Cytokinetics, Incorporated Reports Third Quarter 2013 Financial Results
(Thomson Reuters ONE) -
Company Provides Updates on Key Progress in Development Programs for Heart
Failure and ALS
SOUTH SAN FRANCISCO, CA, October 30, 2013 - Cytokinetics, Incorporated (Nasdaq:
CYTK) reported total revenues for the third quarter of 2013 were $4.5 million,
compared to $1.7 million during the same period in 2012. The net loss for the
third quarter was $12.6 million, or $0.43 per basic and diluted share. This is
compared to a net loss allocated to common stockholders for the same period in
2012, of $10.0 million, or $0.45 per basic and diluted share. As of September
30, 2013, cash, cash equivalents and investments totaled $85.4 million.
"During the third quarter, Cytokinetics announced presentations of the results
from ATOMIC-AHF relating to omecamtiv mecarbil at two leading scientific
meetings, one in Europe and one in the United States," stated Robert I. Blum,
Cytokinetics' President and Chief Executive Officer. "We are pleased these data
from ATOMIC-AHF were supported by the international cardiology community and
inform decisions regarding potential progression of this drug candidate in
continued development. In addition, the completion of the dose escalation phase
of COSMIC-HF relating to omecamtiv mecarbil, alongside today's update on
enrollment of BENEFIT-ALS relating to tirasemtiv, underscore significant
positives in both of our lead clinical trials programs. We look forward to
continued progress through the remainder of 2013 and are making preparations for
results from both trials in 2014."
Company Highlights
Cardiac Muscle Contractility
omecamtiv mecarbil
* During the quarter, the results from ATOMIC-AHF (Acute Treatment with
Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure) were
presented at the ESC Congress 2013, organized by the European Society of
Cardiology in Amsterdam. Additional data were presented at the HFSA Annual
Scientific Meeting, organized by the Heart Failure Society of America in
Orlando, Florida. ATOMIC-AHF was conducted by Amgen in collaboration with
Cytokinetics.
* During the quarter, the second cohort of the dose escalation phase of
COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility
in Heart Failure) completed enrollment. Recently, Cytokinetics and Amgen
reviewed results from COSMIC-HF and selected an oral formulation of
omecamtiv mecarbil for evaluation in the planned expansion phase of the
trial. Cytokinetics and Amgen are discussing an amendment to the protocol
of COSMIC-HF prior to initiating enrollment in the expansion phase. COSMIC-
HF is a Phase II, double-blind, randomized, placebo-controlled, multicenter
study designed to assess the pharmacokinetics, safety, tolerability and
pharmacodynamic effects of oral modified-release formulations of omecamtiv
mecarbil in patients with heart failure and left ventricular systolic
dysfunction. COSMIC-HF is being conducted by Amgen in collaboration with
Cytokinetics.
* Recently, Cytokinetics and Amgen agreed on the protocol and budget for a
planned Phase I pharmacokinetic study of omecamtiv mecarbil in healthy
volunteers of both Japanese and non-Japanese ethnicity. The trial, CY
1211, will be conducted by Cytokinetics in collaboration with Amgen. The
costs of the trial will be reimbursed by Amgen.
Additional information on these and other clinical trials of omecamtiv
mecarbil can be found at www.clinicaltrials.gov.
Skeletal Muscle Contractility
tirasemtiv
* During the quarter, Cytokinetics continued enrollment in BENEFIT-ALS
(Blinded Evaluation of Neuromuscular Effects and Functional Improvement with
Tirasemtiv in ALS) trial. BENEFIT-ALS is 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 is designed
to enroll approximately 680 patients with ALS. To date, over 600 patients
have been enrolled in BENEFIT-ALS and over 300 patients have completed 12
weeks of treatment. The primary analysis of BENEFIT-ALS will compare the
mean change from baseline in the ALS Functional Rating Scale in its revised
form, or ALSFRS-R (a clinically validated instrument designed to measure
disease progression and changes in functional status), in patients receiving
tirasemtiv versus those receiving placebo. Recently, the Data Safety
Monitoring Board completed a pre-scheduled meeting to review the data and
recommended that the trial continue without any changes to the protocol.
Cytokinetics anticipates completion of enrollment in BENEFIT-ALS in the
fourth quarter of 2013.
* During the quarter, Cytokinetics announced the publication of results from
two Phase II trials of tirasemtiv in patients with ALS (CY 4024 and CY
4025) in the online edition of the journal Amyotrophic Lateral Sclerosis and
Frontotemporal Degeneration.
CK-2127107
* During the quarter, Cytokinetics completed enrollment in CY 5011, a first-
time-in-humans, Phase I clinical trial of CK-2127107 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.
* Recently, Cytokinetics initiated dosing in CY 5014, a Phase I clinical trial
of CK-2127107 in healthy male volunteers. CY 5014 is a randomized, open-
label, 2-period crossover study to assess the relative oral bioavailability,
pharmacokinetics, safety and tolerability of two oral formulations of CK-
2127107.
The trials described above are being conducted by Cytokinetics pursuant to our
collaboration with Astellas Pharma Inc.
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 third quarter of 2013 were $4.5 million, compared to $1.7
million during the same period in 2012. Revenues for the third quarter of 2013
included $1.4 million of license revenues and $2.3 million of research and
development revenues from our collaboration with Astellas. Revenues for the
third quarter of 2013 also included $0.2 million of research and development
revenue from our collaboration with MyoKardia, Inc., and $0.6 million of revenue
from our collaboration with Amgen. Revenues for the same period in 2012
included $1.0 million of revenue from our collaboration with Amgen, $0.3 million
in grant revenue, $0.3 million of revenue from our collaboration with Global
Blood Therapeutics, Inc., and $0.1 million of revenue from our collaboration
with MyoKardia.
Total research and development (R&D) expenses in the third quarter of 2013 were
$13.4 million, compared with $8.8 million for the same period in 2012. The $4.6
million increase in R&D expenses for the third quarter of 2013, compared with
the same period in 2012, was primarily due to increased spending for outsourced
clinical costs.
Total general and administrative (G&A) expenses for the third quarter of 2013
were $3.6 million, compared with $3.0 million for the same period in 2012. The
$0.6 million increase in G&A expenses in the third quarter of 2013, compared
with the same period in 2012, was primarily due to increased spending for
personnel-related costs and outsourced costs.
Revenues for the nine months ended September 30, 2013 were $6.3 million,
compared to $5.4 million for the same period in 2012. Revenues for the nine
months ended September 30, 2013 included $1.4 million of license revenues and
$2.3 million of research and development revenues from our collaboration with
Astellas. Revenues for the first nine months of 2013 also included $1.5 million
of revenue from our collaboration with Amgen, $1.0 million revenue from our
collaboration with MyoKardia and $0.1 million of grant revenue. Revenues for the
same period in 2012 included $3.2 million of revenue from our collaboration with
Amgen, $0.9 million in grant revenue, and $1.1 million of revenue from our
collaboration with Global Blood Therapeutics and $0.1 million of revenue from
our collaboration with MyoKardia.
Total R&D expenses for the nine months ended September 30, 2013 were $35.6
million, compared to $25.8 million for the same period in 2012. The $9.8 million
increase in R&D expenses in the first nine months of 2013, over 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 G&A expenses for the nine months ended September 30, 2013 were $11.0
million, compared to $8.6 million for the same period in 2012. The $2.4 million
increase in G&A spending in the first nine months of 2013 compared to the same
period in 2012 was primarily due to increased spending for personnel-related
costs, legal expenses and outside services.
The net loss allocable to common stockholders for the nine months ended
September 30, 2013 was $40.2 million, or $1.52 per basic and diluted share. The
net loss allocable to common stockholders for the same period in 2012 was $30.2
million, or $1.86 per basic and diluted share, which included a one-time, non-
cash dividend of $1.3 million related to the beneficial conversion feature of
the Series B convertible preferred stock.
Financial Guidance 2013
Cytokinetics affirmed its previous financial guidance for 2013: cash revenue are
expected to be approximately $40 to $42 million, cash R&D expenses are expected
to be in the range of $52 to $55 million, and cash G&A expenses are expected to
be in the range of $15 to $16 million. This financial guidance is on a cash
basis and does not include the deferral of approximately $10 million in revenue
to future calendar years and an estimated $5.6 million in non-cash related
operating expenses primarily related to stock compensation expense. The company
anticipates recognizing the license fee of $15 million associated with the June
2013 amendment to our collaboration agreement with Amgen in the fourth quarter
of 2013.
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 92574472.
An archived replay of the webcast will be available via Cytokinetics' website
until November 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 92574472 from October 30, 2013 at
5:30 PM Eastern Time until November 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 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
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. 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' financial guidance, including expected
revenue and R&D and G&A expenses for 2013 and the expected timing of revenue
recognition events; Cytokinetics' and its partners' research and development
activities, including the initiation, conduct, design, enrollment, progress,
continuation, completion and results of clinical trials, and the significance
and utility of clinical trial results; 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 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 Statements of Operations
(in thousands, except per share data)
(unaudited)
Three Months Ended Nine Months Ended
---------------------------- ------------------------------
September September September
30, 30, 30, September 30,
2013 2012 2013 2012
------------- -------------- ------------- ----------------
Revenues:
Research and
development $ 3,059 $ 1,714 $ 4,889 $ 5,375
License and
technology fees 1.410 - 1,410 -
------------- ------------ ----------- --------------
Total revenues 4,469 1,714 6,299 5,375
------------- ------------ ----------- --------------
Operating
Expenses:
Research and
development 13,445 8,798 35,626 25,785
General and
administrative 3,635 2,991 10,999 8,614
Restructuring - (2 ) - (56)
------------- ------------ ----------- --------------
Total operating
expenses 17,080 11,787 46,625 34,343
------------- ------------ ----------- --------------
Operating loss (12,611 ) (10,073 ) (40,326 ) (28,968 )
Interest and
other, net 23 29 78 54
------------- ------------ ----------- --------------
Net loss (12,588) (10,044 ) (40,248 ) (28,914)
Deemed dividend
related to
beneficial
conversion feature
of convertible
preferred stock - - - (1,307 )
-----------------------------------------------------------
Net loss allocable
to common
stockholders (12,588 ) (10,044 ) (40,248 ) (30,221)
----------- ------------ ----------- --------------
Net loss per share
allocable to
common
stockholders -
basic and diluted $ (0.43 ) $ (0.45 ) $ (1.52 ) $ (1.86 )
Weighted average
shares used in
computing net loss
per share
allocable to
common
stockholders -
basic and diluted 29,395 22,360 26,413 16,215
Cytokinetics, Incorporated
Condensed Balance Sheets
(in thousands)
(unaudited)
September 30, December 31,
2013 2012
--------------- --------------
Assets
Cash and cash equivalents $ 19,258 $ 14,907
Short term investments 62,384 59,093
Related party receivables - 4
Other current assets 1,679 2,423
--------------- --------------
Total current assets 83,321 76,427
Property and equipment, net 804 997
Long-term investments 3,754 -
Other assets 127 127
--------------- --------------
Total assets $ 88,006 $ 77,551
--------------- --------------
Liabilities and stockholders' equity
Deferred revenue, current $ 33,322 $ -
Other current liabilities 11,689 7,105
--------------- --------------
Total current liabilities 45,011 7,105
Deferred revenue, non-current 2,696 -
Other non-current liabilities 548 361
Stockholders' equity 39,751 70,085
--------------- --------------
Total liabilities and stockholders' equity $ 88,006 $ 77,551
--------------- --------------
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters 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 Thomson Reuters ONE
[HUG#1739381]
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Datum: 30.10.2013 - 21:04 Uhr
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News-ID 311188
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