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

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

Company Elaborates on Key Progress in Cardiac and Skeletal Muscle Programs

SOUTH SAN FRANCISCO, CA, April  30, 2013- Cytokinetics, Incorporated  (Nasdaq: 
CYTK) reported total research and development revenues of $0.8 million for the
first quarter of 2013. The net loss  for the first quarter was $12.6  million, 
or $0.09 per basic and diluted share, compared to a net loss of $9.9  million, 
or $0.13 per basic and diluted share, for the same period in 2012. As of March
31, 2013, cash, cash equivalents and investments totaled $61.6 million.

"In the first quarter, we progressed  through important milestones in both  of 
our  later-stage  clinical  development  programs,"  stated  Robert  I.  Blum, 
Cytokinetics' President and  Chief Executive Officer.  "We recently  announced 
the completion of enrollment in ATOMIC-AHF, our Phase IIb trial evaluating  an 
intravenous form of omecamtiv  mecarbil in acute  heart failure patients,  and 
the initiation of  dosing in  COSMIC-HF, our  Phase II  trial evaluating  oral 
forms of omecamtiv mecarbil in  outpatients with heart failure. In  addition, 
during the last quarter, BENEFIT-ALS, our Phase IIb clinical trial  evaluating 
tirasemtiv in  patients  with ALS,  exceeded  200 patients  enrolled,  and  we 
initiated Phase  I  dosing of  CK-2127107,  our second  fast  skeletal  muscle 
troponin activator.  We believe  Cytokinetics is  executing well  on our  key 
milestones for 2013  and we are  looking forward to  Phase IIb clinical  trial 
results from each of ATOMIC-AHF and BENEFIT-ALS."

Company Highlights

Cardiac Muscle Contractility

omecamtiv mecarbil

  *In  March,  Cytokinetics  announced  that  ATOMIC-AHF  completed   patient 
    enrollment in its third and final cohort. ATOMIC-AHF (Acute Treatment with
    Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure) is  a 
    Phase  IIb  international,  randomized,  double-blind   placebo-controlled 
    clinical trial designed to evaluate the safety, tolerability and  efficacy 
    of an intravenous formulation of omecamtiv mecarbil in patients with  left 
    ventricular systolic  dysfunction who  are hospitalized  with acute  heart 

  *In  March,  Cytokinetics  announced  that  patient  dosing  initiated   in 
    COSMIC-HF  (Chronic   Oral  Study   of  Myosin   Activation  to   Increase 
    Contractility in Heart Failure). This Phase II, double-blind, randomized,
    placebo-controlled, multicenter,  dose  escalation study  is  designed  to 
    evaluate three modified-release oral formulations of omecamtiv mecarbil in
    patients with  heart failure  and left  ventricular systolic  dysfunction. 
    COSMIC-HF is expected to inform the  selection of an oral formulation  for 
    potential advancement into the Phase III clinical development program. 

  *During the quarter, dosing  completed in Part A  of a Phase I  open-label, 
    single-dose clinical  trial  designed to  evaluate  the  pharmacokinetics, 
    safety and tolerability  of omecamtiv  mecarbil in  patients with  various 
    degrees of renal insufficiency and in patients undergoing hemodialysis. 

The trials described above are being conducted by Amgen in collaboration  with 
Cytokinetics. Additional  information  on  these and  other  clinical  trials 
relating to omecamtiv mecarbil can be found at

Skeletal Muscle Contractility


  *During the  quarter,  Cytokinetics  continued  enrollment  in  BENEFIT-ALS 
    (Blinded Evaluation of  Neuromuscular Effects  and Functional  Improvement 
    with Tirasemtiv in  ALS). This Phase  IIb, multi-national,  double-blind, 
    randomized, placebo-controlled clinical trial is designed to evaluate  the 
    safety, tolerability and potential efficacy of tirasemtiv in patients with
    amyotrophic lateral sclerosis  (ALS). To date,  Cytokinetics has  enrolled 
    over 200  patients  in  this  clinical trial.  A  recent  review  of  the 
    double-blind, aggregate data  from BENEFIT-ALS indicated  that the  actual 
    standard deviation  about  the primary  endpoint  (i.e., the  change  from 
    baseline in  the ALS  Functional  Rating Scale  in  its revised  form)  is 
    slightly higher than the estimate  used to initially calculate the  sample 
    size for  the trial.  Consequently,  in order  to preserve  the  intended 
    statistical power for the trial, the  company is amending the protocol  to 
    allow approximately 500  patients to be  enrolled. Additional  information 
    about BENEFIT-ALS can be found at 

  *In March, Cytokinetics announced the presentation of data from CY 4023,  a 
    Phase IIa Evidence of Effect clinical trial of tirasemtiv in patients with
    generalized myasthenia gravis (MG), during the Emerging Science Program at
    the  American  Academy  of  Neurology  Annual  Meeting.  CY  4023  was  a 
    double-blind,  randomized,  three-period  crossover,   placebo-controlled, 
    pharmacokinetic and  pharmacodynamic  trial  evaluating  single  doses  of 
    tirasemtiv.Tirasemtiv  treatment   was   associated   with   statistically 
    significant, dose-related increases  in skeletal muscle  endurance in  the 
    patients with  MG studied,  as  determined by  the Quantitative  MG  score 
    (QMG). This clinical trial and preclinical research related to tirasemtiv
    in MG were funded by a  grant from the National Institute of  Neurological 
    Disorders and Stroke (NINDS). 


  *In  April,  Cytokinetics   announced  the   initiation  of   CY  5011,   a 
    first-time-in-humans, Phase I clinical trial of CK-2127107, a novel  small 
    molecule activator  of  the  fast skeletal  muscle  troponin  complex,  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. 

Pre-Clinical Research

  *During the quarter, Cytokinetics scientists continued to conduct  research 
    in our muscle biology programs.

  *During  the  quarter,   Cytokinetics  and   Amgen  agreed   to  extend   a 
    collaborative   research   program   directed   to   the   discovery    of 
    next-generation  cardiac  sarcomere   activator  compounds.  Amgen   will 
    reimburse  Cytokinetics  for   certain  research   expenses  incurred   in 
    connection with agreed activities performed under the collaboration.

  *In March,  Cytokinetics and  Families of  Spinal Muscular  Atrophy  (FSMA) 
    announced the  award  of  a  grant  from  FSMA  to  support  Cytokinetics' 
    preclinical research with tirasemtiv related to muscle function in a mouse
    model of SMA. 


  *In February,  Cytokinetics  announced  that B.  Lynne  Parshall  had  been 
    appointed to  the  company's  Board  of  Directors.    The  company  also 
    announced that Steve Dow provided notification that he will not stand  for 
    re-election  to  the  Board  of   Directors  at  the  Annual  Meeting   of 


Revenues for the  first quarter of  2013 were $0.8  million, compared to  $1.8 
million during the  same period in  2012. Revenues for  the first quarter  of 
2013 included $0.4 million of  revenue from our collaboration with  MyoKardia, 
Inc., $0.3 million  of revenue  from our  collaboration with  Amgen, and  $0.1 
million of grant revenue  from the NINDS. Revenues  for the first quarter  of 
2012 included $1.2 million of revenue from our collaboration with Amgen,  $0.3 
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 first  quarter of  2013 
were $9.8 million,  compared with $8.7  million for the  same period in  2012. 
The $1.1 million  increase in  R&D expenses for  the first  quarter of  2013, 
compared with 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 general and administrative (G&A) expenses for the first quarter of  2013 
were $3.6 million,  compared with $3.1  million for the  same period in  2012. 
The $0.5  million increase  in G&A  expenses in  the first  quarter of  2013, 
compared with the same period in 2012, was primarily due to increased spending
for personnel-related costs, outside services and legal expenses.

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

Cardiac Muscle Contractility

omecamtiv mecarbil

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

Skeletal Muscle Contractility


  *By  mid-2013,  Cytokinetics  anticipates   completion  of  enrollment   in 

  *By  the  end  of  2013,  Cytokinetics  expects  to  report  results   from 

Conference Call and Webcast Information

Members of  Cytokinetics' senior  management team  will review  the  company's 
first 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 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 92569832.
An archived replay of the webcast will be available via Cytokinetics'  website 
until May 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 92569832 from  April 30, 2013  at 5:30 PM  Eastern 
Time until May 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  (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 and CK-2127107, both fast skeletal muscle activators, as
potential treatments  for  diseases  and medical  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

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'  and  Amgen's research  and  development 
activities, including the conduct, design, enrollment, progress and results of
clinical trials, the anticipated timing for the availability of clinical trial
results, and the significance and  utility of clinical trial results;  Amgen's 
reimbursement of certain  Cytokinetics research expenses;  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 decisions with respect to the design, initiation, conduct, timing  and 
continuation of development  activities for  omecamtiv mecarbil;  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.

Joanna L. Goldstein   
Manager, Corporate Communications & Marketing
(650) 624-3000

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

                                                    Three Months Ended
                                                    March 31,     March 31,
                                                      2013           2012
Research and development                         $         821  $      1,820
Total revenues                                             821         1,820
Operating Expenses:
Research and development                                 9,834         8,745
General and administrative                               3,634         3,056
Restructuring                                                -          (41)
Total operating expenses                                13,468        11,760
Operating loss                                        (12,647)       (9,940)
Interest and other, net                                     28            12
Net loss                                              (12,619)       (9,928)
Net loss per share allocable to common
stockholders - basic and diluted                 $      (0.09)  $     (0.13)
Weighted average shares used in computing net
loss per share allocable to common stockholders
- basic and diluted                                144,061,001    76,081,592

                          Cytokinetics, Incorporated
                           Condensed Balance Sheets
                                (in thousands)

                                              March 31,    December 31,
                                                2013           2012
Cash and cash equivalents                   $    13,160  $       14,907
Short-term investments                           48,438          59,093
Related party receivables                           328               4
Other current assets                              1,739           2,423
Total current assets                             63,665          76,427
Property and equipment, net                         898             997
Other assets                                        127             127
Total assets                                $    64,690  $       77,551
Liabilities and stockholders' equity
Current liabilities                         $     5,819  $        7,105
Long-term liabilities                               441             361
Stockholders' equity                             58,430          70,085
Total liabilities and stockholders' equity  $    64,690  $       77,551


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Source: Cytokinetics, Inc. via Thomson Reuters ONE
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