We could not find any results for:
Make sure your spelling is correct or try broadening your search.
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 | |
---|---|---|---|---|---|---|---|---|---|---|
-0.23 | -0.44% | 52.40 | 52.37 | 52.40 | 53.42 | 52.01 | 53.01 | 293,631 | 18:47:52 |
"In the second quarter, we announced the results from two Phase II clinical trials of tirasemtiv, formerly known as CK-2017357, in ALS patients. We believe these data inform its progression into a Phase IIb clinical trial that may support potential registration," stated Robert I. Blum, Cytokinetics' President and Chief Executive Officer. "We also announced that the ATOMIC-AHF clinical trial evaluating the intravenous form of omecamtiv mecarbil in hospitalized patients with heart failure has progressed to its second cohort. This trial continues to enroll patients internationally under our collaboration with Amgen and alongside the progress the companies are making in connection with the clinical development of oral formulations of our novel cardiac myosin activator."
Company Highlights
Skeletal Muscle Contractility
tirasemtiv (formerly CK-2017357)
Cardiac Muscle Contractility
omecamtiv mecarbil
Other Non-Clinical Development and Pre-Clinical Research
Corporate
Financials
Revenues for the second quarter of 2012 were $1.8 million, compared to $1.1 million during the same period in 2011. Revenues for the second quarter of 2012 included $1.1 million of revenue from our collaboration agreement with Amgen, $0.4 million from our collaboration agreement with Global Blood Therapeutics, Inc., and $0.3 million of grant revenue from the NINDS. Revenues for the second quarter of 2011 included $0.7 million of revenue under the Amgen collaboration and $0.4 million in grant revenue from the NINDS.
Total research and development (R&D) expenses in the second quarter of 2012 were $8.2 million, compared with $10.5 million for the same period in 2011. The $2.3 million decrease in R&D expenses for the second quarter of 2012, compared with the same period in 2011, was primarily due to decreases in outsourced clinical expenses, laboratory expense, personnel-related costs, and facility costs.
Total general and administrative (G&A) expenses for the second quarter of 2012 were $2.6 million, compared with $4.2 million for the same period in 2011. The $1.6 million decrease in G&A expenses in the second quarter of 2012, compared with the same period in 2011, was primarily due to decreased financial services, legal, personnel-related and facility costs.
Revenues for the six months ended June 30, 2012 were $3.7 million, compared to $1.8 million for the same period in 2011. Revenues for the first six months of 2012 included $2.3 million of reimbursements in program expenses under the Amgen collaboration, $0.8 million from our collaboration agreement with Global Blood Therapeutics, Inc., and $0.6 million of grant revenue from the NINDS. Revenues for the first six months of 2011 of $1.0 million were derived from our collaboration with Amgen and $0.8 million from our NINDS grant.
Total R&D expenses for the six months ended June 30, 2012 were $17.0 million, compared to $19.7 million for the same period in 2011. The $2.7 million decrease in R&D expenses in the first six months of 2012, over the same period in 2011, was primarily due to decreased spending for laboratory expenses, personnel-related costs, outsourced clinical expenses, and facility costs, partially offset by increased outsourced pre-clinical costs.
Total G&A expenses for the six months ended June 30, 2012 were $5.6 million, compared to $7.5 million for the same period in 2011. The $1.9 million decrease in G&A spending in the first six months of 2012 compared to the same period in 2011, was primarily due to lower financial services, legal, personnel-related and facility costs.
The net loss allocable to common stockholders for the six months ended June 30, 2012, was $20.2 million, or $0.26 per basic and diluted share, which includes a one-time, non-cash dividend of $1.3 million related to the beneficial conversion feature of the Series B Convertible Preferred Stock, compared to a net loss allocable to common stockholders of $28.2 million, or $0.41 per basic and diluted share, for the same period in 2011, which includes a one-time, non-cash dividend of $2.9 million related to the beneficial conversion feature of the Series A Convertible Preferred Stock.
Updated Financial Guidance for 2012
Cytokinetics also announced its updated financial guidance for 2012 which incorporates the estimated costs associated with CY 4026. The company anticipates revenue will be in the range of $5.0 to $7.0 million, cash R&D expenses will be in the range of $40.0 to $44.0 million, and cash G&A expenses will be in the range of $10.0 to $12.0 million. This financial guidance is on a cash basis and does not include an estimated $4.0 million in non-cash related operating expenses primarily related to stock compensation expense. In addition, this guidance does not reflect potential revenue from potential collaborations with other partners.
Company Milestones
Skeletal Muscle Contractility
tirasemtiv (formerly known as CK-2017357)
CK-2127107
Cardiac Muscle Contractility
omecamtiv mecarbil
Conference Call and Webcast Information
Members of Cytokinetics' senior management team will review the company's second quarter results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investor Relations 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 21517396.
An archived replay of the webcast will be available via Cytokinetics' website until August 7, 2012. 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 21517396 from July 31, 2012 at 5:30 PM Eastern Time until August 7, 2012.
About Cytokinetics
Cytokinetics is a clinical-stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics that modulate muscle function for the potential treatment of serious diseases and medical conditions. Cytokinetics' lead drug candidate from its cardiac muscle contractility program, omecamtiv mecarbil, is in Phase II clinical development for the potential treatment of heart failure. Amgen Inc. holds an exclusive license worldwide (excluding Japan) to develop and commercialize omecamtiv mecarbil and related compounds, subject to Cytokinetics' specified development and commercialization participation rights. Cytokinetics is independently developing tirasemtiv (formerly CK-2017357), a skeletal muscle activator, as a potential treatment for diseases and conditions associated with aging, muscle wasting or neuromuscular dysfunction. Tirasemtiv is currently the subject of a Phase II clinical trials program and has been granted orphan drug designation and fast track status by the U.S. Food and Drug Administration and orphan medicinal product designation by the European Medicines Agency for the potential treatment of amyotrophic lateral sclerosis, a debilitating disease of neuromuscular impairment in which tirasemtiv demonstrated potentially clinically relevant pharmacodynamic effects in Phase II trials. Cytokinetics is also conducting research of compounds that inhibit smooth muscle contractility and which may be useful as potential treatments for diseases and conditions associated with excessive smooth muscle contraction, such as bronchoconstriction associated with asthma and chronic obstructive pulmonary disease (COPD). All of these drug candidates and potential drug candidates have arisen from Cytokinetics' research activities and are directed towards the cytoskeleton. The cytoskeleton is a complex biological infrastructure that plays a fundamental role within every human cell. Additional information about Cytokinetics can be obtained at www.cytokinetics.com.
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements, and 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' financial guidance, including expected R&D and G&A expenses for 2012; Cytokinetics' and its partners' research and development activities, including the initiation, enrollment, conduct, design, endpoints, size, scope, progress and results of clinical trials of CK-2017357 and omecamtiv mecarbil, the significance and utility of clinical trial results and the anticipated timing for the availability of clinical trial results, the ability of CY 4026 to support potential registration, and anticipated interactions with regulatory authorities; and the properties and potential benefits of Cytokinetics' drug candidates and potential 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, 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, including risks that current and past results of clinical trials or preclinical studies may not be indicative of future clinical trials results, patient enrollment for or conduct of clinical trials may be difficult or delayed, Cytokinetics' drug candidates may have adverse side effects or inadequate therapeutic efficacy, the U.S. Food and Drug Administration (FDA) or foreign regulatory agencies may delay or limit Cytokinetics' or its partners' ability to conduct clinical trials, regulatory authorities may not grant CK-2017357 orphan drug/medicinal product exclusivity in ALS even if it is approved for marketing, and Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; Amgen's decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil; Cytokinetics will require significant additional funding to conduct the registration program for CK-2017357 for the potential treatment of ALS and may be unable to obtain such additional funding on acceptable terms, if at all; funding from the National Institute of Neurological Disorders and Stroke may not be available in future periods; Cytokinetics may incur unanticipated research and development and other costs; Cytokinetics may be unable to enter into future collaboration agreements for its drug candidates and programs on acceptable terms, if at all; standards of care may change, rendering Cytokinetics' drug candidates obsolete; competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics' drug candidates and potential drug candidates may target; and risks and uncertainties relating to the timing and receipt of payments from its partners, including milestones and royalties on future potential product sales under Cytokinetics' collaboration agreements with such partners. For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.
Cytokinetics, Incorporated Condensed Statements of Operations (in thousands, except share and per share data) (unaudited) Three Months Ended Six Months Ended June 30, June 30, June 30, June 30, 2012 2011 2012 2011 ----------- ----------- ----------- ----------- Revenues: Research and development $ 1,841 $ 1,053 $ 3,661 $ 1,817 ----------- ----------- ----------- ----------- Total revenues 1,841 1,053 3,661 1,817 ----------- ----------- ----------- ----------- Operating Expenses: Research and development 8,242 10,513 16,987 19,692 General and administrative 2,568 4,187 5,624 7,524 Restructuring (13) - (54) - ----------- ----------- ----------- ----------- Total operating expenses 10,797 14,700 22,557 27,216 ----------- ----------- ----------- ----------- Operating loss (8,956) (13,647) (18,896) (25,399) Interest and other, net 13 15 26 55 ----------- ----------- ----------- ----------- Net loss (8,943) (13,632) (18,870) (25,344) Deemed dividend related to beneficial conversion feature of convertible preferred stock (1,307) (2,857) (1,307) (2,857) ----------- ----------- ----------- ----------- Net loss allocable to common stockholders $ (10,250) $ (16,489) $ (20,177) $ (28,201) =========== =========== =========== =========== Net loss per share allocable to common stockholders - basic and diluted $ (0.13) $ (0.23) $ (0.26) $ (0.41) Weighted average shares used in computing net loss per share allocable to common stockholders - basic and diluted 81,230,292 71,151,486 78,655,935 69,043,119
Cytokinetics, Incorporated Condensed Balance Sheets (in thousands) (unaudited) June 30, December 31, 2012 2011 ------------- ------------- Assets Cash and cash equivalents $ 63,654 $ 18,833 Short term investments 26,821 30,190 Related party receivables 3 14 Other current assets 2,482 2,103 ------------- ------------- Total current assets 92,960 51,140 Property and equipment, net 994 1,310 Restricted cash - 196 Other assets 127 127 ------------- ------------- Total assets $ 94,081 $ 52,773 ============= ============= Liabilities and stockholders' equity Current liabilities $ 3,989 $ 4,592 Long-term liabilities 111 3 Stockholders' equity 89,981 48,178 ------------- ------------- Total liabilities and stockholders' equity $ 94,081 $ 52,773 ============= =============
Cytokinetics, Incorporated: Jodi L. Goldstein Manager, Corporate Communications & Marketing (650) 624-3000
1 Year Cytokinetics Chart |
1 Month Cytokinetics Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions