Data Monitoring Committee for VITALITY-ALS
Recommended Continuation of Phase 3 Trial; Results Expected in
Q4
Cytokinetics, Inc. (Nasdaq:CYTK) reported total revenues for
the first quarter of 2017 were $4.2 million, compared to $8.4
million, during the same period in 2016. Net loss for the first
quarter was $25.9 million, or $0.62 per basic and diluted share,
respectively. This is compared to a net loss for the same period in
2016 of $12.5 million, or $0.31 per basic and diluted share. As of
March 31, 2017, cash, cash equivalents and investments totaled
$257.2 million.
“In the first quarter of 2017, we advanced our
novel muscle biology-directed programs through important late-stage
clinical trial milestones. In particular, the last patients
enrolled in VITALITY-ALS moved through their primary efficacy
endpoint visits towards the conclusion of the Phase 3 trial and we
look forward to results expected later this year,” said Robert I.
Blum, Cytokinetics’ President and Chief Executive Officer. “We also
made key progress with Astellas in the expansion of our clinical
trials programs for CK-2127107, opening enrollment for Cohort 2 in
our ongoing Phase 2 trial in adolescent and adult patients living
with spinal muscular atrophy, and preparing to start additional
trials in patients with ALS and elderly subjects with limited
mobility.”
Recent Highlights and Upcoming
Milestones
Skeletal Muscle Program
tirasemtiv
- Convened the third Data Monitoring Committee Meeting for
VITALITY-ALS (Ventilatory
Investigation of Tirasemtiv and
Assessment of Longitudinal
Indices after Treatment for a
Year in ALS); the Committee
recommended the continuation of VITALITY-ALS without modification.
- Continued conduct of VITALITY-ALS and enrollment 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 participation
in VITALITY-ALS.
- Announced the advancement of our research collaboration with
Origent Data Sciences to prospectively validate Origent’s computer
model designed to predict the course of disease progression using
baseline data from VITALITY-ALS. The model is expected to be
completed prior to analyzing results of VITALITY-ALS.
- Conducted clinical, regulatory, non-clinical and other planning
activities intended to support potential regulatory filings and
registration of tirasemtiv in North America and Europe.
- Engaged Health Technology Assessment organizations to
understand payor interests and to inform market access activities
in ALS.
- Expect to continue to enroll patients who complete VITALITY-ALS
into VIGOR-ALS throughout 2017.
- Expect results from VITALITY-ALS in Q4 2017.
CK-2127107
- Announced pre-clinical data for CK-2127107 showing that this
next-generation fast skeletal troponin activator (FSTA) improves
muscle function in mouse models of spinal muscular atrophy (SMA).
The results were presented at the MDA Scientific Conference in
Arlington, VA.
- Completed enrollment of Cohort 1 in the Phase 2 clinical trial
of CK-2127107 in patients with SMA, conducted by Cytokinetics in
collaboration with Astellas; announced that Cohort 2 opened
enrollment.
- Expect data from the Phase 2 clinical trial of CK-2127107 in
patients with SMA in 2H 2017.
- Expect Astellas to continue enrollment in a Phase 2 clinical
trial of CK-2127107 in patients with COPD in 2017.
- Expect Astellas to begin a Phase 1b clinical trial of
CK-2127107 in elderly patients with limited mobility in Q2
2017.
- Expect to begin a Phase 2 clinical trial of CK-2127107 in
patients with ALS in mid-2017.
Cardiac Muscle Program
omecamtiv mecarbil
- 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 improved measures of left
ventricular myocardial deformation, a marker of myocardial function
that has been related to outcomes. These results further support
the direct effect of omecamtiv mecarbil to improve myocardial
contractile function. The results were presented in a Poster
Session at the American College of Cardiology’s 66th Annual
Scientific Session (ACC.17) in Washington, D.C.
- Continued to activate sites and enroll patients in GALACTIC-HF
(Global Approach to
Lowering Adverse
Cardiac Outcomes
Through Improving
Contractility in Heart
Failure), the Phase 3 cardiovascular outcomes
clinical trial of omecamtiv mecarbil which is being conducted by
Amgen, in collaboration with Cytokinetics.
- Expect data from a Phase 2 clinical trial of omecamtiv mecarbil
in Japanese patients with chronic heart failure in Q3
2017.
- Expect continued enrollment of patients with chronic heart
failure in GALACTIC-HF throughout 2017.
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
- Agreed to sell to Royalty Pharma a 4.5% royalty on potential
worldwide sales of omecamtiv mecarbil for $90 million and $10
million of Cytokinetics common stock.
- Agreed to exercise an option under our collaboration agreement
with Amgen to co-invest $40 million in the Phase 3
development program of omecamtiv mecarbil. As a result,
Cytokinetics is eligible to receive an incremental royalty of up to
4% on increasing worldwide sales of omecamtiv
mecarbil outside of Japan. Exercising our option and
co-funding affords Cytokinetics the right to
co-promote omecamtiv mecarbil in institutional care
settings in North America, with reimbursement by Amgen for certain
sales force activities.
- Joined the global initiative with 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.
Financials
Revenues for the first quarter of 2017 were $4.2
million, compared to $8.4 million during the same period in
2016. Revenues for the first quarter of 2017 included $2.7
million of research and development revenues and $1.4 million of
license revenues from our collaboration with Astellas, $0.9 million
in research and development revenues from our collaboration with
Amgen, and $0.3 million in research and development revenues from
our collaboration with The ALS Association. Revenues from our
collaboration with Amgen were offset by a payment of $1.3 million
to Amgen related to the option to co-fund the Phase 3 development
program of omecamtiv mecarbil in exchange for an increased royalty
upon potential commercialization. Revenues for the same period in
2016 were comprised of $4.0 million of license revenues and $3.7
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.
Total research and development (R&D)
expenses for the first quarter of 2017 were $19.3 million, compared
to $13.5 million for the same period in 2016. The $5.8 million
increase in R&D expenses for the first quarter of 2017,
compared with the same period in 2016, was primarily due to an
increase of $2.5 million in outsourced clinical costs mainly
associated with VITALITY-ALS, our ongoing Phase 3 trial of
tirasemtiv, $1.4 million in outsourced research and pre-clinical
costs mainly associated with clinical manufacturing activities,
$1.3 million in personnel related expenses due to increased
headcount costs, and $0.2 million in laboratory expenses.
Total general and administrative (G&A)
expenses for the first quarter of 2017 were $8.1 million compared
to $6.8 million for the same period in 2016. The $1.3 million
increases in G&A expenses for the first quarter of 2017,
compared to the same period in 2016, was primarily due to an
increase of $0.7 million in personnel-related expenses due to
increased headcount and non-cash stock compensation expense and
$0.8 million in outsourced costs primarily related to commercial
development, partially offset by a decrease in corporate legal fees
of $0.5 million.
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 46685336.
An archived replay of the webcast will be
available via Cytokinetics’ website until May 4, 2017. 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 46685336 from April
27, 2017 at 7:30 PM Eastern Time until May 4, 2017.
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 troponin activator (FSTA). Tirasemtiv is the
subject of VITALITY-ALS, an international Phase 3 clinical trial in
patients with 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. Cytokinetics is preparing for the
potential commercialization of tirasemtiv in North America and
Europe and has granted an option to Astellas for development and
commercialization in other countries. Cytokinetics is collaborating
with Astellas to develop CK-2127107, a next-generation fast
skeletal muscle activator. CK-2127107 is the subject of two ongoing
Phase 2 clinical trials enrolling patients with spinal muscular
atrophy and chronic obstructive pulmonary disease. Cytokinetics is
collaborating with Amgen Inc. to develop omecamtiv mecarbil, a
novel cardiac muscle activator. Omecamtiv mecarbil is the subject
of GALACTIC-HF, an international Phase 3 clinical trial in patients
with heart failure. Amgen holds an exclusive worldwide license to
develop and commercialize omecamtiv mecarbil with a sublicense held
by Servier for commercialization in Europe and certain other
countries. Astellas holds an exclusive worldwide license to develop
and commercialize CK-2127107. Licenses held by Amgen and Astellas
are subject to Cytokinetics' specified co-development and
co-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, including VITALITY-ALS, the Phase 2
clinical trials of CK-2127107 in patients with SMA and in patients
with COPD and the Phase 2 clinical trial of omecamtiv mecarbil in
Japanese patients with chronic heart failure; the significance and
utility of pre-clinical 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 pre-clinical study and clinical trial
results; the potential benefits of Cytokinetics’ expanded
collaboration with Astellas; the expected timing of events and
milestones; 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 pre-clinical 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 |
|
|
March 31, |
|
March 31, |
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
Research
and development revenues from |
|
|
|
|
|
|
related
parties, net |
$ |
2,366 |
|
|
$ |
4,296 |
|
Research
and development, grant and other |
|
|
|
|
|
|
Revenues |
|
341 |
|
|
|
151 |
|
License
revenues from related parties |
|
1,446 |
|
|
|
3,974 |
|
|
|
|
|
|
|
|
Total revenues |
|
4,153 |
|
|
|
8,421 |
|
|
|
|
|
|
|
|
Operating Expenses: |
|
|
|
|
|
|
Research
and development |
|
19,289 |
|
|
|
13,534 |
|
General
and administrative |
|
8,115 |
|
|
|
6,841 |
|
|
|
|
|
|
|
|
Total operating expenses |
|
27,404 |
|
|
|
20,375 |
|
|
|
|
|
|
|
|
Operating loss |
|
(23,251 |
) |
|
(11,954 |
) |
|
|
|
|
|
|
|
Interest
and other income (expense), net |
|
(2,616 |
) |
|
(501 |
) |
|
|
|
|
|
|
|
Net
loss |
$ |
(25,867 |
) |
$ |
(12,455 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share – basic and diluted |
$ |
(0.62 |
) |
$ |
(0.31 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares used in computing net loss per share – basic and
diluted |
|
41,578 |
|
|
39,592 |
|
|
Cytokinetics, Incorporated |
Condensed Consolidated Balance
Sheets |
(in thousands) |
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2017 |
|
|
2016(1) |
|
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
49,364 |
|
$ |
66,874 |
|
|
|
|
|
|
|
|
Short
term investments |
|
157,192 |
|
|
89,375 |
|
|
|
|
|
|
|
|
Related
party accounts receivable |
|
910 |
|
|
24 |
|
|
|
|
|
|
|
|
Other
current assets |
|
3,557 |
|
|
2,360 |
|
|
|
|
|
|
|
|
Total
current assets |
|
211,023 |
|
|
158,633 |
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
3,488 |
|
|
3,637 |
|
|
|
|
|
|
|
|
Long-term investments |
|
50,622 |
|
|
7,672 |
|
|
|
|
|
|
|
|
Other
assets |
|
241 |
|
|
200 |
|
|
|
|
|
|
|
|
Total assets |
$ |
265,374 |
|
$ |
170,142 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred
revenue, current |
$ |
10,974 |
|
$ |
8,060 |
|
|
|
|
|
|
|
|
Other
current liabilities |
|
25,822 |
|
|
25,198 |
|
|
|
|
|
|
|
|
Total
current liabilities |
|
36,796 |
|
|
33,258 |
|
|
|
|
|
|
|
|
Long-term debt |
|
25,195 |
|
|
27,381 |
|
|
|
|
|
|
|
|
Deferred revenue, non-current |
|
15,000 |
|
|
15,000 |
|
|
|
|
|
|
|
|
Liability related to sale of future royalties |
|
92,928 |
|
|
- |
|
|
|
|
|
|
|
|
Other
non-current liabilities |
|
72 |
|
|
142 |
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
95,383 |
|
|
94,361 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
265,374 |
|
$ |
170,142 |
|
(1) Derived from the audited financial statements,
included in the Company’s Annual Report on Form 10-K for the year
ended December 31, 2016.
Contact:
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(650) 624-3000
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