sv3
As filed
with Securities and Exchange Commission on June 13, 2011
Registration No. 333-_______
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT
Under
The Securities Act of 1933
CYTOKINETICS, INCORPORATED
(Exact name of Registrant as specified in its charter)
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Delaware
(State or other jurisdiction of
incorporation or organization)
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94-3291317
(I.R.S. Employer
Identification Number) |
280 East Grand Avenue
South San Francisco, California 94080
(650) 624-3000
(Address, including zip code, and telephone number, including area code, of Registrants principal executive offices)
Robert I. Blum
President & Chief Executive Officer
Cytokinetics, Incorporated
280 East Grand Avenue
South San Francisco, California 94080
(650) 624-3000
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copies to:
Robert Jones
Michael Tenta
Cooley LLP
3175 Hanover Street
Palo Alto, CA 94304
(650) 843-5000
Approximate date of commencement of proposed sale to the public: From time to time
after effective date of this registration statement.
If the only securities being registered on this Form are being offered pursuant to dividend or
interest reinvestment plans, please check the following box. o
If any of the securities being registered on this Form are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities
offered only in connection with dividend or interest reinvestment plans, check
the following
box.
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If this Form is filed to register additional securities for an offering pursuant to Rule
462(b) under the Securities Act, please check the following box and list the Securities Act
registration statement number of the earlier effective registration statement for the same
offering. o
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities
Act, check the following box and list the Securities Act registration statement number of the
earlier effective registration statement for the same offering. o
If this Form is a registration statement pursuant to General Instruction I.D. or a
post-effective amendment thereto that shall become effective upon filing with the Commission
pursuant to Rule 462(e) under the Securities Act, check the following box. o
If this Form is a post-effective amendment to a registration statement filed pursuant to
General Instruction I.D. filed to register additional securities or additional classes of
securities pursuant to Rule 413(b) under the Securities Act, check the following box.
o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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CALCULATION OF REGISTRATION FEE
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Proposed Maximum |
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Proposed Maximum |
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Title of Each Class of |
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Amount to be |
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Offering Price Per |
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Aggregate Offering |
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Amount of |
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Securities to be Registered |
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Registered |
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Unit |
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Price |
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Registration Fee (1) |
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Common Stock, $0.001 par
value |
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(2) |
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(2) |
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$20,000,000 |
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$2,322 |
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Total |
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$20,000,000 |
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$2,322 |
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(1) |
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Calculated pursuant to Rule 457(o) under the Securities Act. |
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(2) |
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There are being registered hereunder such indeterminate
number of common shares as shall have an aggregate initial
offering price not to exceed $20,000,000, which may be offered from time to time at currently indeterminable prices. In addition, pursuant to Rule 416 under the
Securities Act, the shares being registered hereunder
include such indeterminate number of common shares as may
be issuable with respect to the shares being registered
hereunder as a result of stock splits, stock dividends or
similar transactions. |
The Registrant hereby amends this registration statement on such date or dates as may be
necessary to delay its effective date until the Registrant shall file a further amendment which
specifically states that this registration statement shall thereafter become effective in
accordance with Section 8(a) of the Securities Act of 1933 or until the
registration statement shall become effective on such date as the Commission acting pursuant to
said Section 8(a) may determine.
THE INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED. WE MAY NOT SELL THESE
SECURITIES UNTIL THE REGISTRATION STATEMENT FILED WITH THE SECURITIES AND EXCHANGE COMMISSION IS
EFFECTIVE. THIS PROSPECTUS IS NOT AN OFFER TO SELL THESE SECURITIES AND IS NOT SOLICITING AN OFFER TO
BUY SECURITIES IN ANY STATE WHERE THE OFFER OR SALE IS NOT PERMITTED.
SUBJECT
TO COMPLETION, DATED JUNE 13, 2011
PROSPECTUS
$20,000,000
Cytokinetics, Incorporated
Common Stock
This prospectus relates to the issuance and sale of our common shares from time to time
through our sales agent, McNicoll, Lewis & Vlak LLC, or MLV. These sales, if any, will be made pursuant to
the terms of an At Market Issuance Sales Agreement entered into between us and our sales agent,
the form of which was filed with the Securities and Exchange Commission with the registration
statement of which this prospectus forms a part. Our sales agreement with MLV is limited to the sale of up to a number of common shares not to exceed the amount that can be
sold under the registration statement of which this prospectus forms a part, which amount, as of
the date of this prospectus, is $20.0 million.
Our
common stock is listed on The NASDAQ Global Market under the symbol
CYTK. On June 10,
2011, the last reported sale price of our common stock on The NASDAQ
Global Market was $1.18 per
share.
Sales of our common stock under this prospectus, if any, may be made in sales deemed to be
at-the-market equity offerings as defined in Rule 415 promulgated under the Securities Act of
1933, as amended, including sales made directly on or through The NASDAQ Global Market, the
existing trading market for our common stock, sales made to or through a market maker other than
on an exchange or otherwise, in negotiated transactions at market prices prevailing at the time of
sale or at prices related to such prevailing market prices, and/or any other method permitted by
law. MLV will act as a sales agent using commercially reasonable efforts consistent with its
normal trading and sales practices, on mutually agreed terms between MLV and us. There is no
arrangement for funds to be received in any escrow, trust or similar arrangement.
The compensation to MLV for sales of common stock sold pursuant to the sales agreement will
be an amount equal to 3.0% of the gross proceeds of the sales price per share. In connection with
the sale of the common stock on our behalf, MLV will be deemed to be an underwriter within the
meaning of the Securities Act of 1933, as amended, and the compensation of MLV will be deemed to
be underwriting commissions or discounts. We have also agreed to provide indemnification and
contribution to MLV with respect to certain liabilities, including liabilities under the
Securities Act of 1933, as amended.
Investing in our common stock involves a high degree of risk. Please read Risk
Factors beginning on page [*] of this prospectus and in the documents incorporated by
reference into this prospectus.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal offense.
The
date of the prospectus is , 2011.
TABLE OF CONTENTS
No person has been authorized to give any information or make any representations in
connection with this offering other than those contained or incorporated by reference in this
prospectus and any accompanying prospectus supplement in connection with the offering described
herein and therein, and, if given or made, such information or representations must not be relied
upon as having been authorized by us. Neither this prospectus nor any prospectus supplement shall
constitute an offer to sell or a solicitation of an offer to buy offered securities in any
jurisdiction in which it is unlawful for such person to make such an offering or solicitation.
Neither the delivery of this prospectus or any prospectus supplement nor any sale made hereunder
shall under any circumstances imply that the information contained or incorporated by reference
herein or in any prospectus supplement is correct as of any date subsequent to the date hereof or
of such prospectus supplement.
SUMMARY
The following summary is qualified in its entirety by the more detailed information, including
our consolidated financial statements and related notes incorporated in this prospectus by
reference. You should carefully consider the information set forth in this entire prospectus,
including the Risk Factors section, any accompanying prospectus supplement for such securities and
the other documents we refer to and incorporate by reference. Unless the context otherwise
requires, the terms Cytokinetics, we, us and our refer to Cytokinetics, Incorporated, a
Delaware corporation.
Cytokinetics, Incorporated
Our Business
We are 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. Our research and development activities relating to the
biology of muscle function have evolved from our knowledge and expertise regarding the
cytoskeleton, a complex biological infrastructure that plays a fundamental role within every human
cell. Our current research and development programs relating to the biology of muscle function are
directed to small molecule modulators of the contractility of cardiac, skeletal and smooth muscle.
Our cardiac muscle contractility program is focused on the cardiac sarcomere, the basic unit
of muscle contraction in the heart. Our lead drug candidate from this program, omecamtiv mecarbil
(formerly known as CK-1827452), is a novel cardiac muscle myosin activator. We have conducted a
clinical development program for omecamtiv mecarbil for the potential treatment of heart failure,
comprised of a series of Phase I and Phase IIa clinical trials. In May 2009, Amgen, Inc. (Amgen)
acquired an exclusive license to develop and commercialize omecamtiv mecarbil worldwide, except
Japan, subject to our development and commercialization participation rights.
CK-2017357 is the lead drug candidate from our skeletal sarcomere activator program. The
skeletal muscle sarcomere is the basic unit of skeletal muscle contraction. CK-2017357 is currently
the subject of a Phase IIa clinical trials program. We believe CK-2017357 may be useful in treating
diseases or medical conditions associated with skeletal muscle weakness or wasting. CK-2017357 has
received an orphan drug designation from the FDA for the treatment of amyotrophic lateral sclerosis
(also known as ALS or Lou Gehrigs disease). We are also advancing a second, structurally distinct,
fast skeletal muscle sarcomere activator, CK-2066260, in non-clinical studies intended to enable
the filing of an investigational new drug application (IND) with the U.S. Food and Drug
Administration (FDA). Both of these compounds selectively activate the fast skeletal muscle
troponin complex, which is a set of regulatory proteins that modulates the contractility of the
fast skeletal muscle sarcomere.
In our smooth muscle contractility program, we are conducting non-clinical development of
compounds that directly inhibit smooth muscle myosin, the motor protein central to the contraction
of smooth muscle. These compounds cause the relaxation of contracted smooth muscle, and so may be
useful as potential treatments for diseases and conditions associated with excessive smooth muscle
contraction, such as bronchoconstriction associated with asthma and chronic obstructive pulmonary
disease.
Earlier research activities at the company were directed to the inhibition of mitotic
kinesins, a family of cytoskeletal motor proteins involved in the process of cell division, or
mitosis. This research produced three drug candidates that have progressed into clinical testing
for the potential treatment of cancer: ispinesib, SB-743921 and GSK-923295. Effective February
2010, our strategic alliance with GlaxoSmithKline relating to our mitotic kinesin inhibitors
terminated by mutual agreement. We are currently evaluating strategic alternatives for these drug
candidates with third parties.
Two of our drug candidates directed to muscle contractility have now demonstrated
pharmacodynamic activity in patients: omecamtiv mecarbil in patients with heart failure and
CK-2017357 in patients with ALS and in patients with claudication associated with peripheral artery disease. In 2011, we expect to focus on translating the observed
pharmacodynamic activity of these compounds into potentially meaningful clinical benefits for these
patients. Our potential drug candidate CK-2066260 has demonstrated pharmacological activity in
preclinical models.
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Company Information
We were incorporated in Delaware in August 1997 as Cytokinetics, Incorporated. We conduct our
administration, finance, business development, clinical development, commercial development,
quality assurance and regulatory affairs activities primarily from our headquarters located at 280
East Grand Avenue, South San Francisco, CA. Our general telephone number at that address is (650)
624-3000 and our website is located at www.cytokinetics.com. The information on, or that can be
accessed through, our website is not incorporated by reference in this prospectus, and you should
not consider it to be a part of this prospectus. Our website address is included as an inactive
textual reference only.
CYTOKINETICS and our logo used alone and with the mark CYTOKINETICS are our registered service
marks and trademarks. Other service marks, trademarks and trade names referred to in this
prospectus are the property of their respective owners.
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The Offering
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Common stock offered by us
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Shares of our common stock having an
aggregate offering price of up to $20.0
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Manner of offering
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At-the-market offering that may be made from
time to time through our sales agent, McNicoll,
Lewis & Vlak LLC. See Plan of Distribution on
page 28. |
Use of Proceeds
We currently intend to use the net proceeds, if any, from the sale of shares of our common stock
for research and development, including clinical trials for our drug candidates, and working
capital and other general corporate purposes. See Use of
Proceeds on page 26 of this
prospectus.
Risk Factors
Investing in our securities involves a high degree of risk. See the information contained in or
incorporated by reference under the heading Risk Factors
beginning on page 4 of this prospectus
and in the documents incorporated by reference into this prospectus supplement.
Nasdaq Global Market Listing
Our common stock is listed on The NASDAQ Global Market under the symbol CYTK.
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RISK FACTORS
In evaluating our business, you should carefully consider the following risks in addition to
the other information in this prospectus and in the documents
incorporated by reference in this prospectus. Any of the following risks could materially and adversely
affect our business, results of operations, financial condition or your investment in our
securities, and many are beyond our control. It is not possible to predict or identify all such
factors and, therefore, you should not consider any of these risk factors to be a complete
statement of all the potential risks or uncertainties that we face.
Risks Related To Our Business
We
have a history of significant losses and may not achieve or sustain profitability and, as a
result, you may lose all or part of your investment.
We have generally incurred operating losses in each year since our inception in 1997, due to
costs incurred in connection with our research and development activities and general and
administrative costs associated with our operations. Our drug candidates are all in early and
mid-stage clinical testing, and we and our partners must conduct significant additional clinical
trials before we and our partners can seek the regulatory approvals necessary to begin commercial
sales of our drugs. We expect to incur increasing losses for at least several more years, as we
continue our research activities and conduct development of, and seek regulatory approvals for, our
drug candidates, and commercialize any approved drugs. If our drug candidates fail or do not gain
regulatory approval, or if our drugs do not achieve market acceptance, we will not be profitable.
If we fail to become and remain profitable, or if we are unable to fund our continuing losses, you
could lose all or part of your investment.
We
will continue to need substantial additional capital in the future to sufficiently fund our operations.
We have consumed substantial amounts of capital to date, and our operating expenditures will
increase over the next several years if we expand our research and development activities. We have
funded all of our operations and capital expenditures with proceeds from private and public sales
of our equity securities, strategic alliances with Amgen, GSK and others, equipment financings,
interest on investments and government grants. Not including the
proceeds of this offering, we believe that our existing cash and cash
equivalents, short-term investments and interest earned on investments should be sufficient to meet
our projected operating requirements for at least the next 12 months. We have based this estimate
on assumptions that may prove to be wrong, and we could utilize our available capital resources
sooner than we currently expect. Because of the numerous risks and uncertainties associated with
the development of our drug candidates and other research and development activities, including
risks and uncertainties that could impact the rate of progress of our development activities, we
are unable to estimate with certainty the amounts of capital outlays and operating expenditures
associated with these activities.
For
the foreseeable future, our operations will require significant
funding, in addition to the proceeds of this offering, in
large part due to our research and development expenses and the absence of any revenues from
product sales. Until we can generate a sufficient amount of product revenue, we expect to raise
future capital through strategic alliance and licensing arrangements, public or private equity
offerings and debt financings. We do not currently have any commitments for future funding other
than grant funding for our myasthenia gravis preclinical and clinical activities, and
reimbursements, milestone and royalty payments that we may receive under our collaboration and
option agreement with Amgen. We may not receive any further funds under that agreement. Our ability
to raise funds may be adversely impacted by current economic conditions, including the effects of
the recent disruptions to the credit and financial markets in the United States and worldwide. In
particular, the pool of third-party capital that in the past has been available to
development-stage companies such as ours has decreased significantly in recent years, and such
decreased availability may continue for a prolonged period. As a result of these and other factors,
we do not know whether additional financing will be available when needed, or that, if available,
such financing would be on terms favorable to our stockholders or us.
To the extent that we raise additional funds through strategic alliances or licensing and
other arrangements with third parties, we will likely have to relinquish valuable rights to our
technologies, research programs or drug candidates, or grant licenses on terms that may not be
favorable to us. To the extent that we raise additional funds by issuing equity securities, our
stockholders will experience additional dilution. To the extent that we raise additional funds
through debt financing, the financing may involve covenants that restrict our business activities.
In addition, funding from any of these sources, if needed, may not be available to us on favorable
terms, or at all, or in accordance with our planned timelines.
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If we can not raise the funds we need to operate our business, we will need to discontinue
certain research and development activities and our stock price likely would be negatively
affected.
We depend on Amgen for the conduct, completion and funding of the clinical development and
commercialization of omecamtiv mecarbil (formerly known as CK-1827452).
In May 2009, Amgen exercised its option to acquire an exclusive license to our drug candidate
omecamtiv mecarbil worldwide, except for Japan. As a result, Amgen is responsible for the clinical
development and obtaining and maintaining regulatory approval of omecamtiv mecarbil for the
potential treatment of heart failure worldwide, except Japan.
We do not control the clinical development activities being conducted or that may be conducted
in the future by Amgen, including, but not limited to, the timing of initiation, termination or
completion of clinical trials, the analysis of data arising out of those clinical trials or the
timing of release of data concerning those clinical trials, which may impact our ability to report
on Amgens results. Amgen may conduct these activities more slowly or in a different manner than we
would if we controlled the clinical development of omecamtiv mecarbil. Amgen is responsible for
filing future applications with the FDA or other regulatory authorities for approval of mecamtiv
mecarbil and will be the owner of any marketing approvals issued by the FDA or other regulatory
authorities for omecamtiv mecarbil. If the FDA or other regulatory authorities approve omecamtiv
mecarbil, Amgen will also be responsible for the marketing and sale of the resulting drug, subject
to our right to co-promote omecamtiv mecarbil in North America if we exercise our option to co-fund
Phase III development costs of omecamtiv mecarbil under the collaboration. However, we cannot
control whether Amgen will devote sufficient attention and resources to the clinical development of
omecamtiv mecarbil or will proceed in an expeditious manner, even if we do exercise our option to
co-fund the development of omecamtiv mecarbil. Even if the FDA or other regulatory agencies approve
omecamtiv mecarbil, Amgen may elect not to proceed with the commercialization of the resulting drug
in one or more countries.
Amgen generally has discretion to elect whether to pursue or abandon the development of
omecamtiv mecarbil and may terminate our strategic alliance for any reason upon six months prior
notice. If the initial results of one or more clinical trials with omecamtiv mecarbil do not meet
Amgens expectations, Amgen may elect to terminate further development of omecamtiv mecarbil or
certain of the potential clinical trials for omecamtiv mecarbil, even if the actual number of
patients treated at that time is relatively small. If Amgen abandons omecamtiv mecarbil, it would
result in a delay in or could prevent us from commercializing omecamtiv mecarbil, and would delay
and could prevent us from obtaining revenues for this drug candidate. Disputes may arise between us
and Amgen, which may delay or cause the termination of any omecamtiv mecarbil clinical trials,
result in significant litigation or cause Amgen to act in a manner that is not in our best
interest. If development of omecamtiv mecarbil does not progress for these or any other reasons, we
would not receive further milestone payments or royalties on product sales from Amgen with respect
to omecamtiv mecarbil. If Amgen abandons development of omecamtiv mecarbil prior to regulatory
approval or if it elects not to proceed with commercialization of the resulting drug following
regulatory approval, we would have to seek a new partner for clinical development or
commercialization, curtail or abandon that clinical development or commercialization, or undertake
and fund the clinical development of omecamtiv mecarbil or commercialization of the resulting drug
ourselves. If we seek a new partner but are unable to do so on acceptable terms, or at all, or do
not have sufficient funds to conduct the development or commercialization of omecamtiv mecarbil
ourselves, we would have to curtail or abandon that development or commercialization, which could
harm our business.
We have never generated, and may never generate, revenues from commercial sales of our drugs and we
will not have drugs to market for at least several years, if ever.
We currently have no drugs for sale and we cannot guarantee that we will ever develop or
obtain approval to market any drugs. To receive marketing approval for any drug candidate, we must
demonstrate that the drug candidate satisfies rigorous standards of safety and efficacy to the FDA
in the United States and other regulatory authorities abroad. We and our partners will need to
conduct significant additional research and preclinical and clinical testing before we or our
partners can file applications with the FDA or other regulatory authorities for approval of any of
our drug candidates. In addition, to compete effectively, our drugs must be easy to use,
cost-effective and economical to manufacture on a commercial scale, compared to other therapies
available for the treatment of the same conditions. We may not achieve any of these objectives.
Currently, our only drug candidates that have progressed into clinical development are: omecamtiv
mecarbil, our drug candidate for the potential treatment of heart failure; CK-2017357, our drug
candidate for the potential treatment of diseases associated with aging, muscle wasting and
neuromuscular dysfunction; and ispinesib, SB-743921 and GSK-923295, our drug candidates for the
potential treatment of cancer. We cannot be certain that the clinical development of these or any
future drug candidates
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will be successful, that they will receive the regulatory approvals required to commercialize
them, or that any of our other research programs will yield a drug candidate suitable for clinical
testing or commercialization. Our commercial revenues, if any, will be derived from sales of drugs
that we do not expect to be commercially marketed for at least several years, if at all. The
development of any one or all of these drug candidates may be discontinued at any stage of our
clinical trials programs and we may not generate revenue from any of these drug candidates.
Clinical trials may fail to demonstrate the desired safety and efficacy of our drug candidates,
which could prevent or significantly delay completion of clinical development and regulatory
approval.
Prior to receiving approval to commercialize any of our drug candidates, we or our partners
must adequately demonstrate to the FDA and foreign regulatory authorities that the drug candidate
is sufficiently safe and effective with substantial evidence from well-controlled clinical trials.
In clinical trials we or our partners will need to demonstrate efficacy for the treatment of
specific indications and monitor safety throughout the clinical development process and following
approval. None of our drug candidates have yet been demonstrated to be safe and effective in
clinical trials and they may never be. In addition, for each of our current preclinical compounds,
we or our partners must adequately demonstrate satisfactory chemistry, formulation, stability and
toxicity in order to submit an IND to the FDA, or an equivalent application in foreign
jurisdictions, that would allow us to advance that compound into clinical trials. Furthermore, we
or our partners may need to submit separate INDs (or foreign equivalent) to different divisions
within the FDA (or foreign regulatory authorities) in order to pursue clinical trials in different
therapeutic areas. Each new IND (or foreign equivalent) must be reviewed by the new division before
the clinical trial under its jurisdiction can proceed, entailing all the risks of delay inherent to
regulatory review. If our or our partners current or future preclinical studies or clinical trials
are unsuccessful, our business will be significantly harmed and our stock price could be negatively
affected.
All of our drug candidates are prone to the risks of failure inherent in drug development.
Preclinical studies may not yield results that would adequately support the filing of an IND (or a
foreign equivalent) with respect to our potential drug candidates. Even if the results of
preclinical studies for a drug candidate are sufficient to support such a filing, the results of
preclinical studies do not necessarily predict the results of clinical trials. As an example,
because the physiology of animal species used in preclinical studies may vary substantially from
other animal species and from humans, it may be difficult to assess with certainty whether a
finding from a study in a particular animal species will result in similar findings in other animal
species or in humans. For any of our drug candidates, the results from Phase I clinical trials in
healthy volunteers and clinical results from Phase I and II trials in patients are not necessarily
indicative of the results of larger Phase III clinical trials that are necessary to establish
whether the drug candidate is safe and effective for the applicable indication. Likewise, interim
results from a clinical trial may not be indicative of the final results from that trial.
In addition, while the clinical trials of our drug candidates are designed based on the
available relevant information, in view of the uncertainties inherent in drug development, such
clinical trials may not be designed with focus on indications, patient populations, dosing
regimens, safety or efficacy parameters or other variables that will provide the necessary safety
or efficacy data to support regulatory approval to commercialize the resulting drugs. For example,
in previously conducted two-stage Phase II clinical trials designed to evaluate the safety and
efficacy of ispinesib as monotherapy in the first- or second-line treatment of patients with
different forms of cancer, ispinesib did not satisfy the criteria for advancement to Stage 2. In
addition, individual patient responses to the dose administered of a drug may vary in a manner that
is difficult to predict. Also, the methods we select to assess particular safety or efficacy
parameters may not yield the same statistical precision in estimating our drug candidates effects
as may other alternative methodologies. Even if we believe the data collected from clinical trials
of our drug candidates are promising, these data may not be sufficient to support approval by the
FDA or foreign regulatory authorities. Preclinical and clinical data can be interpreted in
different ways. Accordingly, the FDA or foreign regulatory authorities could interpret these data
in different ways than we or our partners do, which could delay, limit or prevent regulatory
approval.
Administering any of our drug candidates or potential drug candidates may produce undesirable
side effects, also known as adverse effects. Toxicities and adverse effects observed in preclinical
studies for some compounds in a particular research and development program may also occur in
preclinical studies or clinical trials of other compounds from the same program. Potential toxicity
issues may arise from the effects of the active pharmaceutical ingredient itself or from impurities
or degradants that are present in the active pharmaceutical ingredient or could form over time in
the formulated drug candidate or the active pharmaceutical ingredient. These toxicities or adverse
effects could delay or prevent the filing of an IND (or a foreign equivalent) with respect to our
drug candidates or potential drug candidates or cause us or our partners to modify, suspend or
terminate clinical trials with respect to any drug candidate at any time during the development
program. The
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FDA, other regulatory authorities, our partners or we may modify, suspend or terminate
clinical trials with our drug candidates at any time. If these or other adverse effects are severe
or frequent enough to outweigh the potential efficacy of a drug candidate, the FDA or other
regulatory authorities could deny approval of that drug candidate for any or all targeted
indications. Even if one or more of our drug candidates were approved for sale as drugs, the
occurrence of even a limited number of toxicities or adverse effects when used in large populations
may cause the FDA to impose restrictions on, or stop, the further marketing of those drugs.
Indications of potential adverse effects or toxicities which do not seem significant during the
course of clinical trials may later turn out to actually constitute serious adverse effects or
toxicities when a drug is used in large populations or for extended periods of time.
We have observed certain adverse effects in the clinical trials conducted with our drug
candidates. For example, in clinical trials of omecamtiv mecarbil, doses that exceeded the maximum
tolerated dose were associated with complaints of chest discomfort, palpitations, dizziness and
feeling hot, increases in heart rate, declines in blood pressure, electrocardiographic changes
consistent with acute myocardial ischemia and transient rises in the MB fraction of creatine kinase
and cardiac troponins I and T, which are indicative of myocardial infarction. In Phase IIa clinical
trials of CK-2017357, adverse events of dizziness, fatigue, headache, somnolence (sleepiness),
euphoric mood, muscle spasms, gait disturbance, pain in extremity,
feeling drunk, vision blurred, muscular weakness, nausea, balance disorder,
hypertension, asthenia (loss of strength and energy), abnormal coordination and dysarthria (difficulty speaking)
occurred more frequently during treatment with CK-2017357 than with
placebo, with a possible trend for their frequencies to increase with increasing doses of CK-2017357. In clinical trials of
ispinesib, the most commonly observed dose-limiting toxicity was neutropenia, a decrease in the
number of a certain type of white blood cell that results in an increase in susceptibility to
infection.
Further, the administration of two or more drugs contemporaneously can lead to interactions
between them, and in clinical trials, our drug candidates may interact with other drugs that the
trial subjects are taking. For example, many ALS patients take riluzole, a commercially available
treatment for ALS. In a Phase IIa clinical trial of CK-2017357 in ALS patients, we observed in the
patients taking riluzole increases in the blood plasma concentration of riluzole associated with
the administration of CK-2017357. Accordingly, we are conducting a Phase I drug-drug interaction
clinical trial intended to evaluate the effects of CK-2017357 on the pharmacokinetics of riluzole
and other drugs to better understand the significance of this finding. If this drug-drug
interaction trial produces materially adverse findings, it may call into question the feasibility
of developing CK-2017357 as a treatment for ALS.
In addition, clinical trials of omecamtiv mecarbil and CK-2017357 enroll patients who
typically suffer from serious diseases which put them at increased risk of death. These patients
may die while receiving our drug candidates. In such circumstances, it may not be possible to
exclude with certainty a causal relationship to our drug candidate, even though the responsible
clinical investigator may view such an event as not study drug-related. For example, in a Phase IIa
clinical trial designed to evaluate and compare the oral pharmacokinetics of both modified and
immediate release formulations of omecamtiv mecarbil in patients with stable heart failure, a
patient died suddenly after receiving the immediate release formulation of omecamtiv mecarbil,
without having reported any preceding adverse events. The clinical investigator assessed the
patients death as not related to omecamtiv mecarbil. However, the event was reported to the
appropriate regulatory authorities as possibly related to omecamtiv mecarbil because the immediate
cause of the patients death could not be determined, and therefore, a relationship to omecamtiv
mecarbil could not be excluded definitively.
Any failure or significant delay in completing preclinical studies or clinical trials for our
drug candidates, or in receiving and maintaining regulatory approval for the sale of any resulting
drugs, may significantly harm our business and negatively affect our stock price.
Clinical trials are expensive, time-consuming and subject to delay.
Clinical trials are subject to rigorous regulatory requirements and are very expensive,
difficult and time-consuming to design and implement. The length of time and number of trial sites
and patients required for clinical trials vary substantially based on the type, complexity,
novelty, intended use of the drug candidate and safety concerns. We estimate that the clinical
trials of our current drug candidates will each continue for several more years. However, the
clinical trials for all or any of these drug candidates may take significantly longer to complete.
The commencement and completion of our clinical trials could be delayed or prevented by many
factors, including, but not limited to:
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delays in obtaining, or inability to obtain, regulatory or other approvals to commence
and conduct clinical trials in the manner we or our partners deem necessary for the
appropriate and timely development of our drug candidates and commercialization of any
resulting drugs; |
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delays in identifying and reaching agreement, or inability to identify and reach
agreement, on acceptable terms, with prospective clinical trial sites and other entities
involved in the conduct of our clinical trials; |
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delays or additional costs in developing, or inability to develop, appropriate
formulations of our drug candidates for clinical trial use, including an appropriate
modified release oral formulation for omecamtiv mecarbil; |
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slower than expected rates of patient recruitment and enrollment, including as a result
of competition for patients with other clinical trials; limited numbers of patients that
meet the enrollment criteria; patients, investigators or trial sites reluctance to
agree to the requirements of a protocol; or the introduction of alternative therapies or
drugs by others; |
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for those drug candidates that are the subject of a strategic alliance, delays in
reaching agreement with our partner as to appropriate development strategies; |
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a regulatory authority may require changes to a protocol for a clinical trial that then
may require approval from regulatory agencies in other jurisdictions where the trial is
being conducted; |
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an institutional review board (IRB) or its foreign equivalent may require changes to a
protocol that then require approval from regulatory agencies and other IRBs and their
foreign equivalents, or regulatory authorities may require changes to a protocol that
then require approval from the IRBs or their foreign equivalents; |
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for clinical trials conducted in foreign countries, the time and resources required to
identify, interpret and comply with foreign regulatory requirements or changes in those
requirements, and political instability or natural disasters occurring in those
countries; |
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lack of effectiveness of our drug candidates during clinical trials; |
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unforeseen safety issues; |
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inadequate supply of clinical trial materials; |
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uncertain dosing issues; |
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failure by us, our partners, or clinical research organizations, investigators or site
personnel engaged by us or our partners to comply with good clinical practices and other
applicable laws and regulations, including those concerning informed consent; |
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inability or unwillingness of investigators or their staffs to follow clinical protocols; |
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inability to monitor patients adequately during or after treatment; |
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introduction of new therapies or changes in standards of practice or regulatory guidance
that render our drug candidates or their clinical trial endpoints obsolete; and |
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results from non-clinical studies that may adversely impact the timing or further
development of our drug candidates. |
We do not know whether planned clinical trials will begin on time, or whether planned or
currently ongoing clinical trials will need to be restructured or will be completed on schedule, if
at all. Significant delays in clinical trials will impede our ability to commercialize our drug
candidates and generate revenue and could significantly increase our development costs.
8
If we fail to enter into and maintain successful strategic alliances for our drug candidates,
potential drug candidates or research and development programs, we will have to reduce, delay or
discontinue our advancement of those drug candidates, potential drug candidates and programs or
expand our research and development capabilities and increase our expenditures.
Drug development is complicated and expensive. We currently have limited financial and
operational resources to carry out drug development. Our strategy for developing, manufacturing and
commercializing our drug candidates and potential drug candidates currently requires us to enter
into and successfully maintain strategic alliances with pharmaceutical companies or other industry
participants to advance our programs and reduce our expenditures on each program. Accordingly, the
success of our development activities depends in large part on our current and future strategic
partners performance, over which we have little or no control.
We have retained all rights to develop and commercialize CK-2017357, CK-2066260, ispinesib,
SB-743921 and GSK-923295. We currently do not have a strategic partner for these drug candidates.
We are relying on GSK to complete its Phase I clinical trial for GSK-923295. We expect to rely on
one or more strategic partners or other arrangements with third parties to advance and develop each
of CK-2017357, CK-2066260 and other compounds from our skeletal muscle contractility program;
ispinesib, SB-743921 and GSK-923295; and our smooth muscle myosin inhibitors. However, we may not
be able to negotiate and enter into such strategic alliances or arrangements on acceptable terms,
if at all, or in accordance with our planned timelines.
We rely on Amgen to conduct non-clinical and clinical development for omecamtiv mecarbil for
the potential treatment of heart failure. If Amgen elects to terminate its development activities
with respect to omecamtiv mecarbil, we currently do not have an alternative strategic partner for
this drug candidate.
Our ability to commercialize drugs that we develop with our partners and that generate
royalties from product sales depends on our partners abilities to assist us in establishing the
safety and efficacy of our drug candidates, obtaining and maintaining regulatory approvals and
achieving market acceptance of the drugs once commercialized. Our partners may elect to delay or
terminate development of one or more drug candidates, independently develop drugs that could
compete with ours or fail to commit sufficient resources to the marketing and distribution of drugs
developed through their strategic alliances with us. Our partners may not proceed with the
development and commercialization of our drug candidates with the same degree of urgency as we
would because of other priorities they face. In addition, new business combinations or changes in a
partners business strategy may adversely affect its willingness or ability to carry out its
obligations under a strategic alliance.
If we are not able to successfully maintain our existing strategic alliances or establish and
successfully maintain additional strategic alliances, we will have to limit the size or scope of,
or delay or discontinue, one or more of our drug development programs or research programs, or
undertake and fund these programs ourselves. Alternatively, if we elect to continue to conduct any
of these drug development programs or research programs on our own, we will need to expand our
capability to conduct clinical development by bringing additional skills, technical expertise and
resources into our organization. This would require significant additional funding, which may not
be available to us on acceptable terms, or at all.
We depend on contract research organizations to conduct our clinical trials and have limited
control over their performance.
We have used and intend to continue to use contract research organizations (CROs) within and
outside of the United States to conduct clinical trials of our drug candidates, such as CK-2017357.
We do not have control over many aspects of our CROs activities, and cannot fully control the
amount, timing or quality of resources that they devote to our programs. CROs may not assign as
high a priority to our programs or pursue them as diligently as we would if we were undertaking
these programs ourselves. The activities conducted by our CROs therefore may not be completed on
schedule or in a satisfactory manner. CROs may also give higher priority to relationships with our
competitors and potential competitors than to their relationships with us. Outside of the United
States, we are particularly dependent on our CROs expertise in communicating with clinical trial
sites and regulatory authorities and ensuring that our clinical trials and related activities and
regulatory filings comply with applicable laws. Our CROs failure to carry out development
activities on our behalf according to our and the FDAs or other regulatory agencies requirements
and in accordance with applicable U.S. and foreign laws, or our failure to properly coordinate and
manage these activities, could increase the cost of our operations and delay or prevent the
development, approval and commercialization of our drug candidates. In addition, if a CRO fails to
perform as agreed, our ability to collect damages may be contractually limited. If we fail to
effectively manage the CROs carrying out the development of our drug candidates or if our CROs fail
to perform as agreed, the commercialization of our drug candidates will be delayed or prevented.
9
We have no manufacturing capacity and depend on our strategic partners and contract manufacturers
to produce our
clinical trial drug supplies for each of our drug candidates and potential drug candidates, and
anticipate continued reliance on contract manufacturers for the development and commercialization
of our potential drugs.
We do not currently operate manufacturing facilities for clinical or commercial production of
our drug candidates or potential drug candidates. We have limited experience in drug formulation
and manufacturing, and we lack the resources and the capabilities to manufacture any of our drug
candidates or potential drug candidates on a clinical or commercial scale. Amgen has assumed
responsibility to conduct these activities for the ongoing clinical development of omecamtiv
mecarbil worldwide, except Japan. We have relied on GSK to conduct these activities for the
clinical development of GSK-923295. For CK-2017357, CK-2066260 and our other drug candidates and
potential drug candidates, we rely (and for omecamtiv mecarbil, ispinesib and SB-743921, we have
relied) on a limited number of contract manufacturers. In particular, we rely on single-source
contract manufacturers for the active pharmaceutical ingredient and the drug product supply for our
clinical trials. We expect to rely on contract manufacturers to supply all future drug candidates
for which we conduct clinical development. If any of our existing or future contract manufacturers
fail to perform satisfactorily, it could delay clinical development or regulatory approval of our
drug candidates or commercialization of our drugs, producing additional losses and depriving us of
potential product revenues. In addition, if a contract manufacturer fails to perform as agreed, our
ability to collect damages may be contractually limited.
Our drug candidates and potential drug candidates require precise high-quality manufacturing.
The failure to achieve and maintain high manufacturing standards, including failure to detect or
control anticipated or unanticipated manufacturing errors or the frequent occurrence of such
errors, could result in patient injury or death, discontinuance or delay of ongoing or planned
clinical trials, delays or failures in product testing or delivery, cost overruns, product recalls
or withdrawals and other problems that could seriously hurt our business. Contract drug
manufacturers often encounter difficulties involving production yields, quality control and quality
assurance and shortages of qualified personnel. These manufacturers are subject to stringent
regulatory requirements, including the FDAs current good manufacturing practices regulations and
similar foreign laws and standards. Each contract manufacturer must pass a pre-approval inspection
before we can obtain marketing approval for any of our drug candidates and following approval will
be subject to ongoing periodic unannounced inspections by the FDA, the U.S. Drug Enforcement Agency
and other regulatory agencies, to ensure strict compliance with current good manufacturing
practices and other applicable government regulations and corresponding foreign laws and standards.
We seek to ensure that our contract manufacturers comply fully with all applicable regulations,
laws and standards. However, we do not have control over our contract manufacturers compliance
with these regulations, laws and standards. If one of our contract manufacturers fails to pass its
pre-approval inspection or maintain ongoing compliance at any time, the production of our drug
candidates could be interrupted, resulting in delays or discontinuance of our clinical trials,
additional costs and potentially lost revenues. In addition, failure of any third party
manufacturers or us to comply with applicable regulations, including pre-or post-approval
inspections and the current good manufacturing practice requirements of the FDA or other comparable
regulatory agencies, could result in sanctions being imposed on us. These sanctions could include
fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approval
of our products, delay, suspension or withdrawal of approvals, license revocation, product seizures
or recalls, operational restrictions and criminal prosecutions, any of which could significantly
and adversely affect our business.
In addition, our existing and future contract manufacturers may not perform as agreed or may
not remain in the contract manufacturing business for the time required to successfully produce,
store and distribute our drug candidates. If a natural disaster, business failure, strike or other
difficulty occurs, we may be unable to replace these contract manufacturers in a timely or
cost-effective manner and the production of our drug candidates would be interrupted, resulting in
delays and additional costs.
Switching manufacturers or manufacturing sites would be difficult and time-consuming because
the number of potential manufacturers is limited. In addition, before a drug from any replacement
manufacturer or manufacturing site can be commercialized, the FDA and, in some cases, foreign
regulatory agencies, must approve that site. These approvals would require regulatory testing and
compliance inspections. A new manufacturer or manufacturing site also would have to be educated in,
or develop substantially equivalent processes for, production of our drugs and drug candidates. It
may be difficult or impossible to transfer certain elements of a manufacturing process to a new
manufacturer or for us to find a replacement manufacturer on acceptable terms quickly, or at all,
either of which would delay or prevent our ability to develop drug candidates and commercialize any
resulting drugs.
10
We may not be able to successfully scale-up manufacturing of our drug candidates in sufficient
quality and quantity, which would delay or prevent us from developing our drug candidates and
commercializing resulting approved drugs, if
any.
To date, our drug candidates have been manufactured in small quantities for preclinical
studies and early-stage clinical trials. In order to conduct larger scale or late-stage clinical
trials for a drug candidate and for commercialization of the resulting drug if that drug candidate
is approved for sale, we will need to manufacture it in larger quantities. We may not be able to
successfully increase the manufacturing capacity for any of our drug candidates, whether in
collaboration with third-party manufacturers or on our own, in a timely or cost-effective manner or
at all. If a contract manufacturer makes improvements in the manufacturing process for our drug
candidates, we may not own, or may have to share, the intellectual property rights to those
improvements. Significant scale-up of manufacturing may require additional validation studies,
which are costly and which the FDA must review and approve. In addition, quality issues may arise
during those scale-up activities because of the inherent properties of a drug candidate itself or
of a drug candidate in combination with other components added during the manufacturing and
packaging process, or during shipping and storage of the finished product or active pharmaceutical
ingredients. If we are unable to successfully scale-up manufacture of any of our drug candidates in
sufficient quality and quantity, the development of that drug candidate and regulatory approval or
commercial launch for any resulting drugs may be delayed or there may be a shortage in supply,
which could significantly harm our business.
The mechanisms of action of our drug candidates and potential drug candidates are unproven, and we
do not know whether we will be able to develop any drug of commercial value.
We have discovered and are currently developing drug candidates and potential drug candidates
that have what we believe are novel mechanisms of action directed against cytoskeletal targets, and
intend to continue to do so. Because no currently approved drugs appear to operate via the same
biochemical mechanisms as our compounds, we cannot be certain that our drug candidates and
potential drug candidates will result in commercially viable drugs that safely and effectively
treat the indications for which we intend to develop them. The results we have seen for our
compounds in preclinical models may not translate into similar results in humans, and results of
early clinical trials in humans may not be predictive of the results of larger clinical trials that
may later be conducted with our drug candidates. Even if we are successful in developing and
receiving regulatory approval for a drug candidate for the treatment of a particular disease, we
cannot be certain that we will also be able to develop and receive regulatory approval for that or
other drug candidates for the treatment of other diseases. If we or our partners are unable to
successfully develop and commercialize our drug candidates, our business will be materially harmed.
Our success depends substantially upon our ability to obtain and maintain intellectual property
protection relating to our drug candidates, potential drug candidates and research technologies.
We own, or hold exclusive licenses to, a number of U.S. and foreign patents and patent
applications directed to our drug candidates, potential drug candidates and research technologies.
Our success depends on our ability to obtain patent protection both in the United States and in
other countries for our drug candidates and potential drug candidates, their methods of manufacture
and use, and our technologies. Our ability to protect our drug candidates, potential drug
candidates and technologies from unauthorized or infringing use by third parties depends
substantially on our ability to obtain and enforce our patents. If our issued patents and patent
applications, if granted, do not adequately describe, enable or otherwise provide coverage of our
technologies and drug candidates and potential drug candidates, including omecamtiv mecarbil,
CK-2017357, CK-2066260, ispinesib, SB-743921 and GSK-923295, we or our licensees would not be able
to exclude others from developing or commercializing these drug candidates. Furthermore, the degree
of future protection of our proprietary rights is uncertain because legal means may not adequately
protect our rights or permit us to gain or keep our competitive advantage.
Due to evolving legal standards relating to the patentability, validity and enforceability of
patents covering pharmaceutical inventions and the claim scope of these patents, our ability to
enforce our existing patents and to obtain and enforce patents that may issue from any pending or
future patent applications is uncertain and involves complex legal, scientific and factual
questions. The standards which the U.S. Patent and Trademark Office and its foreign counterparts
use to grant patents are not always applied predictably or uniformly and are subject to change. To
date, no consistent policy has emerged regarding the breadth of claims allowed in biotechnology and
pharmaceutical patents. Thus, we cannot be sure that any patents will issue from any pending or
future patent applications owned by or licensed to us. Even if patents do issue, we cannot be sure
that the claims of these patents will be held valid or enforceable by a court of law, will provide
us with any significant protection against competitive products, or will afford us a commercial
advantage over competitive products. In particular:
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we or our licensors might not have been the first to make the inventions covered by each of our pending patent
applications and issued patents;
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we or our licensors might not have been the first to file patent applications for the inventions
covered by our pending patent applications and issued patents; |
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others may independently develop similar or alternative technologies or duplicate any of our
technologies without infringing our intellectual property rights; |
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some or all of our or our licensors pending patent applications may not result in issued
patents or the claims that issue may be narrow in scope and not provide us with competitive
advantages; |
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our and our licensors issued patents may not provide a basis for commercially viable drugs or
therapies or may be challenged and invalidated by third parties; |
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our or our licensors patent applications or patents may be subject to interference, opposition
or similar administrative proceedings that may result in a reduction in their scope or their
loss altogether; |
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we may not develop additional proprietary technologies or drug candidates that are patentable; or |
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the patents of others may prevent us or our partners from discovering, developing or
commercializing our drug candidates. |
Patent protection is afforded on a country-by-country basis. Some foreign jurisdictions do not
protect intellectual property rights to the same extent as in the United States. Many companies
have encountered significant difficulties in protecting and defending intellectual property rights
in foreign jurisdictions. Some of our development efforts are performed in countries outside of the
United States through third party contractors. We may not be able to effectively monitor and assess
intellectual property developed by these contractors. We therefore may not be able to effectively
protect this intellectual property and could lose potentially valuable intellectual property
rights. In addition, the legal protection afforded to inventors and owners of intellectual property
in countries outside of the United States may not be as protective of intellectual property rights
as in the United States. Therefore, we may be unable to acquire and protect intellectual property
developed by these contractors to the same extent as if these development activities were being
conducted in the United States. If we encounter difficulties in protecting our intellectual
property rights in foreign jurisdictions, our business prospects could be substantially harmed.
We rely on intellectual property assignment agreements with our corporate partners, employees,
consultants, scientific advisors and other collaborators to grant us ownership of new intellectual
property that is developed. These agreements may not result in the effective assignment to us of
that intellectual property. As a result, our ownership of key intellectual property could be
compromised.
Changes in either the patent laws or their interpretation in the United States or other
countries may diminish the value of our intellectual property or our ability to obtain patents. For
example, the U.S. Congress is currently considering bills that could change U.S. law regarding,
among other things, post-grant review of issued patents and the calculation of damages once patent
infringement has been determined by a court of law. If enacted into law, these provisions could
severely weaken patent protection in the United States.
If one or more products resulting from our drug candidates is approved for sale by the FDA and
we do not have adequate intellectual property protection for those products, competitors could
duplicate them for approval and sale in the United States without repeating the extensive testing
required of us or our partners to obtain FDA approval. Regardless of any patent protection, under
current law, an application for a generic version of a new chemical entity cannot be approved until
at least five years after the FDA has approved the original product. When that period expires, or
if that period is altered, the FDA could approve a generic version of our product regardless of our
patent protection. An applicant for a generic version of our product may only be required to
conduct a relatively inexpensive study to show that its product is bioequivalent to our product,
and may not have to repeat the lengthy and expensive clinical trials that we or our partners
conducted to demonstrate that the product is safe and effective. In the absence of adequate patent
protection for our products in other countries, competitors may similarly be able to obtain
regulatory approval in those countries of generic versions of our products.
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We also rely on trade secrets to protect our technology, particularly where we believe patent
protection is not appropriate
or obtainable. However, trade secrets are often difficult to protect, especially outside of
the United States. While we endeavor to use reasonable efforts to protect our trade secrets, our or
our partners employees, consultants, contractors or scientific and other advisors may
unintentionally or willfully disclose our information to competitors. In addition, confidentiality
agreements, if any, executed by those individuals may not be enforceable or provide meaningful
protection for our trade secrets or other proprietary information in the event of unauthorized use
or disclosure. Pursuing a claim that a third party had illegally obtained and was using our trade
secrets would be expensive and time-consuming, and the outcome would be unpredictable. Even if we
are able to maintain our trade secrets as confidential, if our competitors independently develop
information equivalent or similar to our trade secrets, our business could be harmed.
If we are not able to defend the patent or trade secret protection position of our
technologies and drug candidates, then we will not be able to exclude competitors from developing
or marketing competing drugs, and we may not generate enough revenue from product sales to justify
the cost of development of our drugs or to achieve or maintain profitability.
If we are sued for infringing third party intellectual property rights, it will be costly and
time-consuming, and an unfavorable outcome would have a significant adverse effect on our business.
Our ability to commercialize drugs depends on our ability to use, manufacture and sell those
drugs without infringing the patents or other proprietary rights of third parties. Numerous U.S.
and foreign issued patents and pending patent applications owned by third parties exist in the
therapeutic areas in which we are developing drug candidates and seeking new potential drug
candidates. In addition, because patent applications can take several years to issue, there may be
currently pending applications, unknown to us, which could later result in issued patents that our
activities with our drug candidates could infringe. There may also be existing patents, unknown to
us, that our activities with our drug candidates could infringe.
Currently, we are aware of an issued U.S. patent and at least one pending U.S. patent
application assigned to Curis, Inc., relating to certain compounds in the quinazolinone class.
Ispinesib falls into this class of compounds. The Curis U.S. patent claims a method of inhibiting
signaling by what is called the hedgehog pathway using certain quinazolinone compounds. Curis also
has pending applications in Europe, Japan, Australia and Canada with claims covering certain
quinazolinone compounds, compositions thereof and methods of their use. Two of the Australian
applications have been allowed and two of the European applications have been granted. We have
opposed the granting of certain of these patents to Curis in Europe and in Australia. Curis has
withdrawn one of the Australian applications. One of the European patents that we opposed was
recently revoked and is no longer valid in Europe. Curis has appealed this decision.
Curis or a third party may assert that the manufacture, use, importation or sale of ispinesib
may infringe one or more of its patents. We believe that we have valid defenses against the issued
U.S. patent owned by Curis if it were to be asserted against us. However, we cannot guarantee that
a court would find these defenses valid or that any additional defenses would be successful. We
have not attempted to obtain a license to these patents. If we decide to seek a license to these
patents, we cannot guarantee that such a license would be available on acceptable terms, if at all.
Other future products of ours may be impacted by patents of companies engaged in competitive
programs with significantly greater resources (such as Merck & Co., Inc., Eli Lilly and Company,
Bristol-Myers Squibb Company, Novartis and AstraZeneca AB). Further development of these products
could be impacted by these patents and result in significant legal fees.
If a third party claims that our actions infringe its patents or other proprietary rights, we
could face a number of issues that could seriously harm our competitive position, including, but
not limited to:
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infringement and other intellectual property claims that, even if
meritless, can be costly and time-consuming to litigate, delay the
regulatory approval process and divert managements attention from our
core business operations; |
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substantial damages for past infringement which we may have to pay if
a court determines that our drugs or technologies infringe a third
partys patent or other proprietary rights; |
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a court prohibiting us from selling or licensing our drugs or
technologies unless the holder licenses the patent or other
proprietary rights to us, which it is not required to do; and |
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if a license is available from a holder, we may have to pay
substantial royalties or grant cross-licenses to our patents or other
proprietary rights. |
If any of these events occur, it could significantly harm our business and negatively affect
our stock price.
We may undertake infringement or other legal proceedings against third parties, causing us to spend
substantial resources on litigation and exposing our own intellectual property portfolio to
challenge.
Third parties may infringe our patents. To prevent infringement or unauthorized use, we may
need to file infringement suits, which are expensive and time-consuming. In an infringement
proceeding, a court may decide that one or more of our patents is invalid, unenforceable, or both.
In this case, third parties may be able to use our technology without paying licensing fees or
royalties. Even if the validity of our patents is upheld, a court may refuse to stop the other
party from using the technology at issue on the ground that the other partys activities are not
covered by our patents. Policing unauthorized use of our intellectual property is difficult, and we
may not be able to prevent misappropriation of our proprietary rights, particularly in countries
where the laws may not protect such rights as fully as in the United States. In addition, third
parties may affirmatively challenge our rights to, or the scope or validity of, our patent rights.
We may become involved in disputes with our strategic partners over intellectual property
ownership, and publications by our research collaborators and clinical investigators could impair
our ability to obtain patent protection or protect our proprietary information, either of which
would have a significant impact on our business.
Inventions discovered under our current or future strategic alliance agreements may become
jointly owned by our strategic partners and us in some cases, and the exclusive property of one of
us in other cases. Under some circumstances, it may be difficult to determine who owns a particular
invention or whether it is jointly owned, and disputes could arise regarding ownership or use of
those inventions. These disputes could be costly and time-consuming, and an unfavorable outcome
could have a significant adverse effect on our business if we were not able to protect or license
rights to these inventions. In addition, our research collaborators and clinical investigators
generally have contractual rights to publish data arising from their work. Publications by our
research collaborators and clinical investigators relating to our research and development
programs, either with or without our consent, could benefit our current or potential competitors
and may impair our ability to obtain patent protection or protect our proprietary information,
which could significantly harm our business.
We may be subject to claims that we or our employees have wrongfully used or disclosed trade
secrets of their former employers.
Many of our employees were previously employed at universities or other biotechnology or
pharmaceutical companies, including our competitors or potential competitors. Although no claims
against us are currently pending, we may be subject to claims that these employees or we have
inadvertently or otherwise used or disclosed trade secrets or other proprietary information of
their former employers. Litigation may be necessary to defend against these claims. If we fail in
defending these claims, in addition to paying monetary damages, we may lose valuable intellectual
property rights or personnel. A loss of key research personnel or their work product could hamper
or prevent our ability to develop and commercialize certain potential drugs, which could
significantly harm our business. Even if we are successful in defending against these claims,
litigation could result in substantial costs and distract management.
Our competitors may develop drugs that are less expensive, safer or more effective than ours, which
may diminish or eliminate the commercial success of any drugs that we may commercialize.
We compete with companies that have developed drugs or are developing drug candidates for
cardiovascular diseases, cancer and other diseases for which our drug candidates may be useful
treatments. For example, if omecamtiv mecarbil is approved for marketing by the FDA for heart
failure, that drug candidate would compete against other drugs used for the treatment of heart
failure. These include generic drugs, such as milrinone, dobutamine or digoxin and newer marketed
drugs such as nesiritide. Omecamtiv mecarbil could also potentially compete against other novel
drug candidates in development, such as bucindolol, which is being developed by ARCA biopharma,
Inc.; relaxin, which is being developed by Novartis; CD-NP, which is being developed by Nile
Therapeutics, Inc., and glial growth factor (GGF-2) which is being developed by Acorda
Therapeutics, Inc. In addition, there are a number of medical devices being developed for the
potential treatment of heart failure.
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With respect to CK-2017357, CK-2066260 and other compounds that may arise from our skeletal
muscle contractility
program, potential competitors include Ligand Pharmaceuticals, Inc., which is developing
LGD-4033, a selective androgen receptor modulator, for muscle wasting; and GTx, Inc., which is
developing ostarine, a selective androgen receptor modulator, for cancer cachexia. Acceleron
Pharma, Inc. is conducting clinical development with ACE-031, a myostatin inhibitor, and related
compounds to evaluate their ability to treat diseases involving the loss of muscle mass, strength
and function. We are aware that other companies are developing potential new therapies for ALS,
such as Biogen Idec, Inc., Mitsubishi Tanabe Pharma Corporation, Eisai Inc., Trophos SA, and Isis
Pharmaceuticals, Inc. If CK-2017357 or other of our skeletal muscle sarcomere activators are
approved for the treatment of claudication associated with peripheral artery disease, they will
compete with currently approved therapies for the treatment of peripheral artery disease. We are
also aware that a number of companies are developing potential new treatments for peripheral artery
disease or associated symptoms of claudication. If CK-2017357 or other of our skeletal muscle
sarcomere activators are approved for the treatment of myasthenia gravis, they will compete with
currently approved therapies for the treatment of myasthenia gravis, including but not limited to
anticholinesterase agents, such as pyridostigmine bromide and neostigmine bromide, corticosteroids,
such as prednisone, and immunomodulatory drugs, such as azathiaprine and cyclosporine. We are also
aware that a number of companies are developing or commercializing in certain markets potential new
treatments for myasthenia gravis, such as Benesis Corp. (GB-0998), Alexion Pharmaceuticals, Inc.
(eculizumab) and Astellas (tacrolimus).
Our competitors may:
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develop drug candidates and market drugs that are less expensive or more effective than our future drugs; |
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commercialize competing drugs before we or our partners can launch any drugs developed from our drug
candidates; |
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hold or obtain proprietary rights that could prevent us from commercializing our products; |
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initiate or withstand substantial price competition more successfully than we can; |
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more successfully recruit skilled scientific workers and management from the limited pool of available talent; |
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more effectively negotiate third-party licenses and strategic alliances; |
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take advantage of acquisition or other opportunities more readily than we can; |
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develop drug candidates and market drugs that increase the levels of safety or efficacy that our drug
candidates will need to show in order to obtain regulatory approval; or |
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introduce therapies or market drugs that render the market opportunity for our potential drugs obsolete. |
We will compete for market share against large pharmaceutical and biotechnology companies and
smaller companies that are collaborating with larger pharmaceutical companies, new companies,
academic institutions, government agencies and other public and private research organizations.
Many of these competitors, either alone or together with their partners, may develop new drug
candidates that will compete with ours. These competitors may, and in certain cases do, operate
larger research and development programs or have substantially greater financial resources than we
do. Our competitors may also have significantly greater experience in:
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developing drug candidates; |
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undertaking preclinical testing and clinical trials; |
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building relationships with key customers and opinion-leading physicians; |
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obtaining and maintaining FDA and other regulatory approvals of drug candidates; |
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formulating and manufacturing drugs; and |
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launching, marketing and selling drugs. |
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If our competitors market drugs that are less expensive, safer or more efficacious than our
potential drugs, or that reach
the market sooner than our potential drugs, we may not achieve commercial success. In
addition, the life sciences industry is characterized by rapid technological change. If we fail to
stay at the forefront of technological change, we may be unable to compete effectively. Our
competitors may render our technologies obsolete by improving existing technological approaches or
developing new or different approaches, potentially eliminating the advantages in our drug
discovery process that we believe we derive from our research approach and proprietary
technologies.
Our failure to attract and retain skilled personnel could impair our drug development and
commercialization activities.
Our business depends on the performance of our senior management and key scientific and
technical personnel. The loss of the services of any member of our senior management or key
scientific or technical staff may significantly delay or prevent the achievement of drug
development and other business objectives by diverting managements attention to transition matters
and identifying suitable replacements. We also rely on consultants and advisors to assist us in
formulating our research and development strategy. All of our consultants and advisors are either
self-employed or employed by other organizations, and they may have conflicts of interest or other
commitments, such as consulting or advisory contracts with other organizations, that may affect
their ability to contribute to us. In addition, if and as our business grows, we will need to
recruit additional executive management and scientific and technical personnel. There is currently
intense competition for skilled executives and employees with relevant scientific and technical
expertise, and this competition is likely to continue. Our inability to attract and retain
sufficient scientific, technical and managerial personnel could limit or delay our product
development activities, which would adversely affect the development of our drug candidates and
commercialization of our potential drugs and growth of our business.
Any future workforce and expense reductions may have an adverse impact on our internal programs and
our ability to hire and retain skilled personnel.
In light of our continued need for funding and cost control, we may be required to implement
future workforce and expense reductions, which may negatively affect our productivity and limit our
research and development activities. For example, as part of our strategic restructuring and
workforce reduction in 2008, we discontinued our early research activities in oncology. Our future
success will depend in large part upon our ability to attract and retain highly skilled personnel.
We may have difficulty retaining and attracting such personnel as a result of a perceived risk of
future workforce reductions. In addition, the implementation of workforce or expense reduction
programs may divert the efforts of our management team and other key employees, which could
adversely affect our business.
We may expand our development and clinical research capabilities and, as a result, we may encounter
difficulties in managing our growth, which could disrupt our operations.
We may have growth in our expenditures, the number of our employees and the scope of our
operations, in particular with respect to those drug candidates that we elect to develop or
commercialize independently or together with a partner. To manage our anticipated future growth, we
must continue to implement and improve our managerial, operational and financial systems, expand
our facilities and continue to recruit and train additional qualified personnel. Due to our limited
resources, we may not be able to effectively manage the expansion of our operations or recruit and
train additional qualified personnel. The physical expansion of our operations may lead to
significant costs and may divert our management and business development resources. Any inability
to manage growth could delay the execution of our business plans or disrupt our operations.
We currently have no sales or marketing staff and, if we are unable to enter into or maintain
strategic alliances with marketing partners or to develop our own sales and marketing capabilities,
we may not be successful in commercializing our potential drugs.
We currently have no sales, marketing or distribution capabilities. We plan to commercialize
drugs that can be effectively marketed and sold in concentrated markets that do not require a large
sales force to be competitive. To achieve this goal, we will need to establish our own specialized
sales force and marketing organization with technical expertise and supporting distribution
capabilities. Developing such an organization is expensive and time-consuming and could delay a
product launch. In addition, we may not be able to develop this capacity efficiently,
cost-effectively or at all, which could make us unable to commercialize our drugs. If we determine
not to market our drugs on our own, we will depend on strategic alliances with third parties, such
as Amgen, which have established distribution systems and direct sales forces to
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commercialize
them. If we are unable to enter into such arrangements on acceptable terms, we may not be able to
successfully commercialize these drugs. To the extent that we are not successful in
commercializing any drugs ourselves or through a strategic alliance, our product revenues and
business will suffer and our stock price would decrease.
Risks Related To Our Industry
The regulatory approval process is expensive, time-consuming and uncertain and may prevent our
partners or us from obtaining approvals to commercialize some or all of our drug candidates.
The research, testing, manufacturing, selling and marketing of drugs are subject to extensive
regulation by the FDA and other regulatory authorities in the United States and other countries,
and regulations differ from country to country. Neither we nor our partners are permitted to market
our potential drugs in the United States until we receive approval of a new drug application
(NDA) from the FDA. Neither we nor our partners have received marketing approval for any of
Cytokinetics drug candidates.
Obtaining NDA approval is a lengthy, expensive and uncertain process. In addition, failure to
comply with FDA and other applicable foreign and U.S. regulatory requirements may subject us to
administrative or judicially imposed sanctions. These include warning letters, civil and criminal
penalties, injunctions, product seizure or detention, product recalls, total or partial suspension
of production, and refusal to approve pending NDAs or supplements to approved NDAs.
Regulatory approval of an NDA or NDA supplement is never guaranteed, and the approval process
typically takes several years and is extremely expensive. The FDA and foreign regulatory agencies
also have substantial discretion in the drug approval process. Despite the time and efforts
exerted, failure can occur at any stage, and we could encounter problems that cause us to abandon
clinical trials or to repeat or perform additional preclinical testing and clinical trials. The
number and focus of preclinical studies and clinical trials that will be required for approval by
the FDA and foreign regulatory agencies varies depending on the drug candidate, the disease or
condition that the drug candidate is designed to address, and the regulations applicable to any
particular drug candidate. In addition, the FDA may require that a proposed Risk Evaluation and
Mitigation Strategy, also known as a REMS, be submitted as part of an NDA if the FDA determines
that it is necessary to ensure that the benefits of the drug outweigh its risks. The FDA and
foreign regulatory agencies can delay, limit or deny approval of a drug candidate for many reasons,
including, but not limited to:
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they might determine that a drug candidate is not safe or effective; |
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they might not find the data from preclinical testing and clinical trials sufficient and could
request that additional trials be performed; |
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they might not approve our, our partners or the contract manufacturers processes or facilities; or |
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they might change their approval policies or adopt new regulations. |
Even if we receive regulatory approval to manufacture and sell a drug in a particular
regulatory jurisdiction, other jurisdictions regulatory authorities may not approve that drug for
manufacture and sale. If we or our partners fail to receive and maintain regulatory approval for
the sale of any drugs resulting from our drug candidates, it would significantly harm our business
and negatively affect our stock price.
If we or our partners receive regulatory approval for our drug candidates, we or they will be
subject to ongoing obligations to and continued regulatory review by the FDA and foreign regulatory
agencies, and may be subject to additional post-marketing obligations, all of which may result in
significant expense and limit commercialization of our potential drugs.
Any regulatory approvals that we or our partners receive for our drug candidates may be
subject to limitations on the indicated uses for which the drug may be marketed or require
potentially costly post-marketing follow-up studies or compliance with a REMS. In addition, if the
FDA or foreign regulatory agencies approves any of our drug candidates, the labeling, packaging,
adverse event reporting, storage, advertising, promotion and record-keeping for the drug will be
subject to extensive regulatory requirements. The subsequent discovery of previously unknown
problems with the drug, including adverse events of unanticipated severity or frequency, or the
discovery that adverse effects or toxicities observed in
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preclinical research or clinical trials
that were believed to be minor actually constitute much more serious problems, may
result in restrictions on the marketing of the drug or withdrawal of the drug from the market.
The FDA and foreign regulatory agencies may change their policies and additional government
regulations may be enacted that could prevent or delay regulatory approval of our drug candidates.
We cannot predict the likelihood, nature or extent of adverse government regulation that may arise
from future legislation or administrative action, either in the United States or abroad. If we are
not able to maintain regulatory compliance, we might not be permitted to market our drugs and our
business would suffer.
If physicians and patients do not accept our drugs, we may be unable to generate significant
revenue, if any.
Even if our drug candidates obtain regulatory approval, the resulting drugs, if any, may not
gain market acceptance among physicians, healthcare payors, patients and the medical community.
Even if the clinical safety and efficacy of drugs developed from our drug candidates are
established for purposes of approval, physicians may elect not to recommend these drugs for a
variety of reasons including, but not limited to:
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introduction of competitive drugs to the market; |
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clinical safety and efficacy of alternative drugs or treatments; |
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cost-effectiveness; |
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availability of coverage and reimbursement from health maintenance organizations and other third-party payors; |
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convenience and ease of administration; |
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prevalence and severity of adverse side effects; |
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other potential disadvantages relative to alternative treatment methods; or |
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insufficient marketing and distribution support. |
If our drugs fail to achieve market acceptance, we may not be able to generate significant
revenue and our business would suffer.
The coverage and reimbursement status of newly approved drugs is uncertain and failure to obtain
adequate coverage and reimbursement could limit our ability to market any drugs we may develop and
decrease our ability to generate revenue.
Even if one or more of our drug candidates is approved for sale, the commercial success of our
drugs in both domestic and international markets will be substantially dependent on whether
third-party coverage and reimbursement is available for our drugs by the medical profession for use
by their patients, which is highly uncertain. Medicare, Medicaid, health maintenance organizations
and other third-party payors are increasingly attempting to contain healthcare costs by limiting
both coverage and the level of reimbursement of new drugs. As a result, they may not cover or
provide adequate payment for our drugs. They may not view our drugs as cost-effective and
reimbursement may not be available to consumers or may be insufficient to allow our drugs to be
marketed on a competitive basis. If we are unable to obtain adequate coverage and reimbursement for
our drugs, our ability to generate revenue will be adversely affected. Likewise, current and future
legislative or regulatory efforts to control or reduce healthcare costs or reform government
healthcare programs, such as the Patient Protection Affordable Care Act and the Health Care and
Education Reconciliation Act of 2010, could result in lower prices or rejection of coverage and
reimbursement for our potential drugs. Changes in coverage and reimbursement policies or healthcare
cost containment initiatives that limit or restrict reimbursement for any of our drug candidates
that are approved could cause our potential future revenues to decline.
We may be subject to costly product liability or other liability claims and may not be able to
obtain adequate insurance.
The use of our drug candidates in clinical trials may result in adverse effects. We cannot
predict all the possible harms or adverse effects that may result from our clinical trials. We
currently maintain limited product liability insurance. We may not
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have sufficient resources to pay
for any liabilities resulting from a personal injury or other claim excluded from, or beyond
the limit of, our insurance coverage. Our insurance does not cover third parties negligence
or malpractice, and our clinical investigators and sites may have inadequate insurance or none at
all. In addition, in order to conduct clinical trials or otherwise carry out our business, we may
have to contractually assume liabilities for which we may not be insured. If we are unable to look
to our own or a third partys insurance to pay claims against us, we may have to pay any arising
costs and damages ourselves, which may be substantial.
In addition, if we commercially launch drugs based on our drug candidates, we will face even
greater exposure to product liability claims. This risk exists even with respect to those drugs
that are approved for commercial sale by the FDA and foreign regulatory agencies and manufactured
in licensed and regulated facilities. We intend to secure additional limited product liability
insurance coverage for drugs that we commercialize, but may not be able to obtain such insurance on
acceptable terms with adequate coverage, or at reasonable costs. Even if we are ultimately
successful in product liability litigation, the litigation would consume substantial amounts of our
financial and managerial resources and may create adverse publicity, all of which would impair our
ability to generate sales of the affected product and our other potential drugs. Moreover, product
recalls may be issued at our discretion or at the direction of the FDA and foreign regulatory
agencies, other governmental agencies or other companies having regulatory control for drug sales.
Product recalls are generally expensive and often have an adverse effect on the reputation of the
drugs being recalled and of the drugs developer or manufacturer.
We may be required to indemnify third parties against damages and other liabilities arising
out of our development, commercialization and other business activities, which could be costly and
time-consuming and distract management. If third parties that have agreed to indemnify us against
damages and other liabilities arising from their activities do not fulfill their obligations, then
we may be held responsible for those damages and other liabilities.
To the extent we elect to fund the development of a drug candidate or the commercialization of a
drug at our expense, we will need substantial additional funding.
The discovery, development and commercialization of new drugs is costly. As a result, to the
extent we elect to fund the development of a drug candidate or the commercialization of a drug, we
will need to raise additional capital to:
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expand our research and development capabilities; |
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fund clinical trials and seek regulatory approvals; |
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build or access manufacturing and commercialization capabilities; |
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implement additional internal systems and infrastructure; |
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maintain, defend and expand the scope of our intellectual property; and |
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hire and support additional management and scientific personnel. |
Our future funding requirements will depend on many factors, including, but not limited to:
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the rate of progress and costs of our clinical trials and other research and development activities; |
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the costs and timing of seeking and obtaining regulatory approvals; |
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the costs associated with establishing manufacturing and commercialization capabilities; |
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the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; |
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the costs of acquiring or investing in businesses, products and technologies; |
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the effect of competing technological and market developments; and |
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the status of, payment and other terms, and timing of any strategic alliance, licensing or other arrangements that
we have entered into or may establish. |
Until we can generate a sufficient amount of product revenue to finance our cash requirements,
which we may never do, we expect to continue to finance our future cash needs primarily through
strategic alliances, public or private equity offerings and debt financings. We cannot be certain
that additional funding will be available on acceptable terms, or at all. If we are not able to
secure additional funding when needed, we may have to delay, reduce the scope of or eliminate one
or more of our clinical trials or research and development programs or future commercialization
initiatives.
Responding to any claims relating to improper handling, storage or disposal of the hazardous
chemicals and radioactive and biological materials we use in our business could be time-consuming
and costly.
Our research and development processes involve the controlled use of hazardous materials,
including chemicals and radioactive and biological materials. Our operations produce hazardous
waste products. We cannot eliminate the risk of accidental contamination or discharge and any
resultant injury from those materials. Federal, state and local laws and regulations govern the
use, manufacture, storage, handling and disposal of hazardous materials. We may be sued for any
injury or contamination that results from our or third parties use of these materials. Compliance
with environmental laws and regulations is expensive, and current or future environmental
regulations may impair our research, development and production activities.
Our facilities in California are located near an earthquake fault, and an earthquake or other types
of natural disasters, catastrophic events or resource shortages could disrupt our operations and
adversely affect our results.
All of our facilities and our important documents and records, such as hard copies of our
laboratory books and records for our drug candidates and compounds and our electronic business
records, are located in our corporate headquarters at a single location in South San Francisco,
California near active earthquake zones. If a natural disaster, such as an earthquake or flood, a
catastrophic event such as a disease pandemic or terrorist attack, or a localized extended outage
of critical utilities or transportation systems occurs, we could experience a significant business
interruption. Our partners and other third parties on which we rely may also be subject to business
interruptions from such events. In addition, California from time to time has experienced shortages
of water, electric power and natural gas. Future shortages and conservation measures could disrupt
our operations and cause expense, thus adversely affecting our business and financial results.
Risks Related To an Investment in Our Securities
We expect that our stock price will fluctuate significantly, and you may not be able to resell your
shares at or at or above your investment price.
The stock market, particularly in recent years, has experienced significant volatility,
particularly with respect to pharmaceutical, biotechnology and other life sciences company stocks,
which often does not relate to the operating performance of the companies represented by the stock.
Factors that could cause volatility in the market price of our common stock include, but are not
limited to:
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announcements concerning any of the clinical trials for our compounds, such as omecamtiv mecarbil
for heart failure and CK-2017357 and CK-2066260 for the potential treatment of diseases associated
with aging, muscle wasting and neuromuscular dysfunction (including, but not limited to, the
timing of initiation or completion of such trials and the results of such trials, and delays or
discontinuations of such trials, including delays resulting from slower than expected or suspended
patient enrollment or discontinuations resulting from a failure to meet pre-defined clinical
end-points); |
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announcements concerning our strategic alliance with Amgen or future strategic alliances; |
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failure or delays in entering additional drug candidates into clinical trials; |
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failure or discontinuation of any of our research programs; |
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issuance of new or changed securities analysts reports or recommendations; |
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failure or delay in establishing new strategic alliances, or the terms of those alliances; |
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market conditions in the pharmaceutical, biotechnology and other healthcare-related sectors; |
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actual or anticipated fluctuations in our quarterly financial and operating results; |
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developments or disputes concerning our intellectual property or other proprietary rights; |
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introduction of technological innovations or new products by us or our competitors; |
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issues in manufacturing our drug candidates or drugs; |
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market acceptance of our drugs; |
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third-party healthcare coverage and reimbursement policies; |
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FDA or other U.S. or foreign regulatory actions affecting us or our industry; |
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litigation or public concern about the safety of our drug candidates or drugs; |
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additions or departures of key personnel; |
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substantial sales of our common stock by our existing shareholders, whether or not related to our
performance; and |
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volatility in the stock prices of other companies in our industry or in the stock market generally. |
These and other external factors may cause the market price and demand for our common stock to
fluctuate substantially, which may limit or prevent investors from readily selling their shares of
common stock and may otherwise negatively affect the liquidity of our common stock. In addition,
when the market price of a stock has been volatile, holders of that stock have instituted
securities class action litigation against the company that issued the stock. If any of our
stockholders brought a lawsuit against us, we could incur substantial costs defending the lawsuit.
Such a lawsuit could also divert our managements time and attention.
If the ownership of our common stock continues to be highly concentrated, it may prevent you
and other stockholders from influencing significant corporate decisions and may result in conflicts
of interest that could cause our stock price to decline.
As of April 30, 2011, our executive officers, directors and their affiliates beneficially
owned or controlled approximately 12.6% of the outstanding shares of our common stock (after giving
effect to the exercise of all outstanding vested and unvested options and warrants). Accordingly,
these executive officers, directors and their affiliates, acting as a group, will have substantial
influence over the outcome of corporate actions requiring stockholder approval, including the
election of directors, any merger, consolidation or sale of all or substantially all of our assets
or any other significant corporate transactions. These stockholders may also delay or prevent a
change of control of us, even if such a change of control would benefit our other stockholders. The
significant concentration of stock ownership may adversely affect the trading price of our common
stock due to investors perception that conflicts of interest may exist or arise.
Volatility in the stock prices of other companies may contribute to volatility in our stock price.
The stock market in general, and the NASDAQ Global Market (NASDAQ) and the market for
technology companies in particular, have experienced significant price and volume fluctuations that
have often been unrelated or disproportionate to the operating performance of those companies.
Further, there has been particular volatility in the market prices of securities of early stage and
development stage life sciences companies. These broad market and industry factors may seriously
harm the market price of our common stock, regardless of our operating performance. In the past,
following periods of volatility in the market price of a companys securities, securities class
action litigation has often been instituted. A securities class action suit against us could result
in substantial costs, potential liabilities and the diversion of managements attention and
resources, and could harm our reputation and business.
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Our common stock is thinly traded and there may not be an active, liquid trading market for our
common stock.
There is no guarantee that an active trading market for our common stock will be maintained on
NASDAQ, or that the volume of trading will be sufficient to allow for timely trades. Investors may
not be able to sell their shares quickly or at the latest market price if trading in our stock is
not active or if trading volume is limited. In addition, if trading volume in our common stock is
limited, trades of relatively small numbers of shares may have a disproportionate effect on the
market price of our common stock.
Evolving regulation of corporate governance and public disclosure may result in additional
expenses, use of resources and continuing uncertainty.
Changing laws, regulations and standards relating to corporate governance and public
disclosure, including the Sarbanes-Oxley Act of 2002, the Dodd-Frank Wall Street Reform and
Consumer Protection Act of 2010 and new Securities and Exchange
Commission, or SEC, regulations and
NASDAQ Stock Market LLC rules are creating uncertainty for public companies. We are presently
evaluating and monitoring developments with respect to new and proposed rules and cannot predict or
estimate the amount of the additional costs we may incur or the timing of these costs. For example,
compliance with the internal control requirements of Section 404 of the Sarbanes-Oxley Act has to
date required the commitment of significant resources to document and test the adequacy of our
internal control over financial reporting. We can provide no assurance as to conclusions of
management or by our independent registered public accounting firm with respect to the
effectiveness of our internal control over financial reporting in the future. In addition, the SEC
has adopted regulations that will require us to file corporate financial statement information in a
new interactive data format known as XBRL beginning in 2011. We may incur significant costs and
need to invest considerable resources to implement and to remain in compliance with these new
requirements.
These new or changed laws, regulations and standards are subject to varying interpretations,
in many cases due to their lack of specificity, and, as a result, their application in practice may
evolve over time as new guidance is provided by regulatory and governing bodies. This could result
in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing
revisions to disclosure and governance practices. We intend to maintain high standards of corporate
governance and public disclosure. As a result, we intend to invest the resources necessary to
comply with evolving laws, regulations and standards, and this investment may result in increased
general and administrative expenses and a diversion of management time and attention from
revenue-generating activities to compliance activities. If our efforts to comply with new or
changed laws, regulations and standards differ from the activities intended by regulatory or
governing bodies, due to ambiguities related to practice or otherwise, regulatory authorities may
initiate legal proceedings against us, which could be costly and time-consuming, and our reputation
and business may be harmed.
We have never paid dividends on our capital stock, and we do not anticipate paying any cash
dividends in the foreseeable future.
We have paid no cash dividends on any of our classes of capital stock to date and we currently
intend to retain our future earnings, if any, to fund the development and growth of our businesses.
In addition, the terms of existing or any future debts may preclude us from paying these dividends.
Our common stock may be at risk for delisting from NASDAQ
in the future. Delisting could adversely affect the liquidity of our common stock and the market price of our common stock
could decrease.
Our common stock is currently listed on NASDAQ.
The NASDAQ Stock Market LLC has minimum requirements that a company must meet in order to remain listed on NASDAQ. These requirements include maintaining a minimum closing bid price of $1.00 per share. Although the
trading price of our common stock is currently above $1.00 per share, there can be no assurance that we will continue to
meet this, or any other, requirement in the future, and, if we do not, it is possible that The NASDAQ Stock Market LLC
may notify us that we have failed to meet the minimum listing requirements and initiate the delisting process. If
our common stock were to be delisted, the liquidity of our common stock would be adversely affected and the market price
of our common stock could decrease.
Our
stockholders will experience substantial additional dilution if our
shares of preferred stock are converted into common stock.
As of June
10, 2011, we had 72,279,751 shares of common stock
outstanding. However, as of that same date, we also had outstanding 8,070 shares of our Series A Convertible Preferred
Stock, which is convertible, without payment of additional consideration, into 8,070,000 shares of common stock.
The conversion of the outstanding shares of our Series A Convertible Preferred Stock into common stock would be
substantially dilutive to the outstanding shares of common stock. Any dilution or potential dilution may cause our
stockholders to sell their shares, which would contribute to a downward movement in the stock price of our common stock.
Risks Relating to This Offering
We will have broad discretion over the use of the proceeds to us from this offering and may apply
it to uses that do not improve our operating results or the value of your securities.
We will have broad discretion to use the net proceeds to us from this offering, and investors
will be relying solely on the judgment of our board of directors and management regarding the
application of these proceeds. Although we expect to use the net proceeds from this offering for
general corporate purposes, we have not allocated these net proceeds for specific purposes.
Investors will not have the opportunity, as part of their investment decision, to assess whether
the proceeds are being used appropriately. Our use of the proceeds may not improve our operating
results or increase the value of the securities being offered hereby.
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You will experience immediate and substantial dilution.
The offering price per share in this offering may exceed the net tangible book value per share
of our common stock outstanding prior to this offering. Assuming that
an aggregate of 14,383,670
shares of our common stock are sold at a price of $1.18 per share, the last reported sale price of
our common stock on NASDAQ on June 10, 2011, for aggregate gross
proceeds of $17.0
million, and after deducting commissions and estimated aggregate offering expenses
payable by us, you will experience immediate dilution of $0.25 per share, representing the
difference between our as adjusted net tangible book value per share as of March 31, 2011 after
giving effect to this offering and the assumed offering price. The exercise of outstanding stock
options and warrants will result in further dilution of your investment. See the section entitled
Dilution below for a more detailed illustration of the dilution you would incur if you
participate in this offering.
This
offering, together with other offerings by us, may harm the market price of, and
market for, our common shares.
The common shares that may be offered and sold under this prospectus represent approximately
19.9% of our issued and outstanding common shares as of the
date of this prospectus. We have commenced an at-the-market offering
of up to $20.0 million in common shares and may conduct
additional offerings of common shares from time to time in the near future. The sales, if any, by
us as part of our at-the-market offering or any other offering may create downward
pressure on the market price of our common shares. In addition, market participants may elect not
to purchase our shares because of the actual or anticipated downward pressure placed on the market
price for our common shares by this offering or separate offerings by the company, which may reduce
trading volume and result in market price declines.
23
DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus and the documents we incorporate by reference in this prospectus include
forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, which we refer to as the Securities Act, and Section 21E of the Securities Exchange Act of
1934, as amended, which we refer to as the Exchange Act, that involve substantial risks and
uncertainties. All statements, other than statements of historical fact that we include in this
prospectus and in the documents we incorporate by reference in this prospectus, including
statements regarding our strategy, future operations, future financial position, future results of
operations, future cash flows, projected costs, financing plans, product development, possible
strategic alliances, competitive position, prospects, plans and objectives of management, may be
deemed forward-looking statements for purposes of the Securities Act and the Exchange Act. We often
use words such as anticipate, estimate, expect, project, intend, plan, believe,
may, predict, will, and would, and similar expressions, to identify forward-looking
statements, although not all forward-looking statements contain these identifying words.
These forward-looking statements include, among other things, statements about:
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guidance concerning revenues, research and development expenses and general and
administrative expenses for 2011; |
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the sufficiency of existing resources to fund our operations for at least the next 12
months; |
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our capital requirements and needs for additional financing; |
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the initiation, design, progress, timing and scope of clinical trials and development
activities for our drug candidates and potential drug candidates conducted by ourselves or our
partners, such as Amgen, including the anticipated timing for initiation of clinical trials
and anticipated dates of data becoming available or being announced from clinical trials; |
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the results from the clinical trials and non-clinical and pre-clinical studies of our drug
candidates and other compounds, and the significance and utility of such results; |
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our plans to file an IND for CK-2066260 with the FDA; |
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our and our partners, such as Amgens, plans or ability to conduct the continued research
and development of our drug candidates and other compounds; |
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our expected roles in research, development or commercialization under our strategic
alliances, such as with Amgen; |
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the properties and potential benefits of, and the potential market opportunities for, our
drug candidates and other compounds, including the potential indications for which they may be
developed; |
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the sufficiency of the clinical trials conducted with our drug candidates to demonstrate
that they are safe and efficacious; |
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our receipt of milestone payments, royalties, reimbursements and other funds from current
or future partners under strategic alliances, such as with Amgen; |
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our plans to seek strategic alternatives for our mitotic kinesin inhibitor drug candidates
with third parties; |
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our ability to continue to identify additional potential drug candidates that may be
suitable for clinical development; |
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our plans or ability to commercialize drugs with or without a partner, including our
intention to develop sales and marketing capabilities; |
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the focus, scope and size of our research and development activities and programs; |
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the utility of our focus on the cytoskeleton and our ability to leverage our experience in
muscle contractility to other muscle functions; |
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our ability to protect our intellectual property and to avoid infringing the intellectual
property rights of others; |
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expected future sources of revenue and capital; |
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losses, costs, expenses and expenditures; |
24
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future payments under loan and lease obligations and equipment financing lines; |
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potential competitors and competitive products; |
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retaining key personnel and recruiting additional key personnel; |
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expected future amortization of employee stock-based compensation; and |
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the potential impact of recent accounting pronouncements on our financial position or
results of operations. |
Such forward-looking statements involve risks and uncertainties, including, but not limited
to, those risks and uncertainties relating to:
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Amgens decisions with respect to the timing, design and conduct of development activities
for omecamtiv mecarbil, including decisions to postpone or discontinue research or development
activities relating to omecamtiv mecarbil; |
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our ability to obtain additional financing; |
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our receipt of funds and access to other resources under our current or future strategic
alliances; |
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difficulties or delays in the development, testing, production or commercialization of our
drug candidates; |
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difficulties or delays in or slower than anticipated patient enrollment in our or our
partners clinical trials; |
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adverse side effects, including potential drug-drug interactions, or inadequate therapeutic
efficacy of our drug candidates that could slow or prevent product approval (including the
risk that current and past results of preclinical research or non-clinical or clinical
development may not be indicative of future clinical trials results); |
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results from non-clinical studies that may adversely impact the timing or the further
development of our drug candidates and potential drug candidates; |
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the possibility that the FDA or foreign regulatory agencies may delay or limit our or our
partners ability to conduct clinical trials or may delay or withhold approvals for the
manufacture and sale of our products; |
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activities and decisions of, and market conditions affecting, current and future strategic
partners; |
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our ability to enter into partnership agreements for any of our programs on acceptable
terms and conditions or in accordance with our planned timelines; |
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the availability of funds under our grant from the National Institute of Neurological
Disorders and Stroke in future periods; |
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changing standards of care and the introduction of products by competitors or alternative
therapies for the treatment of indications we target that may make our drug candidates
commercially unviable; |
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the uncertainty of protection for our intellectual property, whether in the form of
patents, trade secrets or otherwise; and |
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potential infringement or misuse by us of the intellectual property rights of third
parties. |
Our actual results may differ materially from those indicated by these forward-looking
statements as a result of various important factors, including the factors described under Risk
Factors beginning on page 4 of this prospectus and those incorporated herein by reference. These
important factors include the factors that we identify in the documents that we incorporate by
reference in this prospectus. If one or more of these factors materialize, or if any underlying
assumptions prove incorrect, our actual results, performance or achievements may vary materially
from any future results, performance or achievements expressed or implied by these forward-looking
statements. You should consider these factors and the other cautionary statements made in this
prospectus or the documents we incorporate by reference as being applicable to all related
forward-looking statements wherever they appear in this prospectus or the documents incorporated by
reference. We do not assume, and specifically disclaim, any obligation to publicly update
forward-looking statements, whether as a result of new information, future events or otherwise.
Operating results reported are not necessarily indicative of results that may occur in future
periods.
You should read this prospectus, the documents we have filed with the SEC that are
incorporated by reference and any accompanying prospectus supplement in
connection with this offering completely and with the understanding that our actual future results
may be materially different from what we expect. We qualify all of the forward-
looking statements in the foregoing documents by these cautionary statements.
25
You should rely only on the information contained in, or incorporated by reference into, this
prospectus and in any accompanying prospectus supplement in connection with
this offering. Neither we nor MLV have authorized any other person to
provide you with different information. The securities offered under this prospectus are not being
offered in any state where the offer is not permitted. You should not assume that the information
contained in this prospectus is accurate as of any date other than the date on the front of this
prospectus, or that any information incorporated by reference into this prospectus is accurate as
of any date other than the date of the document so incorporated by reference.
USE OF PROCEEDS
We currently intend to use the net proceeds, if any, from the sale of shares of our common
stock for:
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research and development, including clinical trials for our drug candidates; and |
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working capital and other general corporate purposes. |
We cannot estimate precisely the allocation of the net proceeds from this offering among these
uses. The amount that we actually expend for these purposes may vary significantly depending on
numerous factors, such as the progress of our research and development efforts, technological
advances and the competitive environment for our products. We may also use a portion of the net
proceeds to acquire or invest in complementary businesses, products and technologies. Although we
currently have no material agreements or commitments with respect to acquisitions, we evaluate
acquisition opportunities and engage in related discussions from time to time.
Pending the application of the net proceeds, we intend to invest the net proceeds in a variety
of capital preservation instruments, including direct or guaranteed obligations of the U.S.
government, certificates of deposit and money market funds, in accordance with our investment
policy.
26
DILUTION
If you invest in this offering, your ownership interest will be diluted to the extent of the
difference between the public offering price per share and the as adjusted net tangible book value
per share after giving effect to this offering. We calculate net tangible book value per share by
dividing the net tangible book value, which is tangible assets less total liabilities, by the
number of outstanding shares of our common stock. Dilution represents the difference between
the amount per share paid by purchasers of shares in this offering and the as adjusted
net tangible book value per share of our common stock immediately after giving effect to this
offering. Our net tangible book value as of March 31, 2011 was approximately $59.6 million, or
$0.89 per share.
After
giving effect to the sale of our common stock in the aggregate amount of $17.0 million,
which is based on the assumed sale of a number of shares equal to
19.9% of our common stock outstanding as of June 10, 2011 and
an assumed offering price of $1.18 per share, the last reported sale price of our common stock
on The NASDAQ Global Market on June 10, 2011, and after deducting estimated offering commissions and
expenses payable by us, our net tangible book value as of
March 31, 2011 would have been $76.0
million, or $0.93 per share of common stock. This represents an immediate increase in the net
tangible book value of $0.04 per share to our existing stockholders and an immediate dilution in
net tangible book value of $0.25 per share to new investors. The following table illustrates this
per share dilution:
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Assumed public offering price per share |
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1.18 |
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Net tangible book value per share as of March 31, 2011 |
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0.89 |
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Increase in net tangible book value per share attributable to this offering |
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0.04 |
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As adjusted net tangible book value per share as of March 31, 2011, after
giving effect to this offering |
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0.93 |
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Dilution per share to new investors purchasing shares in this offering |
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0.25 |
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The
table above assumes for illustrative purposes that an aggregate of
14,383,670 shares of
our common stock are sold at a price of $1.18 per share, the last reported sale price of our common
stock on The NASDAQ Global Market on June 10,
2011, for aggregate gross proceeds of $17.0 million. The shares sold in this offering, if any,
will be sold from time to time at various prices. An increase of $0.10 per share in the price at
which the shares are sold from the assumed offering price of $1.18 per share shown in the table
above, assuming all of our common stock in the aggregate amount of
$18.4 million is sold at that
price, would increase our adjusted net tangible book value per share after the offering to $0.95
per share and would increase the dilution in net tangible book value per share to new investors in
this offering to $0.33 per share, after deducting commissions and estimated aggregate offering
expenses payable by us. A decrease of $0.10 per share in the price at which the shares are sold
from the assumed offering price of $1.18 per share shown in the table above, assuming all of our
common stock in the aggregate amount of $15.5 million is sold at that price, would decrease our
adjusted net tangible book value per share after the offering to $0.92 per share and would decrease
the dilution in net tangible book value per share to new investors in
this offering to $0.16 per
share, after deducting commissions and estimated aggregate offering expenses payable by us. This
information is supplied for illustrative purposes only.
The above discussion and table are based on 66,916,100 shares of our common stock issued and
outstanding as of March 31, 2011 and excludes the following, all as of March 31, 2011:
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10,074,867 shares of our common stock issuable upon exercise of outstanding
stock options under our stock option plans, at a weighted average exercise price of $3.66; |
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4,027,300 shares of our common stock issuable upon exercise of outstanding
warrants at a weighted average price of $3.44 per share; and |
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3,570,118 shares of our common stock reserved for future
awards under our stock option plans and
employee stock purchase plans. |
The above discussion also excludes 5,300,000 shares of our common stock, 8,070 shares of our Series A Convertible
Preferred Stock, and warrants to purchase 6,685,000 shares of our common stock, all of which were issued pursuant
to that certain Securities Purchase Agreement, dated April 18, 2011, by and between the company and certain investors.
To the extent that options or warrants are
exercised, or other shares are issued, including upon conversion of our outstanding Series A. Convertible Preferred Stock,
investors purchasing shares in this offering could
experience further dilution. In addition, we may choose to raise additional capital due to market
conditions or strategic considerations, even if we believe we have sufficient funds for our current
or future operating plans. To the extent that additional capital is raised through the sale of
equity or convertible debt securities, the issuance of these securities could result in further
dilution to our stockholders.
27
PLAN OF DISTRIBUTION
We have entered into an At the Market Issuance Sales Agreement with MLV, under which we may issue and sell shares of our common stock having aggregate sales
proceeds of up to $20,000,000 from time to time through MLV acting as agent. MLV may sell the
common stock by any method that is deemed to be an at-the-market equity offering as defined in
Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on
or through NASDAQ or any other existing trading market for the common stock in
the U.S. or to or through a market maker. MLV may also sell the common stock in privately negotiated
transactions, subject to our prior approval.
Each time we wish to issue and sell common stock under the sales agreement, we will notify MLV
of the number of shares to be issued, the dates on which such sales are anticipated to be made and
any minimum price below which sales may not be made. Once we have so instructed MLV, unless MLV
declines to accept the terms of this notice, MLV has agreed to use its commercially reasonable
efforts consistent with its normal trading and sales practices to sell such shares up to the amount
specified on such terms. MLVs obligations under the sales
agreement to sell our common stock are
subject to a number of conditions that we must meet.
The settlement between us and MLV is generally anticipated to occur on the third trading day
following the date on which the sale was made. Sales of our common stock as contemplated in this
prospectus will be settled through the facilities of The Depository Trust Company or by such other
means as we and MLV may agree upon. There is no arrangement for funds to be received in an escrow,
trust or similar arrangement.
We will pay MLV a commission equal to an aggregate of 3.0% of the gross proceeds we receive
from the sales of our common stock. Because there is no minimum offering amount required as a
condition to close this offering, the actual total public offering amount, commissions and proceeds
to us, if any, are not determinable at this time. In connection with the sale of the common stock
on our behalf, MLV may, and will with respect to sales effected in an at-the-market-offering, be
deemed to be an underwriter within the meaning of the Securities Act of 1933, as amended, and the
compensation of MLV will be deemed to be underwriting commissions or discounts. We have agreed to
provide indemnification and contribution to
MLV with respect to certain civil liabilities,
including liabilities under the Securities Act. We estimate that the total expenses for the
offering, excluding compensation payable to MLV under the terms of the sales agreement, will be
approximately $84 thousand. The maximum compensation to be received
by any broker/dealer or sales agent will not be greater than 8.0% for
the sale of any securities being registered pursuant to Rule 415.
The offering of our common stock pursuant to the sales agreement will terminate upon the
earlier of (i) the sale of all of our common stock provided for in this prospectus, or (ii)
termination of the sales agreement as permitted therein. MLV may terminate the sales agreement at
any time in certain circumstances, including the occurrence of a material adverse change with
respect to us that, in MLVs sole judgment, makes it impracticable or inadvisable to market the
shares, if there has occurred any material adverse change in the U.S. financial markets or
international financial markets, which in MLVs sole judgment makes it impracticable to market the
shares, if trading in the shares has been suspended or limited by
the SEC or NASDAQ, or if trading generally has been suspended or limited by
NASDAQ, if any suspension of trading of any of our shares on any
exchange or over-the-counter market shall have occurred and be continuing, if there is a major
disruption of securities settlements or clearance services in the U.S. which shall be continuing,
or if a banking moratorium has been declared in the U.S. Federal or New York authorities. We and
MLV may each terminate the sales agreement at any time upon 10 days prior notice.
This summary of the material provisions of the sales agreement does not purport to be a
complete statement of its terms and conditions. A copy of the sales agreement is filed with the
Securities and Exchange Commission and is incorporated by reference into the registration statement
of which this prospectus is a part. See Where You Can Find More Information and Information Incorporated by Reference below.
To the extent required by Regulation M, MLV will not engage in any market making activities
involving our common stock while the offering is ongoing under this prospectus.
DESCRIPTION OF CAPITAL STOCK
As of the date of this prospectus, our authorized capital stock consists of 180,000,000
shares. Those shares consist of 170,000,000 shares designated as common stock, $0.001 par value,
and 10,000,000 shares designated as preferred stock, $0.001 par
value, 8,070 shares of which have been designated as Series A Convertible Preferred Stock (the Series A Preferred Stock). As of
June 10, 2011, there were 72,216,100 shares of common stock issued and outstanding, and 8,070
shares of Series A Preferred Stock issued and outstanding, convertible into an aggregate of 8,070,000 shares of our Common Stock.
The following description summarizes the material terms of our capital stock. This summary is, however, subject to the provisions of our amended and restated
certificate of incorporation and by the provisions of applicable law.
Common Stock
Holders of common stock are entitled to one vote for each share held of record on all matters
submitted to a vote of stockholders. Upon any liquidation, dissolution or winding up of our
business, the holders of common stock are entitled to share equally in all assets available for
distribution after payment of all liabilities and provision for liquidation preference of shares of
preferred stock then outstanding. Holders of common stock have no preemptive rights or rights to
convert their common stock into any other securities. There are no redemption or sinking fund
provisions applicable to the common stock. Holders of common stock are entitled to receive
dividends declared by the board of directors, out of funds legally available for the payment of
dividends, subject to the rights of holders of preferred stock. Currently, we are not paying
dividends.
Our common stock is listed on The NASDAQ Global Market under the symbol CYTK. The transfer
agent and registrar for our common stock is Mellon Investor Services LLC, doing business as BNY
Mellon Shareowner Services. Mellons address is 525 Market Street, 35th Floor, San
Francisco, California 94105.
All outstanding shares of common stock are fully paid and non-assessable, and all shares of
common stock offered by this prospectus, or issuable upon conversion or exercise of securities,
will, when issued, be validly issued and fully paid and non-assessable.
28
Preferred Stock
Each share of Series A Preferred Stock is convertible into 1,000 shares of our common stock at
any time at the option of the holder, provided that the holder will be prohibited from converting
Series A Preferred Stock into shares of our common stock if, as a result of such conversion, the
holder, together with its affiliates, would own more than 9.98% of the total
number of shares of our common stock then issued and outstanding. In the event of our
liquidation, dissolution, or winding up, holders of our Series A Preferred Stock will receive a
payment equal to $0.001 per share of Series A Preferred Stock before any proceeds are distributed
to the holders of our common stock. Shares of Series A Preferred Stock will generally have no
voting rights, except as required by law and except that the consent of holders of a majority of
the outstanding Series A Preferred Stock will be required to amend the terms of the Series A
Preferred Stock.
Our Series A Preferred Stock is not listed on an exchange or any trading system and we do not
expect that a trading market for our Series A Preferred Stock will develop.
Anti-Takeover Effects of Some Provisions of Delaware Law
Provisions of Delaware law and our amended and restated certificate of incorporation and
amended bylaws could make the acquisition of our company through a tender offer, a proxy contest or
other means more difficult and could make the removal of incumbent officers and directors more
difficult. We expect these provisions to discourage coercive takeover practices and inadequate
takeover bids and to encourage persons seeking to acquire control of our company to first negotiate
with our board of directors. We believe that the benefits provided by our ability to negotiate with
the proponent of an unfriendly or unsolicited proposal outweigh the disadvantages of discouraging
these proposals. We believe the negotiation of an unfriendly or unsolicited proposal could result
in an improvement of its terms.
We are subject to Section 203 of the Delaware General Corporation Law, an anti-takeover law.
In general, Section 203 prohibits a publicly held Delaware corporation from engaging in a business
combination with an interested stockholder for a period of three years following the date the
person became an interested stockholder, unless:
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prior to the time the stockholder become an interested stockholder, the board of
directors of the corporation approved either the business
combination or the transaction which resulted in the
stockholder becoming an interested stockholder; |
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upon consummation of the transaction which resulted in the
stockholder becoming an interested stockholder, the
stockholder owned at least 85% of the voting stock of the
corporation outstanding at the time the transaction
commenced, excluding for purposes of determining the
voting stock outstanding those shares owned (a) by
persons who are directors and also officers, and (b)
employee stock plans in which employee participants do not
have the right to determine confidentially whether shares
held subject to the plan will be tendered in a tender or
exchange offer; or |
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at or subsequent to such time the stockholder become an
interested stockholder, the business combination is
approved by the board of directors and authorized at an
annual or special meeting of stockholders, and not by
written consent, by the affirmative vote of at least 66
2/3% of the outstanding voting stock which is not owned by
the interested stockholder. |
Generally, a business combination includes a merger, asset or stock sale, or other
transaction resulting in a financial benefit to the interested stockholder. An interested
stockholder is a person who, together with affiliates and associates, owns or, within three years
prior to the determination of interested stockholder status, did own 15% or more of a corporations
outstanding voting securities. We expect the existence of this provision to have an anti-takeover
effect with respect to transactions our board of directors does not approve in advance. We also
anticipate that Section 203 may also discourage attempts that might result in a premium over the
market price for the shares of common stock held by stockholders.
Anti-Takeover Effects of Provisions of Our Charter Documents
Our amended and restated certificate of incorporation provides for our board of directors to
be divided into three classes serving staggered terms. Approximately one-third of the board of
directors will be elected each year. The provision for a classified board could prevent a party who
acquires control of a majority of the outstanding voting stock from obtaining control of the board
of directors until the second annual stockholders meeting following the date the acquirer obtains
the controlling stock interest. The classified board provision could discourage a potential
acquirer from making a tender offer or otherwise attempting to obtain control of our company and
could increase the likelihood that incumbent directors will retain their positions. Our amended and
restated certificate of incorporation provides that directors may be removed with cause by the
affirmative vote of the holders of the outstanding shares of common stock.
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Our amended and restated bylaws establish an advance notice procedure for stockholder
proposals to be brought before
an annual meeting of our stockholders, including proposed nominations of persons for election
to the board of directors. At an annual meeting, stockholders may only consider proposals or
nominations specified in the notice of meeting or brought before the meeting by or at the direction
of the board of directors. Stockholders may also consider a proposal or nomination by a person who
was a stockholder of record on the record date for the meeting, who is entitled to vote at the
meeting and who has given to our Secretary timely written notice, in proper form, of his or her
intention to bring that business before the meeting. The amended bylaws do not give the board of
directors the power to approve or disapprove stockholder nominations of candidates or proposals
regarding other business to be conducted at a special or annual meeting of the stockholders.
However, our bylaws may have the effect of precluding the conduct of business at a meeting if the
proper procedures are not followed. These provisions may also discourage or deter a potential
acquirer from conducting a solicitation of proxies to elect the acquirers own slate of directors
or otherwise attempting to obtain control of our company.
Under Delaware law, a special meeting of stockholders may be called by the board of directors
or by any other person authorized to do so in the amended and restated certificate of incorporation
or the amended bylaws. Our amended bylaws authorize a majority of our board of directors, the
chairperson of the board, the chief executive officer or the president to call a special meeting of
stockholders.
Because our stockholders do not have the right to call a special meeting, a stockholder could
not force stockholder consideration of a proposal over the opposition of the board of directors by
calling a special meeting of stockholders prior to such time as a majority of the board of
directors believed or the chief executive officer believed the matter should be considered or until
the next annual meeting provided that the requestor met the notice requirements. The restriction on
the ability of stockholders to call a special meeting means that a proposal to replace the board
also could be delayed until the next annual meeting.
Delaware law provides that stockholders may execute an action by written consent in lieu of a
stockholder meeting. However, Delaware law also allows us to eliminate stockholder actions by
written consent. Elimination of written consents of stockholders may lengthen the amount of time
required to take stockholder actions since actions by written consent are not subject to the
minimum notice requirement of a stockholders meeting. However, we believe that the elimination of
stockholders written consents may deter hostile takeover attempts. Without the availability of
stockholders actions by written consent, a holder controlling a majority of our capital stock
would not be able to amend our bylaws or remove directors without holding a stockholders meeting.
The holder would have to obtain the consent of a majority of the board of directors, the
chairperson of the board or the chief executive officer to call a stockholders meeting and satisfy
the notice periods determined by the board of directors. Our amended and restated certificate of
incorporation provides for the elimination of actions by written consent of stockholders.
LEGAL MATTERS
Cooley LLP, Palo Alto, California, will pass upon the validity of the securities offered by
this prospectus. LeClairRyan, P.C., New York, New York, is counsel for MLV in connection with this
offering.
EXPERTS
The
financial statements and managements assessment of the effectiveness of internal control over
financial reporting (which is included in Managements Report on Internal Control over Financial
Reporting) incorporated in this Prospectus by reference to the Annual Report on Form 10-K for the
year ended December 31, 2010 have been so incorporated in reliance on the report of PricewaterhouseCoopers LLP,
an independent registered public accounting firm, given on the authority of said firm as experts in auditing and accounting.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and current reports, proxy statements and other information with the
SEC. We have filed with the SEC a Registration Statement on Form S-3 under the Securities Act with
respect to the shares of common stock we are offering under this prospectus. This prospectus does
not contain all of the information set forth in the Registration Statement and the exhibits to the
Registration Statement. For further information with respect to us and the securities we are
offering under this prospectus, we refer you to the Registration Statement and the exhibits and
schedules filed as a part of the Registration Statement. You may read and copy the Registration
Statement, as well as our reports, proxy statements and other
30
information, at the SECs public
reference room at 100 F Street, N.E., Room 1580, Washington, D.C. 20549-0102. You can request
copies of these documents by writing to the SEC and paying a fee for the copying cost. You may
obtain further
information on the operation of the Public Reference Room by calling the SEC at
1-800-SEC-0330. Our SEC filings are also available on the SEC Internet site at www.sec.gov, which
contains periodic reports and other information regarding issuers that file electronically.
We also maintain a website at www.cytokinetics.com, through which you can access our filings
with the SEC. The information contained in, or accessible through, our website is not a part of
this prospectus.
INFORMATION INCORPORATED BY REFERENCE
The SEC allows us to incorporate by reference information into this prospectus, which means
that we can disclose important information to you by referring you to other documents that we have
filed or will file with the SEC. We are incorporating by reference in
this prospectus the information or documents below that we have filed
with the SEC (Commission File No. 000-50633):
|
|
our Annual Report on Form 10-K for the fiscal year ended December 31, 2010, which
was filed on March 11, 2011; |
|
|
|
our Quarterly Reports on Form 10-Q for the quarter ended March 31, 2011, which was
filed on May 6, 2011; |
|
|
|
our Current Reports on Form 8-K filed on January 4, 2011; February 9, 2011;
February 10, 2011; February 14, 2011 (as to information therein explicitly filed with the SEC
only); March 1, 2011; March 18, 2011; April 18, 2011; April 18, 2011; April 19, 2011 (as
amended on April 20, 2011); April 27, 2011; May 20,
2011; and June 2, 2011; |
|
|
|
the information specifically incorporated by reference into our 2010 Annual Report
on Form 10-K referred to above from our definitive proxy statement relating to our 2011 annual
meeting of stockholders, which was filed on March 28, 2011; and |
|
|
|
the description of our common stock contained in our Registration Statement on
Form 8-A, filed with the SEC on March 12, 2004, including any amendment or reports filed for
the purpose of updating such description. |
All
future documents that we file with the SEC pursuant to Section 13(a), 13(c) or 15(d) of the
Exchange Act, including those made after the date of the initial
filing of the registration statement of which this prospectus is a
part and prior to effectiveness of such registration statement, until the termination or completion of this
offering of common stock shall be deemed to be incorporated by reference in this prospectus and to
be a part of it from the filing dates of such documents (except in each case the information
contained in such documents to the extent furnished and not filed). Certain statements in and
portions of this prospectus update and replace information in the above listed documents
incorporated by reference. Likewise, statements in or portions of a future document incorporated by
reference in this prospectus may update and replace statements in and portions of this prospectus
or the above listed documents. To the extent there is a conflict between the information contained
in this prospectus, on the one hand, and the information contained in any document incorporated by
reference into this prospectus that was filed with the SEC before the date of this prospectus, on
the other hand, you should rely on the information in this prospectus. If any statement in one of
these documents is inconsistent with a statement in another document having a later date, the
statement in the document having the later date modifies or supersedes the earlier statement.
We will provide without charge to each person, including any beneficial owner, to whom a copy
of this prospectus is delivered, upon written or oral request of any such person, a copy of any or
all of the documents that are incorporated herein by reference. Requests should be directed to:
Cytokinetics, Incorporated
280 East Grand Avenue
South San Francisco, California 94080
United States of America
Attn: Investor Relations
(650) 624-3000
31
$20,000,000 Shares of Common Stock
Prospectus
, 2011
PART II
INFORMATION NOT REQUIRED IN THE PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution
The aggregate estimated expenses to be paid by the registrant in connection with this offering
are as follows:
|
|
|
|
|
Securities and Exchange Commission registration fee |
|
$ |
2,322 |
|
Accounting fees and expenses |
|
|
15,000 |
|
Legal fees and expenses |
|
|
50,000 |
|
Printing Fees |
|
|
8,000 |
|
Miscellaneous |
|
|
9,000 |
|
|
|
|
|
Total |
|
$ |
84,322 |
|
|
|
|
|
Item 15. Indemnification of Directors and Officers
Under Section 145 of the Delaware General Corporation Law, we can indemnify any person who is,
or is threatened to be made, a party to any threatened, pending or completed legal action, suit or
proceeding, whether civil, criminal, administrative or investigative other than action by us or on
our behalf, by reason of the fact that such person is or was one of our officers or directors, or
is or was serving at our request as a director, officer, employee or agent of another corporation
or enterprise. The indemnity may include expenses including attorneys fees, judgments, fines and
amounts paid in settlement actually and reasonably incurred by such person in connection with such
action, suit or proceeding, provided that such officer or director acted in good faith and in a
manner he or she reasonably believed to be in or not opposed to our best interests, and, for
criminal proceedings, had no reasonable cause to believe his or her conduct was illegal. Under
Delaware law, we may also indemnify officers and directors in an action by us or on our behalf
under the same conditions, except that no indemnification is permitted without judicial approval if
the officer or director is adjudged to be liable to us in the performance of his or her duty. Where
an officer or director is successful on the merits or otherwise in the defense of any action
referred to above, we must indemnify him or her against the expenses which such officer or director
actually and reasonably incurred.
Our amended and restated certificate of incorporation contains a provision to limit the
personal liability of our directors for violations of their fiduciary duty. This provision
eliminates each directors liability to us or our stockholders for monetary damages to the fullest
extent permitted by Delaware law. The effect of this provision is to eliminate the personal
liability of directors for monetary damages for actions involving a breach of their fiduciary duty
of care, including actions involving gross negligence.
Our amended and restated bylaws provide for indemnification of our officers and directors to
the fullest extent permitted by applicable law.
We have also entered into indemnification agreements with our directors and officers. The
indemnification agreements provide indemnification to our directors and officers under certain
circumstances for acts or omissions which may not be covered by directors and officers liability
insurance. We have also obtained directors and officers liability insurance, which insures
against liabilities that our directors or officers may incur in these capacities.
II-1
Item 16. Exhibits
The following exhibits are filed herewith or incorporated by reference herein:
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|
|
Exhibit |
|
|
Number |
|
Description of Document |
3.1
|
|
Amended and Restated Certificate of Incorporation. |
|
|
|
3.2 (1)
|
|
Amended and Restated Bylaws. |
|
|
|
3.3 (2)
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock. |
|
|
|
4.1 (3)
|
|
Specimen Common Stock Certificate. |
|
|
|
4.2 (4)
|
|
Registration Rights Agreement, dated as of December 29, 2006, by and between Company and Amgen Inc. |
|
|
|
4.3 (5)
|
|
Form of Warrant to Purchase Common Stock of Cytokinetics, Inc. |
|
|
|
5.1
|
|
Opinion of Cooley LLP. |
|
|
|
10.67 (5)
|
|
Securities Purchase Agreement, dated April 18, 2011, by and between the Company and Deerfield Private
Design Fund II, L.P., Deerfield Private Design International II, L.P., Deerfield Special
Situations Funds, L.P., and Deerfield Special Situations Fund International Limited. |
|
|
|
10.68 (6)
|
|
At the Market Issuance Sales Agreement, dated June 10, 2011, by and between the Company and McNicoll,
Lewis & Vlak LLC |
|
|
|
23.1
|
|
Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm. |
|
|
|
23.2
|
|
Consent of Cooley LLP (included in Exhibit 5.1). |
|
|
|
24.1
|
|
Power of Attorney of certain directors and officers of Cytokinetics, Incorporated (included on the
signature page hereof). |
(1) |
|
Incorporated by reference from our registration
statement on Form S-1, registration number 333-112261,
declared effective by the Securities and Exchange
Commission on April 29, 2004. |
|
(2) |
|
Incorporated by reference from our Current Report on Form 8-K, filed with the Securities and Exchange Commission on April 18, 2011. |
|
(3) |
|
Incorporated by reference from our Quarterly Report on
Form 10-Q, filed with the Securities and Exchange
Commission on May 9, 2007. |
|
(4) |
|
Incorporated by reference from our Current Report on
Form 8-K, filed with the Securities and Exchange
Commission on January 3, 2007. |
|
(5) |
|
Incorporated by reference from our Current Report on
Form 8-K, filed with the Securities and Exchange
Commission on April 18, 2011. |
|
(6) |
|
Incorporated by reference from our Current Report on
Form 8-K, filed with the Securities and Exchange
Commission on the date hereof. |
II-2
Item 17. Undertakings
(a) The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a post-effective
amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events arising after the effective date of
the registration statement (or the most recent post-effective amendment thereof) which,
individually or in the aggregate, represent a fundamental change in the information set forth in
the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of
securities offered (if the total dollar value of securities offered would not exceed that which
was registered) and any deviation from the low or high end of the estimated maximum offering
range may be reflected in the form of prospectus filed with the Commission pursuant to Rule
424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change
in the maximum aggregate offering price set forth in the Calculation of Registration Fee table
in the effective registration statement; and
(iii) To include any material information with respect to the plan of distribution not
previously disclosed in the registration statement or any material change to such information in
the registration statement;
Provided, however, that paragraphs (1)(i), (1)(ii) and (1)(iii) shall not apply if the
information required to be included in a post-effective amendment by those paragraphs is
contained in reports filed with or furnished to the SEC by the registrant pursuant to Section 13
or Section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in
the registration statement, or is contained in a form of prospectus filed pursuant to Rule
424(b) that is part of the registration statement.
(2) That, for the purpose of determining any liability under the Securities Act of 1933, each
such post-effective amendment shall be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities
being registered which remain unsold at the termination of the offering.
(4) That, for the purpose of determining liability under the Securities Act of 1933 to any
purchaser:
(i) Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to
be part of the registration statement as of the date the filed prospectus was deemed part of and
included in the registration statement; and
(ii) Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as
part of a registration statement in reliance on Rule 430B relating to an offering made pursuant
to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by
Section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the
registration statement as of the earlier of the date such form of prospectus is first used after
effectiveness or the date of the first contract or sale of securities in the offering described
in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person
that is at that date an underwriter, such date shall be deemed to be a new effective date of the
registration statement relating to the securities in the registration statement to which that
prospectus relates, and the offering of such securities at that time shall be deemed to be the
initial bona fide offering thereof. Provided, however, that no statement made in a registration
statement or prospectus that is part of the registration statement or made in a document
incorporated or deemed incorporated by reference into the registration statement or prospectus
that is part of the registration statement will, as to a purchaser with a time of contract or
sale prior to such effective date, supersede or modify any statement that was made in the
registration statement or prospectus that was part of the registration statement or made in any
such document immediately prior to such effective date.
(5) That, for the purpose of determining liability of a registrant under the Securities Act to
any purchaser in the initial distribution of the securities:
II-3
The undersigned registrant undertakes that in a primary offering of securities of an
undersigned registrant pursuant to this registration statement, regardless of the underwriting
method used to sell the securities to the purchaser, if the securities are offered or sold to
such purchaser by means of any of the following communications, the undersigned registrant will
be a seller to the purchaser and will be considered to offer or sell such securities to such
purchaser:
(i) Any preliminary prospectus or prospectus of the undersigned registrant relating to the
offering required to be filed pursuant to Rule 424;
(ii) Any free writing prospectus relating to the offering prepared by or on behalf of the
undersigned registrant or used or referred to by the undersigned registrant;
(iii) The portion of any other free writing prospectus relating to the offering containing
material information about the undersigned registrant or its securities provided by or on behalf
of the undersigned registrant; and
(iv) Any other communication that is an offer in the offering made by the undersigned
registrant to the purchaser.
(b) Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be
permitted to directors, officers and controlling persons of the registrant pursuant to the
foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the
Securities and Exchange Commission such indemnification is against public policy as expressed in
the Act and is, therefore, unenforceable. In the event that a claim for indemnification against
such liabilities (other than the payment by the registrant of expenses incurred or paid by a
director, officer or controlling person of the registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person in connection with
the securities being registered, the registrant will, unless in the opinion of its counsel the
matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the
question whether such indemnification by it is against public policy as expressed in the Act and
will be governed by the final adjudication of such issue.
(c) The undersigned registrant hereby undertakes that:
(1) For purposes of determining any liability under the Securities Act of 1933, the
information omitted from the form of prospectus filed as part of this registration statement in
reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to
Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this
registration statement as of the time it was declared effective.
(2) For the purpose of determining any liability under the Securities Act of 1933, each
post-effective amendment that contains a form of prospectus shall be deemed to be a new
registration statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering thereof.
II-4
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant
certifies that it has reasonable grounds to believe that it meets all of the requirements for
filing on Form S-3 and has duly caused this registration statement to be signed on its behalf by
the undersigned, thereunto duly authorized, in the City of South San Francisco, State of
California, on the 13th day of June, 2011.
|
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|
|
CYTOKINETICS, INCORPORATED
|
|
|
By: |
/s/
Robert I. Blum
|
|
|
|
Robert I. Blum |
|
|
|
President and Chief Executive Officer |
|
|
POWER OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below constitutes and
appoints Robert I. Blum and Sharon A. Barbari acting singly, true and lawful attorney-in-fact and
agent, with full power of substitution and resubstitution for him and in his name, place and stead,
in any and all capacities to sign any and all amendments including post-effective amendments to
this registration statement, and any additional related registration statement filed pursuant to
Rule 462(b) under the Securities Act of 1933, as amended (including post-effective amendments to
this registration statement and any such related registration statements), and to file the same,
with all exhibits thereto, and any other documents in connection therewith, granting unto said
attorney-in-fact and agent full power and authority to do and perform each and every act and thing
requisite and necessary to be done in and about the premises, as fully to all intents and purposes
as he might or could do in person, hereby ratifying and confirming all that said attorney-in-fact
and agent, or his substitute, may lawfully do or cause to be done by virtue thereof.
Pursuant to the requirements of the Securities Act of 1933, this registration statement has
been signed by the following persons in the capacities and on the dates indicated.
|
|
|
|
|
Signature |
|
Title |
|
Date |
|
/s/ Robert I. Blum
Robert I. Blum
|
|
President, Chief Executive Officer
and Director
(Principal
Executive Officer)
|
|
June 13, 2011 |
|
|
|
|
|
/s/ Sharon A. Barbari
Sharon A. Barbari
|
|
Executive Vice President, Finance and
Chief Financial Officer
(Principal Financial and
Accounting Officer)
|
|
June 13, 2011 |
|
|
|
|
|
/s/ L. Patrick Gage, Ph.D.
L. Patrick Gage, Ph.D
|
|
Chairman of the Board of Directors
|
|
June 13, 2011 |
|
|
|
|
|
/s/ Santo J. Costa
Santo J. Costa
|
|
Director
|
|
June 13, 2011 |
|
|
|
|
|
/s/ Stephen Dow
Stephen Dow
|
|
Director
|
|
June 13, 2011 |
|
|
|
|
|
/s/ Denise M. Gilbert, Ph.D.
Denise M. Gilbert, Ph.D.
|
|
Director
|
|
June 13, 2011 |
|
|
|
|
|
/s/ John T. Henderson, M.B. Ch.B.
John Henderson, M.B. Ch.B.
|
|
Director
|
|
June 13, 2011 |
|
|
|
|
|
/s/ James A. Spudich, Ph.D.
James A. Spudich, Ph.D.
|
|
Director
|
|
June 13, 2011 |
|
|
|
|
|
/s/ Wendell Wierenga, Ph.D.
Wendell Wierenga, Ph.D.
|
|
Director
|
|
June 13, 2011 |
II-5
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
3.1
|
|
Amended and Restated Certificate of Incorporation. |
|
|
|
3.2 (1)
|
|
Amended and Restated Bylaws. |
|
|
|
3.3 (2)
|
|
Certificate of Designation of
Preferences Rights and Limitations of Series A Convertible Preferred
Stock. |
|
|
|
4.1 (3)
|
|
Specimen Common Stock Certificate. |
|
|
|
4.2 (4)
|
|
Registration Rights Agreement, dated as of December 29, 2006, by and between Company and Amgen Inc. |
|
|
|
4.3 (5)
|
|
Form of Warrant to Purchase Common Stock of Cytokinetics, Inc. |
|
|
|
5.1
|
|
Opinion of Cooley LLP. |
|
|
|
10.67 (5)
|
|
Securities Purchase Agreement,
dated April 18, 2011, by and between the Company and Deerfield Private
Design Fund II, L.P., Deerfield Private Design International II, L.P., Deerfield Special
Situations Funds, L.P., and Deerfield Special Situations Fund International Limited. |
|
|
|
10.68 (6)
|
|
At the Market Issuance Sales
Agreement, dated June 10, 2011, by and between the Company and McNicoll,
Lewis & Vlak LLC |
|
|
|
23.1
|
|
Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm. |
|
|
|
23.2
|
|
Consent of Cooley LLP (included in Exhibit 5.1). |
|
|
|
24.1
|
|
Power of Attorney of certain directors and officers of Cytokinetics, Incorporated (included on the
signature page hereof). |
(1) |
|
Incorporated by reference from our registration
statement on Form S-1, registration number 333-112261,
declared effective by the Securities and Exchange
Commission on April 29, 2004. |
|
(2) |
|
Incorporated by reference from our Current Report on Form
8-K, filed with the Securities and Exchange Commission on April 18,
2011. |
|
(3) |
|
Incorporated by reference from our Quarterly Report on
Form 10-Q, filed with the Securities and Exchange
Commission on May 9, 2007. |
|
(4) |
|
Incorporated by reference from our Current Report on
Form 8-K, filed with the Securities and Exchange
Commission on January 3, 2007. |
|
(5) |
|
Incorporated by reference from our Current Report on
Form 8-K, filed with the Securities and Exchange
Commission on April 18, 2011. |
|
(6) |
|
Incorporated by reference from our Current Report on
Form 8-K, filed with the Securities and Exchange
Commission on the date hereof. |