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SOUTH SAN FRANCISCO, Calif., Aug. 08, 2018 (GLOBE NEWSWIRE) -- 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 June 30, 2018.
“This quarter saw MyoKardia initiate three new clinical studies, including the advancement of our lead investigational compound, mavacamten, into a pivotal Phase 3 clinical trial which represents one of the most important milestones in MyoKardia’s five-year history. The EXPLORER-HCM study should provide meaningful data on how mavacamten treatment impacts patients’ symptoms and how they function, potentially leading the way to a new and much-needed treatment option for people with obstructive hypertrophic cardiomyopathy,” said Tassos Gianakakos, Chief Executive Officer. “Advancements across our broader pipeline can also be expected in the coming months as MYK-491 enters into a Phase 2 clinical trial in dilated cardiomyopathy and data from our ongoing Phase 1 study in DCM patients become available. Additionally, our research platform and discovery-stage pipeline continue to advance, and we look forward to sharing more details about our research programs in the coming months.”
Recent Clinical Program Highlights
Mavacamten for Hypertrophic Cardiomyopathy (HCM)
MYK-491 for Dilated Cardiomyopathy (DCM)
Second Quarter 2018 Financial Results
Based on the company’s current balance of cash and investments, plus anticipated payments from Sanofi, MyoKardia estimates having sufficient funds to execute on current operating plans into 2021.
Conference Call and Webcast
MyoKardia management will host a conference call and live audio webcast today, August 8, at 4:30 p.m. ET / 1:30 p.m. PT to review second quarter 2018 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 6176898. 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 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 and rare cardiovascular diseases. MyoKardia’s initial focus is on the treatment of heritable cardiomyopathies, a group of rare, genetically driven forms of heart failure that result from biomechanical defects in cardiac muscle contraction. MyoKardia has generated a pipeline of therapeutic programs for the chronic treatment of two of the most prevalent forms of heritable cardiomyopathy – hypertrophic cardiomyopathy (HCM), and dilated cardiomyopathy (DCM). MyoKardia’s most advanced product candidate is mavacamten (formerly MYK-461), a novel, oral, allosteric modulator of cardiac myosin intended to reduce hypercontractility. Mavacamten is being studied in a pivotal Phase 3 clinical trial, known as EXPLORER-HCM, in patients with symptomatic, obstructive 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 intended to increase contractility and is currently being evaluated in a Phase 1b study in DCM patients. A cornerstone of the MyoKardia platform is the Sarcomeric Human Cardiomyopathy Registry (SHaRe), a multi-center, international repository of clinical and laboratory data on individuals and families with genetic heart disease, which MyoKardia helped form in 2014. MyoKardia’s mission is to change the world for patients 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 progress of and availability of data from the Company’s ongoing Phase 3 EXPLORER-HCM trial of mavacamten in oHCM patients, Phase 2 MAVERICK-HCM trial of mavacamten in nHCM patients and PIONEER-OLE study of mavacamten, the commencement of the Company’s planned LTE study of mavacamten, the progress of and availability of data from the Company’s ongoing Phase 1 study of MYK-491 in DCM patients, the commencement of the Company’s planned Phase 2 study of MYK-491, the advancement of the Company’s research programs, as well as the timing of these events, and the Company’s expected cash runway and ability to receive additional payments from its collaboration agreement with Sanofi, 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 Annual Report on Form 10-K for the year ended December 31, 2017, 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.
Corporate Communications & 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||$||346,827||$||224,571|
|Receivable from collaboration partner||—||1,013|
|Prepaid expenses and other current assets||2,604||1,876|
|Total current assets||401,197||259,393|
|Property and equipment, net||4,883||3,147|
|Other long-term assets||426||368|
|Liabilities and stockholders’ equity|
|Prepayment from collaboration partner||9,115||4,432|
|Total current liabilities||47,022||51,930|
|Other long-term liabilities||99||202|
|Commitments and contingencies (Note 6)|
|Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding||—||—|
|Common stock, $0.0001 par value, 150,000,000 and 150,000,000 shares authorized at June 30, 2018 and December 31, 2017, respectively; 40,049,160 and 35,812,791 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively||4||4|
|Additional paid-in capital||558,376||365,719|
|Accumulated other comprehensive loss||(259||)||(192||)|
|Total stockholders’ equity||387,033||230,676|
|Total liabilities and stockholders’ equity||$||434,154||$||282,808|
Condensed Consolidated Statement of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
Three Months Ended
Six Months Ended
|As Revised||As Revised|
|Collaboration and license revenue||$||6,639||$||3,001||$||11,970||$||5,411|
|Research and development||17,218||13,689||33,836||25,606|
|General and administrative||8,912||5,082||16,225||10,558|
|Total operating expenses||26,130||18,771||50,061||36,164|
|Loss from operations||(19,491||)||(15,770||)||(38,091||)||(30,753||)|
|Interest and other income, net||1,078||309||1,858||530|
|Other comprehensive income (loss)||70||(3||)||(67||)||(58||)|
|Net loss attributable to common stockholders||$||(18,413||)||$||(15,461||)||$||(36,233||)||$||(30,223||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.49||)||$||(0.50||)||$||(0.99||)||$||(0.97||)|
|Weighted average number of shares used to compute net loss per share attributable to common stockholders, basic and diluted||37,440,024||31,200,773||36,620,747||31,151,216|