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2015-03-25

Cytokinetics, Inc.: Cytokinetics Announces Publication of Results from Phase II Trial of Tirasemtiv in Patients with Myasthenia Gravis

Data from Evidence of Effect Trial Provide Support for Novel Mechanism of
Action in Neuromuscular Diseases

South San Francisco, CA, March 25, 2015

-
Cytokinetics, Incorporated (Nasdaq: CYTK) announced the publication of a
manuscript relating to its fast skeletal muscle troponin activatortirasemtiv
in the journalNeurotherapeutics
. This publication summarizes results from a Phase IIa "Evidence of Effect"
or hypothesis-generating clinical trial which evaluatedtirasemtiv
in patients with generalized myasthenia gravis (MG). Tirasemtiv
is the lead drug candidate from Cytokinetics' skeletal muscle contractility
program and is being developed as a potential treatment for amyotrophic
lateral sclerosis (ALS).

"We are pleased to share additional clinical data relating totirasemtiv
in patients with generalized myasthenia gravis," stated Andrew A. Wolff, MD,
FACC, Cytokinetics' Senior Vice President and Chief Medical Officer. "We
believe that effects observed on the Quantitative Myasthenia Gravis score and
on vital capacity following administration of a single dose oftirasemtiv
support the evaluation of skeletal muscle activation in patients with
neuromuscular disorders including ALS. We are preparing to initiate a Phase
III clinical development program to evaluate the effects oftirasemtiv
on measures of respiratory function and other measures of skeletal muscle
performance in patients with ALS."

The publication, titled "A Double-Blinded, Randomized, Placebo-Controlled
Trial to Evaluate Efficacy, Safety, and Tolerability of Single Doses
ofTirasemtiv
in Patients with Acetylcholine Receptor-Binding Antibody-Positive Myasthenia
Gravis," appeared online in the March edition of the
journalNeurotherapeutics.
The primary objective of this early-stage clinical study was to evaluate the
effects of single 250 mg and 500 mg doses oftirasemtiv
versus placebo on measures of skeletal muscle function and fatigability in
patients with generalized MG and persistent muscle weakness. The secondary
objectives of the study were to evaluate and characterize the relationship,
if any, between the doses and plasma concentrations oftirasemtiv
and its pharmacodynamic effects, and to evaluate the safety and tolerability
oftirasemtiv
administered as single doses to patients with MG. The authors concluded that
6 hours after dosing,tirasemtiv
produced dose-related improvements from baseline in the Quantitative MG (QMG)
score (slope: -0.49 QMG point per 250 mg administered; p=0.02; lower scores
indicate better function) and in percent predicted forced vital capacity
(slope: 2.2 % increase per 250 mg administered; p=0.04). The QMG improved
by>3 points in twice as many patients after 500 mgtirasemtiv
than after placebo. Both doses oftirasemtiv
were well tolerated; there were no premature terminations or serious adverse
events. The results of this study suggest thattirasemtiv
may improve muscle function in patients with MG and support further
development oftirasemtiv
in neuromuscular diseases.

AboutTirasemtiv

Tirasemtiv
, a novel skeletal muscle activator, is the lead drug candidate from
Cytokinetics' skeletal muscle contractility program.Tirasemtiv
selectively activates the fast skeletal muscle troponin complex by increasing
its sensitivity to calcium and, in preclinical studies and early clinical
trials, demonstrated increases in skeletal muscle force in response to
neuronal input and delays in the onset and reductions in the degree of muscle
fatigue. Cytokinetics is developingtirasemtiv
, a fast skeletal muscle activator, as a potential treatment for ALS.
Cytokinetics conducted BENEFIT-ALS, a Phase IIb, multi-national, double-blind,
randomized, placebo-controlled, clinical trial designed to evaluate the
safety, tolerability and efficacy of tirasemtiv
in patients with ALS. BENEFIT-ALS enrolled 711 patients from 73 centers in
8 countries. Following review of results from BENEFIT-ALS and initial
regulatory interactions in both the United States and Europe, the company is
preparing to advance tirasemtiv
to a Phase III clinical development program that is designed to potentially
confirm and extend results from BENEFIT-ALS. Objectives of the Phase III
program will include measures of respiratory function after longer duration
treatment in patients with ALS, including effects on Slow Vital Capacity.

About Myasthenia Gravis

Myasthenia gravis is a progressive, chronic neuromuscular disease that
commonly strikes people between the ages of 40 and 70 and afflicts between
50,000 and 85,000 people in the United States. Approximately 13,600 new cases
of myasthenia gravis are diagnosed each year. Myasthenia gravis is an
autoimmune disease in which the immune system attacks the junction between
nerve and muscle, targeting either the muscle cell's acetylcholine receptor
(which receives signals from the associated nerve cell) or the
muscle-specific kinase, a protein that helps to organize acetylcholine
receptors on the muscle cell. The cause of myasthenia gravis is unclear.
Researchers suspect viruses or bacteria may trigger the autoimmune response;
the thymus gland also may play a role in the disease. Symptoms include
fatigue and weakness of voluntary muscles, including partial paralysis of eye
movements, double vision, droopy eyelids, and weakness and fatigue in neck
and jaw regions. This weakness fluctuates daily but tends to progress over
the course of a few years, especially as may be untreated.

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 is developingtirasemtiv
, a fast skeletal muscle activator, as a potential treatment for amyotrophic
lateral sclerosis (ALS).Tirasemtiv
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 ALS. Cytokinetics is
collaborating with Amgen Inc. to developomecamtiv mecarbil
, a cardiac muscle activator, for the potential treatment of heart failure.
Cytokinetics is collaborating with Astellas Pharma Inc. to develop
CK-2127107, a fast skeletal muscle activator, for the potential treatment of
spinal muscular atrophy. Amgen holds an exclusive license worldwide to
develop and commercializeomecamtiv mecarbil
and Astellas holds an exclusive license worldwide to develop and commercialize
CK-2127107. Both licenses are subject to Cytokinetics' specified development
and commercialization participation rights. 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
athttp://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' and its partners' research
and development activities, including the initiation, conduct, design, and
results of clinical trials, the significance and utility of clinical trial
results, the expected availability of clinical trial results, and the use of
effects on respiratory function, including slow vital capacity, as a Phase
III clinical trial endpoint for tirasemtiv; potential markets for tirasemtiv;
and the properties and potential benefits 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 further clinical development
of tirasemtiv in ALS patients which will require significant additional
funding, and Cytokinetics may be unable to obtain such additional funding on
acceptable terms, if at all; the FDA and/or other regulatory authorities may
not accept effects on slow vital capacity as a clinical endpoint to support
registration of tirasemtiv for the treatment of ALS; 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.

Funding:
Cytokinetics received $3.4 million in grants (Award Number RC3NS070670) from
the National Institute of Neurological Disorders and Stroke (NINDS) to fund
research and development oftirasemtiv
in MG. Cytokinetics incurred $4.7 million in research and development
expenses associated with its MG program; 73% of the program's funding was
from the NINDS. The content of this press re...

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