Catalyst Pharmaceutical Partners Inc.
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PROSPECTUS SUPPLEMENT
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Filed Pursuant to Rule 424(b)(5) |
(To Prospectus dated June 26, 2008)
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Registration No. 333-151368 |
1,488,332 Shares
COMMON STOCK
Catalyst Pharmaceutical Partners, Inc. is offering 1,488,332 shares of its common stock at a price
of $3.00 per share.
Our common stock is listed on the Nasdaq Global Market under the symbol CPRX. On September 11,
2008, the last reported sale price of our common stock on the Nasdaq Global Market was $4.05 per
share.
We have retained Rodman & Renshaw to act as placement agent for us in connection with the shares
offered by this prospectus supplement and the accompanying prospectus and they will use their
commercially practicable best efforts to arrange for the sale of the shares of common stock to
certain institutional investors. The placement agent has no commitment to buy any of the shares.
INVESTING IN OUR COMMON STOCK INVOLVES RISKS. SEE RISK FACTORS BEGINNING ON PAGE S-4.
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Proceeds to company, |
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Price to Public |
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Placement Fees |
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before expenses |
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Per share |
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$ |
3.00 |
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0.20 |
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$ |
2.80 |
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Total |
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$ |
4,464,996 |
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$ |
290,225 |
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$ |
4,174,771 |
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RODMAN & RENSHAW
September 11, 2008
TABLE OF CONTENTS
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Prospectus Supplement |
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S-1 |
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S-3 |
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S-4 |
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S-4 |
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S-5 |
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S-5 |
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S-6 |
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S-7 |
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S-7 |
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Prospectus |
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1 |
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1 |
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3 |
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3 |
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4 |
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10 |
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11 |
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This document is in two parts. The first part is this prospectus supplement, which describes
the terms of the offering of common stock hereby and also adds to and updates the information
contained in the accompanying prospectus and the documents incorporated by reference into this
prospectus supplement and the accompanying prospectus. The second part is the accompanying
prospectus, which provides more general information. To the extent that there is any conflict
between the information contained in this prospectus supplement, on the one hand, and the
information contained in the accompanying prospectus or any document incorporated by reference
herein or therein, on the other hand, you should rely on the information in this prospectus
supplement.
You should rely only on the information contained in this prospectus supplement, contained in
the accompanying prospectus or incorporated herein or therein by reference. We have not authorized
anyone to provide you with information that is different. We are offering to sell, and seeking
offers to buy, shares of common stock only in jurisdictions where offers and sales are permitted.
The information contained, or incorporated by reference, in this prospectus supplement and
contained, or incorporated by reference, in the accompanying prospectus is accurate only as of the
respective dates thereof, regardless of the time of delivery of this prospectus supplement and the
accompany prospectus, or of any sale of our common stock. It is important for you to read and
consider all information contained in this prospectus supplement and the accompanying prospectus,
including the documents we have referred you to in the section entitled Where You Can Find
Additional Information below in the accompanying prospectus.
SUMMARY
This summary highlights information contained elsewhere or incorporated by reference in this
prospectus supplement or the accompanying prospectus. This summary is not complete and does not
contain all of the information that you should consider before investing in our common stock. You
should read the entire prospectus supplement and accompanying prospectus carefully, including the
Risk Factors section of this prospectus supplement, as well as our financial statements and the
notes thereto incorporated by reference into the accompanying prospectus, for a more complete
understanding of this offering and our business.
Overview
We are a development-stage biopharmaceutical company focused on the acquisition, development
and commercialization of prescription drugs for the treatment of drug addiction and obsessive
compulsive disorders. Our initial product candidate is CPP-109.
The successful development of CPP-109 or any other product we may develop, acquire, or license
is highly uncertain. We cannot reasonably estimate or know the nature, timing, or estimated
expenses of the efforts necessary to complete the development of, or the period in which material
net cash inflows are expected to commence due to the numerous risks and uncertainties associated
with developing, such products, including the uncertainty of:
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the scope, rate of progress and expense of our clinical trials and our other product
development activities; |
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the results of future clinical trials, and the number of clinical trials (and the scope of
such trials) that will be required to seek and obtain approval of an NDA for CPP-109; and |
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the expense of filing, prosecuting, defending and enforcing any patent claims and other
intellectual property rights. |
We currently estimate that we will require additional funding to complete the Phase III
clinical trial that we believe will be required before we are in a position to file an NDA, or new
drug application, for CPP-109.
Status of U.S. Phase II clinical trial for cocaine addiction
During July 2007, we initiated a randomized, double-blind, placebo-controlled U.S. Phase II
clinical trial evaluating the use of CPP-109 in treating patients with cocaine addiction. We have
retained Health Decisions, Inc. as the Contract Research Organization (CRO) to oversee the trial on
our behalf. We currently estimate that the cost of this trial will be approximately $6,100,000.
The trial is expected to enroll 180 cocaine addicted patients at not less than 11 addiction
treatment clinical centers in the United States. Patients will be treated for a period of 12 weeks,
with an additional 12 weeks of follow-up. The primary endpoint of the trial is to demonstrate that
a larger proportion of CPP-109-treated subjects than placebo-treated subjects will be cocaine-free
during their last two weeks of treatment (weeks 11 and 12). Additionally, we will be measuring
several secondary endpoints based on reductions of cocaine use and craving. To be eligible to
participate in this trial, participants must meet specific clinical standards for cocaine
dependence, as specified in DSM-IV, a set of diagnosis guidelines established for clinical
professionals. Additionally, trial participants cannot meet the DSM-IV criteria for dependence on
most other addictive substances. Further, eye safety studies will be conducted on all trial
S-1
participants before and after the trial to determine the extent of visual field defects that may
occur as a result of the trial among such participants, if any. We began enrolling patients in our
trial in January 2008 after the protocol for our trial was accepted by the U.S. Food and Drug
Administration (FDA). Based on currently available information, we expect to have initial
top-line results from this trial in the first quarter of 2009. However, the date we obtain the
results from our study will ultimately depend on the timing of patient enrollment into our study,
which cannot be predicted with absolute certainty. Additional information about our cocaine trial
can be found at www.clinicaltrials.gov.
Status of U.S. Phase II clinical trial for methamphetamine addiction
During June 2008, we initiated a similar randomized, double-blind, placebo-controlled U.S.
Phase II clinical trial evaluating the use of CPP-109 in treating patients with methamphetamine
addiction. We have retained Health Decisions, Inc. as the CRO to oversee the trial on our behalf.
We currently estimate that the cost of this trial will be approximately $7,300,000.
The trial is expected to enroll 180 methamphetamine addicted patients at 15 addiction
treatment clinical centers in the United States. Patients will be treated for a period of 12 weeks,
with an additional 12 weeks of follow-up. The primary endpoint of the trial is to demonstrate that
a larger proportion of CPP-109-treated subjects than placebo-treated subjects will be
methamphetamine-free during their last two weeks of treatment (weeks 11 and 12). Additionally, we
will be measuring several secondary endpoints based on reductions of methamphetamine use and
craving. To be eligible to participate in this trial, participants must meet specific clinical
standards for methamphetamine dependence, as specified in DSM-IV, a set of diagnosis guidelines
established for clinical professionals. Additionally, trial participants cannot meet the DSM-IV
criteria for dependence on most other addictive substances. Further, eye safety studies will be
conducted on all trial participants before and after the trial to determine the extent of visual
field defects that may occur as a result of the trial among such participants, if any. Based on
currently available information, we expect to have initial top-line results from this trial during
the third quarter of 2009. However, the date we obtain the results from our study will ultimately
depend on the timing of patient enrollment into our study, which cannot be predicted with absolute
certainty. Additional information about our methamphetamine trial can be found at
www.clinicaltrials.gov.
Contemplated pilot clinical trials
We are seeking to conduct a Phase II clinical trial evaluating CPP-109 for the treatment of
Binge Eating Disorder. Binge eating disorder, or BED, which impacts a subset of the obese
population, affects approximately four million people in the United States. Those afflicted with
BED frequently eat large amounts of food while feeling a loss of control over their eating.
Catalyst is very interested in BED for several reasons. First, Brookhaven National Laboratories,
our exclusive licensing partner, has recently published positive results from a series of animal
studies that they have conducted evaluating the use of vigabatrin to treat obesity. In addition,
research conducted by scientists sponsored by the National Institute on Drug Abuse (NIDA) has shown
that addiction and compulsive eating both involve impaired impulse control and distorted valuation
of the rewards to be derived from a certain behaviori.e., drug-taking or eating. Studies have
indicated that there is a neurological overlap between addiction and eating disorders.
We are also hoping to conduct, subject to the availability of funds, additional pilot studies
evaluating the use of CPP-109 for the treatment of other addictions, which may include addictions
to alcohol and nicotine. However, there can be no assurance that these studies will be undertaken,
or if these studies are undertaken, that they will be successful.
S-2
Ongoing discussions with strategic partners
We continue to have discussions with potential strategic partners interested in working with
us on the development of CPP-109. These discussions are very preliminary and may not result in
relationships that we determine to pursue, and no agreements have been entered into to date with
any potential strategic partners.
THE OFFERING
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Common stock offered by us pursuant to this
prospectus supplement
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1,488,332 shares |
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Common stock to be outstanding after this offering
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14,060,385 shares |
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Use of proceeds
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We will use the net
proceeds from the sale
of the securities to
fund one or more pilot
studies evaluating the
use of CPP-109 in
treating binge eating
disorder and other
addictions, to fund
certain required
non-clinical studies of
CPP-109, and for
general corporate
purposes. We will need
additional funding
beyond this offering to
complete the Phase III
clinical trial that we
believe will be
required before we are
permitted to file an
NDA for CPP-109 for use
in treating cocaine
addiction. |
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Risk Factors
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See Risk Factors on
page S-4 for a
discussion of factors
you should consider
carefully before
deciding to invest in
our common stock. |
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Dividend Policy
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We currently intend to
retain any future
earnings to fund the
development and growth
of our business and do
not anticipate paying
cash dividends in the
foreseeable future. |
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NASDAQ Global Market symbol
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CPRX |
The number of shares of common stock outstanding after this offering excludes: (i) 2,667,149
shares of common stock underlying currently outstanding stock options, and (ii) 10,000 shares of
common stock underlying restricted stock units that were previously granted and will vest in future
periods. Further, an additional 1,819,451 shares of common stock are reserved for future issuance
under our 2006 Stock Incentive Plan.
S-3
RISK FACTORS
Investing in our securities involves risk. Please see the risk factors under the heading Risk
Factors in our Annual Report on Form 10-K for the year ended December 31, 2007 as filed with the
SEC on March 25, 2008, as well as any subsequent updates that may be filed with our quarterly
reports on Form 10-Q (including our Quarterly Report on Form 10-Q for the quarter ended June 30,
2008). Before making an investment decision, you should carefully consider these risks as well as
other information we include or incorporate by reference in this prospectus supplement and the
accompanying prospectus. The risks and uncertainties we have described are not the only ones facing
our company. Additional risks and uncertainties not presently known to us or that we currently deem
to be immaterial may also affect our business operations.
FORWARD LOOKING STATEMENTS
Some of the statements provided in or incorporated by reference by this prospectus contain
forward-looking statements, including statements regarding our expectations, beliefs, plans or
objectives for future operations and anticipated results of operations. For this purpose, any
statements contained herein that are not statements of historical fact may be deemed to be
forward-looking statements. Without limiting the foregoing, the words, believes, anticipates,
proposes, plans, expects, intends, may and similar expressions are intended to identify
forward-looking statements. Such statements involve known and unknown risks, uncertainties and
other factors that may cause our actual results, performance or achievements to be materially
different from any future results, performance or achievements expressed or implied by such
forward-looking statements. The forward-looking statements made in this prospectus are based on
current expectations that involve numerous risks and uncertainties, including but not limited to
the following:
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our having sufficient financial resources and the ability to successfully complete the
clinical trials required for us to file an NDA for CPP-109; |
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our ability to complete such trials on a timely basis and within the budgets we establish
for such trials; |
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our ability to protect our intellectual property; |
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whether others develop and commercialize products competitive to our products; |
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changes in the regulations affecting our business; |
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our ability to attract and retain skilled employees; and |
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changes in general economic conditions and interest rates. |
Our current plans and objectives are based on assumptions relating to the development of our
business. Although we believe that our assumptions are reasonable, any of our assumptions could
prove inaccurate. In light of the significant uncertainties inherent in the forward-looking
statements made herein, which reflect our views only as of the date of this prospectus, you should
not place undue reliance upon such statements. We undertake no obligation to update or revise
publicly any forward-looking statements, whether as a result of new information, future events or
otherwise.
S-4
USE OF PROCEEDS
We will use the net proceeds from the sale of the securities (approximating $4,107,500) to
fund one or more pilot studies evaluating the use of CPP-109 in treating binge eating disorder and
other addictions, to fund certain required non-clinical studies of CPP-109, and for general
corporate purposes. We will need additional funding beyond this offering to complete the Phase III
clinical trial that we believe will be required before we are permitted to file an NDA for CPP-109
for use in treating cocaine addiction.
Pending the application of the net proceeds for these purposes, we expect to invest the
proceeds in short-term, interest-bearing instruments or other investment-grade securities.
DILUTION
Purchasers of our common stock offered by this prospectus supplement and the accompanying
prospectus will experience an immediate dilution in the net tangible book value of their common
stock from the public offering price. The net tangible book value of our common stock as of June
30, 2008 was $12,745,872, or $1.01 per share. Net tangible book value per share of our common sock
is equal to our net tangible assets (tangible assets less total liabilities) divided by the number
of shares of our common stock issued and outstanding as of June 30, 2008.
Dilution per share represents the difference between the public offering price per share of
our common stock and the adjusted net tangible book value per share of our common stock after
giving effect to this offering. After reflecting the sale of 1,488,332 shares of our common stock
offered by us at the public offering price of $3.00 per share, less placement agent fees and
estimated offering expenses, our adjusted net tangible book value per share of our common stock at
June 30, 2008 would have been $16,853,372, or $1.20 per share. This change represents an immediate
increase in net tangible book value per share of our common stock of $0.19 per share to existing
shareholders and an immediate dilution of $1.80 per share to new investors purchasing shares of our
common stock pursuant to this offering. The following table illustrates this per-share dilution:
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Public offering price per share |
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$ |
3.00 |
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Net tangible book value per share as of June 30, 2008 |
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1.01 |
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Increase per share attributable to existing investors |
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0.19 |
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Adjusted net tangible book value per share as of June 30, 2008 |
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1.20 |
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Dilution per share to new investors |
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$ |
1.80 |
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S-5
CAPITALIZATION
The following table sets forth our capitalization as of June 30, 2008:
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on an actual basis, and |
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on a pro forma basis after giving effect to: (i) our issuance of 4,827 shares of common
stock subsequent to June 30, 2008 upon the vesting of previously issued restricted stock units
that were issued for services, and (ii) our sale in this offering of 1,488,332 shares of
common stock at an offering price of $3.00 per share and our receipt of an estimated
$4,107,500 in net proceeds therefrom, after deducting placement fees and commissions and
estimated offering expenses to be paid by us. |
This table should be read in conjunction with our financial statements contained in our Annual
Report on Form 10-K for the Fiscal Year ended December 31, 2007, which we filed on March 25, 2008,
and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2008, which we filed on August
14, 2008.
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June 30, 2008 |
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Actual |
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Pro Forma |
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Cash and cash equivalents |
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$ |
13,084,108 |
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$ |
17,191,608 |
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Stockholders equity |
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Preferred stock, $0.001 par value,
5,000,000 shares
authorized, none outstanding |
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Common stock, $0.001 par value, 100,000,000
shares authorized, 12,567,226 shares
outstanding;
14,060,385 shares pro forma |
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12,567 |
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14,060 |
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Additional Paid-in capital |
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26,593,499 |
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30,717,224 |
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Accumulated deficit |
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(13,860,194 |
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(13,877,912 |
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Total stockholders equity |
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12,745,872 |
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16,853,372 |
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Total capitalization |
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12,745,872 |
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$ |
16,853,372 |
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The number of shares of common stock outstanding after this offering excludes: (i) 2,667,149
shares of common stock underlying currently outstanding stock options, and (ii) 10,000 shares of
common stock underlying restricted stock units that were previously granted and will vest in future
periods. Further, an additional 1,819,451 shares of common stock are reserved for future issuance
under our 2006 Stock Incentive Plan.
S-6
PLAN OF DISTRIBUTION
We are offering the shares of our common stock through our placement agent, Rodman and
Renshaw, pursuant to a letter agreement entered into as of this date. Rodman & Renshaw has agreed
to use its commercially best practicable efforts to arrange for the sale of the shares of our
common stock being sold in this offering.
The placement agent is not purchasing or selling any shares by this prospectus statement or
the accompanying prospectus, nor are they required to arrange for the purchase or sale of any
specific number or dollar amount of the shares. The placement agency agreement provides that the
obligations of the placement agent and the investors are subject to certain conditions precedent,
including the absence of any material adverse change in our business and the receipt of certain
customary legal opinions, letters and certificates.
This prospectus supplement will be distributed to the investors who agree to purchase our
common stock, informing the investors of the closing date as to such shares. We currently
anticipate that the closing of the sale of 1,488,332 shares of our common stock will take place on
or about September 16, 2008. Investors will also be informed of the date and manner in which they
must transmit the purchase price for their shares.
On the scheduled closing date, the following will occur:
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we will receive funds in the amount of the aggregate purchase price; and |
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the placement agent will receive the placement fee in accordance with the terms of the
placement agency agreement. |
We will pay the placement agent a commission equal to 6.5% of the gross proceeds of the sale
of shares of our common stock in this offering. We will also reimburse the placement agent for
certain expenses, not to exceed 1.5% of the proceeds from this offering, subject to a maximum of
$20,000. In no event will the total amount of compensation paid to the placement agent and other
securities brokers and dealers upon completion of this offering exceed 8% of the gross proceeds of
this offering. Our estimated offering expenses, including fees due to our placement agent, legal
fees, accounting fees, printing fees, and other costs and expenses associated with the registration
and listing of our common stock pursuant to this offering are $357,496. After deducting such fees,
we expect our net proceeds from this offering will be $4,107,500.
Our shares of common stock are quoted on the Nasdaq Global Market under the symbol CPRX.
We have agreed to indemnify the placement agent against certain liabilities, including
liabilities under the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934,
as amended, and liabilities arising from breaches of representations and warranties contained in
the placement agency agreement.
Delivery of the shares in this offering is expected on or about September 16, 2008, which will
be on or before the fourth business day following the trade date of the shares. Pursuant to Rule
15c6-1 of the Exchange Act, trades in the secondary market generally are required to settle in
three business days, unless the parties to any such trade expressly agree otherwise. Accordingly,
if the closing date is on the fourth business day following the trade date of the shares, then
purchasers who wish to trade shares purchased in this offering on the trade date will be required,
by virtue of the fact that the shares purchased in this offering initially will settle on the
fourth business day, to specify an alternate settlement cycle at
the time of any such trade to prevent a failed settlement. Purchasers of the shares in this
offering who wish to trade their shares on the trade date should consult their own advisor.
LEGAL MATTERS
The validity of the shares of common stock we are offering will be passed upon by Akerman
Senterfitt, Miami, Florida.
S-7
PROSPECTUS
$ 30,000,000
Common Stock
We may, from time to time, sell shares of our common stock in one or more offerings in
amounts, at prices and on terms that we determine at the time of the offering, with an aggregate
initial offering price of up to $30,000,000. We will provide you of the specific terms of such
securities in supplements to this prospectus. However, in no event will we sell securities with a
value exceeding more than 1/3 of our public float in any 12-month period. You should read this
prospectus and any prospectus supplement carefully before you invest.
INVESTING IN OUR SECURITIES INVOLVES RISKS. THE RISKS ASSOCIATED WITH AN INVESTMENT IN OUR
SECURITIES WILL BE DESCRIBED IN THE APPLICABLE PROSPECTUS SUPPLEMENT AND IN OUR FILINGS WITH THE
SECURITIES AND EXCHANGE COMMISSION THAT ARE INCORPORATED BY REFERENCE HEREIN, ALL AS MORE
PARTICULARLY DESCRIBED UNDER THE CAPTION RISK FACTORS ON PAGE 3 OF THIS PROSPECTUS.
Our common stock is listed on the Nasdaq Global Market and trades under the symbol CPRX. On
May 30, 2008, the last reported sale price for our common stock on the Nasdaq Global Market was
$3.59 per share.
The common stock may be sold by us to or through underwriters or dealers, directly to
purchasers or through agents designated from time to time. For additional information on the
methods of sale, you should refer to the section entitled Plan of Distribution in this
prospectus. If any underwriters are involved in the sale of any common stock with respect to which
this prospectus is delivered, the names of such underwriters and any applicable discounts or
commissions, and any over-allotment options will be set forth in a prospectus supplement. The price
to the public and the net proceeds we expect to receive from such sale will also be set forth in
the prospectus supplement.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of the common stock or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal offense.
The date of this prospectus is June 26, 2008.
TABLE OF CONTENTS
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About this Prospectus |
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1 |
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About the Company |
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1 |
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Information Regarding Forward-Looking Statements |
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Risk Factors |
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Use of Proceeds |
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Price Range of Common Stock and Dividend Policy |
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General Description of our Common Stock |
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Plan of Distribution |
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Legal Matters |
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Experts |
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Where You Can Find Additional Information |
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Incorporation by Reference |
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ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement that we have filed with the Securities and
Exchange Commission (the SEC), utilizing a shelf registration process. Under this shelf
registration process, we may sell shares of our common stock in one or more offerings up to a total
dollar amount of $30,000,000. However, in no event will we sell securities with a value exceeding
more than 1/3 of our public float (the market value of our common stock held by non-affiliates)
in any 12 month period. This prospectus provides you with a general description of our common
stock. Each time we sell securities under this shelf registration, we will provide a prospectus
supplement that will contain specific information about the terms of the applicable offering. The
prospectus supplement may also add, change, or update information contained in this prospectus. You
should read both this prospectus and any prospectus supplement, together with any additional
information described under the heading Incorporation by Reference.
We have not authorized any dealer, salesperson or other person to give any information or to
make any representation other than those contained or incorporated by reference in this prospectus
and any accompanying supplement to this prospectus. You must not rely upon any information or
representation not contained or incorporated by reference in this prospectus or any accompanying
prospectus supplement. This prospectus and any accompanying supplement to this prospectus do not
constitute an offer to sell or the solicitation of an offer to buy any securities other than the
registered securities to which they relate, nor do this prospectus and any accompanying supplement
to this prospectus constitute an offer to sell or the solicitation of an offer to buy securities in
any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such
jurisdiction. You should not assume that the information contained in this prospectus and any
accompanying prospectus supplement is accurate on any date subsequent to the date set forth on the
front of the document or that any information we have incorporated by reference is correct on any
date subsequent to the date of the document incorporated by reference, even though this prospectus
and any accompanying prospectus supplement is delivered or securities are sold on a later date.
Reference in this prospectus to we, our, us, the Company, or Catalyst refer to
Catalyst Pharmaceutical Partners, Inc., a Delaware corporation.
ABOUT THE COMPANY
We are a development-stage biopharmaceutical company focused on the acquisition, development
and commercialization of prescription drugs for the treatment of drug addiction and obsessive
compulsive disorders. Our initial product candidate is CPP-109, which is our version of vigabatrin.
The successful development of CPP-109 or any other product we may develop, acquire, or license
is highly uncertain. We cannot reasonably estimate or know the nature, timing, or estimated
expenses of the efforts necessary to complete the development of, or the period in which material
net cash inflows are expected to commence due to the numerous risks and uncertainties associated
with developing, such products, including the uncertainty of:
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the scope, rate of progress and expense of our clinical trials and our other product
development activities; |
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the results of future clinical trials, and the number of clinical trials (and the scope of
such trials) that will be required to seek and obtain approval of a New Drug Application
(NDA) for CPP-109; and |
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the expense of filing, prosecuting, defending and enforcing any patent claims and other
intellectual property rights. |
Our principal executive offices are located at 355 Alhambra Circle, Suite 1370, Coral Gables,
Florida 33134. Our telephone number is (305) 529-2522. Our website is
http://www.catalystpharma.com . The information contained in, or that can be accessed
through, our website is not a part of this prospectus.
Recent Developments
U.S. Phase II clinical trial for cocaine addiction
During July 2007, we initiated a randomized, double-blind, placebo-controlled U.S. Phase II
clinical trial evaluating the use of CPP-109 in treating patients with cocaine addiction. We
estimate that the cost of this trial will be approximately $6,000,000.
The trial is expected to enroll 180 cocaine addicted patients at not less than 11 addiction
treatment clinical centers in the United States. Patients will be treated for a period of 12 weeks,
with an additional 12 weeks of follow-up. The primary endpoint of the trial is to demonstrate that
a larger proportion of CPP-109-treated subjects than placebo-treated subjects will be cocaine-free
during their last two weeks of treatment (weeks 11 and 12). Additionally, we will be measuring
several secondary endpoints based on reductions of cocaine use and craving. To be eligible to
participate in this trial, participants must meet specific clinical standards for cocaine
dependence, as specified in DSM-IV, a set of diagnosis guidelines established for clinical
professionals. Additionally, trial participants cannot meet the DSM-IV criteria for dependence on
most other addictive substances. Further, eye safety studies will be conducted on all trial
participants before and after the trial to determine the extent of visual field defects that may
occur as a result of the trial among such participants, if any. We began enrolling patients in this
trial in January 2008 after the protocol for our trial was accepted by the U.S. Food and Drug
Administration (FDA). Based on currently available information, we expect to have initial
top-line results from this trial in the fourth quarter of 2008. However, the date we obtain the
results from our study will ultimately depend on the timing of patient enrollment into our study,
which cannot be predicted with absolute certainty. Additional information about our trial can be
found at www.clinicaltrials.gov .
U.S. Phase II clinical trial for methamphetamine addiction
We expect to initiate during the second quarter of 2008 a 180 patient randomized,
double-blind, placebo-controlled U.S. Phase II clinical trial evaluating the use of CPP-109 in
treating patients with methamphetamine addiction. This trial will be similar to our cocaine trial.
We currently estimate that the cost of this trial will be approximately $5,900,000. Based on
currently available information, we expect to have initial top-line results from this trial during
the third quarter of 2009.
Contemplated pilot clinical trials
We hope to initiate during 2008 a Phase II clinical trial evaluating CPP-109 for the treatment
of binge eating disorder. We are also contemplating and hope to launch during 2008 additional Phase
II proof-of-concept trials evaluating the use of CPP-109 for the treatment of other addictions,
including alcohol and nicotine.
Discussions with strategic partners
We have had in the past, and expect to continue to have in the future, discussions with
potential strategic partners interested in working with us on the development of CPP-109. No
agreements have been entered into to date with any potential strategic partners.
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INFORMATION REGARDING FORWARD LOOKING STATEMENTS
Some of the statements provided in or incorporated by reference by this prospectus contain
forward-looking statements, including statements regarding our expectations, beliefs, plans or
objectives for future operations and anticipated results of operations. For this purpose, any
statements contained herein that are not statements of historical fact may be deemed to be
forward-looking statements. Without limiting the foregoing, the words, believes, anticipates,
proposes, plans, expects, intends, may and similar expressions are intended to identify
forward-looking statements. Such statements involve known and unknown risks, uncertainties and
other factors that may cause our actual results, performance or achievements to be materially
different from any future results, performance or achievements expressed or implied by such
forward-looking statements. The forward-looking statements made in this prospectus are based on
current expectations that involve numerous risks and uncertainties, including but not limited to
the following:
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our having sufficient financial resources and the ability to successfully complete the
clinical trials required for us to file an NDA for CPP-109; |
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our ability to complete our clinical trials on a timely basis and within the budgets we
establish for such trials; |
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our ability to protect our intellectual property; |
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whether others develop and commercialize products competitive to our products; |
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changes in the regulations affecting our business; |
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our ability to attract and retain skilled employees; and |
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changes in general economic conditions and interest rates. |
Our current plans and objectives are based on assumptions relating to the development of our
business. Although we believe that our assumptions are reasonable, any of our assumptions could
prove inaccurate. In light of the significant uncertainties inherent in the forward-looking
statements made herein, which reflect our views only as of the date of this prospectus, you should
not place undue reliance upon such statements. We undertake no obligation to update or revise
publicly any forward-looking statements, whether as a result of new information, future events or
otherwise.
RISK FACTORS
Before making an investment decision, you should carefully consider the risks described under
Risk Factors in the applicable prospectus supplement and in our most recent Annual Report on Form
10-K, or any updates in subsequent Quarterly Reports on Form 10-Q, together with all of the other
information appearing in this prospectus or incorporated in this prospectus by reference and any
applicable prospectus supplement, in light of your particular investment objectives.
3
USE OF PROCEEDS
Except as may otherwise be provided in a prospectus supplement, we will use the net proceeds
from the sale of the securities to fund a Phase III clinical trial evaluating the use of CPP-109 to
treat cocaine addiction, to fund additional clinical trials required to allow us to file an NDA for
cocaine addiction, to fund additional clinical trials evaluating the use of CPP-109 to treat other
addictions or obsessive compulsive disorders, and for general corporate purposes. When particular
securities are offered, the prospectus supplement relating to that offering will set forth our
intended use of the net proceeds received from the sale of these securities. Pending the
application of the net proceeds for these purposes, we expect to invest the proceeds in short-term,
interest-bearing instruments or other investment-grade securities.
PRICE RANGE OF COMMON STOCK AND DIVIDEND POLICY
Since November 8, 2006, our common stock has been traded on the Nasdaq Global Market under the
symbol CPRX. Prior to such date, there was no market for our common stock. The last reported sale
price of our common stock on May 30, 2008 on the Nasdaq Global Market was $3.59 per share. The
following table sets forth the high and low sale prices for our common stock for the periods
indicated as reported on the Nasdaq Global Market.
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High |
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Low |
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Year Ended December 31, 2006 |
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Fourth Quarter (from November 8, 2006) |
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6.15 |
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$ |
4.25 |
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Year Ended December 31, 2007 |
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First Quarter |
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$ |
6.83 |
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$ |
3.80 |
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Second Quarter |
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$ |
4.65 |
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$ |
3.48 |
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Third Quarter |
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$ |
4.00 |
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$ |
2.70 |
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Fourth Quarter |
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$ |
3.51 |
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$ |
2.50 |
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Year Ended December 31, 2008 |
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First Quarter |
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$ |
3.87 |
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$ |
2.94 |
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Second Quarter (through May 30, 2008) |
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3.99 |
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3.30 |
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We have never declared or paid any cash dividends on our capital stock. We currently intend to
retain all available funds and any future earnings to support operations and finance the growth and
development of our business and do not intend to pay cash dividends on our common stock for the
foreseeable future. Any future determination related to our dividend policy will be made at the
discretion of our Board of Directors.
4
GENERAL DESCRIPTION OF OUR COMMON STOCK
The following summary of the material features of our common stock does not purport to be
complete and is subject to, and qualified in its entirety by the provisions of our Certificate of
Incorporation, our Bylaws and other applicable law. See Where You Can Find Additional
Information.
Our authorized capital currently consists of 100,000,000 shares of common stock, par value
$0.001 per share, and 5,000,000 shares of preferred stock, par value $0.001 per share. As of the
date of this prospectus, we had 12,567,226 shares of our common stock outstanding. There are no
shares of preferred stock outstanding.
We are a Delaware corporation, and were incorporated on July 24, 2006. We are the successor by
merger to Catalyst Pharmaceutical Partners, Inc., a Florida corporation, which was incorporated in
January 2002.
Each holder of common stock is entitled to one vote for each share held of record on all
matters presented to our stockholders, including the election of directors. In the event of our
liquidation, dissolution, or winding-up, the holders of common stock are entitled to share ratably
and equally in our assets, if any, that remain after paying all debts and liabilities and the
liquidation preferences of any outstanding preferred stock. The common stock has no preemptive or
cumulative rights and no redemption or conversion provisions.
Holders of our common stock are entitled to receive dividends if, as, and when declared by our
Board of Directors out of funds legally available therefor, subject to the dividend and liquidation
rights of any preferred stock that may be issued and outstanding, all subject to any dividend
restrictions in our credit facilities. No dividend or other distribution (including redemptions and
repurchases of shares of capital stock) may be made, if after giving effect to such distribution,
we would not be able to pay our debts as they come due in the usual course of business, or if our
total assets would be less than the sum of our total liabilities plus the amount that would be
needed at the time of a liquidation to satisfy the preferential rights of any holders of preferred
stock.
Provisions of the Certificate and Bylaws
A number of provisions of our certificate of incorporation and bylaws concern matters of
corporate governance and the rights of stockholders. Certain of these provisions, as well as the
ability of our board of directors to issue shares of preferred stock and to set the voting rights,
preferences and other terms thereof, may be deemed to have an anti-takeover effect and may
discourage takeover attempts not first approved by the board of directors (including takeovers
which certain stockholders may deem to be in their best interests). To the extent takeover attempts
are discouraged, temporary fluctuations in the market price of the common stock, which may result
from actual or rumored takeover attempts, may be inhibited. These provisions, together with the
classified board of directors (which we are proposing to declassify) and the ability of the board
to issue preferred stock without further stockholder action, also could delay or frustrate the
removal of incumbent directors or the assumption of control by stockholders, even if such removal
or assumption would be beneficial to our stockholders. These provisions also could discourage or
make more difficult a merger, tender offer or proxy contests, even if they could be favorable to
the interests of stockholders, and could potentially depress the market price of the common stock.
The board of directors believes that these provisions are appropriate to protect our interest and
the interests of our stockholders.
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Issuance of Rights . The certificate authorized the board of directors to create and
issue rights (the rights) entitling the holders thereof to purchase from us shares of capital
stock or other securities. The
times at which, and the terms upon which, the rights are to be issued may be determined by the
board of directors and set forth in the contracts or instruments that evidence the rights. The
authority of the board of directors with respect to the rights includes, but is not limited to, the
determination of (1) the initial purchase price per share of the capital stock or other securities
of Catalyst Pharmaceutical Partners, Inc. to be purchased upon exercise of the rights, (2)
provisions relating to the times at which and the circumstances under which the rights may be
exercised or sold or otherwise transferred, either together with or separately from, any other
securities of Catalyst Pharmaceutical Partners, Inc., (3) antidilutive provisions which adjust the
number or exercise price of the rights or amount or nature of the securities or other property
receivable upon exercise of the rights, (4) provisions which deny the holder of a specified
percentage of the outstanding securities of Catalyst Pharmaceutical Partners, Inc. the right to
exercise the rights and/or cause the rights held by such holder to become void, (5) provisions
which permit Catalyst Pharmaceutical Partners, Inc. to redeem the rights and (6) the appointment of
a rights agent with respect to the rights.
Meetings of Stockholders . The bylaws provide that a special meeting of stockholders
may be called only by the board of directors unless otherwise required by law. The bylaws provide
that only those matters set forth in the notice of the special meeting may be considered or acted
upon at that special meeting, unless otherwise provided by law. In addition, the bylaws set forth
certain advance notice and informational requirements and time limitations on any director
nomination or any new business which a stockholder wishes to propose for consideration at an annual
meeting of stockholders.
No Stockholder Action by Written Consent . The certificate provides that any action
required or permitted to be taken by our stockholders at an annual or special meeting of
stockholders must be effected at a duly called meeting and may not be taken or effected by a
written consent of stockholders in lieu thereof.
Amendment of the Certificate . The certificate provides that an amendment thereof must
first be approved by a majority of the board of directors and (with certain exceptions) thereafter
approved by the holders of a majority of the total votes eligible to be cast by holders of voting
stock with respect to such amendment or repeal; provided, however, that the affirmative vote of 80%
of the total votes eligible to be cast by holders of voting stock, voting together as a single
class, is required to amend provisions relating to the establishment of the board of directors and
amendments to the certificate.
Amendments of Bylaws . The certificate provides that the board of directors or the
stockholders may amend or repeal the bylaws. Such action by the board of directors requires the
affirmative vote of a majority of the directors then in office. Such action by the stockholders
requires the affirmative vote of the holders of at least two-thirds of the total votes eligible to
be cast by holders of voting stock with respect to such amendment or repeal at an annual meeting of
stockholders or a special meeting called for such purposes, unless the board of directors
recommends that the stockholders approve such amendment or repeal at such meeting, in which case
such amendment or repeal shall only require the affirmative vote of a majority of the total votes
eligible to be cast by holders of voting stock with respect to such amendment or repeal.
6
Certain Anti-Takeover Matters
We are subject to the provisions of Section 203 of the Delaware General Corporation Law, or
Delaware law, regulating corporate takeovers. In general, these provisions prohibit a Delaware
corporation from engaging in any business combination with any interested stockholders for a period
of three years following the date that the stockholder became an interested stockholder, unless:
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either the business combination or the transaction that resulted in the stockholder becoming
an interested stockholder is approved by our board of directors before the date the
interested stockholder attained that status; |
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upon consummation of the transaction that resulted in the stockholder becoming an
interested stockholder, the interested stockholder owned at least 85% of the voting stock
of the corporation outstanding at the time the transaction commenced, excluding for
purposes of determining the voting stock outstanding (but not the outstanding voting stock
owned by the interested stockholder) those shares owned (i) by persons who are directors
and also officers and (ii) employee stock plans in which employee participates do not have
the right to determine confidentially whether shares held subject to the plan will be
tendered in a tender or exchange offer; or |
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on or after that date, the business combination is approved by our board of directors
and authorized at a meeting of stockholders, and not by written consent, by at least
two-thirds of the outstanding voting stock that is not owned by the interested stockholder. |
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Section 203 defines business combination to include the following: |
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any merger or consolidation involving the corporation and the interested stockholder; |
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any sale, transfer, pledge or other disposition of 10% or more of the assets of the
corporation involving the interested stockholder; |
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subject to certain exceptions, any transaction that results in the issuance or transfer
by the corporation of any stock of the corporation to the interested stockholder; |
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any transaction involving the corporation that has the effect of increasing the
proportionate share of the stock of any class or series of the corporation beneficially
owned by the interested stockholder; or |
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the receipt by the interested stockholder of the benefit of any loans, advances,
guarantees, pledges or other financial benefits provided by or through the corporation. |
In general, Section 203 defines an interested stockholder as any entity or person beneficially
owning 15% or more of the outstanding voting stock of the corporation and any entity or person
affiliated with or controlling or controlled by any of these entities or persons.
A Delaware corporation may opt out of this provision either with an express provision in its
original certificate of incorporation or in an amendment to its certificate of incorporation or
bylaws approved by its stockholders. However, we have not opted out of this provision. The statute
could prohibit or delay mergers or other takeover or change in control attempts and, accordingly,
may discourage attempts to acquire us.
Limitation of Liability and Indemnification Matters
Our certificate of incorporation limits the liability for monetary damages for breach of
fiduciary duty by members of our Board of Directors, except for liability that cannot be eliminated
under Delaware law. Under Delaware law, our directors have a fiduciary duty to us which is not
eliminated by this provision in our certificate of incorporation. In addition, each of our
directors is subject to liability under Delaware law for breach of their duty of loyalty for acts
or omissions which are found by a court of
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competent jurisdiction to be not in good faith or which involve intentional misconduct or knowing
violations of law for actions leading to improper personal benefit to the director and for payments
of dividends or approval of stock repurchases or redemptions that are prohibited by Delaware law.
This provision does not affect our directors responsibilities under any other laws, such as
federal securities laws.
Delaware law provides that the directors of a company will not be personally liable for
monetary damages for breach of their fiduciary duty as directors, except for liability for any of
the following:
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any breach of a directors duty of loyalty to us or our stockholders; |
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acts or omissions not in good faith or which involve intentional misconduct or a
knowing violation of law; |
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unlawful payment of dividends or unlawful stock repurchases or redemptions; or |
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any transaction from which the director derived an improper personal benefit. |
Delaware law provides that the indemnification permitted thereunder shall not be deemed
exclusive of any other rights to which our directors and officers may be entitled to under our
bylaws, any agreement, a vote of stockholders or otherwise. Our certificate of incorporation and
bylaws eliminate the personal liability of directors to the maximum extent permitted by Delaware
law. In addition, our certificate of incorporation and bylaws provide that we may fully indemnify
any person who is or was a party to or is threatened to be made a party to any threatened, pending
or completed action, suit of proceeding (whether civil, criminal, administrative or investigative)
by reason of the fact that such person is or was one of our directors, officers, employees or other
agents, against 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.
Listing
Our common stock is listed on the Nasdaq Global Market and trades under the symbol CPRX.
Transfer Agent and Registrar
The transfer agent and registrar for our common stock is Continental Stock Transfer & Trust
Company. They are located at 17 Battery Park, 8th Floor, New York, New York 10004. They can be
reached via telephone at (212) 509-4000.
8
PLAN OF DISTRIBUTION
We may sell the securities from time-to-time pursuant to underwritten public offerings,
negotiated transactions, block trades or a combination of these methods. We may sell the securities
(1) through underwriters or dealers, (2) through agents, and/or (3) directly to one or more
purchasers. However, in any given 12-month period, we may only sell securities hereunder with a
value of up to one third of our public float (the market value of our common stock held by
non-affiliates). We may distribute the securities from time to time in one or more transactions at:
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a fixed price or prices, which may change; |
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market prices prevailing at the time of sale; |
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prices relating to the prevailing market prices; |
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varying prices determined at the time of sale; or |
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negotiated prices. |
The applicable prospectus supplement with respect to a particular offering of securities will
describe the terms of the offering of the securities, including:
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the name or names of any underwriters, and if required, any dealers or agents; |
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the purchase price of the securities and the proceeds we will receive from the sale; |
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any underwriting discounts and other items constituting underwriters compensation; |
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any discounts or concessions allowed or reallowed or paid to dealers; and |
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any securities exchange or market on which the securities may be listed. |
We may solicit directly offers to purchase the securities being offered by this prospectus. We
may also designate agents to solicit offers to purchase the securities from time to time. We will
name in a prospectus supplement any agent involved in the offer or sale of our securities.
If we utilize a dealer in the sale of the securities being offered by this prospectus, we will
sell the securities to the dealer, as principal. The dealer may then resell the securities to the
public at varying prices to be determined by the dealer at the time of resale. If we utilize an
underwriter in the sale of the securities being offered by this prospectus, we will execute an
underwriting agreement with the underwriter at the time of sale and we will provide the name of any
underwriter in the prospectus supplement which the underwriter will use to make resales of the
securities to the public. In connection with the sale of the securities, we, or the purchasers of
securities for whom the underwriter may act as agent, may compensate the underwriter in the form of
underwriting discounts or commissions. The underwriter may sell the securities to or through
dealers, and the underwriter may compensate those dealers in the form of discounts, concessions or
commissions.
With respect to underwritten public offerings, negotiated transactions and block trades, we
will provide in the applicable prospectus supplement any compensation we pay to underwriters,
dealers or agents in connection with the offering of the securities, and any discounts, concessions
or commissions allowed by underwriters to participating dealers. Underwriters, dealers and agents
participating in the distribution of the securities may be deemed to be underwriters within the
meaning of the Securities Act
of 1933, as amended, and any discounts and commissions received by them and any profit realized by
them on resale of the securities may be deemed to be underwriting discounts and commissions. We may
enter into agreements to indemnify underwriters, dealers and agents against civil liabilities,
including liabilities under the Securities Act, or to contribute to payments they may be required
to make in respect thereof.
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To facilitate the offering of securities, certain persons participating in the offering may
engage in transactions that stabilize, maintain or otherwise affect the price of the securities.
This may include overallotments or short sales of the securities, which involve the sale by
persons participating in the offering of more securities than we sold to them. In these
circumstances, these persons would cover such overallotments or short positions by making
purchases in the open market or by exercising their overallotment option. In addition, these
persons may stabilize or maintain the price of the securities by bidding for or purchasing
securities in the open market or by imposing penalty bids, whereby selling concessions allowed to
dealers participating in the offering may be reclaimed if securities sold by them are repurchased
in connection with stabilization transactions. The effect of these transactions may be to stabilize
or maintain the market price of the securities at a level above that which might otherwise prevail
in the open market. These transactions may be discontinued at any time.
The underwriters, dealers and agents may engage in other transactions with us, or perform
other services for us, in the ordinary course of their business.
LEGAL MATTERS
Certain legal matters in connection with any offering of securities made by this prospectus
will be passed upon for us by Akerman Senterfitt, Miami, Florida.
EXPERTS
The financial statements contained in the Annual Report on Form 10-K for the year ended
December 31, 2007 incorporated by reference in this Prospectus have been audited by Grant Thornton
LLP, independent registered public accountants, as indicated in their report with respect thereto,
and is included herein in reliance upon the authority of said firm as experts in accounting and
auditing in giving said report.
WHERE YOU CAN FIND ADDITIONAL INFORMATION
We file annual, quarterly and special reports, proxy statements and other information with the
SEC. Our SEC filings are available to the public over the SECs website at
http://www.sec.gov. You may also read and copy any document we file at the SECs Public
Reference Room at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at (800)
SEC-0330 for further information on the operating rules and procedures for the public reference
room.
This prospectus does not contain all of the information included in the registration
statement. We have omitted certain parts of the registration statement in accordance with the rules
and regulations of the SEC. For further information, we refer you to the registration statement,
including its exhibits and schedules. Statements contained in this prospectus and any accompanying
prospectus supplement about the provisions or contents of any contract, agreement or any other
document referred to are not necessarily complete. Please refer to the actual exhibit for a more
complete description of the matters involved.
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INCORPORATION BY REFERENCE
The SEC allows us to incorporate by reference information into this prospectus, which means
that we can disclose important information to you by referring you to another document filed
separately with the SEC. The information incorporated by reference is deemed to be a part of this
prospectus, except for any information superseded by information in this prospectus or by any
information in a prospectus supplement accompanying this prospectus.
The following documents filed with the SEC are incorporated by reference in this prospectus:
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Our Annual Report on Form 10-K for the year ended December 31, 2007, filed with
the SEC on March 25, 2008; |
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Our Proxy Statement for our Annual Meeting of Stockholders to be held on June
18, 2008, filed with the SEC on April 29, 2008; |
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Our Quarterly Report on Form 10-Q for the three months ended March 31, 2008,
filed with the SEC on May 15, 2008; |
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Our description of our common stock contained in our Registration Statement on
Form 8-A, filed with the SEC on September 29, 2006, along with Amendment No. 1 thereto,
filed with the SEC on October 18, 2006; and |
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All documents subsequently filed by the Company pursuant to Sections 13(a),
13(c), 14 and 15(d) of the Exchange Act, from the date of filing of such documents,
before the filing of a post-effective amendment to this Registration Statement which
indicates that all securities offered hereunder have been sold or which deregisters all
securities then remaining unsold. |
You may obtain a copy of any of these documents at no cost by requesting them from us or by
writing or calling: Catalyst Pharmaceutical Partners, Inc., 355 Alhambra Circle, Suite 1370, Coral
Gables, Florida 33134, Attn: Investor Relations, or by calling (305) 529-2522. Copies of each of
these filings are also available for no cost on our website, http://www.catalystpharma.com,
or on the SECs web site, http://www.sec.gov.
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