On November 2, 2023 Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the third quarter of 2023 (Press release, Cytokinetics, NOV 2, 2023, View Source [SID1234636753]). Net loss for the third quarter was $129.4 million, or $1.35 per share, compared to net loss for the third quarter of 2022 of $142.3 million, or $1.52 per share. Cash, cash equivalents and investments totaled $554.7 million on September 30, 2023.
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"During the third quarter we made considerable progress across our specialty cardiology franchise, with aficamten remaining our top priority. Of note, the baseline characteristics of patients enrolled in SEQUOIA-HCM met our objectives for the trial and align with our goal to assess aficamten as a potential next-in-class cardiac myosin inhibitor in a population with a substantial deficit in exercise capacity and significant symptom burden despite existing standard of care," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "In addition, we recently shared longer-term data from FOREST-HCM that demonstrate durable reductions in pressure gradients and cardiac biomarkers as well as improved symptoms in patients with obstructive HCM. During the quarter we also started ACACIA-HCM, a pivotal Phase 3 clinical trial of aficamten in patients with non-obstructive HCM. Alongside these increasing commitments to aficamten, we are approaching the end of 2023 in a strong position with the resources and pipeline to execute on our goals in service to both patients and shareholders."
Q3 and Recent Highlights
Cardiac Muscle Programs
aficamten (cardiac myosin inhibitor)
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Presented baseline characteristics from 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), at the HCM Society Scientific Sessions 2023.
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Shared new long-term 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, at the Company’s recent Investor and Analyst Day, demonstrating sustained reductions in left ventricular outflow tract (LVOT) gradients with no treatment interruptions for low left ventricular ejection fraction (LVEF) due to aficamten. Additionally, patients experienced sustained reductions in cardiac biomarkers and improved symptoms. Aficamten has been generally well-tolerated, with no treatment-related serious adverse events (SAEs) as assessed by investigators, and no patient deaths.
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Announced the start of ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM), a pivotal Phase 3 clinical trial of aficamten in patients with non-obstructive HCM.
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Published a manuscript entitled "Aficamten in Patients with Drug-Refractory Obstructive Hypertrophic Cardiomyopathy Receiving Disopyramide: REDWOOD-HCM Cohort 3 Analysis" in the Journal of Cardiac Failure.
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Published a manuscript entitled "Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of Aficamten in Healthy Chinese Participants: a Randomized, Double-blind, Placebo-controlled, Phase 1 Study" in the Frontiers of Pharmacology.
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Published a manuscript entitled "Exercise Capacity in Patients With Obstructive Hypertrophic Cardiomyopathy: SEQUOIA-HCM Baseline Characteristics and Study Design" in the Journal of the American College of Cardiology: Heart Failure.
omecamtiv mecarbil (cardiac myosin activator)
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Submitted a Formal Dispute Resolution Request to the Office of New Drugs (OND) of the U.S. Food and Drug Administration (FDA) regarding the Complete Response Letter (CRL) for omecamtiv mecarbil with objective to appeal the FDA’s conclusion, as stated in the CRL, that
substantial evidence of effectiveness had not been established to support approval of omecamtiv mecarbil.
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Submitted responses to the Day 120 questions to the European Medicines Agency (EMA) in connection with its review of the marketing application for omecamtiv mecarbil for the treatment of advanced or worsening heart failure with reduced ejection fraction (HFrEF).
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Ji Xing Pharmaceuticals submitted a request for voluntary withdrawal of the NDA for omecamtiv mecarbil to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People’s Republic of China, subject to potential re-submission upon receipt of favorable feedback from EMA or FDA with regard to potential drug approval for omecamtiv mecarbil in the EU or U.S., respectively.
CK-3828136 (CK-136, cardiac troponin activator)
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Completed the single ascending dose (SAD) cohorts of the Phase 1 study of CK-136 in healthy participants. Initiated analyses of the SAD data to inform potentially proceeding to the multiple ascending dose (MAD) cohorts of the Phase 1 study.
CK-4021586 (CK-586, cardiac myosin inhibitor)
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Completed the SAD cohorts of the Phase 1 study of CK-586 in healthy participants. Completed analyses of the SAD data which are supportive of proceeding to the MAD cohorts of the Phase 1 study in Q4 2023.
Pre-Clinical Development and Ongoing Research
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Continued research activities directed to our other muscle biology research programs.
Corporate
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Announced a call for proposals for the sixth annual Cytokinetics Communications Grant Program. The program awards five grants worth $20,000 each to patient advocacy organizations serving the HCM, heart failure or ALS communities, and is intended to support increased capacity in communications and outreach.
Upcoming Corporate Milestones
Cardiac Muscle Programs
aficamten (cardiac myosin inhibitor)
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Expect topline results from SEQUOIA-HCM in late December.
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Continue enrollment of MAPLE-HCM.
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Continue enrollment of ACACIA-HCM.
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Continue advancing go-to-market strategy for aficamten.
omecamtiv mecarbil (cardiac myosin activator)
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Continue to pursue potential approval for omecamtiv mecarbil in Europe.
CK-3828136 (CK-136, cardiac troponin activator)
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Analyze SAD data from the Phase 1 study of CK-136 to inform potentially proceeding with the MAD cohorts in the Phase 1 study.
CK-4021586 (CK-586, cardiac myosin inhibitor)
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Proceed to the MAD cohorts in the Phase 1 study of CK-586.
Financials
Revenues for the three and nine months ended September 30, 2023 were $0.4 million and $5.9 million (inclusive of $2.5 million milestone, in the nine months ended, from Ji Xing Pharmaceuticals upon the start of ACACIA-HCM), respectively, compared to $2.5 million and $92.6 million (inclusive of $87 million from the sale of our royalty on mavacamten) for the corresponding periods in 2022.
Research and development expenses for the three and nine months ended September 30, 2023 increased to $82.5 million and $245.2 million, respectively, compared to $62.7 million and $165.8 million for the same periods in 2022, respectively, due primarily to increased spending for our cardiac myosin inhibitor programs.
General and administrative expenses for the three months ended September 30, 2023 decreased to $40.1 million from $48.2 million from the three months ended September 20, 2022, primarily due to lower outside services spend. General and administrative expenses for the nine months ended September 30, 2023 increased to $129.5 million from $124.0 million from the nine months ended September 20, 2022,
primarily due to higher personnel related cost including stock-based compensation offset by lower outside service spend.
During the quarter we also received a $50 million cash milestone payment from Royalty Pharma plc upon the start of ACACIA-HCM, treated as a liability on our balance sheet in accordance with GAAP.
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s third 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 Q3 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.