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): December 30, 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)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
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 7.01 Regulation FD Disclosure
On January 3, 2017, MyoKardia, Inc. (the Company) issued a press release announcing the receipt of the SOE Confirmation Notice (the Notice) from Aventis, Inc. (Aventis), a wholly-owned subsidiary of Sanofi S.A. (together with Aventis, Sanofi), pursuant to the License and Collaboration Agreement dated August 1, 2014 between the Company and Aventis (the Collaboration Agreement) and Sanofis decision to continue the Collaboration Agreement. 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 8.01 Other Events.
On December 30, 2016, the Company received the Notice. The Notice serves as formal notification of Sanofis decision to continue the research program under the Collaboration Agreement through December 31, 2018. In connection with the continuation of the Collaboration Agreement, Sanofi is required to make a one-time, non-refundable, non-creditable cash payment to the Company of $45.0 million by January 31, 2017.
Item 9.01 Financial Statements and Exhibits
(d) | Exhibits. |
Exhibit No. |
Description | |
99.1 | Press Release issued by MyoKardia, Inc. on January 3, 2017, furnished herewith |
SIGNATURE
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: January 3, 2017 |
MyoKardia, Inc. | |||
By: | /s/ Jacob Bauer | |||
Jacob Bauer | ||||
Senior Vice President, Finance and Corporate Development (principal financial officer) |
EXHIBIT INDEX
Exhibit No. |
Description | |
99.1 | Press Release issued by MyoKardia, Inc. on January 3, 2017, furnished herewith |
Exhibit 99.1
MyoKardia Announces Advancement to Next Phase of Global Collaboration with Sanofi
Sanofi Decision to Continue Provides $45 Million Milestone to MyoKardia
Collaboration has Advanced Two Novel Clinical Compounds
South San Francisco, Calif. Jan. 3, 2017 - MyoKardia, Inc. (Nasdaq: MYOK), a clinical stage biopharmaceutical company pioneering a precision medicine approach for the treatment of heritable cardiovascular diseases, announced today that Sanofi has notified the Company that it has elected to continue the global cardiomyopathy research collaboration formed in August 2014.
The terms of the research agreement provided Sanofi the option of either concluding the collaboration at year-end 2016 or extending the agreement. Per Sanofis decision to advance the collaboration, MyoKardia is now eligible for a $45 million milestone payment payable by January 31, 2017.
MyoKardia and Sanofi share a passion for science and a commitment to patients, said Tassos Gianakakos, chief executive officer. The continuation of this research collaboration provides valuable support for further innovation and development of critically important therapies for patients with serious cardiovascular diseases.
The research and development agreement is one of the most significant commitments to heritable cardiomyopathies, and encompasses three MyoKardia programs. Two of these programs are focused on hypertrophic cardiomyopathy (HCM) and one targets dilated cardiomyopathy (DCM).
In September, MyoKardia outlined its expected path to registration for its lead product candidate MYK-461 in the initial indication of symptomatic, obstructive HCM, for which the Company was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA). MyoKardia is studying MYK-461 in the Phase 2 PIONEER-HCM trial.
MyoKardia received a separate, $25 million milestone payment from Sanofi in November 2016 for the filing of an Investigational New Drug (IND) application with the FDA for its MYK-491 program in DCM. MyoKardia intends to initiate a Phase 1 study of MYK-491 in healthy volunteers in the first half of 2017.
In the United States, MyoKardia maintains commercial rights to MYK-461 and HCM-2 as well as co-promotion rights for MYK-491.
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 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 has been evaluated in three Phase 1 clinical trials. MyoKardia is now studying MYK-461 in the Phase 2 PIONEER-HCM trial in symptomatic, obstructive HCM (oHCM), a subset of HCM. In April 2016, the U.S. Food and Drug Administration (FDA) granted MYK-461 Orphan Drug Designation for the treatment of symptomatic oHCM. MYK-491, the second clinical candidate generated by MyoKardias product engine, is designed to increase the overall force of the hearts contraction in DCM patients by increasing cardiac contractility. MyoKardia intends to initiate a Phase 1 study of MYK-491 in healthy volunteers in the first half of 2017. 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 mission is to change the world for patients with serious cardiovascular disease through bold and innovative science. For more information, please visit www.myokardia.com.
MyoKardia 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 of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, 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 clinical and therapeutic potential of MYK-461 and MYK-491, the Companys ability to initiate Phase 1 clinical development of MYK-491, and the timing of these events, 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 our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, and our other filings with the SEC. 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.
MyoKardia
Investors:
Beth DelGiacco
Stern Investor Relations, Inc.
212-362-1200
beth@sternir.com
Media:
Steven Cooper
Edelman
415-486-3264
steven.cooper@edelman.com
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