Recently Announced Positive Top-line
Results From COSMIC-HF; Data Demonstrated Statistically Significant
Improvements in Several Pre-Specified Measures of Cardiac
Function
Cytokinetics, Inc. (Nasdaq:CYTK) reported total research and
development revenues for the third quarter of 2015 were $7.9
million, compared to $9.4 million during the same period in 2014.
The net loss for the third quarter was $8.8 million, or $0.23
per basic and diluted share. This is compared to a net loss for the
same period in 2014 of $6.0 million, or $0.16 per basic share and
diluted share. As of September 30, 2015, cash, cash equivalents and
investments totaled $98.0 million.
“With the recently announced positive results
from COSMIC-HF, Cytokinetics has entered a transformative time in
the maturation of our company. We look forward to working with our
partners at Amgen to prepare for potential progression of omecamtiv
mecarbil to Phase 3,” said Robert I. Blum, Cytokinetics’ President
and Chief Executive Officer. “During the quarter, we achieved
another key milestone for the company with the start of our first
Phase 3 clinical trial of tirasemtiv in patients with ALS and
prepared to advance CK-2127107 into a Phase 2 clinical trial in
patients with SMA, in collaboration with Astellas. This is truly an
exciting time for our company and our key stakeholders.”
Recent Highlights and Upcoming
Milestones
Skeletal Muscle Program
tirasemtiv
- Initiated enrollment in VITALITY-ALS
(Ventilatory Investigation of
Tirasemtiv and Assessment of
Longitudinal Indices after
Treatment for a Year in
ALS), a Phase 3 clinical trial 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.
- Achieved first milestone in accordance with a $1.5M grant from
The ALS Association to support VITALITY-ALS and the collection of
plasma samples to advance the discovery of biomarkers for ALS.
CK-2127107
- Continued planning for the initiation of a Phase 2 clinical
trial of CK-2127107 in patients with spinal muscular atrophy (SMA),
in collaboration with Astellas, to occur in the fourth quarter of
2015.
- Anticipate Astellas will initiate a Phase 2 clinical trial of
CK-2127107 in patients with COPD in the first half of 2016.
Cardiac Muscle Program
omecamtiv mecarbil
- Recently announced positive results from COSMIC-HF (Chronic
Oral Study of Myosin Activation to Increase Contractility in Heart
Failure) which demonstrated statistically significant improvements
in several pre-specified echocardiographic measures of cardiac
function, including systolic ejection time, stroke volume and
N-terminal-pro-brain natriuretic peptide, at 20 weeks following
randomization. These pharmacodynamic effects of omecamtiv mecarbil
were generally dose dependent. Data from the expansion phase of
COSMIC-HF showed that pharmacokinetic-guided dose titration
adequately controlled patient exposure to omecamtiv mecarbil and
resulted in statistically significant decreases in cardiac
dimensions and heart rate in the dose-titration group. Adverse
events, including serious adverse events, in patients on omecamtiv
mecarbil, appeared comparable to those on placebo. COSMIC-HF was
conducted by Amgen in collaboration with Cytokinetics.
- Conducted planning in collaboration with Amgen, for the
potential advancement of omecamtiv mecarbil into a Phase 3
program.
Pre-Clinical Research
- 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
- Established a $40 million Controlled Equity Offering line with
Cantor Fitzgerald.
- Entered into a $40 million tranched growth capital loan with
Oxford Financial LLC and Silicon Valley Bank, with the first
tranche of $15 million funded in October 2015.
- Participated in several events associated with Gold Level
Sponsorship of the National Walks to Defeat ALS and Platinum Level
Sponsorship of the ALS Association Golden West Chapter.
Financials
Revenues for the third quarter of 2015 were $7.9
million, compared to $9.4 million during the same period in
2014. Revenues for the third quarter of 2015 included $4.1
million of license revenues and $3.2 million of research and
development revenues from our collaboration with Astellas, and $0.6
million in research and development revenues from our collaboration
with Amgen. Revenues for the same period in 2014 were comprised of
$2.7 million of license revenues and $4.8 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 research and development (R&D)
expenses for the third quarter of 2015 were $11.6 million, compared
to $11.4 million for the same period in 2014. The $0.2 million
increase in R&D expenses for the third quarter of 2015,
compared with the same period in 2014, was primarily due to an
increase of $0.6 million in outsourced preclinical costs and lab
expenses and an increase of $0.6 million in personnel related
expenses, partially offset by a decrease of $1.0 million in
outsourced clinical costs associated with the completion of
BENEFIT-ALS in the second quarter of 2014.
Total general and administrative (G&A)
expenses for the third quarter of 2015 were $5.3 million compared
to $4.0 million for the same period in 2014. The $1.3 million
increase in G&A expenses for the third quarter of 2015,
compared to the same period in 2014, was primarily due to an
increase of $0.7 million in outsourced costs, $0.4 million in legal
fees, and $0.2 million in personnel related expenses due to an
increase in headcount.
Revenues for the nine months ended September 30,
2015 were $18.9 million, compared to $25.2 million for the same
period in 2014. Revenues for the first nine months of 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. Revenues for the same period in 2014 were comprised of
$7.6 million of license revenues and $14.1 million of research and
development revenues from our collaboration with Astellas, and $3.4
million of research and development revenues from our collaboration
with Amgen.
Total R&D expenses for the nine months ended
September 30, 2015 were $33.1 million, compared to $35.6 million
for the same period in 2014. The $2.5 million decrease in R&D
expenses in the first nine months of 2015, over the same period in
2014, was primarily due to a decrease of $5.0 million in outsourced
clinical costs associated with the completion of BENEFIT-ALS in the
second quarter of 2014, partially offset by an increase of $0.8
million in outsourced preclinical costs, an increase of $0.6
million in lab expenses, and an increase of $1.0 million in
personnel related expenses due to increased headcount.
Total G&A expenses for the nine months ended
September 30, 2015 were $14.1 million, compared to $12.7 million
for the same period in 2014. The $1.4 million increase in G&A
spending in the first nine months of 2015 compared to the same
period in 2014, was primarily due to an increase of $0.8 million in
personnel related costs due to an increase in headcount, an
increase of $0.6 in legal fees, and an increase of $0.1 million in
outsourced costs.
The net loss for the nine months ended September
30, 2015, was $28.3 million, or $0.73 per basic and diluted share,
compared to a net loss of $23.1 million, or $0.65 per basic and
diluted share, for the same period in 2014.
Financial Guidance
Cytokinetics also announced updated financial
guidance for 2015. The company anticipates cash revenue will be in
the range of $44 to $47 million, cash R&D expenses will be in
the range of $51 to $54 million, and cash G&A expenses will be
in the range of $18 to $21 million. This guidance includes
approximately $30.0 million in revenue which will be deferred and
recognized over a two year period ending in 2016 under generally
accepted accounting principles. This guidance excludes an estimated
$4.6 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 34469080.
An archived replay of the webcast will be
available via Cytokinetics' website until November 5, 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 34469080 from
October 29, 2015 at 5:30 PM Eastern Time until November 5,
2015.
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 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 holds
the exclusive right to develop and commercialize tirasemtiv
throughout the world. Cytokinetics is collaborating with Amgen Inc.
to develop omecamtiv mecarbil, a novel 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. For
additional information about Cytokinetics, visit
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; enrollment in VITALITY-ALS; 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. 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, |
|
|
2015 |
2014 |
|
2015 |
|
2014 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenues
from |
|
|
|
|
|
|
|
|
|
|
|
|
related parties |
$ |
3,786 |
|
$ |
1,920 |
|
$ |
10,087 |
|
$ |
3,428 |
|
Research and development, grant and
other |
|
|
|
|
|
|
|
|
|
|
|
|
revenues |
|
27 |
|
|
4,761 |
|
|
27 |
|
|
14,189 |
|
License revenues from related
parties |
|
4,132 |
|
|
— |
|
|
8,787 |
|
|
— |
|
License revenues |
|
— |
|
|
2,734 |
|
|
— |
|
|
7,565 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
7,945 |
|
|
9,415 |
|
|
18,901 |
|
|
25,182 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
11,557 |
|
|
11,420 |
|
|
33,149 |
|
|
35,647 |
|
General and administrative |
|
5,276 |
|
|
3,993 |
|
|
14,138 |
|
|
12,710 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
16,833 |
|
|
15,413 |
|
|
47,287 |
|
|
48,357 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(8,888 |
) |
|
(5,998 |
) |
|
(28,386 |
) |
|
(23,175 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
and other, net |
|
39 |
|
|
27 |
|
|
114 |
|
|
86 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
$ |
(8,849 |
) |
$ |
(5,971 |
) |
$ |
(28,272 |
) |
$ |
(23,089 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share – basic and diluted |
$ |
(0.23 |
) |
$ |
(0.16 |
) |
$ |
(0.73 |
) |
$ |
(0.65 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares used in computing net loss per share – basic and
diluted |
|
38,752 |
|
|
36,609 |
|
|
38,718 |
|
|
35,359 |
|
Cytokinetics, Incorporated |
Condensed Consolidated Balance
Sheets |
(in thousands) |
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2015 |
|
|
2014(1) |
|
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
25,962 |
|
$ |
20,215 |
|
|
|
|
|
|
|
|
Short
term investments |
|
72,023 |
|
|
63,013 |
|
|
|
|
|
|
|
|
Accounts
receivable and related party receivable |
|
47 |
|
|
46,646 |
|
|
|
|
|
|
|
|
Other
current assets |
|
2,483 |
|
|
1,257 |
|
|
|
|
|
|
|
|
Total
current assets |
|
100,515 |
|
|
131,131 |
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
1,481 |
|
|
1,637 |
|
|
|
|
|
|
|
|
Other
assets |
|
200 |
|
|
200 |
|
|
|
|
|
|
|
|
Total assets |
$ |
102,196 |
|
$ |
132,968 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred
revenue, current |
$ |
21,367 |
|
$ |
17,042 |
|
|
|
|
|
|
|
|
Other
current liabilities |
|
8,776 |
|
|
6,813 |
|
|
|
|
|
|
|
|
Total
current liabilities |
|
30,143 |
|
|
23,855 |
|
|
|
|
|
|
|
|
Deferred
revenue, non-current |
|
4,346 |
|
|
16,558 |
|
|
|
|
|
|
|
|
Other
non-current liabilities |
|
407 |
|
|
491 |
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
67,300 |
|
|
92,064 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
102,196 |
|
$ |
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:
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(650) 624-3000
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