On May 4, 2023 Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the first quarter of 2023 (Press release, Cytokinetics, MAY 4, 2023, View Source [SID1234631027]). Net loss for the first quarter was $131.3 million, or $1.38 per share, compared to net loss for the first quarter of 2022 of $89.4 million, or $1.05 per share. Cash, cash equivalents and investments totaled $704.4 million at March 31, 2023.
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"In the first quarter we continued to prioritize the broad development program for aficamten for the potential treatment of obstructive and non-obstructive HCM and with focus to SEQUOIA-HCM, our pivotal Phase 3 clinical trial in obstructive HCM. We expect to complete patient enrollment in the coming weeks and read out the results later this year," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "In parallel, we continue to deepen our specialty cardiology pipeline with the advancement of CK-136 and CK-586 in earlier phase clinical trials. Finally, as good stewards of shareholder capital, we are reducing our spending to ensure we maintain over two years of cash runway."
Q1 and Recent Highlights
Cardiac Muscle Programs
aficamten (cardiac myosin inhibitor)
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Presented data from Cohort 4 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), a Phase 2 clinical trial of aficamten in patients with non-obstructive hypertrophic cardiomyopathy, at the American College of Cardiology 72nd Annual Scientific Session (ACC.23), showing that treatment with aficamten resulted in significant
improvements in heart failure symptoms as measured by New York Heart Association (NYHA) Class, as well as in NT-proBNP and high-sensitivity troponin I, cardiac biomarkers.
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Presented 48-week data from FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM) at ACC.23 showing that long-term treatment with aficamten was associated with sustained treatment effect, well-tolerated with no treatment-related serious adverse events, and was associated with rapid and sustained improvements in echocardiographic hemodynamics paralleled by significant improvements in NYHA class.
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Continued enrolling patients in SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the first Phase 3 trial of aficamten in obstructive hypertrophic cardiomyopathy (HCM).
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Continued preparations for the start of MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM), the second Phase 3 clinical trial of aficamten as monotherapy in patients with obstructive HCM.
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Began preparations for the Phase 3 clinical trial of aficamten in non-obstructive HCM.
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Published the following manuscripts:
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"Phase 2 Study of Aficamten in Patients with Obstructive Hypertrophic Cardiomyopathy" in the Journal of the American College of Cardiology.
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"Effects of Aficamten on Cardiac Contractility in a Feline Translational Model of Hypertrophic Cardiomyopathy" in Scientific Reports.
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"Pharmacokinetics of a Single Dose of Aficamten (CK-274) on Cardiac Contractility in a A31P MYBPC3 Hypertrophic Cardiomyopathy Cat Model" in the Journal of Veterinary Pharmacology and Therapeutics.
omecamtiv mecarbil (cardiac myosin activator)
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Announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for omecamtiv mecarbil.
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Continued to support review of the Marketing Authorization Application (MAA) for omecamtiv mecarbil by the European Medicines Agency (EMA) for the treatment of advanced or worsening HFrEF.
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Published the following manuscripts:
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"Omecamtiv Mecarbil in Black Patients with Heart Failure and Reduced Ejection Fraction: Insights From GALACTIC-HF" in the Journal of the American College of Cardiology: Heart Failure.
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"Efficacy of Omecamtiv Mecarbil in Heart Failure with Reduced Ejection Fraction According to N-terminal pro-B-type Natriuretic Peptide Level: Insights from the GALACTIC-HF Trial" in the European Journal of Heart Failure.
CK-3828136 (CK-136, cardiac troponin activator)
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Completed 3 single ascending dose cohorts in the Phase 1 study of CK-136 in healthy volunteers.
Skeletal Muscle Program
reldesemtiv (fast skeletal muscle troponin activator (FSTA))
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Announced that COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS) met criteria for futility at the second planned interim analysis. The company will conclude study conduct and plans to discontinue treatment with reldesemtiv in all patients, including those in the open-label extension study, COURAGE-ALS OLE.
Pre-Clinical Development and Ongoing Research
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Received U.S. Food & Drug Administration (FDA) clearance for the Investigational New Drug (IND) application to initiate a Phase 1 study of CK-4021586 (CK-586).
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Continued research activities directed to our other muscle biology research programs.
Corporate
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Released inaugural Corporate Responsibility Report outlining the Company’s commitment to social and environmental responsibility, ethics and governance and patient and community engagement.
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Joined with the European Organisation for Rare Diseases (EURORDIS) and the National Organization for Rare Disorders (NORD) to recognize Rare Disease Day, an international campaign elevating the public understanding of rare diseases.
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Awarded Cytokinetics Communications Fellowship Grants to patient advocacy organizations serving the heart failure, HCM and ALS communities to support increased capacity in communications, awareness building and community engagement for nonprofit organizations serving the patient community.
2023 Corporate Milestones
Cardiac Muscle Programs
aficamten (cardiac myosin inhibitor)
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Present additional data from Cohort 4 of REDWOOD-HCM at the European Society of Cardiology Heart Failure 2023 Congress on May 20, 2023.
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Complete patient enrollment in SEQUOIA-HCM in Q2 2023, with results expected in Q4 2023.
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Begin MAPLE-HCM, the second Phase 3 clinical trial of aficamten as monotherapy compared to metoprolol in patients with obstructive HCM, in Q2 2023.
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Begin a Phase 3 clinical trial of aficamten in non-obstructive HCM in 2H 2023.
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Advance U.S. go-to-market strategy for aficamten.
omecamtiv mecarbil (cardiac myosin activator)
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Continue to pursue potential international approvals for omecamtiv mecarbil in Europe and China.
CK-3828136 (CK-136, cardiac troponin activator)
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Expect single ascending dose data from the Phase 1 study of CK-136 in 2H 2023.
CK-4021586 (CK-586, cardiac myosin inhibitor)
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Expect to advance CK-586 into a first-in-human study in Q2 2023.
Skeletal Muscle Program
reldesemtiv (fast skeletal muscle troponin activator (FSTA))
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Conclude clinical trial conduct and complete majority of close-out activities for COURAGE-ALS in Q2 2023; expect to share results from COURAGE-ALS in 2H 2023.
Financials
Revenues for the first quarter 2023 were $4.6 million compared to $1.1 million for the corresponding period in 2022. The increase in revenues is due to our recognizing a $2.5 million milestone from Ji Xing Pharmaceuticals in anticipation of the start of a Phase 3 trial on nHCM.
Research and development expenses for the first quarter 2023 increased to $79.4 million compared to $45.9 million for the same period in 2022, due primarily to increased spending for our clinical development activities for our cardiac myosin inhibitor programs and COURAGE-ALS.
General and administrative expenses for the first quarter 2023 increased to $49.7 million from $33.1 million for the same period in 2022 due primarily to higher personnel related costs including stock-based compensation and precommercial launch expenses.
The company expects to reduce spending in 2023, primarily through a reduction in planned outsourced services and headcount growth, thereby resulting in projected savings of more than 10% relative to forecasted spending for 2023.
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s first quarter 2023 results on a conference call today at 4:30 PM Eastern Time. The conference call will be simultaneously webcast and can be accessed from the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by registering in advance at the following link: Cytokinetics Q1 2023 Earnings Conference Call. Upon registration, participants will receive a dial-in number and a unique passcode to access the call. An archived replay of the webcast will be available via Cytokinetics’ website for twelve months.