On November 3, 2022 Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the third quarter of 2022 (Press release, Cytokinetics, NOV 3, 2022, View Source [SID1234622969]). Net loss for the third quarter was $142.3 million, or $1.52 per share, compared to net loss for the third quarter of 2021 of $76.1 million, or $0.95 per share. Cash, cash equivalents and investments totaled $896.2 million at September 30, 2022.
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"During the third quarter, we continued to execute towards our potential transformation to commercialization with expansion of teams and readiness activities in preparation for our upcoming FDA Advisory Committee meeting and the potential launch of omecamtiv mecarbil," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "At the same time, the development program for aficamten is proceeding with continued conduct of Cohort 4 of REDWOOD-HCM and SEQUOIA-HCM, alongside start up activities for our second Phase 3 clinical trial of aficamten. We also are continuing COURAGE-ALS following its first interim analysis marking progress aligned with our commitment to ALS. We have entered the fourth quarter with a strong balance sheet ahead of key corporate milestones."
Q3 and Recent Highlights
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin activator)
Engaged in further interactions with the U.S. Food and Drug Administration (FDA) related to our New Drug Application (NDA) for omecamtiv mecarbil. Continued discussions with FDA regarding matters related to substantial evidence of efficacy, benefit-risk, and dosing.
Conducted meetings with assigned rapporteurs to discuss the planned submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA).
Continued commercial preparations for the potential U.S. launch of omecamtiv mecarbil including convening meetings with national and regional payers, advancing wholesaler agreements for distribution, finalizing third party logistics agreement, completing strategic sourcing of drug substance and drug product contract manufacturing organizations, continuing development of patient services hub, and beginning the final wave of hiring for sales force leaders.
Expanded the headquarters- and field-based medical affairs team, continued support of independent medical education activities at medical conferences, and initiated planning for our Medical Contact Center.
Launched "The Heart of Contractility," a disease state education campaign for healthcare providers to build awareness of worsening heart failure and the importance of contractility.
aficamten (cardiac myosin inhibitor)
Continued clinical trial site activation and enrollment of patients with obstructive HCM in SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), our first Phase 3 trial of aficamten, with 70 sites now enrolling in the U.S. and Europe.
Completed screening for patients with non-obstructive HCM to enroll in Cohort 4 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM).
Renamed the open-label extension clinical study of aficamten in patients with hypertrophic cardiomyopathy (HCM), previously known as REDWOOD-HCM OLE (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM Open Label Extension) to FOREST-HCM (Five-Year, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM) to reflect the entry of patients from additional clinical trials of aficamten including SEQUOIA-HCM.
Presented data from FOREST-HCM (previously known as REDWOOD-HCM OLE) at the Heart Failure Society of America (HFSA) Annual Scientific Meeting showing that treatment with aficamten was associated with substantial and significant symptom improvements as measured by the change in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores.
Presented data from FOREST-HCM at the 2022 HCM Society Scientific Sessions demonstrating in patients treated with aficamten the successful reduction or withdrawal of standard of care therapies.
Published a manuscript entitled "A Phase 1 Dose-Escalation Study of the Cardiac Myosin Inhibitor Aficamten in Healthy Participants" in JACC: Basic to Translational Science.
Skeletal Muscle Program
reldesemtiv (fast skeletal muscle troponin activator (FSTA))
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 and recommended that conduct of the Phase 3 trial continue.
Pre-Clinical Development and Ongoing Research
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 in the next year.
Continued research activities directed to our other muscle biology research programs.
Corporate
Raised $523.6 million in net proceeds from a 3.50% convertible senior notes offering (due 2027), after deducting underwriters’ discounts and transaction fees, and before repurchasing approximately $117 million of previously outstanding 4.00% convertible senior notes (due 2026).
Announced a new release of the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database updated with clinical data from Cytokinetics’ completed clinical trials in ALS.
Announced a call for proposals for the fifth annual Cytokinetics Communications Grant program. The program awards five grants worth $20,000 each to patient advocacy organizations serving the ALS, heart failure, and HCM communities, and is intended to help support increased capacity in communications and outreach.
Upcoming Corporate Milestones
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin activator)
Participate in Advisory Committee meeting to review the NDA for omecamtiv mecarbil on December 13, 2022.
Launch omecamtiv mecarbil in the U.S. subject to FDA approval in Q1 2023.
Submit Marketing Authorization Application (MAA) to the European Medicines Agency by the end of 2022.
aficamten (cardiac myosin inhibitor)
Continue enrolling patients with obstructive HCM in SEQUOIA-HCM through 1H 2023 with results expected in 2H 2023.
Complete enrolling patients with non-obstructive HCM in Cohort 4 of REDWOOD-HCM with data expected in 1H 2023.
Begin second Phase 3 clinical trial of aficamten in obstructive HCM in Q4 2022.
CK-3828136 (CK-136) (cardiac troponin activator)
Begin Phase 1 study of CK-136 in Q4 2022.
Skeletal Muscle Program
reldesemtiv (fast skeletal muscle troponin activator (FSTA))
Expect the Data Monitoring committee to conduct the second interim analysis from COURAGE-ALS in 1H 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.
Continue enrolling patients with ALS in COURAGE-ALS and expect to complete enrollment in 1H 2023.
Financials
Revenues for the three and nine months ended September 30, 2022 were $2.5 million and $92.6 million, respectively, compared to $5.4 million and $14.8 million for the corresponding period in 2021. The increase in revenues for the nine months ended September 30, 2022 was primarily due to the recognition of $87.0 million of deferred revenue for royalties on the net sales of products containing mavacamten as a result of the extinguishment of royalty obligations.
Research and development expenses for the three and nine months ended September 30, 2022 increased to $62.7 million and $165.8 million, respectively, compared to $48.4 million and $116.4 million for the same period in 2021. The changes were primarily due to increases in spending for clinical development activities for COURAGE-ALS and SEQUOIA-HCM, and for our other cardiac muscle inhibitor and early research programs.
General and administrative expenses for the three and nine months ended September 30, 2022 increased to $48.2 million and $124.0 million, respectively, from $26.2 million and $63.0 million for the same period in 2021 due primarily to higher outside services spending in anticipation of the potential commercial launch of omecamtiv mecarbil, and an increase in personnel related costs including stock-based compensation.
During the quarter, we recognized a loss of $22.2 million related to the conversion and partial settlement of our 2026 Convertible Notes.
Conference Call and Webcast Information
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 Q3 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.