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
(Registrants 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 Companys 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. Agarwals 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 companys 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 Companys 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 Companys 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 Companys 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. Agarwals 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 |
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 |
Exhibit 99.1
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 companys 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. Agarwals 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 MyoKardias vice president, biology, leading the companys biology research and translational medicine efforts to deliver on our preclinical pipeline strategy. Dr. Graziano is a member of MyoKardias 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
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 MyoKardias dilated cardiomyopathy program, as well as MyoKardias 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. MyoKardias 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 cardiomyopathyhypertrophic cardiomyopathy, or HCM, and dilated cardiomyopathy, or DCM. MyoKardias 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 worlds largest registry of patients with heritable cardiomyopathies. MyoKardias 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
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 Companys 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.
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Pure Communications, Inc.
910-509-3977
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Investor Contact:
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Pure Communications, Inc.
949-370-8500
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