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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Cytokinetics Inc | NASDAQ:CYTK | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.93 | 1.45% | 65.27 | 63.62 | 67.01 | 66.605 | 65.00 | 66.08 | 900,209 | 01:00:00 |
“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)
AMG 594 (cardiac troponin activator)
CK-3773274 (CK-274, cardiac myosin inhibitor)
CK-271 (CK-271, second cardiac myosin inhibitor)
Skeletal Muscle Program
reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))
Pre-Clinical Development and Ongoing Research
Corporate
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.
About Cytokinetics
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-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 omecamtiv mecarbil, a novel cardiac muscle activator. Omecamtiv mecarbil is the subject of an international clinical trials program in patients with heart failure including GALACTIC-HF, of which topline results were recently reported, and METEORIC-HF, which is ongoing. Amgen holds an exclusive worldwide license to develop and commercialize omecamtiv mecarbil with a sublicense held by Servier for commercialization in Europe and certain other countries. Cytokinetics is developing reldesemtiv, a fast skeletal muscle troponin activator (FSTA) for the potential treatment of ALS and other neuromuscular indications following conduct of FORTITUDE-ALS and other Phase 2 clinical trials. The company is considering potential advancement of reldesemtiv to Phase 3. Cytokinetics is collaborating with Astellas Pharma Inc. (Astellas) to research, develop and commercialize other novel mechanism skeletal sarcomere activators (excluding FSTAs). 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 (HCM). Cytokinetics has granted Ji Xing Pharmaceuticals Limited an exclusive license to develop and commercialize CK-274 in China and Taiwan, in accordance with Cytokinetics’ planned global registration programs. Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of CK-274 in patients with obstructive HCM. 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.
For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on Twitter, LinkedIn, Facebook and YouTube.
Forward-Looking Statements
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 and commercial readiness activities, including the initiation, conduct, design, enrollment, progress, continuation, completion, timing and results of clinical trials, including the completion of enrollment in METEORIC-HF and the availability of results from the first cohort of patients in REDWOOD-HCM, Cytokinetics’ ability to ensure commercial readiness and develop co-promotion plans in collaboration with Amgen; the significance and utility of pre-clinical study and clinical trial results, including the results of GALACTIC-HF in respect of omecamtiv mecarbil; planned interactions with regulatory authorities in connection to any of Cytokinetics’ drug candidates and the outcomes of such interactions, including discussions in preparation for a potential Phase 3 clinical trial and registration program for reldesemtiv in patients with ALS and the prospects for FDA and other regulatory agency approval of omecamtiv mecarbil; the ability of Cytokinetics to fulfill applicable contractual conditions and receive a combination of committed capital, funding and sale proceeds of up to $250 million or any portion of such amount from affiliates of RTW Investments, LP, and/or Ji Xing Pharmaceuticals Limited; the ability of Cytokinetics to earn milestone payments and royalties from Ji Xing Pharmaceuticals Limited in connection to the development and commercialization of CK-274 in certain Asian countries; the expected timing of events and milestones; 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 decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil and AMG 594; 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.
Contact:Diane WeiserSenior Vice President, Corporate Communications, Investor Relations(415) 290-7757
Cytokinetics, Incorporated | |||||||
Condensed Consolidated Balance Sheets | |||||||
(in thousands) | |||||||
September 30, 2020 | December 31, 2019 | ||||||
(unaudited) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and short term investments | $ | 410,264 | $ | 225,112 | |||
Other current assets | 8,148 | 8,640 | |||||
Total current assets | 418,412 | 233,752 | |||||
Long-term investments | 40,958 | 42,650 | |||||
Property and equipment, net | 7,667 | 4,530 | |||||
Operating lease right-of-use assets and other assets | 7,075 | 8,882 | |||||
Total assets | $ | 474,112 | $ | 289,814 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | |||||||
Current liabilities: | |||||||
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 | |||||
Total liabilities | 324,507 | 300,751 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity (deficit): | |||||||
Common stock | 70 | 59 | |||||
Additional paid-in capital | 1,096,953 | 853,341 | |||||
Accumulated other comprehensive income | 958 | 679 | |||||
Accumulated deficit | (948,376 | ) | (865,016 | ) | |||
Total stockholders’ equity (deficit) | 149,605 | (10,937 | ) | ||||
Total liabilities and stockholders’ equity (deficit) | $ | 474,112 | $ | 289,814 |
Cytokinetics, Incorporated | |||||||||||||||
Condensed Consolidated Statements of Operations | |||||||||||||||
(in thousands except per share data) | |||||||||||||||
(unaudited) | |||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||
September 30, 2020 | September 30, 2019 | September 30, 2020 | September 30, 2019 | ||||||||||||
Revenues: | |||||||||||||||
Research and development revenues | $ | 5,187 | $ | 6,055 | $ | 12,605 | $ | 21,656 | |||||||
License revenues | 36,501 | — | 36,501 | — | |||||||||||
Total revenues | 41,688 | 6,055 | 49,106 | 21,656 | |||||||||||
Operating expenses: | |||||||||||||||
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 | ) | ||||||||
Interest expense | (3,976 | ) | (1,345 | ) | (11,945 | ) | (3,892 | ) | |||||||
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 | $ | (3,175 | ) | $ | (29,573 | ) | $ | (83,360 | ) | $ | (91,052 | ) | |||
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 |
1 Year Cytokinetics Chart |
1 Month Cytokinetics Chart |
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