About the MyoKardia-Sanofi Collaboration
MyoKardia and Sanofi entered into a multi-product collaboration in 2014 focused on developing novel treatments for cardiomyopathies, including HCM. The companies discontinued that agreement in conjunction with the end of the Research term of the collaboration in December 2018 and the collaboration agreement with Sanofi concluded in its entirety on April 1, 2019. Over the course of the collaboration, MyoKardia received approximately $230 million in funding from Sanofi, advanced mavacamten from preclinical development into a late-stage pivotal study for the treatment of HCM, andMYK-491 from discovery to a Phase 2proof-of-concept study in patients with dilated cardiomyopathy (DCM).
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 cardiovascular diseases. MyoKardia’s initial focus is on the development of small molecule therapeutics aimed at the cardiac muscle proteins that modulate cardiac muscle contraction and underlie diseases of systolic and diastolic dysfunction. Based on anin-depth understanding of disease biology, MyoKardia applies a precision medicine approach to develop its therapeutic candidates for patient populations with shared characteristics, such as causal genetic mutations or disease subtypes. MyoKardia’s most advanced product candidate is mavacamten (formerlyMYK-461), a novel, oral, allosteric modulator of cardiac myosin intended to reduce hypercontractility. Mavacamten has advanced into a pivotal Phase 3 clinical trial, known asEXPLORER-HCM in patients with symptomatic, obstructive hypertrophic cardiomyopathy (HCM). MyoKardia is also developing mavacamten in a second indication,non-obstructive HCM, in the Phase 2MAVERICK-HCM clinical trial.MYK-491, MyoKardia’s second product candidate, is designed to increase cardiac output among patients with systolic heart dysfunction by increasing the overall extent of the heart’s cardiac contractility. MyoKardia is currently evaluatingMYK-491 in a Phase 1b/2a study in stable heart failure patients.
MyoKardia’s mission is to change the world for people with serious cardiovascular disease through bold and innovative science.
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 Company’s ability to enroll patients in its Phase 3EXPLORER-HCM study of mavacamten in symptomatic oHCM and the timing of the completion of enrollment, the availability of data fromEXPLORER-HCM, the Company’s expectation with respect to release of data from these studies, the Company’s ability to advanceMYK-224 into clinical development, and the timing of these events, as well as the Company’s projected cash runway, 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 Quarterly Report on Form10-Q for the quarter ended March 31, 2019, 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.
