Company is Readying to
Initiate a Phase III Clinical Trial of Tirasemtiv in Patients With
ALS following Recent Meetings With FDA and EMA
Completion of Patient
Enrollment in COSMIC-HF Enable Results Expected Later This
Year
Cytokinetics, Incorporated (Nasdaq:CYTK) reported total research
and development revenues for the first quarter of 2015 were $4.4
million, compared to $8.0 million during the same period in 2014.
The net loss for the first quarter was $8.9 million, or $0.23 per
basic and diluted share. This is compared to a net loss for the
same period in 2014, of $8.7 million, or $0.27 per basic share and
diluted share. As of March 31, 2015, cash, cash equivalents and
investments totaled $117.5 million.
"During the first quarter, Cytokinetics convened meetings with
each of FDA and EMA to review results from BENEFIT-ALS and to
discuss plans to advance tirasemtiv to the next stage of clinical
development. Based on feedback from those meetings, Cytokinetics is
preparing to initiate a large, international Phase III clinical
trial of tirasemtiv in patients with ALS." stated Robert I. Blum,
Cytokinetics' President and Chief Executive Officer. "In addition,
we are pleased that COSMIC-HF recently completed patient
enrollment. We are readying for the availability of results from
this clinical trial which are expected later this year and are
preparing for the potential progression of omecamtiv mecarbil to
Phase III in collaboration with Amgen."
Company Highlights
Skeletal Muscle Contractility
tirasemtiv
- During the quarter, Cytokinetics convened meetings with
regulatory authorities in both the United States and Europe to
discuss the results of BENEFIT-ALS and plans to advance tirasemtiv
to Phase III. While regulatory interactions are on-going, the
company believes that the current feedback from the FDA and EMA
inform the advancement of tirasemtiv to a Phase III program.
- During the quarter, Cytokinetics conducted readiness activities
to support the initiation of a Phase III clinical trial of
tirasemtiv in patients with amyotrophic lateral sclerosis
(ALS). Objectives of the Phase III program are to confirm and
extend results observed in BENEFIT-ALS and will include assessments
of measures of respiratory function after longer duration treatment
with tirasemtiv in patients with ALS, including effects on slow
vital capacity (SVC).
- During the quarter, a manuscript titled "A Double-Blinded,
Randomized, Placebo-Controlled Trial to Evaluate Efficacy, Safety,
and Tolerability of Single Doses of Tirasemtiv in Patients with
Acetylcholine Receptor-Binding Antibody-Positive Myasthenia Gravis"
was published in the journal Neurotherapeutics. This
publication summarized results from a Phase IIa clinical trial
which evaluated two doses of tirasemtiv in patients with
generalized myasthenia gravis (MG). The authors concluded that
tirasemtiv may improve muscle function in patients with MG and that
the results support further development of tirasemtiv in
neuromuscular diseases.
CK-2127107
- During the quarter, Cytokinetics and Astellas Pharma Inc.
engaged neuromuscular experts to inform the planning of a Phase II
clinical trial of CK-2127107 in patients with spinal muscular
atrophy (SMA) which is expected to be conducted by Cytokinetics in
accordance with an agreed plan with Astellas. Cytokinetics and
Astellas also engaged in additional preclinical activities,
including manufacturing and formulation development for
CK-2127107.
Cardiac Muscle Contractility
omecamtiv mecarbil
- During the quarter, patient enrollment completed in
COSMIC-HF
(Chronic Oral Study
of Myosin Activation
to Increase Contractility
in Heart Failure).
COSMIC-HF is a Phase II, double-blind, randomized,
placebo-controlled, multicenter clinical trial designed to assess
the pharmacokinetics and tolerability
of omecamtiv mecarbil dosed orally in patients with
heart failure and left ventricular systolic dysfunction as well as
its effects on echocardiographic measures of cardiac function.
Over 275 patients have completed the
20-week duration of dosing in the expansion phase of COSMIC-HF.
This trial is being conducted by Amgen in collaboration with
Cytokinetics.
- During the quarter, Cytokinetics collaborated with Amgen on
activities directed to the potential advancement of omecamtiv
mecarbil to a Phase III program.
Pre-Clinical Research
- During the quarter, Cytokinetics and Amgen agreed to extend the
joint research program directed to next-generation cardiac
sarcomere activator compounds. Terms of the amendment to the
companies' collaboration agreement provide for Amgen's continued
support of Cytokinetics scientists through 2015 and potential
additional milestone payments from Amgen to Cytokinetics for
compounds that may arise out of the collaborative research.
- During the quarter, a manuscript titled "The Small Molecule
Fast Skeletal Troponin Activator, CK-2127107, Improves Exercise
Tolerance in a Rat Model of Heart Failure" was published in The
Journal of Pharmacology and Experimental Therapeutics. In this
preclinical study, CK-2127107 was associated with increased
exercise performance in this heart failure model. The authors
concluded that CK-2127107 substantially increased exercise
performance in this model, suggesting that modulation of skeletal
muscle function by a fast skeletal troponin activator may be a
useful therapeutic approach in heart failure associated exercise
intolerance.
Corporate
- During the quarter, Cytokinetics supported the global efforts
of patient and disease advocacy groups to raise awareness of rare
diseases, like ALS and SMA, through participation in Rare Disease
Day on February 28,
2015.
Financials
Revenues for the first quarter of 2015 were $4.4 million,
compared to $8.0 million during the same period in
2014. Revenues for the first quarter of 2015 included $1.6
million of license revenues and $2.1 million of research and
development revenues from our collaboration with Astellas, and $0.7
million in research and development revenues from our collaboration
with Amgen. Revenues for the same period in 2014 were comprised of
$2.1 million of license revenues and $5.2 million of research and
development revenues from our collaboration with Astellas, which
included a $2.0 million milestone payment related to research
activities; and $0.7 million of research and development revenues
from our collaboration with Amgen.
Total research and development (R&D) expenses for the first
quarter of 2015 were $9.0 million, compared with $12.5 million for
the same period in 2014. The $3.5 million decrease in R&D
expenses for the first quarter of 2015, compared with the same
period in 2014, was primarily due to a decrease of $3.9 million in
outsourced clinical and preclinical costs partially offset by an
increase of $0.2 million in personnel related expenses.
Total general and administrative (G&A) expenses for the
first quarter of 2015 were $4.4 million, compared with $4.3 million
for the same period in 2014.
R&D Day Meeting
Cytokinetics is hosting a R&D Day on Tuesday, May 12, 2015.
The meeting is scheduled to occur from 8:00 AM – 11:00 AM Eastern
Time at the New York Grand Hyatt Hotel in New York, New York and
will be simultaneously webcast. Representatives of
Cytokinetics' senior management team will be joined by expert
clinicians to provide updates regarding the company's discovery and
development programs including recent progress, milestones and
other commentary.
Annual Stockholders' Meeting
Cytokinetics' Annual Stockholders' Meeting will be held on
Wednesday, May 20, 2015. The meeting is scheduled to occur at
10:30 AM Pacific Time at the Embassy Suites Hotel in South San
Francisco, CA and will be simultaneously webcast.
Company Milestones
Skeletal Muscle
Contractility
tirasemtiv
- Cytokinetics expects to initiate a Phase III clinical
development program for tirasemtiv in patients with ALS in the
second quarter of 2015.
CK-2127107
- Cytokinetics expects to initiate a Phase II trial of CK-2127107
in patients with SMA in the second half of 2015.
Cardiac Muscle Contractility
omecamtiv mecarbil
- Cytokinetics expects results from COSMIC-HF to be available in
the second half of 2015.
- Cytokinetics expects to continue joint development activities
in collaboration with Amgen directed to the potential advancement
of omecamtiv mecarbil to Phase III clinical development.
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 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 34463154.
An archived replay of the webcast will be available via
Cytokinetics' website until May 7, 2015. 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 34463154 from April 30, 2015 at 5:30 PM Eastern Time
until May 7, 2015.
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
is developing tirasemtiv, a fast skeletal muscle activator, as a
potential treatment for amyotrophic lateral sclerosis (ALS).
Tirasemtiv 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 ALS. Cytokinetics is collaborating with
Amgen Inc. to develop omecamtiv mecarbil, a cardiac muscle
activator, for the potential treatment of heart failure.
Cytokinetics is collaborating with Astellas Pharma Inc. to develop
CK-2127107, a fast skeletal muscle activator, for the potential
treatment of spinal muscular atrophy. Amgen holds an exclusive
license worldwide to develop and commercialize omecamtiv mecarbil
and Astellas holds an exclusive license worldwide to develop and
commercialize CK-2127107. Both licenses are subject to
Cytokinetics' specified development and commercialization
participation rights. 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 http://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' and its partners' research and
development activities, including expected revenue and R&D and
G&A expenses, the initiation, conduct, design, enrollment,
progress, continuation, completion and results of clinical trials,
the significance and utility of preclinical study and clinical
trial results, the expected availability of clinical trial results,
planned interactions with regulatory authorities and the outcomes
of such interactions, the potential conduct of a Phase III trial of
tirasemtiv and the timing for initiation of such a trial; the
potential progression of CK-2127107 to Phase II development,
the potential progression of omecamtiv mecarbil to Phase III
development; potential milestone payments; the expected timing of
events; 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
further clinical development of tirasemtiv in ALS patients which
will require significant additional funding, and Cytokinetics may
be unable to obtain such additional funding on acceptable terms, if
at all; the FDA and/or other regulatory authorities may not accept
effects on slow vital capacity as a clinical endpoint to support
registration of tirasemtiv for the treatment of ALS; additional
Phase I clinical trials for CK-2127107 may be required; 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.
|
|
|
Cytokinetics,
Incorporated Condensed Consolidated Statements of
Operations (in thousands, except per share
data) (unaudited) |
|
Three Months
Ended |
|
March 31, |
March 31, |
|
2015 |
2014 |
|
|
|
Revenues: |
|
|
Research and development
revenues from related parties |
$ 2,791 |
$ 665 |
Research and development, grant
and other revenues |
— |
5,232 |
License revenues from related
parties |
1,623 |
— |
License revenues |
— |
2,082 |
|
|
|
Total revenues |
4,414 |
7,979 |
|
|
|
Operating Expenses: |
|
|
Research and development |
8,956 |
12,490 |
General and administrative |
4,367 |
4,259 |
|
|
|
Total operating expenses |
13,323 |
16,749 |
|
|
|
Operating loss |
(8,909) |
(8,770) |
|
|
|
Interest and other, net |
37 |
26 |
|
|
|
Net loss |
$ (8,872) |
$ (8,744) |
|
|
|
|
|
|
Net loss per share – basic and diluted |
$ (0.23) |
$ (0.27) |
|
|
|
|
|
|
Weighted average shares used in computing net
loss per share - basic and diluted |
38,675 |
32,985 |
|
|
|
Cytokinetics,
Incorporated Condensed Consolidated Balance
Sheets (in thousands) |
|
March 31, |
December 31, |
|
2015 |
2014(1) |
|
(unaudited) |
|
Assets |
|
|
|
|
|
Cash and cash equivalents |
$ 22,546 |
$ 20,215 |
|
|
|
Short-term investments |
85,322 |
63,013 |
|
|
|
Related party accounts receivable |
970 |
46,646 |
|
|
|
Prepaid and other current assets |
1,972 |
1,257 |
|
|
|
Total current assets |
110,810 |
131,131 |
|
|
|
Property and equipment, net |
1,551 |
1,637 |
|
|
|
Long-term investments |
9,653 |
— |
|
|
|
Other assets |
200 |
200 |
|
|
|
Total assets |
$ 122,214 |
$ 132,968 |
|
|
|
|
|
|
Liabilities and stockholders'
equity |
|
|
|
|
|
Deferred revenue, current |
$ 19,942 |
$ 17,042 |
|
|
|
Other current liabilities |
5,443 |
6,813 |
|
|
|
Total current liabilities |
25,385 |
23,855 |
|
|
|
Deferred revenue, non-current |
12,211 |
16,558 |
|
|
|
Other non-current liabilities |
466 |
491 |
|
|
|
Stockholders' equity |
84,152 |
92,064 |
|
|
|
Total liabilities and stockholders'
equity |
$ 122,214 |
$ 132,968 |
|
(1) Derived from
the audited financial statements, included in the Company's Annual
Report on Form 10-K for the year ended December 31, 2014.
|
CONTACT: Joanna L. Goldstein
Manager, Investor Relations & Corporate Communications
(650) 624-3000
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