-month period ended March 31,|
|Other operating income||6||3|
|Research and development expenses||(13,057)||(3,815)|
|General and administrative expenses||(2,745)||(659)|
|Total operating expenses||(15,802)||(4,474)|
|NET LOSS BEFORE TAX||(15,538)||(4,681)|
|Income tax expense||-||-|
|NET LOSS FOR THE PERIOD||(15,538)||(4,681)|
|Net loss per share|
OTHER COMPREHENSIVE INCOME
|Items that will not be reclassified to profit and loss|
|Remeasurements on post-retirement benefit plans||-||-|
Items that may be reclassified to profit or loss
|Currency translation differences||-||2,403|
|TOTAL OTHER COMPREHENSIVE INCOME||-||2,403|
|TOTAL COMPREHENSIVE LOSS FOR THE PERIOD||(15,538)||(2,278)|
Consolidated Balance Sheet
| (in USD '000)
||As at March 31, 2017||As at December 31, 2016|
|Cash and cash equivalents||104,158||25,508|
|Prepaid expenses and deferred costs||1,047||2,415|
|Total current assets||106,193||28,706|
|Plant and equipment||118||121|
|Other long-term assets||171||90|
|Total non-current assets||16,897||16,819|
|LIABILITIES AND SHAREHOLDERS EQUITY|
|Other payables and current liabilities||1,836||2,383|
|Total current liabilities||8,748||6,652|
|Total non-current liabilities||2,859||2,832|
|Total shareholders' equity||111,483||36,041|
|Total liabilities and shareholders' equity||123,090||45,525|