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SOUTH SAN FRANCISCO, Calif., Nov. 04, 2019 (GLOBE NEWSWIRE) -- MyoKardia, Inc. (Nasdaq: MYOK), today reported financial results for the quarter ended September 30, 2019.
“As we look across the milestones recently achieved and those just ahead, we see steady progress on our near- and long-term corporate objectives. We are forging a position of disease-area leadership in the improved care of hypertrophic cardiomyopathy, while applying all that we are learning from those efforts to tackle additional targeted populations with diseases caused by diastolic or systolic dysfunction,” said Tassos Gianakakos, MyoKardia’s Chief Executive Officer. “Before year-end, we will be reporting 48-week data from our PIONEER-OLE study in obstructive HCM, as well as data from our Phase 2 MAVERICK-HCM study in patients with non-obstructive hypertrophic cardiomyopathy. Our momentum will continue into next year, with additional data and program progress planned across our portfolio for the first half of 2020, including the topline readout from our pivotal Phase 3 EXPLORER-HCM trial of mavacamten in obstructive HCM and the advancement of MYK-491 into a targeted genetic cardiomyopathy population.”
Recent Clinical Program Highlights
Mavacamten for Obstructive Hypertrophic Cardiomyopathy
MYK-491 for Dilated Cardiomyopathy
MYK-224 for HCM
Recent Corporate Highlights
Third Quarter 2019 Financial Results
Based on the company’s current balance of cash and investments, MyoKardia estimates having sufficient funds to execute on current operating plans into the second half of 2021.
In lieu of conducting a third quarter financial results call, MyoKardia management will host a conference call on Monday, November 11, 2019 at 8:30 a.m. ET/5:30 a.m. PT to discuss PIONEER-OLE 48-week data being presented at the upcoming American Heart Association Scientific Sessions 2019. Investors and analysts are invited to participate by phone by calling 844-494-0913 in the U.S. and Canada or 508-637-5584 internationally and using the conference ID 3177984 or by webcast. The webcast can be accessed from the investor section of the MyoKardia website at www.myokardia.com.
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 muscle proteins of the heart that modulate cardiac muscle contraction and underlying diseases of systolic and diastolic dysfunction. 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 has discovered a pipeline of product candidates directed at diseases driven by excessive contraction, impaired relaxation, or insufficient contraction. Among its discoveries are three clinical-stage therapeutics: mavacamten (formerly 461) in Phase 3 and Phase 2 clinical trials for hypertrophic cardiomyopathies (HCM); MYK-491 in Phase 2 for patients with stable heart failure; and MYK-224, in Phase 1 development for HCM.
MyoKardia’s mission is to change the world for people with serious cardiovascular disease through bold and innovative science.
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 mavacamten, MYK-491 and MYK-224, the availability of the 48-week data from PIONEER-OLE and data from EXPLORER-HCM, as well as from the Phase 2 MAVERICK-HCM study in patients with non-obstructive HCM, the Company’s expectation with respect to release of data from these studies, the Company’s ability to advance MYK-491 into a Phase 2 study in patients with genetic DCM and the commencement of a study of mavacamten in symptomatic, obstructive HCM patients referred for SRT, and the timing of these events and the availability of data from the Phase 1 study of MYK-224 in healthy subjects, 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 ad 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 Form 10-Q for the quarter ended September 30, 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.
Senior Director, Corporate Communications and Investor Relations
Hannah Deresiewicz (investors)
Stern Investor Relations, Inc.
Julie Normart (Media)
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
|Cash and cash equivalents||$||235,159||$||246,122|
|Prepaid expenses and other current assets||7,598||4,760|
|Total current assets||424,689||319,446|
|Property and equipment, net||7,148||5,138|
|Operating lease right-of-use assets||1,028||—|
|Restricted cash and other||2,404||2,521|
|Liabilities and stockholders’ equity|
|Prepayment from collaboration partner||—||12,973|
|Operating lease liabilities - current||1,050||—|
|Total current liabilities||44,085||36,677|
|Other long-term liabilities||2,159||9|
|Commitments and contingencies|
|Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding||—||—|
|Common stock, $0.0001 par value, 150,000,000 shares authorized at September 30, 2019 and December 31, 2018; 46,218,925 and 40,288,949 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively||5||4|
|Additional paid-in capital||871,894||573,183|
|Accumulated other comprehensive income (loss)||453||(67||)|
|Total stockholders’ equity||452,353||370,567|
|Total liabilities and stockholders’ equity||$||498,597||$||407,253|
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
Three Months Ended
Nine Months Ended
|Collaboration and license revenue||$||—||$||9,188||$||—||$||21,158|
|Repurchase of royalty rights||80,000||—||80,000||—|
|Research and development||47,372||15,910||101,270||49,746|
|Selling, general and administrative||17,746||10,957||45,153||27,182|
|Total operating expenses||145,118||26,867||226,423||76,928|
|Loss from operations||(145,118||)||(17,679||)||(226,423||)||(55,770||)|
|Interest and other income, net||3,332||1,890||8,775||3,748|
|Loss before income taxes||(141,786||)||(15,789||)||(217,648||)||(52,022||)|
|Income tax expense (benefit)||16||—||(202||)||—|
|Other comprehensive (loss) income, net of tax effect of $17, $0, $(202) and $0, respectively||(44||)||37||520||(30||)|
|Net loss per share, basic and diluted||$||(3.07||)||$||(0.39||)||$||(4.91||)||$||(1.38||)|
|Weighted average number of shares used to compute net loss per share, basic and diluted||46,133,068||40,116,644||44,255,657||37,765,631|