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):
|
|
July 30, 2014
|
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 July 30, 2014, Cytokinetics, Incorporated issued a press release announcing its results for the second quarter ended June 30, 2014. 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 July 30, 2014.
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
|
|
|
|
|
|
July 30, 2014
|
|
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 July 30, 2014
|
CYTOKINETICS, INCORPORATED REPORTS SECOND QUARTER 2014 FINANCIAL RESULTS
Company Provides Updates to Development Programs Focused to Muscle Biology
SOUTH SAN FRANCISCO, CA, July 30, 2014 Cytokinetics, Incorporated (Nasdaq: CYTK) reported total
research and development revenues for the second quarter of 2014 were $7.8 million, compared to
$1.0 million during the same period in 2013. The net loss for the second quarter was $8.4 million,
or $0.23 per basic and diluted share. This is compared to a net loss for the same period in 2013,
of $15.0 million, or $0.58 per basic and diluted share. As of June 30, 2014, cash, cash
equivalents and investments totaled $92.1 million.
In the second quarter, we conducted additional pre-specified analyses of data arising from
BENEFIT-ALS and consulted with expert neuromuscular and pulmonary specialists with the objective to
better understand the significance of the effects of tirasemtiv on respiratory function and its
implications for the potential further development of our novel mechanism skeletal muscle
activator, stated Robert I. Blum, Cytokinetics President and Chief Executive Officer. Potential
next steps in the development of tirasemtiv will be defined by our continuing analysis of results
from this Phase IIb clinical trial as well as our expected interactions with regulatory authorities
and possible corporate partners. In the meantime, we continue to advance our heart failure
program with Amgen and our skeletal muscle program with Astellas and look forward to important
milestones from both of these programs.
Company Highlights
Skeletal Muscle Contractility
tirasemtiv
|
|
|
During the quarter, Cytokinetics announced further results from BENEFIT-ALS (Blinded
Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS) at
the Joint Congress of European Neurology. BENEFIT-ALS was a Phase IIb, multinational,
double-blind, randomized, placebo-controlled clinical trial designed to evaluate the
safety, tolerability and potential efficacy of tirasemtiv in patients with amyotrophic
lateral sclerosis (ALS). The differences in the decline in Slow Vital Capacity (SVC, a
measure of the strength of the skeletal muscles responsible for breathing) on tirasemtiv
versus placebo observed after 12 weeks of double-blind treatment were maintained for up to
4 weeks after discontinuation of treatment. |
|
|
|
Recently, Cytokinetics announced the results relating to tirasemtiv from pre-specified
subgroup analyses of BENEFIT-ALS at the 13th International Congress on Neuromuscular
Diseases. The results indicate that reduced declines in SVC on tirasemtiv versus placebo
were observed consistently across all subgroups of patients in BENEFIT-ALS that were
examined. |
|
|
|
During the quarter, Cytokinetics announced that data from preclinical research relating
to tirasemtiv in mouse models of spinal muscular atrophy (SMA) were presented at the 2014
Annual Spinal Muscular Atrophy Conference. In these models, tirasemtiv increased muscle
force and improved grip strength, grid hang time, and resistance to fatigue. These studies
were supported in part by a grant from the Families of Spinal Muscular Atrophy. |
|
|
|
During the quarter, Cytokinetics announced the publication of three peer-reviewed
manuscripts relating to tirasemtiv and fast skeletal muscle troponin activation in the
journals PLOS ONE, Muscle & Nerve, and the American Journal of Respiratory and Critical
Care Medicine. These papers elaborated on the mechanistic effects of tirasemtiv and
related compounds in humans as well as in a mouse model of ALS. |
CK-2127107
|
|
|
During the quarter, Cytokinetics continued to enroll patients in CY 5012, a
double-blind, randomized, placebo-controlled, multiple ascending dose, parallel group study
intended to assess the safety, tolerability, and pharmacokinetics of CK-2127107 following
multiple ascending doses in healthy volunteers. |
|
|
|
During the quarter, Cytokinetics initiated and completed enrollment in CY 5013, a Phase
I randomized, placebo-controlled, single dose, 4-period crossover study of CK-2127107 in
healthy male volunteers. CY 5013 is designed to evaluate the change in the force-frequency
profile and its relationship to dose and plasma concentrations of CK-2127107. |
These trials are being conducted by Cytokinetics in collaboration with Astellas.
Cardiac Muscle Contractility
omecamtiv mecarbil
|
|
|
During the quarter, enrollment continued in the expansion phase of COSMIC-HF (Chronic
Oral Study of Myosin Activation to Increase Contractility in Heart Failure). COSMIC-HF is a
Phase II, double-blind, randomized, placebo-controlled, multicenter clinical trial designed
to assess the pharmacokinetics and tolerability of omecamtiv mecarbil dosed orally in
patients with heart failure and left ventricular systolic dysfunction as well as its
effects on echocardiographic measures of cardiac function. The expansion phase of
COSMIC-HF has enrolled over 150 of the 450 planned heart failure patients from 95 clinical
sites in 13 countries. This trial is being conducted by Amgen in collaboration with
Cytokinetics. |
|
|
|
During the quarter, Cytokinetics initiated dosing in CY 1211, a Phase I single center,
placebo-controlled, double-blind study comparing the pharmacokinetics of omecamtiv mecarbil
between healthy Japanese and Caucasian volunteers. This trial is being conducted by
Cytokinetics in collaboration with Amgen. |
Additional information on COSMIC-HF and other clinical trials of omecamtiv mecarbil can be found
at www.clinicaltrials.gov.
Pre-Clinical Research
|
|
|
During the quarter, Cytokinetics continued to conduct research under our joint research
program with Amgen, directed to the discovery of next-generation cardiac sarcomere
activators, and our joint research program with Astellas, directed to the discovery of
next-generation skeletal muscle activators. In addition, the company continued research
activities directed to other muscle biology programs. |
Financials
Revenues for the second quarter of 2014 were $7.8 million, compared to $1.0 million during the same
period in 2013. Revenues for the second quarter of 2014 included $4.2 million of research and
development revenues and $2.7 million of license revenues from Cytokinetics collaboration with
Astellas, and $0.8 million of research and development revenues from Cytokinetics collaboration
with Amgen. Revenues for the same period in 2013 included $0.4 million of revenue from
Cytokinetics collaboration with MyoKardia, Inc., $0.6 million of revenue from Cytokinetics
collaboration with Amgen, and $36,000 of grant revenue.
Total research and development (R&D) expenses in the second quarter of 2014 were $11.7 million,
compared with $12.3 million for the same period in 2013. The $0.6 million decrease in R&D expenses
for the second quarter of 2014, compared with the same period in 2013, was primarily due to a
decrease of $2.5 million in outsourced clinical costs partially offset by an increase of $1.0
million in outsourced pre-clinical costs and an increase of $0.7 million in personnel expenses.
Total general and administrative (G&A) expenses for the second quarter of 2014 were $4.5 million,
compared with $3.7 million for the same period in 2013. The $0.8 million increase in G&A expenses
in the second quarter of 2014, compared with the same period in 2013, was primarily due to an
increase of $0.8 million in outside services costs related to commercial development and medical
affairs, partially offset by a decrease of $0.2 million in legal expenses.
Revenues for the six months ended June 30, 2014 were $15.8 million, compared to $1.8 million for
the same period in 2013. Revenues for the first six months of 2014 included $9.4 million of
research and development revenues and $4.8 million of license revenues from Cytokinetics
collaboration with Astellas, and $1.5 million of research and development revenues from
Cytokinetics collaboration with Amgen. Revenues for the same period in 2013 included $0.9 million
of research and development expenses from Cytokinetics collaboration with Amgen collaboration,
$0.8 million revenue from Cytokinetics collaboration with MyoKardia and $0.1 million of grant
revenue.
Total R&D expenses for the six months ended June 30, 2014 were $24.2 million, compared to $22.2
million for the same period in 2013. The $2.0 million increase in R&D expenses in the first six
months of 2014, over the same period in 2013, was primarily due to an increase of $2.5 million in
outsourced pre-clinical costs and an increase of $1.5 million in personnel expenses, partially
offset by a decrease of $2.5 million in outsourced clinical costs.
Total G&A expenses for the six months ended June 30, 2014 were $8.7 million, compared to $7.4
million for the same period in 2013. The $1.3 million increase in G&A spending in the first six
months of 2014 compared to the same period in 2013, was primarily due to an increase of $1.4
million in outside services costs related to commercial development, partially offset by a decrease
of $0.3 million in legal expenses.
The net loss for the six months ended June 30, 2014, was $17.1 million, or $0.49 per basic and
diluted share, compared to a net of $27.7 million, or $1.11 per basic and diluted share, for the
same period in 2013.
Company Milestones
Skeletal Muscle Contractility
tirasemtiv
|
|
|
Cytokinetics expects to interact with regulatory authorities regarding a potential
development path for tirasemtiv in the second half of 2014. |
CK-2127107
|
|
|
Cytokinetics expects to conduct additional Phase I studies and certain Phase II
readiness activities for CK-2127107 in 2014 pursuant to our collaboration agreement with
Astellas. |
Cardiac Muscle Contractility
omecamtiv mecarbil
|
|
|
Cytokinetics expects both the enrollment of patients in the expansion phase of COSMIC-HF
and the conduct of CY 1211 to be completed in 2014. |
Conference Call and Webcast Information
Members of Cytokinetics senior management team will review the companys second quarter results
via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed
through the Homepage and Investor Relations 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 34950990.
An archived replay of the webcast will be available via Cytokinetics website until August 6, 2014.
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 34950990 from July 30, 2014 at
5:30 PM Eastern Time until August 6, 2014.
About Cytokinetics
Cytokinetics is a clinical-stage biopharmaceutical company focused on the discovery and development
of novel small molecule therapeutics that modulate muscle function for the potential treatment of
serious diseases and medical conditions. Cytokinetics lead drug candidate from its cardiac muscle
contractility program, omecamtiv mecarbil, is in Phase II clinical development for the potential
treatment of heart failure. Amgen Inc. holds an exclusive license worldwide to develop and
commercialize omecamtiv mecarbil and related compounds, subject to Cytokinetics specified
development and commercialization participation rights. Cytokinetics is independently developing
tirasemtiv, a fast skeletal muscle activator, as a potential treatment for diseases and medical
conditions associated with neuromuscular dysfunction. Tirasemtiv is the subject of a Phase II
clinical trials program and 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 amyotrophic lateral sclerosis (ALS). Cytokinetics
is collaborating with Astellas Pharma Inc. to develop CK-2127107, a skeletal muscle activator
structurally distinct from tirasemtiv, for non-neuromuscular indications. All of these drug
candidates have arisen from Cytokinetics muscle biology focused research activities and are
directed towards the cytoskeleton. The cytoskeleton is a complex biological infrastructure that
plays a fundamental role within every human cell. Additional information about Cytokinetics can be
obtained at 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 the
initiation, conduct, design, enrollment, progress, continuation, completion and results of clinical
trials and preclinical research, the potential significance and utility of the results from such
trials and research, planned further analyses of the results from BENEFIT-ALS and the potential
outcomes of such analyses, potential further development of tirasemtiv, conduct of additional Phase
I clinical trials and Phase II readiness activities for CK-2127107 and the anticipated timing for
the occurrence of events; expected interactions with regulatory authorities and possible corporate
partners; and the properties and potential benefits of tirasemtiv and Cytokinetics other 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 will require significant additional funding, and
Cytokinetics may be unable to obtain such additional funding on acceptable terms, if at all;
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
Contact:
Joanna L. Goldstein
Manager, Investor Relations & Corporate Communications
(650) 624-3000
1
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, |
|
|
2014 |
|
|
|
|
|
2013 |
|
|
|
|
|
2014 |
|
|
|
|
|
2013 |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
revenues from related parties |
|
$ |
843 |
|
|
|
|
|
|
|
|
|
|
$ |
563 |
|
|
|
|
|
|
$ |
1,508 |
|
|
|
|
|
|
$ |
891 |
|
Research and development,
grant and other revenues |
|
|
4,196 |
|
|
|
|
|
|
|
|
|
|
|
446 |
|
|
|
|
|
|
|
9,428 |
|
|
|
|
|
|
|
939 |
|
License revenues |
|
|
2,749 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,831 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
7,788 |
|
|
|
|
|
|
|
|
|
|
|
1,009 |
|
|
|
|
|
|
|
15,767 |
|
|
|
|
|
|
|
1,830 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
11,737 |
|
|
|
|
|
|
|
|
|
|
|
12,347 |
|
|
|
|
|
|
|
24,227 |
|
|
|
|
|
|
|
22,181 |
|
General and administrative |
|
|
4,458 |
|
|
|
|
|
|
|
|
|
|
|
3,730 |
|
|
|
|
|
|
|
8,717 |
|
|
|
|
|
|
|
7,364 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
16,195 |
|
|
|
|
|
|
|
|
|
|
|
16,077 |
|
|
|
|
|
|
|
32,944 |
|
|
|
|
|
|
|
29,545 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(8,407 |
) |
|
|
|
|
|
|
|
|
|
|
(15,068 |
) |
|
|
|
|
|
|
(17,177 |
) |
|
|
|
|
|
|
(27,715 |
) |
Interest and other, net |
|
|
33 |
|
|
|
|
|
|
|
|
|
|
|
27 |
|
|
|
|
|
|
|
59 |
|
|
|
|
|
|
|
55 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(8,374 |
) |
|
|
|
|
|
|
|
|
|
$ |
(15,041 |
) |
|
|
|
|
|
$ |
(17,118 |
) |
|
|
|
|
|
$ |
(27,660 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share basic and diluted |
|
$ |
(0.23 |
) |
|
|
|
|
|
|
|
|
|
$ |
(0.58 |
) |
|
|
|
|
|
$ |
(0.49 |
) |
|
|
|
|
|
$ |
(1.11 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used in
computing net loss per share basic
and diluted |
|
|
36,443 |
|
|
|
|
|
|
|
|
|
|
|
25,773 |
|
|
|
|
|
|
|
34,724 |
|
|
|
|
|
|
|
24,896 |
|
2
Cytokinetics, Incorporated
Condensed Consolidated Balance Sheets
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2014 |
|
2013(1) |
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
12,355 |
|
|
$ |
20,158 |
|
Short term investments |
|
|
65,395 |
|
|
|
57,570 |
|
Accounts receivable and related party receivable |
|
|
319 |
|
|
|
5 |
|
Other current assets |
|
|
2,009 |
|
|
|
1,605 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
80,078 |
|
|
|
79,338 |
|
Property and equipment, net |
|
|
1,513 |
|
|
|
1,221 |
|
Long-term investments |
|
|
14,352 |
|
|
|
2,502 |
|
Other assets |
|
|
200 |
|
|
|
127 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
96,143 |
|
|
$ |
83,188 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders equity |
|
|
|
|
|
|
|
|
Deferred revenue, current |
|
$ |
8,984 |
|
|
$ |
14,701 |
|
Other current liabilities |
|
|
7,933 |
|
|
|
12,003 |
|
Total current liabilities |
|
|
16,917 |
|
|
|
26,704 |
|
Deferred revenue, non-current |
|
|
|
|
|
|
1,500 |
|
Other non-current liabilities |
|
|
529 |
|
|
|
542 |
|
Stockholders equity |
|
|
78,697 |
|
|
|
54,442 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
96,143 |
|
|
$ |
83,188 |
|
|
|
|
|
|
|
|
|
|
(1) Derived from the audited financial statements, included in the Companys
Annual Report on Form 10-K for the year ended December 31, 2013.
3
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Aug 2024 to Sep 2024
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Sep 2023 to Sep 2024