Agile Therapeutics, Inc. Reports First Quarter 2017 Financial Results

PRINCETON, N.J., May 08, 2017 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq:AGRX), a women's healthcare company today reported financial results for the three months ended March 31, 2017, and provided a corporate update for the first quarter 2017.

First quarter 2017 and other recent corporate developments include:

• Twirla^® Update – In January 2017, the Company announced positive top-line results from its Phase 3 SECURE clinical trial of Twirla^®, its investigational low-dose combined hormonal contraceptive patch. SECURE was a multicenter, single-arm, open-label, 13 cycle trial that evaluated the safety, efficacy and tolerability of Twirla in 2,032 healthy women, aged 18 and over, at 102 experienced investigative sites across the United States. In April 2017, the Company announced it had received the final meeting minutes from its recent New Drug Application (NDA) pre-submission meeting with the U.S. Food and Drug Administration (FDA) for Twirla. Based on the feedback from the FDA, the Company believes it has the necessary information needed to complete the resubmission of its NDA, which is expected to be submitted by the end of the second quarter of 2017.
  
• Medical Congress Updates – In March 2017, the Company announced a poster presentation of data from the Phase 3 SECURE clinical trial for Twirla. The poster, titled “The SECURE Study, a Real-World Trial of a Low-Dose Contraceptive Patch: Addressing the Changing U.S. Population,” was presented at the Contraceptive Technology Conferences in San Francisco, CA and Boston, MA. The first author is Anita Nelson, MD, one of the co-primary investigators for the SECURE trial. On April 29, 2017, Dr. Anita Nelson presented “An Update on Hormonal Contraception and The Changing U.S. Population” at the Academy of Women’s Health, and on May 6, 2017, the Company also presented an interactive ePoster session during the 2017 Annual Clinical and Scientific Meeting of the American Congress of Obstetricians and Gynecologists. The ePoster included efficacy and safety findings for the overall population and pre-specified body mass index categories in the SECURE clinical trial. The ePoster also included results on the bleeding profile of subjects in the SECURE trial that have not previously been reported.
  
• Hercules Loan and Security Agreement Amendment – In May 2017, the Company amended its loan and security agreement with Hercules Capital, Inc. (Hercules) to extend the period during which the Company may draw an additional tranche of $8.5 million until January 31, 2018 subject to the consent of Hercules.

“During the first quarter, we continued to advance towards our goal of receiving regulatory approval for Twirla, participated in a productive pre-submission meeting with the FDA and continued to prepare our NDA for resubmission. Additionally we have had multiple scientific opportunities to discuss our Phase 3 SECURE trial results at medical conferences. We continue to expect to submit our NDA by the end of the second quarter of 2017,” said Al Altomari, Chairman and Chief Executive Officer of Agile. “Additionally, we continue to focus on developing our commercialization plans in coordination with the prudent management of our capital resources. We believe that the flexibility built into our business plan can enable us to fund our operations into the second quarter of 2018.”

First Quarter Financial Results