2013-02-05 22:01:21 -
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 million.
"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."
Company Highlights
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 at www.clinicaltrials.gov.
* 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.
CK-2127107
* 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
omecamtiv mecarbil
* 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.
Pre-Clinical Research
* During the quarter, Cytokinetics continued to conduct research in its muscle
biology-related research programs.
Corporate
* 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.
Financials
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 laboratory expenses.
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 Therapeutics, Inc.
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 collaborations.
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.
Company Milestones
Skeletal Muscle Contractility
tirasemtiv
* By mid-year 2013, Cytokinetics anticipates completion of enrollment in
BENEFIT-ALS.
* By the end of 2013, Cytokinetics expects to report data from BENEFIT-ALS.
CK-2127107
* In the first half of 2013, Cytokinetics anticipates initiating a Phase I
clinical trial evaluating CK-2127107 in healthy volunteers.
Cardiac Muscle Contractility
omecamtiv mecarbil
* 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.
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 (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 Exchange Commission.
Contact:
Jodi L. Goldstein
Manager, Corporate Communications & Marketing
(650) 624-3000
Cytokinetics, Incorporated
Condensed Statements of Operations
(in thousands, except share and per share data)
(unaudited)
Three Months Ended Twelve Months Ended
December December
December 31, 31, December 31, 31,
2012 2011 2012 2011
---------------- --------------- ---------------- -------------
Revenues:
Research and $ 2,184 $ 757 $ 7,559 $ 4,000
development
---------------- --------------- ---------------- -------------
Total revenues 2,184 757 7,559 4,000
---------------- --------------- ---------------- -------------
Operating
Expenses:
Research and
development 9,214 8,599 35,000 37,182
General and
administrative 3,103 2,863 11,717 13,590
Restructuring - 1,192 (56) 1,192
---------------- --------------- ---------------- -------------
Total operating
expenses 12,317 12,654 46,661 51,964
---------------- --------------- ---------------- -------------
Operating loss (10,133) (11,897) (39,102) (47,964)
Interest and
other, net 33 20 87 104
---------------- --------------- ---------------- -------------
Net loss (10,100) (11,877) (39,015) (47,860)
Deemed dividend
related to
beneficial
conversion
feature of
convertible
preferred stock - - (1,307) (2,857)
-------------------------------- ------------------------------
Net loss
allocable to
common
stockholders $ (10,100) $ (11,877) $ (40,322) $ (50,717)
---------------- --------------- ---------------- -------------
Net loss per
share allocable
to common
stockholders -
basic and
diluted $ (0.07) $ (0.16) $ (0.37) $ (0.72)
Weighted
average shares
used in
computing net
loss per share
allocable to
common
stockholders -
basic and
diluted 142,442,508 72,775,298 108,641,962 70,799,637
Cytokinetics, Incorporated
Condensed Balance Sheets
(in thousands)
(unaudited)
December 31, December 31,
2012 2011
---------------- ---------------
Assets
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
---------------- ---------------
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originality of the information contained therein.
Source: Cytokinetics, Inc. via Thomson Reuters ONE
[HUG#1675776]
