Cytokinetics, Incorporated Reports Third Quarter Financial Results; Company Reports Progress in Oncology and Cardiovascular Programs.SOUTH SAN FRANCISCO South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , Calif. -- Cytokinetics, Incorporated (Nasdaq: CYTK), for the third quarter, reported revenues from research and development collaborations of $2.4 million. Net loss for the third quarter was $10.2 million or $0.36 per share. As of September 30, 2004, cash, cash equivalents, restricted cash and marketable securities Marketable Securities Very liquid securities that can be converted into cash quickly at a reasonable price. Notes: Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has totaled $127.1 million. "We are pleased with the progress that has been made in advancing both our oncology and cardiovascular development programs. During the quarter, GlaxoSmithKline initiated another Phase II study. This study will evaluate SB-715992 in the treatment of advanced breast cancer patients. GlaxoSmithKline also prepared for the initiation of several more Phase II and Phase Ib studies in line with the broad development plan for SB-715992," stated James Sabry, President and Chief Executive Officer. "Furthermore, we are continuing to make progress in advancing several potential drug candidates for the treatment of acute congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. , with the goal of initiating clinical trials in 2005." Company Highlights --Second Mitotic mitotic pertaining to mitosis. mitotic activity degree to which a cell population is proliferating; used as an index of tumor aggression. Kinesin Cancer Drug Target: During the quarter, GlaxoSmithKline (GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) ) advanced another mitotic kinesin target forward in collaborative research, triggering a pre-defined milestone payment of $250 thousand. --SB-715992: In July, GSK initiated an international, 55 patient Phase II monotherapy monotherapy /mono·ther·a·py/ (-ther´ah-pe) treatment of a condition by means of a single drug. mon·o·ther·a·py n. Treatment of a disorder with a single drug. clinical trial evaluating the efficacy of SB-715992 in the treatment of second- or third-line breast cancer patients. Based on the current rate of patient enrollment, interim data are expected during the second half of 2005, with final data available during the first half of 2006. --SB-715992: GSK continued to enroll patients in an international, 70 patient Phase II monotherapy clinical trial evaluating the efficacy of SB-715992 in the treatment of second-line non-small cell lung cancer Lung Cancer, Non-Small Cell Definition Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description There are two kinds of lung cancers, primary and secondary. patients. Based on the current rate of site initiation and patient enrollment rates communicated to us by our partner, data from the platinum sensitive arm of this study are expected in mid-2005 and data from the platinum refractory arm are expected later in 2005. --SB-715992: GSK continued to enroll patients in a Phase Ib clinical trial in the United Kingdom that is evaluating the safety of this compound in combination with docetaxel. Additional Phase Ib combination therapy studies are also expected to begin in the coming months. Data from these studies are expected in 2005. --SB-715992: The National Cancer Institute, in collaboration with GSK, will be initiating several Phase II and Phase I studies in the coming months which will further evaluate the efficacy of this compound in colorectal, head and neck, renal, hepatocellular, prostate, melanoma melanoma: see skin cancer. melanoma Dark-coloured malignant tumour of skin cells that produce the protective skin-darkening pigment melanin. and hematological hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. cancers. --SB-743921: GSK continued to enroll patients in a dose-escalating Phase I study evaluating the safety, tolerability, and pharmacokinetics of this second kinesin spindle spindle: see spinning. A rotating shaft in a disk drive. In a fixed disk, the platters are attached to the spindle. In a removable disk, the spindle remains in the drive. Laptops use spindle designations to indicate the number of built-in drives. protein inhibitor in advanced cancer patients. We anticipate enrollment will be completed in the first half of 2005, with data available shortly thereafter. --Cardiac Myosin myosin (mī`əsĭn), one of the two major protein constituents responsible for contraction of muscle. In muscle cells myosin is arranged in long filaments called thick filaments that lie parallel to the microfilaments of actin. Activators: Cytokinetics scientists continued to optimize and characterize several novel cardiac myosin activators, including CK-1213296 and other drug candidates. We plan to put one of the drug candidates from our congestive heart failure program into human clinical studies in 2005. The company is discontinuing negotiations with a potential partner for our cardiac myosin activator program in favor of a current plan to pursue both the acute and chronic congestive heart failure indications. --Senior Management: During the quarter, the Company hired Sharon Surrey-Barbari, as Senior Vice President of Finance and Chief Financial Officer and Dr. Andrew Wolff, as Senior Vice President of Clinical Research and Development & Chief Medical Officer. In addition, Robert Blum This article is about the German politician Robert Blum. For the American artist, see Robert Frederick Blum. Robert Blum (10 November 1807 - 9 November 1848) was a German politician and member of the National Assembly of 1848. assumed the responsibilities of Chief Business Officer in addition to his responsibilities as Executive Vice President of Corporate Development and Commercial Operations. Financials Revenue from research and development collaborations for the third quarter of 2004 were $2.4 million, compared to revenue in the third quarter of 2003 of $2.6 million. Revenue included payments for research collaborations with GSK and AstraZeneca. The decline in collaborative research revenues for the third quarter of 2004, as compared to the third quarter of 2003, was a result of the net effect of a contractual decrease in funding by GSK, offset in part by an increase in AstraZeneca funding. Total research and development (R&D) expenses for the third quarter were $9.5 million compared to $9.1 million for the same period in 2003. Expenses related to the development of the Company's drug candidates for the treatment of acute congestive heart failure and research for the treatment of fungal infections Fungal infections Several thousand species of fungi have been described, but fewer than 100 are routinely associated with invasive diseases of humans. were the primary reasons for the increased spending in 2004. Total general and administrative (G&A) expenses of $3.6 million for the three months ended September 30, 2004, increased $1.4 million from $2.2 million in the third quarter of 2003. The increase over the prior year was primarily due to additional outside services of $0.8 million associated with the cost of being a public company. The net loss for the three months ended September 30, 2004, was $10.2 million, or $0.36 per share. This compares to a net loss for the same period in 2003 of $8.7 million, or $4.51 per share, which does not take into account the conversion of preferred stock Stock shares that have preferential rights to dividends or to amounts distributable on liquidation, or to both, ahead of common shareholders. Preferred stock is given preference over common stock. Holders of preferred stock receive dividends at a fixed annual rate. into shares of common stock on a weighted average basis, pre IPO (Initial Public Offering) The first time a company offers shares of stock to the public. While not a computer term per se, many founders, employees and insiders of computer companies have found this acronym more exciting than any tech term they ever heard. . Cytokinetics also reported results of its operations for the nine months ended September 30, 2004. Revenue from research and development collaborations for the nine month period were $11.2 million, compared to revenue of $7.9 million for the same period in 2003. The increase in revenues for the nine months ended September 30, 2004, as compared to the same period in 2003, was primarily the result of achieving a milestone for the initiation of a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II for SB-715992 by our partner GSK and an increase in AstraZeneca funding. Total R&D expenses for the nine months ended September 30, 2004 increased to $28.6 million, from $24.1 million for the same period in 2003. Expenses related to the development of the Company's drug candidates for the treatment of acute congestive heart failure and research for the treatment of fungal infections were the primary reasons for the increased spending in 2004. Total G&A expenses for the nine months ended September 30, 2004 were $8.7 million, compared to $7.3 million for the nine months ended September 30, 2003. The increase in G&A expenses was largely due to increased professional services (job) professional services - A department of a supplier providing consultancy and programming manpower for the supplier's products. associated with the cost of being a public company. The net loss for the nine months ended September 30, 2004 was $25.4 million, or $1.50 per share. This compares to a net loss for the same period in 2003 of $23.5 million, or $12.48 per share, which does not take into account the conversion of preferred stock into shares of common stock on a weighted average basis, pre IPO. Conference Call and Webcast Information James Sabry, M.D., Ph.D., President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , and Sharon Surrey-Barbari, SVP SVP S'il Vous Plaît (French: Please) SVP Senior Vice President SVP Schweizerische Volkspartei (Swiss People~s Party) SVP Society of Vertebrate Paleontology SVP Social Venture Partners SVP St Vincent de Paul of Finance and CFO See Chief Financial Officer. , and other members of the management team, will review third quarter results via webcast and conference call today at 4:30 PM EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT . To access the live webcast, please log on in the Investor Relations Investor relations The process by which the corporation communicates with its investors. section of Cytokinetics' website at www.cytokinetics.com. Investors, members of the news media and the general public may also access the live conference call by dialing either 866-761-0748 (United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. and Canada) or 617-614-2706 (International) and typing in the passcode 98589738. The replay of the call and webcast will be available through November 21, 2004. The replay phone number is 888-286-8010 (United States and Canada) or 617-801-6888 (International) passcode is 67240248. About Cytokinetics Cytokinetics is a leading biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule drugs that specifically target the cytoskeleton cytoskeleton System of microscopic filaments or fibres, present in the cytoplasm of eukaryotic cells (see eukaryote), that organizes other cell components, maintains cell shape, and is responsible for cell locomotion and for movement of the organelles within it. . The cytoskeleton is a complex biological infrastructure that plays a fundamental role within every human cell. Cytokinetics' focus on the cytoskeleton enables it to develop novel and potentially safer and more effective classes of drugs directed at treatments for cancer, cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease , fungal diseases fungal diseases or mycoses Diseases caused by any fungus that invades the tissues. Superficial fungal infections (e.g., athlete's foot) are confined to the skin. and other diseases. Cytokinetics has developed a cell biology Cell biology The study of the activities, functions, properties, and structures of cells. Cells were discovered in the middle of the seventeenth century after the microscope was invented. driven approach and proprietary technologies to evaluate the function of many interacting proteins in the complex environment of the intact human cell. Cytokinetics employs the PUMA(TM) system and Cytometrix(TM) technologies to enable early identification and automated prioritization of compounds that are highly selective for their intended protein targets without other cellular effects, and are thereby less likely to give rise to clinical side effects Side effects Effects of a proposed project on other parts of the firm. . Cytokinetics and GlaxoSmithKline have entered into a strategic alliance to discover, develop and commercialize small molecule therapeutics targeting human mitotic kinesins for applications in the treatment of cancer and other diseases. GlaxoSmithKline is conducting Phase II and Phase Ib clinical trials for SB-715992 and a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I for SB-743921, each a drug candidate that has emerged from the strategic alliance. Additional information about Cytokinetics can be obtained at www.cytokinetics.com. This press release contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. for purposes of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, statements relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the expected timing, scope and results of our clinical development and research programs and statements regarding the potential benefits of our drug candidates and potential drug candidates and the enabling capabilities of its proprietary technologies. Such statements are based on management's current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of Cytokinetics' drug candidates that could slow or prevent clinical development, product approval or market acceptance (including the risk that uncertainty of patent protection for Cytokinetics' intellectual property or trade secrets, Cytokinetics' ability to obtain additional financing if necessary and unanticipated research and development and other costs). For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.
Condensed Statement of Operations
(in thousands, except per share data)
(unaudited)
Three Months Ended Nine Months Ended
September September September September
30, 30, 30, 30,
2004 2003 2004 2003
----------- ---------- ----------- ----------
Revenues:
Research and development
and grant revenues $1,749 $1,867 $9,116 $5,770
License fees 700 700 2,100 2,100
----------- ---------- ----------- ----------
Total revenues 2,449 2,567 11,216 7,870
----------- ---------- ----------- ----------
Operating Expenses
Research and development 9,535 9,099 28,644 24,141
General and
administrative 3,569 2,176 8,716 7,339
----------- ---------- ----------- ----------
Total operating expenses 13,104 11,275 37,360 31,480
----------- ---------- ----------- ----------
Operating loss: (10,655) (8,708) (26,144) (23,610)
Interest and other income 983 685 2,283 1,798
Interest and other
expense (543) (646) (1,517) (1,722)
----------- ---------- ----------- ----------
Net loss $(10,215) $(8,669) $(25,378) $(23,534)
=========== ========== =========== ==========
Net loss per common
share:
Basic and diluted $(0.36) $(4.51) $(1.50) $(12.48)
Weighted average shares
used in computing net
loss per common share,
basic and diluted 28,154,119 1,921,414 16,888,804 1,885,913
Condensed Balance Sheet Data
(in thousands)
(unaudited)
September 30, December 31,
2004 2003
------------- ------------
Assets
Cash and cash equivalents $19,775 $10,991
Short term investments 91,327 24,197
Other current assets 2,453 1,888
------------- ------------
Total current assets 113,555 37,076
Property and equipment, net 7,505 8,870
Non-current and restricted investments 6,669 8,345
Investments 10,441 7,857
Other assets 756 725
------------- ------------
Total assets $138,926 $62,873
============= ============
Liabilities, convertible preferred stock
and stockholders' equity (deficit)
Current liabilities $10,789 $9,457
Long-term obligations 9,764 12,275
Preferred stock - 133,172
Stockholder's equity (deficit) 118,373 (92,031)
------------- ------------
Total liabilities, convertible preferred
stock and stockholders' equity (deficit) $138,926 $62,873
============= ============
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