Cytokinetics, Inc.: Cytokinetics Announces Additional Data from BENEFIT-ALS to be Presented at the 13th International Congress

Cytokinetics, Inc.: Cytokinetics Announces Additional Data from BENEFIT-ALS to
  be Presented at the 13th International Congress on Neuromuscular Diseases

South San Francisco,  CA, July  3, 2014-  Cytokinetics, Incorporated  (Nasdaq: 
CYTK)   announced    today    that   additional    data    from    BENEFIT-ALS 
(BlindedEvaluation    ofNeuromuscularEffects     andFunctionalImprovement 
withTirasemtiv in  ALS)  will  be  presented  during  a  poster  presentation 
scheduled at the 13^th International Congress on Neuromuscular Diseases to  be 
held July 5-10, 2014 at the Acropolis Convention Centre in Nice, France.  The 
poster will include the first public presentation of the effects of tirasemtiv
across patient subgroups on pre-specified secondary endpoints.

Poster Presentation  at the  13^th  International Congress  on  Neuromuscular 
Diseases

Title: Novel Data from BENEFIT-ALS: Blinded Evaluation of Neuromuscular
Effects and Functional Improvement with Tirasemtiv in Patients with
Amyotrophic Lateral Sclerosis
Presenter: Andrew Wolff, MD, FACC
Date: Thursday, July 10, 2014
Presentation Time: 11:30 AM - 12:30 pm Central European Summer Time
Poster Number: PS4-411
Abstract Number: 428

About Tirasemtiv and BENEFIT-ALS

Tirasemtiv, a novel skeletal muscle activator, is the lead drug candidate from
Cytokinetics' skeletal  muscle  contractility  program.Tirasemtivselectively 
activates  the  fast  skeletal  muscle  troponin  complex  by  increasing  its 
sensitivity to calcium and, in preclinical studies, demonstrated increases  in 
skeletal muscle force in  response to neuronal input  and delays in the  onset 
and reductions in the degree of  muscle fatigue. BENEFIT-ALS was 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 
did not achieve its primary efficacy  endpoint, the mean change from  baseline 
in the ALS Functional  Rating Scale in its  revised form (ALSFRS-R);  however, 
treatment  with  tirasemtiv  resulted  in  a  statistically  significant   and 
potentially clinically  meaningful  reduction in  the  decline of  Slow  Vital 
Capacity (SVC), a measure of the strength of the skeletal muscles  responsible 
for breathing that  has been  shown to be  an important  predictor of  disease 
progression  and  survival  in  prior  trials  in  patients  with  ALS.   The 
statistically significant difference between  treatment groups in change  from 
baseline in SVC  persisted through at  least 4  weeks after the  last dose  of 
study drug. The analyses of other pre-specified secondary efficacy  endpoints 
produced mixed results. Cytokinetics expects to continue to analyze the  data 
from BENEFIT-ALS to inform the potential further development of tirasemtiv  in 
patients living with ALS.

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 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 (ALS). 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.

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' research  and  development  activities, 
including  the  potential  significance  and  utility  of  the  results   from 
preclinical  studies  and  clinical  trials  of  tirasemtiv;  planned  further 
analyses of the results  from BENEFIT-ALS and the  potential outcomes of  such 
analyses; potential further development of tirasemtiv; planned  presentations; 
and the properties and potential benefits of skeletal muscle activators and of
tirasemtiv and Cytokinetics' other 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,  the 
results of  BENEFIT-ALS  may  not  support  further  clinical  development  of 
tirasemtiv; further clinical  development of  tirasemtiv in  ALS patients,  if 
supported  by  the  BENEFIT-ALS  data,  will  require  significant  additional 
funding, and Cytokinetics 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

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Source: Cytokinetics, Inc. via Globenewswire
HUG#1812290
 
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