Evofem Biosciences (EVFM) Reports Q2 Loss of $1.11
Evofem Biosciences (NASDAQ: EVFM) reported Q2 EPS of ($1.11), versus ($0.48) reported last year.
Second Quarter Financial Results and Recent Highlights:
- Significant numbers of women completed the 6-month treatment phase of our fully enrolled, confirmatory, Phase 3 clinical trial of Amphora® (L-lactic acid, citric acid, and potassium bitartrate) vaginal gel for the prevention of pregnancy (AMP002). With the study continuing to move ahead of schedule, the Company now expects to report top-line results in late 2018.
- Received positive early findings from a market research survey querying user satisfaction among women who have completed AMP002 and their male partners, and related observations from participating study investigators. Evofem expects to present results of the commissioned User Experience Satisfaction Survey at medical society meetings once completed.
- Advanced patient enrollment in our Phase 2b clinical trial evaluating the ability of Amphora to prevent urogenital acquisition of Chlamydia trachomatis (primary endpoint). 1.6 million new cases of chlamydia were reported in 2016 in the U.S. alone.1
- Raised $37.5 million in net proceeds from a public offering of stock and pre-funded warrants to new and existing institutional investors, net of underwriting discounts and commissions but excluding estimated offering costs.
- Unrestricted cash increased to $22.8 million at June 30, 2018, as compared to $5.0 million at March 31, 2018.
"The second quarter of 2018 was highlighted by the successful completion of a financing that significantly strengthened our balance sheet while bringing several new healthcare-focused institutional investors into our shareholder base," said Saundra Pelletier, CEO of Evofem.
"Since completing enrollment in our confirmatory Phase 3 trial of Amphora for contraception ahead of schedule in February 2018, we have been actively supporting the 112 participating U.S. study centers as women complete the treatment phase, while preparing for data lock and analysis. Over 400 women have now completed their last visit, and based on progress of the remaining women we now anticipate the last participant out will be this fall, enabling us to report top-line results in late 2018. Assuming positive results, we will re-submit the Amphora New Drug Application (NDA) in the first half of 2019, positioning us to commercialize Amphora as the first and only hormone-free, on-demand contraceptive drug in early 2020."
For earnings history and earnings-related data on Evofem Biosciences (EVFM) click here.
