Cytokinetics Reports Third Quarter 2020 Financial Results
Topline Results From GALACTIC-HF Show Trial Met Primary Composite Endpoint
of Reduction in Cardiovascular Death or Heart Failure Events; Trial Did Not Meet Secondary Endpoint
of Reduction in Cardiovascular Death
Primary results from GALACTIC-HF to be presented as Late Breaking Clinical Trial Session at the
Enrollment Completed in Cohort 1 of REDWOOD-HCM
“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
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, 2020from 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
Cytokineticsin 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.
- 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.
- Executed a series of transactions with affiliates of
RTW Investments, LP, and Ji Xing Pharmaceuticals Limitedrelated to CK-274 whereby Cytokineticswill receive a combination of committed capital, funding and sale proceeds of up to $250 millionand is eligible to receive up to $200 millionin milestone payments plus royalties on future sales of CK-274 in certain Asian countries
$189 millionin 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.
$1 milliongrant 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
$100,000in grants to five selected patient advocacy organizations serving the ALS, heart failure, HCM, or SMA communities, and is intended to support increased capacity in communications, awareness building and community engagement.
Revenues for the three and nine months ended
Research and development expenses for the three and nine months ended
General and administrative expenses for the three and nine months ended
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s third quarter 2020 results via a webcast and conference call today at
An archived replay of the webcast will be available via Cytokinetics’ website until
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”).
Senior Vice President, Corporate Communications, Investor Relations
|Condensed Consolidated Balance Sheets|
|Cash and short term investments||$||410,264||$||225,112|
|Other current assets||8,148||8,640|
|Total current assets||418,412||233,752|
|Property and equipment, net||7,667||4,530|
|Operating lease right-of-use assets and other assets||7,075||8,882|
|LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)|
|Accounts payable and accrued liabilities||$||21,224||$||20,283|
|Short-term lease liability||3,943||4,616|
|Other current liabilities||2,406||1,124|
|Total current liabilities||27,573||26,023|
|Term loan, net||45,920||45,052|
|Convertible notes, net||88,102||84,205|
|Liability related to the sale of future royalties, net||160,395||143,276|
|Long-term lease and other non-current liabilities||2,517||2,195|
|Commitments and contingencies|
|Stockholders’ equity (deficit):|
|Additional paid-in capital||1,096,953||853,341|
|Accumulated other comprehensive income||958||679|
|Total stockholders’ equity (deficit)||149,605||(10,937||)|
|Total liabilities and stockholders’ equity (deficit)||$||474,112||$||289,814|
|Condensed Consolidated Statements of Operations|
|(in thousands except per share data)|
|Three Months Ended||Nine Months Ended|
|Research and development revenues||$||5,187||$||6,055||$||12,605||$||21,656|
|Research and development||24,202||20,229||67,730||67,791|
|General and administrative||12,302||9,753||38,912||29,026|
|Total operating expenses||36,504||29,982||106,642||96,817|
|Operating income (loss)||5,184||(23,927||)||(57,536||)||(75,161||)|
|Non-cash interest expense on liability related to the sale of future royalties||(5,461||)||(5,321||)||(17,062||)||(15,204||)|
|Interest and other income||1,078||1,020||3,183||3,205|
|Net loss per share — basic and diluted||$||(0.05||)||$||(0.50||)||$||(1.34||)||$||(1.60||)|
|Weighted-average number of shares used in computing net loss per share — basic and diluted||68,279||58,640||62,406||57,050|
Source: Cytokinetics, Incorporated