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Cytokinetics (CYTK) Q2 Loss Wider Than Expected, Pipeline in Focus
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Cytokinetics, Incorporated (CYTK - Free Report) reported a net loss of $1.31 per share in the second quarter of 2024, wider than the Zacks Consensus Estimate of a loss of $1.02. In the year-ago quarter, the company reported a net loss of $1.34 per share.
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing muscle biology-directed drug candidates as potential treatments for debilitating diseases in which cardiac muscle performance is compromised.
Since the company does not have any approved product in its portfolio yet, it does not generate drug sales. Research and development revenues totaled $0.2 million, which missed the Zacks Consensus Estimate of $14 million. Revenues were also down from $0.9 million recorded in the year-ago quarter.
Year to date, Cytokinetics’ shares have lost 35.3% compared with the industry’s 5.9% decline.
Image Source: Zacks Investment Research
Quarter in Detail
R&D expenses amounted to $79.6 million, down 4.4% year over year due to the timing of clinical trial activities and wind down activities for COURAGE-ALS, which ended in the first quarter of 2023.
General and administrative expenses surged 27.9% to $50.8 million, driven by investments toward commercial readiness and personnel-related expenses.
Cash Balance Increase
As of Jun 30, 2024, CYTK had approximately $1.4 billion in cash, cash equivalents and investments, up from $634.3 million as of Mar 31, 2024.
During the second quarter, CYTK completed a public offering of 11.27 million shares of its common stock, raising approximately $563.2 million in net proceeds.
In May 2024, Cytokinetics entered into a strategic funding collaboration (worth $575 million) with Royalty Pharma (RPRX - Free Report) to support the commercialization of late-stage candidate aficamten and advance the company’s expanding cardiovascular pipeline.
The company received $250 million upon execution. The funding included $100 million to fund a confirmatory phase III study of omecamtiv mecarbil, $50 million to fund a proof-of-concept phase IIa study for CK-586, $50 million term loan to support the potential commercial launch of aficamten in obstructive hypertrophic cardiomyopathy (HCM) and $50 million from the purchase of Cytokinetics’ common stock in a private placement.
Per the terms of the deal, CYTK can borrow up to $175 million upon satisfaction of certain conditions and receive up to $150 million investment in a phase III study of CK-586. However, these are subject to Royalty Pharma exercising its option to participate in the funding of such a trial in exchange for an additional revenue interest in the net sales of CK-586.
Pipeline Updates
Cytokinetics is preparing for regulatory submissions for aficamten, its next-in-class cardiac myosin inhibitor, following positive results from the phase III SEQUOIA-HCM study in obstructive HCM.
CYTK had a type B meeting with the FDA to discuss potential strategies related to safety monitoring and risk mitigation for aficamten. Consequently, the company intends to propose a distinct risk mitigation approach specific to aficamten with the new drug application (NDA). The rolling submission of the NDA is underway (completion expected in the third quarter of 2024).
A marketing authorization application for aficamten in the EU is planned for the fourth quarter. Aficamten is also currently being evaluated in MAPLE-HCM, a phase III study of aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM (enrollment expected to be completed in the third quarter of 2024) and ACACIA-HCM, a phase III study of aficamten in patients with non-obstructive HCM (enrollment expected to be completed in 2025).
Other studies include CEDAR-HCM, a clinical trial of aficamten in a pediatric population with obstructive HCM, and FOREST-HCM, an open-label extension clinical study of aficamten in patients with HCM. Enrollment is ongoing in CEDAR-HCM.
Other pipeline candidates include omecamtiv mecarbil, a cardiac muscle activator, in patients with heart failure. CYTK participated in a Type C meeting with the FDA that addressed design features of a confirmatory phase III study of omecamtiv mecarbil with a discussion of the patient population, endpoints, as well as several additional pragmatic elements related to clinical trial conduct.
Additionally, Cytokinetics is developing CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten for the potential treatment of heart failure with preserved ejection fraction (HFpEF). Data from the phase I study support progression to a phase IIa study in patients with HFpEF (initiation expected in the fourth quarter).
Zacks Rank and Stocks to Consider
Cytokinetics currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for Entrada Therapeutics’ 2024 loss per share have narrowed from 14 cents to 13 cents, and the same for 2025 loss per share have narrowed from $3.44 to $3.21.
In the past 60 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2024 loss per share has narrowed from 44 cents to 43 cents, and the same for 2025 loss per share has remained constant at 45 cents.
ANIX’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 2.27%.
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Cytokinetics (CYTK) Q2 Loss Wider Than Expected, Pipeline in Focus
Cytokinetics, Incorporated (CYTK - Free Report) reported a net loss of $1.31 per share in the second quarter of 2024, wider than the Zacks Consensus Estimate of a loss of $1.02. In the year-ago quarter, the company reported a net loss of $1.34 per share.
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing muscle biology-directed drug candidates as potential treatments for debilitating diseases in which cardiac muscle performance is compromised.
Since the company does not have any approved product in its portfolio yet, it does not generate drug sales. Research and development revenues totaled $0.2 million, which missed the Zacks Consensus Estimate of $14 million. Revenues were also down from $0.9 million recorded in the year-ago quarter.
Year to date, Cytokinetics’ shares have lost 35.3% compared with the industry’s 5.9% decline.
Image Source: Zacks Investment Research
Quarter in Detail
R&D expenses amounted to $79.6 million, down 4.4% year over year due to the timing of clinical trial activities and wind down activities for COURAGE-ALS, which ended in the first quarter of 2023.
General and administrative expenses surged 27.9% to $50.8 million, driven by investments toward commercial readiness and personnel-related expenses.
Cash Balance Increase
As of Jun 30, 2024, CYTK had approximately $1.4 billion in cash, cash equivalents and investments, up from $634.3 million as of Mar 31, 2024.
During the second quarter, CYTK completed a public offering of 11.27 million shares of its common stock, raising approximately $563.2 million in net proceeds.
In May 2024, Cytokinetics entered into a strategic funding collaboration (worth $575 million) with Royalty Pharma (RPRX - Free Report) to support the commercialization of late-stage candidate aficamten and advance the company’s expanding cardiovascular pipeline.
The company received $250 million upon execution. The funding included $100 million to fund a confirmatory phase III study of omecamtiv mecarbil, $50 million to fund a proof-of-concept phase IIa study for CK-586, $50 million term loan to support the potential commercial launch of aficamten in obstructive hypertrophic cardiomyopathy (HCM) and $50 million from the purchase of Cytokinetics’ common stock in a private placement.
Per the terms of the deal, CYTK can borrow up to $175 million upon satisfaction of certain conditions and receive up to $150 million investment in a phase III study of CK-586. However, these are subject to Royalty Pharma exercising its option to participate in the funding of such a trial in exchange for an additional revenue interest in the net sales of CK-586.
Pipeline Updates
Cytokinetics is preparing for regulatory submissions for aficamten, its next-in-class cardiac myosin inhibitor, following positive results from the phase III SEQUOIA-HCM study in obstructive HCM.
CYTK had a type B meeting with the FDA to discuss potential strategies related to safety monitoring and risk mitigation for aficamten. Consequently, the company intends to propose a distinct risk mitigation approach specific to aficamten with the new drug application (NDA). The rolling submission of the NDA is underway (completion expected in the third quarter of 2024).
A marketing authorization application for aficamten in the EU is planned for the fourth quarter. Aficamten is also currently being evaluated in MAPLE-HCM, a phase III study of aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM (enrollment expected to be completed in the third quarter of 2024) and ACACIA-HCM, a phase III study of aficamten in patients with non-obstructive HCM (enrollment expected to be completed in 2025).
Other studies include CEDAR-HCM, a clinical trial of aficamten in a pediatric population with obstructive HCM, and FOREST-HCM, an open-label extension clinical study of aficamten in patients with HCM. Enrollment is ongoing in CEDAR-HCM.
Other pipeline candidates include omecamtiv mecarbil, a cardiac muscle activator, in patients with heart failure. CYTK participated in a Type C meeting with the FDA that addressed design features of a confirmatory phase III study of omecamtiv mecarbil with a discussion of the patient population, endpoints, as well as several additional pragmatic elements related to clinical trial conduct.
Additionally, Cytokinetics is developing CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten for the potential treatment of heart failure with preserved ejection fraction (HFpEF). Data from the phase I study support progression to a phase IIa study in patients with HFpEF (initiation expected in the fourth quarter).
Zacks Rank and Stocks to Consider
Cytokinetics currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the biotech sector are Entrada Therapeutics (TRDA - Free Report) and Anixa Biosciences (ANIX - Free Report) . While TRDA sports a Zacks Rank #1 (Strong Buy), ANIX carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Entrada Therapeutics’ 2024 loss per share have narrowed from 14 cents to 13 cents, and the same for 2025 loss per share have narrowed from $3.44 to $3.21.
In the past 60 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2024 loss per share has narrowed from 44 cents to 43 cents, and the same for 2025 loss per share has remained constant at 45 cents.
ANIX’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 2.27%.