Cytokinetics, Inc. : Cytokinetics, Incorporated Reports Fourth Quarter 2012
Company Recaps Significant Milestones in Ongoing Phase IIb Clinical Trials
Expected to Generate Results in 2013
SOUTH SAN FRANCISCO, CA, February 5, 2013- Cytokinetics, Incorporated (Nasdaq:
CYTK) reported total research and development revenues of $2.2 million for the
fourth quarter of 2012. The net loss for the fourth quarter was $10.1 million,
or $0.07 per basic and diluted share, compared to a net loss of $11.9 million,
or $0.16 per basic and diluted share, for the same period in 2011. As of
December 31, 2012, cash, cash equivalents and investments totaled $74.0
"During the fourth quarter, we continued to make substantial progress in both
of our ongoing Phase IIb clinical development programs," stated Robert I.
Blum, Cytokinetics' President and Chief Executive Officer. "In the last
quarter, we opened BENEFIT-ALS, our Phase IIb clinical trial evaluating
tirasemtiv in patients with amyotrophic lateral sclerosis, to enrollment and
also announced the progression to the third and final cohort of ATOMIC-AHF,
our Phase IIb trial evaluating omecamtiv mecarbil in patients hospitalized
with acute heart failure. We expect to announce results from each of these
important trials in 2013, a year that holds significant promise for
Cytokinetics and our first-in-class compounds directed to muscle biology."
Skeletal Muscle Contractility
tirasemtiv (formerly CK-2017357)
*In October, Cytokinetics announced the opening to enrollment of
BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional
Improvement with Tirasemtiv in ALS), a Phase IIb, multi-national,
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). This trial is designed
to randomize approximately 400 patients to 12 weeks of double-blind
treatment with tirasemtiv or placebo. The primary analysis of BENEFIT-ALS
will compare the mean change from baseline in the ALS Functional Rating
Scale in its revised form (ALSFRS-R) on tirasemtiv versus placebo.
Secondary endpoints will include Maximum Voluntary Ventilation (MVV) and
measures of skeletal muscle function. Cytokinetics plans to conduct
BENEFIT-ALS at over 70 sites across the United States, Canada, and several
European countries. Additional information about this trial can be found
*In November, Cytokinetics announced positive data from CY 4023, a Phase
IIa Evidence of Effect, double-blind, randomized, three-period crossover,
placebo-controlled, pharmacokinetic and pharmacodynamic clinical trial of
tirasemtiv in patients with generalized myasthenia gravis (MG). In CY
4023, at six hours after dosing, improvements (i.e., decreases) in the
Quantitative MG score (QMG) were related to the dose of tirasemtiv in a
statistically significant manner (-0.49 QMG points per 250 mg; p = 0.02).
Also at six hours after dosing in CY 4023, increases in the percent
predicted forced vital capacity were statistically significantly related
to the dose level of tirasemtiv (2.2% per 250 mg; p = 0.04), as were the
individual comparisons of each dose level of tirasemtiv versus placebo.
Both the 250 mg and 500 mg single oral doses of tirasemtiv studied in
this Phase IIa clinical trial were well-tolerated by the 32 patients
enrolled in CY 4023; there were no premature terminations and no serious
adverse events were reported. This clinical trial and preclinical
research on MG were funded by a grant from the National Institute of
Neurological Disorders and Stroke (NINDS).
*In December, Cytokinetics announced pharmacokinetic data and
pharmacokinetic/pharmacodynamic analyses from three previously-reported
clinical trials of tirasemtiv in patients with ALS during a platform
presentation at the 23^rd International Symposium on ALS and Motor Neurone
Diseases (ALS/MND) in Chicago, IL.
*During the quarter, Cytokinetics filed an Investigational New Drug (IND)
application for CK-2127107, which has recently cleared review by the U.S.
Food and Drug Administration (FDA). CK-2127107, a selective, fast
skeletal muscle troponin activator, is a drug candidate that was
discovered during Cytokinetics' optimization of a different chemical
series than that which produced tirasemtiv.
Cardiac Muscle Contractility
*In November, Cytokinetics announced the opening to enrollment of the third
and final cohort of the ongoing, international, randomized, double-blind,
placebo-controlled, Phase IIb clinical trial of an intravenous formulation
of omecamtiv mecarbil, known as ATOMIC-AHF (Acute Treatment with Omecamtiv
Mecarbil to Increase Contractility in Acute Heart Failure). This trial is
sponsored by Amgen in collaboration with Cytokinetics and is designed to
evaluate the safety, tolerability, and efficacy of omecamtiv mecarbil in
patients with left ventricular systolic dysfunction who are hospitalized
with acute heart failure. Additional information about ATOMIC-AHF can be
found at www.clinicaltrials.gov.
*During the quarter, Cytokinetics and Amgen collaborated to enable the
initiation of a Phase II double-blind, randomized, placebo-controlled,
multicenter, dose escalation study designed to evaluate several
modified-release oral formulations of omecamtiv mecarbil, known as
COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase
Contractility in Heart Failure) in patients with heart failure and left
ventricular systolic dysfunction. This trial is expected to inform the
selection of an oral formulation for potential advancement into the Phase
III clinical program.
*During the quarter, dosing initiated in a Phase I open-label, single-dose
clinical trial designed to evaluate the safety, tolerability and
pharmacokinetics of omecamtiv mecarbil in patients with various degrees of
renal insufficiency and in patients undergoing hemodialysis. This trial is
sponsored by Amgen in collaboration with Cytokinetics. Additional
information about this trial can be found at www.clinicaltrials.gov.
*During the quarter, Cytokinetics continued to conduct research in its
muscle biology-related research programs.
*In December, Cytokinetics hosted an R&D Day to update the investment
community on the company's research and development pipeline and to
highlight the potential opportunities, specifically in ALS and heart
failure, for novel drug candidates directed to the biology of muscle
contractility. Following the company update, Cytokinetics hosted a panel
discussion with experts convened to discuss the integrated care of
patients with ALS.
*Recently, Cytokinetics received a notice from The Nasdaq Stock Market
("Nasdaq") confirming that it has regained compliance with the minimum
$1.00 bid price per share requirement for its common stock.
Revenues for the fourth quarter of 2012 were $2.2 million, compared to $0.8
million during the same period in 2011. Revenues for the fourth quarter of
2012 included $0.9 million of revenue from our collaboration with Amgen, $0.5
million from our collaboration with MyoKardia, Inc., $0.4 million from our
collaboration with Global Blood Therapeutics, Inc., and $0.4 million of grant
revenue from the NINDS. Revenues for the fourth quarter of 2011 included $0.5
million in grant revenue from the NINDS, and $0.3 million of revenue from our
collaboration with Global Blood Therapeutics, Inc.
Total research and development (R&D) expenses in the fourth quarter of 2012
were $9.2 million, compared with $8.6 million for the same period in 2011.
The $0.6 million increase in R&D expenses for the fourth quarter of 2012,
compared with the same period in 2011, was primarily due to increased spending
for outsourced clinical and preclinical expenses and facility expenses,
partially offset by decreased spending for personnel-related costs and
Total general and administrative (G&A) expenses for the fourth quarter of 2012
were $3.1 million, compared with $2.9 million for the same period in 2011.
The $0.2 million increase in G&A expenses in the fourth quarter of 2012,
compared with the same period in 2011, was primarily due to increased spending
for outside services and legal expenses, partially offset by decreased
spending for personnel-related costs and facility expenses.
Revenues for the twelve months ended December 31, 2012 were $7.6 million,
compared to $4.0 million for the same period in 2011. Revenues for the twelve
months of 2012 included $4.2 million from our collaboration with Amgen, $1.5
million from our collaboration with Global Blood Therapeutics, Inc., $1.3
million of grant revenue from the NINDS, and $0.6 million from our
collaboration with MyoKardia, Inc. Revenues for the twelve months of 2011
included $2.0 million from our collaboration with Amgen, $1.7 million from our
NINDS grant, and $0.3 million from our collaboration with Global Blood
Total R&D expenses for the twelve months ended December 31, 2012 were $35.0
million, compared to $37.2 million for the same period in 2011. The $2.2
million decrease in R&D expenses in the twelve months of 2012, over the same
period in 2011, was primarily due to decreased spending for laboratory
expenses, and personnel-related costs, partially offset by increased
outsourced preclinical and clinical expenses, and facility expenses.
Total G&A expenses for the twelve months ended December 31, 2012 were $11.7
million, compared to $13.6 million for the same period in 2011. The $1.9
million decrease in G&A spending in the twelve months of 2012 compared to the
same period in 2011, was primarily due to decreased spending for
personnel-related costs, outside services, and facility expenses.
The net loss allocable to common stockholders for the twelve months ended
December 31, 2012, was $40.3 million, or $0.37 per basic and diluted share,
which includes a one-time, non-cash dividend of $1.3 million related to the
beneficial conversion feature of the Series B Convertible Preferred Stock.
This compares to a net loss allocable to common stockholders of $50.7
million, or $0.72 per basic and diluted share, for the same period in 2011,
which included a one-time, non-cash dividend of $2.9 million related to the
beneficial conversion feature of the Series A Convertible Preferred Stock.
Financial Guidance for 2013
Cytokinetics also announced its financial guidance for 2013. The company
anticipates revenue will be in the range of $1 to $3 million, cash R&D
expenses will be in the range of $40 to $44 million, and cash G&A expenses
will be in the range of $12 to $13 million. This financial guidance is on a
cash basis and does not include an estimated $4.8 million in non-cash related
operating expenses primarily related to stock compensation expense. In
addition, this guidance does not reflect potential revenue from any new
Annual Stockholders' Meeting
Cytokinetics' Annual Stockholders' Meeting will be held at the Embassy Suites
Hotel located at 250 Gateway Boulevard in South San Francisco, CA at 1:30 PM
on Wednesday, May 22, 2013.
Skeletal Muscle Contractility
*By mid-year 2013, Cytokinetics anticipates completion of enrollment in
*By the end of 2013, Cytokinetics expects to report data from BENEFIT-ALS.
*In the first half of 2013, Cytokinetics anticipates initiating a Phase I
clinical trial evaluating CK-2127107 in healthy volunteers.
Cardiac Muscle Contractility
*In the first quarter of 2013, Cytokinetics anticipates the opening to
enrollment of COSMIC-HF.
*In the first half of 2013, Cytokinetics anticipates the completion of
enrollment in ATOMIC-AHF.
*In mid-year 2013, Cytokinetics expects to report results from ATOMIC-AHF.
Conference Call and Webcast Information
Members of Cytokinetics' senior management team will review the company's
fourth quarter results via a webcast and conference call today at 4:30 PM
Eastern Time. The webcast can be accessed through the 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 92558691.
An archived replay of the webcast will be available via Cytokinetics' website
until February 12, 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 92558691from February 5, 2013 at
5:30 PM Eastern Time until February 12, 2013.
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 (excluding Japan) to develop and commercialize omecamtiv
mecarbil and related compounds, subject to Cytokinetics' specified development
and commercialization participation rights. Cytokinetics is independently
developing tirasemtiv, a skeletal muscle activator, as a potential treatment
for diseases and conditions associated with aging, muscle wasting or
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 in which treatment with tirasemtiv produced
potentially clinically relevant pharmacodynamic effects in Phase II trials.
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' financial guidance, including expected
revenue and R&D and G&A expenses for 2013;statements relating to Cytokinetics'
and Amgen's research and development activities, including the initiation,
enrollment, conduct, design, endpoints, size, scope, progress and results of
clinical trials of tirasemtiv, omecamtiv mecarbil and CK-2127107; the
significance and utility of clinical trial results and the anticipated timing
for the availability of clinical trial results; and the properties and
potential benefits of Cytokinetics' drug candidates and potential 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, and the U.S. Food and Drug Administration (FDA) or foreign
regulatory agencies may delay or limit Cytokinetics' or its partners' ability
to conduct clinical trials; Amgen's decisions with respect to the design,
initiation, conduct, timing and continuation of development activities for
omecamtiv mecarbil; Cytokinetics may be unable to obtain or maintain patent or
trade secret protection for its intellectual property; Cytokinetics may incur
unanticipated research and development and other costs; 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; regulatory authorities may not grant tirasemtiv orphan drug
exclusivity in ALS even if it is approved for marketing; 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
Jodi L. Goldstein
Manager, Corporate Communications & Marketing
Condensed Statements of Operations
(in thousands, except share and per share data)
Three Months Ended Twelve Months Ended
December 31, 31, December 31, 31,
2012 2011 2012 2011
Research and $ 2,184 $ 757 $ 7,559 $ 4,000
Total revenues 2,184 757 7,559 4,000
development 9,214 8,599 35,000 37,182
administrative 3,103 2,863 11,717 13,590
Restructuring - 1,192 (56) 1,192
expenses 12,317 12,654 46,661 51,964
Operating loss (10,133) (11,897) (39,102) (47,964)
other, net 33 20 87 104
Net loss (10,100) (11,877) (39,015) (47,860)
preferred stock - - (1,307) (2,857)
stockholders $ (10,100) $ (11,877) $ (40,322) $ (50,717)
Net loss per
basic and diluted $ (0.07) $ (0.16) $ (0.37) $ (0.72)
shares used in
loss per share
basic and diluted 142,442,508 72,775,298 108,641,962 70,799,637
Condensed Balance Sheets
December 31, December 31,
Cash and cash equivalents $ 14,907 $ 18,833
Short-term investments 59,093 30,190
Related party receivables 4 14
Other current assets 2,423 2,103
Total current assets 76,427 51,140
Property and equipment, net 997 1,310
Restricted cash - 196
Other assets 127 127
Total assets $ 77,551 $ 52,773
Liabilities and stockholders' equity
Current liabilities $ 5,750 $ 4,592
Long-term liabilities 361 3
Stockholders' equity 71,440 48,178
Total liabilities and stockholders' equity $ 77,551 $ 52,773
This announcement is distributed by Thomson Reuters on behalf of Thomson
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
information contained therein.
Source: Cytokinetics, Inc. via Thomson Reuters ONE
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