sv3za
As filed
with the Securities and Exchange Commission on November 30, 2005
Registration
No. 333-129786
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Amendment
No. 1
to
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
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94-3291317 |
(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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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)
James H. Sabry, M.D., Ph.D.
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:
Michael ODonnell, Esq.
Martin Waters, Esq.
Gavin T. McCraley, Esq.
Wilson Sonsini Goodrich & Rosati
Professional Corporation
650 Page Mill Road
Palo Alto, CA 94304
(650) 493-9300
Approximate date of commencement of proposed sale to the public: From time to time after the 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. þ
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
delivery of the prospectus is expected to be made pursuant to
Rule 434, please check the following box. o
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 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 WE ARE NOT SOLICITING
OFFERS TO BUY THESE SECURITIES IN ANY STATE WHERE THE OFFER OR SALE IS NOT PERMITTED
PRELIMINARY PROSPECTUS
Subject
to Completion, Dated November 30, 2005
5,947,488 Shares
Common Stock
This prospectus relates to the resale of up to 5,947,488 shares of our common stock that we may
issue to the selling stockholder listed in the section beginning on
page 26 of this prospectus.
The shares of common stock offered under this prospectus by the selling stockholder are issuable to
Kingsbridge Capital Limited, or Kingsbridge, pursuant to a common stock purchase agreement between
Kingsbridge and ourselves dated October 28, 2005 and a warrant we issued to Kingsbridge on that
date. We are not selling any securities under this prospectus and will not receive any of the
proceeds from the sale of shares by the selling stockholder.
The selling stockholder may sell the shares of common stock described in this prospectus in a
number of different ways and at varying prices. We provide more information about how the selling
stockholder may sell its shares of common stock in the section titled Plan of Distribution on
page 27. We will not be paying any underwriting discounts or
commissions in this offering. We will pay the expenses incurred in
registering the shares, including legal and accounting fees.
Our common stock is quoted on The Nasdaq National Market under the symbol CYTK. The last
reported sale price for our common stock on November 29, 2005
was $8.58 per share.
Investment in our common stock involves a high degree of risk.
See
Risk Factors beginning on page 5 of 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 or the accompanying prospectus are truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus is ____________.
You should rely only on the information contained or incorporated by reference in this
prospectus. We have not, and the selling stockholder has not, authorized anyone to provide you
with additional or different information. These securities are not being offered in any
jurisdiction where the offer is not permitted. You should assume that the information in this
prospectus is accurate only as of the date on the front of the document and that any information we
have incorporated by reference is accurate only as of the date of the document incorporated by
reference, regardless of the time of delivery of this prospectus or of any sale of our common
stock. Unless the context otherwise requires, references to we, or the company in this
prospectus mean Cytokinetics, Incorporated.
TABLE OF CONTENTS
PROSPECTUS SUMMARY
The following summary highlights information contained in this prospectus or incorporated by
reference. While we have included what we believe to be the most important information about the
company and this offering, the following summary may not contain all the information that may be
important to you. You should read this entire prospectus carefully, including the risks of
investing discussed under Risk Factors beginning on page 5, and the information to which we refer
you and the information incorporated into this prospectus by reference, for a complete
understanding of our business and this offering. References in this prospectus to our company,
we, our, Cytokinetics and us refer to Cytokinetics, Incorporated. References to selling
stockholder refers to the stockholder listed herein under the heading Selling Stockholder on
page 26, who may sell shares from time to time as described in this prospectus.
Cytokinetics, Incorporated
Cytokinetics, Incorporated is a leading biopharmaceutical company focused on the discovery,
development and commercialization of novel small molecule drugs that specifically target the
cytoskeleton. A number of commonly used drugs and a growing body of research validate the role the
cytoskeleton plays in a wide array of human diseases. Our focus on the cytoskeleton enables us to
develop novel and potentially safer and more effective drugs for the treatment of these diseases.
We believe that our cell biology driven approach and proprietary technologies enhance the speed,
efficiency and yield of our drug discovery and development process. To date, our unique approach
has produced two cancer drug candidates, a drug candidate for the treatment of heart failure, and
other research programs addressing a variety of other disease areas including high blood pressure
and asthma.
Equity Financing Facility With Kingsbridge Capital
On October 28, 2005, we entered into a Committed Equity Financing Facility, or CEFF, with
Kingsbridge, pursuant to which Kingsbridge committed to purchase, subject to certain conditions, up
to $75 million of our common stock. In connection with the CEFF, we entered into a common stock
purchase agreement and registration rights agreement with Kingsbridge, both dated October 28, 2005,
and on that date we also issued a warrant to Kingsbridge to purchase 244,000 shares of our common
stock at a price of $9.13 per share. This warrant is fully exercisable beginning six months after
October 28, 2005 and for a period of five years thereafter.
The common stock purchase agreement entitles us to sell and obligates Kingsbridge to purchase, from
time to time over a period of three years, shares of our common stock for cash consideration up to
an aggregate of $75 million, subject to certain conditions and restrictions. The shares of common
stock that may be issued to Kingsbridge under the common stock purchase agreement and the warrant
will be issued pursuant to an exemption from registration under the Securities Act of 1933, as
amended, or the Securities Act. Pursuant to the registration rights agreement, we have filed a
registration statement of which this prospectus is a part, covering the possible resale by
Kingsbridge of any shares that we may issue to Kingsbridge under the common stock purchase
agreement or upon exercise of the warrant. Through this prospectus, the selling stockholder may
offer to the public for resale shares of our common stock that we may issue to Kingsbridge pursuant
to the common stock purchase agreement, or that Kingsbridge may acquire upon exercise of the
warrant.
For a period of 36 months from the first trading day following the effectiveness of this
prospectus, we may, from time to time, at our discretion, and subject to certain conditions that we
must satisfy, draw down funds
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under the CEFF by selling shares of our common stock to Kingsbridge. The purchase price of these
shares will be at a discount of up to 10 percent from the volume weighted average of the price of
our common stock for each of the eight trading days following our election to sell shares, or draw
down under the CEFF. The discount on each of these eight trading days will be determined as
follows:
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PERCENT OF VWAP |
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VWAP* |
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(APPLICABLE DISCOUNT) |
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Greater than $10.05 per share |
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94 |
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(6 |
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Less than or equal to $10.05 per share but greater than $7.00 per share |
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92 |
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(8 |
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Less than or equal to $7.00 per share but greater than or equal to $3.50 per share |
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90 |
% |
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(10 |
)% |
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As set forth in the common stock purchase agreement, VWAP means the volume weighted
average price (the aggregate sales price of all trades of our common stock during each trading
day divided by the total number of shares of common stock traded during that trading day) of
our common stock during any trading day as reported by Bloomberg, L.P. using the AQR function.
The VWAP and corresponding discount will be determined for each of the eight trading days
during a draw down pricing period. |
During the eight trading day pricing period for a draw down, if the VWAP for any one trading day is
less than the greater of (i) $3.50 or (ii) 85 percent of the closing price of our common stock for
the trading day immediately preceding the beginning of the draw down period, the VWAP from that
trading day will not be used in calculating the number of shares to be issued in connection with
that draw down, and the draw down amount for that pricing period will be reduced by one-eighth of
the draw down amount we had initially specified. In addition, if trading in our common stock is
suspended for any reason for more than three consecutive or non-consecutive hours during any
trading day during a draw down pricing period, that trading day will not be used in calculating the
number of shares to be issued in connection with that draw down, and the draw down amount for that
pricing period will be reduced by one eighth of the draw down amount we had initially specified.
The maximum number of shares of common stock that we can issue pursuant to the CEFF is 5,703,488
shares. An additional 244,000 shares of common stock are issuable if Kingsbridge exercises the
warrant that we issued to it in connection with its entry into the CEFF. We intend to exercise our
right to draw down amounts under the CEFF, if and to the extent available, at such times as we have
a need for additional capital and when we believe that sales of stock under the CEFF provide an
appropriate means of raising capital.
Our ability to require Kingsbridge to purchase our common stock is subject to various limitations.
We can make draw downs to a maximum of 2.5 percent of the closing price market value of our
outstanding shares of common stock at the time of the draw down, or $15 million, whichever is less.
Unless Kingsbridge agrees otherwise, a minimum of three trading days must elapse between the
expiration of any draw down pricing period and the beginning of the next draw down pricing period.
Kingsbridge is not obligated to purchase shares at prices below $3.50 per share.
During the term of the CEFF, without Kingsbridges prior written consent, we may not issue
securities that are, or may become, convertible or exchangeable into shares of common stock where
the purchase, conversion or exchange price for that our common stock is determined using a floating
discount or other post-issuance adjustable discount to the market price of the common stock,
including pursuant to an equity line or other financing that is substantially similar to the
arrangement provided for in the CEFF, but excluding a Rule 144 offering to qualified institutional
buyers that contain price adjustments customary for such transactions.
The issuance of our common stock under the CEFF or upon exercise of the Kingsbridge warrant will
have no effect on the rights or privileges of existing holders of common stock except that the
economic and voting
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interests of each stockholder will be diluted as a result of the issuance. Although the number of
shares of common stock that stockholders presently own will not decrease, these shares will
represent a smaller percentage of our total shares that will be outstanding after any issuances of
shares of common stock to Kingsbridge. If we draw down amounts under the CEFF when our share price
is decreasing, we will need to issue more shares to raise the same amount than if our stock price
was higher. Such issuances will have a dilutive effect and may further decrease our stock price.
Kingsbridge agreed in the common stock purchase agreement that during the term of the CEFF, neither
Kingsbridge nor any of its affiliates, nor any entity managed or controlled by it, will enter into
any short sale of any shares of our common stock as defined in Regulation SHO promulgated under the
Securities Exchange Act of 1934, as amended.
Before Kingsbridge is obligated to buy any shares of our common stock pursuant to a draw down, the
following conditions, none of which is in Kingsbridges control, must be met:
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Each of our representations and warranties in the common stock purchase agreement
shall be true and correct in all material respects as of the date when made and as of
the draw down exercise date as though made at that time, except for representations and
warranties that are expressly made as of a particular date. |
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We shall have performed, satisfied and complied in all material respects with all
covenants, agreements and conditions required by the common stock purchase agreement,
the registration rights agreement and the warrant to be performed, satisfied or
complied with by us. |
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We shall have complied in all material respects with all applicable federal, state
and local governmental laws, rules, regulations and ordinances in connection with the
execution, delivery and performance of the common stock purchase agreement and the
consummation of the transactions it contemplates. |
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The registration statement, which includes this prospectus, shall have previously
become effective and shall remain effective. |
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We shall not have knowledge of any event that could reasonably be expected to have
the effect of causing the registration statement applicable to Kingsbridges resale of
shares of our common stock to be suspended or otherwise ineffective. |
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Trading in our common stock shall not have been suspended by the Securities and
Exchange Commission, or the SEC, the Nasdaq Stock Market or the National Association of
Securities Dealers and trading in securities generally on the Nasdaq Stock Market shall
not have been suspended or limited. |
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No statute, rule, regulation, executive order, decree, ruling or injunction shall
have been enacted, entered, promulgated or endorsed by any court or governmental
authority which prohibits the consummation of any of the transactions contemplated by
the common stock purchase agreement. |
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No action, suit or proceeding before any arbitrator or any governmental authority
shall have been commenced, and no investigation by any governmental authority shall
have been threatened, against us or any of our officers, directors or affiliates
seeking to enjoin, prevent or change the transactions contemplated by the common stock
purchase agreement. |
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We shall have sufficient shares of common stock, calculated using the closing trade
price of the common stock as of the trading day immediately preceding a draw down,
registered under the registration statement to issue and sell such shares in accordance
with such draw down. |
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The warrant to purchase 244,000 shares of our common stock shall have been duly
executed, delivered and issued to Kingsbridge, and we shall not be in default in any
material respect under the warrant. |
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Kingsbridge shall have received an opinion in the form previously agreed to. |
There is no guarantee that we will be able to meet the foregoing conditions or any other conditions
under the common stock purchase agreement or that we will be able to draw down any portion of the
amounts available under the CEFF.
We also entered into a registration rights agreement with Kingsbridge. Pursuant to the
registration rights agreement, we have filed a registration statement, which includes this
prospectus, with the SEC relating to Kingsbridges resale of any shares of common stock purchased
by Kingsbridge under the common stock purchase agreement or issued to Kingsbridge as a result of
the exercise of the Kingsbridge warrant. The effectiveness of this registration statement is a
condition precedent to our ability to sell common stock to Kingsbridge under the common stock
purchase agreement. We are entitled in certain circumstances, including the existence of certain
kinds of nonpublic information, to deliver a blackout notice to Kingsbridge to suspend the use of
this prospectus and prohibit Kingsbridge from selling shares under this prospectus. If we deliver
a blackout notice in the 15 trading days following the settlement of a draw down, or if the
registration statement of which this prospectus is a part is not effective in circumstances not
permitted by the registration rights agreement, then we must pay amounts to Kingsbridge, or issue
Kingsbridge additional shares in lieu of payment, calculated by means of a varying percentage of an
amount based on the number of shares held by Kingsbridge that were purchased pursuant to the draw
down and the change in the market price of our common stock between the date the blackout notice is
delivered (or the registration statement is not effective) and the date the prospectus again
becomes available.
The foregoing summary of the CEFF does not purport to be complete and is qualified by reference to
the common stock purchase agreement, the registration rights agreement and the warrant, copies of
which have been filed as exhibits to the registration statement of which this prospectus is a part.
We were incorporated in Delaware in August 1997. Our principal executive offices are located at
280 East Grand Avenue, South San Francisco, California 94080 and our telephone number at that
address is (650) 624-3000.
CYTOKINETICS, our logo used alone and with the mark CYTOKINETICS, and CYTOMETRIX 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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RISK FACTORS
Investing in our common stock involves a high degree of risk. You should consider carefully the
risk factors described below, and all other information contained in or incorporated by reference
in this prospectus, before deciding to invest in our common stock. If any of the following risks
actually occur, they may materially harm our business, financial condition, operating results or
cash flow. As a result, the market price of our common stock could decline, and you could lose all
or part of your investment. Additional risks and uncertainties that are not yet identified or that
we think are immaterial may also materially harm our business, operating results or financial
condition and could result in a complete loss of your investment.
Risks Related To Our Business
Our drug candidates are in the early stages of clinical testing and 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.
Our drug candidates are in the early stages of clinical testing and we must conduct significant
additional clinical trials before we can seek the regulatory approvals necessary to begin
commercial sales of our drugs. We have 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. We expect to incur increasing
losses for at least several 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 in clinical trials 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 have never generated, and may never generate, revenues from commercial sales of our drugs
and we may 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 have marketable
drugs. We must demonstrate that our drug candidates satisfy rigorous standards of safety and
efficacy to the Food and Drug Administration, or FDA, and other regulatory authorities in the
United States and 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 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. Ispinesib, our most advanced drug candidate for the
treatment of cancer, SB-743921, our second drug candidate for the treatment of cancer, and
CK-1827452, our drug candidate for the treatment of heart failure, are currently our only drug
candidates in clinical trials and we cannot be certain that the clinical development of these or
any other drug candidate in preclinical testing or clinical development 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 entry into clinical trials. Our
commercial revenues, if any, will be derived from sales of drugs that we do not expect to be
commercially available for several years, if at all. The development of one or both of these drug
candidates may be discontinued at any stage of our clinical trials programs and we may not generate
revenue from either of these drug candidates.
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We have funded all of our operations and capital expenditures with proceeds from both private and
public sales of our equity securities, strategic alliances with GlaxoSmithKline, or GSK,
AstraZeneca and others, equipment financings, interest on investments and government grants. We
believe that our existing cash and cash equivalents, future payments from GSK and AstraZeneca,
interest earned on investments, proceeds from equipment financings and potential proceeds from the
CEFF will be sufficient to meet our projected operating requirements for at least the next 12
months. To meet our future cash requirements, we may raise funds through public or private equity
offerings, debt financings or strategic alliances. To the extent that we raise additional funds by
issuing equity securities, our stockholders may experience additional dilution. To the extent that
we raise additional funds through debt financing, if available, such financing may involve
covenants that restrict our business activities. To the extent that we raise additional funds
through strategic alliance and licensing arrangements, 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. In addition, we cannot assure you that any such funding, if needed,
will be available on attractive terms, or at all.
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 must demonstrate with
substantial evidence from well-controlled clinical trials, and to the satisfaction of the FDA and
other regulatory authorities in the United States and abroad, that such drug candidate is both
sufficiently safe and effective. Before we can commence clinical trials, we must demonstrate
through preclinical studies satisfactory product chemistry, formulation, stability and toxicity
levels in order to file an investigational new drug application, or IND, (or the foreign equivalent
of an IND) to commence clinical trials. In clinical trials we will need to demonstrate efficacy
for the treatment of specific indications and monitor safety throughout the clinical development
process. Long-term safety and efficacy have not yet been demonstrated in clinical trials for any
of our drug candidates, and satisfactory chemistry, formulation, stability and toxicity levels have
not yet been demonstrated for our drug candidates or compounds that are currently the subject of
preclinical studies. If our preclinical studies, clinical trials or future clinical trials are
unsuccessful, our business and reputation will be harmed and our stock price will 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 satisfactorily support the filing of an IND or
comparable regulatory filing abroad with respect to our drug candidates, and, even if these
applications would be or have been filed with respect to our drug candidates, the results of
preclinical studies do not necessarily predict the results of clinical trials. Similarly,
early-stage clinical trials do not predict the results of later-stage clinical trials, including
the safety and efficacy profiles of any particular drug candidate. In addition, there can be no
assurance that the design of our clinical trials is focused on appropriate tumor types, patient
populations, dosing regimens or other variables which will result in obtaining the desired efficacy
data to support regulatory approval to commercialize the drug. Even if we believe the data
collected from clinical trials of our drug candidates are promising, such data may not be
sufficient to support approval by the FDA or any other United States or foreign regulatory
authority. Preclinical and clinical data can be interpreted in different ways. Accordingly, FDA
officials or officials from foreign regulatory authorities could interpret the 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 that are the subject of
preclinical studies to animals may produce undesirable side effects, also known as adverse effects.
Toxicities and adverse effects that we have observed in preclinical studies for some compounds in
a particular research and development program may occur in preclinical studies or clinical trials
of other compounds from the same program. Such toxicities or adverse effects could delay or
prevent the filing of an IND or comparable regulatory filing abroad with respect to such drug
candidates or potential drug candidates or cause us to cease
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clinical trials with respect to any drug candidate. In Phase I clinical trials of ispinesib and
SB-743921, the 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. In clinical
trials, administering any of our drug candidates to humans may produce adverse effects. These
adverse effects could interrupt, delay or halt clinical trials of our drug candidates and could
result in the FDA or other regulatory authorities denying approval of our drug candidates for any
or all targeted indications. The FDA, other regulatory authorities, our partners or we may suspend
or terminate clinical trials at any time. Even if one or more of our drug candidates were approved
for sale, 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 prevent, the further marketing of
such drugs. Indications of potential adverse effects or toxicities which may occur in clinical
trials and which we believe are not significant during the course of such trials may later turn out
to actually constitute serious adverse effects or toxicities when a drug has been used in large
populations or for extended periods of time. 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 drugs resulting from our drug candidates, may severely harm
our reputation and business.
Clinical trials are expensive, time consuming and subject to delay.
Clinical trials are very expensive and difficult to design and implement, especially in the cancer
and heart failure indications that we are pursuing, in part because they are subject to rigorous
requirements. The clinical trial process is also time consuming. According to industry sources,
the entire drug development and testing process takes on average 12 to 15 years. According to
industry studies, the fully capitalized resource cost of new drug development averages
approximately $800 million, however, individual trials and individual drug candidates may incur a
range of costs above or below this average. We estimate that clinical trials of our most advanced
drug candidates will continue for several years, but may take significantly longer to complete.
The commencement and completion of our clinical trials could be delayed or prevented by several
factors, including, but not limited to:
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delays in obtaining regulatory approvals to commence a clinical trial; |
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delays in identifying and reaching agreement on acceptable terms with prospective
clinical trial sites; |
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slower than expected rates of patient recruitment and enrollment, including as a
result of the introduction of alternative therapies or drugs by others; |
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lack of effectiveness during clinical trials; |
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unforeseen safety issues; |
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adequate supply of clinical trial material; |
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uncertain dosing issues; |
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introduction of new therapies or changes in standards of practice or regulatory
guidance that render our clinical trial endpoints or the targeting of our proposed
indications obsolete; |
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inability to monitor patients adequately during or after treatment; and |
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inability or unwillingness of medical investigators to follow our clinical protocols. |
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We do not know whether planned clinical trials will begin on time, 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.
We depend on GSK for the conduct, completion and funding of the clinical development and
commercialization of our current drug candidates for the treatment of cancer.
Under our strategic alliance with GSK, as amended, GSK is currently responsible for the clinical
development and regulatory approval of our drug candidate ispinesib for all indications of cancer,
and our cancer drug candidate SB-743921 for all cancer indications except non-Hodgkins lymphoma,
Hodgkins lymphoma, and multiple myeloma. Other than for SB-743921 for these three hematologic
cancer indications, GSK is responsible for filing applications with the FDA or other regulatory
authorities for approval of these drug candidates, and will be the owner of any marketing approvals
issued by the FDA or other regulatory authorities. If the FDA or other regulatory authorities
approve these drug candidates, GSK will also be responsible for the marketing and sale of these
drugs, with the exception of SB-743921 for non-Hodgkins lymphoma, Hodgkins lymphoma, and multiple
myeloma. Because GSK is responsible for these functions, we cannot control whether GSK will devote
sufficient attention and resources to the clinical trials program or will proceed in an expeditious
manner. Under certain circumstances, GSK has discretion to elect whether to pursue the development
of our drug candidates or to abandon the clinical trial programs, and, after June 20, 2006, GSK may
terminate our strategic alliance for any reason upon nine months prior notice. These decisions are
outside our control. Both of our cancer drug candidates being developed by GSK act through
inhibition of kinesin spindle protein, or KSP, a protein that is a member of a class of
cytoskeletal proteins called mitotic kinesins that regulate cell division, or mitosis, during cell
division. Because these drug candidates have similar mechanisms of action, GSK may elect to
proceed with the development of only one such drug candidate. If GSK were to elect to proceed with
the development of SB-743921 in lieu of ispinesib, and because SB-743921 is at an earlier stage of
clinical development than ispinesib, the approval, if any, of a new drug application, or NDA, with
respect to a drug candidate from our cancer program would be delayed. In particular, if the
initial clinical results of some of our early clinical trials do not meet GSKs expectations, GSK
may elect to terminate further development of one or both drug candidates, even though the actual
number of patients that have been treated is relatively small. Abandonment of one or both of
ispinesib and SB-743921 by GSK would result in a delay in or prevent us from commercializing such
drug candidates, and would delay or prevent our ability to generate revenues. Disputes may arise
between us and GSK, which may delay or cause termination of any clinical trials program, result in
significant litigation or arbitration, or cause GSK to act in a manner that is not in our best
interest. If development of our drug candidates does not progress for these or any other reasons,
we would not receive further milestone payments from GSK. GSK also has the contractual right to
reduce its funding of our full time equivalents, or FTEs, for this program at its discretion,
subject to certain agreed minimum levels, in the beginning of each contract year based on the
activities of the agreed upon research plan. Even if the FDA or other regulatory agencies approve
one or more of our drug candidates, GSK may elect not to proceed with the commercialization of such
drugs, or may elect to pursue commercialization of one drug but not others, and these decisions are
outside our control. In such event, or in the event that GSK abandons development of any drug
candidate prior to regulatory approval, we would have to undertake and fund the clinical
development of our drug candidates or commercialization of our drugs, seek a new partner for
clinical development or commercialization, or curtail or abandon the clinical development or
commercialization programs. If we were unable to do so on acceptable terms, or at all, our
business would be harmed, and the price of
our common stock would be negatively affected.
-8-
If we fail to enter into and maintain successful strategic alliances for certain of our drug
candidates, we may have to reduce or delay our drug candidate development or increase our
expenditures.
Our strategy for developing, manufacturing and commercializing certain of our 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. We have formed a strategic alliance with GSK with respect to
ispinesib, SB-743921 and certain other research activities. However, we may not be able to
negotiate additional strategic alliances on acceptable terms, if at all. If we are not able to
maintain our existing strategic alliances or establish and maintain additional strategic alliances,
we may have to limit the size or scope of, or delay, one or more of our drug development programs
or research programs or undertake and fund these programs ourselves. If we elect to increase our
expenditures to fund drug development programs or research programs on our own, we will need to
obtain additional capital, which may not be available on acceptable terms, or at all.
The success of our development efforts depends in part on the performance of our partners and
the National Cancer Institute, or NCI, over which we have little or no control.
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 particular, we are relying on the NCI to conduct several important
clinical trials of ispinesib. The NCI is a government agency and there can be no assurance that
the NCI will not modify its plans to conduct such trials or will proceed with such trials
diligently. If our partners fail to perform as we expect, our potential for revenue from drugs
developed through our strategic alliances, if any, could be dramatically reduced.
Our focus on the discovery of drug candidates directed against specific proteins and pathways
within the cytoskeleton is unproven, and we do not know whether we will be able to develop any drug
candidates of commercial value.
We believe that our focus on drug discovery and development directed at the cytoskeleton is novel
and unique. While a number of commonly used drugs and a growing body of research validate the
importance of the cytoskeleton in the origin and progression of a number of diseases, no existing
drugs specifically and directly interact with the cytoskeletal proteins and pathways that our drug
candidates seek to modulate. As a result, we cannot be certain that our drug candidates will
appropriately modulate targeted cytoskeletal proteins and pathways or produce commercially viable
drugs that safely and effectively treat cancer, heart failure or other diseases, or that the
results we have seen in preclinical models will translate into similar results in humans. In
addition, even if we are successful in developing and receiving regulatory approval for a
commercially viable drug for the treatment of one disease focused on the cytoskeleton, we cannot be
certain that we will also be able to develop and receive regulatory approval for drug candidates
for the treatment of other forms of that disease or other diseases. If we or our partners fail to
develop and commercialize viable drugs, we will not achieve commercial success.
-9-
Our proprietary rights may not adequately protect our technologies and drug candidates.
Our commercial success will depend in part on our obtaining and maintaining patent protection and
trade secret protection of our technologies and drug candidates as well as successfully defending
these patents against third-party challenges. We will only be able to protect our technologies and
drug candidates from unauthorized use by third parties to the extent that valid and enforceable
patents or trade secrets cover them. Furthermore, the degree of future protection of our
proprietary rights is uncertain because legal means afford only limited protection and may not
adequately protect our rights or permit us to gain or keep our competitive advantage.
The patent positions of life sciences companies can be highly uncertain and involve complex legal
and factual questions for which important legal principles remain unresolved. No consistent policy
regarding the breadth of claims allowed in such companies patents has emerged to date in the
United States. The patent situation outside the United States is even more uncertain. Changes in
either the patent laws or in interpretations of patent laws in the United States or other countries
may diminish the value of our intellectual property. Accordingly, we cannot predict the breadth of
claims that may be allowed or enforced in our patents or in third-party patents. For example:
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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
these inventions; |
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others may independently develop similar or alternative technologies or duplicate
any of our technologies; |
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it is possible that none of our pending patent applications or the pending patent
applications of our licensors will result in issued patents; |
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our issued patents and issued patents of our licensors may not provide a basis for
commercially viable drugs, or may not provide us with any competitive advantages, or
may be challenged and invalidated by third parties; and |
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we may not develop additional proprietary technologies or drug candidates that are
patentable. |
We also rely on trade secrets to protect our technology, especially where we believe patent
protection is not appropriate or obtainable. However, trade secrets are difficult to protect.
While we use reasonable efforts to protect our trade secrets, our or our strategic partners
employees, consultants, contractors or scientific and other advisors may unintentionally or
willfully disclose our information to competitors. If we were to enforce a claim that a third
party had illegally obtained and was using our trade secrets, our enforcement efforts would be
expensive and time consuming, and the outcome would be unpredictable. In addition, courts outside
the United States are sometimes less willing to protect trade secrets. Moreover, if our
competitors independently develop equivalent knowledge, methods and know-how, it will be more
difficult for us to enforce our rights and 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 and to achieve or maintain profitability.
-10-
If we are sued for infringing intellectual property rights of third parties, such litigation
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 sell such drugs without infringing the
patents or other proprietary rights of third parties. Numerous U.S. and foreign issued patents and
pending patent applications, which are owned by third parties, exist in the areas that we are
exploring. In addition, because patent applications can take several years to issue, there may be
currently pending applications, unknown to us, which may later result in issued patents that our
drug candidates may infringe. There could also be existing patents of which we are not aware that
our drug candidates may inadvertently infringe.
In particular, we are aware of an issued U.S. patent and at least one pending U.S. patent
application assigned to Curis, Inc., or Curis, relating to certain compounds in the quinazolinone
class. Ispinesib falls into this class of compounds. The Curis patent claims a method of use for
inhibiting signaling by what is called the hedgehog pathway using certain such compounds. Curis
has pending applications in Europe, Japan, Australia and Canada with claims covering certain
quinazolinone compounds, compositions thereof, and/or methods of their use. We are also aware that
two of the Australian applications have been allowed and two of the European applications have been
granted. In addition, in Europe, Australia and elsewhere, the grant of a patent may be opposed by
one or more parties. We and GSK have each opposed the granting of certain such patent to Curis in
Europe and in Australia. Curis or a third party may assert that the sale of ispinesib may infringe
one or more of these or other patents. We believe that we have valid defenses against the Curis
patents if asserted against us. However, we cannot guarantee that a court would find such defenses
valid or that such oppositions would be successful. We have not attempted to obtain a license to
this patent. If we decide to obtain a license to this patent, we cannot guarantee that we would be
able to obtain such a license on commercially reasonable terms, or at all.
In addition, we are aware of various issued U.S. and foreign patents and pending U.S. and foreign
patent applications assigned to Fisher Scientific International, Inc., or Fisher (formerly
Cellomics, Inc.), relating to an automated method for analyzing cells. Fisher or a third party may
assert that our Cytometrix technologies fall within the scope of, and thus infringe, one or more of
these patents. We have received a letter from Fisher notifying us that Fisher believes we may be
practicing one or more of their patents and that Fisher offers a use license for such patents
through its licensing program. We believe that we have valid defenses to such an assertion.
Moreover, the grant of the European patent has been opposed by another company. However, we cannot
guarantee that a court would find such defenses valid or that such opposition would be successful.
If we decide to obtain a license to these patents, we cannot guarantee that we would be able to
obtain such a license on commercially reasonable terms, or 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., or Merck). Further
development of these products could be impacted by these patents and result in the expenditure of
significant legal fees.
If a third party claims that our actions infringe on their 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, with or without merit, can
be costly and time consuming to litigate and can delay the regulatory approval process
and divert managements attention from our core business strategy; |
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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 upon a competitors 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. |
We may become involved in disputes with our strategic partners over intellectual property
ownership, and publications by our research collaborators and scientific advisors could impair our
ability to obtain patent protection or protect our proprietary information, which, in either case,
would have a significant impact on our business.
Inventions discovered under our strategic alliance agreements 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 of those inventions. These disputes
could be costly and time consuming, and an unfavorable outcome would 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 scientific advisors have contractual rights to publish our
data and other proprietary information, subject to our prior review. Publications by our research
collaborators and scientific advisors containing such information, either with our permission or in
contravention of the terms of their agreements with us, may impair our ability to obtain patent
protection or protect our proprietary information, which could significantly harm our business.
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 novel small molecule drugs focused on the
cytoskeleton for the treatment of a wide array of diseases is costly. As a result, 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 to raise additional capital to:
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expand our research and development and technologies; |
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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 cost 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 payment and other terms and timing of any strategic alliance, licensing or other
arrangements that we 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 finance future cash needs primarily through public or private
equity offerings, debt financings and strategic alliances. 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.
We have limited capacity to carry out our own clinical trials in connection with the
development of our drug candidates and potential drug candidates, and to the extent we elect to
develop a drug candidate without a strategic partner we will need to expand our development
capacity, and we will require additional funding.
The development of drug candidates is complicated, and requires resources and experience for which
we currently have limited resources. Currently, we generally rely on our strategic partners to
carry out these activities for certain of our drug candidates that are in clinical trials. We do
not have a partner for our cardiac myosin activator drug candidate, CK-1827452, and, in the event
GSK elects to terminate its development efforts, we do not have an alternative partner for our
cancer drug candidates. Pursuant to the amendment of our Collaboration and License Agreement with
GSK, we may initiate and conduct clinical trials for SB-743921 for the treatment of non-Hodgkins
lymphoma, Hodgkins lymphoma, and multiple myeloma. For the clinical trials we conduct with
SB-743921 for these hematologic cancer indications, under the terms of our amended agreement with
GSK, we plan to rely on contractors for the manufacture and distribution of clinical supplies. To
the extent we conduct clinical trials for a drug candidate without support from a strategic
partner, as we are doing with our drug candidate CK-1827452, and as we currently plan to do for our
drug candidate SB-743921 pursuant to the amendment of our strategic alliance with GSK, we will need
to develop additional skills, technical expertise and resources necessary to carry out such
development efforts on our own or through the use of other third parties, such as contract research
organizations, or CROs.
If we utilize CROs, we will not have control over many aspects of their activities, and will not be
able to fully control the amount or timing of resources that they devote to our programs. These
third parties also may not assign as high a priority to our programs or pursue them as diligently
as we would if we were undertaking such programs ourselves, and therefore may not complete their
respective activities on schedule. CROs may also have relationships with our competitors and
potential competitors, and may prioritize those relationships ahead of their relationships with us.
Typically, we would prefer to qualify more than one vendor for each function performed outside of
our control, which could be time consuming and costly. The failure of CROs to carry out
development efforts on our behalf according to our requirements and FDA or other regulatory
agencies standards, or our failure to properly coordinate and manage such efforts, could increase
the cost of our operations and delay or prevent the development, approval and commercialization of
our drug candidates.
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If we fail to develop additional skills, technical expertise and resources necessary to carry out
the development of our drug candidates, or if we fail to effectively manage our CROs carrying out
such development, the commercialization of our drug candidates will be delayed or prevented.
We currently have no marketing or sales staff, and if we are unable to enter into or maintain
strategic alliances with marketing partners or if we are unable 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. To commercialize our drugs
that we determine not to market on our own, we will depend on strategic alliances with third
parties, such as GSK, which have established distribution systems and direct sales forces. If we
are unable to enter into such arrangements on acceptable terms, we may not be able to successfully
commercialize such drugs.
We plan to commercialize drugs on our own, with or without a partner, 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 with 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, or at all, which could make
us unable to commercialize our drugs.
To the extent that we are not successful in commercializing any drugs ourselves or through a
strategic alliance, our product revenues will suffer, we will incur significant additional losses
and the price of our common stock will be negatively affected.
We have no manufacturing capacity and depend on our partners or 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 that are under development. We have no experience in
drug formulation or manufacturing, and we lack the resources and the capabilities to manufacture
any of our drug candidates on a clinical or commercial scale. As a result, we currently rely on
our partner, GSK, to manufacture supply, store and distribute drug supplies for the ispinesib
clinical trials. For our drug candidate CK-1827452, and our drug candidate SB-743921 for
non-Hodgkins lymphoma, Hodgkins lymphoma, and multiple myeloma, we currently rely on a limited
number of contract manufacturers, and, in particular, we expect to rely on single-source contract
manufacturers for the active pharmaceutical ingredient and the drug product supply for our clinical
trials. In addition, we anticipate continued reliance on a limited number of contract
manufacturers. Any performance failure on the part of our existing or future contract
manufacturers 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.
Our drug candidates require precise, high quality manufacturing. Our failure or our contract
manufacturers failure to achieve and maintain high manufacturing standards, including the
incidence of manufacturing errors, could result in patient injury or death, product recalls or
withdrawals, delays or failures in product testing or delivery, cost overruns or other problems
that could seriously hurt our business. Contract drug manufacturers often encounter difficulties
involving production yields, quality control and quality assurance, as well as shortages of
qualified personnel. These manufacturers are subject to ongoing periodic unannounced inspection 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
-14-
regulations and corresponding foreign standards; however, we do not have control over contract
manufacturers compliance with these regulations and standards. If one of our contract
manufacturers fails to maintain compliance, the production of our drug candidates could be
interrupted, resulting in delays, additional costs and potentially lost revenues. Additionally,
our contract manufacturer must pass a preapproval inspection before we can obtain marketing
approval for any of our drug candidates in development.
If the FDA or other regulatory agencies approve any of our drug candidates for commercial sale, we
will need to manufacture them in larger quantities. To date, our drug candidates have been
manufactured in small quantities for preclinical testing and clinical trials and we may not be able
to successfully increase the manufacturing capacity, whether in collaboration with contract
manufacturers or on our own, for any of our drug candidates in a timely or economic manner, or at
all. Significant scale-up of manufacturing may require additional validation studies, which the
FDA must review and approve. If we are unable to successfully increase the manufacturing capacity
for a drug candidate, the regulatory approval or commercial launch of any related drugs may be
delayed or there may be a shortage in supply. Even if any 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 such improvements.
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. In the event of a natural disaster, business failure, strike
or other difficulty, we may be unable to replace such contract manufacturer in a timely manner and
the production of our drug candidates would be interrupted, resulting in delays and additional
costs.
Switching manufacturers may be difficult because the number of potential manufacturers is limited
and the FDA must approve any replacement manufacturer prior to manufacturing our drug candidates.
Such approval would require new testing and compliance inspections. In addition, a new
manufacturer would have to be educated in, or develop substantially equivalent processes for,
production of our drug candidates after receipt of FDA approval. It may be difficult or impossible
for us to find a replacement manufacturer on acceptable terms quickly, or at all.
We expect to expand our development, clinical research and marketing capabilities, and as a
result, we may encounter difficulties in managing our growth, which could disrupt our operations.
We expect to have significant growth in 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.
The failure to attract and retain skilled personnel could impair our drug development and
commercialization efforts.
Our performance is substantially dependent on the performance of our senior management and key
scientific and technical personnel, particularly James H. Sabry, M.D., Ph.D., our President and
Chief Executive Officer, Robert I. Blum, our Executive Vice President, Corporate Development and
Commercial Operations
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and Chief Business Officer, Andrew A. Wolff, M.D., F.A.C.C., our Senior Vice President, Clinical
Research and Chief Medical Officer, Sharon A. Surrey-Barbari, our Senior Vice President, Finance
and Chief Financial Officer, David J. Morgans, Ph.D., our Senior Vice President of Drug Discovery
and Development, and Jay K. Trautman, Ph.D., our Vice President of Discovery Biology and
Technology. The employment of these individuals and our other personnel is terminable at will with
short or no notice. We carry key person life insurance on James H. Sabry. The loss of the
services of any member of our senior management, 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 identification of suitable replacements, and could
have a material adverse effect on our business, operating results and financial condition. 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, we believe that 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 efforts, which would adversely affect the
development of our drug candidates and commercialization of our potential drugs and growth of our
business.
Risks Related to Our Industry
Our competitors may develop drugs that are less expensive, safer, or more effective, which may
diminish or eliminate the commercial success of any drugs that we may commercialize.
We compete with companies that are also developing drug candidates that focus on the cytoskeleton,
as well as companies that have developed drugs or are developing alternative drug candidates for
cancer and cardiovascular, infectious and other diseases. For example, with respect to cancer,
Bristol-Myers Squibbs Taxol, Sanofi Aventis Pharmaceuticals Inc.s Taxotere, and generic
equivalents of Taxol are currently available on the market and commonly used in cancer treatment.
Furthermore, we are aware that Merck, Chiron Corp. and Bristol-Myers Squibb are conducting
research focused on KSP and other mitotic kinesins. In addition, Bristol-Myers Squibb, Merck,
Novartis and other pharmaceutical and biopharmaceutical companies are developing other approaches
to inhibiting mitosis. With respect to heart failure, we are aware of a potentially competitive
approach being developed by Orion in collaboration with Abbott Laboratories.
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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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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have greater success in recruiting skilled scientific workers 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 or alter other drug candidate profile aspects that our drug candidates need to
show in order to obtain regulatory approval; and |
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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, as 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. |
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. Because our research approach integrates many technologies, it may be
difficult for us to stay abreast of the rapid changes in each technology. 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 advances in existing technological approaches or the
development of 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.
The regulatory approval process is expensive, time consuming and uncertain and may prevent our
partners or us from obtaining approvals for the commercialization of some or all of our drug
candidates.
The research, testing, manufacturing, selling and marketing of drug candidates are subject to
extensive regulation by the FDA and other regulatory authorities in the United States and other
countries, which 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 an NDA
from the FDA. Neither we nor our partners have received marketing approval for any of Cytokinetics
drug candidates. Obtaining an NDA can be a lengthy, expensive and uncertain process. In addition,
failure to comply with the FDA and other applicable
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foreign and United States 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 also has substantial discretion
in the drug approval process. Despite the time and expense 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 FDA approval 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. The FDA can delay, limit or deny approval
of a drug candidate for many reasons, including:
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a drug candidate may not be safe or effective; |
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FDA officials may not find the data from preclinical testing and clinical trials sufficient; |
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the FDA might not approve our or our contract manufacturers processes or facilities; or |
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the FDA may change its approval policies or adopt new regulations. |
If we or our partners receive regulatory approval for our drug candidates, we will also be
subject to ongoing FDA obligations and continued regulatory review, such as continued safety
reporting requirements, and we may also be subject to additional FDA post-marketing obligations,
all of which may result in significant expense and limit our ability to commercialize our potential
drugs.
Any regulatory approvals that we or our partners receive for our drug candidates may also be
subject to limitations on the indicated uses for which the drug may be marketed or contain
requirements for potentially costly post-marketing follow-up studies. In addition, if the FDA
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, may result in restrictions on the marketing
of the drug, and could include withdrawal of the drug from the market.
The FDAs policies may change 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 could 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, 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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timing of market introduction of competitive drugs; |
-18-
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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 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; and |
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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.
There is significant uncertainty related to the coverage and reimbursement of newly approved drugs.
The commercial success of our potential drugs in both domestic and international markets is
substantially dependent on whether third-party coverage and reimbursement is available for the
ordering of our potential drugs by the medical profession for use by their patients. 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,
and, as a result, they may not cover or provide adequate payment for our potential drugs. They may
not view our potential drugs as cost-effective and reimbursement may not be available to consumers
or may not be sufficient to allow our potential drugs to be marketed on a competitive basis.
Likewise, legislative or regulatory efforts to control or reduce healthcare costs or reform
government healthcare programs could result in lower prices or rejection of coverage for our
potential drugs. Changes in coverage and reimbursement policies or healthcare cost containment
initiatives that limit or restrict reimbursement for our drugs may cause our revenue to decline.
We may be subject to costly product liability claims and may not be able to obtain adequate
insurance.
If we conduct clinical trials in humans, we face the risk that the use of our drug candidates will
result in adverse effects. We currently maintain product liability insurance in the amount of
$10.0 million with a $5,000 deductible per occurrence. We cannot predict the possible harms or
side effects that may result from our clinical trials. We may not have sufficient resources to pay
for any liabilities resulting from a claim excluded from, or beyond the limit of, our insurance
coverage.
In addition, once we have commercially launched drugs based on our drug candidates, we will face
exposure to product liability claims. This risk exists even with respect to those drugs that are
approved for commercial sale by the FDA and manufactured in facilities licensed and regulated by
the FDA. We intend to secure limited product liability insurance coverage, but may not be able to
obtain such insurance on acceptable terms with adequate coverage, or at reasonable costs. There is
also a risk that third parties that we have agreed to indemnify could incur liability. Even if we
were ultimately successful in product liability litigation, the
-19-
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 as well as our other potential drugs. Moreover, product recalls may be issued at our
discretion or at the direction of the FDA, other governmental agencies or other companies having
regulatory control for drug sales. If product recalls occur, such recalls are generally expensive
and often have an adverse effect on the image of the drugs being recalled as well as the reputation
of the drugs developer or manufacturer.
We may be subject to damages resulting from claims that our employees or we have wrongfully
used or disclosed alleged 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 such 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 commercialize certain potential drugs, which could severely harm our
business. Even if we are successful in defending against these claims, litigation could result in
substantial costs and be a distraction to management.
We use hazardous chemicals and radioactive and biological materials in our business. Any
claims relating to improper handling, storage or disposal of these materials 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 use or the use by third parties of these materials.
Compliance with environmental laws and regulations is expensive, and current or future
environmental regulations may impair our research, development and production efforts.
In addition, our partners may use hazardous materials in connection with our strategic alliances.
To our knowledge, their work is performed in accordance with applicable biosafety regulations. In
the event of a lawsuit or investigation, however, we could be held responsible for any injury
caused to persons or property by exposure to, or release of, these hazardous materials used by
these parties. Further, we may be required to indemnify our partners against all damages and other
liabilities arising out of our development activities or drugs produced in connection with these
strategic alliances.
Our facilities in California are located near an earthquake fault, and an earthquake or other
types of natural disasters or resource shortages could disrupt our operations and adversely affect
results.
Important documents and records, such as hard copies of our laboratory books and records for our
drug candidates and compounds, are located in our corporate headquarters at a single location in
South San Francisco, California near active earthquake zones. In the event of a natural disaster,
such as an earthquake, drought or flood, or localized extended outages of critical utilities or
transportation systems, we do not have a formal business continuity or disaster recovery plan, and
could therefore experience a significant business interruption. 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.
-20-
Risks Related To Our Common Stock
We expect that our stock price will fluctuate significantly, and you may not be able to resell
your shares 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. The
volatility of pharmaceutical, biotechnology and other life sciences company stocks often does not
relate to the operating performance of the companies represented by the stock. Factors that could
cause this volatility in the market price of our common stock include, but are not limited to:
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results from, and any delays in, the clinical trials programs for our drug
candidates for the treatment of cancer and heart failure, including the clinical trials
for ispinesib and SB-743921 for cancer, and CK-1827452 for heart failure, and including
delays resulting from slower than expected patient enrollment in such clinical trials; |
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delays in or discontinuation of the development of any of our drug candidates by GSK; |
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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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delays or other developments in establishing new strategic alliances; |
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announcements concerning our strategic alliances with GSK or AstraZeneca or future
strategic alliances; |
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issuance of new or changed securities analysts reports or recommendations; |
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market conditions in the pharmaceutical and biotechnology 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 commercial 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 reimbursement policies; |
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FDA or other United States 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; and |
-21-
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volatility in the stock prices of other companies in our industry. |
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 the time and attention of our management.
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 October 31, 2005, our executive officers, directors and their affiliates beneficially owned
or controlled approximately 39% percent 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.
Future sales of common stock by our existing stockholders may cause our stock price to fall.
The market price of our common stock could decline as a result of sales of common stock by
stockholders who held shares of our capital stock prior to our initial public offering, or the
perception that these sales could occur. These sales might also make it more difficult for us to
sell equity securities at a time and price that we deem appropriate. The lock-up agreements
delivered by our executive officers and directors, and substantially all of our stockholders and
option holders, in connection with our initial public offering on April 29, 2004, expired on
October 27, 2004. Subject to applicable securities law restrictions and other agreements between
us and certain of such stockholders, these shares are now freely tradable.
Evolving regulation of corporate governance and public disclosure may result in additional
expenses and continuing uncertainty.
Changing laws, regulations and standards relating to corporate governance and public disclosure,
including the Sarbanes-Oxley Act of 2002, new Securities and Exchange Commission regulations and
Nasdaq National Market 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 such costs. For example,
compliance with the internal control requirements of Sarbanes-Oxley Section 404 for the year ended
December 31, 2005 requires the commitment of significant resources to document and test the
adequacy of our internal control over financial reporting. While we are expending significant
resources on the required documentation and testing procedures required by Section 404, 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.
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
-22-
governance practices. We are committed to maintaining high standards of corporate governance and
public disclosure. As a result, we intend to invest resources 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
and we may be harmed.
Volatility in the stock prices of other companies may contribute to volatility in our stock
price.
The stock market in general, 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.
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 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.
Risks Related To The Committed Equity Financing Facility With Kingsbridge
The Committed Equity Financing Facility that we entered into with Kingsbridge may not be
available to us if we elect to make a draw down, may require us to make additional blackout
or other payments to Kingsbridge, and may result in dilution to our stockholders.
The CEFF entitles us to sell and obligates Kingsbridge to purchase, from time to time over a
period of three years, shares of our common stock for cash consideration up to an aggregate of $75
million, subject to certain conditions and restrictions. Kingsbridge will not be obligated to
purchase shares under the CEFF unless certain conditions are met, which include a minimum price for
our common stock; the accuracy of representations and warranties made to Kingsbridge; compliance
with laws; effectiveness of the registration statement of which this prospectus is a part; and the
continued listing of our stock on the Nasdaq National Stock market. In addition, Kingsbridge is
permitted to terminate the CEFF if it determines that a material and adverse event has occurred
affecting our business, operations, properties or financial condition and if such condition
continues for a period of 10 days from the date Kingsbridge provides us notice of such material and
adverse event. If we are unable to access funds through the CEFF, or if the CEFF is terminated by
Kingsbridge, we may be unable to access capital on favorable terms or at all.
We are entitled in certain circumstances, to deliver a blackout notice to Kingsbridge to suspend
the use of the registration statement of which this prospectus is a part and prohibit Kingsbridge
from selling shares under this prospectus. If we deliver a blackout notice in the 15 trading days
following the settlement of a draw down, or if the registration statement is not effective in
circumstances not permitted by the agreement, then we must make a payment to Kingsbridge, or issue
Kingsbridge additional shares in lieu of this payment, calculated on the basis of the number of
shares held by Kingsbridge (exclusive of shares that Kingsbridge may hold pursuant to exercise of
the Kingsbridge warrant) and the change in the market price of our common stock during the period
in which the use of the registration statement is suspended. If the trading price of our common
stock declines during a suspension of the registration statement, the blackout or other payment
could be significant.
Should we sell shares to Kingsbridge under the CEFF, or issue shares in lieu of a blackout payment,
it will have a dilutive effective on the holdings of our current stockholders, and may result in
downward pressure on the price of our common stock. If we draw down under the CEFF, we will issue
shares to Kingsbridge at a discount of up to 10 percent from the volume weighted average price of
our common stock. If we draw down amounts under the CEFF when our share price is decreasing, we
will need to issue more shares to raise the same amount than if our stock price was higher.
Issuances in the face of a declining share price will have an even greater dilutive effect than if
our share price were stable or increasing, and may further decrease our share price.
-23-
DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS
In addition to the other information contained or incorporated by reference in this prospectus, you
should carefully consider the risk factors disclosed in this prospectus or any prospectus
supplement when evaluating an investment in our securities. This prospectus contains
forward-looking statements that are based upon current expectations that are within the meaning of
the Private Securities Reform Act of 1995. It is the Companys intent that such statements be
protected by the safe harbor created thereby.
Forward-looking statements involve risks and uncertainties and our actual results and the timing of
events may differ significantly from the results discussed in the forward-looking statements.
Examples of such forward-looking statements include, but are not limited to, statements regarding:
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the potential benefits of our drug candidates and potential drug candidates; |
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the utility of our proprietary technologies and biological focus; |
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our plans or ability to commercialize drugs, with or without a partner; |
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increasing expenditures and losses; |
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expansion of the scope and size of research and development efforts; |
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potential competitors; |
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our needs for additional financing; |
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expected future sources of revenue and capital; |
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protection of our intellectual property; |
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issuance of shares of our common stock under the CEFF; |
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registration for resale of our securities issued under, and in connection with, the CEFF; and |
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increasing the number of our employees and recruiting additional key personnel. |
-24-
USE OF PROCEEDS
We will not receive any of the proceeds from the sale of shares of our common stock by the selling
stockholder pursuant to this prospectus. Any sale of shares by us to Kingsbridge under the common
stock purchase agreement or in connection with the exercise of the Kingsbridge warrant will be made
pursuant to an exemption from the registration requirements of the Securities Act. We will use the
proceeds from these sales for general corporate purposes, including capital expenditures, the
advancement of our drug candidates in clinical trials, and to meet working capital needs. The
amounts and timing of the expenditures will depend on numerous factors, such as the timing and
progress of our clinical trials and research and development efforts, technological advances and
the competitive environment for our drug candidates. We expect from time to time to evaluate the
acquisition of businesses, products and technologies for which a portion of the net proceeds may be
used, although we currently are not planning or negotiating any such transactions. As of the date
of this prospectus, we cannot specify with certainty all of the particular uses for the net
proceeds to us from the sale of shares to Kingsbridge. Accordingly, we will retain broad
discretion over the use of these proceeds, if any.
-25-
SELLING STOCKHOLDER
This prospectus relates to the possible resale by the selling stockholder, Kingsbridge, of shares
of common stock that we may issue pursuant to the common stock purchase agreement we entered into
with Kingsbridge on October 28, 2005, or upon exercise of the warrant we issued to Kingsbridge. We
are filing the registration statement of which this prospectus is a part pursuant to the provisions
of the registration rights agreement we entered into with Kingsbridge on October 28, 2005.
The selling stockholder may from time to time offer and sell pursuant to this prospectus any or all
of the shares that it acquires under the common stock purchase agreement or upon exercise of the
warrant.
The following table presents information regarding Kingsbridge and the shares that it may offer and
sell from time to time under this prospectus. This table is prepared based on information supplied
to us by the selling stockholder, and reflects holdings as of October 31, 2005. As used in this
prospectus, the term selling stockholder includes Kingsbridge and any donees, pledges,
transferees or other successors in interest selling shares received after the date of this
prospectus from a selling stockholder as a gift, pledge or other non-sale related transfer. The
number of shares in the column Number of Shares Being Offered represents all of the shares that
the selling stockholder may offer under this prospectus. The selling stockholder may sell some,
all or none of its shares. We do not know how long the selling stockholder will hold the shares
before selling them, and we currently have no agreements, arrangements or understandings with the
selling stockholder regarding the sale of any of the shares.
Beneficial ownership is determined in accordance with Rule 13d-3(d) promulgated by the SEC under
the Securities Exchange Act of 1934, as amended. The percentage of shares beneficially owned prior
to the offering is based both on 28,661,230 shares of our common stock actually outstanding as of
October 31, 2005 and on the assumption that all shares of common stock issuable under the common
stock purchase agreement we entered into with Kingsbridge on October 28, 2005 and all shares of
common stock issuable upon exercise of the warrant held by Kingsbridge are outstanding as of that
date.
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Shares of Common Stock |
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Number of |
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Shares of Common Stock |
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Beneficially Owned |
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Shares Being |
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Beneficially Owned |
Security Holders |
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Prior to Offering |
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Offered |
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After Offering |
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Number |
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Percent |
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Number |
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Percent |
Kingsbridge Capital Limited (1) |
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5,947,488 |
(2) |
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20.75 |
% |
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5,947,488 |
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% |
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(1) |
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The address of Kingsbridge is Kingsbridge Capital Limited, c/o Kingsbridge Corporate Services
Limited, Main Street, Kilcullen, County Kildare, Republic of Ireland. |
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Consists of 5,703,488 shares of common stock issuable under the common stock purchase
agreement we entered into with Kingsbridge on October 28, 2005 and 244,000 shares of common
stock issuable upon exercise of a warrant, which warrant is not exercisable before April 28,
2006. For the purposes hereof, we assume the issuance of all
5,947,488 shares. Maria ODonoghue and Adam Gurney have shared voting and investment control of the securities held by
Kingsbridge. Kingsbridge does not accept third party investments. |
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PLAN OF DISTRIBUTION
We are registering 5,947,488 shares of common stock under this prospectus on behalf of Kingsbridge.
Except as described below, to our knowledge, the selling stockholder has not entered into any
agreement, arrangement or understanding with any particular broker or market maker with respect to
the shares of common stock offered hereby, nor, except as described below, do we know the identity
of the brokers or market makers that will participate in the sale of the shares.
The selling stockholder may decide not to sell any shares. The selling stockholder may from time
to time offer some or all of the shares of common stock through brokers, dealers or agents who may
receive compensation in the form of discounts, concessions or commissions from the selling
stockholder and/or the purchasers of the shares of common stock for whom they may act as agent. In
effecting sales, broker-dealers that are engaged by the selling stockholder may arrange for other
broker-dealers to participate. Kingsbridge is an underwriter within the meaning of the
Securities Act. Any brokers, dealers or agents who participate in the distribution of the shares
of common stock may also be deemed to be underwriters, and any profits on the sale of the shares
of common stock by them and any discounts, commissions or concessions received by any such brokers,
dealers or agents may be deemed to be underwriting discounts and commissions under the Securities
Act. Kingsbridge has advised us that it may effect resales of our common stock through any one or
more registered broker-dealers. To the extent the selling stockholder may be deemed to be an
underwriter, the selling stockholder will be subject to the prospectus delivery requirements of the
Securities Act and may be subject to certain statutory liabilities of, including but not limited
to, Sections 11, 12 and 17 of the Securities Act and Rule 10b-5 under the Securities Exchange Act
of 1934, as amended, or the Exchange Act.
The selling stockholder will act independently of us in making decisions with respect to the
timing, manner and size of each sale. Such sales may be made over the NASDAQ Stock Market, on the
over-the-counter market, otherwise or in a combination of such methods of sale, at then prevailing
market prices, at prices related to prevailing market prices or at negotiated prices. The shares
of common stock may be sold according to one or more of the following methods:
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a block trade in which the broker or dealer so engaged will attempt to sell the
shares of common stock as agent but may position and resell a portion of the block as
principal to facilitate the transaction; |
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purchases by a broker or dealer as principal and resale by such broker or dealer for
its account pursuant to this prospectus; |
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an over-the-counter distribution in accordance with the NASDAQ rules; |
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ordinary brokerage transactions and transactions in which the broker solicits purchasers; |
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privately negotiated transactions; |
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a combination of such methods of sale; and |
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any other method permitted pursuant to applicable law. |
Any shares covered by this prospectus which qualify for sale pursuant to Rule 144 of the Securities
Act may be sold under Rule 144 rather than pursuant to this prospectus. In addition, the selling
stockholder may transfer the shares by other means not described in this prospectus.
-27-
Any broker-dealer participating in such transactions as agent may receive commissions from
Kingsbridge (and, if they act as agent for the purchaser of such shares, from such purchaser).
Broker-dealers may agree with Kingsbridge to sell a specified number of shares at a stipulated
price per share, and, to the extent such a broker-dealer is unable to do so acting as agent for
Kingsbridge, to purchase as principal any unsold shares at the price required to fulfill the
broker-dealer commitment to Kingsbridge. Broker-dealers who acquire shares as principal may
thereafter resell such shares from time to time in transactions (which may involve crosses and
block transactions and which may involve sales to and through other broker-dealers, including
transactions of the nature described above) on the NASDAQ National Market, on the over-the-counter
market, in privately-negotiated transactions or otherwise at market prices prevailing at the time
of sale or at negotiated prices, and in connection with such resales may pay to or receive from the
purchasers of such shares commissions computed as described above. To the extent required under
the Securities Act, an amendment to this prospectus, or a supplemental prospectus will be filed,
disclosing:
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the name of any such broker-dealers; |
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the number of shares involved; |
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the price at which such shares are to be sold; |
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the commission paid or discounts or concessions allowed to such broker-dealers,
where applicable; |
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that such broker-dealers did not conduct any investigation to verify the information
set out or incorporated by reference in this prospectus, as supplemented; and |
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other facts material to the transaction. |
Underwriters and purchasers that are deemed underwriters under the Securities Act may engage in
transactions that stabilize, maintain or otherwise affect the price of the securities, including
the entry of stabilizing bids or syndicate covering transactions or the imposition of penalty bids.
Kingsbridge and any other persons participating in the sale or distribution of the shares will be
subject to the applicable provisions of the Exchange Act and the rules and regulations thereunder
including, without limitation, Regulation M. These provisions may restrict certain activities of,
and limit the timing of, purchases by the selling stockholder or other persons or entities.
Furthermore, under Regulation M, persons engaged in a distribution of securities are prohibited
from simultaneously engaging in market making and certain other activities with respect to such
securities for a specified period of time prior to the commencement of such distributions, subject
to special exceptions or exemptions. Regulation M may restrict the ability of any person engaged
in the distribution of the securities to engage in market-making and certain other activities with
respect to those securities. In addition, the anti-manipulation rules under the Exchange Act may
apply to sales of the securities in the market. All of these limitations may affect the
marketability of the shares and the ability of any person to engage in market-making activities
with respect to the securities.
We have agreed to pay the expenses of registering the shares of common stock under the Securities
Act, including registration and filing fees, printing expenses, administrative expenses and certain
legal and accounting fees, as well as certain fees of counsel for the selling stockholder incurred
in the preparation of the CEFF agreements and the registration statement of which this prospectus
forms a part. The selling stockholder will bear all discounts, commissions or other amounts
payable to underwriters, dealers or agents, as well as transfer taxes and certain other expenses
associated with the sale of securities.
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Under the terms of the Kingsbridge common stock purchase agreement and the registration rights
agreement, we have agreed to indemnify the selling stockholder and certain other persons against
certain liabilities in connection with the offering of the shares of common stock offered hereby,
including liabilities arising under the Securities Act or, if such indemnity is unavailable, to
contribute toward amounts required to be paid in respect of such liabilities.
At any time a particular offer of the shares of common stock is made, a revised prospectus or
prospectus supplement, if required, will be distributed. Such prospectus supplement or
post-effective amendment will be filed with the SEC, to reflect the disclosure of required
additional information with respect to the distribution of the shares of common stock. We may
suspend the sale of shares by the selling stockholder pursuant to this prospectus for certain
periods of time for certain reasons, including if the prospectus is required to be supplemented or
amended to include additional material information.
-29-
DESCRIPTION OF CAPITAL STOCK
As of the date of this prospectus, our authorized capital stock consists of 130,000,000 shares.
Those shares consist of 120,000,000 shares designated as common stock, $0.001 par value, and
10,000,000 shares designated as preferred stock, $0.001 par value. The only equity securities
currently outstanding are shares of common stock. As of October 31, 2005, there were approximately
28,661,230 shares of common stock issued and outstanding.
The following description summarizes the material terms of our capital stock. This summary is,
however, subject to the provisions of our restated certificate of incorporation and any applicable
certificate of designations for a series of preferred stock, 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 National Market under the symbol CYTK. The transfer
agent and registrar for our common stock is Mellon Investor Services LLC. Mellons address is 235
Montgomery Street, San Francisco, California 94104 and its telephone number is (415) 743-1422.
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.
Preferred Stock
Pursuant to our restated certificate of incorporation, our board of directors has the authority,
without further approval by the stockholders, to designate and issue up 10,000,000 shares of
preferred stock in one or more series. Our board of directors may designate the powers,
preferences, privileges and relative participating, optional or special rights and the
qualifications, limitations or restrictions of each series of preferred stock, including dividend
rights, conversion rights, voting rights, terms of redemption and liquidation preferences, any or
all of which may be greater than the rights of the common stock. Thus, without stockholder
approval, our board of directors could authorize the issuance of preferred stock with voting,
conversion and other rights that could dilute the voting power and other rights of holders of our
common stock, and may have the effect of decreasing the market price of the common stock.
The description of certain provisions of the preferred stock set forth in any prospectus supplement
does not purport to be complete and is subject to and qualified in its entirety by reference to our
certificate of incorporation and the certificate of designations relating to each series of
preferred stock. The applicable prospectus supplement will describe the specific terms of any
series of preferred stock being offered which may include:
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the specific designation, number of shares, seniority and purchase price; |
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any liquidation preference per share and any accumulated dividends upon the
liquidation, dissolution or winding up of our affairs; |
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any date of maturity; |
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any redemption, repayment or sinking fund provisions; |
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any dividend rate or rates, whether dividend rate is fixed or variable, the date
dividends accrue, the dates on which any such dividends will be payable (or the method
by which such rates or dates will be determined), and whether dividends will be
cumulative; |
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any voting rights; |
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if other than the currency of the United States, the currency or currencies
(including composite currencies) in which such preferred stock is denominated and in
which payments will or may be payable; |
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the method by which amounts in respect of such series of preferred stock may be
calculated and any commodities, currencies or indices, or value, rate or price,
relevant to such calculation; |
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whether such series of preferred stock is convertible and, if so, the securities or
rights into which it is convertible, and the terms and conditions upon which such
conversions will be effected; |
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the place or places where dividends and other payments on such series of preferred
stock will be payable; and |
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any additional voting, dividend, liquidation, redemption and other rights,
preferences, privileges, limitations and restrictions. |
All shares of preferred 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.
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:
-31-
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prior to the date of the transaction, 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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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 number of shares outstanding (a) shares owned by persons who are
directors and also officers, and (b) shares owned by employee stock plans in which
employee participants do not have the right to determine; |
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confidentially whether shares held subject to the plan will be tendered in a tender
or exchange offer; or |
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on or subsequent to the date of the transaction, the business combination is
approved by the board and authorized at an annual or special meeting of stockholders,
and not by written consent, by the affirmative vote of at least 66% 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.
Our amended 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
-32-
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
chairman of the board or the chief executive officer 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 chairman
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 upon the
closing of this offering.
-33-
LEGAL MATTERS
The validity of the securities being offered by this prospectus will be passed upon for us by
Wilson Sonsini Goodrich & Rosati, Professional Corporation, of Palo Alto, California.
EXPERTS
The
financial statements incorporated in this Prospectus by reference to
the Annual Report on Form 10-K for the year ended
December 31, 2004 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 are a reporting company and file annual, quarterly and current reports, proxy statements and
other information with the SEC. You may read and copy these reports, proxy statements and other
information at the SECs public reference rooms at 100 F Street, N.E., Washington, D.C. 20549.
You can request copies of these documents by writing to the SEC and paying a fee for the copying
cost. Please call the SEC at 1-800-SEC-0330 for more information about the operation of the public
reference rooms. In addition, you can read and copy our SEC filings at the office of the National
Association of Securities Dealers, Inc. at 1735 K Street, Washington, D.C. 20006. Our SEC filings
are also available at the SECs web site at www.sec.gov and our website at www.cytokinetics.com.
We have not incorporated by reference into this prospectus the information contained on our website
and you should not consider it to be part of this prospectus.
-34-
INCORPORATION BY REFERENCE
The SEC allows us to incorporate by reference information that we file with them, which means
that we can disclose important information to you by referring you to those documents. The
information incorporated by reference is an important part of this prospectus , and information
that we file later with the SEC will automatically update and supersede this information. We
incorporate by reference the documents listed below and any future filings we will make with the
SEC under Section 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, after the date
of this prospectus but before the end of any offering made under this prospectus and accompanying
prospectus (other than current reports or portions thereof furnished under Item 2.02, Item 7.01 or
8.01 of Form 8-K):
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our annual report on Form 10-K for the fiscal year ended December 31, 2004; |
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our quarterly report on Form 10-Q for the quarter ended March 31, 2005; |
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our quarterly report on Form 10-Q for the quarter ended June 30, 2005; |
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our quarterly report on Form 10-Q for the quarter ended September 30, 2005; |
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our definitive proxy statement on Schedule 14A, filed on April 6, 2005; |
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our current reports on Form 8-K, filed with the SEC on January 6, 2005, February 7,
2005, March 28, 2005, March 30, 2005, April 6, 2005, August 24, 2005, September 27,
2005 and November 2, 2005; and |
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the description of our common stock contained in our Registration Statement on Form
8-A, filed with the Securities and Exchange Commission on March 12, 2004, and any
further amendment or report filed hereafter for the purpose of updating such
description. |
Copies of documents incorporated by reference, excluding exhibits except to the extent such
exhibits are specifically incorporated by reference, are available from us without charge, upon
oral or written request to:
Cytokinetics, Incorporated
280 East Grand Avenue
South San Francisco, California 94080
United States of America
Attn: Investor Relations
(650) 624-3000
-35-
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other expenses of issuance and distribution
The following table sets forth all expenses, other than the underwriting discounts and commissions,
payable by the registrant in connection with the sale of the securities being registered. All the
amounts shown are estimates except for the registration fee.
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Securities and Exchange Commission Registration Fee |
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$ |
5,880.17 |
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Legal Fees and Expenses |
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75,000 |
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Accountants Fees and Expenses |
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15,000 |
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Printing Expenses |
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2,500 |
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Transfer Agent Fees and Expenses |
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2,500 |
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Miscellaneous |
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5,119.83 |
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Total |
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$ |
106,000 |
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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 any
such 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 such capacities.
II-1
Item 16. Exhibits and Financial Statement Schedules
(a) The following exhibits are filed herewith or incorporated herein by reference:
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Exhibit |
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Number |
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Description |
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4.1* |
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Specimen Common Stock Certificate. |
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4.2* |
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Fourth Amended and Restated Investors Rights Agreement, dated March 21, 2003, by and
among the Registrant and certain stockholders of the Registrant. |
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4.3* |
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Loan and Security Agreement, dated September 25, 1998, by and between the Registrant
and Comdisco. |
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4.4* |
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Amendment No. One to Loan and Security Agreement, dated February 1, 1999. |
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4.5* |
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Warrant for the purchase of shares of Series A preferred stock, dated September 25,
1998, issued by the Registrant to Comdisco. |
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4.6* |
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Loan and Security Agreement, dated December 16, 1999, by and between the Registrant and
Comdisco. |
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4.7* |
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Amendment No. 1 to Loan and Security Agreement, dated June 29, 2000, by and between the
Registrant and Comdisco. |
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4.8* |
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Warrant for the purchase of shares of Series B preferred stock, dated December 16,
1999, issued by the Registrant to Comdisco. |
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4.9* |
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Master Security Agreement, dated February 2, 2001, by and between the Registrant and
General Electric Capital Corporation. |
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4.10* |
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Cross-Collateral and Cross-Default Agreement by and between the Registrant and Comdisco. |
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4.11* |
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Warrant for the purchase of shares of common stock, dated July 20, 1999, issued by the
Registrant to Bristow Investments, L.P. |
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4.12* |
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Warrant for the purchase of shares of common stock, dated July 20, 1999, issued by the
Registrant to the Laurence and Magdalena Shushan Family Trust. |
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4.13* |
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Warrant for the purchase of shares of common stock, dated July 20, 1999, issued by the
Registrant to Slough Estates USA Inc. |
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4.14* |
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Warrant for the purchase of shares of Series B preferred stock, dated August 30, 1999,
issued by the Registrant to The Magnum Trust. |
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4.15 |
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Warrant for the purchase of shares of common stock, dated October 28, 2005, issued by
the Registrant to Kingsbridge Capital Limited. |
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4.16 |
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Registration Rights Agreement, dated October 28, 2005, by and between the Registrant
and Kingsbridge Capital Limited. |
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5.1 |
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Opinion of Wilson Sonsini Goodrich & Rosati, Professional Corporation. |
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10.57 |
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Common Stock Purchase Agreement, dated as of October 28, 2005, by and between the
Registrant and Kingsbridge Capital Limited. |
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23.1 |
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Consent of PricewaterhouseCoopers, LLP, Independent Registered Public Accounting Firm. |
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23.2 |
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Consent of Wilson Sonsini Goodrich & Rosati, Professional Corporation (included in
Exhibit 5.1). |
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24.1 |
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Power of Attorney of certain directors and officers of Cytokinetics, Incorporated
(see Page II-6 of original filing). |
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* |
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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. |
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Previously filed. |
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Item 17. Undertakings
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:
II-2
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933, as
amended (the Securities Act);
(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 and 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 percent change in the maximum aggregate
offering price set forth in the Calculation of Registration Fee table in the effective
registration statement;
(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) and (1)(ii) do not apply if the Registration Statement is
on Form S-3, Form S-8 or Form F-3, and the information required to be included in a post-effective
amendment by those paragraphs is contained in periodic reports filed by the Registrant pursuant to
Section 13 or Section 15(d) of the Exchange Act, that are incorporated by reference in the
Registration Statement.
(2) That, for the purpose of determining any liability under the Securities Act, 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: (i) for purposes of determining any liability under the Securities Act, the information
omitted from the form of prospectus filed as part of the registration statement in reliance upon
Rule 430A and contained in the 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 the registration
statement as of the time it was declared effective; and (ii) for the purpose of determining any
liability under the Securities Act, 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.
(5) That, for purposes of determining any liability under the Securities Act, each filing of the
registrants annual report pursuant to Section 13(a) or Section 15(d) of the Exchange Act (and,
where applicable, each filing of an employee benefit plans annual report pursuant to Section 15(d)
of the Exchange Act) that is incorporated by reference in the Registration Statement 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.
Insofar as indemnification for liabilities arising under the Securities Act 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 Securities Act and is,
therefore, unenforceable. In the event that a claim for indemnification against such liabilities
(other than the payment by the registrant of
II-3
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 of whether such indemnification by it is against
public policy as expressed in the Securities Act and will be governed by the final adjudication of
such issue.
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 30th day
of November 2005.
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CYTOKINETICS, INCORPORATED
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By: |
/s/ James Sabry
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James Sabry |
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Chief Executive Officer and President |
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II-5
POWER OF ATTORNEY
We, the undersigned officers and directors of Cytokinetics, Incorporated, and each of us, do hereby
constitute and appoint each and any of James Sabry and Sharon Surrey-Barbari, our true and lawful
attorney and agent, with full power of substitution and resubstitution, to do any and all acts and
things in our name and behalf in any and all capacities and to execute any and all instruments for
us in our names, in connection with this registration statement or any registration statement for
the same offering that is to be effective upon filing under the Securities Act of 1933, as amended,
and to file the same, with all exhibits thereto and other documents in connection therewith, with
the Securities and Exchange Commission, including specifically, but without limitation, power and
authority to sign for us or any of us in our names in the capacities indicated below, any and all
amendments (including post-effective amendments) hereto; and we hereby ratify and confirm all that
said attorney and agent, or his substitute, shall 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 as of the dates indicated.
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Signature |
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Title |
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Date |
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/s/ James Sabry, M.D., Ph.D.
James Sabry, M.D., Ph.D.
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Chief Executive
Officer, President
and Director
(Principal
Executive Officer)
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November 30, 2005 |
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/s/ Sharon Surrey-Barbari
Sharon Surrey-Barbari
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Chief Financial Officer
(Principal Financial and Accounting Officer)
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November 30, 2005 |
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/s/ A. Grant Heidrich*
A. Grant Heidrich
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Director
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November 30, 2005 |
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Director
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/s/ Charles Homcy, M.D.*
Charles Homcy, M.D.
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Director
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November 30, 2005 |
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/s/ Stephen Dow*
Stephen Dow
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Director
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November 30, 2005 |
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/s/ Michael Schmertzler*
Michael Schmertzler
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Director
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November 30, 2005 |
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/s/ Mark McDade*
Mark McDade
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Director
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November 30, 2005 |
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*By: |
/s/ James Sabry
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James Sabry, Attorney-in-fact |
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II-6
EXHIBIT INDEX
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Exhibit |
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Number |
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Description |
4.1*
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Specimen Common Stock Certificate. |
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4.2*
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Fourth Amended and Restated Investors Rights Agreement, dated March 21, 2003, by and
among the Registrant and certain stockholders of the Registrant. |
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4.3*
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Loan and Security Agreement, dated September 25, 1998, by and between the Registrant
and Comdisco. |
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|
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4.4*
|
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Amendment No. One to Loan and Security Agreement, dated February 1, 1999. |
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|
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4.5*
|
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Warrant for the purchase of shares of Series A preferred stock, dated September 25,
1998, issued by the Registrant to Comdisco. |
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4.6*
|
|
Loan and Security Agreement, dated December 16, 1999, by and between the Registrant and
Comdisco. |
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4.7*
|
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Amendment No. 1 to Loan and Security Agreement, dated June 29, 2000, by and between the
Registrant and Comdisco. |
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4.8*
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Warrant for the purchase of shares of Series B preferred stock, dated December 16,
1999, issued by the Registrant to Comdisco. |
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4.9*
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Master Security Agreement, dated February 2, 2001, by and between the Registrant and
General Electric Capital Corporation. |
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4.10*
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Cross-Collateral and Cross-Default Agreement by and between the Registrant and Comdisco. |
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|
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4.11*
|
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Warrant for the purchase of shares of common stock, dated July 20, 1999, issued by the
Registrant to Bristow Investments, L.P. |
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|
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4.12*
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Warrant for the purchase of shares of common stock, dated July 20, 1999, issued by the
Registrant to the Laurence and Magdalena Shushan Family Trust. |
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4.13*
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Warrant for the purchase of shares of common stock, dated July 20, 1999, issued by the
Registrant to Slough Estates USA Inc. |
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4.14*
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Warrant for the purchase of shares of Series B preferred stock, dated August 30, 1999,
issued by the Registrant to The Magnum Trust. |
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4.15
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Warrant for the purchase of shares of common stock, dated October 28, 2005, issued by
the Registrant to Kingsbridge Capital Limited. |
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|
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4.16
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Registration Rights Agreement, dated October 28, 2005, by and between the Registrant
and Kingsbridge Capital Limited. |
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5.1
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|
Opinion of Wilson Sonsini Goodrich & Rosati, Professional Corporation. |
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|
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10.57
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Common Stock Purchase Agreement, dated as of October 28, 2005, by and between the
Registrant and Kingsbridge Capital Limited. |
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23.1
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Consent of PricewaterhouseCoopers, LLP, Independent Registered Public Accounting Firm. |
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23.2
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Consent of Wilson Sonsini Goodrich & Rosati, Professional Corporation (included in
Exhibit 5.1). |
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|
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24.1
|
|
Power of Attorney of certain directors and officers of Cytokinetics, Incorporated
(see Page II-6 of original filing). |
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|
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* |
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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. |
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Previously filed. |
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