0001193125-16-495883.txt : 20160308 0001193125-16-495883.hdr.sgml : 20160308 20160308060600 ACCESSION NUMBER: 0001193125-16-495883 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20160304 ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160308 DATE AS OF CHANGE: 20160308 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MyoKardia Inc CENTRAL INDEX KEY: 0001552451 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 455500552 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37609 FILM NUMBER: 161490244 BUSINESS ADDRESS: STREET 1: 333 ALLERTON AVENUE CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: 650-741-0900 MAIL ADDRESS: STREET 1: 333 ALLERTON AVENUE CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 8-K 1 d129165d8k.htm 8-K 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

Date of Report (Date of earliest event reported): March 4, 2016

 

 

MYOKARDIA, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-37609   44-5500552

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

333 Allerton Ave.

South San Francisco, CA 94080

(Address of principal executive offices, including zip code)

(650) 741-0900

(Registrant’s telephone number, including area code)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

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

 

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

 

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

 

¨ 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.

(d)

On March 4, 2016, the board of directors (the “Board”) of MyoKardia, Inc. (the “Company”) elected Sunil Agarwal, M.D. to serve as a Class I director of the Company until the Company’s 2016 Annual Meeting of Stockholders or until his successor has been duly elected and qualified, or until his earlier death, resignation or removal. The Board also appointed Dr. Agarwal to serve as a member of the Audit Committee, replacing Eric J. Topol, M.D., who resigned from the Audit Committee effective as of Dr. Agarwal’s appointment, and as a member of the Science and Technology Committee of the Board.

Dr. Agarwal serves as executive vice president and chief medical officer at Ultragenyx Pharmaceutical, Inc., where he leads the company’s clinical development and operations, regulatory affairs, biometrics, pharmacovigilance and non-clinical research. Prior to that, from September 2003 through July 2014, Dr. Agarwal served in various leadership roles, including senior vice president and global head of clinical development for ophthalmology, metabolism, neurosciences, immunology and infectious diseases, at Genentech Inc. Dr. Agarwal holds a B.S. in neurobiology at Cornell University and an M.D. from Tufts University School of Medicine.

In connection with his election and in accordance with the Company’s non-employee director compensation policy (a copy of which has been filed with the Securities and Exchange Commission as Exhibit 10.16 to Amendment No. 2 to the Company’s Registration Statement on Form S-1 filed on October 19, 2015 (Registration No. 333-207151)), on March 7, 2016, the Company granted Dr. Agarwal a stock option to purchase 22,000 shares of common stock with an exercise price of $7.40, the closing price of the Company’s common stock on the NASDAQ Global Select Market on March 7, 2016. As a non-employee director, Dr. Agarwal is also entitled to receive cash compensation for his Board and committee service in accordance with the non-employee director compensation policy.

Dr. Agarwal is not a party to any transaction with the Company that would require disclosure under Item 404(a) of Regulation S-K, and there are no arrangements or understandings between Dr. Agarwal and any other persons pursuant to which he was selected as a director.

 

Item 7.01 Regulation FD Disclosure

On March 7, 2016, the Company issued a press release announcing Dr. Agarwal’s appointment to the Board. A copy of this press release is furnished as Exhibit 99.1 to this report on Form 8-K.

The information in this Item 7.01 and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits

(d) Exhibits.

 

Exhibit
No.

  

Description

99.1    Press Release issued by MyoKardia, Inc. on March 7, 2016, furnished herewith


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.

 

Date: March 7, 2016     MyoKardia, Inc.
    By:  

/s/ Steven Chan

      Steven Chan
     

Vice President, Corporate Controller

(principal financial and accounting officer)


EXHIBIT INDEX

 

Exhibit

No.

  

Description

99.1    Press Release issued by MyoKardia, Inc. on March 7, 2016, furnished herewith
EX-99.1 2 d129165dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

MyoKardia Names Sunil Agarwal, M.D., to Board of Directors, New VPs Strengthen Research and Development

SOUTH SAN FRANCISCO, Calif. – March 7, 2016 – MyoKardia, Inc. (Nasdaq:MYOK), a clinical stage biopharmaceutical company pioneering a precision medicine approach for the treatment of heritable cardiovascular diseases, today announced the addition of Sunil Agarwal, M.D., to its board as an independent director.

Dr. Agarwal is executive vice president and chief medical officer at Ultragenyx Pharmaceutical, where he leads the company’s clinical development and operations, regulatory affairs, biometrics, pharmacovigilance, medical affairs, pharmacology and toxicology. Previously, Dr. Agarwal served in various leadership roles for more than a decade at Genentech.

“We are delighted to have such a talented clinical leader and seasoned biotech executive join our board of directors,” said MyoKardia CEO Tassos Gianakakos. “Dr. Agarwal’s counsel will be invaluable as we continue to pursue a new, pioneering approach to the treatment of heritable cardiomyopathies. Dr. Agarwal possesses not only broad industry and medical expertise, but a distinguished career of multiple drug approvals across various therapeutic areas, including rare diseases.”

Dr. Agarwal stated, “I am thrilled to join the MyoKardia team. Their robust precision medicine platform positions them well to develop treatment options for patients with severe and rare heart diseases.”

At Genentech, Dr. Agarwal was senior vice president and global head of clinical development for ophthalmology, metabolism, neurosciences, immunology and infectious diseases. His experience includes both development and medical affairs roles at MedImmune and Guilford Pharmaceuticals.

Dr. Agarwal obtained a B.S. in neurobiology at Cornell University, and earned his M.D. from Tufts University School of Medicine.

Leadership Appointments Strengthen Research and Development

MyoKardia also announced that two senior leaders have joined the company to strengthen areas key to its development programs and product pipeline.

Michael Graziano, Ph.D., is MyoKardia’s vice president, biology, leading the company’s biology research and translational medicine efforts to deliver on our preclinical pipeline strategy. Dr. Graziano is a member of MyoKardia’s executive committee.

Previously, Dr. Graziano was an executive director in cardiovascular discovery at Merck Research Laboratories. His more than 25 years in cardiovascular and metabolic disease


 

LOGO

 

drug discovery and development include roles of increasing responsibility both at Merck and the Schering-Plough Research Institute. He is also a founder of The Institute for Life Science Entrepreneurship, a not-for-profit organization that fosters the creation of life science startups. Dr. Graziano holds a Ph.D. in pharmacology from the State University of New York, Stony Brook, and a B.A. in biology from New York University. He completed postdoctoral training in pharmacology at the University of Texas Southwestern Medical Center.

Lisa Alaimo is vice president and program team leader for MyoKardia’s dilated cardiomyopathy program, as well as MyoKardia’s collaboration with Sanofi. The alliance of the two companies, one of the largest research and development commitments in genetic forms of cardiomyopathy, encompasses three major development programs at MyoKardia. Ms. Alaimo has served in project and strategic product development leadership roles at Portola Pharmaceuticals, Cor Therapeutics and Millennium Pharmaceuticals. She holds a B.S. in genetics and biochemistry from University of California, Davis.

About MyoKardia

MyoKardia is a clinical stage biopharmaceutical company pioneering a precision medicine approach to discover, develop and commercialize targeted therapies for the treatment of serious and neglected rare cardiovascular diseases. MyoKardia’s initial focus is on the treatment of heritable cardiomyopathies, a group of rare, genetically-driven forms of heart failure that result from biomechanical defects in cardiac muscle contraction. MyoKardia has used its precision medicine platform to generate a pipeline of therapeutic programs for the chronic treatment of the two most prevalent forms of heritable cardiomyopathy—hypertrophic cardiomyopathy, or HCM, and dilated cardiomyopathy, or DCM. MyoKardia’s most advanced product candidate, MYK- 461, is an orally-administered small molecule designed to reduce excessive cardiac muscle contractility leading to HCM and is currently being evaluated in three Phase 1 clinical trials. A cornerstone of the MyoKardia platform is the Sarcomeric Human Cardiomyopathy Registry, or SHaRe, a multi-center, international repository of clinical and laboratory data on individuals and families with genetic heart disease, which MyoKardia helped form in 2014. MyoKardia believes that SHaRe, currently consisting of data from approximately 10,000 individuals, is the world’s largest registry of patients with heritable cardiomyopathies. MyoKardia’s purpose is to improve the lives of patients and families suffering from cardiovascular disease by creating targeted therapies that can change the course of their condition. For more information, please visit www.myokardia.com.

Forward-Looking Statements

Statements we make in this press release may include statements which are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act, which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such


 

LOGO

 

words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements regarding the Company’s approach to the treatment of heritable cardiomyopathies and the benefits of that approach, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made.

Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, risks associated with the development and regulation of our product candidates, as well as those set forth in the prospectus for our recent initial public offering of common stock and our most recent Quarterly Report on Form 10-Q. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Media Contact:

Katie Engleman

Pure Communications, Inc.

910-509-3977

katie@purecommunicationsinc.com

Investor Contact:

Matt Clawson

Pure Communications, Inc.

949-370-8500

matt@purecommunicationsinc.com

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