Agile Therapeutics Reports Third Quarter 2016 Financial Results And Announces Completion Of Subject Visits For Twirla® Phase 3 SECURE Clinical Trial

Top-Line Data Expected in Early January 2017; Resubmission Planned for First Half 2017

 Cash Expected to Fund Operations Through the End of 2017

PRINCETON, N.J., Nov. 07, 2016 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq:AGRX), a women's health specialty pharmaceutical company, today announced completion of all final subject visits for its Twirla ® Phase 3 SECURE clinical trial, reported financial results for the three and nine months ended September 30, 2016, and provided a corporate update for the third quarter 2016.

"Completion of all subject visits in our SECURE clinical trial is a significant milestone in the development of Twirla," said Elizabeth Garner, M.D., M.P.H., Chief Medical Officer of Agile.  "We can now move forward with data verification and database lock activities, which we anticipate being completed by the end of December 2016. We will then proceed with initial data analysis and expect to announce top-line data in early January 2017.  We believe we have conducted a well-run trial focused on quality and the key metrics the U.S. Food and Drug Administration (FDA) has indicated would be most important in their assessment of SECURE. We look forward to submitting a comprehensive package of reliable data that we believe can respond to the FDA's questions as well as establish the safety and efficacy profile for Twirla. We would like to thank our investigators and their staff, our partners and, most importantly, the women who participated in SECURE for helping us conduct such a rigorous study."

SECURE is a multicenter, single-arm, open-label Phase 3 clinical trial evaluating the safety, efficacy and tolerability of Twirla in 2032 healthy women aged 18 and over at 102 experienced investigative sites across the United States.  The clinical trial was designed in consultation with the FDA in response to their 2013 complete response letter (CRL).  The FDA recommended that the Company conduct a clinical trial that would address prior conduct and quality issues and demonstrate efficacy as measured by an acceptable pearl index and related confidence interval in a representative sample of U.S. women with respect to key demographic criteria including contraceptive user status, age, race, ethnicity, and body mass index (BMI).  Twirla contains the active ingredients ethinyl estradiol and levonorgestrel, both of which have an established history of efficacy and safety in currently marketed low-dose combination oral contraceptives. The patch is intended to be applied once weekly for three weeks followed by a patch-free week, and is designed to promote user compliance.

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