Bay Street News

MyoKardia Reports Third Quarter 2018 Financial Results

SOUTH SAN FRANCISCO, Calif., Nov. 07, 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 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)

MYK-491 for Systolic Dysfunction

Research Pipeline

Third 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.

About MyoKardia
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 development of small molecule therapeutics aimed at the cardiac muscle proteins that modulate cardiac muscle contraction and underlie 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 has formed a collaboration with Sanofi to support the commercialization of mavacamten outside the U.S. and for MYK-491’s worldwide late-stage development and commercialization. MyoKardia’s mission is to change the world for people with serious cardiovascular disease through bold and innovative science.

Forward-Looking Statements
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.

Contacts:
Michelle Corral
Corporate Communications & Investor Relations
MyoKardia, Inc.
650-351-4690
mcorral@myokardia.com

Hannah Deresiewicz (Investors)
Stern Investor Relations, Inc.
212-362-1200
hannahd@sternir.com

Steven Cooper (Media)
Edelman
415-486-3264
steven.cooper@edelman.com

 
MYOKARDIA, INC.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)
 
    September 30,     December 31,  
    2018     2017  
            (As Revised)  
Assets                
Current assets                
Cash and cash equivalents   $ 335,279     $ 224,571  
Short-term investments     43,845       31,933  
Receivable from collaboration partner     2,565       1,013  
Prepaid expenses and other current assets     2,566       1,876  
Total current assets     384,255       259,393  
Property and equipment, net     4,905       3,147  
Long-term investments     32,506       19,900  
Restricted cash and other     2,312       368  
Total assets   $ 423,978     $ 282,808  
Liabilities and stockholders’ equity                
Current liabilities                
Accounts payable   $ 2,454     $ 2,301  
Accrued liabilities     18,790       11,639  
Prepayment from collaboration partner     10,943       4,432  
Deferred revenue     12,400       33,558  
Total current liabilities     44,587       51,930  
Other long-term liabilities     54       202  
Total liabilities     44,641       52,132  
Commitments and contingencies                
Stockholders’ equity                
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 September 30, 2018 and December 31, 2017,
    respectively; 40,240,530 and 35,812,791 shares issued and
    outstanding at September 30, 2018 and December 31, 2017,
    respectively
    4       4  
Additional paid-in capital     566,432       365,719  
Accumulated other comprehensive loss     (222 )     (192 )
Accumulated deficit     (186,877 )     (134,855 )
Total stockholders’ equity     379,337       230,676  
Total liabilities and stockholders’ equity   $ 423,978     $ 282,808  

MYOKARDIA, INC.
Condensed Consolidated Statement of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)
 
    Three Months Ended     Nine Months Ended  
    September 30,     September 30,  
    2018     2017     2018     2017  
            (As Revised)             (As Revised)  
Collaboration and license revenue   $ 9,188     $ 3,077     $ 21,158     $ 8,488  
Operating expenses:                                
Research and development     15,910       14,361       49,746       39,967  
General and administrative     10,957       5,884       27,182       16,442  
Total operating expenses     26,867       20,245       76,928       56,409  
Loss from operations     (17,679 )     (17,168 )     (55,770 )     (47,921 )
Interest and other income, net     1,890       447       3,748       977  
Net loss     (15,789 )     (16,721 )     (52,022 )     (46,944 )
Other comprehensive gain (loss)     37       2       (30 )     60  
Comprehensive loss     (15,752 )     (16,719 )     (52,052 )     (46,884 )
Net loss attributable to common stockholders   $ (15,789 )   $ (16,721 )   $ (52,022 )   $ (46,944 )
Net loss per share attributable to common
stockholders, basic and diluted
  $ (0.39 )   $ (0.50 )   $ (1.38 )   $ (1.47 )
Weighted average number of shares used to
compute net loss per share attributable to
common stockholders, basic and diluted
    40,116,644       33,525,567       37,765,631       31,951,631