EXHIBIT 99.1

 

 

MyoKardia Reports First Quarter 2019 Financial Results

 

Announces Enrollment Completing in the Phase 2 MAVERICK-HCM Trial

 

Company to Host Conference Call and Webcast Today at 4:30 p.m. ET (1:30 p.m. PT)

 

SOUTH SAN FRANCISCO, Calif., May 9, 2019

– MyoKardia, Inc. (Nasdaq: MYOK), a clinical-stage biopharmaceutical company pioneering a precision medicine approach for the treatment of serious cardiovascular diseases, today reported financial results for the quarter ended March 31, 2019.  

 

“With a strong first quarter behind us, MyoKardia continues to make progress toward our aim of becoming a world-leader in developing new treatments for cardiovascular diseases.  As we head into the second half of 2019, our focus remains on realizing the full potential of mavacamten and unlocking the full potential of our growing pipeline, including MYK-491 and MYK-224.  Underpinning our strategy is continued HCM disease-area leadership, including initiatives to engage with the broader HCM and cardiology community,” said Tassos Gianakakos, Chief Executive Officer. “The MAVERICK study exemplifies this focus and the completion of enrollment is a significant milestone.  In MAVERICK, we’re exploring mavacamten's potential to help individuals with non-obstructive HCM – a population for which no targeted therapies exist.  We expect findings from this trial to enable us to move into a registration program for nHCM - extending mavacamten's franchise into an additional important indication and providing critically valuable insights to fuel our pipeline of earlier-stage therapeutics aimed at addressing additional diseases of diastolic dysfunction and cardiac contractility.”

 

Recent Clinical Program Highlights

 

Mavacamten for Hypertrophic Cardiomyopathy (HCM)

-

Presented 12- and 24-week data from PIONEER Open-Label Extension (PIONEER-OLE) Study of Mavacamten in Obstructive HCM (oHCM):  At the American College of Cardiology (ACC) 68th Annual Scientific Session in March 2019, MyoKardia presented positive twenty-four week safety and efficacy data from the PIONEER-OLE study.  Mavacamten treatment improved patient symptoms as measured by NYHA classification and reduced or eliminated obstruction of the left ventricular outflow tract (LVOT) to levels below the guideline-based thresholds for diagnosis (30 mmHg) and for invasive intervention (50 mmHg) in all patients, without reducing left ventricular ejection fraction below normal. Mavacamten was well tolerated with no cardiac-related adverse events.  These data reflect the longest duration of mavacamten treatment reported to date.

 

 

o

Thirty-six-week data from PIONEER-OLE has been accepted for presentation at ESC Congress 2019:  PIONEER-OLE investigators will present safety, efficacy and biomarker data for twelve patients at the upcoming European Society of Cardiology (ESC) Congress being held August 31-September 4, 2019 in Paris.

 

-

Enrollment Completing in Phase 2 MAVERICK-HCM Clinical Trial of Mavacamten in Non-Obstructive HCM (nHCM): MyoKardia announced that screening of patients for the Phase 2 MAVERICK clinical trial was closed on schedule on April 19, 2019 and that the last patient will be enrolled by May 17, 2019.  The randomized, double-blind, placebo-controlled MAVERICK-HCM Phase 2 clinical trial is designed to assess the safety and tolerability of a 16-week treatment course of mavacamten in patients with nHCM. Patients are being randomized evenly into three groups to receive a once-daily dose of mavacamten targeting one of two plasma concentration levels (200 ng/mL, 500 ng/mL) or placebo. MyoKardia plans to report topline data from the MAVERICK-HCM study in the fourth quarter of 2019.

 

Driven by the Heart

 

 

 

333 Allerton Avenue, South San Francisco, CA 94080 / +1 650 741-0900/ myokardia.com

 

 
The following information was filed by Myokardia Inc (MYOK) on Thursday, May 9, 2019 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.

View differences made from one quarter to another to evaluate Myokardia Inc's financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ)
Sample 10-K Year-over-Year (YoY) Comparison

Compare this 10-Q Quarterly Report to its predecessor by reading our highlights to see what text and tables were  removed  ,   added    and   changed   by Myokardia Inc.

Continue

Never Miss A New SEC Filing Again


Real-Time SEC Filing Notifications
Screenshot taken from Gmail for a new 10-K Annual Report
Last10K.com Member Feature

Receive an e-mail as soon as a company files an Annual Report, Quarterly Report or has new 8-K corporate news.

Continue

We Highlighted This SEC Filing For You


SEC Filing Sentiment Analysis - Bullish, Bearish, Neutral
Screenshot taken from Wynn's 2018 10-K Annual Report
Last10K.com Member Feature

Read positive and negative remarks made by management in their entirety without having to find them in a 10-K/Q.

Continue

Widen Your SEC Filing Reading Experience


Increased Reading Area for SEC Filings
Screenshot taken from Adobe Inc.'s 10-Q Quarterly Report
Last10K.com Member Feature

Remove data columns and navigations in order to see much more filing content and tables in one view

Continue

Uncover Actionable Information Inside SEC Filings


SEC Filing Disclosures
Screenshot taken from Lumber Liquidators 10-K Annual Report
Last10K.com Member Feature

Read both hidden opportunities and early signs of potential problems without having to find them in a 10-K/Q

Continue

Adobe PDF, Microsoft Word and Excel Downloads


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshots of actual 10-K and 10-Q SEC Filings in PDF, Word and Excel formats
Last10K.com Member Feature

Export Annual and Quarterly Reports to Adobe PDF, Microsoft Word and Excel for offline viewing, annotations and analysis

Continue

FREE Financial Statements


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshot of actual balance sheet from company 10-K Annual Report
Last10K.com Member Feature

Get one-click access to balance sheets, income, operations and cash flow statements without having to find them in Annual and Quarterly Reports

Continue for FREE

Intrinsic Value Calculator


Intrinsic Value Calculator
Screenshot of intrinsic value for AT&T (2019)
Last10K.com Member Feature

Our Intrinsic Value calculator estimates what an entire company is worth using up to 10 years of financial ratios to determine if a stock is overvalued or not

Continue

Financial Stability Report


Financial Stability Report
Screenshot of financial stability report for Coco-Cola (2019)
Last10K.com Member Feature

Our Financial Stability reports uses up to 10 years of financial ratios to determine the health of a company's EPS, Dividends, Book Value, Return on Equity, Current Ratio and Debt-to-Equity

Continue

Log in with your credentials

or    

Forgot your details?

Create Account