Cytokinetics, Incorporated (NASDAQ: CYTK) reported total research
and development revenues of $1.8 million for the second quarter of
2012. The net loss allocable to common stockholders for the second
quarter was $10.3 million, or $0.13 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 is compared with a net loss
allocable to common stockholders of $16.5 million, or $0.23 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. As of June 30, 2012, cash, cash equivalents and
investments totaled $90.5 million.
"In the second quarter, we announced the results from two Phase
II clinical trials of tirasemtiv, formerly known as CK-2017357, in
ALS patients. We believe these data inform its progression into a
Phase IIb clinical trial that may support potential registration,"
stated Robert I. Blum, Cytokinetics' President and Chief Executive
Officer. "We also announced that the ATOMIC-AHF clinical trial
evaluating the intravenous form of omecamtiv mecarbil in
hospitalized patients with heart failure has progressed to its
second cohort. This trial continues to enroll patients
internationally under our collaboration with Amgen and alongside
the progress the companies are making in connection with the
clinical development of oral formulations of our novel cardiac
myosin activator."
Company Highlights
Skeletal Muscle Contractility
tirasemtiv (formerly CK-2017357)
- Cytokinetics has received notification from the United States
Adopted Names (USAN) Council and the World Health Organization's
International Nonproprietary Names for Pharmaceutical Substances
(INN) Programme indicating the adoption of tirasemtiv as the
generic name for CK-2017357.
- In April, Cytokinetics presented data from both Parts A and B
of CY 4024, a Phase II, two-part, randomized, double-blind,
placebo-controlled, multiple-dose, safety, tolerability,
pharmacokinetic and pharmacodynamic clinical trial of tirasemtiv in
patients with amyotrophic lateral sclerosis (ALS). Patients in Part
A of this trial were not taking riluzole; patients in Part B
received riluzole at the reduced dose of 50 mg daily. In this
trial, tirasemtiv appeared to be generally safe and well-tolerated
when dosed daily at 125 mg, 250 mg, and 375 mg for two weeks.
Encouraging dose-related trends were observed in ALSFRS-R (a
clinically validated instrument designed to measure disease
progression and changes in functional status) and MVV (a clinical
assessment of pulmonary function and endurance). As expected,
plasma concentrations of tirasemtiv were unaffected by
co-administration with riluzole, while riluzole levels increased
during co-administration with tirasemtiv. Adverse events and
clinical assessments during treatment with tirasemtiv 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.
- In April, Cytokinetics announced data from CY 4025, a Phase II,
randomized, double-blind, placebo-controlled, multiple-dose
titration clinical trial of tirasemtiv in patients with ALS
receiving riluzole at the reduced dose of 50 mg daily. In this
trial, the twice-daily dose-titration regimen of tirasemtiv
appeared to be generally safe and well-tolerated. The dose
escalation regimen we studied in CY 4025 enabled a majority of
patients to achieve titration to 250 mg twice daily, a higher total
daily dose of tirasemtiv than in prior studies of tirasemtiv in ALS
patients with comparable tolerability. In this trial, tirasemtiv
treatment was associated with increases in the ALSFRS-R that were
similar in direction and in MVV that were similar in both direction
and magnitude to those observed in CY 4024.
- During the quarter, Cytokinetics submitted a clinical trial
protocol to the U.S. Food and Drug Administration (FDA) for a Phase
IIb trial designed to evaluate the longer-term safety, tolerability
and efficacy of tirasemtiv in patients with ALS. The trial, called
CY 4026, is intended to be an international, randomized,
double-blind, placebo-controlled, dose-titration clinical trial of
tirasemtiv dosed twice-daily in patients with ALS receiving
riluzole at the reduced dose of 50 mg daily. The trial is designed
to enroll approximately 400 patients who are expected to receive
tirasemtiv or placebo for three months. The proposed primary
endpoint is ALSFRS-R. The proposed secondary endpoints will include
MVV. In April, Cytokinetics announced that tirasemtiv was granted
Fast Track designation by FDA for the potential treatment of
ALS.
- During the quarter, Cytokinetics met with the European
Medicines' Agency (EMA) Scientific Advice Working Party (SAWP) to
seek advice and protocol assistance in connection with its interest
to further expand the clinical development program for tirasemtiv
to include countries in Europe.
- In June, Cytokinetics announced the publication of the Phase II
Evidence of Effect Study of tirasemtiv in the online edition of the
journal Amyotrophic Lateral Sclerosis.
- Cytokinetics continues to enroll and dose patients in its Phase
IIa Evidence of Effect clinical trial of tirasemtiv, 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
- In May, Cytokinetics announced the opening to enrollment of the
second 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), which is designed to evaluate the safety,
tolerability, and efficacy of successive ascending-dose cohorts of
omecamtiv mecarbil in patients with left ventricular systolic
dysfunction who are hospitalized with acute heart failure.
Following a review of the data from the first cohort in this
ongoing Phase IIb clinical trial, the independent data monitoring
committee concluded that the data supported progression to the
second cohort of this trial. ATOMIC-AHF is sponsored by Amgen in
collaboration with Cytokinetics. Additional information about the
trial can be found at www.clinicaltrials.gov.
- Recently, Cytokinetics and Amgen reviewed data from the
completed randomized, open-label, 4-period cross-over, Phase I
clinical trial designed to assess the safety, tolerability and
pharmacokinetics of multiple oral formulations of omecamtiv
mecarbil in healthy volunteers. The companies have selected oral
formulations that warrant further evaluation in patients with heart
failure.
Other Non-Clinical Development and Pre-Clinical Research
- 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 tirasemtiv.
- Cytokinetics continues to conduct research in its smooth muscle
myosin inhibitor program.
Corporate
- In June, Cytokinetics announced two separate concurrent,
underwritten offerings of shares of its common stock and
accompanying warrants and shares of its Series B Convertible
Preferred Stock ("Series B") and accompanying warrants. In
aggregate for the concurrent offerings, the company issued 55.9
million shares of common stock, 23,026 shares of Series B
Convertible Preferred Stock and warrants to purchase 47.4 million
shares of its common stock at an exercise price of $0.88 per share.
Cytokinetics received gross proceeds of $60.0 million from these
offerings before deducting the issuance costs.
Financials
Revenues for the second quarter of 2012 were $1.8 million,
compared to $1.1 million during the same period in 2011. Revenues
for the second quarter of 2012 included $1.1 million of revenue
from our collaboration agreement with Amgen, $0.4 million from our
collaboration agreement with Global Blood Therapeutics, Inc., and
$0.3 million of grant revenue from the NINDS. Revenues for the
second quarter of 2011 included $0.7 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 second
quarter of 2012 were $8.2 million, compared with $10.5 million for
the same period in 2011. The $2.3 million decrease in R&D
expenses for the second quarter of 2012, compared with the same
period in 2011, was primarily due to decreases in outsourced
clinical expenses, laboratory expense, personnel-related costs, and
facility costs.
Total general and administrative (G&A) expenses for the
second quarter of 2012 were $2.6 million, compared with $4.2
million for the same period in 2011. The $1.6 million decrease in
G&A expenses in the second quarter of 2012, compared with the
same period in 2011, was primarily due to decreased financial
services, legal, personnel-related and facility costs.
Revenues for the six months ended June 30, 2012 were $3.7
million, compared to $1.8 million for the same period in 2011.
Revenues for the first six months of 2012 included $2.3 million of
reimbursements in program expenses under the Amgen collaboration,
$0.8 million from our collaboration agreement with Global Blood
Therapeutics, Inc., and $0.6 million of grant revenue from the
NINDS. Revenues for the first six months of 2011 of $1.0 million
were derived from our collaboration with Amgen and $0.8 million
from our NINDS grant.
Total R&D expenses for the six months ended June 30, 2012
were $17.0 million, compared to $19.7 million for the same period
in 2011. The $2.7 million decrease in R&D expenses in the first
six months of 2012, over the same period in 2011, was primarily due
to decreased spending for laboratory expenses, personnel-related
costs, outsourced clinical expenses, and facility costs, partially
offset by increased outsourced pre-clinical costs.
Total G&A expenses for the six months ended June 30, 2012
were $5.6 million, compared to $7.5 million for the same period in
2011. The $1.9 million decrease in G&A spending in the first
six months of 2012 compared to the same period in 2011, was
primarily due to lower financial services, legal, personnel-related
and facility costs.
The net loss allocable to common stockholders for the six months
ended June 30, 2012, was $20.2 million, or $0.26 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, compared to a net loss allocable to
common stockholders of $28.2 million, or $0.41 per basic and
diluted share, for the same period in 2011, which includes a
one-time, non-cash dividend of $2.9 million related to the
beneficial conversion feature of the Series A Convertible Preferred
Stock.
Updated Financial Guidance for 2012
Cytokinetics also announced its updated financial guidance for
2012 which incorporates the estimated costs associated with CY
4026. The company anticipates revenue will be in the range of $5.0
to $7.0 million, cash R&D expenses will be in the range of
$40.0 to $44.0 million, and cash G&A expenses will be in the
range of $10.0 to $12.0 million. This financial guidance is on a
cash basis and does not include an estimated $4.0 million in
non-cash related operating expenses primarily related to stock
compensation expense. In addition, this guidance does not reflect
potential revenue from potential collaborations with other
partners.
Company Milestones
Skeletal Muscle Contractility
tirasemtiv (formerly known as 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 tirasemtiv in patients with generalized
myasthenia gravis (CY 4023).
- In the fourth quarter of 2012, Cytokinetics plans to initiate
CY 4026, a Phase IIb, multi-national, double-blind, randomized,
placebo-controlled trial designed to evaluate the safety,
tolerability and efficacy of tirasemtiv in patients with ALS.
- In 2012, Cytokinetics anticipates additional interactions with
regulatory authorities to discuss the development of tirasemtiv 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 fourth quarter of 2012, Cytokinetics anticipates a
decision regarding the potential progression to the third cohort of
the ATOMIC-AHF clinical trial, following a review of data from the
second cohort by an independent data monitoring committee.
- In the second half of 2012, Cytokinetics expects to collaborate
with Amgen in the finalization of a protocol for a Phase II
clinical trial of oral formulations of omecamtiv mecarbil in
patients with heart failure. In addition, the companies anticipate
making other preparations for the potential initiation of this
Phase II clinical trial.
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 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 21517396.
An archived replay of the webcast will be available via
Cytokinetics' website until August 7, 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 21517396 from July 31, 2012 at 5:30 PM Eastern Time until
August 7, 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 tirasemtiv (formerly
CK-2017357), 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 tirasemtiv demonstrated
potentially clinically relevant pharmacodynamic effects in Phase II
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' financial guidance, including expected
R&D and G&A expenses for 2012; Cytokinetics' and its
partners' research and development activities, including the
initiation, enrollment, conduct, design, endpoints, 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, the ability of CY 4026 to support potential registration,
and anticipated interactions with regulatory authorities; 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 Six Months Ended
June 30, June 30, June 30, June 30,
2012 2011 2012 2011
----------- ----------- ----------- -----------
Revenues:
Research and
development $ 1,841 $ 1,053 $ 3,661 $ 1,817
----------- ----------- ----------- -----------
Total revenues 1,841 1,053 3,661 1,817
----------- ----------- ----------- -----------
Operating Expenses:
Research and
development 8,242 10,513 16,987 19,692
General and
administrative 2,568 4,187 5,624 7,524
Restructuring (13) - (54) -
----------- ----------- ----------- -----------
Total operating
expenses 10,797 14,700 22,557 27,216
----------- ----------- ----------- -----------
Operating loss (8,956) (13,647) (18,896) (25,399)
Interest and other, net 13 15 26 55
----------- ----------- ----------- -----------
Net loss (8,943) (13,632) (18,870) (25,344)
Deemed dividend related
to beneficial
conversion feature of
convertible preferred
stock (1,307) (2,857) (1,307) (2,857)
----------- ----------- ----------- -----------
Net loss allocable to
common stockholders $ (10,250) $ (16,489) $ (20,177) $ (28,201)
=========== =========== =========== ===========
Net loss per share
allocable to common
stockholders - basic
and diluted $ (0.13) $ (0.23) $ (0.26) $ (0.41)
Weighted average shares
used in computing net
loss per share
allocable to common
stockholders - basic
and diluted 81,230,292 71,151,486 78,655,935 69,043,119
Cytokinetics, Incorporated
Condensed Balance Sheets
(in thousands)
(unaudited)
June 30, December 31,
2012 2011
------------- -------------
Assets
Cash and cash equivalents $ 63,654 $ 18,833
Short term investments 26,821 30,190
Related party receivables 3 14
Other current assets 2,482 2,103
------------- -------------
Total current assets 92,960 51,140
Property and equipment, net 994 1,310
Restricted cash - 196
Other assets 127 127
------------- -------------
Total assets $ 94,081 $ 52,773
============= =============
Liabilities and stockholders' equity
Current liabilities $ 3,989 $ 4,592
Long-term liabilities 111 3
Stockholders' equity 89,981 48,178
------------- -------------
Total liabilities and stockholders' equity $ 94,081 $ 52,773
============= =============
Cytokinetics, Incorporated: Jodi L. Goldstein Manager, Corporate
Communications & Marketing (650) 624-3000
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