Company Provides Updates to Development
Programs Focused to Muscle Biology
SOUTH SAN FRANCISCO, CA, July 30,
2014 - Cytokinetics, Incorporated (Nasdaq: CYTK)
reported total research and development revenues for the
second quarter of 2014 were $7.8 million, compared to $1.0 million
during the same period in 2013. The net loss for the second
quarter was $8.4 million, or $0.23 per basic and diluted
share. This is compared to a net loss for the same period in
2013, of $15.0 million, or $0.58 per basic and diluted share.
As of June 30, 2014, cash, cash equivalents and
investments totaled $92.1 million.
"In the second quarter, we
conducted additional pre-specified analyses of data arising from
BENEFIT-ALS and consulted with expert neuromuscular and pulmonary
specialists with the objective to better understand the
significance of the effects of tirasemtiv on respiratory function and its
implications for the potential further development of our novel
mechanism skeletal muscle activator," stated Robert I. Blum,
Cytokinetics' President and Chief Executive Officer. "Potential
next steps in the development of tirasemtiv will be defined by our continuing
analysis of results from this Phase IIb clinical trial as well as
our expected interactions with regulatory authorities and possible
corporate partners. In the meantime, we continue to
advance our heart failure program with Amgen and our skeletal
muscle program with Astellas and look forward to important
milestones from both of these programs."
Company
Highlights
Skeletal
Muscle Contractility
tirasemtiv
- During the quarter, Cytokinetics
announced further results from BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS) at the Joint Congress of European
Neurology. 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). The differences in the decline in
Slow Vital Capacity (SVC, a measure of the strength of the skeletal
muscles responsible for breathing) on tirasemtiv versus placebo
observed after 12 weeks of double-blind treatment were maintained
for up to 4 weeks after discontinuation of treatment.
- Recently, Cytokinetics announced the
results relating to tirasemtiv from pre-specified subgroup
analyses of BENEFIT-ALS at the 13th International Congress on
Neuromuscular Diseases. The results indicate that reduced declines
in SVC on tirasemtiv versus placebo were observed
consistently across all subgroups of patients in BENEFIT-ALS that
were examined.
- During the quarter, Cytokinetics
announced that data from preclinical research relating
to tirasemtiv in mouse models of spinal
muscular atrophy (SMA) were presented at the 2014 Annual Spinal
Muscular Atrophy Conference. In these models, tirasemtiv increased
muscle force and improved grip strength, grid hang time, and
resistance to fatigue. These studies were supported in part
by a grant from the Families of Spinal Muscular Atrophy.
- During the quarter, Cytokinetics
announced the publication of three peer-reviewed manuscripts
relating to tirasemtiv and fast skeletal muscle troponin
activation in the journals PLOS ONE, Muscle
& Nerve, and the American Journal of Respiratory and Critical Care
Medicine. These papers elaborated on the
mechanistic effects of tirasemtiv and related compounds in humans
as well as in a mouse model of ALS.
CK-2127107
- During the quarter, Cytokinetics
continued to enroll patients in CY 5012, a double-blind,
randomized, placebo-controlled, multiple ascending dose, parallel
group study intended to assess the safety, tolerability, and
pharmacokinetics of CK-2127107 following multiple ascending doses
in healthy volunteers.
- During the quarter, Cytokinetics
initiated and completed enrollment in CY 5013, a Phase I
randomized, placebo-controlled, single dose, 4-period crossover
study of CK-2127107 in healthy male volunteers. CY 5013 is
designed to evaluate the change in the force-frequency profile and
its relationship to dose and plasma concentrations of
CK-2127107.
These trials are being conducted
by Cytokinetics in collaboration with Astellas.
Cardiac
Muscle Contractility
omecamtiv mecarbil
- During the quarter, enrollment
continued in the expansion phase of COSMIC-HF (Chronic Oral Study
of Myosin Activation
to Increase Contractility in Heart Failure). COSMIC-HF is a Phase II, double-blind,
randomized, placebo-controlled, multicenter clinical trial designed
to assess the pharmacokinetics and tolerability of omecamtiv
mecarbil dosed orally in patients with
heart failure and left ventricular systolic dysfunction as well as
its effects on echocardiographic measures of cardiac function.
The expansion phase of COSMIC-HF has enrolled over 150 of the
450 planned heart failure patients from 95 clinical sites in 13
countries. This trial is being conducted by Amgen in collaboration
with Cytokinetics.
- During the quarter, Cytokinetics
initiated dosing in CY 1211, a Phase I single center,
placebo-controlled, double-blind study comparing the
pharmacokinetics of omecamtiv mecarbil between healthy Japanese
and Caucasian volunteers. This trial is being conducted by
Cytokinetics in collaboration with Amgen.
Additional information on
COSMIC-HF and other clinical trials of omecamtiv mecarbil can be found
at www.clinicaltrials.gov.
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 second quarter of
2014 were $7.8 million, compared to $1.0 million during the
same period in 2013. Revenues for the second quarter of 2014
included $4.2 million of research and development
revenues and $2.7 million of license revenues
from Cytokinetics' collaboration with Astellas, and
$0.8 million of research and development revenues
from Cytokinetics' collaboration with Amgen.
Revenues for the same period in 2013 included $0.4 million of
revenue from Cytokinetics' collaboration with MyoKardia,
Inc., $0.6 million of revenue
from Cytokinetics' collaboration with Amgen, and $36,000
of grant revenue.
Total research and development
(R&D) expenses in the second quarter of 2014 were $11.7
million, compared with $12.3 million for the same period in
2013. The $0.6 million decrease in R&D expenses for the
second quarter of 2014, compared with the same period in 2013, was
primarily due to a decrease of $2.5 million in outsourced clinical
costs partially offset by an increase of $1.0 million in outsourced
pre-clinical costs and an increase of $0.7 million in personnel
expenses.
Total general and administrative
(G&A) expenses for the second quarter of 2014 were $4.5
million, compared with $3.7 million for the same period in
2013. The $0.8 million increase in G&A expenses in the
second quarter of 2014, compared with the same period in 2013, was
primarily due to an increase of $0.8 million in outside services
costs related to commercial development and medical affairs,
partially offset by a decrease of $0.2 million in legal
expenses.
Revenues for the six months ended
June 30, 2014 were $15.8 million, compared to $1.8 million for the
same period in 2013. Revenues for the first six months of 2014
included $9.4 million of research and development revenues and $4.8
million of license revenues from Cytokinetics' collaboration with
Astellas, and $1.5 million of research and development revenues
from Cytokinetics' collaboration with Amgen. Revenues for the same
period in 2013 included $0.9 million of research and development
expenses from Cytokinetics' collaboration with Amgen collaboration,
$0.8 million revenue from Cytokinetics' collaboration with
MyoKardia and $0.1 million of grant revenue.
Total R&D expenses for the six
months ended June 30, 2014 were $24.2 million, compared to $22.2
million for the same period in 2013. The $2.0 million increase in
R&D expenses in the first six months of 2014, over the same
period in 2013, was primarily due to an increase of $2.5 million in
outsourced pre-clinical costs and an increase of $1.5 million in
personnel expenses, partially offset by a decrease of $2.5 million
in outsourced clinical costs.
Total G&A expenses for the six
months ended June 30, 2014 were $8.7 million, compared to $7.4
million for the same period in 2013. The $1.3 million increase in
G&A spending in the first six months of 2014 compared to the
same period in 2013, was primarily due to an increase of $1.4
million in outside services costs related to commercial
development, partially offset by a decrease of $0.3 million in
legal expenses.
The net loss for the six months ended
June 30, 2014, was $17.1 million, or $0.49 per basic and diluted
share, compared to a net of $27.7 million, or $1.11 per basic and
diluted share, for the same period in 2013.
Company
Milestones
Skeletal Muscle
Contractility
tirasemtiv
- Cytokinetics expects to interact
with regulatory authorities regarding a potential development path
for tirasemtiv in the second half of 2014.
CK-2127107
- Cytokinetics expects to conduct
additional Phase I studies and certain Phase II readiness
activities for CK-2127107 in 2014 pursuant to our collaboration
agreement with Astellas.
Cardiac Muscle
Contractility
omecamtiv mecarbil
- Cytokinetics expects both the
enrollment of patients in the expansion phase of COSMIC-HF and the
conduct of CY 1211 to be completed in 2014.
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 34950990.
An archived replay of the webcast
will be available via Cytokinetics' website until August 6,
2014. 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 34950990 from July 30, 2014 at 5:30 PM
Eastern Time until August 6, 2014.
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.
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' and its partners' research and
development activities, including the initiation, conduct, design,
enrollment, progress, continuation, completion and results of
clinical trials and preclinical research, the potential
significance and utility of the results from such trials and
research, planned further analyses of the results from BENEFIT-ALS
and the potential outcomes of such analyses, potential further
development of tirasemtiv, conduct of additional Phase I clinical
trials and Phase II readiness activities for CK-2127107 and the
anticipated timing for the occurrence of events; expected
interactions with regulatory authorities and possible corporate
partners; 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 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
Cytokinetics,
Incorporated
Condensed Consolidated Statements of
Operations
(in thousands, except per share
data)
(unaudited)
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June
30, |
|
June
30, |
|
June
30, |
|
June 30, |
|
|
2014 |
2013 |
|
2014 |
|
2013 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenues from related
parties |
$ |
843 |
|
$ |
563 |
|
$ |
1,508 |
|
$ |
891 |
|
Research and development, grant and other revenues |
|
4,196 |
|
|
446 |
|
|
9,428 |
|
|
939 |
|
License revenues |
|
2,749 |
|
|
- |
|
|
4,831 |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
7,788 |
|
|
1,009 |
|
|
15,767 |
|
|
1,830 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
11,737 |
|
|
12,347 |
|
|
24,227 |
|
|
22,181 |
|
General and administrative |
|
4,458 |
|
|
3,730 |
|
|
8,717 |
|
|
7,364 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
16,195 |
|
|
16,077 |
|
|
32,944 |
|
|
29,545 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(8,407) |
|
|
(15,068) |
|
|
(17,177) |
|
|
(27,715) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other, net |
|
33 |
|
|
27 |
|
|
59 |
|
|
55 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(8,374) |
|
$ |
(15,041) |
|
$ |
(17,118) |
|
$ |
(27,660) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and diluted |
$ |
(0.23) |
|
$ |
(0.58) |
|
$ |
(0.49) |
|
$ |
(1.11) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used in computing net loss per
share - basic and diluted |
|
36,443 |
|
|
25,773 |
|
|
34,724 |
|
|
24,896 |
|
Cytokinetics,
Incorporated
Condensed Consolidated Balance
Sheets
(in thousands)
|
|
June 30, |
|
|
December 31, |
|
|
|
2014 |
|
|
2013(1) |
|
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
12,355 |
|
$ |
20,158 |
|
|
|
|
|
|
|
|
Short term investments |
|
65,395 |
|
|
57,570 |
|
|
|
|
|
|
|
|
Accounts receivable and related party receivable |
|
319 |
|
|
5 |
|
|
|
|
|
|
|
|
Other current assets |
|
2,009 |
|
|
1,605 |
|
|
|
|
|
|
|
|
Total current assets |
|
80,078 |
|
|
79,338 |
|
|
|
|
|
|
|
|
Property and equipment, net |
|
1,513 |
|
|
1,221 |
|
|
|
|
|
|
|
|
Long-term investments |
|
14,352 |
|
|
2,502 |
|
|
|
|
|
|
|
|
Other assets |
|
200 |
|
|
127 |
|
|
|
|
|
|
|
|
Total assets |
$ |
96,143 |
|
$ |
83,188 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders'
equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue, current |
$ |
8,984 |
|
$ |
14,701 |
|
|
|
|
|
|
|
|
Other current liabilities |
|
7,933 |
|
|
12,003 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
16,917 |
|
|
26,704 |
|
|
|
|
|
|
|
|
Deferred revenue, non-current |
|
- |
|
|
1,500 |
|
|
|
|
|
|
|
|
Other non-current liabilities |
|
529 |
|
|
542 |
|
|
|
|
|
|
|
|
Stockholders' equity |
|
78,697 |
|
|
54,442 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders'
equity |
$ |
96,143 |
|
$ |
83,188 |
|
(1) Derived
from the audited financial statements, included in the Company's
Annual Report on Form 10-K for the year ended December 31,
2013.
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Cytokinetics, Inc. via Globenewswire
HUG#1843250
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