Company Reviews Recent Advancements in Its Skeletal and Cardiac Muscle Contractility Programs
SOUTH SAN FRANCISCO, CA, Apr 26, 2012 (MARKETWIRE via COMTEX) --Cytokinetics, Incorporated (NASDAQ: CYTK) reported total research
and development revenues of $1.8 million for the first quarter of
2012. The net loss for the first quarter was $9.9 million, or $0.13
per basic and diluted share. This compared to a net loss of $11.7
million, or $0.18 per basic and diluted share, for the same period in
2011. As of March 31, 2012, cash, cash equivalents and investments,
excluding restricted cash, totaled $43.1 million.
"I am pleased to update our recent progress relating to the first
quarter of 2012 by first highlighting yesterday's important
announcements at the American Academy of Neurology 64th Annual
Meeting in New Orleans regarding additional Phase II safety and
tolerability data for CK-2017357 in ALS patients," stated Robert I.
Blum, Cytokinetics' President and Chief Executive Officer. "We
believe that the results we announced can importantly inform our
plans to proceed to a potential registration program for CK-2017357
and we look forward to further interactions with regulatory
authorities to discuss those plans. In addition, we are pleased that
the Phase IIb clinical trial of omecamtiv mecarbil in patients
hospitalized with acute heart failure has recently achieved a key
enrollment milestone. We look forward to a decision from the data
monitoring committee that may enable dose-escalation and enrollment
into the second cohort of this trial."
Company Highlights
Skeletal Muscle Contractility
CK-2017357
-- At the American Academy of Neurology (AAN) 64th Annual meeting,
investigators presented data from the second cohort, or Part B, of CY
4024, a Phase II, two-part, randomized, double-blind,
placebo-controlled, multiple dose, safety, tolerability,
pharmacokinetic and pharmacodynamic clinical trial of CK-2017357 in
patients with ALS who received riluzole at the reduced dose of 50 mg
daily. In Part B, CK-2017357 appeared to be safe and well-tolerated
dosed daily for two weeks at 125 mg, 250 mg, or 375 mg. Adverse events
and clinical assessments during treatment with CK-2017357 appeared
similar, with or without co-administration of riluzole. Dizziness, the
most commonly reported adverse event, was mostly mild and generally
began and resolved early after initiating treatment. While the trial
was not designed or powered to evaluate statistically the effects of
CK-2017357 on the various outcome measures that were assessed during
the study, a combined analysis of patients from Part A (without
riluzole) and Part B (with riluzole) suggests encouraging trends that
appear dose-related and potentially clinically meaningful in
magnitude. Such trends were observed in the ALS Functional Rating
Scale in its revised form (ALSFRS-R) and in Maximum Voluntary
Ventilation (MVV). There were no statistically significant differences
in outcomes measures between patients in Part A and those in Part B.
-- Also at the AAN Annual meeting, investigators presented data from CY
4025, a Phase II, randomized, double-blind, placebo-controlled,
multiple dose clinical trial of CK-2017357 in patients with ALS
receiving riluzole at the reduced dose of 50 mg daily. The primary
objective of CY 4025 was to assess the safety and tolerability of
CK-2017357 when administered using a twice-daily dose titration
regimen to patients with ALS, and to determine if the total daily dose
of CK-2017357 could be increased from the 375 mg once daily dose that
had been evaluated in earlier trials of CK-2017357 in patients with
ALS to a target of 250 mg dosed twice daily. The authors concluded
that the twice-daily dose titration regimen evaluated in the trial was
generally safe and well-tolerated, that the majority of patients could
be titrated successfully to a CK-2017357 dose level of 250 mg twice
daily, and that encouraging trends toward functional improvements were
observed on CK-2017357 versus placebo. CY 4025 was not designed or
powered to evaluate statistically the effects of CK-2017357 on the
various outcome measures that were assessed during the study;
nevertheless, increases in ALSFRS-R and MVV were observed on
CK-2017357 relative to placebo that were similar in direction and
magnitude to those observed in CY 4024.
-- Last week, Cytokinetics announced that CK-2017357 has been granted
Fast Track designation by the U.S. Food and Drug Administration (FDA)
for the potential treatment of ALS.
-- In March, Cytokinetics announced that CK-2017357 was granted orphan
medicinal product designation by the European Medicines Agency (EMA)
for the potential treatment of ALS.
-- Cytokinetics continues to enroll and dose patients in its Phase IIa
Evidence of Effect clinical trial of CK-2017357, CY 4023, in patients
with generalized myasthenia gravis (MG). This clinical trial and
preclinical research on MG are funded by a grant from the National
Institute of Neurological Disorders and Stroke (NINDS). Additional
information about this trial can be found at www.clinicaltrials.gov.
Cardiac Muscle Contractility
Omecamtiv Mecarbil
-- Enrollment in the first cohort of the 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), was completed with over 200 patients enrolled.
This trial, sponsored by Amgen in collaboration with Cytokinetics, 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.
-- In February, Cytokinetics announced that Amgen initiated a randomized,
open-label, 4-way cross-over Phase I study designed to assess the
safety, tolerability and pharmacokinetics of multiple oral
formulations of omecamtiv mecarbil in healthy volunteers.
Other Non-Clinical Development and Pre-Clinical Research
-- During the quarter, Cytokinetics announced the publication of
preclinical research regarding the activation of the troponin complex
of fast skeletal muscle by CK-2017357, and the potential role that
this novel mechanism may play for improving muscle function in
patients with neuromuscular disorders, in the March 2012 issue of the
journal Nature Medicine.
-- In addition, at the AAN Annual Meeting, Cytokinetics presented results
from a preclinical study designed to examine the effects of CK-2017357
in SOD1 mutant transgenic mice, a model of ALS in humans. Company
scientists concluded that mice treated with CK-2017357 maintained
hindlimb grip strength during disease progression and that CK-2017357
increased muscle strength of a nerve-muscle pair in situ. There
appeared to be a delay in the time to a pre-specified humane endpoint
in the CK-2017357-treated mice compared to the age-matched control
SOD1 mice. The authors concluded that the preclinical findings
support the hypothesis that CK-2017357 may benefit patients with ALS
by increasing force generation in fast skeletal muscle fibers.
-- Yesterday, at the 2012 Experimental Biology Annual Conference,
Cytokinetics presented results from a preclinical study designed to
assess the effects of CK-2017357 in two models of running fatigue, one
of aerobic exercise and the other of anaerobic exercise. The authors
concluded that troponin activators, such as CK-2017357 are capable of
substantially improving performance in an endurance-type fatigue assay
and in an assay that tests motor coordination under moderately
fatiguing and increasingly difficult conditions. These data suggest a
role for CK-2017357 and other troponin activators in reducing
muscle-related fatigue that may have utility in disease conditions in
which muscle-related fatigue may lead to disability.
-- Cytokinetics continued investigational new drug application
(IND)-enabling studies of CK-2127107, a selective, fast skeletal
muscle troponin activator. CK-2127107 is a potential drug candidate
that was discovered during Cytokinetics' optimization of a different
chemical series than that which produced CK-2017357.
-- Cytokinetics continues to conduct research in its smooth muscle myosin
inhibitor program.
Corporate
-- During the quarter, the company announced changes to its Board of
Directors with the appointment of Sandford D. Smith and the
resignation of James A. Spudich, Ph.D.
Financials
Revenues for the first quarter of 2012 were $1.8 million, compared to
$0.8 million during the same period in 2011. Revenues for the first
quarter of 2012 included $1.2 million of revenue from our
collaboration agreement with Amgen, $0.3 million from our
collaboration agreement with Global Blood Therapeutics, Inc., and
$0.3 million of grant revenue from the NINDS. Revenues for the first
quarter of 2011 included $0.4 million of revenue under the Amgen
collaboration and $0.4 million in grant revenue from the NINDS.
Total research and development (R&D) expenses in the first quarter of
2012 were $8.7 million, compared to $9.2 million for the same period
in 2011. The $0.5 million decrease in R&D expenses for the first
quarter of 2012, compared to the same period in 2011, was primarily
due to decreases in laboratory expense and personnel-related costs,
partially offset by increases in preclinical and clinical outsourced
expenses and facility-related costs.
Total general and administrative (G&A) expenses for the first quarter
of 2012 were $3.1 million, compared to $3.3 million for the same
period in 2011. The $0.2 million decrease in G&A expenses in the
first quarter of 2012, compared to the same period in 2011, was
primarily due to decreased personnel-related costs and
facility-related costs, partially offset by an increase in legal
expenses.
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 10:00 AM on Tuesday, May 22, 2012.
Company Milestones
Skeletal Muscle Contractility
CK-2017357
-- In the second half of 2012, Cytokinetics anticipates that data will be
available from its ongoing Phase IIa Evidence of Effect clinical trial
of CK-2017357 in patients with generalized myasthenia gravis (CY
4023).
-- In 2012, Cytokinetics anticipates additional interactions with
regulatory authorities to discuss the development of CK-2017357 as a
potential treatment for patients with ALS, including potential
registration strategies.
CK-2127107
-- By the end of 2012, Cytokinetics anticipates filing an IND for
CK-2127107.
Cardiac Muscle Contractility
Omecamtiv Mecarbil
-- In the second quarter of 2012, Cytokinetics anticipates a decision
regarding the potential progression to the second cohort of the
ATOMIC-AHF clinical trial, following a review of data from the first
cohort by an independent data monitoring committee.
-- In the second half of 2012, Cytokinetics anticipates that safety,
tolerability, and pharmacokinetic data from the ongoing Phase I
clinical trial of oral formulations of omecamtiv mecarbil in healthy
volunteers will be evaluated in order to enable selection of one or
more of these oral formulations for potential use in future clinical
studies in stable heart failure patients.
Conference Call and Webcast Information
Members of Cytokinetics' senior management team will review the
company's first 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 21514127.
An archived replay of the webcast will be available via Cytokinetics'
website until May 3, 2012. 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 21514127
from April 26, 2012 at 5:30 PM Eastern Time until May 3, 2012.
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 CK-2017357, a skeletal muscle activator, as a potential
treatment for diseases and conditions associated with aging, muscle
wasting or neuromuscular dysfunction. CK-2017357 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 CK-2017357 demonstrated potentially clinically relevant
pharmacodynamic effects in Phase IIa trials. Cytokinetics is also
conducting research of compounds that inhibit smooth muscle
contractility and which may be useful as potential treatments for
diseases and conditions associated with excessive smooth muscle
contraction, such as bronchoconstriction associated with asthma and
chronic obstructive pulmonary disease (COPD). All of these drug
candidates and potential drug candidates have arisen from
Cytokinetics' 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' and its partners' research and development activities,
including the initiation, enrollment, conduct, design, size, scope,
progress and results of clinical trials of CK-2017357 and omecamtiv
mecarbil, the significance and utility of clinical trial results and
the anticipated timing for the availability of clinical trial
results, anticipated meetings with regulatory authorities, plans with
respect to a potential registration program for CK-2017357; 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, 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 (FDA) or foreign
regulatory agencies may delay or limit Cytokinetics' or its partners'
ability to conduct clinical trials, regulatory authorities may not
grant CK-2017357 orphan drug/medicinal product exclusivity in ALS
even if it is approved for marketing, and Cytokinetics may be unable
to obtain or maintain patent or trade secret protection for its
intellectual property; Amgen's decisions with respect to the design,
initiation, conduct, timing and continuation of development
activities for omecamtiv mecarbil; Cytokinetics will require
significant additional funding to conduct the registration program
for CK-2017357 for the potential treatment of ALS and may be unable
to obtain such additional funding on acceptable terms, if at all;
funding from the National Institute of Neurological Disorders and
Stroke may not be available in future periods; 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; 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.
Cytokinetics, Incorporated
Condensed Statements of Operations
(in thousands, except share and per share data)
(unaudited)
Three Months Ended
March 31, March 31,
2012 2011
------------- -------------
Revenues:
Research and development $ 1,820 $ 763
------------- -------------
Total revenues 1,820 763
Operating expenses:
Research and development 8,745 9,179
General and administrative 3,056 3,336
Restructuring (41) -
------------- -------------
Total operating expenses 11,760 12,515
------------- -------------
Operating loss (9,940) (11,752)
Interest and other, net 12 40
------------- -------------
Net loss $ (9,928) $ (11,712)
============= =============
Net loss per common share - basic and diluted $ (0.13) $ (0.18)
Weighted average shares used in computing net
loss per common share - basic and diluted 76,081,592 66,911,328
Cytokinetics, Incorporated
Condensed Balance Sheets
(in thousands)
(unaudited)
March 31, December 31,
2012 2011
------------- -------------
Assets
Cash and cash equivalents $ 17,815 $ 18,833
Short-term investments 25,265 30,190
Related party receivables 83 14
Other current assets 2,058 2,103
------------- -------------
Total current assets 45,221 51,140
Property and equipment, net 1,132 1,310
Restricted cash 51 196
Other assets 127 127
============= =============
Total assets $ 46,531 $ 52,773
============= =============
Liabilities and stockholders' equity
Current liabilities $ 4,467 $ 4,592
Long-term liabilities 57 3
Stockholders' equity 42,007 48,178
------------- -------------
Total liabilities and stockholders' equity $ 46,531 $ 52,773
============= =============
Cytokinetics, Incorporated:
Jodi L. Goldstein
Manager, Investor Relations, Corporate Communications & Marketing
(650) 624-3000
SOURCE: Cytokinetics, Inc.
