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Announces Last Patient to be Enrolled in EXPLORER-HCM Phase 3 during the Week of August 12th; Topline Data Accelerated to 2nd Quarter 2020
Topline Phase 2 Clinical Data from MAVERICK-HCM and MYK-491 on Track for Fourth Quarter 2019
Company to Host Conference Call and Webcast Today at 4:30 p.m. ET (1:30 p.m. PT)
SOUTH SAN FRANCISCO, Calif., Aug. 07, 2019 (GLOBE NEWSWIRE) -- MyoKardia, Inc. (Nasdaq: MYOK) today reported financial results for the second quarter ended June 30, 2019.
“We are now less than a year away from potentially game-changing pivotal data from our EXPLORER-HCM clinical trial of mavacamten in obstructive HCM, with activities in full swing for NDA preparation and potential commercial introduction of MyoKardia’s first product,” said Tassos Gianakakos, MyoKardia’s Chief Executive Officer. “The remainder of this year will see us share multiple meaningful clinical results including topline data from our Phase 2 MAVERICK-HCM study in patients with non-obstructive HCM and from our Phase 2 study of MYK-491 for patients with stable heart failure. We will also be advancing our third clinical-stage compound, MYK-224, into a Phase 1 clinical trial. Taken together, these events highlight the meaningful progress we continue to make in the development of much-needed new treatments for serious cardiovascular diseases.”
Recent Clinical Program Highlights
Mavacamten for Hypertrophic Cardiomyopathy (HCM)
MYK-491 for Dilated Cardiomyopathy (DCM)
Recent Corporate Highlights
Second Quarter 2019 Financial Results
Based on its current operating plans, MyoKardia anticipates that current cash, cash equivalents and investments are sufficient to fund operations into the second half of 2021.
Conference Call and Webcast
MyoKardia management will host a conference call and live audio webcast on Wednesday, August 7, 2019, at 4:30 p.m. ET / 1:30 p.m. PT to discuss current operations and second quarter 2019 financial results. The call may be accessed by phone by calling 844-494-0193 from the U.S. and Canada or 508-637-5584 internationally and using the conference ID 7881918. The webcast may be accessed live on the Investor Relations section of the Company's website at http://investors.myokardia.com. A replay of the webcast will be available on the MyoKardia website for approximately 90 days following the call.
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 underlying diseases of systolic and diastolic dysfunction. Based on an in-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 (formerly MYK-461), a novel, oral, allosteric modulator of cardiac myosin intended to reduce hypercontractility. Mavacamten has advanced into a pivotal Phase 3 clinical trial, known as EXPLORER-HCM in patients with symptomatic, obstructive hypertrophic cardiomyopathy (HCM). MyoKardia is also developing mavacamten in a second indication, non-obstructive HCM, in the Phase 2 MAVERICK-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 evaluating MYK-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.
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 and MYK-491, the Company’s ability to complete the enrollment of patients in its Phase 3 EXPLORER-HCM study of mavacamten in symptomatic oHCM, the availability of data from EXPLORER-HCM, as well as from the Phase 2 MAVERICK-HCM study in patients with non-obstructive HCM, and the MYK-491 Phase 2 study for patients with stable heart failure, the Company’s expectation with respect to release of data from these studies, the Company’s ability to advance MYK-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 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 June 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.
Steven Cooper (media)
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
|Cash and cash equivalents||$||443,693||$||246,122|
|Prepaid expenses and other current assets||4,316||4,760|
|Total current assets||562,801||319,446|
|Property and equipment, net||5,435||5,138|
|Operating lease right-of-use assets||1,756||—|
|Restricted cash and other||2,109||2,521|
|Liabilities and stockholders’ equity|
|Prepayment from collaboration partner||2,256||12,973|
|Operating lease liabilities - current||1,831||—|
|Total current liabilities||31,868||36,677|
|Other long-term liabilities||—||9|
|Commitments and contingencies|
|Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none
issued and outstanding
|Common stock, $0.0001 par value, 150,000,000 shares authorized
at June 30, 2019 and December 31, 2018; 46,098,059 and
40,288,949 shares issued and outstanding at June 30, 2019
and December 31, 2018, respectively
|Additional paid-in capital||861,880||573,183|
|Accumulated other comprehensive income (loss)||497||(67||)|
|Total stockholders’ equity||584,185||370,567|
|Total liabilities and stockholders’ equity||$||616,053||$||407,253|
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
Three Months Ended
Six Months Ended
|Collaboration and license revenue||$||—||$||6,639||$||—||$||11,970|
|Research and development||27,708||17,218||53,898||33,836|
|Selling, general and administrative||13,856||8,912||27,407||16,225|
|Total operating expenses||41,564||26,130||81,305||50,061|
|Loss from operations||(41,564||)||(19,491||)||(81,305||)||(38,091||)|
|Interest and other income, net||3,172||1,078||5,443||1,858|
|Loss before income taxes||(38,392||)||(18,413||)||(75,862||)||(36,233||)|
|Income tax benefit||(218||)||—||(218||)||—|
|Other comprehensive income (loss), net of tax effect of $219, $0, $219, $0, respectively||201||70||564||(67||)|
|Net loss per share, basic and diluted||$||(0.83||)||$||(0.49||)||$||(1.75||)||$||(0.99||)|
|Weighted average number of shares used to compute net loss
per share, basic and diluted