Company Summarizes Recent Progress in Development Programs and Provides Expected
Milestones and Financial Guidance for 2014
SOUTH SAN FRANCISCO, CA, February 6, 2014 - Cytokinetics, Incorporated (Nasdaq:
CYTK) reported total revenues of $24.3 million for the fourth quarter of 2013,
compared to $2.2 million during the same period in 2012. Net income for the
fourth quarter was $6.5 million, or $0.22 per basic share and $0.21 per diluted
share. Â This is compared to a net loss for the same period in 2012, of $(11.5)
million, or $(0.48) per basic and diluted share. Â As of December 31, 2013, cash,
cash equivalents and investments totaled $80.2 million.
"During the fourth quarter, Cytokinetics announced significant progress in both
our clinical development programs. Â The recent completion of enrollment in
BENEFIT-ALS shifts focus to finalizing patient treatment and the collection and
analyses of data," stated Robert I. Blum, Cytokinetics' President and Chief
Executive Officer. "We anticipate announcing results from BENEFIT-ALS in the
next few months and are now busily preparing for potential next steps in our
development program for tirasemtiv. Â In parallel, we are pleased with the
planned advancement of omecamtiv mecarbil into the final expansion phase of
COSMIC-HF and with the continued progression of CK-2127107 in Phase I studies
and Phase II readiness activities. Â Cytokinetics executed on operational and
financial objectives in 2013 setting the stage for another productive year
ahead."
Company Highlights
Skeletal Muscle Contractility
tirasemtiv
* During the quarter, Cytokinetics completed enrollment in BENEFIT-ALS
(Blinded Evaluation of Neuromuscular Effects and Functional Improvement with
Tirasemtiv in ALS). Â BENEFIT-ALS is 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). Â Enrollment closed with 711
patients and, to date, over 400 patients have completed 12 weeks of
treatment.
* Recently, the Data Safety Monitoring Board (DSMB) for BENEFIT-ALS reviewed
data relating to safety, tolerability and potential efficacy of tirasemtiv
from the ongoing trial. Â The DSMB recommended that the trial proceed to
completion without any changes to the protocol.
* During the quarter, Cytokinetics continued to make preparations for the
potential further development and the commercialization of tirasemtiv.
 These activities included interactions with regulatory authorities and
other manufacturing, corporate development and commercial planning
activities to support planning scenarios.
* During the quarter, a platform presentation providing an update on BENEFIT-
ALS was made at the International Symposium on ALS/MND. Â In the
presentation, the clinical trial design was explained and interim, double-
blind, aggregate data on patient enrollment, baseline demographics, dose
escalation, and tolerability were presented.
CK-2127107
* During the quarter, Cytokinetics presented data from CY 5011, a first-time-
in-humans, Phase I clinical trial of CK-2127107 in healthy male volunteers.
CY 5011 was a double-blind, randomized, placebo-controlled study designed to
assess the safety, tolerability, and pharmacokinetics of single ascending
oral doses of CK-2127107 administered in a three-period crossover design.
 Planned single doses of CK-2127107 up to 4000 mg, the highest dose
administered in this trial were well-tolerated. Â A maximum tolerated dose
was not defined. The pharmacokinetic profile of CK-2127107 was linear and
dose-proportional across the dose range studied, with a mean terminal half-
life compatible with once or twice daily dosing.
* During the quarter, Cytokinetics completed dosing in CY 5014, a Phase I
clinical trial of CK-2127107 in healthy male volunteers. Â CY 5014 is a
randomized, open-label, 2-period crossover study designed to assess the
relative oral bioavailability, pharmacokinetics, safety and tolerability of
two oral formulations of CK-2127107.
The clinical trials of CK-2127107 described above are being conducted by
Cytokinetics in collaboration with Astellas Pharma Inc.
Cardiac Muscle Contractility
omecamtiv mecarbil
* Recently, Cytokinetics and Amgen agreed to amend the protocol to evaluate a
plasma concentration-guided dose titration strategy in the expansion phase
of COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase
Contractility in Heart Failure). Â The size of the expansion phase also has
been increased with the objective to provide greater statistical power for
the planned evaluation of several pharmacodynamic parameters during oral
dosing with omecamtiv mecarbil. Â This trial is being conducted by Amgen in
collaboration with Cytokinetics.
* Recently, Cytokinetics and Amgen began making preparations for CY 1211, a
Phase I single center, placebo-controlled, double-blind study comparing the
pharmacokinetics of omecamtiv mecarbil between healthy Japanese and
Caucasian volunteers. Â This trial is being conducted by Cytokinetics in
collaboration with Amgen.
* Cytokinetics is collaborating with Amgen to respond to information requests
received from regulatory authorities relating to their ongoing review of
protocols submitted for COSMIC-HF and CY 1211.
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. Â In addition, the company continued research activities directed
to other muscle biology programs.
Financials
Revenues for the fourth quarter of 2013 were $24.3 million, compared to $2.2
million during the same period in 2012. Â Revenues for the fourth quarter of
2013 included $2.4 million of license revenues and $4.1 million of research and
development revenues from our collaboration with Astellas and $17.2 million of
license revenues and $0.6 million of research and development revenues from our
collaboration with Amgen. Â Revenues for the same period in 2012 included $0.9
million of revenue from our collaboration with Amgen, $0.4 million in grant
revenue, $0.5 million of revenue from our collaboration with MyoKardia and $0.4
million in revenue from our collaboration with Global Blood Therapeutics, Inc.
Total research and development (R&D) expenses in the fourth quarter of 2013 were
$13.8 million, compared with $9.9 million for the same period in 2012. Â The $3.9
million increase in R&D expenses for the fourth quarter of 2013, compared with
the same period in 2012, was primarily due to increased spending for outsourced
clinical and preclinical costs.
Total general and administrative (G&A) expenses for the fourth quarter of 2013
were $4.1 million, compared with $3.8 million for the same period in 2012. Â The
$0.3 million increase in G&A expenses in the fourth quarter of 2013, compared
with the same period in 2012, was primarily due to increased spending for
corporate development planning.
Revenues for the twelve months ended December 31, 2013 were $30.6 million,
compared to $7.6 million for the same period in 2012. Revenues for the twelve
months ended December 31, 2013 primarily consisted of $3.9 million of license
revenues and $6.4 million of research and development revenues from our
collaboration with Astellas, $17.2 million of license revenue and $2.0 million
of research and development revenues from our collaboration with Amgen and $1.0
million in revenue from our collaboration with MyoKardia. Revenues for the same
period in 2012 included $4.2 million of revenue from our collaboration with
Amgen, $1.3 million in grant revenue, and $1.5 million of revenue from our
collaboration with Global Blood Therapeutics and $0.6 million of revenue from
our collaboration with MyoKardia.
Total R&D expenses for the twelve months ended December 31, 2013 were $49.5
million, compared to $35.6 million for the same period in 2012. The $13.9
million increase in R&D expenses in the twelve months of 2013, over the same
period in 2012, was primarily due to increased spending for outsourced clinical
and laboratory costs, partially offset by decreased spending for outsourced
preclinical expenses.
Total G&A expenses for the twelve months ended December 31, 2013 were $15.1
million, compared to $12.4 million for the same period in 2012. The $2.7 million
increase in G&A spending in the twelve months of 2013 compared to the same
period in 2012 was primarily due to increased spending for personnel-related
costs, outside services and legal expenses.
The net loss allocable to common stockholders for the twelve months ended
December 31, 2013 was $(33.7) million, or $(1.24) per basic and diluted share.
 The net loss allocable to common stockholders for the same period in 2012 was
$(41.7) million, or $(2.30) per basic and diluted share, which included a one-
time, non-cash dividend of $1.3 million related to the beneficial conversion
feature of the Series B convertible preferred stock.
Financial Guidance 2014
Cytokinetics also announced its financial guidance for 2014. The company
anticipates cash revenue will be in the range of $19 to $21 million, cash R&D
expenses will be in the range of $50 to $53 million, and cash G&A expenses will
be in the range of $15 to $17 million. Â This guidance is on a cash basis and
does not include approximately $10 million in revenue deferred from 2013 to
2014 under generally accepted accounting principles and an estimated $3 million
in non-cash related operating expenses primarily related to stock compensation
expense. In addition, this guidance does not reflect potential revenues from
milestone payments that may be achieved in partnered programs.
Company Milestones
Skeletal Muscle Contractility
tirasemtiv
* Cytokinetics expects to report data from BENEFIT-ALS at the American Academy
of Neurology Annual Meeting in Philadelphia in April 2014.
CK-2127107
* Cytokinetics expects to conduct additional Phase I studies and certain Phase
II readiness activities in 2014 pursuant to our collaboration agreement with
Astellas.
Cardiac Muscle Contractility
omecamtiv mecarbil
* Cytokinetics expects commencement of patient enrollment in both the
expansion phase of COSMIC-HF and in CY 1211 to occur in the first half of
2014 following regulatory authorities' review of responses relating to
information requests provided in connection with the protocols submitted for
the two trials.
* Cytokinetics expects both the enrollment of patients in the expansion phase
of COSMIC-HF as well as the conduct of CY 1211 to be completed in 2014.
Conference Call and Webcast Information
Members of Cytokinetics' senior management team will review the company's fourth
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 34948581.
An archived replay of the webcast will be available via Cytokinetics' website
until February 13, 2014. Â 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 34948581 from February 6, 2014 at
5:30 PM Eastern Time until February 13, 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
currently 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 Act's Safe Harbor for forward-looking
statements. Examples of such statements include, but are not limited to,
statements relating to Cytokinetics' financial guidance, including expected
revenue and R&D and G&A expenses for 2014; Cytokinetics' and its partners'
research and development activities, including the initiation, conduct, design,
enrollment, progress, continuation, completion and results of clinical trials,
the anticipated timing for the availability of clinical trial results and
planned presentations of such results, and the significance and utility of
clinical trial results; the further development and commercialization of
tirasemtiv; 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, Cytokinetics anticipates that it will be required
to conduct at least one confirmatory Phase III clinical trial of tirasemtiv in
ALS patients which will require significant additional funding, and it 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; 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; 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
Cytokinetics, Incorporated
Condensed Statements of Operations
(in thousands, except per share data)
(unaudited)
  Three Months Ended  Year Ended
---------------------------- -----------------------------
 December  December
31, December 31, 31, December 31,
 2013 2012  2013  2012
------------ --------------- ------------ ----------------
Revenues:
Research and
development $ 4,677 Â $ 2,184 Â $ 9,566 Â $ 7,559
License and
technology fees  19,672   -   21,082   -
------------ ------------- ---------- --------------
Total revenues  24,349   2,184   30,648   7,559
------------ ------------- ---------- --------------
Operating Expenses:
Research and
development  13,824   9,857   49,450   35,643
General and
administrative  4,093   3,815   15,092   12,429
Restructuring  -   -   -   (56)
------------ ------------- ---------- --------------
Total operating
expenses  17,917   13,672   64,542   48,016
------------ ------------- ---------- --------------
Operating income
(loss) Â 6,432 Â Â (11,488 ) Â (33,894 ) Â (40,457 )
Interest and other,
net  99   33   177   87
------------ ------------- ---------- --------------
Net income (loss) Â 6,531 Â Â (11,455 ) Â (33,717 ) Â Â (40,370 )
Deemed dividend
related to
beneficial
conversion feature
of convertible
preferred stock  -   -   -   (1,307 )
----------------------------------------------------------
Net income (loss)
allocable to common
stockholders  6,531   (11,455 )  (33,717 )  (41,677 )
---------- ------------- ---------- --------------
Net income (loss)
per share allocable
to common
stockholders -
basic $ 0.22 Â $ (0.48 ) $ (1.24 ) $ (2.30 )
Net income (loss)
per share allocable
to common
stockholders -
diluted $ 0.21 Â $ (0.48 ) $ (1.24 ) $ (2.30 )
Weighted average
shares used in
computing net
income (loss) per
share allocable to
common stockholders
- basic  29,836   23,740   27,275   18,107
Weighted average
shares used in
computing net
income (loss) per
share allocable to
common stockholders
- diluted  31,190   23,740   27,275   18,107
Cytokinetics, Incorporated
Condensed Balance Sheets
(in thousands)
(unaudited)
  December 31,   December 31,
  2013   2012
-------------- --------------
Assets
Cash and cash equivalents $ 20,158 Â $ 14,907
Short term investments  57,570   59,093
Related party receivables  5   4
Other current assets  1,605   2,423
-------------- --------------
Total current assets  79,338   76,427
Property and equipment, net  1,221   997
Long-term investments  2,502   -
Other assets  127   127
-------------- --------------
Total assets $ 83,188 Â $ 77,551
-------------- --------------
Liabilities and stockholders' equity
Deferred revenue, current $ 14,701 Â $ -
Other current liabilities  12,003   7,105
-------------- --------------
Total current liabilities  26,704   7,105
Deferred revenue, non-current  1,500   -
Other non-current liabilities  542   361
Stockholders' equity  54,442   70,085
-------------- --------------
Total liabilities and stockholders' equity $ 83,188 Â $ 77,551
-------------- --------------
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Cytokinetics, Inc. via GlobeNewswire
[HUG#1759665]