Cytokinetics, Inc. Reports First Quarter 2016 Financial Results
April 28 2016 - 4:00PM
Cytokinetics, Inc. (Nasdaq:CYTK) reported total research and
development revenues for the first quarter of 2016 were $8.4
million, compared to $4.4 million, during the same period in 2015.
The net loss for the first quarter was $12.5 million, or
$0.31 per basic and diluted share. This is compared to the net loss
for the same period in 2015 of $8.9 million, or $0.23 per basic and
diluted share. As of March 31, 2016, cash, cash equivalents and
investments totaled $108.6 million.
“We made meaningful progress this quarter
advancing our portfolio of muscle-biology directed programs,” said
Robert I. Blum, Cytokinetics’ President and Chief Executive
Officer. “Notably, in partnership with Amgen we participated in
several productive meetings with regulatory authorities which
inform the potential Phase 3 development program for omecamtiv
mecarbil. We also made strides in our ongoing skeletal muscle
activator clinical development programs for tirasemtiv and
CK-2127107 and decided with Astellas to move a next-generation
skeletal muscle activator into IND enabling studies, further
expanding our development pipeline.”
Recent Highlights and Upcoming
Milestones
Cardiac Muscle Program
omecamtiv mecarbil
- Announced the start of a Phase 2 clinical trial of omecamtiv
mecarbil in Japanese subjects with heart failure due to reduced
ejection fraction. The primary objectives of the trial are to
assess the pharmacokinetics, safety and tolerability of omecamtiv
mecarbil. The secondary objective of the trial is to measure
changes from baseline in systolic ejection time.
- The manuscript, “Acute Treatment with Omecamtiv Mecarbil to
Increase Contractility in Acute Heart Failure, The ATOMIC-AHF
Study,” published in the Journal of the American College of
Cardiology. Results from this trial were first presented at the
European Society of Cardiology Meeting in 2013.
- Participated with Amgen in regulatory meetings with the FDA,
EMA and Health Canada intended to inform the design of a potential
Phase 3 development program for omecamtiv mecarbil.
- Conducted various clinical, non-clinical and planning
activities in collaboration with Amgen to support the potential
advancement of omecamtiv mecarbil into a Phase 3 development
program.
- Expect to make a decision regarding the advancement of
omecamtiv mecarbil to Phase 3 in the coming months.
Skeletal Muscle Program
tirasemtiv
- Enrolled more than 50% of targeted patients in VITALITY-ALS
(Ventilatory Investigation
of Tirasemtiv and
Assessment
of Longitudinal Indices
after Treatment for
a Year in ALS), an
ongoing, international 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.
- Convened the first Data Monitoring Committee Meeting for
VITALITY-ALS to review unblinded safety and efficacy data;
Committee recommended continuing the trial without modifications or
changes to the protocol.
- Presented “Decline in Slow Vital Capacity Predicts Respiratory
Insufficiency in Patients with ALS,” at the Muscular Dystrophy
Association’s 2016 National Clinical Conference.
- The manuscript, “A Randomized, Placebo-controlled, Double-blind
Phase IIb Trial Evaluating the Safety and Efficacy of Tirasemtiv in
Patients with Amyotrophic Lateral Sclerosis,” published in
Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration.
Results from this trial were first presented at the Annual Meeting
of the American Academy of Neurology in 2014.
- Participated in the ALS Guidance Development Project and the
Clinical Trial Guidelines Workshop Meeting in collaboration with
ALS community stakeholders.
- Announced a collaboration with Origent Data Sciences to refine
and prospectively validate an Origent computer model to predict ALS
disease progression leveraging data from our clinical trials of
tirasemtiv.
- Expect to complete target enrollment of 600 patients in
VITALITY-ALS in the first half of 2016.
CK-2127107
- Continued enrollment of Phase 2 clinical trial of CK-2127107 in
patients with spinal muscular atrophy (SMA), in collaboration with
Astellas.
- Expect to complete enrollment of our Phase 2 clinical trial of
CK-2127107 in patients with SMA in the second half of 2016.
- Expect Astellas will initiate a Phase 2 clinical trial of
CK-2127107 in patients with COPD in the first half of 2016.
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.
- Anticipate potential advancement of one next-generation
compound from each joint research program into pre-clinical
development in 2016.
Corporate
- Announced Cytokinetics’ Vision 2020: Empowering Our Future, a
strategic initiative designed to deepen and expand our pipeline
over the next five years as well as advance a portfolio of
muscle-biology directed drug candidates toward late-stage
development and commercialization to address unmet needs of people
living with conditions characterized by impaired muscle
function.
- Drew down the second, $15.0 million tranche from our growth
capital loan with Oxford Finance LLC and Silicon Valley Bank.
- Announced support of the European Organisation for Rare
Diseases (EURORDIS) and the National Organization for Rare
Disorders (NORD) to raise awareness of Rare Disease Day®, an
international campaign dedicated to elevating the public
understanding of rare diseases.
- In observance of ALS Awareness Month, Cytokinetics will ring
the Nasdaq closing bell on Monday, May 2, 2016.
Financials
Revenues for the first quarter of 2016 were $8.4
million, compared to $4.4 million during the same period in
2015. Revenues for the first quarter of 2016 included $4.0
million of license revenues and $3.7 million of research and
development revenues from our collaboration with Astellas, $0.6
million in research and development revenues from our collaboration
with Amgen and $0.2 million in research and development revenues
from our collaboration with ALSA. Revenues for the same period in
2015 were comprised of $1.6 million of license revenues and $2.1
million of research and development revenues from our collaboration
with Astellas, 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 2016 were $13.5 million, compared
to $9.0 million for the same period in 2015. The $4.5 million
increase in R&D expenses for the first quarter of 2016,
compared with the same period in 2015, was primarily due to an
increase of $4.2 million in outsourced clinical costs mainly
associated with the ongoing VITALITY-ALS trial, and an increase of
$1.0 million in personnel related expenses due to increased
headcount, partially offset by a decrease of $0.6 million in
outsourced preclinical costs associated with research activities
conducted in 2015.
Total general and administrative (G&A)
expenses for the first quarter of 2016 were $6.8 million compared
to $4.4 million for the same period in 2015. The $2.4 million
increase in G&A expenses for the first quarter of 2016,
compared to the same period in 2015, was primarily due to an
increase of $1.1 million in personnel related expenses due to
increased non-cash stock compensation expense and increased
headcount, an increase of $0.6 million in outsourced costs related
to medical affairs and commercial development, and an increase of
$0.6 million in corporate and patent legal fees.
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 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 29638364.
An archived replay of the webcast will be
available via Cytokinetics' website until May 5, 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 29638364 from April
28, 2016 at 5:30 PM Eastern Time until May 5, 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 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 and chronic obstructive pulmonary disease.
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 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; enrollment and progress of the Phase 2
clinical trial of CK-2127107 in patients with SMA; initiation,
design and conduct of the potential Phase 3 clinical trial of
omecamtiv mecarbil; the significance and utility of preclinical
study and clinical trial results; 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 U.S. Food and Drug Administration 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 |
|
|
March 31, |
|
March 31, |
|
|
2016 |
|
2015 |
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
Research and development revenues
from related parties |
$ |
|
4,296 |
|
|
$ |
2,791 |
|
Research and development, grant and
other revenues |
|
|
151 |
|
|
|
— |
|
License revenues from related
parties |
|
|
3,974 |
|
|
|
1,623 |
|
License revenues |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
Total revenues |
|
|
8,421 |
|
|
|
4,414 |
|
|
|
|
|
|
|
|
Operating Expenses: |
|
|
|
|
|
|
Research and development |
|
|
13,534 |
|
|
|
8,956 |
|
General and administrative |
|
|
6,841 |
|
|
|
4,367 |
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
20,375 |
|
|
|
13,323 |
|
|
|
|
|
|
|
|
Operating loss |
|
|
(11,954 |
) |
|
|
(8,909 |
) |
|
|
|
|
|
|
|
Interest
and other income (expense), net |
|
|
(501 |
) |
|
|
37 |
|
|
|
|
|
|
|
|
Net
loss |
$ |
|
(12,455 |
) |
|
$ |
(8,872 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share – basic and diluted |
$ |
|
(0.31 |
) |
|
$ |
(0.23 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares used in computing net loss per share – basic and
diluted |
|
|
39,592 |
|
|
|
38,675 |
|
|
|
|
|
|
|
|
|
|
Cytokinetics, Incorporated |
Condensed Consolidated Balance
Sheets |
(in thousands) |
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2016 |
|
|
2015(1) |
|
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
42,269 |
|
$ |
65,076 |
|
|
|
|
|
|
|
|
Short
term investments |
|
61,153 |
|
|
46,366 |
|
|
|
|
|
|
|
|
Related
party accounts receivable |
|
---- |
|
|
12 |
|
|
|
|
|
|
|
|
Prepaid
and other current assets |
|
2,696 |
|
|
1,653 |
|
|
|
|
|
|
|
|
Total
current assets |
|
106,118 |
|
|
113,107 |
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
1,760 |
|
|
1,751 |
|
|
|
|
|
|
|
|
Long-term investments |
|
5,140 |
|
|
179 |
|
|
|
|
|
|
|
|
Other
assets |
|
200 |
|
|
200 |
|
|
|
|
|
|
|
|
Total assets |
$ |
113,218 |
|
$ |
115,237 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred
revenue, current |
$ |
15,911 |
|
$ |
20,858 |
|
|
|
|
|
|
|
|
Other
current liabilities |
|
8,772 |
|
|
10,791 |
|
|
|
|
|
|
|
|
Total
current liabilities |
|
24,683 |
|
|
31,649 |
|
|
|
|
|
|
|
|
Long-term debt |
|
29,466 |
|
|
14,639 |
|
|
|
|
|
|
|
|
Deferred
revenue, non-current |
|
851 |
|
|
---- |
|
|
|
|
|
|
|
|
Other
non-current liabilities |
|
312 |
|
|
359 |
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
57,906 |
|
|
68,590 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
113,218 |
|
$ |
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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