MyoKardia Reports Third Quarter 2020 Financial Results

Rhea-AI Summary

MyoKardia reported its third-quarter financial results, highlighting significant clinical advancements in its therapies. The company demonstrated notable progress with mavacamten in treating hypertrophic cardiomyopathy, achieving positive outcomes in its Phase 3 study, and initiated a Phase 2 trial for danicamtiv in genetic dilated cardiomyopathy. Additionally, a strategic partnership with LianBio aims to enhance mavacamten's market presence in China. MyoKardia is set for an acquisition by Bristol-Myers Squibb for $13.1 billion, expected to finalize in Q4 2020.

Positive

• Mavacamten's Phase 3 study shows statistically significant improvements in symptoms and cardiac function.
• Phase 2 clinical trial of danicamtiv initiated, targeting genetic dilated cardiomyopathy.
• Strategic partnership with LianBio to develop and commercialize mavacamten in China.
• Improved cash position with $895.9 million as of September 30, 2020.

Negative

• Net loss of $84.7 million ($1.60 loss per share) for Q3 2020, although improved from $141.8 million in Q3 2019.
• Research and development expenses increased to $59.1 million, leading to higher overall costs.

Acquisition of MyoKardia by Bristol-Myers Squibb Expected to Close During 4th Quarter of 2020

BRISBANE, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- MyoKardia, Inc. (Nasdaq: MYOK) today reported financial results for the third quarter ended September 30, 2020.

Recent Clinical Program Highlights

Mavacamten for Hypertrophic Cardiomyopathy (HCM)

• EXPLORER-HCM Data Presented at the European Society of Cardiology 2020 Virtual Congress and Published in The Lancet: Results from MyoKardia’s Phase 3 clinical study of mavacamten for the potential treatment of symptomatic, obstructive HCM demonstrated statistically significant improvements in patient symptoms and cardiac function, as well as reductions in left ventricular outflow tract (LVOT) obstruction. In addition to meeting the primary and all secondary endpoints, mavacamten showed reductions in biomarkers of cardiac wall stress and myocardial injury and was well tolerated, with a safety profile similar to placebo. The benefits observed were consistent across multiple prespecified subgroups.
  

Danicamtiv (formerly MYK-491) for Dilated Cardiomyopathy (DCM)

• Initiated Phase 2 Clinical Trial of Danicamtiv in Genetic DCM: Danicamtiv binds directly to and activates myosin, the heart’s motor protein, to boost the power of each contraction without impacting the ability of the heart to relax and fill with oxygenated blood. MyoKardia’s Phase 2 study of danicamtiv is enrolling patients with DCM with documented genetic variants of MYH7 or titin. Pathogenic variants in single genes encoding proteins of the sarcomere have been associated with the contractile dysfunction underlying approximately 20-30 percent of dilated cardiomyopathies.
  

Recent Corporate Highlights

• Entered into Strategic Partnership with LianBio to Develop and Commercialize Mavacamten in China: The partnership will initially pursue a registration strategy for mavacamten in China for obstructive HCM, with plans for additional indications to follow, in keeping with MyoKardia’s development strategy.
  
  
• Bristol-Myers Squibb to Acquire MyoKardia for $13.1 Billion in Cash: Bristol-Myers Squibb (BMS) and MyoKardia announced a definitive merger agreement under which BMS will acquire MyoKardia for $13.1 billion, or $225.00 per share in cash. The transaction is expected to close during the fourth quarter of 2020.
  

Third Quarter 2020 Financial Results

• Cash Position: Cash, cash equivalents and investments as of September 30, 2020 were $895.9 million, compared to $430.3 million as of December 31, 2019. The quarter end cash receipts include $40.0 million from LianBio related to the strategic partnership to develop and commercialize mavacamten in greater China.
  
  
• R&D Expenses: Research and development expenses were $59.1 million in the third quarter of 2020, up from $47.4 million for the same period in 2019. The increase in R&D expenses was primarily driven by the payment of approximately $10.0 million to Fulcrum Therapeutics, as well as increases in personnel, facility and information technology expenses, offset by reductions in clinical expenses due to completion of our EXPLORER clinical trial.
  
  
• G&A Expenses: General and administrative expenses were $26.3 million for the third quarter of 2020, compared to $17.7 million for same period in 2019. The increase in G&A expense was primarily driven by increases in personnel and professional fees.
  
  
• Net Loss: Net loss was $84.7 million ($1.60 loss per share) for the third quarter of 2020, compared to a net loss of $141.8 million ($3.07 loss per share) for the third quarter of 2019.
  

About MyoKardia
MyoKardia is a clinical-stage biopharmaceutical company discovering and developing targeted therapies for the treatment of serious cardiovascular diseases. The company is pioneering a precision medicine approach to its discovery and development efforts by 1) understanding the biomechanical underpinnings of disease; 2) targeting the proteins that modulate a given condition; 3) identifying patient populations with shared disease characteristics; and 4) applying learnings from research and clinical studies to inform and guide pipeline growth and product advancement. MyoKardia’s initial focus is on small molecule therapeutics aimed at the proteins of the heart that modulate cardiac muscle contraction to address diseases driven by excessive contraction, impaired relaxation, or insufficient contraction. Among its discoveries are three clinical-stage therapeutics: mavacamten (formerly MYK-461); danicamtiv (formerly MYK-491) and MYK-224.

MyoKardia’s mission is to change the world for people with serious cardiovascular disease through bold and innovative science.

Forward-Looking Statements
This press release contains “forward-looking statements” relating to the development and commercialization of MyoKardia’s product candidates, MyoKardia’s collaboration agreement with LianBio, and the pending acquisition of MyoKardia by Bristol Myers Squibb. Such forward-looking statements are generally identified by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar words. These statements are only predictions, and such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks are (i)  the development and commercialization of MyoKardia’s product candidates may be delayed or halted for a variety of reasons, (ii) MyoKardia may not realize the anticipated benefits of its collaboration with LianBio, (iii) there can be no guarantee that the acquisition of MyoKardia by Bristol Myers Squibb will be completed, or if it is completed, that it will close within the anticipated time period or that the expected benefits of the acquisition will be realized, (iv) the outcome of any legal proceedings that may be instituted against the parties and others related to the

FAQ

What are the highlights of MyoKardia's Q3 2020 financial results?

MyoKardia reported a net loss of $84.7 million, with cash reserves of $895.9 million and a rise in R&D expenses to $59.1 million.

When is the acquisition of MyoKardia by Bristol-Myers Squibb expected to close?

The acquisition is expected to close during the fourth quarter of 2020.

What are the key outcomes from the mavacamten clinical trial?

The mavacamten Phase 3 study met primary and secondary endpoints, showing significant improvements in symptoms and cardiac function.

What is the purpose of MyoKardia's partnership with LianBio?

The partnership seeks to develop and commercialize mavacamten in China, starting with a registration strategy for obstructive HCM.