Cytokinetics, Inc. : Cytokinetics, Incorporated Reports Fourth Quarter 2012 Financial Results

 Cytokinetics, Inc. : Cytokinetics, Incorporated Reports Fourth Quarter 2012
                              Financial Results

Company Recaps Significant Milestones in Ongoing Phase IIb Clinical Trials
Expected to Generate Results in 2013

SOUTH SAN FRANCISCO, CA, February 5, 2013- Cytokinetics, Incorporated (Nasdaq:
CYTK) reported total research and development revenues of $2.2 million for the
fourth quarter of 2012. The net loss for the fourth quarter was $10.1 million,
or $0.07 per basic and diluted share, compared to a net loss of $11.9 million,
or $0.16 per  basic and  diluted share,  for the same  period in  2011. As  of 
December 31,  2012,  cash,  cash equivalents  and  investments  totaled  $74.0 
million.

"During the fourth quarter, we continued to make substantial progress in  both 
of our  ongoing Phase  IIb clinical  development programs,"  stated Robert  I. 
Blum, Cytokinetics'  President  and  Chief Executive  Officer.  "In  the  last 
quarter, we  opened  BENEFIT-ALS,  our Phase  IIb  clinical  trial  evaluating 
tirasemtiv in patients with amyotrophic  lateral sclerosis, to enrollment  and 
also announced the progression  to the third and  final cohort of  ATOMIC-AHF, 
our Phase IIb  trial evaluating  omecamtiv mecarbil  in patients  hospitalized 
with acute heart failure.  We expect to announce  results from each of  these 
important  trials  in  2013,  a  year  that  holds  significant  promise   for 
Cytokinetics and our first-in-class compounds directed to muscle biology." 

Company Highlights

Skeletal Muscle Contractility

tirasemtiv (formerly CK-2017357)

  *In  October,  Cytokinetics   announced  the  opening   to  enrollment   of 
    BENEFIT-ALS (Blinded Evaluation  of Neuromuscular  Effects and  Functional 
    Improvement  with  Tirasemtiv  in  ALS),  a  Phase  IIb,   multi-national, 
    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). This trial is  designed 
    to randomize  approximately  400  patients to  12  weeks  of  double-blind 
    treatment with tirasemtiv or placebo. The primary analysis of  BENEFIT-ALS 
    will compare the mean  change from baseline in  the ALS Functional  Rating 
    Scale in  its  revised  form  (ALSFRS-R)  on  tirasemtiv  versus  placebo. 
    Secondary endpoints will include  Maximum Voluntary Ventilation (MVV)  and 
    measures of  skeletal  muscle  function. Cytokinetics  plans  to  conduct 
    BENEFIT-ALS at over 70 sites across the United States, Canada, and several
    European countries. Additional information about this trial can be  found 
    at www.clinicaltrials.gov. 

  *In November, Cytokinetics announced  positive data from  CY 4023, a  Phase 
    IIa Evidence of Effect, double-blind, randomized, three-period  crossover, 
    placebo-controlled, pharmacokinetic and pharmacodynamic clinical trial  of 
    tirasemtiv in  patients with  generalized myasthenia  gravis (MG).  In  CY 
    4023, at six  hours after  dosing, improvements (i.e.,  decreases) in  the 
    Quantitative MG score (QMG)  were related to the  dose of tirasemtiv in  a 
    statistically significant manner (-0.49 QMG points per 250 mg; p =  0.02). 
    Also at  six hours  after dosing  in CY  4023, increases  in the  percent 
    predicted forced vital capacity  were statistically significantly  related 
    to the dose level of tirasemtiv (2.2% per  250 mg; p = 0.04), as were  the 
    individual comparisons of  each dose level  of tirasemtiv versus  placebo. 
    Both the 250 mg  and 500 mg  single oral doses  of tirasemtiv studied  in 
    this Phase  IIa clinical  trial  were well-tolerated  by the  32  patients 
    enrolled in CY 4023; there were  no premature terminations and no  serious 
    adverse  events  were  reported.  This  clinical  trial  and  preclinical 
    research on  MG were  funded by  a grant  from the  National Institute  of 
    Neurological Disorders and Stroke (NINDS). 

  *In   December,   Cytokinetics    announced   pharmacokinetic   data    and 
    pharmacokinetic/pharmacodynamic analyses  from  three  previously-reported 
    clinical trials  of tirasemtiv  in  patients with  ALS during  a  platform 
    presentation at the 23^rd International Symposium on ALS and Motor Neurone
    Diseases (ALS/MND) in Chicago, IL. 

CK-2127107

  *During the quarter, Cytokinetics filed  an Investigational New Drug  (IND) 
    application for CK-2127107, which has recently cleared review by the  U.S. 
    Food  and  Drug  Administration  (FDA).  CK-2127107,  a  selective,  fast 
    skeletal  muscle  troponin  activator,  is  a  drug  candidate  that   was 
    discovered during  Cytokinetics'  optimization  of  a  different  chemical 
    series than that which produced tirasemtiv.

Cardiac Muscle Contractility

omecamtiv mecarbil

  *In November, Cytokinetics announced the opening to enrollment of the third
    and final cohort of the ongoing, international, randomized,  double-blind, 
    placebo-controlled, Phase IIb clinical trial of an intravenous formulation
    of omecamtiv mecarbil, known as ATOMIC-AHF (Acute Treatment with Omecamtiv
    Mecarbil to Increase Contractility in Acute Heart Failure). This trial  is 
    sponsored by Amgen in collaboration  with Cytokinetics and is designed  to 
    evaluate the safety, tolerability, and  efficacy of omecamtiv mecarbil  in 
    patients with left ventricular  systolic dysfunction who are  hospitalized 
    with acute heart failure. Additional  information about ATOMIC-AHF can  be 
    found at www.clinicaltrials.gov.

  *During the  quarter, Cytokinetics  and Amgen  collaborated to  enable  the 
    initiation of  a Phase  II double-blind,  randomized,  placebo-controlled, 
    multicenter,  dose   escalation  study   designed  to   evaluate   several 
    modified-release  oral  formulations  of  omecamtiv  mecarbil,  known   as 
    COSMIC-HF  (Chronic   Oral  Study   of  Myosin   Activation  to   Increase 
    Contractility in Heart Failure)  in patients with  heart failure and  left 
    ventricular systolic dysfunction. This trial  is expected to inform  the 
    selection of an oral formulation for potential advancement into the  Phase 
    III clinical program. 

  *During the quarter, dosing initiated in a Phase I open-label,  single-dose 
    clinical  trial  designed  to   evaluate  the  safety,  tolerability   and 
    pharmacokinetics of omecamtiv mecarbil in patients with various degrees of
    renal insufficiency and in patients undergoing hemodialysis. This trial is
    sponsored  by  Amgen  in   collaboration  with  Cytokinetics.   Additional 
    information about this trial can be found at www.clinicaltrials.gov. 

Pre-Clinical Research

  *During the  quarter, Cytokinetics  continued to  conduct research  in  its 
    muscle biology-related research programs.

Corporate

  *In December,  Cytokinetics hosted  an  R&D Day  to update  the  investment 
    community on  the  company's  research and  development  pipeline  and  to 
    highlight the  potential  opportunities,  specifically in  ALS  and  heart 
    failure, for  novel drug  candidates  directed to  the biology  of  muscle 
    contractility. Following the company update, Cytokinetics hosted a  panel 
    discussion with  experts  convened  to  discuss  the  integrated  care  of 
    patients with ALS. 

  *Recently, Cytokinetics  received a  notice from  The Nasdaq  Stock  Market 
    ("Nasdaq") confirming that  it has  regained compliance  with the  minimum 
    $1.00 bid price per share requirement for its common stock.

Financials

Revenues for the fourth  quarter of 2012 were  $2.2 million, compared to  $0.8 
million during the same  period in 2011. Revenues  for the fourth quarter  of 
2012 included $0.9 million of revenue from our collaboration with Amgen,  $0.5 
million from our  collaboration with  MyoKardia, Inc., $0.4  million from  our 
collaboration with Global Blood Therapeutics, Inc., and $0.4 million of  grant 
revenue from the NINDS. Revenues for the fourth quarter of 2011 included $0.5
million in grant revenue from the NINDS, and $0.3 million of revenue from  our 
collaboration with Global Blood Therapeutics, Inc.

Total research and development  (R&D) expenses in the  fourth quarter of  2012 
were $9.2 million,  compared with $8.6  million for the  same period in  2011. 
The $0.6 million  increase in R&D  expenses for the  fourth quarter of  2012, 
compared with the same period in 2011, was primarily due to increased spending
for outsourced  clinical  and  preclinical  expenses  and  facility  expenses, 
partially  offset  by  decreased  spending  for  personnel-related  costs  and 
laboratory expenses.

Total general and administrative (G&A) expenses for the fourth quarter of 2012
were $3.1 million,  compared with $2.9  million for the  same period in  2011. 
The $0.2 million  increase in  G&A expenses in  the fourth  quarter of  2012, 
compared with the same period in 2011, was primarily due to increased spending
for outside  services  and  legal  expenses,  partially  offset  by  decreased 
spending for personnel-related costs and facility expenses.

Revenues for the  twelve months  ended December  31, 2012  were $7.6  million, 
compared to $4.0 million for the same period in 2011. Revenues for the  twelve 
months of 2012 included $4.2 million  from our collaboration with Amgen,  $1.5 
million from  our collaboration  with Global  Blood Therapeutics,  Inc.,  $1.3 
million  of  grant  revenue  from  the  NINDS,  and  $0.6  million  from   our 
collaboration with  MyoKardia, Inc.  Revenues for  the twelve  months of  2011 
included $2.0 million from our collaboration with Amgen, $1.7 million from our
NINDS grant,  and  $0.3  million  from our  collaboration  with  Global  Blood 
Therapeutics, Inc. 

Total R&D expenses for  the twelve months ended  December 31, 2012 were  $35.0 
million, compared  to $37.2  million for  the same  period in  2011. The  $2.2 
million decrease in R&D expenses in the  twelve months of 2012, over the  same 
period in  2011,  was  primarily  due to  decreased  spending  for  laboratory 
expenses,  and  personnel-related   costs,  partially   offset  by   increased 
outsourced preclinical and clinical expenses, and facility expenses.

Total G&A expenses for  the twelve months ended  December 31, 2012 were  $11.7 
million, compared  to $13.6  million for  the same  period in  2011. The  $1.9 
million decrease in G&A spending in the twelve months of 2012 compared to  the 
same  period  in   2011,  was   primarily  due  to   decreased  spending   for 
personnel-related costs, outside services, and facility expenses.

The net loss  allocable to  common stockholders  for the  twelve months  ended 
December 31, 2012, was  $40.3 million, or $0.37  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. 
This compares  to  a net  loss  allocable  to common  stockholders  of  $50.7 
million, or $0.72 per basic  and diluted share, for  the same period in  2011, 
which included a one-time,  non-cash dividend of $2.9  million related to  the 
beneficial conversion feature of the Series A Convertible Preferred Stock.

Financial Guidance for 2013

Cytokinetics also  announced its  financial guidance  for 2013.  The  company 
anticipates revenue  will be  in  the range  of $1  to  $3 million,  cash  R&D 
expenses will be in  the range of  $40 to $44 million,  and cash G&A  expenses 
will be in the range of $12 to  $13 million. This financial guidance is on  a 
cash basis and does not include an estimated $4.8 million in non-cash  related 
operating expenses  primarily  related  to  stock  compensation  expense.  In 
addition, this  guidance  does not  reflect  potential revenue  from  any  new 
collaborations. 

Annual Stockholders' Meeting

Cytokinetics' Annual Stockholders' Meeting will be held at the Embassy  Suites 
Hotel located at 250 Gateway Boulevard in  South San Francisco, CA at 1:30  PM 
on Wednesday, May 22, 2013. 

Company Milestones

Skeletal Muscle Contractility

tirasemtiv

  *By mid-year  2013, Cytokinetics  anticipates completion  of enrollment  in 
    BENEFIT-ALS. 

  *By the end of 2013, Cytokinetics expects to report data from BENEFIT-ALS.

CK-2127107

  *In the first half of 2013,  Cytokinetics anticipates initiating a Phase  I 
    clinical trial evaluating CK-2127107 in healthy volunteers. 

Cardiac Muscle Contractility

omecamtiv mecarbil

  *In the  first quarter  of 2013,  Cytokinetics anticipates  the opening  to 
    enrollment of COSMIC-HF.

  *In the  first half  of 2013,  Cytokinetics anticipates  the completion  of 
    enrollment in ATOMIC-AHF. 

  *In mid-year 2013, Cytokinetics expects to report results from ATOMIC-AHF.

Conference Call and Webcast Information

Members of  Cytokinetics' senior  management team  will review  the  company's 
fourth 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 92558691.

An archived replay of the webcast will be available via Cytokinetics'  website 
until February 12, 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 92558691from  February 5, 2013  at 
5:30 PM Eastern Time until February 12, 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  (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, 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  treatment   with  tirasemtiv   produced 
potentially clinically relevant  pharmacodynamic effects in  Phase II  trials. 
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.

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;statements relating to Cytokinetics'
and Amgen's  research and  development activities,  including the  initiation, 
enrollment, conduct, design, endpoints, size,  scope, progress and results  of 
clinical  trials  of  tirasemtiv,  omecamtiv  mecarbil  and  CK-2127107;   the 
significance and utility of clinical trial results and the anticipated  timing 
for the  availability  of  clinical  trial results;  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, 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,  and  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;  Amgen's decisions  with respect  to the  design, 
initiation, conduct,  timing and  continuation of  development activities  for 
omecamtiv mecarbil; Cytokinetics may be unable to obtain or maintain patent or
trade secret protection for its intellectual property; 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;  regulatory  authorities   may  not  grant   tirasemtiv  orphan   drug 
exclusivity in  ALS  even if  it  is approved  for  marketing; 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:
     
Jodi L. Goldstein 
Manager, Corporate Communications & Marketing
(650) 624-3000

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

                        Three Months Ended             Twelve Months Ended
                                     December                       December
                    December 31,        31,        December 31,        31,
                        2012           2011            2012           2011
Revenues:
Research and      $        2,184  $         757  $        7,559  $       4,000
development
Total revenues             2,184            757           7,559          4,000
Operating
Expenses:
Research and
development                9,214          8,599          35,000         37,182
General and
administrative             3,103          2,863          11,717         13,590
Restructuring                  -          1,192            (56)          1,192
Total operating
expenses                  12,317         12,654          46,661         51,964
Operating loss          (10,133)       (11,897)        (39,102)       (47,964)
Interest and
other, net                    33             20              87            104
                                                                        
Net loss                (10,100)       (11,877)       (39,015)     (47,860)
Deemed dividend
related to
beneficial
conversion
feature of
convertible
preferred stock                -              -         (1,307)      (2,857) 
Net loss
allocable to
common
stockholders      $     (10,100)  $    (11,877)  $     (40,322)  $    (50,717)
Net loss per
share allocable
to common
stockholders -
basic and diluted $       (0.07)  $      (0.16)  $       (0.37)  $      (0.72)
Weighted average
shares used in
computing net
loss per share
allocable to
common
stockholders -
basic and diluted    142,442,508     72,775,298     108,641,962     70,799,637

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

                                              December 31,    December 31,
                                                  2012            2011
Assets
Cash and cash equivalents                   $       14,907  $       18,833
Short-term investments                              59,093          30,190
Related party receivables                                4              14
Other current assets                                 2,423           2,103
Total current assets                                76,427          51,140
Property and equipment, net                            997           1,310
Restricted cash                                          -             196
Other assets                                           127             127
Total assets                                $       77,551  $       52,773
Liabilities and stockholders' equity
Current liabilities                         $        5,750  $        4,592
Long-term liabilities                                  361               3
Stockholders' equity                                71,440          48,178
Total liabilities and stockholders' equity  $       77,551  $       52,773

------------------------------------------------------------------------------

This announcement is distributed by Thomson Reuters on behalf of Thomson
Reuters clients.

The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other
applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of
the
information contained therein.

Source: Cytokinetics, Inc. via Thomson Reuters ONE
HUG#1675776