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Enrollment Completed in GALACTIC-HF with More than 8,200 Heart Failure Patients;
Second Interim Analysis Expected in Q1 2020
Data from Phase 1 Study of CK-274 Support Progression;
Phase 2 Clinical Trial in Patients with Obstructive Hypertrophic Cardiomyopathy to Begin in Q4 2019
Faster Progressing Patients Receiving Reldesemtiv in FORTITUDE-ALS Experienced Slower Decline
in ALSFRS-R and Greater Difference from Placebo than Slower Progressing Patients
SOUTH SAN FRANCISCO, Calif., Oct. 31, 2019 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq:CYTK) reported financial results for the third quarter of 2019. Net loss for the third quarter was $29.6 million, or $0.50 per share, compared to net loss for the third quarter of 2018 of $22.0 million, or $0.40 per share. Cash, cash equivalents and investments totaled $166.0 million at September 30, 2019.
“In the third quarter of 2019, we achieved major milestones in both our cardiovascular and neuromuscular programs representing progress on key priorities across our pipeline of muscle-directed therapies,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Completion of enrollment of GALACTIC-HF represents a significant step forward towards the completion of this important trial which holds promise for advancing the treatment of millions of patients suffering from heart failure. Additionally, recently presented Phase 1 data for CK-274 reaffirms its next-generation profile and supports advancing this program into a Phase 2 trial in patients with obstructive hypertrophic cardiomyopathy this year. Furthermore, additional analyses of results from FORTITUDE-ALS, as well as ongoing regulatory interactions, provide support for a potential Phase 3 trial of reldesemtiv in patients with ALS next year. We believe this progress positions us well to leverage our leadership in muscle pharmacology to benefit a wide array of patients suffering from varied diseases of muscle dysfunction.”
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin activator)
AMG 594 (cardiac troponin activator)
CK-3773274 (CK-274, cardiac myosin inhibitor)
Skeletal Muscle Program
reldesemtiv (next-generation, fast skeletal muscle troponin activator (FSTA))
Pre-Clinical Development and Ongoing Research
Revenues for the three and nine months ended September 30, 2019 were $6.1 million and $21.7 million, respectively, compared to $10.6 million and $22.1 million for the corresponding periods in 2018. The decrease in revenues for the three and nine months ended September 30, 2019 was due primarily to the winding down of FORTITUDE-ALS in addition to a lack of license revenue in 2019. License revenues in the third quarter and first nine months of 2018 were related to the Phase 2 trial of reldesemtiv in spinal muscular atrophy completed in 2018.
Research and development expenses for the three and nine months ended September 30, 2019 were $20.2 million and $67.8 million, respectively compared to $21.4 million and $65.9 million for the same periods in 2018, respectively. The changes were primarily due to reduced spending for reldesemtiv as well as tirasemtiv following suspension of development of tirasemtiv in late 2017 offset by increased spending related to METEORIC-HF and the development of CK-274.
General and administrative expenses for the three and nine months ended September 30, 2019 increased to $9.8 million and $29.0 million, respectively, from $7.2 million and $23.7 million for the same periods in 2018, respectively, due primarily to an increase in outside legal counsel and personnel related costs including stock-based compensation.
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s third quarter 2019 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 (706) 679-3078 (international) and typing in the passcode 9440838.
An archived replay of the webcast will be available via Cytokinetics’ website until November 7, 2019. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 9440838 from October 31, 2019 at 7:30 PM Eastern Time until November 7, 2019.
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and best-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is collaborating with Amgen Inc. (Amgen) to develop omecamtivmecarbil, a novel cardiac muscle activator. Omecamtivmecarbil is the subject of an international clinical trials program in patients with heart failure including GALACTIC-HF and METEORIC-HF. Amgen holds an exclusive worldwide license to develop and commercialize omecamtivmecarbil with a sublicense held by Servier for commercialization in Europe and certain other countries. Cytokinetics is collaborating with Astellas Pharma Inc. (Astellas) to develop reldesemtiv, a fast skeletal muscle troponin activator (FSTA) for diseases of neuromuscular dysfunction, including SMA and ALS. Astellas holds an exclusive worldwide license to develop and commercialize reldesemtiv. Licenses held by Amgen and Astellas are subject to specified co-development and co-commercialization rights of Cytokinetics. Cytokinetics is also developing CK-274, a novel cardiac myosin inhibitor that company scientists discovered independent of its collaborations, for the potential treatment of hypertrophic cardiomyopathies. Cytokinetics continues its over 20-year history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness.
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics’ and its partners’ research and development activities, including the initiation, conduct, design, enrollment, progress, continuation, completion, timing and results of clinical trials; the significance and utility of pre-clinical study and clinical trial results; planned interactions with regulatory authorities and the outcomes of such interactions; the expected timing of events and milestones, including the receipt of milestone payments; the agreement in principle to revise the terms of the collaboration agreement between Astellas and Cytokinetics; and the properties and potential benefits of Cytokinetics’ drug candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to Cytokinetics’ need for additional funding and such additional funding may not be available on acceptable terms, if at all; potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; patient enrollment for or conduct of clinical trials may be difficult or delayed; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials; Amgen’s and Astellas’ decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil and reldesemtiv, respectively; Cytokinetics may incur unanticipated research and development and other costs; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics' actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Vice President, Corporate Communications, Investor Relations
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
|Three Months Ended||Nine Months Ended|
|September 30, 2019||September 30, 2018||September 30, 2019||September 30, 2018|
|Research and development revenues||$||6,055||$||8,726||$||21,656||$||16,991|
|Research and development||20,229||21,391||67,791||65,858|
|General and administrative||9,753||7,164||29,026||23,724|
|Total operating expenses||29,982||28,555||96,817||89,582|
|Non-cash interest expense on liability related to the sale of future royalties||(5,321||)||(4,559||)||(15,204||)||(13,026||)|
|Interest and other income||1,020||1,323||3,205||3,291|
|Net (loss) income before income taxes||(29,573||)||(22,017||)||(91,052||)||(79,821||)|
|Income tax benefit||-||-||-||-|
|Net loss per share — basic and diluted||$||(0.50||)||$||(0.40||)||$||(1.60||)||$||(1.47||)|
|Weighted-average shares in net loss per share — basic and diluted||58,640||54,626||57,050||54,329|
Condensed Consolidated Balance Sheets
|September 30, 2019||December 31, 2018 (1)|
|Cash and short term investments||$||166,039||$||198,731|
|Other current assets||10,496||8,943|
|Total current assets||176,535||207,674|
|Property and equipment, net||3,615||3,204|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accounts payable and accrued liabilities||$||16,551||$||19,521|
|Current portion of long-term debt||-||2,607|
|Short-term lease liability||4,577||—|
|Other current liabilities||389||66|
|Total current liabilities||21,517||22,194|
|Long-term debt, net||44,762||39,806|
|Liability related to the sale of future royalties, net||137,726||122,473|
|Long-term lease liability||3,257||—|
|Other long-term liabilities||—||771|
|Additional paid-in capital||813,729||768,703|
|Accumulated other comprehensive income||719||500|
|Total stockholders’ equity||(19,869||)||25,934|
|Total liabilities and stockholders’ equity||$||187,393||$||211,178|
(1) Derived from the audited financial statements, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018.