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Cytokinetics, Inc.: Cytokinetics, Incorporated Reports Third Quarter 2013 Financial Results

  Cytokinetics, Inc.: Cytokinetics, Incorporated Reports Third Quarter 2013
                              Financial Results

Company Provides Updates on Key Progress in Development Programs for Heart
Failure and ALS

SOUTH SAN FRANCISCO, CA, October 30, 2013- Cytokinetics, Incorporated (Nasdaq:
CYTK) reported total revenues for the third quarter of 2013 were $4.5 million,
compared to $1.7 million during the same period in 2012. The net loss for  the 
third quarter was $12.6 million, or  $0.43 per basic and diluted share.  This 
is compared to a net loss allocated to common stockholders for the same period
in 2012, of  $10.0 million,  or $0.45  per basic and  diluted share.   As  of 
September 30,  2013,  cash, cash  equivalents  and investments  totaled  $85.4 
million.

"During the third quarter, Cytokinetics announcedpresentations of the results
from ATOMIC-AHF  relating  to omecamtiv  mecarbil  at two  leading  scientific 
meetings, one in Europe and one in the United States," stated Robert I.  Blum, 
Cytokinetics' President and  Chief Executive  Officer. "We  are pleased  these 
data from ATOMIC-AHF were supported by the international cardiology  community 
and inform decisions regarding potentialprogression of this drug candidate in
continued development. In  addition, the  completion of  the dose  escalation 
phase of COSMIC-HF relating to omecamtiv mecarbil, alongside today's update on
enrollment of  BENEFIT-ALS  relating  to  tirasemtiv,  underscore  significant 
positives in both of  our lead clinical trials  programs. We look forward  to 
continued progress through the remainder  of 2013 and are making  preparations 
for results from both trials in 2014."

Company Highlights

Cardiac Muscle Contractility

omecamtiv mecarbil



  *During the  quarter, the  results from  ATOMIC-AHF (Acute  Treatment  with 
    Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure)  were 
    presented at the ESC Congress 2013,  organized by the European Society  of 
    Cardiology in  Amsterdam.  Additional data  were  presented at  the  HFSA 
    Annual Scientific  Meeting,  organized by  the  Heart Failure  Society  of 
    America in  Orlando,  Florida.  ATOMIC-AHF  was  conducted  by  Amgen  in 
    collaboration with Cytokinetics.

  *During the quarter,  the second  cohort of  the dose  escalation phase  of 
    COSMIC-HF  (Chronic   Oral  Study   of  Myosin   Activation  to   Increase 
    Contractility  in   Heart   Failure)  completed   enrollment.   Recently, 
    Cytokinetics and Amgen  reviewed results  from COSMIC-HF  and selected  an 
    oral formulation  of  omecamtiv mecarbil  for  evaluation in  the  planned 
    expansion phase of the  trial. Cytokinetics and  Amgen are discussing  an 
    amendment to the protocol of  COSMIC-HF prior to initiating enrollment  in 
    the expansion phase. COSMIC-HF is  a Phase II, double-blind,  randomized, 
    placebo-controlled,   multicenter   study    designed   to   assess    the 
    pharmacokinetics, safety, tolerability and pharmacodynamic effects of oral
    modified-release formulations of omecamtiv mecarbil in patients with heart
    failure and  left ventricular  systolic dysfunction.  COSMIC-HF is  being 
    conducted by Amgen in collaboration with Cytokinetics.

  *Recently, Cytokinetics and Amgen agreed on  the protocol and budget for  a 
    planned Phase I  pharmacokinetic study  of omecamtiv  mecarbil in  healthy 
    volunteers  ofbothJapaneseand  non-Japaneseethnicity.  Thetrial,  CY 
    1211,will be conducted by Cytokinetics in collaboration with Amgen.  The 
    costs of the trialwill be reimbursedby Amgen.

Additional information on these and other clinical trials ofomecamtiv
mecarbilcan be found atwww.clinicaltrials.gov.

Skeletal Muscle Contractility

tirasemtiv

  *During the  quarter,  Cytokinetics  continued  enrollment  in  BENEFIT-ALS 
    (Blinded Evaluation of  Neuromuscular Effects  and Functional  Improvement 
    with Tirasemtiv in ALS) trial. BENEFIT-ALS is a Phase IIb, multinational,
    double-blind, randomized,  placebo-controlled clinical  trial designed  to 
    evaluate the safety, tolerability and potential efficacy of tirasemtiv  in 
    patients  with  amyotrophic  lateral  sclerosis  (ALS).  BENEFIT-ALS   is 
    designed to enroll approximately 680 patients with ALS. To date, over  600 
    patients have  been enrolled  in BENEFIT-ALS  and over  300 patients  have 
    completed 12 weeks of treatment. The primary analysis of BENEFIT-ALS will
    compare the mean change from baseline  in the ALS Functional Rating  Scale 
    in its  revised  form,  or ALSFRS-R  (a  clinically  validated  instrument 
    designed to measure disease progression and changes in functional status),
    in  patients  receiving   tirasemtiv  versus   those  receiving   placebo. 
    Recently, the  Data Safety  Monitoring  Board completed  a  pre-scheduled 
    meeting to review the data and recommended that the trial continue without
    any changes  to  the  protocol. Cytokinetics  anticipates  completion  of 
    enrollment in BENEFIT-ALS in the fourth quarter of 2013.

  *During the quarter, Cytokinetics announced the publication of results from
    two Phase II trials  of tirasemtiv in  patients with ALS  (CY 4024 and  CY 
    4025) in the online edition  of the journal Amyotrophic Lateral  Sclerosis 
    and Frontotemporal Degeneration.

CK-2127107

  *During the  quarter,  Cytokinetics  completed enrollment  in  CY  5011,  a 
    first-time-in-humans, Phase I clinical trial of CK-2127107 in healthy male
    volunteers. CY  5011  is a  double-blind,  randomized,  placebo-controlled 
    study designed to assess the safety, tolerability, and pharmacokinetics of
    single ascending oral doses of  CK-2127107 administered in a  three-period 
    crossover design. 

  *Recently, Cytokinetics initiated  dosing in  CY 5014, a  Phase I  clinical 
    trial of CK-2127107 in healthy male volunteers. CY 5014 is a  randomized, 
    open-label,  2-period  crossover  study   to  assess  the  relative   oral 
    bioavailability, pharmacokinetics,  safety and  tolerability of  two  oral 
    formulations of CK-2127107.

The trials described above are being conducted by Cytokinetics pursuant to our
collaboration with Astellas Pharma Inc.

Pre-Clinical Research

  *During the quarter, Cytokinetics continued  to conduct research under  our 
    joint  research  program  with  Amgen,   directed  to  the  discovery   of 
    next-generation cardiac  sarcomere  activators,  and  our  joint  research 
    program with  Astellas,  directed  to  the  discovery  of  next-generation 
    skeletal muscle activators. In  addition, the company continued  research 
    activities directed to other muscle biology programs. 

Financials

Revenues for the  third quarter of  2013 were $4.5  million, compared to  $1.7 
million during the  same period in  2012. Revenues for  the third quarter  of 
2013 included $1.4 million  of license revenues and  $2.3 million of  research 
and development revenues  from our collaboration  with Astellas. Revenues  for 
the third  quarter  of  2013  also included  $0.2  million  of  research  and 
development revenue  from our  collaboration with  MyoKardia, Inc.,  and  $0.6 
million of revenue from our collaboration  with Amgen. Revenues for the  same 
period in 2012 included  $1.0 million of revenue  from our collaboration  with 
Amgen, $0.3  million  in grant  revenue,  $0.3  million of  revenue  from  our 
collaboration with  Global  Blood  Therapeutics, Inc.,  and  $0.1  million  of 
revenue from our collaboration with MyoKardia.

Total research and  development (R&D) expenses  in the third  quarter of  2013 
were $13.4 million, compared  with $8.8 million for  the same period in  2012. 
The $4.6 million  increase in  R&D expenses for  the third  quarter of  2013, 
compared with the same period in 2012, was primarily due to increased spending
for outsourced clinical costs.

Total general and administrative (G&A) expenses for the third quarter of  2013 
were $3.6 million,  compared with $3.0  million for the  same period in  2012. 
The $0.6  million increase  in G&A  expenses in  the third  quarter of  2013, 
compared with the same period in 2012, was primarily due to increased spending
for personnel-related costs and outsourced costs.

Revenues for  the nine  months ended  September 30,  2013 were  $6.3  million, 
compared to $5.4 million for  the same period in  2012. Revenues for the  nine 
months ended September 30, 2013 included $1.4 million of license revenues  and 
$2.3 million of research and development revenues from our collaboration  with 
Astellas. Revenues  for the  first  nine months  of  2013 also  included  $1.5 
million of revenue  from our  collaboration with Amgen,  $1.0 million  revenue 
from our  collaboration with  MyoKardia  and $0.1  million of  grant  revenue. 
Revenues for the same period in 2012 included $3.2 million of revenue from our
collaboration with Amgen, $0.9 million in  grant revenue, and $1.1 million  of 
revenue from our collaboration with Global Blood Therapeutics and $0.1 million
of revenue from our collaboration with MyoKardia.

Total R&D expenses  for the nine  months ended September  30, 2013 were  $35.6 
million, compared  to $25.8  million for  the same  period in  2012. The  $9.8 
million increase in R&D expenses  in the first nine  months of 2013, over  the 
same period in 2012,  was primarily due to  increased spending for  outsourced 
clinical and personnel-related costs,  partially offset by decreased  spending 
for outsourced preclinical expenses.

Total G&A expenses  for the nine  months ended September  30, 2013 were  $11.0 
million, compared  to $8.6  million for  the  same period  in 2012.  The  $2.4 
million increase in G&A spending in the first nine months of 2013 compared  to 
the  same  period  in  2012  was  primarily  due  to  increased  spending  for 
personnel-related costs, legal expenses and outside services.

The net  loss allocable  to  common stockholders  for  the nine  months  ended 
September 30, 2013 was  $40.2 million, or $1.52  per basic and diluted  share. 
The net loss allocable to common stockholders for the same period in 2012 was
$30.2 million,  or  $1.86  per  basic and  diluted  share,  which  included  a 
one-time,  non-cash  dividend  of  $1.3  million  related  to  the  beneficial 
conversion feature of the Series B convertible preferred stock.

Financial Guidance 2013

Cytokinetics affirmed its previous financial  guidance for 2013: cash  revenue 
are expected to  be approximately $40  to $42 million,  cash R&D expenses  are 
expected to be in the range of $52  to $55 million, and cash G&A expenses  are 
expected to be in the range of $15 to $16 million. This financial guidance is
on a cash basis and does not include the deferral of approximately $10 million
in revenue to future calendar years and an estimated $5.6 million in  non-cash 
related operating expenses  primarily related to  stock compensation  expense. 
The company anticipates recognizing the license fee of $15 million associated
with the June 2013 amendment to our collaboration agreement with Amgen in  the 
fourth quarter of 2013.

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 Homepage and  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 92574472.

An archived replay of the webcast will be available via Cytokinetics'  website 
until November 7, 2013.  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  92574472 from October 30, 2013  at 
5:30 PM Eastern Time until November 7, 2013.

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 to develop and commercialize omecamtiv mecarbil and  related 
compounds,   subject    to    Cytokinetics'    specified    development    and 
commercialization  participation   rights.   Cytokinetics   is   independently 
developing tirasemtiv,  a  fast  skeletal muscle  activator,  as  a  potential 
treatment for diseases  and medical conditions  associated with  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. 
Cytokinetics is collaborating with Astellas Pharma Inc. to develop CK-2127107,
a  skeletal  muscle  activator  structurally  distinct  from  tirasemtiv,  for 
non-neuromuscular indications. All of these  drug candidates have arisen  from 
Cytokinetics' muscle  biology focused  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.

Forward-Looking Statements



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 
revenue and R&D and G&A expenses for  2013 and the expected timing of  revenue 
recognition events; Cytokinetics' and  its partners' research and  development 
activities, including the initiation,  conduct, design, enrollment,  progress, 
continuation, completion and results of clinical trials, and the  significance 
and utility  of  clinical trial  results;  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 anticipates that  it will  be required  to conduct  at least  one 
confirmatory Phase III clinical trial of tirasemtiv in ALS patients which will
require significant additional funding,  and it may be  unable to obtain  such 
additional funding 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, 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  or 
foreign regulatory agencies may delay or limit Cytokinetics' or its  partners' 
ability to conduct clinical trials, and  Cytokinetics may be unable to  obtain 
or maintain patent or trade  secret protection for its intellectual  property; 
Amgen's and  Astellas'  decisions  with respect  to  the  design,  initiation, 
conduct, timing  and  continuation  of development  activities  for  omecamtiv 
mecarbil and CK-2127107,  respectively; Cytokinetics  may incur  unanticipated 
research and development  and other costs  or be unable  to obtain  additional 
financing necessary to conduct development  of its products; 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.



Contact:
Joanna L. Goldstein   
Manager, Investor Relations & Corporate Communications
(650) 624-3000

                          Cytokinetics, Incorporated
                      Condensed Statements of Operations
                    (in thousands, except per share data)
                                 (unaudited)

                          Three Months Ended          Nine Months Ended
                                     September     September     September
                    September 30,       30,           30,           30,
                        2013           2012          2013           2012
Revenues:           
Research and                              
development           $     3,059   $   1,714    $    4,889   $      5,375
License and
technology fees             1.410             -         1,410              -
Total revenues              4,469         1,714         6,299          5,375
Operating Expenses:
Research and
development                13,445         8,798        35,626         25,785
General and
administrative              3,635         2,991        10,999          8,614
Restructuring                   -            (2 )           -           (56)
Total operating
expenses                   17,080        11,787        46,625         34,343
Operating loss            (12,611 )     (10,073 )     (40,326 )      (28,968 )
Interest and other,
net                            23            29            78             54
                                                                    
Net loss                 (12,588)       (10,044 )     (40,248 )    (28,914)
Deemed dividend
related to
beneficial
conversion feature
of convertible
preferred stock                 -             -             -         (1,307 )
Net loss allocable
to common
stockholders              (12,588 )     (10,044 )     (40,248 )     (30,221)
Net loss per share
allocable to common
stockholders -
basic and diluted     $     (0.43 ) $     (0.45 )  $    (1.52 ) $      (1.86 )
Weighted average
shares used in
computing net loss
per share allocable
to common
stockholders -
basic and diluted          29,395        22,360        26,413         16,215

                          Cytokinetics, Incorporated
                           Condensed Balance Sheets
                                (in thousands)
                                 (unaudited)

                                             September 30,    December 31,
                                                 2013             2012
Assets
Cash and cash equivalents                  $        19,258  $       14,907
Short term investments                              62,384          59,093
Related party receivables                                -               4
Other current assets                                 1,679           2,423
Total current assets                                83,321          76,427
Property and equipment, net                            804             997
Long-term investments                                3,754               -
Other assets                                           127             127
Total assets                               $        88,006  $       77,551
Liabilities and stockholders' equity
Deferred revenue, current                  $        33,322  $            -
Other current liabilities                           11,689           7,105
Total current liabilities                           45,011           7,105
Deferred revenue, non-current                        2,696               -
Other non-current liabilities                          548             361
Stockholders' equity                                39,751          70,085
Total liabilities and stockholders' equity $        88,006  $       77,551



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Source: Cytokinetics, Inc. via Thomson Reuters ONE
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