WALTHAM, Mass.--(BUSINESS WIRE)--OvaScienceSM (NASDAQ: OVAS), a global fertility company focused on the discovery, development and commercialization of new treatment options, today reported financial results and provided a business update for the first quarter ended March 31, 2017.
“During the first quarter, we advanced our portfolio of novel treatments for female fertility. We progressed our research and development efforts with OvaTure, and we are on track with patient enrollment in our ongoing clinical study of OvaPrime. We continue to expect multiple potential milestones by year-end, including the successful fertilization of a bovine Egg PC cell-derived egg and an initial data readout from our ongoing clinical study of OvaPrime,” said Michelle Dipp, M.D., Ph.D., Executive Chair and Co-Founder of OvaScience.
“By realigning our organization to increase our focus on OvaTure and OvaPrime, we have reduced our operational cash spend,” added Christophe Couturier, Chief Financial Officer of OvaScience. “We are now positioned to successfully execute on our strategic priorities, while also achieving our financial plans for 2017.”
First Quarter and Recent Business Highlights:
OvaTureSM Treatment: OvaTure is a potential next-generation in vitro fertilization (IVF) treatment that could help a woman produce healthy, young, fertilizable eggs without hormone injections by maturing egg precursor (EggPC SM) cells into eggs in vitro.
- Through its joint venture, OvaXonSM, OvaScience and Intrexon® (NYSE: XON) continue to progress fertilization studies for bovine EggPC cell-derived eggs. The companies remain on track to successfully fertilize a bovine EggPC cell-derived egg by year-end.
- OvaScience continues to work with its clinical partners to develop a repeatable and robust process for the maturation of human EggPC cells and to secure authorization to fertilize human EggPC cell-derived eggs and embryos by the end of the first half of 2018.
OvaPrimeSM Treatment: OvaPrime is a potential fertility treatment that could enable a woman who makes too few or no eggs to increase her egg reserve, by transferring her EggPC cells to her own ovary, where they may mature into fertilizable eggs.
- OvaScience is enrolling patients in its ongoing, prospective, controlled, blinded and randomized clinical study of OvaPrime, which is designed to evaluate the treatment’s safety and effect on patients’ hormone levels and follicular development as measured by ultrasound. The study is designed to enroll 70 women with either diminished ovarian reserve (DOR) or primary ovarian insufficiency (POI). To date, the Company has enrolled 60 patients and completed reintroductions in 36 patients.
- OvaScience expects to complete enrollment of 70 patients by the end of the first half of 2017 and to complete biopsies in 70 patients by year-end. OvaScience also expects to announce initial data from the first 20 patients, including six months of post-EggPC reintroduction safety data, by year-end.
AUGMENT SM Treatment: AUGMENT is a fertility treatment designed to improve egg health and with that, IVF success rates, by using mitochondria from a woman’s own EggPC cells during IVF.
- OvaScience continues to maintain its footprint for AUGMENT, offering the treatment to patients at clinics in Canada and Japan. The Company may opportunistically expand in these countries on a limited basis.
- OvaScience met with the U.S. Food and Drug Administration (FDA) and will continue to work with the agency under its available procedures to determine the most appropriate regulatory pathway for potential entry into the U.S. The Company will provide an update at the appropriate time in the future.
Upcoming 2017 Milestones
The Company expects to achieve the following milestones in 2017:
