Cytokinetics, Incorporated Reports Third Quarter 2014 Financial Results
(Thomson Reuters ONE) -
Company Provides Updates on the Advancement of Development Programs Focused to
Muscle Biology
SOUTH SAN FRANCISCO, CA, October 30, 2014 - Cytokinetics, Incorporated (Nasdaq:
CYTK) reported total research and development revenues for the third quarter of
2014 were $9.4 million, compared to $4.5 million during the same period in
2013. The net loss for the third quarter was $6.0 million, or $0.16 per basic
and diluted share. This is compared to a net loss for the same period in 2013,
of $12.6 million, or $0.43 per basic and diluted share. As of September
30, 2014, cash, cash equivalents and investments totaled $82.5 million.
"In the third quarter, Cytokinetics made considerable progress across our
development stage programs as we elaborated in our public announcements
containing program updates. In particular, I am pleased that we have completed
our review of the results from BENEFIT-ALS and that we may have identified a
potential path forward for tirasemtiv to Phase III development. In recent
months, we have witnessed increases in the levels of awareness, education,
fundraising and advocacy for ALS and Cytokinetics is proud to stand tall with
patients with ALS and their caregivers and lead the fight against this grievous
illness," stated Robert I. Blum, Cytokinetics' President and Chief Executive
Officer. "In the most recent quarter, we also concluded the conduct of the
clinical trials for which we are responsible under our collaborations with each
of Astellas and Amgen. We look forward to the advancement of CK-2127107 towards
Phase II and omecamtiv mecarbil towards Phase III under our strategic
alliances."
Company Highlights
Skeletal Muscle Contractility
tirasemtiv
* During the quarter, Cytokinetics completed its review of results from
BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional
Improvement with Tirasemtiv in ALS) and has concluded that effects observed
on Slow Vital Capacity (SVC) in patients treated with tirasemtiv are robust
and potentially clinically meaningful. In addition, following consultation
with clinical and statistical advisors, the company believes that data from
BENEFIT-ALS support progression of tirasemtiv to a Phase III clinical trial
in patients with amyotrophic lateral sclerosis (ALS).
* Recently, Cytokinetics announced that it has begun regulatory interactions
with the U.S. Food and Drug Administration (FDA) regarding results from
BENEFIT-ALS and has received initial feedback from the FDA. The company
believes that effects on SVC could be a Phase III clinical trial endpoint
and could support registration of tirasemtiv as a potential treatment for
patients with ALS. As a result, Cytokinetics has initiated planning for a
potential Phase III clinical trial of tirasemtiv that could begin in 2015.
* During the quarter, a manuscript was published in the August edition of the
journal Vascular Medicine highlighting the results from a previously
reported Phase IIa "Evidence of Effect" clinical trial designed to evaluate
the safety, tolerability, pharmacokinetics and pharmacodynamics of a single
doses of tirasemtiv in patients with claudication due to peripheral artery
disease (PAD). The published results from this trial suggest that
tirasemtiv was associated with a positive effect on calf muscle performance
at the highest dose and plasma concentrations in individuals with PAD and
claudication.
CK-2127107
* Recently, Cytokinetics announced the completion of five Phase I clinical
trials evaluating CK-2127107 in healthy volunteers. These studies were
conducted pursuant to an agreed development plan under the collaboration
between the company and Astellas Pharma Inc. Results are summarized below:
CY 5011 was a double-blind, randomized, placebo-controlled study designed to
assess the safety, tolerability, and pharmacokinetics of single ascending oral
doses of CK-2127107 administered to healthy adult males. Planned single doses
of CK-2127107 up to 4000 mg, the highest dose administered in this trial, were
well-tolerated without an emerging pattern of adverse events observed;
therefore, a maximum tolerated dose could not be defined. The pharmacokinetic
profile of CK-2127107 was linear and dose-proportional across the dose range
studied with a mean terminal half-life compatible with once or twice daily
dosing.
CY 5012 was a double-blind, randomized, placebo-controlled, multiple ascending
dose, parallel group study designed to assess the safety, tolerability, and
pharmacokinetics of CK-2127107 in healthy young and elderly volunteers. This
Phase I clinical trial demonstrated that a 10-day course of CK-2127107, either
300 mg or 500 mg twice daily, was well-tolerated by both younger (18-55 years)
and older (65-85 years) subjects. Plasma concentrations of CK-2127107 achieved
steady state and no differences in pharmacokinetics between younger and older
subjects were observed.
CY 5013 was a randomized, placebo-controlled, single dose, 4-period crossover
study of CK-2127107 in healthy male volunteers designed to evaluate the change
in the force-frequency profile of the tibialis anterior muscle during
transcutaneous stimulation of the deep fibular nerve and its relationship to
dose and plasma concentrations of CK-2127107. This clinical trial demonstrated
that CK-2127107 amplified the response of muscle to nerve activation following a
single dose of CK-2127107 in these subjects and that the results observed in
preclinical models can be translated into humans.
CY 5014 was a randomized, open-label, 2-period crossover study designed to
assess the relative oral bioavailability, pharmacokinetics, safety and
tolerability of two oral formulations of CK-2127107 in healthy volunteers. This
clinical trial demonstrated that single doses of CK-2127107 in suspension, dosed
at 300 mg and 1000 mg, were well-tolerated by all 25 healthy men enrolled and
provided pharmacokinetic data on two different physical forms of CK-2127107 to
inform ongoing development of tablet formulations for use in potential future
trials.
CY 5015 was an open-label, randomized, single dose study designed to evaluate
the pharmacokinetics, in a fed and fasted state, of an oral tablet form of CK-
2127107 in healthy male volunteers. This clinical trial demonstrated that
single doses of CK-2127107, administered at doses of 250 mg, 500 mg and 1000 mg,
were well-tolerated and appeared appropriate for use in potential future
clinical trials.
These trials were conducted by Cytokinetics under Astellas' sponsorship.
* During the quarter, Cytokinetics conducted other Phase II readiness
activities for CK-2127107 in accordance with an agreed development plan
under the joint oversight of the company and Astellas. These activities
included process improvement and optimization activities for the
manufacturing of CK-2127107, pre-clinical and toxicology studies, and Phase
II indication prioritization analyses.
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 275 towards the objective of
450 patients. Over 70 patients in the expansion phase of COSMIC-HF have
completed dosing. Recently, The Data Monitoring Committee reviewed data
from COSMIC-HF and recommended that the trial continue without any changes
to the protocol. This trial is being conducted by Amgen in collaboration
with Cytokinetics.
* During the quarter, Cytokinetics completed the trial known as CY 1211, a
Phase I single center, placebo-controlled, double-blind study comparing the
pharmacokinetics of omecamtiv mecarbil between healthy Japanese and
Caucasian volunteers. Data from CY 1211 indicate no clinically meaningful
differences between the two groups studied. This trial was 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 under 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 third quarter of 2014 were $9.4 million, compared to $4.5
million during the same period in 2013. Revenues for the third quarter of 2014
included $4.8 million of research and development revenues and $2.7 million of
license revenues from Cytokinetics' collaboration with Astellas, and $1.9
million of research and development revenues from Cytokinetics' collaboration
with Amgen. Revenues for the same period in 2013 included $2.3 million of
research and development revenues and $1.4 million of license revenues from
Cytokinetics' collaboration with Astellas, and $0.6 million of research and
development revenues from Cytokinetics' collaboration with Amgen.
Total research and development (R&D) expenses in the third quarter of 2014 were
$11.4 million, compared with $13.4 million for the same period in 2013. The $2.0
million decrease in R&D expenses for the third quarter of 2014, compared with
the same period in 2013, was primarily due to a decrease of $2.7 million in
outsourced clinical costs partially offset by an increase of $0.6 million in
personnel expenses.
Total general and administrative (G&A) expenses for the third quarter of 2014
were $4.0 million, compared with $3.6 million for the same period in 2013. The
$0.4 million increase in G&A expenses in the third quarter of 2014, compared
with the same period in 2013, was primarily due to an increase of $0.2 million
in personnel expenses.
Revenues for the nine months ended September 30, 2014 were $25.2 million,
compared to $6.3 million for the same period in 2013. Revenues for the first
nine months of 2014 were primarily comprised of $14.1 million of research and
development revenues and $7.6 million of license revenues from Cytokinetics'
collaboration with Astellas, and $3.4 million of research and development
revenues from Cytokinetics' collaboration with Amgen. Revenues for the same
period in 2013 included $2.3 million of research and development revenues and
$1.4 million of license revenues from Cytokinetics' collaboration with Astellas,
$1.5 million of research and development revenues from Cytokinetics'
collaboration with Amgen, and $1.0 million revenue from Cytokinetics'
collaboration with MyoKardia.
Total R&D expenses for the nine months ended September 30, 2014 and September
30, 2013 were $35.6 million, in both periods. The R&D expenses for 2014 compared
to the same period in 2013 reflected a decrease of $5.2 million in outsourced
clinical costs were mainly offset by an increase of $2.4 million in outsourced
pre-clinical costs and an increase of $2.1 million in personnel expense.
Total G&A expenses for the nine months ended September 30, 2014 were $12.7
million, compared to $11.0 million for the same period in 2013. The $1.7 million
increase in G&A spending in the first nine 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, and $0.4 million in personnel
expenses, partially offset by a decrease of $0.2 million in legal expenses.
The net loss for the nine months ended September 30, 2014 was $23.1 million, or
$0.65 per basic and diluted share, compared to a net loss of $40.2 million, or
$1.52 per basic and diluted share, for the same period in 2013.
Financial Guidance
Cytokinetics provided updated financial guidance for 2014: cash revenues are
expected to be approximately $19 to $21 million, cash R&D expenses are expected
to be in the range of $45 to $48 million, and cash G&A expenses are expected to
be in the range of $15 to $17 million. This financial guidance is on a cash
basis and does not include the deferral of approximately $11 million in revenue
associated with the Astellas and Amgen collaborations and an estimated $3.6
million in non-cash related operating expenses primarily related to stock
compensation expense.
Company Milestones
Skeletal Muscle Contractility
tirasemtiv
* Cytokinetics expects to have further interactions with regulatory
authorities regarding the potential path forward for tirasemtiv.
* Cytokinetics expects to continue planning for a potential Phase III clinical
trial of tirasemtiv that could begin in 2015.
CK-2127107
* Cytokinetics expects to conclude certain Phase II readiness activities in
2014 pursuant to our collaboration agreement with Astellas in order to
inform the potential progression of CK-2127107 to Phase II development.
Cardiac Muscle Contractility
omecamtiv mecarbil
* Cytokinetics expects the enrollment of patients in the expansion phase of
COSMIC-HF to conclude by the end of 2014.
* Cytokinetics expects the data from CY 1211 to inform plans for the
development of omecamtiv mecarbil in Japan and the inclusion of Japan in
potential global Phase III program activities.
Conference Call and Webcast Information
Members of Cytokinetics' senior management team will review the company's third
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 34950991.
An archived replay of the webcast will be available via Cytokinetics' website
until November 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 34950991 from October 30, 2014 at
5:30 PM Eastern Time until November 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 expected revenue and R&D and G&A expenses; Cytokinetics'
and its partners' research and development activities, including the initiation,
conduct, design, enrollment, progress, continuation, completion and results of
clinical trials, the significance and utility of clinical trial results, planned
interactions with regulatory authorities and the outcomes of such interactions,
the potential conduct of a Phase III clinical trial of tirasemtiv and the timing
for the initiation of such a trial; the use of effects on slow vital capacity as
a Phase III clinical trial endpoint for tirasemtiv; the potential progression of
CK-2127107 to Phase II development and omecamtiv mecarbil to Phase III
development; the expected timing of events; 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 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; additional Phase I clinical trials for CK-2127107 may be required;
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 Nine Months Ended
---------------------------- ---------------------------
September September September September
30, 30, 30, 30,
2014 2013 2014 2013
------------- ------------- ------------- -------------
Revenues:
Research and
development revenues
from
related parties $ 1,920 $ 564 $ 3,428 $ 1,455
Research and
development, grant and
other
revenues 4,761 2,495 14,189 3,434
License revenues 2,734 1,410 7,565 1,410
----------- ------------ ----------- -----------
Total revenues 9,415 4,469 25,182 6,299
----------- ------------ ----------- -----------
Operating Expenses:
Research and
development 11,420 13,445 35,647 35,626
General and
administrative 3,993 3,635 12,710 10,999
----------- ------------ ----------- -----------
Total operating
expenses 15,413 17,080 48,357 46,625
----------- ------------ ----------- -----------
Operating loss (5,998 ) (12,611 ) (23,175 ) (40,326 )
Interest and other, net 27 23 86 78
----------- ------------ ----------- -----------
Net loss $ (5,971 ) $ (12,588 ) $ (23,089 ) $ (40,248 )
----------- ------------ ----------- -----------
Net loss per share -
basic and diluted $ (0.16 ) $ (0.43 ) $ (0.65 ) $ (1.52 )
Weighted average shares
used in computing net
loss per share - basic
and diluted 36,609 29,395 35,359 26,413
Cytokinetics, Incorporated
Condensed Consolidated Balance Sheets
(in thousands)
September 30, December 31,
2014 2013((1))
--------------- --------------
(unaudited)
Assets
Cash and cash equivalents $ 12,907 $ 20,158
Short term investments 65,589 57,570
Accounts receivable and related party
receivable 1,191 5
Other current assets 1,804 1,605
--------------- --------------
Total current assets 81,491 79,338
Property and equipment, net 1,491 1,221
Long-term investments 4,003 2,502
Other assets 200 127
--------------- --------------
Total assets $ 87,185 $ 83,188
--------------- --------------
Liabilities and stockholders' equity
Deferred revenue, current $ 5,284 $ 14,701
Other current liabilities 7,702 12,003
--------------- --------------
Total current liabilities 12,986 26,704
Deferred revenue, non-current 52 1,500
Other non-current liabilities 517 542
Stockholders' equity 73,630 54,442
--------------- --------------
Total liabilities and stockholders' equity $ 87,185 $ 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 GlobeNewswire on behalf of
GlobeNewswire 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 GlobeNewswire
[HUG#1867375]
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Datum: 30.10.2014 - 21:00 Uhr
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