Exhibit 99.1

 

MyoKardia Reports Third Quarter 2018 Financial Results

 

SOUTH SAN FRANCISCO, Calif., November 7, 2018

– MyoKardia, Inc. (Nasdaq: MYOK), a clinical-stage biopharmaceutical company pioneering precision medicine for the treatment of cardiovascular diseases, today reported financial results for the quarter ended September 30, 2018.  

 

“MyoKardia continues to make encouraging progress toward our mission of changing the world for patients with serious cardiovascular disease.  Within just the past few months, we have initiated the MAVA-LTE clinical study of mavacamten and the Phase 2a portion of our active clinical trial of MYK-491, unveiled three new preclinical programs and through our efforts with the SHaRe registry, our MyoSeeds grant program and newly formed collaboration with 23andMe, demonstrated our commitment to supporting the HCM community and helping to build awareness of this debilitating and progressive disease,” said Tassos Gianakakos, Chief Executive Officer.  “We’ll be sharing additional progress across our programs in the coming weeks, with the presentation of clinical, preclinical and registry data at the upcoming American Heart Association Scientific Sessions and the release of topline data from our Phase 1b clinical trial of MYK-491 in patients with dilated cardiomyopathy before the end of the year.”

 

Recent Clinical Program Highlights

 

Mavacamten for Hypertrophic Cardiomyopathy (HCM)

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Dosed first patient in MAVA Long-Term Extension (LTE) Study of Mavacamten in HCM: The MAVA-LTE study will assess long-term safety of mavacamten, as well as its effects on hypertrophic cardiomyopathy (HCM) symptoms and cardiac function in patients who successfully complete either MyoKardia’s MAVERICK-HCM or EXPLORER-HCM clinical trials of mavacamten.  Data from the MAVA-LTE clinical trial, along with results of the pivotal Phase 3 EXPLORER-HCM trial, are intended to support the registration submission for mavacamten for the treatment of obstructive HCM (oHCM).

 

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Reported encouraging initial data from PIONEER Open-Label Extension (OLE) Study: Twelve of twenty patients with oHCM who previously completed MyoKardia’s Phase 2 PIONEER-HCM study of mavacamten for the treatment of symptomatic oHCM have enrolled in the PIONEER-OLE trial.  Interim data for seven patients at twelve weeks of treatment with mavacamten demonstrated statistically significant reductions in left ventricular outflow tract (LVOT) obstruction compared to baseline.  All patients maintained ejection fraction well in the normal range of greater than 50 percent, and there have been no significant adverse events reported.  Individualized dose adjustments in PIONEER-OLE are consistent with the regimen being used in MyoKardia’s pivotal Phase 3 EXPLORER-HCM trial of mavacamten for the treatment of oHCM.  

 

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Announced acceptance of twelve abstracts at the 2018 AHA Scientific Sessions:  Among the highlights of the data being presented are an analysis of mavacamten’s effect on left ventricular relaxation based on an analysis of patient data from the Phase 2 PIONEER-HCM clinical trial, which will be presented in a poster session on Saturday, November 10, and preclinical data examining the in vivo effect of myosin inhibition in a proprietary large-animal model of non-obstructive hypertrophic cardiomyopathy (nHCM), which will be shared in an oral presentation on Sunday, November 11.  MyoKardia management will host a call on Monday, November 12 at 8:00 a.m. ET to review the data being presented.

 

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Published new data from the Sarcomeric Human Cardiomyopathy Registry (SHaRe) in Circulation:  Results from a multicenter, international, longitudinal study of data from nearly 4,600 HCM patients were published in the October 2, 2018 issue of Circulation.  These data revealed that HCM patients are at substantially elevated risks of long-term complications and comorbidities, as well as increased mortality rates compared to that of the general U.S. population.

 

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Launched the MyoSeeds™ Grant Program: MyoKardia issued a call for proposals for its MyoSeeds initiative to support original, independent research in the biology and underlying mechanisms of cardiomyopathies and precision treatment for heart disease.  Through this program, MyoKardia will fund up to four awards, with a total investment of up to $1 million in funding over 2018-2019.  Grants will be awarded by December 31, 2018.


The following information was filed by Myokardia Inc (MYOK) on Wednesday, November 7, 2018 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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