Cytokinetics, Incorporated CYTK reported a net loss of $1.26 per share in the fourth quarter of 2024, wider than the Zacks Consensus Estimate of a loss of $1.22. In the year-ago quarter, the company reported a net loss of $1.38 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.

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Revenues totaled $16.9 million, which missed the Zacks Consensus Estimate of $20 million. The top line was up from $1.7 million recorded in the year-ago quarter.

Total revenues in fourth-quarter and full-year 2024 benefited from a $15.0 million upfront milestone payment from Corxel Pharmaceuticals.  

Collaboration revenues totaled $2 million.

Since the company does not have any approved product in its portfolio yet, it does not generate drug sales.

Cytokinetics’ shares have lost 35% in the past year compared with the industry’s 7.9% decline.

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CYTK’S Q4 Quarter in Detail

R&D expenses amounted to $93.6 million, up 10.2% year over year due to the advancement of clinical trials and higher personnel-related costs.

General and administrative expenses surged 41.3% to $62.3 million due to investments in the commercial readiness of lead pipeline candidate aficamten and personnel-related expenses.

As of Dec. 31, 2024, the company had approximately $1.2 billion in cash, cash equivalents and investments.

CYTK’s Progress With Aficamten

The FDA accepted CYTK’s new drug application (NDA) for lead pipeline candidate aficamten, a next-in-class cardiac myosin inhibitor, for the treatment of obstructive hypertrophic cardiomyopathy (HCM). The regulatory body assigned a standard review to the candidate with a target action date of Sept. 26, 2025.

CYTK is currently responding to information requests from the FDA and preparing for clinical site and other inspections. A meeting with the FDA is expected in March.

Cytokinetics submitted the 120-Day Safety Update to the FDA for the NDA for aficamten with an additional 10 months of safety data from FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM), the open label extension clinical study of aficamten in patients with HCM.

Meanwhile, the European Medicines Agency (“EMA”) also validated the company’s Marketing Authorization Application (“MAA”) seeking approval for aficamten for the treatment of obstructive HCM. The MAA will now be reviewed by the Committee for Medicinal Products for Human Use and CYTK expects to receive the Day 120 List of questions from EMA in April.

CYTK entered into a collaboration and license agreement with Bayer BAYRY for the exclusive development and commercialization of aficamten in Japan for the treatment of patients with obstructive and non-obstructive HCM.

The deal included an upfront payment of €50 million and milestone payments of €90 million. Cytokinetics is also eligible to receive up to €490 million in commercial milestone payments upon Bayer's achievement of certain sales milestones and tiered royalties on net sales of aficamten in Japan.

Pharma giant Sanofi SNY acquired the exclusive rights to develop and commercialize aficamten for the treatment of patients with obstructive and non-obstructive HCM in Greater China.

Cytokinetics remains eligible to receive up to $150 million in development and commercial milestone payments from Sanofi as well as royalties in the low-to-high teens on future sales of aficamten in Greater China.

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 completed in the third quarter of 2024) and ACACIA-HCM, a phase III study of aficamten in patients with non-obstructive HCM.

Other studies include CEDAR-HCM, a clinical trial of aficamten in a pediatric population with obstructive HCM.

CYTK’s Other Pipeline Candidates

Other pipeline candidates include omecamtiv mecarbil, a cardiac muscle activator, in patients with heart failure. CYTK initiated the confirmatory phase III multi-center, double-blind, randomized, placebo-controlled trial, COMET-HF, to assess the efficacy and safety of omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction.

Additionally, Cytokinetics initiated AMBER-HFpEF, a phase II randomized, placebo-controlled, double-blind, multi-center, dose-finding clinical trial on CK-586 in patients with symptomatic heart failure with preserved ejection fraction (with left ventricular ejection fraction [LVEF] ≥ 60%).

A phase I randomized, double-blind, placebo-controlled, multi-part, single and multiple ascending dose clinical study of CK-089 in healthy human participants was also initiated.

CYTK’s Zacks Rank

Cytokinetics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.



 

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