Financial Statements and Exhibits.Īgile Therapeutics, Inc. SECURE was a 1-year, multicenter, single-arm, open-label trial in 2032 healthy women aged 18 and over, at 102 experienced investigative sites across the United States.Ī copy of Agiles poster is attached hereto as Exhibit 99.1 and is hereby incorporated by reference herein. The SECURE clinical trial was designed to evaluate the efficacy, safety, and tolerability of AG200-15, also known as Twirla (levonorgestrel/ethinyl estradiol), in a representative population of women seeking birth control. Dr. Anita Nelson, MD, Professor and Chair, Obstetrics and Gyencology at the College of Osteopathic Medicine of the Pacific, will present the poster titled The Patch Wear Profile from SECURE: A Once-Weekly Low Dose Contraceptive Patch Study, which includes data on the adhesion profile and wearability of AG200-15. (∺gile) a womens healthcare company, has had a poster presentation of additional results from the Phase 3 SECURE study of AG200-15 (Twirla ®), an investigational, once weekly, low-dose hormonal contraceptive patch accepted at the 2018 Annual Clinical and Scientific Meeting of the American Congress of Obstetricans and Gynecologists (ACOG) being held April 27 th through April 30 th, 2018 in Austin, Texas. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter O Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) O Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)). O Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12). O Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425). Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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