Agile Therapeutics Reports Second Quarter 2016 Financial Results

8/9/16

PRINCETON, N.J., Aug. 08, 2016 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq:AGRX), a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products, today reported financial results for the three and six months ended June 30, 2016 and provided a corporate update for the second quarter 2016.

Second quarter 2016 and other recent corporate developments include:

  • In June 2016, the Company received notice that the U.S. Patent and Trademark Office issued a patent with claims covering the formulation of a progestin-only transdermal patch containing levonorgestrel.
  • In July 2016, the Company announced the appointment of Renee Selman as its new Chief Commercial Officer. Ms. Selman is a former senior executive at Johnson & Johnson who led the commercial launch of ORTHO EVRA®, one of the most successful contraceptive launches in the U.S. and the first ever contraceptive patch.
  • In July 2016, the Company announced that it planned to begin clinical development of AG200-SP, an intended line extension of Twirla®, a once weekly contraceptive patch currently in Phase 3 development. The Company is preparing to conduct an initial Phase 2 clinical trial that will examine the use of AG200-SP in a novel regimen designed to allow women to experience shorter, lighter periods. The planned AG200-SP regimen will include the use of Twirla for three weeks followed by the use of a small patch in the fourth week of the woman’s cycle. The initial Phase 2 clinical trial is designed to optimize the bleeding profile by delivering hormones beyond the typical 21-day regimen using a smaller lower-dose combination ethinyl/levonorgestrel patch in the fourth week of the woman’s cycle.
  • In July 2016, the Company announced the appointment of Seth H. Z. Fischer to the Company’s Board of Directors. Mr. Fischer, who brings significant management and commercial experience, has more than three decades of healthcare experience in the pharmaceutical and medical device industry and currently serves as Chief Executive Officer and Director of Vivus, Inc., a publicly traded biopharmaceutical company.

“During the first half of this year, we believe we made significant progress on the execution of our business strategy to build a commercially competitive women’s health franchise,” stated Al Altomari, President and Chief Executive Officer of Agile. “Our primary focus continues to be on the SECURE trial, which we expect to complete in the fourth quarter of 2016. In addition, with the planned clinical development of our first line extension for Twirla, we believe we will be positioned to expand our market potential.”

Second Quarter 2016 Financial Results

  • Cash and cash equivalents: As of June 30, 2016, Agile had $59.2 million of cash and cash equivalents compared to $34.4 million of cash and cash equivalents as of December 31, 2015. Based on its current business plan, Agile believes its cash and cash equivalents will be sufficient to meet its operating requirements through the end of 2017.
  • Research and development (R&D) expenses: R&D expenses were $5.6 million for the quarter ended June 30, 2016, compared to $6.2 million for the comparable period in 2015. The decrease in R&D expense was primarily due to decreased clinical site costs associated with the ongoing Phase 3 clinical trial for Twirla.
  • General and administrative (G&A) expenses: G&A expenses were $2.3 million for the quarter ended June 30, 2016, compared to $1.8 million for the comparable period in 2015. The increase in G&A expenses was primarily due to increased stock-based compensation expense associated with 2016 stock option grants as well as increased legal costs, search fees and consulting expense.
  • Net loss: Net loss was $8.4 million, or $0.29 per basic share for the quarter ended June 30, 2016, compared to a net loss of $8.5 million, or $0.38 per basic share for the quarter ended June 30, 2015.
  • Shares Outstanding: At June 30, 2016, Agile had 28,752,719 shares of common stock outstanding.

About Agile Therapeutics, Inc.
Agile Therapeutics is a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products. Our product candidates are designed to provide women with contraceptive options that offer greater convenience and facilitate compliance. Our lead product candidate, Twirla®, (ethinyl estradiol and levonorgestrel transdermal system), also known as AG200-15, is a once-weekly prescription contraceptive patch currently in Phase 3 clinical development. Twirla is based on our proprietary transdermal patch technology, called Skinfusion®, which is designed to provide advantages over currently available patches and is intended to optimize patch adherence and patient acceptability. For more information, please visit the company website atwww.agiletherapeutics.com. The company may occasionally disseminate material, nonpublic information on the company website.

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