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

 

October 5, 2018

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))

 

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

 

Emerging growth company  x

 

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. x

 

 

 



 

Item 8.01. Other Events.

 

Agile Therapeutics, Inc. (“Agile”) a women’s healthcare company, will have 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 American Society for Reproductive Medicine 2018 Scientific Congress & Expo (ASRM) being held October 6th through October 10th, 2018 in Denver, Colorado.  Dr. Paula M. Castaño, MD, MPH, Associate Professor of Obstetrics and Gynecoloy at Columbia University Medical Center, will present the poster titled The Safety Profile of an Investigational Contraceptive Patch in Women With and Without Hormonal Contraceptive Experience, which includes safety data on AG200-15.

 

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.  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.

 

A copy of Agile’s poster 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. Poster Presentation to be available between October 6-10, 2018.

 

2



 

SIGNATURES

 

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

 

 

Agile Therapeutics, Inc.

 

 

 

 

Dated: October 5, 2018

By:

/s/ Alfred Altomari

 

Name:

Alfred Altomari

 

Title:

Chairman and Chief Executive Officer

 

3


Exhibit 99.1

Paula M. Castañoa, James A. Simonb, Beatrice A. Chenc, Lisa Floodd, Michelle Previterad, Joseph A. Chiodo IIId, Elizabeth I.O. Garnerd aColumbia University Irving Medical Center, 622 West 168th Street, New York, NY 10032, USA; bGeorge Washington University, Women's Health & Research Consultants®, 1850 M Street, NW #450 Washington, DC 20036; cUniversity of Pittsburgh/Magee-Womens Research Institute, 300 Halket Street, Pittsburgh, PA 15213, USA; dAgile Therapeutics, 101 Poor Farm Road, Princeton, NJ 08540, USA. • The mean age (in years) of naïve users was 24.5 and 27.9 for current users. Further baseline information is presented in Table 2 Safety • AG200-15 (Twirla®) is a transdermal contraceptive delivery system under investigation as a once-weekly prescription contraceptive patch AG200-15 delivers daily exposure of 120 g of levonorgestrel (LNG) and 30 g of ethinyl estradiol (EE) A 28-day cycle consists of consecutive administration of three 7-day patches followed by 7 days off-treatment SECURE (Study to Evaluate Contraception Use, Reliability, and Effectiveness) was a 1-year, single-arm, open-label, multicenter Phase 3 study of the contraceptive efficacy, safety and tolerability of AG200-15 (ClinicalTrials.gov NCT02158572) • • • • 2031 participants applied at least one patch and were included in the safety analysis o49% of subjects completed the study 1085 (53%) subjects experienced a TEAE (Table 4) 552 (27%) were definitely related, probably related, or possibly related to study drug 224 (11%) subjects discontinued due to an adverse event • 3 naïve users and 6 current users experienced 10 serious adverse events (SAEs) (Table 6) oOne current user experienced 2 SAEs 6 of the 10 SAEs were characterized as unrelated to study drug Table 1: Subject Disposition • • • Table 6. Serious Adverse Events • Table 4. Safety Evaluation • To evaluate the safety of the AG200-15 patch in women with a range of experience with hormonal contraception. related • SECURE employed broad enrollment criteria with no restrictions on body mass index or weight Subjects were 18 years of age, sexually active, and with menses every 21-38 days All study sites were in the U.S. Safety was evaluated for women who were: oCurrent (actively using a hormonal contraceptive at study entry) users of hormonal contraception oNaïve (had never used any hormonal contraceptive) users of hormonal contraception Treatment-emergent adverse events (TEAEs) were evaluated and defined as adverse events that occurred from start of treatment to the day after the last patch was removed Hormone-related adverse reactions were evaluated and defined as reactions likely caused by combination hormonal contraception *Drug-related: definitely related, probably related, or possibly related. Table 2. Baseline Population Characteristics • • For naïve users (Table 5): 81 (43%) reported TEAEs 16 (8%) reported TEAEs resulting in study drug discontinuation 3 (2%) reported SAEs 2 (1%) reported SAEs resulting in study drug discontinuation o o o o • • *Ectopic Pregnancy was classified as occurring on treatment • For current users: 431 (61%) reported TEAEs 92 (13%) reported TEAEs resulting in study drug discontinuation 6 (0.9%) reported SAEs 3 (0.4%) reported SAEs resulting in study drug discontinuation Summary of TEAEs o o o o Table 5. • Overall, the safety profile for AG200-15 is comparable to recently approved combined hormonal contraceptives1 Higher percentages of any TEAEs and TEAEs resulting in study drug discontinuation were reported among women who were current users compared to naïve users. Knowledge of the contraceptive history of women seeking hormonal contraception may help prescribers focus their counseling. Hormone-related adverse events were similar between naïve and current users. • • • • • • • Of current users, 551 (78%) had never used transdermal contraceptives The most widely used current hormonal contraceptive method was oral contraceptive pills (33%) (Table 3) The most used method overall was the male condom with or without spermicide (57%) • 1 Grossman Barr N. Managing Adverse Effects of Hormonal Contraceptives. Am Fam Physicians. 2010;82(12):1499-1596. Figure 1. Schematic of the AG200-15 Contraceptive Patch (Not an actual patch; Not drawn to scale) Table 3. Summary of Current Contraceptive Methods PC: Consultant/Advisor: Bayer, Merck; Research Support: Bayer, Merck. JS: Consultant/Advisor: AbbVie, Allergan, AMAG, Amgen, Ascend, Azure, Millendo, Nuelle, Radius, Regeneron, Roivant, Sanofi, Sebela, Sermonix, Shionogi, Symbiotec, TherapeuticsMD, Valeant; Speaker: Novo Nordisk, Shionogi, Valeant; Research Support: AbbVie, Agile, Allergan, Bayer, New England Research Institute, Palatin, Symbio, TherapeuticsMD; Stock Ownership, Sermonix. BC: Research support: Medicines 360 and Merck, managed by Magee-Womens Research Institute. Advisory board: Merck. LF: Former employee of Agile Therapeutics. MP: Former Consultant/Advisor: Agile Therapeutics. JC/EG: Employee/Stock Ownership: Agile Therapeutics. *Drug-related: definitely related, probably related, or possibly related. • Hormone-related adverse events reported by at least 2% of naïve users were headache (n=8, 4.2%), nausea (n=6, 3.2%), dysmenorrhea (n=5, 2.6%), mood swings (n=4, 2.1%), and acne (n=3, 1.6%) For current users, hormone-related adverse reactions reported by at least 2% were nausea (n=27, 3.8%), headache (n= 23, 3.3%), dysmenorrhea (n=21, 3.0%), acne (n=16, 2.3%), and mood swings (n=8, 1.1%) • Subject Disposition and Characteristics • • 190 naïve users were enrolled in the study and 78 (41%) completed the study (Table 1) 704 current users were enrolled and 403 (57%) completed the study Former and recent users are not presented *Two subjects reported both patch and oral • Presented at American Society for Reproductive Medicine 2018 Scientific Congress & Expo October 6-10, 2018, in Denver, CO Current Contraceptive MethodUsers n (%) Oral*604 (33) Patch*41 (2) Vaginal Ring61 (3) Injectable1 (0.1) Male Condom with or without Spermicide1050 (57) Female Condom with or without Spermicide12 (0.7) Diaphragm, Cervical Cap, or Sponge with or without6 (0.3) Spermicide Rhythm Method (Fertility Awareness), Withdrawal, or314 (17) Outercourse Emergency Contraception1 (0.1) Other4 (0.2) DISCLOSURES RESULTS REFERENCES ParameterNaïve Users (%,Current Users (%, n=190)n=704) TEAEs81 (43)431 (61) Study-Related* TEAEs45 (24)221 (31) Severe TEAEs6 (3)31 (4) Serious TEAEs (SAE)3 (2)6 (0.9) (including death) Drug-Related* Serious1 (0.5)3 (0.4) TEAEs (SAE) TEAEs Resulting in16 (8)92 (13) Study Drug Discontinuation TEAEs Resulting in00 Death CONCLUSIONS ParameterNaïve Users (n=190)Current Users (n=704) Age, mean (SD)24.5 years (5.7)27.9 years (6.2) Weight, median (range)73.9 kg (39.5-147.0)73.8 kg (39.0-144.7) BMI, median (range)27.5 kg/m2 (16.7-50.7)27.4 kg/m2 (15.1-51.5) BMI  30 kg/m2(obese), %3329 Black/ African3116 American, % White, %5675 Hispanic/ Latino, %2818 STUDY DESIGN, MATERIAL, & METHODS OBJECTIVE Serious Adverse EventUser StatusStudy Drug Relationship AppendectomyNaïveUnrelated Suicide AttemptNaïvePossibly related Ectopic Pregnancy*NaïveUnrelated Bipolar DisorderCurrentUnrelated Seizure/Recurrent SeizureCurrentUnrelated/Possibly Deep Vein ThrombosisCurrentUnrelated CholelithiasisCurrentPossibly Related AppendicitisCurrentUnrelated Pulmonary EmbolismCurrentProbably related CategoryAG200-15 (%, N=2031) Subjects with Any TEAEs1085 (53) Subjects with Any Study Drug-Related* TEAEs552 (27) Subjects with Severe TEAEs92 (5) Subjects with Serious TEAEs (SAE)40 (2) Subjects with Study Drug-Related* Serious TEAEs15 (0.7) (SAE) Subjects with TEAEs Resulting in Study Drug224 (11) Discontinuation Subjects with TEAEs Resulting in Death0 Disposition StatusNaïve UsersCurrent (%)Users (%) Enrolled190704 Safety190704 Completer78 (41)403 (57) Reason for Discontinuation Any Reason112 (59)301 (43) Adverse Event13 (7)93 (13) Death00 Non-Compliance22 (12)26 (4) Lost to Follow Up33 (17)48 (7) Subject Decision29 (15)92 (13) Pregnancy7 (4)15 (2) INTRODUCTION