UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(D)

of the Securities Exchange Act of 1934

 

August 31, 2015

Date of report (Date of earliest event reported)

 

 

Agile Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

001-36464

 

23-2936302

(State or other jurisdiction
of incorporation)

 

(Commission
File Number)

 

(IRS Employer
Identification No.)

 

101 Poor Farm Road
Princeton, New Jersey
(Address of principal executive offices)

 

08540
(Zip Code)

 

Registrant’s telephone number, including area code (609) 683-1880

 

 

(Former name or former address, if changed since last report)

 

 

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:

 

o                                    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425).

 

o                                    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12).

 

o                                    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)).

 

o                                    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


 

Item 8.01. Other Events.

 

On August 31, 2015, Agile Therapeutics, Inc. (“Agile”) issued a press release announcing that active recruitment has closed in its ongoing single-arm, open-label Twirla® Phase 3 SECURE clinical trial.  Participating sites will complete screening over the next two weeks, and Agile expects to complete enrollment by the end of the third quarter of 2015.  The SECURE study is a multicenter Phase 3 clinical trial of Twirla (AG200-15) which will enroll approximately 2,100 female subjects who will receive treatment for up to one year. The study will assess the effectiveness of the patch in preventing pregnancy using the Pearl Index as the primary contraceptive efficacy measure. Safety and tolerability will also be evaluated.

 

A copy of Agile’s press release is attached hereto as Exhibit 99.1 and is hereby incorporated by reference herein.

 

Item 9.01. Financial Statements and Exhibits.

 

(d)                                 Exhibits.

 

Exhibit
Number

 

Description

99.1

 

Agile Therapeutics, Inc. Press Release dated August 31, 2015 relating to the completion of patient recruitment in the SECURE clinical trial.

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

Agile Therapeutics, Inc.

 

 

 

 

Dated: August 31, 2015

By:

/s/ Alfred Altomari

 

Name:

Alfred Altomari

 

Title:

President and Chief Executive Officer

 

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