Company Recently Announced
Option Right for Tirasemtiv and
Expansion of Global Collaboration for CK-2127107 in ALS with
Astellas
Cytokinetics, Inc. (Nasdaq:CYTK) reported total revenues for
the second quarter of 2016 were $5.8 million, compared to $6.5
million, during the same period in 2015. The net loss for the
second quarter was $11.6 million, or $0.29 per basic and diluted
share. This is compared to the net loss for the same period in 2015
of $10.6 million, or $0.27 per basic and diluted share. As of June
30, 2016, cash, cash equivalents and investments totaled $98.0
million.
“We had a productive quarter advancing key
clinical, regulatory and commercial planning initiatives across our
portfolio of muscle-biology directed drug candidates,” said Robert
I. Blum, Cytokinetics’ President and Chief Executive Officer. “Our
recently expanded collaboration with Astellas aligns our interests
with regard to tirasemtiv and ALS and provides a path forward for
our two skeletal muscle activators as potential treatments for ALS.
Toward that objective, we expect that VITALITY-ALS will soon
conclude patient enrollment, a major milestone for our Phase 3
clinical trial of tirasemtiv in patients with ALS. We
also continue to prepare for the start of a potential Phase 3
development program for omecamtiv mecarbil in collaboration with
Amgen. These are especially promising and hopeful times at
Cytokinetics as our programs advance towards late-stage
milestones.”
Recent Highlights and Upcoming
Milestones
Cardiac Muscle Program
omecamtiv mecarbil
- Announced the start of a double-blind, randomized,
placebo-controlled, multi-center Phase 2 clinical trial to evaluate
the safety, pharmacokinetics and efficacy of omecamtiv mecarbil in
Japanese subjects with heart failure and reduced ejection
fraction.
- Presented a poster titled “COSMIC-HF: Improved Contractility
and Evolution of Ventricular Remodeling through Time” at Heart
Failure 2016, the annual congress of the Heart Failure Association
of the European Society of Cardiology. The results indicated
that omecamtiv mecarbil improved left ventricular (LV) systolic
function, LV end-diastolic volume and NT-proBNP over time,
suggesting potentially favorable ventricular remodeling and
progressive reduction in myocardial wall stress.
- Participated with Amgen in additional regulatory interactions
with the FDA, EMA and Health Canada to inform the design and
conduct of a potential Phase 3 development program for omecamtiv
mecarbil.
- Conducted clinical, regulatory, non-clinical and commercial
planning activities in collaboration with Amgen to support the
potential advancement of omecamtiv mecarbil to a Phase 3
development program.
- Expect to make a decision regarding the advancement of
omecamtiv mecarbil to Phase 3 in the third quarter of 2016.
Skeletal Muscle Program
tirasemtiv
- Recently announced that we have granted Astellas an option
right for the development and commercialization of tirasemtiv
outside of North America, Europe and other select countries.*
- Completing screening of 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.
- Expect to complete enrollment of VITALITY-ALS in August
2016. Expect data from VITALITY–ALS in the second half of
2017.
- Conducted regulatory interactions with each of FDA and EMA to
inform the design and conduct of an open-label extension clinical
trial for patients who complete VITALITY-ALS.
- Expect to begin an open-label extension trial for patients who
complete VITALITY-ALS in the fourth quarter of 2016.
CK-2127107
- Recently announced that we have amended our collaboration
agreement with Astellas to enable the development of CK-2127107 for
the potential treatment of 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 second
half of 2016. Expect data from this clinical trial in
first half of 2017.
- Announced the start of a Phase 2 clinical trial of CK-2127017
in patients with COPD. Expect to complete enrollment and to analyze
data from this clinical trial in 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.
- Recently announced that we have extended our joint research
program with Astellas focused on the discovery of next-generation
skeletal muscle activators through 2017.*
- Anticipate potential advancement of one next-generation
compound from a joint research program into pre-clinical
development during 2016.
Corporate
- Expect to receive $65 million in committed capital from
Astellas which includes upfront payments for Astellas’ option right
exercisable for tirasemtiv and amended terms of the companies’
collaboration agreement to include ALS for CK-2127107. In
addition, Cytokinetics expects to receive approximately $30 million
in additional sponsored research and development funding through
2017 from Astellas.*
- Received 2016 Essey Commitment to a Cure Award from the ALS
Association Golden West Chapter.
- Announced appointment of Edward M. Kaye, M.D. to Cytokinetics
Board of Directors.
- Appointed Caryn McDowell, Cytokinetics’ General Counsel as
Chief Compliance Officer.
- Rang the closing bell at NASDAQ accompanied by leaders of the
ALS Association in recognition of ALS Awareness month and the
company’s commitment to education, awareness, research and
development activities focused to amyotrophic lateral sclerosis
(ALS).
* The effectiveness of the amended agreement with
Astellas is subject to clearance under the Hart-Scott-Rodino
Antitrust Improvements Act.
Financials
Revenues for the second quarter of 2016 were
$5.8 million, compared to $6.5 million during the same period in
2015. Revenues for the second quarter of 2016 included $2.9
million of research and development revenues and $1.9 million of
license revenues from our collaboration with Astellas, $0.6 million
in research and development revenues from our collaboration with
Amgen and $0.3 million in research and development revenues from
our collaboration with ALSA. Revenues for the same period in 2015
were comprised of $3.0 million of license revenues and $2.9 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 decrease in revenues for the
second quarter of 2016, compared with the same period in 2015, was
mainly due to timing of license revenue recorded under the Astellas
collaboration agreement, due to the extension of the timeframe of
development services.
Total research and development (R&D)
expenses for the second quarter of 2016 were $9.7 million, compared
to $12.6 million for the same period in 2015. The $2.9 million
decrease in R&D expenses for the second quarter of 2016,
compared with the same period in 2015, was primarily due to a
decrease of $2.3 million in outsourced preclinical costs associated
with clinical manufacturing activities, and a decrease of $1.7
million in outsourced clinical costs, partially offset by an
increase of $1.3 million in personnel related expenses due to
increased headcount costs. The decrease in outsourced clinical
costs was comprised of an increase of $2.8 million in outsourced
clinical costs mainly associated with the ongoing VITALITY-ALS
trial, offset by a $4.5 million litigation settlement in June 2016
from a contract research organization for our Phase 2 BENEFIT-ALS
clinical trial which was concluded in 2014.
Total general and administrative (G&A)
expenses for the second quarter of 2016 were $7.1 million compared
to $4.5 million for the same period in 2015. The $2.6 million
increase in G&A expenses for the second 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 $0.7 million in outsourced costs related
to accounting and finance and commercial development, and an
increase of $0.8 million in corporate and patent legal fees.
Revenues for the six months ended June 30, 2016
were $14.2 million, compared to $11.0 million for the same period
in 2015. Revenues for the first six months of 2016 included $6.6
million of research and development revenues and $5.9 million of
license revenues from our collaboration with Astellas, $1.2 million
of research and development revenues from our collaboration with
Amgen, and $0.5 million in research and development revenues from
our collaboration with ALSA. Revenues for the same period in 2015
included $5.0 million of research and development revenues and $4.7
million of license revenues from our collaboration with Astellas,
and $1.3 million of research and development revenues from our
collaboration with Amgen.
Total R&D expenses for the six months ended
June 30, 2016 were $23.3 million, compared to $21.6 million for the
same period in 2015. The $1.7 million increase in R&D expenses
in the first six months of 2016, over the same period in 2015, was
primarily due to an increase of $2.4 million in outsourced clinical
costs and an increase of $2.3 million in personnel related expenses
due to increased headcount, partially offset by a decrease of $2.9
million in outsourced preclinical costs associated with clinical
manufacturing activities. The increase in outsourced clinical costs
was comprised of an increase of $6.9 million in outsourced clinical
costs mainly associated with the ongoing VITALITY-ALS trial, offset
by a $4.5 million settlement in June 2016 with a contract research
organization for our Phase 2 BENEFIT-ALS clinical trial which was
concluded in 2014.
Total G&A expenses for the six months ended
June 30, 2016 were $13.9 million, compared to $8.9 million for the
same period in 2015. The $5.0 million increase in G&A spending
in the first six months of 2016 compared to the same period in
2015, was primarily due to an increase of $2.1 million in personnel
related expenses due to increased non-cash stock compensation
expense and increased headcount, an increase of $1.3 million in
outsourced costs related to accounting and finance and commercial
development, and an increase of $1.4 million in corporate and
patent legal fees.
The net loss for the six months ended June 30,
2016, was $24.1 million, or $0.61 per basic and diluted share,
compared to a net loss of $19.4 million, or $0.50 per basic and
diluted share, for the same period in 2015.
Financial Guidance
We will not update our financial guidance until
our Q3 Earnings due to the recent expansion of our collaboration
with Astellas; at that time we expect to provide updated 2016
financial guidance on both a cash and GAAP basis.
Conference Call and Webcast
Information
Members of Cytokinetics' senior management team
will review the company's second 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 29639098.
An archived replay of the webcast will be
available via Cytokinetics' website until August 4. 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 29639098 from July
28, 2016 at 5:30 PM Eastern Time until August 4, 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
retains the right to develop and commercialize tirasemtiv, subject
to Astellas Pharma Inc.’s option. 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 to
develop CK-2127107, a fast skeletal muscle activator, for the
potential treatment of spinal muscular atrophy, chronic obstructive
pulmonary disease and ALS. 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 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
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 |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
June 30, |
|
June 30, |
|
|
2016 |
2015 |
|
2016 |
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenues
from |
|
|
|
|
|
|
|
|
|
|
|
|
|
related parties |
$ |
|
3,515 |
|
|
$ |
3,510 |
|
|
$ |
|
7,811 |
|
|
$ |
6,301 |
|
Research and development, grant and
other |
|
|
|
|
|
|
|
|
|
|
|
|
|
revenues |
|
|
337 |
|
|
|
— |
|
|
|
|
488 |
|
|
|
— |
|
License revenues from related
parties |
|
|
1,950 |
|
|
|
3,032 |
|
|
|
|
5,923 |
|
|
|
4,655 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
5,802 |
|
|
|
6,542 |
|
|
|
|
14,222 |
|
|
|
10,956 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
9,723 |
|
|
|
12,636 |
|
|
|
|
23,256 |
|
|
|
21,592 |
|
General and administrative |
|
|
7,090 |
|
|
|
4,495 |
|
|
|
|
13,931 |
|
|
|
8,862 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
16,813 |
|
|
|
17,131 |
|
|
|
|
37,187 |
|
|
|
30,454 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(11,011 |
) |
|
|
(10,589 |
) |
|
|
|
(22,965 |
) |
|
|
(19,498 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
and other income(expense), net |
|
|
(600 |
) |
|
|
38 |
|
|
|
|
(1,101 |
) |
|
|
75 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
$ |
|
(11,611 |
) |
|
$ |
(10,551 |
) |
|
$ |
|
(24,066 |
) |
|
$ |
(19,423 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share – basic and diluted |
$ |
|
(0.29 |
) |
|
$ |
(0.27 |
) |
|
$ |
|
(0.61 |
) |
|
$ |
(0.50 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares used in computing net loss per share – basic and
diluted |
|
|
39,666 |
|
|
|
38,725 |
|
|
|
|
39,629 |
|
|
|
38,700 |
|
Cytokinetics, Incorporated |
|
Condensed Consolidated Balance
Sheets |
|
(in thousands)
(unaudited) |
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2016 |
|
|
2015(1) |
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
27,724 |
|
$ |
65,076 |
|
|
|
|
|
|
|
|
Short
term investments |
|
62,614 |
|
|
46,366 |
|
|
|
|
|
|
|
|
Related
party accounts receivable |
|
26 |
|
|
12 |
|
|
|
|
|
|
|
|
Prepaid
and other current assets |
|
6,254 |
|
|
1,653 |
|
|
|
|
|
|
|
|
Total
current assets |
|
96,618 |
|
|
113,107 |
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
1,659 |
|
|
1,751 |
|
|
|
|
|
|
|
|
Long-term investments |
|
7,684 |
|
|
179 |
|
|
|
|
|
|
|
|
Other
assets |
|
200 |
|
|
200 |
|
|
|
|
|
|
|
|
Total assets |
$ |
106,161 |
|
$ |
115,237 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred
revenue, current |
$ |
13,559 |
|
$ |
20,858 |
|
|
|
|
|
|
|
|
Other
current liabilities |
|
12,713 |
|
|
10,791 |
|
|
|
|
|
|
|
|
Total
current liabilities |
|
26,272 |
|
|
31,649 |
|
|
|
|
|
|
|
|
Long-term debt |
|
29,604 |
|
|
14,639 |
|
|
|
|
|
|
|
|
Deferred
revenue, non-current |
|
1,275 |
|
|
— |
|
|
|
|
|
|
|
|
Other
non-current liabilities |
|
264 |
|
|
359 |
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
48,746 |
|
|
68,590 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
106,161 |
|
$ |
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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