8-K

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

May 4, 2019

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)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol	Name of exchange on which registered:
Common stock, par value $0.0001 per share	AGRX	The Nasdaq Capital Market

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

On May 4, 2019, the Company presented an ePoster of combined safety data from the three Phase 3 studies of Twirla® (AG200-15), an investigational, once weekly, low-dose hormonal contraceptive patch, at the 2019 Annual Clinical and Scientific Meeting of the American Congress of Obstetricians and Gynecologists (ACOG) that was held from May 3rd through May 6th, 2019 in Nashville Tennessee.   Lead author Dr. Anita Nelson, MD, Professor and Chair of Obstetrics and Gynecology, Western University of Health Sciences presented the poster titled, “Safety of AG200-15, an Investigational Transdermal Patch, in Three Phase 3 Studies.”

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.

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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: May 6, 2019	By:	/s/ Alfred Altomari
	Name:	Alfred Altomari
	Title:	Chairman and Chief Executive Officer

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EX-99.1

Exhibit 99.1

Safety of AG200-15, an Investigational Transdermal Patch, in Three Phase 3 Studies Table 2. Phase 3 Studies Summary of Treatment Emergent Adverse Events Table 4. Phase 3 Studies Potentially Hormone-Related TEAEs and Application Site Disorder Adverse Events (> 2% of Subjects) (N=3481) Anita L. Nelson1, Andrew Kaunitz2, Robin Kroll3 James A. Simon4, Paula Castaño5, , Elizabeth I.O. Garner6 1 Western University of Health Sciences, Pomona, CA, David Geffen School of Medicine, Los Angeles, CA; 2 University of Florida College of Medicine-Jacksonville, Jacksonville, FL; 3 University of Washington, Seattle, WA; 4 George Washington University School of Medicine, and IntimMedicine Specialists, Washington, DC; 5 Columbia University Irving Medical Center, New York, NY 6 Agile Therapeutics, Princeton, NJ INTRODUCTION RESULTS • Across all three Phase 3 studies 6,556 subjects were screened and 3,611 were enrolled; ATI-CL23 accounted for over half of these subjects (Table 1) • Overall the mean age was 27.0, mean BMI was 27.9 (15.1 kg/m2 to 63.0 kg/m2), 35.1% were obese (BMI >30 kg/m2), 69.4% were White, 23% were Black or African American, and 18.3% were Hispanic or Latino • The safety population includes subjects who wore at least one patch for any length of time. Approximately half of the subjects who wore at least one patch completed the studies • AG200-15 (Twirla®) is alow-dose transdermal contraceptive delivery system under investigation as a once-weekly prescription contraceptive patch (Figure 1) • A 28-day cycle consists of consecutive administration of three 7-day patches followed by 7 days without treatment • We report the safety from three Phase 3 studies - SECURE (ATI-CL23) study, ATI-CL12, and ATI-CL13 the • Common TEAEs (i.e., those reported in at least 2% of subjects summarized in (Table 3) • Overall no individual TEAE was reported in > 6.0% of subjects are * A bundle of terms coded using MedDRA version 18.1 ** Application site disorder TEAE most frequently reported by subjects • Across all studies, 56 (1.6%) subjects reported SAEs • Hormone related SAEs occurring in 19 subjects included cholelithiasis (4), deep vein thrombosis/embolism venous (4), pulmonary embolism (3), cholecystitis (3), major depression (3), suicidal ideation (2), suicide attempt (1), necrotizing pancreatitis (1), vomiting (1) Figure 1. Schematic of the AG200-15 Contraceptive Patch (Not drawn to scale) • The most common reasons for discontinuation of study subject decision, lost to follow-up and adverse events drug were • In ATI-CL23, nasopharyngitis and upper respiratory tract infection were the two most frequently reported TEAEs; in ATI-CL12/13, nausea were the two TEAEs most frequently reported nasopharyngitis and • The percentage of subjects lost to follow-up was lower than in previous Phase 3 studies (ATI-CL12/13) combined Table 1. Phase 3 Studies Subject Disposition in ATI-CL23 • AmongtheobservedTEAEs,nausea, headache, considered cervicaldysplasia, dysmenorrhea, related TEAEs and increase weight were potentially hormone-- There were six women with venous thromboembolic events, five had baseline BMI > 30 kg/m2 and weight > 200 lbs There were six women with cholelithiasis or cholecystitis, all had baseline BMI > 35 kg/m2 and weight > 210 lbs Table 3. Phase 3 Studies Incidence of Most Common Treatment Emergent Adverse Events (> 2%) - AIM • To present the safety and tolerability profile of the investigational combined hormonal contraceptive AG200-15, in women of child bearing potential patch, CONCLUSION • AG200-15 was generally well-tolerated and had an overall favorable safety profile • The most-frequent hormone-related adverse events, none of which were experienced by more than 5% of subjects, were generally in line with adverse events observed in approved low dose combined hormonal products • Overall, patch-related skin irritation was infrequent and was mild in severity • Serious potentially hormone-related adverse events occurred in a population of women at higher baseline risk for these events (VTE and gallbladder disease) STUDY DESIGN, MATERIAL, & METHODS • SECURE(Study to EvaluateContraception Use, Reliability, and Effectiveness) was a single-arm, 13-cycle, open-label study conducted in 2014-2016 • ATI-CL12 (13-cycles) and ATI-CL13 (6-cycles) were open-label, randomized, active-controlled (approved oral contraceptives (OC)) safety and efficacy studies Note: Preferred terms are coded using MedDRA version 18.1 conducted in 2010-2011 • All study sites were in the U.S. • Treatment-emergentadverse Disclosures AN: Consultant/Advisor: Agile, AMAG Pharma, Bayer, ContraMed, Merck, Pharmanest; Honoraria/ Speaker: Bayer, Merck; Grants/Research Support: Agile, ContraMed, Estetra SPRL, Evofem Inc, FHI (MonaLisa), Mithra Pharma. • Overall 726 (Table 4) (20.9%) had TEAEs considered potentially hormone-related events (TEAEs) were • A total of 15.6% had a hormone-related TEAEs that were considered drug-evaluated and defined as adverse events that occurred from start of treatment to the day after the last patch was removed related, 1.6% had a hormone-related severe TEAEs, 0.6% had related SAEs, and 5.3% had a hormone-related TEAEs that discontinuation of the study drug a hormone resulted in AK: Consultant/Advisor: Bayer, Merck, Mithra;Consultant (institution): Medicines360; Research Support (institution): Agile, Allergan, Bayer, Evofem, Merck, Mithra. RK: Research Support: AbbVie, Agile, Allergan, Bayer, Chemo Group, Contramed, Merck, Mithra. 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, • An overall summary of TEAEs for subjects who wore the AG200-15 patch in the three Phase 3 studies is provided in (Table 2) • There were no deaths among subjects who wore the patch • Fewer than 2% of subjects had an SAE, and approximately 11% had TEAEs that resulted in study drug discontinuation • The percentages of subjects with any TEAE, SAE, and TEAE resulting in study drug discontinuation in ATI-CL23 were comparable to those seen in the previous Phase 3 studies (ATI-CL12/13) • Hormone-related the investigators adverse reactions were evaluated by and defined as reactions likely caused • Application site skin irritation was the most frequently reported application site disorder and the application site disorder TEAE most frequently leading to discontinuation of study drug by combination hormonal contraception • Subjects rated patch site skin irritation on a 4-point scale 2 = moderate, 4 = severe) (0 = none, 1 = mild, Allergan, Bayer, New EnglandResearch Institute, Palatin, Symbio, TherapeuticsMD; Stock Ownership: Sermonix. PC: Consultant/Advisor: Bayer; Research Support: Bayer. EG: Employee/Stock Ownership: Agile Therapeutics. • Across the safety population, for Cycles 1-13 combined, the subject-reported mean skin irritation score was 1.3 ATI-CL12/13 ATI-CL23 Overall Cycles 1-6 (CL13) (N=1220) 1-13 (CL12) (N=1450) 1-13 (N=2031) All (N=3481) Nasopharyngitis 64 (5.3%) 83 (5.7%) 116 (5.7%) 199 (5.7%) Upper respiratory tract infection 43 (3.5%) 55 (3.8%) 100 (4.9%) 155 (4.5%) Nausea 50 (4.1%) 64 (4.4%) 84 (4.1%) 148 (4.3%) Headache 41 (3.4%) 52 (3.6%) 72 (3.6%) 124 (3.6%) Urinary tract infection 26 (2.1%) 48 (3.3%) 72 (3.6%) 120 (3.5%) Cervical dysplasia 28 (2.3%) 90 (6.2%) 17 (0.8%) 107 (3.1%) Sinusitis 35 (2.9%) 52 (3.6%) 54 (2.7%) 106 (3.1%) Dysmenorrhea 22 (1.8%) 26 (1.8%) 47 (2.3%) 73 (2.1%) Weight increased 23 (1.9%) 30 (2.0%) 41 (2.0%) 71 (2.0%) ATI-CL12/13 ATI-CL23 Overall Cycles 1-6 (CL13) 1-13 (CL12) 1-13 All Women Screened 2243 2523 4033 6556 Randomized/Enrolled 1330 1579 2032 3611 Safety Population 1220 1450 2031 3481 Completed Study 597 (48.9%) 747 (51.5%) 989 (48.7%) 1736 (49.9%) Reason for Discontinuation Any 623 (51.1%) 703 (48.5%) 1042 (51.3%) 1745 (50.1%) Subject Decision 176 (14.4%) 200 (13.8%) 310 (15.3%) 510 (14.7%) Lost to Follow-up 207 (17.0%) 229 (15.8%) 229 (11.3%) 458 (13.2%) Adverse Events 135 (11.1%) 151 (10.4%) 222 (10.9%) 373 (10.7%) Non-compliance 42 (3.4%) 47 (3.2%) 116 (5.7%) 163 (4.7%) Pregnancy 38 (3.1%) 46 (3.2%) 73 (3.6%) 119 (3.4%) Investigator's Decision 14 (1.1%) 16 (1.1%) 17 (0.8%) 33 (0.9%) Protocol Violation 4 (0.3%) 4 (0.3%) 14 (0.7%) 18 (0.5%) Sponsor Decision 0 0 18 (0.9%) 18 (0.5%) Sponsor Decision (Study Termination) 0 0 2 (0.1%) 2 (0.1%) Death 0 0 0 0 Other 8 (0.7%) 10 (0.7%) 41 (2.0%) 51 (1.5%) Preferred Term Any Hormone-Related TEAE Severe TEAE Drug Related TEAE SAE TEAE Resulting in Discontinuing Study Drug Any Hormone-Related AE 726 (20.9%) 55 (1.6%) 543 (15.6%) 19 (0.6%) 183 (5.3%) Nausea 148 (4.6%) 5 (0.1%) 103 (3.0%) 0 26 (0.8%) Headache 124 (3.6%) 12 (0.3%) 75 (2.2%) 0 12 (0.3%) / Dysmenorrhea 73 (2.1%) 6 (0.2%) 56 (1.6%) 0 10 (0.3%) Weight Increased 71 (2.0%) 2 (0.1%) 58 (1.7%) 0 9 (0.3%) Application Site Disorder* 197 (5.7%) 24 (0.7%) 193 (5.5%) 0 125 (3.6%) Application site irritation** 64 (1.8%) 6 (0.2%) 64 (1.8%) 0 52 (1.5%) ATI-CL12/13 ATI-CL23 Overall Cycles 1-6 (CL13) (N=1220) 1-13 (CL12) (N=1450) 1-13 (N=2031) All (N=3481) Subjects with Any TEAEs 580 (47.5%) 781 (53.4%) 1085 (53.4%) 1866 (53.6%) Subjects with Any Study Drug-Related TEAEs 261 (21.4%) 338 (23.3%) 552 (27.2%) 890 (25.6%) Subjects with Severe TEAEs 50 (4.1%) 73 (5.0%) 92 (4.5%) 165 (4.7%) Subjects with SAEs 14 (1.2%) 16 (1.1%) 40 (2.0%) 56 (1.6%) Subjects with Study Drug-Related SAEs 3 (0.3%) 3 (0.2%) 15 (0.7%) 18 (0.5%) Subjects with TEAEs Resulting in Study Drug Discontinuation 119 (9.8%) 151 (10.4%) 224 (11.0%) 375 (10.8%) Subjects Who Died 0 0 0 0