UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
|
|
|
Date of Report (Date of Earliest Event Reported):
|
|
October 29, 2015
|
Cytokinetics, Incorporated
__________________________________________
(Exact name of registrant as specified in its charter)
|
|
|
Delaware
|
000-50633
|
94-3291317
|
_____________________
(State or other jurisdiction
|
_____________
(Commission
|
______________
(I.R.S. Employer
|
of incorporation)
|
File Number)
|
Identification No.)
|
|
|
|
280 East Grand Avenue, South San Francisco, California
|
|
94080
|
_________________________________
(Address of principal executive offices)
|
|
___________
(Zip Code)
|
|
|
|
Registrants telephone number, including area code:
|
|
(650) 624 - 3000
|
Not Applicable
______________________________________________
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02 Results of Operations and Financial Condition.
On October 29, 2015, Cytokinetics, Incorporated issued a press release announcing its results for the third quarter ended September 30, 2015. A copy of the press release is being filed as Exhibit 99.1 to this Current Report and is hereby incorporated by reference into this item 2.02.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
The following Exhibits are filed as part of this Current Report on Form 8-K:
Exhibit No. Description
----------------------------------
99.1 Press Release, dated October 29, 2015.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
|
|
|
|
|
|
|
Cytokinetics, Incorporated
|
|
|
|
|
|
October 29, 2015
|
|
By:
|
|
/s/ Sharon Barbari
|
|
|
|
|
|
|
|
|
|
Name: Sharon Barbari
|
|
|
|
|
Title: Executive Vice President, Finance and Chief Financial Officer
|
Exhibit Index
|
|
|
Exhibit No.
|
|
Description
|
|
|
|
99.1
|
|
Press Release, dated October 29, 2015
|
CYTOKINETICS, INC. REPORTS THIRD QUARTER 2015 FINANCIAL RESULTS
Recently Announced Positive Top-line Results From COSMIC-HF; Data Demonstrated Statistically
Significant Improvements in Several Pre-Specified Measures of Cardiac Function
Company Lowers 2015 R&D Expense Guidance
SOUTH SAN FRANCISCO, CA, October 29, 2015 - 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 companys 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 Acts 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 managements 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; Amgens 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.
Contact:
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(650) 624-3000
1
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 |
|
2
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 Companys
Annual Report on Form 10-K for the year ended December 31, 2014.
3
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Apr 2023 to Apr 2024