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

 

November 18, 2014

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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

On November 18, 2014, the Board of Directors (the “Board”) of Agile Therapeutics, Inc. (the “Company”), appointed John W. Hubbard, Ph.D. FCP, as a director and as a member of the Board’s Nominating and Corporate Governance Committee.  Dr. Hubbard will serve as a Class I member of the Board.  The terms of Class I directors expire at the 2015 Annual Meeting of Shareholders.

 

Dr. Hubbard currently serves as Senior Vice President and Worldwide Head of Development Operations for Pfizer Inc., and is responsible for the global clinical trial operations and management of more than 450 clinical projects from Phase I to IV.  He recently announced that he will leave Pfizer in January 2015, to pursue an executive leadership role in the healthcare services area. Dr. Hubbard has been leading pharmaceutical research and development activity for nearly thirty years and held positions of increasing responsibility in the biopharmaceutical and clinical research & development services industries.  Prior to joining Pfizer in 2010, he was Group President, Clinical Research Services at ICON Clinical Research, a leading global clinical research organization, where he was responsible for the global business and operations. During his career, Dr. Hubbard has been directly responsible for drug discovery and non-clinical pharmacology, clinical pharmacology, project management, product development optimization, commercial assessment of new chemical entities, and clinical development operations.  He has led several drug development teams to successful commercialization of new chemical entities and has participated at FDA meetings to support end of Phase II and end of Phase III data presentations for psychiatric, neurological, cardiovascular, and anti-infective drugs.  Based on his extensive scientific, drug development, and clinical operations management experience, the Company believes he will be a valuable addition to the Board.

 

Dr. Hubbard will receive the standard compensation amounts payable to non-employee directors of the Company, as described in the Company’s final prospectus relating to its initial public offering.  His annual cash retainer will be pro-rated for 2014 to reflect his expected term of service during the calendar year. Also pursuant to these arrangements, on November 18, Dr. Hubbard received an initial grant of an option to purchase 21,000 shares of the Company’s common stock with an exercise price equal to the closing price of the Company’s common stock on the date of grant. The option vests in three equal annual installments beginning on November 18, 2015, subject to the his continued service on the Company’s Board through each vesting date and provided that he attends at least 75% of the Board meetings held during each respective year of Board service.

 

Item 7.01 Regulation FD Disclosure

 

On November 18, 2014, the Company issued a press release announcing that Dr. John W. Hubbard, Ph.D. FCP had been appointed to the Company’s Board.  The Company is furnishing a copy of the press release, which is attached hereto as Exhibit 99.1.

 

In accordance with General Instructions B.2 and B.6 of Form 8-K, the information included in Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1 attached hereto), shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act

 

2



 

or Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.

 

Item 9.01.                Financial Statements and Exhibits.

 

(d)                                 Exhibits.

 

Exhibit
Number

 

Description

99.1

 

Agile Therapeutics, Inc. Press Release dated November 18, 2014.

 

3



 

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: November 18, 2014

By:

/s/ Alfred Altomari

 

Name:

Alfred Altomari

 

Title:

President and Chief Executive Officer

 

4


Exhibit 99.1

 

Agile Therapeutics Appoints John Hubbard, Ph.D., FCP to its Board of Directors

 

PRINCETON, N.J., November 18, 2014 — Agile Therapeutics, Inc., (Nasdaq: AGRX) today announced that John Hubbard, Ph.D., FCP has been appointed to the Company’s Board of Directors, effective November 18, 2014.  Dr. Hubbard will serve on Agile’s Nominating and Corporate Governance Committee.

 

“John’s exceptional pharmaceutical experience and expertise leading global clinical trial operations and research and development programs will provide us with a valuable perspective as we advance our Phase 3 clinical trial for Twirla®,” said Al Altomari, President and Chief Executive Officer at Agile.  “We welcome John to our board and look forward to his insight and guidance as we continue to execute on our core strategies to develop innovative women’s contraceptive healthcare products.”

 

Dr. John Hubbard currently serves as Senior Vice President and Worldwide Head of Development Operations for Pfizer Inc., and is responsible for the global clinical trial operations and management of more than 450 clinical projects from Phase 1 to 4.  He recently announced that he will leave Pfizer in January 2015, to pursue an executive leadership role in the healthcare services area. Dr. Hubbard has been leading pharmaceutical research and development activity for nearly thirty years and held positions of increasing responsibility in the biopharmaceutical and clinical research & development services industries.  Prior to joining Pfizer in 2010, he was Group President, Clinical Research Services at ICON Clinical Research, a leading global clinical research organization, where he was responsible for the global business and operations. During his career, Dr. Hubbard has been directly responsible for drug discovery and non-clinical pharmacology, clinical pharmacology, project management, product development optimization, commercial assessment of new chemical entities, and clinical development operations.  He has led several drug development teams to successful commercialization of new chemical entities and has participated at FDA meetings to support end of Phase 2 and end of Phase 3 data presentations for psychiatric, neurological, cardiovascular, and anti-infective drugs.

 

He is a member of the Society of Clinical Pharmacology and Therapeutics, Drug Information Association and served on the Special Interest Advisory Committee on Project Management.  He also served as Chairman of the Fellow of the American College of Clinical Pharmacology (ACCP) Public Policy Committee from 1999 to 2007.  Dr. Hubbard is a Board Certified Diplomat in Applied Pharmacology and elected to Fellow of the ACCP in 1994.  Dr. Hubbard received a Bachelor of Science degree in Biopsychology from the University of Santa Clara and a Doctorate from the University of Tennessee, with a research focus on the genetic basis of hypertension and autonomic dysfunction.  He was a National Institute of Health Postdoctoral Fellow in Cardiovascular and Clinical Pharmacology at the University of Texas Health Sciences Center.

 

Dr. Hubbard has authored and co-authored several book chapters and published numerous articles and abstracts in the areas of biopsychology, cardiovascular and autonomic pharmacology, clinical pharmacology, and global drug development. He is a Board Member of TransCelerate Biopharma, Inc., a Business Advisory Board Member of SAFE Biopharma, and an Advisory Board Member and Fundraising Vice-chair for the Children’s Brain Tumor Foundation.

 

About Agile

 

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 at www.agiletherapeutics.com.