On March 1, 2023 Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the fourth quarter and full year 2022. Net loss for the fourth quarter was $137.4 million or $1.45 per share and the net loss for the year 2022 was $389.0 million or $4.33 per share (Press release, Cytokinetics, MAR 1, 2023, View Source [SID1234627975]). Net loss for the fourth quarter of 2021 was $30.6 million or $0.36 per share and net loss for the year 2021 was $215.3 million or $2.80 per share. Cash, cash equivalents and investments totaled $829.3 million at December 31, 2022.
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"Aficamten remains our top priority and is advancing in a broad development program with emphasis on the conduct of SEQUOIA-HCM, our pivotal Phase 3 clinical trial in obstructive HCM, and the start of two additional Phase 3 trials." said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "At the same time, COURAGE-ALS, our Phase 3 clinical trial of reldesemtiv, is continuing to enroll with the planned second interim analysis expected to occur in the second quarter. These activities will continue as company priorities while we will also assess potential next steps for omecamtiv mecarbil. We entered 2023 with a strong balance sheet as we advance multiple late-stage programs as well as make progress in our early-stage pipeline, continuing our 25-year commitment to bringing forward potential new medicines for patients in need."
Q4 and Recent Highlights
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin activator)
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Cytokinetics 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, stating that GALACTIC-HF is not sufficiently persuasive to establish substantial evidence of effectiveness for reducing the risk of heart failure events and cardiovascular death in adults with chronic heart failure with
reduced ejection fraction, in lieu of evidence from at least two adequate and well-controlled clinical investigations.
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The European Medicines Agency (EMA) accepted the Marketing Authorization Application (MAA) for omecamtiv mecarbil for the treatment of advanced or worsening HFrEF.
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Ji Xing Pharmaceuticals announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People’s Republic of China has accepted the submission of the New Drug Application (NDA) for omecamtiv mecarbil for the treatment of heart failure with reduced ejection fraction (HFrEF) in China.
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Presented results from two additional analyses from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) at the American Heart Association Scientific Sessions 2022, including one showing that the estimated cost reduction due to heart failure events avoided due to treatment with omecamtiv mecarbil averaged $6,052 per patient (26.9% reduction) at three years, and one that showed that women had lower quality of life at baseline and a lower rate of the primary composite outcome, but the treatment benefit of omecamtiv mecarbil did not differ between men and women (interaction p=0.68).
aficamten (cardiac myosin inhibitor)
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Continued enrolling patients with obstructive hypertrophic cardiomyopathy (HCM) in SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), our first Phase 3 trial of aficamten in the U.S. and Europe.
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Completed enrollment of patients with non-obstructive HCM in Cohort 4 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM).
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Continued preparations for the second Phase 3 clinical trial of aficamten as monotherapy in patients with obstructive HCM, MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM).
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Hired a U.S. marketing leader and continued to advance the go-to-market strategy for aficamten in the U.S.
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Published a manuscript entitled "Phase 2 Study of Aficamten in Patients with Obstructive Hypertrophic Cardiomyopathy" in the Journal of the American College of Cardiology.
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Published a manuscript entitled "Pharmacokinetics of a Single Dose of Aficamten (CK-274) on Cardiac Contractility in a A31P MYBPC3 Hypertrophic Cardiomyopathy Cat Model" in Journal of Veterinary Pharmacology and Therapeutics.
Skeletal Muscle Program
reldesemtiv (fast skeletal muscle troponin activator (FSTA))
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Continued enrolling patients with ALS in COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS), the Phase 3 clinical trial of reldesemtiv.
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Announced that the Data Monitoring Committee (DMC) for COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS) convened to review unblinded data from the clinical trial for the first interim analysis and recommended that conduct of the Phase 3 trial continue.
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Presented results from an additional analysis from FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), the Phase 2 clinical trial of reldesemtiv showing that the ENCALS predicted risk scores are strongly correlated with the rate of decline in ALSFRS-R.
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Published a manuscript entitled "MiToS and King’s staging as clinical outcome measures in ALS: a retrospective analysis of the FORTITUDE-ALS trial" in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration.
Pre-Clinical Development and Ongoing Research
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Continued to advance new muscle directed compounds and conduct IND-enabling studies with the expectation of our potentially moving 1-2 drug candidates into clinical development this year.
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Continued research activities directed to our other muscle biology research programs.
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Published a manuscript entitled "Distinct Mechanisms for Increased Cardiac Contraction Through Selective Alteration of Either Myosin or Troponin Activity" in the Journal of the American College of Cardiology: Basic to Translational Science.
Corporate
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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 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
omecamtiv mecarbil (cardiac myosin activator)
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Request meeting with FDA to understand what may be required to support potential approval of omecamtiv mecarbil in the United States.
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Engage with EMA regarding the MAA for the treatment of HFrEF.
aficamten (cardiac myosin inhibitor)
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Present data from Cohort 4 of REDWOOD-HCM at the American College of Cardiology’s 72nd Annual Scientific Session.
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Present data from 48 weeks of treatment with aficamten in FOREST-HCM at the American College of Cardiology’s 72nd Annual Scientific Session.
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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 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.
CK-3828136 (CK-136) (cardiac troponin activator)
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Expect data from the Phase 1 study of CK-136 in 2H 2023.
Skeletal Muscle Program
reldesemtiv (fast skeletal muscle troponin activator (FSTA))
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Expect the Data Monitoring committee to conduct the second interim analysis from COURAGE-ALS in Q2 2023, which will assess for futility and allow for a fixed increase in total enrollment, if deemed necessary, to augment the statistical power of the trial.
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Complete patient enrollment in COURAGE-ALS in Q2 2023, subject to second interim analysis.
Pre-Clinical Development and Ongoing Research
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Expect to advance CK-4021586, an additional cardiac myosin inhibitor, into clinical development in 1H 2023.
Financials
Revenues for the three and twelve months ended December 31, 2022 were $2.0 million and $94.6 million, respectively, compared to $55.6 million and $70.4 million for the corresponding period in 2021. The increase in revenues for the prior year was primarily due to the recognition of $54.9 million of license revenue recognized for the transaction with Ji Xing.
Research and development expenses for the three and twelve months ended December 31, 2022 increased to $75.0 million and $240.8 million, respectively, compared to $43.5 million and $159.9 million for the same period in 2021.
The changes were primarily due to increases in current year activities for clinical development for COURAGE-ALS and our cardiac myosin inhibitor programs.
General and administrative expenses for the three and twelve months ended December 31, 2022 increased to $54.0 million and $178.0 million, respectively, from $33.8 million and $96.8 million for the same period in 2021 due to higher outside service spending in anticipation of the potential launch of omecamtiv mecarbil and an increase in personnel related cost including stock-based compensation.
2023 Financial Guidance
The company reported financial guidance for 2023. The company anticipates revenue will be up to $5 million, driven by Astellas reimbursement of the costs of COURAGE-ALS. In addition, we expect to receive $50 million in a milestone payment from Royalty Pharma upon the start of the pivotal Phase 3 clinical trial of aficamten in nHCM. Operating expenses will be in the range of $420 to $450 million, and net cash utilization will be approximately $350 to $375 million. Our current cash balance of approximately $830 million represents more than 2 years of forward cash based on our projected 2023 operating expenses and net cash utilization.
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s fourth quarter 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 homepage and in 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 Q4 2022 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.