On November 4, 2020 Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the third quarter of 2020 (Press release, Cytokinetics, NOV 4, 2020, View Source [SID1234569931]). Net loss for the third quarter was $3.2 million, or $0.05 per share, compared to net loss for the third quarter of 2019 of $29.6 million, or $0.50 per share. Cash, cash equivalents and investments totaled $451.2 million at September 30, 2020 and does not include $85 million expected upon the closing of RTW Investments’ purchase of Cytokinetics’ royalty rights on the future sales of mavacamten.
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"We were pleased to recently announce positive topline results in GALACTIC-HF which demonstrated a reduction in the primary efficacy outcome endpoint with omecamtiv mecarbil." said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "We look forward to the presentation of the primary results at the AHA Scientific Sessions, including pre-specified subgroup analyses which will elaborate on patients that had differential effects with our cardiac myosin activator. During the third quarter, we continued to make progress on our pipeline, highlighted by the advancement of CK-274 in REDWOOD-HCM and our advancing a second cardiac myosin inhibitor into clinical development. With a strong balance sheet, fortified by business development and financing deals completed in July, we are well positioned to continue funding the progression of our muscle-directed drug candidates in clinical trials."
Recent Highlights
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin activator)
Completed conduct of closeout activities for GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil. Topline results from the trial were recently announced showing that treatment with omecamtiv mecarbil achieved the primary composite efficacy endpoint and demonstrated a statistically significant effect to reduce in cardiovascular (CV) death or heart failure events (heart failure hospitalization and other urgent treatment for heart failure), compared to placebo in patients treated with standard of care (HR: 0.92; 95% CI: 0.86, 0.99, p=0.0252). No reduction in the secondary endpoint of CV death was observed. Adverse events, including major ischemic cardiac events, were balanced between treatment arms.
Primary results from GALACTIC-HF will be presented at the American Heart Association (AHA) Scientific Sessions 2020, as part of a virtual Late Breaking Clinical Trial session on Friday, November 13, 2020 from 10:35-10.45 a.m. CDT.
Reviewing prespecified analyses and supplemental analyses of results of GALACTIC-HF in collaboration with Amgen. Discussions ongoing with Amgen on potential next steps.
Continued conduct of METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil. We expect enrollment to be completed in 1H 2021. METEORIC-HF is being conducted by Cytokinetics in collaboration with Amgen.
AMG 594 (cardiac troponin activator)
Convened advisory board of consultants to discuss potential indications to inform Phase 2 trial planning. Continued discussions of potential next steps in the development program with Amgen.
CK-3773274 (CK-274, cardiac myosin inhibitor)
Continued conduct of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), the Phase 2 clinical trial designed to determine the safety and tolerability of CK-274 in patients with obstructive hypertrophic cardiomyopathy (HCM). Recently completed enrollment of first cohort of patients in REDWOOD-HCM, summary data from which will inform progression to the second cohort of the trial, expected by the end of 2020.
Presented preclinical data at the American Association of Pharmaceutical Scientists (AAPS) 2020 PharmSci 360 showing that CK-274 demonstrated desirable pharmacokinetics in vivo, supporting the intended pharmacokinetic profile of once-daily oral dosing in humans and steady state plasma concentrations achieved within two weeks of initiation of dosing.
CK-271 (CK-271, second cardiac myosin inhibitor)
Initiated a Phase 1 study of CK-271, our second cardiac myosin inhibitor. We expect to complete the study by the end of 2020.
Skeletal Muscle Program
reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))
Convened meetings with ALS community stakeholders to obtain feedback on endpoints and other matters relating to the design of a potential Phase 3 trial of reldesemtiv in patients with ALS.
Conducted readiness activities in preparation for the start of a potential Phase 3 clinical trial of reldesemtiv in patients with ALS.
Pre-Clinical Development and Ongoing Research
Continued pre-clinical development of CK-3762601 (CK-601), a next-generation FSTA. We expect to continue conduct of IND-enabling studies of CK-601 in 2020.
Published a manuscript on pre-clinical data in the Journal of Cachexia, Sarcopenia and Muscle, showing the fast skeletal muscle troponin activator CK-2066260 (CK-260) increases submaximal force in conditions with muscle weakness in vitro.
Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators.
Continued independent research activities directed to our other muscle biology research programs.
Corporate
Executed a series of transactions with affiliates of RTW Investments, LP, and Ji Xing Pharmaceuticals Limited related to CK-274 whereby Cytokinetics will receive a combination of committed capital, funding and sale proceeds of up to $250 million and is eligible to receive up to $200 million in milestone payments plus royalties on future sales of CK-274 in certain Asian countries
Raised $189 million in net proceeds, after deducting underwriting discounts and commissions, from an underwritten public offering in July of 8,385,417 shares of common stock including the underwriter’s exercise of their overallotment option.
Convened a virtual investor & analyst day to provide updates on the company’s advancing cardiovascular pipeline and strategies to build a commercial franchise.
Participated in the launch of Kainomyx, Inc., a new biopharmaceutical company focused on the discovery and development of small molecule therapeutics for the treatment of parasitic diseases.
Provided $1 million grant and entered four-year partnership with the HCM Registry (HCMR), a global registry of patients with hypertrophic cardiomyopathy focused on improving predictive measures of risk for complications and identifying biomarkers associated with adverse clinical outcomes.
Renewed our partnership with Cure SMA to increase education, awareness, public policy and fundraising for spinal muscular atrophy (SMA).
Announced a call for proposals for the third annual Cytokinetics Communications Fellowship Grant program. The program provides $100,000 in grants to five selected patient advocacy organizations serving the ALS, heart failure, HCM, or SMA communities, and is intended to support increased capacity in communications, awareness building and community engagement.
Financials
Revenues for the three and nine months ended September 30, 2020 were $41.7 million and $49.1 million, respectively, compared to $6.1 million and $21.7 million for the corresponding periods in 2019. The increase in revenues for the three and nine month ended September 30, 2020 was primarily due to $36.5 million of license revenue recognized in the third quarter 2020 for the RTW transactions.
Research and development expenses for the three and nine months ended September 30, 2020 increased to $24.2 million and $67.7 million, respectively, compared to $20.2 million and $67.8 million for the same periods in 2019, respectively, due to increased spending on readiness for reldesemtiv and an increase in spending for our cardiac myosin inhibitor programs.
General and administrative expenses for the three and nine months ended September 30, 2020 increased to $12.3 million and $38.9 million from $9.8 million and $29.0 million in 2019 due primarily to an increase in personnel related costs including stock-based compensation and higher outside spending for commercial readiness.
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s third quarter 2020 results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or +1 (706) 679-3078 (international) and typing in the passcode 3979672.
An archived replay of the webcast will be available via Cytokinetics’ website until November 18, 2020. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or +1 (404) 537-3406 (international) and typing in the passcode 3979672 from November 4, 2020 at 7:30 PM Eastern Time until November 18, 2020.