MyoKardia (MYOK) Misses Q3 EPS by 28c; Updates on Recent Developments

November 7, 2016 8:14 AM EST
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MyoKardia (NASDAQ: MYOK) reported Q3 EPS of ($0.35), $0.28 worse than the analyst estimate of ($0.07). Revenue for the quarter came in at $3.55 million versus the consensus estimate of $4.83 million.

“MyoKardia continues to make significant progress in our mission to help people with genetic cardiomyopathies,” said Tassos Gianakakos, chief executive officer. “In this last quarter, we advanced our pipeline of therapeutic candidates, including MYK-461 and MYK-491, and in October, we completed an equity financing to further support our precision medicine platform and product engine. For MYK-461, our recently initiated Phase 2 PIONEER-HCM study will generate data across a broad range of clinically important measurements in oHCM which we expect to significantly de-risk subsequent clinical studies.”

PIONEER-HCM will study relationships among important disease biomarkers such as contractility, left ventricular outflow tract (LVOT) gradient and potential registrable endpoints of functional capacity (i.e., peak VO2) and clinical symptoms. Topline data for PIONEER-HCM are expected in the second half of 2017.

“In addition to MYK-461 in oHCM, our MYK-491 program in dilated cardiomyopathy (DCM) is making great progress and is on track to initiate a Phase 1 study in healthy volunteers in the first half of 2017,” said Mr. Gianakakos. “Like our MYK-461 candidate in HCM, MYK-491 is the first potential therapy designed to target the underlying biomechanical defect causing genetic DCM.”

Other developments during the quarter include MyoKardia’s inaugural Research and Development Day in which the Company outlined the anticipated pathway to registration for MYK-461 in oHCM, as well as further updates on its pipeline strategy and product engine. To advance its research and development pipeline and support its operations, the Company in October completed a follow-on public offering of common stock resulting in net proceeds of approximately $61 million.

For earnings history and earnings-related data on MyoKardia (MYOK) click here.

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