Omecamtiv Mecarbil Advancing to Phase 3
With Agreement from FDA on Key Elements of
Special Protocol Assessment
Cytokinetics, Inc. (Nasdaq:CYTK) reported total revenues for
the third quarter of 2016 were $59.0 million, compared to $7.9
million, during the same period in 2015. The net income for the
third quarter was $31.9 million, or $0.80 and $0.74 per basic and
diluted share, respectively. This is compared to the net loss for
the same period in 2015 of $(8.8) million, or $(0.23) per basic and
diluted share. As of September 30, 2016, cash, cash equivalents and
investments totaled $86.3 million and the Company received an
additional $65.0 million in October 2016, from the expanded
collaboration with Astellas Pharma, Inc. ("Astellas"), which was
effective in September 2016.
“We had a very productive quarter advancing our
growing portfolio of novel mechanism drug candidates,” said Robert
I. Blum, Cytokinetics’ President and Chief Executive Officer. “We
are especially pleased to be moving omecamtiv mecarbil into
GALACTIC-HF with agreement from FDA on key elements of a SPA and
look forward to finalizing the protocol in collaboration with
Amgen. We also made great progress completing enrollment in
VITALITY-ALS and initiating VIGOR-ALS, the open-label extension
trial for patients with ALS who have completed VITALITY-ALS.
Finally, it’s gratifying to have again expanded our collaboration
with Astellas and to align our interests for tirasemtiv and
CK-2127107 in ALS and other indications, while advancing another
next-generation fast skeletal muscle activator into pre-clinical
development. We believe the activities of the past quarter
demonstrate the power of our muscle biology platform and the
promise of innovations arising from our pioneering research and
development.”
Recent Highlights and Upcoming
Milestones
Cardiac Muscle Program
omecamtiv mecarbil
- Announced the advancement of omecamtiv mecarbil to a Phase 3
clinical trials program. The first Phase 3 trial, GALACTIC-HF
(Global Approach to
Lowering Adverse
Cardiac Outcomes Through
Improving Contractility in
Heart Failure), to be conducted
by Amgen in collaboration with Cytokinetics, is designed to
evaluate the effect of treatment with omecamtiv mecarbil compared
with placebo on the time to cardiovascular death or first heart
failure event, whichever comes first, in approximately 8,000
subjects with chronic heart failure with reduced ejection fraction
receiving standard of care therapy.
- Announced additional results from COSMIC-HF
(Chronic Oral
Study of Myosin Activation to
Increase Contractility in
Heart Failure), a Phase 2 trial
evaluating omecamtiv mecarbil in patients with chronic heart
failure, showing that omecamtiv mecarbil may improve symptoms
versus placebo in patients with moderate to severe heart failure
symptoms at baseline after 20 weeks of double-blind treatment, as
measured by the Kansas City Cardiomyopathy Questionnaire Total
Symptom Score, one of the sub-domains of a self-administered
questionnaire that measures quality-of-life in patients with heart
failure. The results were presented at the 20th Annual Heart
Failure Society of America Scientific Meeting in Orlando, FL.
- Reached agreement with FDA on key elements of GALACTIC-HF
through a Special Protocol Assessment (SPA). Details of the
protocol are being finalized with regulators.
- Expect to initiate sites for GALACTIC-HF in the fourth quarter
of 2016.
Skeletal Muscle Program
tirasemtiv
- Announced the completion of patient enrollment in VITALITY-ALS
(Ventilatory Investigation of
Tirasemtiv and Assessment of
Longitudinal Indices after
Treatment for a Year in
ALS), an international Phase 3 clinical trial of
tirasemtiv in patients with ALS. VITALITY-ALS is designed to assess
the effects of tirasemtiv versus placebo on slow vital capacity
(SVC) and other measures of skeletal muscle strength in patients
with ALS. VITALITY-ALS enrolled more than 700 patients.
- Convened the second Data Monitoring Committee Meeting for
VITALITY-ALS to review unblinded safety and efficacy data; the
Committee recommended continuing the trial without modifications to
the protocol.
- Amended our collaboration agreement with Astellas to provide an
option right for the development and commercialization of
tirasemtiv outside of North America, Europe and select other
countries.
- Announced the first patient has been enrolled in VIGOR-ALS
(Ventilatory Investigations in
Global Open-Label
Research in ALS), an open-label
extension clinical trial designed to assess the long-term safety
and tolerability of tirasemtiv, in patients with ALS who have
completed their participation in VITALITY-ALS.
- Expect data from VITALITY–ALS in the fourth quarter of
2017.
CK-2127107
- Amended our collaboration agreement with Astellas to enable the
development of CK-2127107, under an agreed plan for the potential
treatment of patients with ALS.
- Continued enrollment of the ongoing Phase 2 clinical trial of
CK-2127107 in patients with spinal muscular atrophy (SMA) in
collaboration with Astellas.
- Expect to complete enrollment of Cohort 1 in the Phase 2
clinical trial of CK-2127107 in patients with SMA in the fourth
quarter of 2016. Expect data from this clinical trial in first half
of 2017.
- Expect Astellas to complete enrollment in a Phase 2 clinical
trial of CK-2127107 in patients with COPD in 2017.
Pre-Clinical Research
- Announced the initiation of IND-enabling studies for a
next-generation fast skeletal muscle activator under our
collaboration with Astellas.
- Extended our joint research program with Astellas focused on
the discovery of next-generation skeletal muscle activators through
2017.
- Continued research activities under our joint research program
with Amgen directed to the discovery of next-generation cardiac
muscle activators and under our joint research program with
Astellas directed to the discovery of next-generation skeletal
muscle activators. In addition, company scientists continued
independent research activities directed to our other muscle
biology programs.
Corporate
- Announced that the Federal Trade Commission granted early
termination of the waiting period under the Hart-Scott-Rodino
Antitrust Improvements Act of 1976 (HSR Act) in connection with the
2016 amendment to the License and Collaboration Agreement initially
executed between Cytokinetics and Astellas Pharma Inc., in 2013 and
amended in 2014.
- Recently received the upfront payment of $65 million from
Astellas related to the amendment to our collaboration
agreement.
- Received a $2 million milestone payment related to the
initiation of IND-enabling studies for a next-generation fast
skeletal muscle activator under our collaboration with
Astellas.
- Earned a $150,000 milestone payment related to our
collaboration with MyoKardia.
- Announced the continuation and expansion of our partnership
with The ALS Association in the fight against ALS, including
renewal of our Gold Level Sponsorship of the National Walks to
Defeat ALS® and Platinum Level Sponsorship for initiatives led by
The ALS Association’s Golden West Chapter.
Financials
Revenues for the third quarter of 2016 were
$59.0 million, compared to $7.9 million during the same period in
2015. Revenues for the third quarter of 2016 included $53.0
million of license revenues, $3.0 million of research and
development revenues and $2.0 million of milestone payments from
our collaboration with Astellas, $0.6 million in research and
development revenues from our collaboration with Amgen, $0.3
million in research and development revenues from our collaboration
with ALSA and $0.2 million in milestone revenue from our
collaboration with MyoKardia. Revenues for the same period in 2015
were comprised of $4.1 million of license revenues and $3.2 million
of research and development revenues from our collaboration with
Astellas, and $0.6 million of research and development revenues
from our collaboration with Amgen. The increase in revenues for the
third quarter of 2016, compared with the same period in 2015, was
mainly due to the license revenue associated with the expansion of
the Astellas collaboration agreement, which was effective in
September 2016.
Total research and development (R&D)
expenses for the third quarter of 2016 were $19.3 million, compared
to $11.6 million for the same period in 2015. The $7.7 million
increase in R&D expenses for the third quarter of 2016,
compared with the same period in 2015, was primarily due to an
increase of $6.6 million in outsourced pre-clinical and clinical
costs mainly associated with the ongoing VITALITY-ALS trial, and an
increase of $1.1 million in personnel related expenses due to
increased headcount costs and increased non-cash stock compensation
expense.
Total general and administrative (G&A)
expenses for the third quarter of 2016 were $7.2 million compared
to $5.3 million for the same period in 2015. The $1.9 million
increase in G&A expenses for the third quarter of 2016,
compared to the same period in 2015, was primarily due to an
increase of $1.3 million in personnel related expenses due to
increased headcount and increased non-cash stock compensation
expense, an increase of $0.4 million in outsourced costs related to
commercial development and information technology, and an increase
of $0.2 million in corporate and patent legal fees.
Revenues for the nine months ended September 30,
2016 were $73.3 million, compared to $18.9 million for the same
period in 2015. Revenues for the first nine months of 2016 included
$59.0 million of license revenues, $9.5 million of research and
development revenues and $2.0 million of milestone payments from
our collaboration with Astellas, $1.8 million of research and
development revenues from our collaboration with Amgen, $0.8
million in research and development revenues from our collaboration
with ALSA and $0.2 million in milestone payment revenue from our
collaboration with MyoKardia. Revenues for the same period in 2015
included $8.8 million of license revenues and $8.2 million of
research and development revenues from our collaboration with
Astellas, and $1.9 million of research and development revenues
from our collaboration with Amgen.
Total R&D expenses for the nine months ended
September 30, 2016 were $42.6 million, compared to $33.1 million
for the same period in 2015. The $9.5 million increase in R&D
expenses in the first nine months of 2016, over the same period in
2015, was primarily due to an increase of $9.5 million in
outsourced clinical costs, an increase of $3.5 million in personnel
related expenses due to increased headcount costs and increased
non-cash stock compensation expense, partially offset by a decrease
of $3.6 million in outsourced preclinical costs mainly associated
with clinical manufacturing activities. The increase in outsourced
clinical costs was comprised of an increase of $14.0 million in
outsourced clinical costs mainly associated with VITALITY-ALS,
offset by a $4.5 million litigation settlement in June 2016 from a
contract research organization for BENEFIT-ALS, our Phase 2
clinical trial which was concluded in 2014.
Total G&A expenses for the nine months ended
September 30, 2016 were $21.1 million, compared to $14.1 million
for the same period in 2015. The $7.0 million increase in G&A
spending in the first nine months of 2016 compared to the same
period in 2015, was primarily due to an increase of $3.3 million in
personnel related expenses due to increased headcount costs and
increased non-cash stock compensation expense, an increase of $1.9
million in outsourced costs related to commercial development,
grants and sponsorships, and accounting and finance, and an
increase of $1.6 million in corporate and patent legal fees.
The net income for the nine months ended
September 30, 2016, was $7.8 million, or $0.20 and $0.19 per basic
and diluted share, respectively, compared to a net loss of $(28.3)
million, or $(0.73) per basic and diluted share, for the same
period in 2015.
Financial Guidance
Cytokinetics also updated its financial guidance
for 2016. The company anticipates cash revenue will be in the range
of $84 to $87 million, cash R&D expenses will be in the range
of $65 to $67 million, and cash G&A expenses will be in the
range of $23 to $26 million. This guidance excludes approximately
$13.5 million in unearned revenue from the 2014 amendment of our
collaboration with Astellas, which will be recognized in 2016 under
generally accepted accounting principles, as well as any potential
future milestones that may be achieved in accordance with our
collaboration agreements with our partners Amgen and Astellas. We
expect a milestone payment from Amgen of approximately $27 million
relating to the start of GALACTIC-HF in the fourth quarter 2016.
The guidance includes $15 million in cash revenue under the 2016
amendment to our collaboration with Astellas, which will be
recorded under generally accepted accounting principles once
Astellas exercises its option to add tirasemtiv to the
collaboration. This guidance also excludes an estimated $7.2
million in non-cash related operating expenses primarily related to
stock compensation expense.
Conference Call and Webcast
Information
Members of Cytokinetics’ senior management team
will review the company’s third quarter results via a webcast and
conference call today at 4:30 PM Eastern Time. The webcast can be
accessed through the Investors & Media 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 29639748.
An archived replay of the webcast will be
available via Cytokinetics’ website until November 3, 2016.
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 29639748 from
October 27, 2016 at 5:30 PM Eastern Time until November 3,
2016.
About Cytokinetics
Cytokinetics is a late-stage
biopharmaceutical company focused on discovering, developing and
commercializing first-in-class muscle activators as potential
treatments for debilitating diseases in which muscle performance is
compromised and/or declining. As a leader in muscle biology and the
mechanics of muscle performance, the company is developing small
molecule drug candidates specifically engineered to increase muscle
function and contractility. Cytokinetics’ lead drug candidate
is tirasemtiv, a fast skeletal muscle troponin activator, for
the potential treatment of 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 retains the right to develop and
commercialize tirasemtiv, subject to an option held
by Astellas Pharma Inc. Cytokinetics is also
collaborating with Astellas to develop CK-2127107, a fast skeletal
muscle activator, for the potential treatment of spinal muscular
atrophy, chronic obstructive pulmonary disease and
ALS. Cytokinetics is collaborating with Amgen
Inc. to develop omecamtiv mecarbil, a novel cardiac
muscle activator, for the potential treatment of heart
failure. 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. For additional information
about Cytokinetics, visit 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 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,
including our discussions with the FDA regarding the key elements
of GALACTIC-HF and the potential for a SPA; the significance and
utility of preclinical study and clinical trial results; the
potential benefits of Cytokinetics’ expanded collaboration with
Astellas; 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; 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; the FDA or foreign regulatory agencies may
delay or limit Cytokinetics’ or its partners’ ability to conduct
clinical trials; 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; and competitive products or
alternative therapies may be developed by others for the treatment
of indications Cytokinetics’ drug candidates and potential drug
candidates may target. For further information regarding these and
other risks related to Cytokinetics’ business, investors should
consult Cytokinetics’ filings with the Securities and Exchange
Commission. Forward-looking statements are not guarantees of future
performance, and Cytokinetics' actual results of operations,
financial condition and liquidity, and the development of the
industry in which it operates, may differ materially from the
forward-looking statements contained in this press release. Any
forward-looking statements that Cytokinetics makes in this press
release speak only as of the date of this press release.
Cytokinetics assumes no obligation to update its forward-looking
statements whether as a result of new information, future events or
otherwise, after the date of this press release.
Cytokinetics,
Incorporated |
Condensed
Consolidated Statements of Operations |
(in thousands,
except per share data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
Three
Months Ended |
|
Nine Months
Ended |
|
|
September
30, |
|
September
30, |
|
September
30, |
|
September
30, |
|
|
2016 |
2015 |
|
2016 |
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenues
from |
|
|
|
|
|
|
|
|
|
|
|
|
related parties |
$ |
|
5,573 |
|
|
$ |
3,786 |
|
$ |
|
13,383 |
|
|
$ |
10,087 |
|
Research and development, grant and
other |
|
|
|
|
|
|
|
|
|
|
|
|
revenues |
|
|
441 |
|
|
|
27 |
|
|
|
930 |
|
|
|
27 |
|
License revenues from related
parties |
|
|
53,033 |
|
|
|
4,132 |
|
|
|
58,956 |
|
|
|
8,787 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
59,047 |
|
|
|
7,945 |
|
|
|
73,269 |
|
|
|
18,901 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
19,340 |
|
|
|
11,557 |
|
|
|
42,596 |
|
|
|
33,149 |
|
General and administrative |
|
|
7,217 |
|
|
|
5,276 |
|
|
|
21,149 |
|
|
|
14,138 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
26,557 |
|
|
|
16,833 |
|
|
|
63,745 |
|
|
|
47,287 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
|
|
32,490 |
|
|
|
(8,888 |
) |
|
|
9,524 |
|
|
|
(28,386 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
and other income (expense), net |
|
|
(603 |
) |
|
|
39 |
|
|
|
(1,703 |
) |
|
|
114 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income (loss) |
$ |
|
31,887 |
|
|
$ |
(8,849 |
) |
$ |
|
7,821 |
|
|
$ |
(28,272 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income (loss) per share – basic |
$ |
|
0.80 |
|
|
$ |
(0.23 |
) |
$ |
|
0.20 |
|
|
$ |
(0.73 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income (loss) per share – diluted |
$ |
|
0.74 |
|
|
$ |
(0.23 |
) |
$ |
|
0.19 |
|
|
$ |
(0.73 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares used in computing net income (loss) per share –
basic |
|
|
39,926 |
|
|
|
38,752 |
|
|
|
39,729 |
|
|
|
38,718 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares used in computing net income (loss) per share –
diluted |
|
|
43,217 |
|
|
|
38,752 |
|
|
|
42,247 |
|
|
|
38,718 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cytokinetics,
Incorporated |
Condensed
Consolidated Balance Sheets |
(in
thousands) (unaudited) |
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2016 |
|
|
2015(1) |
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
30,300 |
|
$ |
65,076 |
|
|
|
|
|
|
|
|
Short
term investments |
|
48,309 |
|
|
46,366 |
|
|
|
|
|
|
|
|
Related
party accounts receivable |
|
67,000 |
|
|
12 |
|
|
|
|
|
|
|
|
Prepaid
and other current assets |
|
2,575 |
|
|
1,653 |
|
|
|
|
|
|
|
|
Total
current assets |
|
148,184 |
|
|
113,107 |
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
2,049 |
|
|
1,751 |
|
|
|
|
|
|
|
|
Long-term investments |
|
7,737 |
|
|
179 |
|
|
|
|
|
|
|
|
Other
assets |
|
200 |
|
|
200 |
|
|
|
|
|
|
|
|
Total assets |
$ |
158,170 |
|
$ |
115,237 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred
revenue, current |
$ |
10,497 |
|
$ |
20,858 |
|
|
|
|
|
|
|
|
Other
current liabilities |
|
18,837 |
|
|
10,791 |
|
|
|
|
|
|
|
|
Total
current liabilities |
|
29,334 |
|
|
31,649 |
|
|
|
|
|
|
|
|
Long-term debt |
|
29,742 |
|
|
14,639 |
|
|
|
|
|
|
|
|
Deferred
revenue, non-current |
|
15,635 |
|
|
— |
|
|
|
|
|
|
|
|
Other
non-current liabilities |
|
209 |
|
|
359 |
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
83,250 |
|
|
68,590 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
158,170 |
|
$ |
115,237 |
|
(1) Derived from the audited financial statements,
included in the Company’s Annual Report on Form 10-K for the year
ended December 31, 2015.
Contact:
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(650) 624-3000
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