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Public Companies : Healthcare/BioTech


Cytokinetics, Incorporated Reports Second Quarter 2008 Financial Results

Jul 31, 2008 - 3:36:01 PM

News Source MARKET WIRE

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SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- 07/31/08 -- Cytokinetics, Incorporated (NASDAQ: CYTK), reported revenues from research and development collaborations of$3.1 million for the second quarter of 2008. Net loss for the secondquarter of 2008 was $15.4 million, or $0.31 per share. As of June 30, 2008,cash, cash equivalents, restricted cash and long-term investments totaled$109.8 million.

"The second quarter showcased continuing progress in our cardiovascularprogram with the announcement of statistically significant data from anongoing clinical trial of CK-1827452 in stable heart failure patients.These promising data reflect what we believe is the clinically relevantactivity of this novel drug candidate," stated Robert I. Blum, Presidentand Chief Executive Officer. "In addition, we are sharpening our focus toareas in which we believe we have competitive advantage. We have leveragedthe expertise and capabilities in muscle contractility gained through ourfocus on cardiac muscle activators to identify novel modulators of skeletaland smooth muscle. During the second quarter, we announced the selection ofa development compound that represents a potentially novel therapeuticapproach to activating skeletal muscle. This and other compounds arisingfrom our programs directed to muscle biology may form a cornerstone to thecompany's expanding pipeline and allow us to develop novel drugs targetingan array of potential clinical indications."

Company Highlights

Cardiovascular

--  In June, as part of the Late Breaking Trials Session at the 2008 Heart    Failure Congress of the European Society of Cardiology in Milan, Italy,    Cytokinetics announced results from an interim analysis of an ongoing Phase    IIa clinical trial evaluating CK-1827452 administered intravenously to    patients with stable heart failure. The safety data from this analysis    suggest that CK-1827452 was well-tolerated with no serious adverse events    reported in patients exposed to the intended range of doses and plasma    concentrations.  A pharmacodynamic-pharmacokinetic analysis of data from 22    patients showed that when compared to placebo, CK-1827452 produced    statistically significant and clinically relevant increases in Doppler-    derived stroke volume and fractional shortening as a consequence of    statistically significant prolongations of systolic ejection time.    Cytokinetics continues to enroll patients in the fourth cohort of this    trial.--  Cytokinetics recently completed enrollment of the first cohort of    patients in a Phase IIa trial designed to evaluate the safety and    tolerability of both an intravenous and an oral formulation of CK-1827452    in patients with ischemic cardiomyopathy and angina. Cytokinetics is    conducting an interim safety analysis of clinical data arising from the    first cohort in order to enable the initiation of the second and final    cohort.--  Cytokinetics continues to screen patients for the potential initiation    of an open-label, non-randomized Phase IIa clinical trial designed to    evaluate an intravenous formulation of CK-1827452 administered to patients    with stable heart failure undergoing clinically indicated coronary    angiography in a cardiac catheterization laboratory.--  During the quarter, Cytokinetics announced an update to an ongoing    Phase I clinical trial of CK-1827452 to evaluate the potential for drug-    drug interactions occurring via each of two drug-metabolizing enzymes.    Cytokinetics continues to screen and enroll subjects in this trial.--  In the second quarter, Cytokinetics provided results from two    completed Phase I clinical trials of CK-1827452.  Final results of the    single-dose to multi-dose oral formulation trial showed CK-1827452 was well-    tolerated with no drug-related serious adverse events and with dose-    proportionality between the two dose levels studied. The second trial    assessed three modified release formulations of CK-1827452; a formulation    which reduced the peak and raised the trough plasma concentrations of this    drug candidate without a substantial effect on overall bioavailability, as    compared to an immediate release formulation, has been selected for further    clinical testing.    

Oncology

--  In June, at the Annual Meeting of the American Society of Clinical    Oncology (ASCO), in Chicago Illinois, Cytokinetics announced interim data    from the Phase I portion of the ongoing Phase I/II clinical trial of    ispinesib, a novel kinesin spindle protein (KSP) inhibitor, administered as    monotherapy as a first-line treatment in chemotherapy-naïve patients with    locally advanced or metastatic breast cancer. The authors concluded that    preliminary data suggest that ispinesib is well-tolerated when dosed on    days 1 and 15 every 28 days at doses up to 12 mg/m2. Cytokinetics continues    to enroll patients and dose-escalate in the Phase I portion of this trial.--  Also at ASCO, the National Cancer Institute presented final data from    a Phase I clinical trial designed to evaluate the safety, tolerability,    pharmacodynamics, and pharmacokinetic profile of ispinesib as monotherapy    administered to pediatric patients with relapsed or refractory solid    tumors. The authors concluded that the maximum tolerated dose (MTD) on this    schedule for this patient population was 9 mg/m2. The best response    observed was stable disease at 7 courses. Three patients experienced stable    disease for longer than 3 courses of therapy.  The authors concluded that    ispinesib was well-tolerated in pediatric patients, with neutropenia and    hepatotoxicity representing the most commonly observed dose-limiting    toxicities (DLTs).--  In June, in association with proceedings at both ASCO and the 10th    International Conference on Malignant Lymphoma in Lugano, Switzerland,    interim data from the Phase I portion of a Phase I/II clinical trial of SB-    743921, a novel KSP inhibitor, in patients with Hodgkin or non-Hodgkin    lymphoma were presented. The authors concluded that the pattern of    neutropenia onset and recovery support a dosing schedule for SB-743921 of    days 1 and 15 of a 28-day cycle.  This represents a greater dose density    (0.43 mg/m2/day) than on the previously studied dosing regimen of 4 mg/m2    or 0.19 mg/m2/day every 3 weeks. The only DLT observed without granulocyte    colony-stimulating factor (G-CSF) was neutropenia; therefore, further dose    escalation with empiric, prophylactic G-CSF is ongoing.  To date, one    objective partial response has been observed at the MTD without G-CSF in a    patient with Hodgkin lymphoma.--  Also in June, Cytokinetics announced the results of a Phase Ib    clinical trial sponsored by GlaxoSmithKline (GSK) designed to evaluate    ispinesib in combination with capecitabine, an oral chemotherapy agent    commonly used in the treatment of breast cancer. The investigators in this    clinical trial concluded that the combination of ispinesib with    capecitabine had an acceptable tolerability profile on the 21-day schedule    investigated in the trial. The DLTs in this combination regimen were    consistent with the monotherapy toxicities of ispinesib (prolonged    neutropenia) and capecitabine (rash). In this trial, the best response    observed among the 24 patients treated was a partial response in a patient    with advanced breast cancer. In addition, 11 patients had a response of    stable disease.--  During the quarter, GSK continued to enroll and dose-escalate patients    in the ongoing first-time-in-humans clinical trial of GSK-923295, a novel    inhibitor of centromere-associated protein E (CENP-E).  This open-label,    non-randomized, dose-finding Phase I trial is designed to investigate the    safety, tolerability, pharmacodynamics and pharmacokinetic profile of GSK-    923295 in patients with advanced solid tumors.  An oral presentation at the    2008 American Association of Cancer Research (AACR) Annual Meeting held in    San Diego, California highlighted interim clinical data from this trial.    

Research

--  During the quarter, Cytokinetics announced the selection of a    development compound that is an activator of the skeletal sarcomere. This    compound has demonstrated encouraging pharmacological activity in non-    clinical models suggesting that it could be developed as a potential    treatment for skeletal muscle weakness associated with neuromuscular    diseases or other conditions. This compound is the fifth development    compound to emerge from Cytokinetics' research activities focused on    discovering novel therapeutics directed towards cytoskeletal biology.--  In the second quarter, Cytokinetics advanced novel smooth muscle    myosin inhibitors in lead optimization activities towards the potential    selection of one or more development compounds.  Company scientists have    characterized compounds arising from this research in pharmacology studies    and have demonstrated encouraging evidence of efficacy for an inhaled    formulation of certain of these compounds in preclinical    bronchoconstriction models related to asthma and other reactive airways    disorders.--  In June, Cytokinetics announced that it agreed to extend the research    term under its strategic alliance with GSK to continue research activities    focused towards CENP-E.    

Corporate

--  During the quarter, Cytokinetics appointed Denise Gilbert, Ph.D. to    the company's Board of Directors.--  On July 1, 2008, Charles Homcy, M.D. resigned from the company's Board    of Directors.  Dr. Homcy remains a member of the Cytokinetics' Scientific    Advisory Board and a consultant to the company.    

Financials

Revenues from research and development collaborations for the secondquarter of 2008 were $3.1 million, compared to $3.2 million for the sameperiod in 2007. Revenues for the second quarter of 2008 and 2007 wereprimarily derived from the company's collaboration and option agreementwith Amgen.

Total research and development (R&D) expenses in the second quarter of 2008were $14.9 million, compared to $13.7 million for the same period in 2007.The increase in R&D expenses in the second quarter of 2008, compared to thesame period in 2007, was primarily due to increased spending related to thecompany's clinical and preclinical outsourcing costs and higher laboratoryand personnel expenses.

Total general and administrative (G&A) expenses for the second quarter of2008 were $4.3 million, compared to $4.0 million for the same period in2007. The increase in G&A expenses in the second quarter of 2008, comparedto the same period in 2007, was primarily due to increased spending foroutside services.

The net loss for the three months ended June 30, 2008, was $15.4 million,or $0.31 per share, compared to a net loss for the same period in 2007 of$12.6 million, or $0.27 per share.

Cytokinetics also reported results of its operations for the six monthsended June 30, 2008. Revenues from research and development collaborationsfor the six months ended June 30, 2008 were $6.1 million, compared torevenues of $6.4 million for the same period in 2007. The decrease incollaborative research revenues for the first six months of 2008, ascompared to the same period in 2007, was primarily the result of lowerrevenue from our collaboration and research agreement with GSK.

Total R&D expenses for the six months ended June 30, 2008 were $29.0million, compared to $26.2 million for the same period in 2007. Theincrease in R&D expenses in the first six months of 2008, over the sameperiod in 2007, was primarily due to the company's clinical and preclinicaloutsourcing costs and higher laboratory and personnel expenses.

Total G&A expenses for the six months ended June 30, 2008 were $8.4million, compared to $8.5 million for the same period in 2007. Thedecreased spending in the first six months of 2008, over the same period in2007, was primarily due to lower legal fees, which was partially offset byan increase in spending for outside services and personnel expenses.

The net loss for the six months ended June 30, 2008, was $29.3 million, or$0.59 per share, compared to a net loss of $24.3 million, or $0.52 pershare, for the same period in 2007.

Company Milestones for 2008

Cardiovascular

CK-1827452

--  In August, Cytokinetics plans to present additional data from the    first 22 patients who completed treatment in the ongoing Phase IIa clinical    trial of CK-1827452 in stable heart failure patients at the European    Society of Cardiology 2008 Congress in Munich, Germany.--  In September, Cytokinetics plans to present interim data from    additional patients who have completed treatment in the ongoing Phase IIa    clinical trials program of CK-1827452 in stable heart failure patients as    part of the Late Breaking Clinical Trials Session at the Annual Meeting of    the Heart Failure Society of America in Toronto, Ontario, Canada.--  In the second half of 2008, Cytokinetics plans to initiate a Phase IIa    clinical trial designed to evaluate an intravenous formulation of CK-    1827452 administered to patients with stable heart failure undergoing    clinically indicated coronary angiography in a cardiac catheterization    laboratory. Cytokinetics anticipates data will be available from this trial    in 2009.--  In the second half of 2008, Cytokinetics anticipates that data will be    available from the ongoing Phase IIa trial of CK-1827452 in patients with    ischemic cardiomyopathy and angina.--  In the second half of 2008, Cytokinetics anticipates that final data    will be available from the Phase I trial of CK-1827452 evaluating the    potential for certain drug-drug interactions in healthy volunteers.    

As enrollment progresses in 2008 in all of the ongoing clinical trials ofCK-1827452, Cytokinetics anticipates providing updated guidance on thetiming and availability of expected data.

Oncology

Ispinesib (SB-715992)

--  In September, Cytokinetics plans to present data from the ongoing    Phase I portion of its open-label, non-randomized Phase I/II clinical trial    designed to evaluate ispinesib as monotherapy administered as a first-line    treatment for chemotherapy-naïve patients with locally advanced or    metastatic breast cancer at ASCO's 2008 Breast Cancer Symposium in    Washington, D C.    

SB-743921

--  In the second half of 2008, Cytokinetics anticipates final data will    be available from the Phase I portion of its ongoing Phase I/II clinical    trial of SB-743921 as a potential treatment of patients with Hodgkin or non-    Hodgkin lymphoma.    

GSK-923295

--  In October, GSK plans to present data from its Phase I clinical trial    of GSK-923295 in advanced solid tumors at the EORTC-NCI-AACR International    Conference in Geneva, Switzerland.    

As enrollment progresses in 2008 in all of our clinical trials in oncology,Cytokinetics anticipates providing updated guidance on the timing andavailability of expected data.

Corporate

--  In the second half of 2008, Cytokinetics anticipates providing the    required clinical data from its CK-1827452 Phase IIa clinical trials    program to Amgen in order to inform the potential exercise of Amgen's    option under the companies' strategic alliance.    

Conference Call and Webcast Information

Members of Cytokinetics' management team will review second quarter resultsvia a webcast and conference call today at 4:30 PM Eastern Time. Thewebcast can be accessed in the Investor Relations section of Cytokinetics'website at www.cytokinetics.com. The live audio of the conference call isalso accessible via telephone to investors, members of the news media andthe general public by dialing either (866) 999-CYTK (2985) (United Statesand Canada) or (706) 679-3078 (International) and typing in the passcode57547896.

An archived replay of the webcast will be available via Cytokinetics'website until August 14, 2008. The replay will also be available viatelephone by dialing (800) 642-1687 (United States and Canada) or (706)645-9291 (International) and typing in the passcode 57547896 from July 31,2008 at 5:30 PM Eastern Time until August 14, 2008.

About Cytokinetics

Cytokinetics is a biopharmaceutical company focused on the discovery,development and commercialization of novel small molecule drugs that mayaddress areas of significant unmet clinical needs. Cytokinetics'cardiovascular disease program is focused to cardiac myosin, a motorprotein essential to cardiac muscle contraction. Cytokinetics' leadcompound from this program, CK-1827452, a novel small molecule cardiacmyosin activator, entered Phase II clinical trials for the treatment ofheart failure in 2007. Under a strategic alliance established in 2006,Cytokinetics and Amgen Inc. are performing joint research focused onidentifying and characterizing activators of cardiac myosin as back-up andfollow-on potential drug candidates to CK-1827452. Amgen has obtained anoption for an exclusive license to develop and commercialize CK-1827452,subject to Cytokinetics' development and commercial participation rights.Cytokinetics' cancer program is focused on mitotic kinesins, a family ofmotor proteins essential to cell division. Under a strategic allianceestablished in 2001, Cytokinetics and GlaxoSmithKline (GSK) are conductingresearch and development activities focused on the potential treatment ofcancer. Cytokinetics is developing two novel drug candidates that havearisen from this program, ispinesib and SB-743921, each a novel inhibitorof kinesin spindle protein (KSP), a mitotic kinesin. Cytokinetics issponsoring a Phase I/II clinical trial of ispinesib as monotherapy as afirst-line treatment in chemotherapy-naïve patients with locally advancedor metastatic breast cancer. In addition, Cytokinetics is conducting aPhase I/II trial of SB-743921 in patients with non-Hodgkin and Hodgkinlymphomas. GSK has obtained an option for the joint development andcommercialization of ispinesib and SB-743921. Cytokinetics and GSK areconducting collaborative research activities directed to the mitotickinesin centromere-associated protein E (CENP-E). GSK-923295, a CENP-Einhibitor, is being developed under the strategic alliance by GSK; GSKbegan a Phase I clinical trial with GSK-923295 in 2007. In April 2008,Cytokinetics announced the selection of a potential drug candidate directedtowards skeletal muscle contractility which may be developed as a potentialtreatment for skeletal muscle weakness associated with neuromusculardiseases or other conditions. All of these drug candidates and potentialdrug candidates have arisen from Cytokinetics' research activities and aredirected towards the cytoskeleton. The cytoskeleton is a complex biologicalinfrastructure that plays a fundamental role within every human cell.Additional information about Cytokinetics can be obtained atwww.cytokinetics.com.

This press release contains forward-looking statements for purposes of thePrivate Securities Litigation Reform Act of 1995 (the "Act"). Cytokineticsdisclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harborfor forward-looking statements contained in the Act. Examples of suchstatements include, but are not limited to, statements relating toCytokinetics' and its partners' research and development activities,including the initiation, conduct, design, focus, scope, enrollment,progress and results of Cytokinetics' and its partners' planned researchand development activities, including clinical trials and the anticipatedtiming for the announcement, presentation or availability of data fromclinical trials; Cytokinetics' provision to Amgen of clinical data toinform Amgen's potential exercise of its option under the companies'collaboration and option agreement; and the potential benefits ofCytokinetics' drug candidates and potential drug candidates. Suchstatements are based on management's current expectations, but actualresults may differ materially due to various risks and uncertainties,including, but not limited to, potential difficulties or delays in thedevelopment, testing, regulatory approval or production of Cytokinetics'drug candidates that could slow or prevent clinical development, productapproval, including risks that current and past results of clinical trialsor preclinical studies may not be indicative of future clinical trialsresults, patient enrollment for clinical trials may be difficult ordelayed, Cytokinetics' drug candidates may have adverse side effects orinadequate therapeutic efficacy, the U.S. Food and Drug Administration orforeign regulatory agencies may delay or limit Cytokinetics' or itspartners' ability to conduct clinical trials, and Cytokinetics may beunable to obtain or maintain patent or trade secret protection for itsintellectual property; GSK may decide to postpone or discontinuedevelopment activities for GSK-923295, Cytokinetics may incur unanticipatedresearch and development and other costs or be unable to obtain additionalfinancing necessary to conduct development of its products, standards ofcare may change, others may introduce products or alternative therapies forthe treatment of indications Cytokinetics' drug candidates and potentialdrug candidates may target, and risks and uncertainties relating to thetiming and receipt of payments from our partners, including milestones androyalties on future potential product sales under Cytokinetics'collaboration agreements with such partners. For further informationregarding these and other risks related to Cytokinetics' business,investors should consult Cytokinetics' filings with the Securities andExchange Commission.



                  Condensed Statement 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,                               2008        2007        2008        2007                            ----------  ----------  ----------  ----------Revenues:  Research and development  $       16  $      119  $       27  $      265  License revenues               3,058       3,058       6,117       6,117                            ----------  ----------  ----------  ----------    Total revenues               3,074       3,177       6,144       6,382                            ----------  ----------  ----------  ----------Operating Expenses:  Research and development      14,859      13,726      28,961      26,213  General and   administrative                4,252       4,015       8,409       8,497                            ----------  ----------  ----------  ----------    Total operating     expenses                   19,111      17,741      37,370      34,710                            ----------  ----------  ----------  ----------Operating loss:                (16,037)    (14,564)    (31,226)    (28,328)  Interest and other income        808       2,122       2,249       4,363  Interest and other   expense                        (135)       (186)       (281)       (356)                            ----------  ----------  ----------  ----------Net loss                    $  (15,364) $  (12,628) $  (29,258) $  (24,321)                            ==========  ==========  ==========  ==========Net loss per common share - basic and diluted          $    (0.31) $    (0.27) $    (0.59) $    (0.52)Weighted average shares used in computing net loss per common share - basic and diluted                49,365,685  46,899,720  49,329,775  46,825,800                            Condensed Balance Sheet                                 (in thousands)                                  (unaudited)                                                    June 30,   December 31,                                                      2008         2007                                                  ------------ ------------AssetsCash and cash equivalents                         $     86,861 $    116,564Short term investments                                       -        3,175Other current assets                                     2,474        2,277                                                  ------------ ------------Total current assets                                    89,335      122,016Long term investments                                   18,749       20,025Property and equipment, net                              6,728        7,728Restricted investments                                   4,147        5,167Other assets                                               407          434                                                  ------------ ------------Total assets                                      $    119,366 $    155,370                                                  ============ ============Liabilities and stockholders' equityCurrent liabilities                               $     24,952 $     26,448Long-term obligations                                   21,826       29,006Stockholders' equity                                    72,588       99,916                                                  ------------ ------------Total liabilities and stockholders' equity        $    119,366 $    155,370                                                  ============ ============

Cytokinetics, Incorporated
Christopher S. Keenan (Investors)
Director, Investor Relations
(650) 624-3000

Cytokinetics, Incorporated
Scott R. Jordan (Media)
Director, Corporate Development
(650) 624-3000



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