OvaScience Reports First Quarter 2017 Financial Results
–Fertilization of Bovine EggPC Cell-Derived Egg in OvaTure Program on Track for Year-End–
–OvaPrime Clinical Trial Progressing Toward Year-End Initial Readout–
–Robust Financial Position Supports Corporate Strategy into 1Q19–
–Conference Call Today at 4:30 p.m. ET–
“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
“By realigning our organization to increase our focus on OvaTure and
OvaPrime, we have reduced our operational cash spend,” added
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,
OvaScienceand 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.
OvaSciencecontinues 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.
OvaScienceis 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.
OvaScienceexpects 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. OvaSciencealso 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.
OvaSciencecontinues to maintain its footprint for AUGMENT, offering the treatment to patients at clinics in Canadaand Japan. The Company may opportunistically expand in these countries on a limited basis.
OvaSciencemet 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 Companywill provide an update at the appropriate time in the future.
Upcoming 2017 Milestones
The Company expects to achieve the following milestones in 2017:
- Fertilize a bovine EggPC cell-derived egg by year-end
- Complete enrollment of 70 patients in the ongoing Canadian study by the end of the first-half
- Complete biopsies in 70 patients in the ongoing Canadian study by year-end
- Provide initial read-out, including six months of post-EggPC reintroduction safety data from 20 patients, by year-end.
First Quarter 2017 Financial Results
Revenue for the quarter ended
March 31, 2017was $63,000, compared to $146,000in the same period of 2016.
Research and development expense for the quarter ended
March 31, 2017, excluding restructuring charges, was $5.8 million, compared to $6.0 millionfor the same period in 2016. This decrease was driven primarily by a $0.8 milliondecrease in stock-based compensation expense and a $0.4 milliondecrease in costs associated with certain ongoing research agreements, partially offset by a $1.0 millionincrease in costs related to the refocus from commercial expansion to research and development.
Selling, general and administrative expense for the quarter ended
March 31, 2017, excluding restructuring charges, was $7.1 million, compared to $14.5 millionfor the same period in 2016. This year-over-year decrease of $7.3 million, or 51%, was driven by a $4.2 milliondecrease in employee-related costs due to reduced headcount, a $1.8 milliondecrease in marketing-related costs, and a $1.3 milliondecrease in legal, accounting, tax and other related expenses associated with international expansion.
Net loss for the quarter ended
March 31, 2017was $14.9 million, or ($0.42)per share, compared to net loss of $21.8 million, or ($0.80)per share, for the same period in 2016. The net loss for the quarter ended March 31, 2017includes restructuring charges of $1.5 million.
This press release includes forward-looking statements about the Company’s plans for the OvaPrime treatment, OvaTure treatment and AUGMENT treatment, including statements relating to the Company’s plans to fertilize a bovine EggPC cell-derived egg by year-end; to complete enrollment of all 70 patients in the ongoing Canadian study of OvaPrime by the end of the first half of 2017; to complete biopsies in all patients in the ongoing Canadian study of OvaPrime by year-end; to present initial data from 20 OvaPrime patients, including six months of post-EggPC reintroduction safety data, by year-end; availability of sufficient funding to support the preclinical development of OvaTure and clinical development of OvaPrime into the first quarter of 2019; the Company’s further efforts on human egg maturation; the Company’s plans to work with its clinical partners in pursuit of its goals to develop a repeatable and robust process for the maturation of human EggPC cells and to secure authorization to fertilize human EggPC cell-derived eggs and embryos by the end of the first half of 2018; the Company potentially expanding its AUGMENT footprint in
- Financial Tables to Follow –
|Condensed Consolidated Balance Sheets|
|Cash and cash equivalents||$||25,433||$||43,930|
|Prepaid expenses and other current assets||2,048||2,056|
|Total current assets||101,150||116,444|
|Property and equipment, net||4,707||5,572|
|Investment in joint venture||-||65|
|Other long-term assets||23||23|
|Liabilities and stockholders’ equity|
|Total current liabilities||10,591||13,209|
|Other non-current liabilities||1,006||1,116|
|Total stockholders’ equity||94,722||108,218|
|Total liabilities and stockholders’ equity||$||106,319||$||122,543|
|Condensed Consolidated Statements of Operations|
|(In thousands, except per share data)|
Three Months Ended
|Costs and expenses:|
|Costs of revenues||269||1,176|
|Research and development||5,764||5,955|
|Selling, general and administrative||7,129||14,454|
|Total operating expenses||14,650||21,585|
|Loss from operations||(14,587||)||(21,439||)|
|Interest income, net||182||174|
|Other expense, net||(60||)||(27||)|
|Loss from equity method investment||(421||)||(391||)|
|Loss before income taxes||(14,886||)||(21,683||)|
|Income tax expense||(9||)||75|
|Net loss per share—basic and diluted||$||(0.42||)||$||(0.80||)|
|Weighted average number of shares used in net loss per share—basic and diluted||35,642||27,301|
Media and Investor Contact:
Jennifer Viera, 617-420-8748