This
filing is made pursuant to Rule 424(b)(5)
under
the Securities Act of 1933, as amended, in connection
with
Registration No. 333-163648
Prospectus
Supplement
(To
Prospectus Dated January 5, 2010)
Up
to $10,000,000
Common
Stock
We have
entered into an equity distribution agreement with Ladenburg Thalmann & Co.,
Inc. (“Ladenburg”) relating to shares of common stock offered by this prospectus
supplement and the accompanying prospectus. In accordance with the terms
of the equity distribution agreement, we may offer and sell up to $10,000,000 of
our common stock from time to time through Ladenburg, subject to applicable
regulatory requirements which currently would allow us to offer and sell up to
approximately $7.8 million.
Our
common stock is traded on the Nasdaq Capital Market under the symbol
“RPRX”. The last reported sale price of our common stock on the Nasdaq
Capital Market on March 1, 2010 was $0.78 per share.
The
aggregate market value of our outstanding common stock held by non-affiliates is
$23,616,424 based on 25,820,005 shares of outstanding common stock, of which
25,675,608 shares are held by non-affiliates, and a per share price of $0.9198
based on the closing sale price of our common stock on January 27,
2010. We have not offered any securities pursuant to General
Instruction I.B.6. of Form S-3 during the prior 12 calendar month period that
ends on, and includes, the date of this prospectus.
Sales of
shares of common stock, if any, under this prospectus supplement and the
accompanying prospectus may be made in negotiated transactions or transactions
that are deemed to be “at the market” offerings as defined in Rule 415
under the Securities Act of 1933, as amended, including sales made directly on
the Nasdaq Capital Market or sales made to or through a market maker other than
on an exchange. The sales agent will make all sales using commercially
reasonable efforts consistent with its normal trading and sales practices, on
mutually agreed terms between the sales agent and us.
Ladenburg
will receive from us a commission equal to 4% of the gross sales price of all
shares sold through it under the equity distribution agreement. In
connection with the sale of the shares of common stock on our behalf, Ladenburg
may be deemed to be an “underwriter” within the meaning of the Securities Act of
1933, as amended, and the compensation of Ladenburg may be deemed to be
underwriting commissions or discounts.
Investing
in our common stock involves risks. See “Risk Factors” on page 5 of
the accompanying prospectus and beginning on page 2 of our Annual Report on
Form 10-K for the year ended December 31, 2008, which is incorporated
by reference into the accompanying prospectus, and in our periodic reports and
other information that we file from time to time with the Securities and
Exchange Commission.
Neither
the Securities and Exchange Commission, any state securities commission, nor any
other regulatory body has approved or disapproved of these securities or
determined if this prospectus supplement and the prospectus to which it relates
are truthful and complete. Any representation to the contrary is a
criminal offense.
_______________________________
Ladenburg
Thalmann & Co., Inc.
The date
of this prospectus supplement is March 2, 2010.
Table
of Contents
Prospectus
Supplement
|
Prospectus
Supplement Summary
|
S-1
|
Risk
Factors
|
S-6
|
Forward-Looking
Statements
|
S-7
|
Use
of Proceeds
|
S-8
|
Price
Range of Common Stock
|
S-9
|
Dividend
Policy
|
S-9
|
Dilution
|
S-10
|
Plan of Distribution
|
S-11
|
Legal
Matters
|
S-12
|
Experts
|
S-12
|
Where
You Can Find More Information
|
S-12
|
Important
Information Incorporated By Reference
|
S-12
|
|
Prospectus
|
|
|
Table
of Contents
|
i
|
About
This Prospectus
|
1
|
About
Repros Therapeutics Inc.
|
1
|
Risk
Factors
|
5
|
Forward-Looking
Information
|
5
|
Use
of Proceeds
|
6
|
Description
of Capital Stock
|
7
|
Description
of Warrants
|
8
|
Plan
of Distribution
|
9
|
Legal
Matters
|
11
|
Experts
|
11
|
Where
You Can Find More Information
|
11
|
About
this Prospectus Supplement
We
provide information to you about this offering of shares of our common stock in
two separate documents that are bound together: (1) this prospectus
supplement, which describes the specific details regarding this offering; and
(2) the accompanying prospectus, which provides general information, some
of which may not apply to this offering. Generally, when we refer to this
“prospectus,” we are referring to both documents combined. If information in
this prospectus supplement is inconsistent with the accompanying prospectus, you
should rely on this prospectus supplement.
You
should rely only on information contained in or incorporated by reference into
this prospectus supplement and the accompanying prospectus. We have not, and
Ladenburg has not, authorized anyone to provide you with information that is
different. We are offering to sell and seeking offers to buy shares of our
common stock only in jurisdictions where offers and sales are permitted. The
information contained in this prospectus supplement, the accompanying prospectus
and the documents incorporated by reference herein and therein are accurate only
as of their respective dates, regardless of the time of delivery of this
prospectus supplement or of any sale of our common stock.
Proellex®
and Androxal® are our trademarks. This prospectus supplement and the
accompanying prospectus also contain trademarks, trade names and service marks
of other companies, which are the property of their respective
owners.
Prospectus
Supplement Summary
This
summary highlights selected information contained elsewhere or incorporated by
reference in this prospectus supplement and the accompanying prospectus. This
summary may not contain all the information that you should consider before
investing in our common stock. You should read the entire prospectus supplement
and the accompanying prospectus carefully, including “Risk Factors” contained in
this prospectus supplement and the financial statements incorporated by
reference in the accompanying prospectus, before making an investment decision.
This prospectus supplement may add to, update or change information in the
accompanying prospectus.
ABOUT
REPROS THERAPEUTICS INC.
Overview
The
Company was organized as a Delaware corporation on August 20,
1987. We are a development stage biopharmaceutical company focused on
the development of oral small molecule drugs for major unmet medical needs
associated with male and female reproductive disorders. The clinical
trials relating to Proellex® have been placed on clinical hold by the FDA due to
safety-related concerns resulting from elevated liver enzymes in a number of
patients enrolled in the clinical trials. Completion of our ongoing
clinical trial activities relating to our other product candidate, Androxal®, is
subject to, among other things, adequate cash being available.
As of
September 30, 2009, we had accumulated losses of $173.1 million, approximately
$2.5 million in cash and cash equivalents, and our accounts payable and accrued
expenses were approximately $12.2 million. As a result of the October
Settlement Agreement and the Subsequent Settlement Agreements (each as defined
in “Recent Developments” below) with certain of our creditors to issue them
shares of our common stock and cash as payment in full for our then-outstanding
liabilities with such creditors, subsequent to September 30, 2009, we have
reduced the amount of our accounts payable and accrued expenses by approximately
$9.2 million. Notwithstanding, the amount of cash on hand is not
sufficient to continue to fund our ongoing clinical trials of Androxal®,
complete all necessary activities relating to the suspension of our clinical
trial program for Proellex®, and pay our accounts payable and accrued expenses
as well as our normal corporate overhead and expenses. The foregoing
and other matters raise substantial doubt about our ability to continue as a
going concern.
We
continue to explore potential additional financing alternatives that may allow
us to maintain our current reduced level of operations; however, there can be no
assurance that we will be successful in raising any such additional funds on a
timely basis or at all. Significant additional
capital will be required for us to continue development of either of our product
candidates. Failure to raise sufficient funds during the first half
of 2010 will likely result in the dissolution of the Company.
Our
current product candidates consist of the following:
Androxal®
(male reproductive health)
We
believe our product candidate for male reproductive health, Androxal®, is a new
chemical entity. Androxal® is a single isomer of clomiphene citrate and is an
orally active proprietary small molecule compound. Androxal® is
currently being developed, subject to adequate funds being available and
appropriate regulatory approvals, for two product indications-fertility and type
2 diabetes.
Fertility
We are
developing Androxal® for
men of reproductive age with low testosterone levels who want to maintain their
fertility while being treated for their low testosterone condition. During the
second quarter of 2008, we initiated a Phase 2b proof-of-concept clinical trial
in which we monitored the effects of Androxal® on male fertility and
testicular function in patients being treated for low testosterone as compared
to Testim®, a popular marketed topical testosterone medication. On October 6,
2009 we announced that Androxal® was able to maintain sperm counts in men being
treated for their low testosterone levels. Testim® resulted in suppressed sperm
levels while men were being treated with that topical gel. We
requested a meeting with the FDA to discuss such results. In
correspondence leading up to such meeting, the FDA stated that it could not
agree with such proposed indication for Androxal® at that time because the patient
population had not been adequately defined and that it was not aware of certain
data to support our position.
On
January 25, 2010, we participated in a teleconference with the FDA relating to
the future clinical path for Androxal®. During such
teleconference, the FDA requested that we (i) propose a label that better
defines the population of individuals for whom we believe will benefit from the
use of Androxal® and
(ii) conduct a literature review of the incidence of infertility associated with
the use of exogenous testosterone as supportive of our data. The FDA
suggested that if it finds the submission appropriate, no additional
clarifying
meeting regarding this indication for Androxal® may be
required. On February 8, 2010, we announced that we submitted the
requested information to the FDA and we are currently awaiting the FDA’s
response to such submissions. Given that there is currently an acceptable
treatment regimen for men with low testosterone, there is significant
uncertainty as to whether or not an additional approach such as Androxal® would be approved by the FDA
or accepted in the market. At this time there can be no assurances
that the Company and the FDA will agree on a mutually acceptable clinical path
for Androxal®.
On
February 1, 2010, the Company received confirmation from the Division of
Metabolic and Endocrine Products that our Investigational New Drug Application
for the study of oral Androxal® in the treatment of hypogonadal men with type 2
diabetes was accepted, and that we may initiate a Phase 2a
trial. This clinical trial is dependent on additional funds
being raised. At this time it is too early in the clinical
development process to estimate when or even if a NDA for Androxal® will be
submitted for this indication. The plan to develop Androxal® in this new
indication replaces our previously announced plan to develop Androxal® in men
with adult-onset idiopathic hypogonadotrophic hypogonadism, or AIHH, with
concomitant plasma glucose and lipid elevations, all of which are components of
Metabolic Syndrome.
Proellex®
(female reproductive health)
Proellex®,
our product candidate for female reproductive health, is a new chemical entity
that acts as a selective blocker of the progesterone receptor and is being
developed for the treatment of symptoms associated with uterine fibroids and
endometriosis. However, as a result of the recent liver toxicity exhibited by
Proellex®, all ongoing clinical trial activities have been put on hold by the
FDA. There is currently no FDA-approved orally administered drug treatment
for the long-term treatment of uterine fibroids or endometriosis.
Our
estimates regarding the timing of our Proellex® clinical development program are
completely on hold at this time in light of the FDA clinical hold and our recent
discontinuation of ongoing clinical trials. In addition, any future development
efforts are totally dependent on our ability to raise sufficient capital or find
an appropriate partner to proceed and on decisions by the FDA regarding the
current clinical hold on Proellex® clinical trials. If the FDA were to lift the
clinical hold on Proellex®, and if the FDA requires a lower dosage of Proellex®
to be used for future clinical trials, the Company would be required to commence
Phase 2 studies again with the required lower dosage, thereby resulting in
extensive additional costs and delays. The length of time required to complete
Phase 1, Phase 2 and Phase 3 clinical trials and long-term Open Label Safety
Trials may vary substantially according to factors relating to the particular
trial, such as the type and intended use of the drug candidate, the clinical
trial design and the ability to enroll suitable patients. We have also, in the
past, had difficulty recruiting patients into our Proellex® clinical trials
primarily due to the various test procedures that are required, including
multiple endometrial biopsies. Recruiting patients would likely be even more
difficult due to the recent liver toxicity exhibited by Proellex®.
Business
Strategy
Provided
we are able to obtain sufficient funds to continue our business, we plan to
focus our clinical program on Androxal®. Should the FDA permit the
resumption of the Proellex® clinical trials, we will assess whether there are
sufficient funds available to continue development ourselves of such product
candidate or whether such program would be more appropriately funded by a
corporate partner. Therefore, we will continue to explore corporate
partnering opportunities for assistance in the clinical development funding and
commercialization of our products, as appropriate; however, there can be no
assurance that a corporate partnering opportunity will be found.
Risks
Affecting Us
Our
business is subject to numerous risks as discussed more fully in “Risk Factors”
below. We are exploring various financing alternatives to address our
short term liquidity needs. No assurance can be given that we will be successful
in obtaining financing on acceptable terms or at all. We anticipate
that if we are able to secure financing, that such financing will result in
significant dilution of the ownership interests of our current stockholders and
may provide certain rights to the new investors senior to the rights of our
current stockholders, including but not limited to voting rights and rights to
proceeds in the event of a sale or liquidation of the Company. In the
event that we are unable to obtain adequate financing to meet our short term
liquidity needs, we will pursue other options, including but not limited to,
reductions of expenses, sale of the Company, sale or license of a portion or all
of our assets or the liquidation of the Company.
In
addition, we have suspended dosing in the clinical trials of Proellex®,
have not received regulatory approval for any of our product candidates, have
not successfully earned any significant commercial revenues from any of our
product candidates and may never launch either of our product
candidates. If we cannot resume dosing in the clinical trials of
Proellex® or do not successfully commercialize any of our product candidates, we
will be unable to achieve our business objectives. In addition, the
reported
results of our clinical trials completed to date may not be indicative of
results that will be achieved in later-stage clinical trials involving larger
and more diverse patient populations. As of September 30, 2009, we
had an accumulated deficit of approximately $173.1 million, accounts payable and
accrued expenses of approximately $12.2 million and cash and cash equivalents of
approximately $2.5 million. As a result of the October Settlement
Agreement and the Subsequent Settlement Agreements (each as defined in “Recent
Developments” below) with certain of our creditors to issue them shares of our
common stock and cash as payment in full for our then-outstanding liabilities
with such creditors, subsequent to September 30, 2009, we have reduced the
amount of our accounts payable and accrued expenses by approximately $9.2
million. Notwithstanding, there is a substantial doubt about our
ability to continue as a going concern and we expect to continue to incur
significant losses over the next several years, and we may never become
profitable. Our financial statements do not include any adjustments
that might result from the outcome of these uncertainties.
Corporate
Information
Our
principal executive offices are located at 2408 Timberloch Place, Suite B-7, The
Woodlands, Texas, 77380, and our telephone number is (281) 719-3400. We maintain
an internet website at www.reprosrx.com. The information on our
website or any other website is not incorporated by reference into this
prospectus supplement and does not constitute a part of this prospectus
supplement. Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and
Current Reports on Form 8-K and all amendments to such reports are made
available free of charge through the Investor Relations section of our website
as soon as reasonably practicable after they have been filed or furnished with
the Securities and Exchange Commission.
Recent
Developments
On
October 29, 2009, we entered into a Master Settlement Agreement and Releases
(the “October Settlement Agreement”) with certain trade creditors, pursuant to
which we issued 5,361,194 shares of our common stock, at $1.10 per share, and
paid approximately $2.77 million in cash to such creditors as payment in full
for our then-outstanding liabilities of approximately $8.7 million and for the
release of the claims held by and the dismissal of the litigation commenced by
such creditors against the Company. Pursuant to the terms of the
October Settlement Agreement, we filed a registration statement on Form S-3
(File No. 333-163510), which was filed with the Securities and Exchange
Commission on December 4, 2009, to register the resale of such shares by such
creditors. Such registration statement was declared effective by the
Securities and Exchange Commission on January 7, 2010.
On
October 29, 2009, Katherine A. Anderson was engaged as the Chief Accounting
Officer of the Company.
Effective
October 29, 2009, Dr. Paul Lammers, resigned his position of
President.
Effective
October 30, 2009, the Company eliminated the position of Senior Vice President
of Regulatory and Clinical Affairs held by Dr. Andre van As. The
Company is obligated to pay Dr. van As, under his employment contract, salary
and benefits for six months. Dr. Jean Fourcroy, member of the
Company’s Board of Directors and former Medical Officer at the FDA’s Division of
Reproductive and Urological Products, has agreed to serve as Company’s Chief
Medical Officer on an as needed basis.
On
November 12, 2009, Mark Lappe resigned his position as a member of the Company’s
board of directors and chairperson of the board of directors. Since
such date, Nola E. Masterson, a member of the Company’s board of directors since
2004, has been acting as chairperson of the Company’s board of
directors.
On
November 12, 2009, Dr. Jaye Thompson was appointed to our board of directors and
to serve as a member of the audit committee of our board of
directors.
On
November 16, 2009, our board of directors elected Joseph S. Podolski as
President of the Company.
On
November 17, 2009, our stockholders approved an amendment to our Restated
Certificate of Incorporation, as amended, to increase the number of authorized
shares of our common stock from 30 million to 75 million.
On
December 15, 2009, we received notice from Nasdaq advising that we have not
maintained a minimum bid price of $1.00 per share as required for continued
listing on the Nasdaq Stock Market. We have been provided until June
14, 2010 to regain compliance with such listing requirement. If we do
not demonstrate compliance by such date, our securities will be subject to
delisting from the Nasdaq Stock Market.
On
January 12, 2010, we received a letter from the Nasdaq Hearings Panel (the
“Panel”) stating that our shares would be transferred from the Nasdaq Global
Market to the Nasdaq Capital Market, effective at the open of the trading
session on Thursday, January 14, 2010. As previously announced, we
have not been in compliance with Marketplace Rules 5450(b)(2)(A) and (C),
requiring (i) a minimum $50 million market value of listed securities and (ii) a
minimum market value of publicly held shares of $15 million, respectively, for
continued inclusion on the Nasdaq Global Market. The Panel’s determination to
transfer our shares to the Nasdaq Capital Market follows our hearing before the
Panel on December 3, 2009. If we cannot demonstrate compliance with
certain requirements for continued listing on the Nasdaq Capital Market,
including the requirement to maintain either stockholders’ equity of at least
$2.5 million or a market value of listed securities of $35 million, by May 5,
2010, our shares will be subject to immediate delisting. As described
above, we continue to have until June 14, 2010 to regain compliance with the
listing requirement to maintain a minimum bid price of $1.00 per
share.
Between
November 30, 2009 and January 21, 2010, the Company entered into settlement
agreements and mutual releases (the “Subsequent Settlement Agreements”) with
certain of its creditors, pursuant to which the Company issued an aggregate of
281,407 shares (the “Additional Settlement Shares”) of common stock and paid an
aggregate of $87,672 in cash as payment in full for its then-outstanding
liabilities to such creditors. Pursuant to the Subsequent Settlement
Agreements, the Company agreed to use its best efforts to prepare and file a
registration statement to register the Additional Settlement Shares as soon as
possible following the date of each Subsequent Settlement Agreement, to use its
best efforts to have such registration statement declared effective as soon as
possible and to maintain such registration statement until all such Additional
Settlement Shares registered thereunder to such creditors have been sold or for
a period of one year, whichever comes first.
On March
1, 2010, we received notice that we were named as a co-defendant in a lawsuit
brought against one of our clinical regulatory service providers (“CRO”) relating to
the Proellex® clinical trial study. The lawsuit was filed by an
investigator and claims that the CRO did not pay it amounts owing to it relating
to the Proellex® study. We did not engage the
investigator and under our agreement with the CRO, we believe that we will
be entitled to indemnification for any such costs or damages
regarding such lawsuit. The amount claimed is approximately
$175,000. An estimate of the possible costs or expenses to
defend ourselves in this matter or risk of exposure under the litigation cannot
be made at this time. Pursuant to the October Settlement Agreement,
such CRO, on behalf of itself and its agents, released us from all claims which
could be asserted by them against us. We believe such release covers
the claims set forth in this lawsuit.
The
Offering
Common
stock offered by Repros
|
|
Shares
of common stock having an aggregate offering price of up to $10 million,
subject to applicable regulatory requirements which currently would allow
us to offer and sell up to approximately $7.8 million.
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|
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Manner
of offering
|
|
“At
the market” offering that may be made from time to time through Ladenburg,
as sales agents using commercially reasonable efforts. See “Plan of
Distribution.”
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Use
of proceeds
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We
intend to use the net proceeds from this offering for general corporate
purposes.
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Nasdaq
Capital Market symbol
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RPRX
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Investing
in our common stock involves a high degree of risk. You should
carefully consider the risks and all other information contained in or
incorporated by reference in this prospectus supplement and the accompany
prospectus, including the risk factors discussed in the section entitled “Risk
Factors” contained in our most recent Annual Report on Form 10-K for the year
ended December 31, 2008 and our other public filings, before making an
investment decision. You should also refer to the other information in this
prospectus supplement and the accompanying prospectus, including our financial
statements and the related notes incorporated by reference in the accompanying
prospectus. The risks and uncertainties described in these sections and
documents are not the only risks and uncertainties we face. Additional risks and
uncertainties not presently known to us or that we currently deem immaterial
also may impair our business operations. If any of these risks actually occur,
our business, results of operations and financial condition could suffer. In
that event the trading price of our common stock could decline, and you may lose
all or part of your investment in our common stock. This prospectus supplement,
the accompanying prospectus and the incorporated documents also include
forward-looking statements and our actual results may differ substantially from
those discussed in these forward-looking statements, including the risks
mentioned above.
Forward-Looking
Statements
Some of
the statements contained (i) in this prospectus supplement and the
accompanying prospectus or (ii) incorporated by reference into this
prospectus supplement are forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E
of the Securities Exchange Act of 1934, as amended, and are subject to the safe
harbor created by the Securities Litigation Reform Act of 1995. Examples of
these forward-looking statements include, but are not limited to:
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§
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our
ability to continue as a going concern and to raise additional capital
during the first half of 2010 on acceptable terms or at
all;
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§
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our
ability to successfully defend the recently filed class action
lawsuits;
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§
|
our
ability to maintain the Company’s listing on the Nasdaq Capital
Market;
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§
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whether
a clear clinical path for Androxal® can be
realized;
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§
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the
removal of the current clinical hold on further clinical trials for
Proellex® by the Food and Drug Administration, or FDA, and the
reestablishment of safe dosing in clinical trials for
Proellex®;
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§
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having
available funding for the continued development of Proellex® and
Androxal®;
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§
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uncertainty
related to our ability to obtain approval of our products by the FDA and
regulatory bodies in other
jurisdictions;
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§
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uncertainty
relating to our patent portfolio;
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§
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market
acceptance of our products and the estimated potential size of these
markets;
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§
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dependence
on third parties for clinical development and
manufacturing;
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§
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dependence
on a limited number of key
employees;
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§
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competition
and risk of competitive new
products;
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§
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volatility
in the value of our common stock;
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§
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volatility
in the financial markets generally;
and
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§
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any
other risks and uncertainties described in the Company's filings with the
Securities and Exchange Commission.
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While
these forward-looking statements made by us are based on our current intent,
beliefs and judgments, they are subject to risks and uncertainties that could
cause actual results to vary from the projections in the forward-looking
statements. You should consider the risks above carefully in addition to other
information contained in this report before engaging in any transaction
involving shares of our common stock. If any of these risks occur, they could
harm our business, financial condition or results of operations. In such case,
the trading price of our common stock could decline, and you may lose all or
part of your investment.
The words
“believe,” “should,” “predict,” “future,” “may,” “will,” “estimate,” “continue,”
“anticipate,” “intend,” “plan,” “expect,” “potential,” “continue,” or
“opportunity,” or other words and terms of similar meaning, as they relate to
us, our business, future financial or operating performance or our management,
are intended to identify forward-looking statements. Any forward-looking
statement speaks only as of the date on which it is made, and except as required
by law we undertake no obligation to update or revise any forward-looking
statement to reflect events or circumstances after the date on which the
statement is made or to reflect the occurrence of unanticipated events. New
factors emerge from time to time, and it is not possible for us to predict which
factors will arise. In addition, we cannot assess the impact of each factor on
our business or the extent to which any factor, or combination of factors, may
cause actual results to differ materially from those contained in any
forward-looking statements. Past financial or operating performance is not
necessarily a reliable indicator of future performance and you should not use
our historical performance to anticipate results or future period
trends.
We expect
to receive approximately $7.4 million in net proceeds from this offering,
assuming we sold the maximum amount currently allowed under General Instruction
I.B.6. of Form S-3 which is approximately $7.8 million. “Net proceeds” is what
we expect to receive after paying the expenses of this offering, including the
sales agent fees, as described in “Plan of Distribution” below, and other
estimated offering expenses payable by us, which include legal, accounting and
printing fees.
We intend
to use the net proceeds from this offering for general corporate
purposes.
Until we
use the net proceeds of this offering, we intend to invest the funds in
short-term, investment grade, interest-bearing securities.
Price
Range of Common Stock
Our
common stock is quoted on the Nasdaq Capital Market under the symbol “RPRX”. The
following table shows the high and low sale prices per share of our common stock
as reported by the Nasdaq Stock Market during the periods
presented.
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Price Range
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High
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Low
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2008
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First
Quarter
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$ |
10.20 |
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$ |
8.11 |
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Second
Quarter
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|
11.09 |
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8.21 |
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Third
Quarter
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|
10.00 |
|
|
|
5.31 |
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Fourth
Quarter
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|
|
11.25 |
|
|
|
5.68 |
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2009
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First
Quarter
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$ |
13.94 |
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$ |
5.84 |
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Second
Quarter
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|
8.30 |
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5.70 |
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Third
Quarter
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|
6.01 |
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0.65 |
|
Fourth
Quarter
|
|
|
2.48 |
|
|
|
0.64 |
|
|
|
|
|
|
|
|
|
|
2010
|
|
|
|
|
|
|
|
|
First
Quarter (January 2nd through March
1)
|
|
$ |
1.22 |
|
|
$ |
0.68 |
|
|
|
|
|
|
|
|
|
|
All of
the foregoing prices reflect interdealer quotations, without retail mark-up,
markdowns or commissions and may not necessarily represent actual transactions
in the common stock.
On March
1, 2010, the last sale price of our common stock, as reported by the Nasdaq
Capital Market, was $0.78 per share. On March 1, 2010, there were
approximately 177 holders of record and approximately 3,750 beneficial holders
of our common stock.
We have
never declared or paid cash dividends on our capital stock. We currently intend
to retain our future earnings, if any, for use in our business and therefore do
not anticipate paying cash dividends in the foreseeable future. Payment of
future dividends, if any, will be at the discretion of our board of directors
after taking into account various factors, including our financial condition,
operating results, current and anticipated cash needs.
If you
purchase shares of our common stock from us, your interest will be diluted to
the extent of the difference between the public offering price per share you pay
and the net tangible book value per share of our common stock immediately after
this offering. Our net tangible book value as of September 30, 2009, was
($9.4) million, or approximately ($0.56) per share of common
stock. After giving effect to the issuances under the October
Settlement Agreement, the Subsequent Settlement Agreements and sale of 3,500,000
shares of common stock on October 13, 2009 (the "Prior Issuances") and after
deduction of estimated expenses related thereto at such time, our pro forma net
tangible book value as of September 30, 2009 would have been approximately
$900,000, or $0.03 per share of common stock. Net tangible book value
per share represents total assets minus capitalized patent costs and total
liabilities, divided by the number of shares of common stock
outstanding. Dilution in net tangible book value per share
represents the difference between the amount per share paid by purchasers
of common stock in this offering and the net tangible book value per share of
our common stock immediately after the offering.
Assuming
we sold the entire aggregate amount of $10 million provided for in the
equity distribution agreement at an assumed price to the public of $0.78 per
share, the last reported sale price of our common stock on March 1, 2010, and
after deducting the estimated commissions and offering expenses payable by us,
our pro forma net tangible book value as of September 30, 2009, after giving
effect to the Prior Issuances, would have been $10.4 million, or $0.27 per share
of common stock. The adjustments made to determine pro forma net
tangible book value per share are the following:
·
|
An
increase in total assets to reflect the net proceeds of the offering as
described under “Use of Proceeds”;
and
|
·
|
The
addition of the number of shares offered by this prospectus supplement to
the number of shares outstanding.
|
The
following table illustrates the pro forma increase in net tangible book value
attributable to new investors in this offering of $0.24 per share and the
dilution (the difference between the offering price per share and net tangible
book value per share) to new investors:
Assumed
offering price per share
|
|
|
$ |
0.78 |
|
Net
tangible book value per share as of September 30, 2009, after giving
effect to the Prior Issuances
|
|
$ |
0.03 |
|
|
|
|
|
Increase
per share attributable to new investors of this offering
|
|
|
0.24 |
|
|
|
|
|
Pro
forma net tangible book value per share as of September 30,
2009,
after
giving effect to this offering and the Prior Issuances
|
|
|
|
0.27 |
|
Dilution
per share to investors participating in this offering
|
|
|
$ |
0.51 |
|
|
|
|
|
|
|
|
|
|
The
information in the foregoing table does not take into account further dilution
to new investors that could occur upon the exercise of outstanding options
having a per share exercise price less than the price per share at which new
investors purchase the shares offered hereby. The number of shares in
the table above excludes as of September 30, 2009:
·
|
2,209,608 shares
of common stock issuable upon the exercise of outstanding options at a
weighted average exercise price of $5.76 per share;
and
|
·
|
1,262,201
shares of common stock available for future issuance under our stock
option plans.
|
The
information in the foregoing table is provided for illustrative purposes and
assumes that all of our common stock offered hereby in the aggregate amount of
$10 million is sold at a price of $0.78 per share, the last reported sale
price of our common stock on March 1, 2010. The shares, if any, sold pursuant to
the equity distribution agreement will be sold from time to time at various
prices that will depend largely on the market price of our common stock at the
time of sale. In addition, based on the closing price of our common
stock on the Nasdaq Stock Market on January 27, 2010, we are currently limited
to offer and sell no more than approximately $7.8 million in this
offering.
Plan
of Distribution
Upon its
acceptance of written instructions from us, Ladenburg will use its commercially
reasonable efforts consistent with its sales and trading practices to solicit
offers to purchase shares of our common stock, under the terms and subject to
the conditions set forth in the equity distribution agreement. We will
instruct Ladenburg as to the amount of common stock to be sold by Ladenburg. We
may instruct Ladenburg not to sell common stock if the sales cannot be effected
at or above the price designated by us in any instruction. We or Ladenburg may
suspend the offering of common stock upon proper notice and subject to other
conditions. Ladenburg may sell shares of our common stock by any
method deemed to be an “at the market” offering, including without limitation
sales made directly on the Nasdaq Capital Market or any other existing trading
market for our common stock or to or through market makers. With our
prior consent, Ladenburg may also sell shares of our common stock in privately
negotiated transactions.
We will
pay Ladenburg commissions for its services in acting as agent and/or principal
in the sale of common stock. Ladenburg will be entitled to compensation of 4% of
the gross sales price of all shares sold through it under the equity
distribution agreement. We estimate that the total expenses for the offering,
excluding compensation payable to Ladenburg under the terms of the equity
distribution agreement, will be approximately $50,000.
Settlement
for sales of common stock will occur on the third trading day following the date
on which any sales are made, or on some other date that is agreed upon by us and
Ladenburg in connection with a particular transaction, in return for payment of
the net proceeds to us. There is no arrangement for funds to be received in an
escrow, trust or similar arrangement.
We will
report at least quarterly the number of shares of common stock sold through
Ladenburg, as agent, under the equity distribution agreement, the net proceeds
to us and the compensation paid by us to Ladenburg in connection with the sales
of common stock.
Ladenburg
has provided, and may in the future provide, various investment banking and
advisory services for us from time to time for which they have received, and may
in the future receive, customary fees and expenses. Ladenburg may, from time to
time, engage in other transactions with and perform services for us in the
ordinary course of their business.
In
connection with the sale of the common stock on our behalf, Ladenburg may, and
will with respect to sales effected in an “at the market” offering, be deemed to
be an “underwriter” within the meaning of the Securities Act of 1933, and the
compensation of Ladenburg may be deemed to be underwriting commissions or
discounts. We have agreed to indemnify Ladenburg against specified liabilities,
including liabilities under the Securities Act, or to contribute to payments
that Ladenburg may be required to make because of those
liabilities.
The
offering of shares of our common stock pursuant to the equity distribution
agreement will terminate upon the earlier of (1) the sale of all common
stock subject to the agreement or (2) termination of the equity
distribution agreement. The equity distribution agreement may be terminated by
Ladenburg at any time upon ten days notice to us or by us at any time upon
thirty days notice to Ladenburg, or by Ladenburg at any time in certain
circumstances, including our failure to maintain a listing of our common stock
on the Nasdaq Capital Market or the occurrence of a material adverse change in
our company.
Legal
Matters
The
validity of the common stock being offered hereby will be passed upon by
Winstead PC, The Woodlands, Texas. Jeffrey R. Harder, a member of the law
firm, beneficially owned as of February 26, 2010, an aggregate of
11,899 shares of our common stock. Mr. Harder also holds options to
purchase 52,500 shares of our common stock.
Experts
The
consolidated financial statements and management’s assessment of the
effectiveness of internal control over financial reporting (which is included in
Management’s Report on Internal Control over Financial Reporting) incorporated
in this prospectus supplement by reference to the Annual Report on Form 10-K for
the year ended December 31, 2008 have been so incorporated in reliance on the
report (which contains an explanatory paragraph relating to the Company's
ability to continue as a going concern as described in Note 1 to the
consolidated financial statements) 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 have
filed with the SEC a registration statement on Form S-3 under the
Securities Act with respect to the shares of common stock we are offering under
this prospectus supplement. This prospectus supplement and the accompanying
prospectus do not contain all of the information set forth in the registration
statement and the exhibits to the registration statement. For further
information with respect to us and the securities we are offering under this
prospectus supplement, we refer you to the registration statement and the
exhibits and schedules filed as a part of the registration statement. We also
file annual, quarterly and current reports, proxy statements and other
information with the SEC. You may read and copy the registration statement, as
well as any other material we file with the SEC, at the SEC’s Public Reference
Room at 100 F Street, NE, Washington, D.C. 20549. Please call the
SEC at 1-800-SEC-0330 for more information on the Public Reference Room. The SEC
maintains an Internet site that contains reports, proxy and information
statements, and other information regarding issuers that file electronically
with the SEC, including Repros. The SEC’s Internet site can be found at
http://www.sec.gov.
The SEC
allows us to “incorporate by reference” into this prospectus supplement the
information we file with it, which means that we can disclose important
information to you by referring you to those documents. Information incorporated
by reference is part of this prospectus supplement. Later information filed with
the SEC will update and supersede this information. The SEC’s Internet site can
be found at http://www.sec.gov.
We
incorporate by reference the documents listed below and any future filings made
with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act
until this offering is completed:
§
|
our
Annual Report on Form 10-K for the year ended December 31, 2008 filed
with the Securities and Exchange Commission on March 16,
2009;
|
§
|
our
Quarterly Reports on Form 10-Q for the quarters ended March 31,
June 30, 2009 and September 30, 2009 filed with the Securities and
Exchange Commission on May 11, August 17, and November 9, 2009,
respectively, as amended by our Quarterly Report on Form 10-Q/A for the
quarter ended June 30, 2009 filed with the Securities and Exchange
Commission on August 18, 2009;
|
§
|
our
Current Reports on Form 8-K (other than information furnished rather than
filed), filed with the Securities and Exchange Commission on January 13,
2009, January 27, 2009, February 3, 2009, February 24, 2009, March 9,
2009, March 12, 2009, March 16, 2009, March 17, 2009, March 20, 2009,
April 20, 2009, May 11, 2009, May 20, 2009, May 27, 2009, June 8, 2009,
July 2, 2009, July 8, 2009, July 10, 2009, , (as amended by our Current
Report on Form 8-K/A filed with the Securities and Exchange Commission on
December 22, 2009), July 23, 2009, August 3, 2009, August 7, 2009, August
11, 2009, August 18, 2009, September 10, 2009, September 21, 2009,
September 30, 2009, October 14, 2009, November 3, 2009, November 9, 2009,
November 10, 2009, November 17, 2009; November 19, 2009, December 21,
2009, January 11, 2010, January 19, 2010, January 26, 2010, January 27,
2010, February 2, 2010, February 8, 2010 and February 19, 2010;
and
|
§
|
the
description of our common stock contained in our registration statement on
Form 8-A filed with the Securities and Exchange Commission on
February 2, 1993, including all amendments and reports filed for the
purpose of updating such
information.
|
Information
furnished to the Securities and Exchange Commission under Item 2.02 or
Item 7.01 in Current Reports on Form 8-K, and any exhibit relating to such
information, filed prior to, on or subsequent to the date of this prospectus
supplement is not incorporated by reference into this prospectus
supplement.
We will
furnish without charge to you, upon written or oral request, a copy of any or
all of the documents incorporated by reference, including exhibits to these
documents. You should direct any requests for documents to Repros Therapeutics
Inc., Attention: Secretary, 2408 Timberloch Place, Suite B-7, The
Woodlands, Texas 77380. Our telephone number is
(281) 719-3400.
In
accordance with Section 412 of the Exchange Act, any statement contained in
a document incorporated by reference herein shall be deemed modified or
superseded to the extent that a statement contained herein or in any other
subsequently filed document which also is or is deemed to be incorporated by
reference herein modifies or supersedes such statement.
PROSPECTUS
$20,000,000
Common
Stock
Preferred
Stock
Warrants
From time
to time, Repros Therapeutics Inc. (“the Company”, "Repros," or "we," "us" or
"our") may offer and sell shares of common stock or preferred stock, either individually or
represented by warrants. We may also offer common stock issuable upon
the conversion of preferred stock. The total amount of these
securities will have an initial aggregate offering price of up to $20,000,000.
As a result:
§
|
we
will provide this prospectus and a prospectus supplement each time we sell
the securities;
|
§
|
the
prospectus supplement will inform you about the specific terms of that
offering and may also add, update or change information contained in this
prospectus; and
|
§
|
you
should
read this prospectus and any prospectus supplement, as well as any
documents incorporated by reference in this prospectus and any prospectus
supplement, carefully before you invest in our
securities.
|
Our
common stock is quoted on the NASDAQ Global Market under the trading symbol
“RPRX.” On December 30, 2009, the last reported sale price of our common stock
on the NASDAQ Global Market was $0.82 per share.
The
aggregate market value of our outstanding common stock held by non-affiliates is
$16,055,327 based on 25,538,598 shares of outstanding common stock, of which
22,299,065 shares are held by non-affiliates, and a per share price of $0.72
based on the closing sale price of our common stock on December 8,
2009. We have not offered any securities pursuant to General
Instruction I.B.6. of Form S-3 during the prior 12 calendar month period that
ends on, and includes, the date of this prospectus.
THIS
PROSPECTUS MAY NOT BE USED TO OFFER OR SELL ANY SECURITIES UNLESS ACCOMPANIED BY
A PROSPECTUS SUPPLEMENT.
The
securities may be sold directly by us to purchasers, to or through underwriters
or dealers designated from time to time, or through agents designated from time
to time. For additional information on the methods of sale, you should refer to
“Plan of Distribution” in this prospectus and to the accompanying prospectus
supplement. If any underwriters are involved in a sale of the securities, their
names and any applicable commissions or discounts will be set forth in a
prospectus supplement. The net proceeds we expect to receive from the sale will
also be set forth in a prospectus supplement.
NEITHER
THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS
APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF THIS PROSPECTUS IS
TRUTHFUL OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL
OFFENSE.
INVESTING
IN OUR SECURITIES INVOLVES A HIGH DEGREE OF RISK. YOU SHOULD CAREFULLY CONSIDER
THE “RISK FACTORS” CONTAINED IN OUR ANNUAL REPORT ON FORM 10-K FOR THE FISCAL
YEAR ENDED DECEMBER 31, 2008, UPDATES IN PART II ITEM 1A OF OUR FORM 10-Q
FILINGS AND IN OUR FUTURE FILINGS MADE WITH THE SECURITIES AND EXCHANGE
COMMISSION, WHICH ARE INCORPORATED BY REFERENCE IN THIS PROSPECTUS. SEE
THE SECTION ENTITLED “RISK FACTORS” ON PAGE 5 OF THIS
PROSPECTUS.
The date
of this prospectus is January 5, 2010
Table of
Contents
|
|
|
1 |
|
ABOUT
REPROS THERAPEUTICS INC.
|
|
|
1 |
|
RISK
FACTORS
|
|
|
5 |
|
FORWARD-LOOKING
INFORMATION
|
|
|
5 |
|
USE
OF PROCEEDS
|
|
|
6 |
|
DESCRIPTION
OF CAPITAL STOCK
|
|
|
7 |
|
DESCRIPTION
OF WARRANTS
|
|
|
8 |
|
PLAN
OF DISTRIBUTION
|
|
|
9 |
|
LEGAL
MATTERS
|
|
|
11 |
|
EXPERTS
|
|
|
11 |
|
WHERE
YOU CAN FIND MORE INFORMATION
|
|
|
11 |
|
We
have not authorized any dealer, salesman or other person to give any information
or to make any representation other than those contained or incorporated by
reference in this prospectus and the accompanying supplement to this prospectus.
You must not rely upon any information or representation not contained or
incorporated by reference in this prospectus or the accompanying prospectus
supplement. This prospectus and the accompanying supplement to this prospectus
do not constitute an offer to sell or the solicitation of an offer to buy
securities, nor do this prospectus and the 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 the 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 sold on a later date.
ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement that we filed with the Securities
and Exchange Commission using a “shelf” registration process. Under this shelf
registration process, we may offer and sell shares of common stock or preferred
stock, either
individually or represented by warrants. We may also offer common
stock issuable upon the conversion of preferred stock. The
total amount of these securities will have an initial aggregate offering price
of up to $20,000,000.
This
prospectus provides you with a general description of the securities we may
offer. Each time we sell securities, we will provide a prospectus supplement
that will contain more specific information about the terms of that offering. We
may also add, update or change in the prospectus supplement any of the
information contained in this prospectus. This prospectus, together with
applicable prospectus supplements, includes all material information relating to
this offering. If there is any inconsistency between the information in this
prospectus and the information in the accompanying prospectus supplement, you
should rely on the information in the prospectus supplement.
Please
carefully read both this prospectus and any prospectus supplement together with
the additional information described below under “Where You Can Find More
Information.”
Unless
otherwise mentioned or unless the context requires otherwise, all references in
this prospectus to “the Company,” “Repros,” “we,” “us,” “our” or similar
references mean Repros Therapeutics Inc.
ABOUT
REPROS THERAPEUTICS INC.
Overview
The
Company was organized as a Delaware corporation on August 20,
1987. We are a development stage biopharmaceutical company focused on
the development of oral small molecule drugs for major unmet medical needs
associated with male and female reproductive disorders. The clinical
trials relating to Proellex® have been placed on clinical hold by the FDA due to
safety-related concerns resulting from elevated liver enzymes in a number of
patients enrolled in the clinical trials. Completion of our ongoing
clinical trial activities relating to our other product candidate, Androxal®, is
subject to, among other things, adequate cash being available.
As of
September 30, 2009, we had accumulated losses of $173.1 million, approximately
$2.5 million in cash and cash equivalents, and our accounts payable and accrued
expenses were approximately $12.2 million. As a result of the October
29, 2009 settlement agreement with certain of our creditors to issue them shares
of our common stock and cash as payment in full for our then-outstanding
liabilities with such creditors (See “Recent Developments – Settlement with
Trade Creditors” below), subsequent to September 30, 2009, we have reduced the
amount of our accounts payable and accrued expenses by approximately $8.7
million. Notwithstanding, the amount of cash on hand is not
sufficient to continue to fund our ongoing clinical trials of Androxal®,
complete all necessary activities relating to the suspension of our clinical
trial program for Proellex®, and pay our accounts payable and accrued expenses
as well as our normal corporate overhead and expenses. The foregoing
and other matters raise substantial doubt about our ability to continue as a
going concern.
We
continue to explore potential additional financing alternatives that may allow
us to maintain our current reduced level of operations; however, there can be no
assurance that we will be successful in raising any such additional funds on a
timely basis or at all. Significant additional
capital will be required for us to continue development of either of our product
candidates. Failure to raise sufficient funds before the second
quarter of 2010 will likely result in the filing of bankruptcy and dissolution
of the Company.
Our
current product candidates consist of the following:
Androxal®
(male reproductive health)
We
believe our product candidate for male reproductive health, Androxal®, is a new
chemical entity. Androxal® is a single isomer of clomiphene citrate and is an
orally active proprietary small molecule compound.
We are
developing Androxal® for
men of reproductive age with low testosterone levels who want to maintain their
fertility while being treated for their low testosterone condition. During the
second quarter of 2008, we initiated a Phase 2b proof-of-concept clinical trial
in which we are monitoring the effects of Androxal® on male fertility and
testicular function in patients being treated for low testosterone as compared
to Testim®, a popular marketed topical testosterone medication. On October 6,
2009 we announced that Androxal was able to maintain sperm counts in men being
treated for their low testosterone levels. Testim® resulted in suppressed sperm
levels while men were being treated with that topical gel. We recently submitted
a request for a Type C meeting with the FDA and expect to hold a meeting with
the FDA in late January, 2010, provided that sufficient funds can be raised to
continue development of this product. Given that there is currently an
acceptable treatment regimen for men with low testosterone, there is significant
uncertainty as to whether or not an additional approach such as Androxal® would be approved by the FDA
or accepted in the market. At this time it is too early in the
clinical development process to estimate when or even if an NDA for
Androxal® will be
submitted for this indication.
In April
2008, we submitted a White Paper, based on the results from a previously
conducted non-pivotal Phase 2 clinical trial with Androxal® for the treatment of
testosterone deficiency due to secondary hypogonadism, to the FDA's Division of
Reproductive and Urology Products. The data demonstrated that in subjects with
serum glucose levels of greater than 105 mg/dL, there was a statistically
significant reduction in fasting serum glucose and a higher response rate in the
treatment group with Androxal® as compared with groups receiving either placebo
or Androgel®, the current standard of care for the treatment of testosterone
deficiency. In November 2008, after the FDA reviewed this paper we received
guidance suggesting that we open a new IND with the Division of Metabolic and
Endocrine Products, or DMEP, for the investigation of Androxal® as a potential
treatment for type 2 diabetes. Provided that sufficient cash is available, we
plan to submit a new IND for this indication to the DMEP in the fourth quarter
of 2009. Should we raise adequate funds to continue our operations, we
anticipate conducting a Phase 2b proof-of-concept clinical trial with Androxal®
for glucose regulation after receiving additional feedback from the FDA. At this
time it is too early in the clinical development process to estimate when or
even if a NDA for Androxal® will be submitted for this indication. The plan to
develop Androxal® in this new indication replaces our previously announced plan
to develop Androxal® in men with adult-onset idiopathic hypogonadotrophic
hypogonadism, or AIHH, with concomitant plasma glucose and lipid elevations, all
of which are components of Metabolic Syndrome.
We were
previously developing Androxal® in the United States to treat testosterone
deficiency due to secondary hypogonadism by restoring normal testosterone
production in males with functional testes and diminished pituitary function, a
common condition in the aging male. After a Type "C" meeting held with the FDA
on October 15, 2007, we believed that there was no clear clinical path to
develop Androxal® for this indication in the U.S. Androxal® might be developed
outside of the U.S. for this indication if our future financial resources are
sufficient.
Proellex®
(female reproductive health)
Proellex®,
our product candidate for female reproductive health, is a new chemical entity
that acts as a selective blocker of the progesterone receptor and is being
developed for the treatment of symptoms associated with uterine fibroids and
endometriosis. However, as a result of the recent liver toxicity exhibited
by Proellex®, all ongoing clinical trial activities have been put on hold by the
FDA. There is currently no FDA-approved orally administered drug treatment
for the long-term treatment of uterine fibroids or endometriosis.
Our
estimates regarding the timing of our Proellex® clinical development program are
completely on hold at this time in light of the FDA clinical hold and our recent
discontinuation of ongoing clinical trials. In addition, any future development
efforts are totally dependent on our ability to raise sufficient capital or find
an appropriate partner to proceed and on decisions by the FDA regarding the
current clinical hold on Proellex® clinical trials. If the FDA were to lift the
clinical hold on Proellex®, and if the FDA requires a lower dosage of Proellex®
to be used for future clinical trials, the Company would be required to commence
Phase 2 studies again with the required lower dosage, thereby resulting in
extensive additional costs and delays. The length of time required to complete
Phase 1, Phase 2 and Phase 3 clinical trials and long-term Open Label Safety
Trials may vary substantially according to factors relating to the particular
trial, such as the type and intended use of the drug candidate, the clinical,
trial design and the ability to enroll suitable patients. We have also, in the
past, had difficulty recruiting patients into our Proellex® clinical trials
primarily due to the various test procedures that are required, including
multiple endometrial biopsies. Recruiting patients would likely be even more
difficult due to the recent liver toxicity exhibited by Proellex®.
Business
Strategy
Provided
we are able to obtain sufficient funds to continue our business, we plan to
focus our clinical program on Androxal® to determine if a clear clinical path
can be realized with the FDA.
Should
the FDA permit the resumption of the Proellex® clinical trials, we will assess
whether there are sufficient funds available to continue development ourselves
of such product candidate or whether such program would be more appropriately
funded by a corporate partner. Therefore, we will continue to explore
corporate partnering opportunities for assistance in the clinical development
funding and commercialization of our products, as appropriate; however, there
can be no assurance that a corporate partnering opportunity will be
found.
Risks
Affecting Us
Our
business is subject to numerous risks as discussed more fully in “Risk Factors”
below. We are exploring various financing alternatives to address our
short term liquidity needs. No assurance can be given that we will be successful
in obtaining financing on acceptable terms or at all. We anticipate
that if we are able to secure financing, that such financing will result in
significant dilution of the ownership interests of our current stockholders and
may provide certain rights to the new investors senior to the rights of our
current stockholders, including but not limited to voting rights and rights to
proceeds in the event of a sale or liquidation of the Company. In the
event that we are unable to obtain adequate financing to meet our short term
liquidity needs, we will pursue other options, including but not limited to,
reductions of expenses, sale of the Company, sale or license of a portion or all
of our assets, a bankruptcy filing or the liquidation of the
Company.
In
addition, we have recently suspended dosing in the clinical trials of Proellex®,
have not received regulatory approval for any of our product candidates, have
not successfully earned any significant commercial revenues from any of our
product candidates and may never launch either of our product
candidates. If we cannot resume dosing in the clinical trials of
Proellex® or do not successfully commercialize any of our product candidates, we
will be unable to achieve our business objectives. In addition, the
reported results of our clinical trials completed to date may not be indicative
of results that will be achieved in later-stage clinical trials involving larger
and more diverse patient populations. As of September 30, 2009, we
had an accumulated deficit of approximately $173.1 million, accounts payable and
accrued expenses of approximately $12.2 million and cash and cash equivalents of
approximately $2.5 million. As a result of the October 29, 2009
settlement agreement with certain of our creditors to issue them shares of our
common stock and cash as payment in full for our then-outstanding liabilities
with such creditors (as described below) we have reduced the amount of our
accounts payable and accrued expenses by approximately $8.7
million. Notwithstanding, there is a substantial doubt about our
ability to continue as a going concern and we expect to continue to incur
significant losses over the next several years, and we may never become
profitable. Our financial statements do not include any adjustments
that might result from the outcome of these uncertainties.
Corporate
Information
Our
principal executive offices are located at 2408 Timberloch Place, Suite B-7, The
Woodlands, Texas, 77380, and our telephone number is (281) 719-3400. We maintain
an internet website at www.reprosrx.com. The information on our
website or any other website is not incorporated by reference into this
prospectus supplement and does not constitute a part of this prospectus
supplement. Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and
Current Reports on Form 8-K and all amendments to such reports are made
available free of charge through the Investor Relations section of our website
as soon as reasonably practicable after they have been filed or furnished with
the Securities and Exchange Commission.
Recent
Developments
General
On
September 11, 2009, we completed a direct registered offering of 1.5 million
shares of our common stock at a purchase price of $0.65 per share for aggregate
proceeds after expenses of approximately $869,000. On October 13,
2009, we completed a direct registered offering of 3.5 million shares of our
common stock at a purchase price of $1.27 per share for aggregate proceeds after
expenses of approximately $4.1 million. Such registered direct
offerings resulted in an aggregate of approximately $5.0 million net proceeds to
us. The shares of common stock offered by us in such offerings were
registered under our prior shelf registration statement on Form S-3 (File No.
333-155265), which was filed with the Securities and Exchange Commission on
November 10, 2008 and declared effective by the Securities and Exchange
Commission on November 26, 2008.
On
October 29, 2009, Katherine A. Anderson was engaged as the Chief Accounting
Officer of the Company.
Effective
October 29, 2009, Dr. Paul Lammers, resigned his position of
President.
Effective
October 30, 2009, the Company eliminated the position of Senior Vice President
of Regulatory and Clinical Affairs held by Dr. Andre van As. The
Company is obligated to pay Dr. van As, under his employment contract, salary
and benefits for six months. Dr. Jean Fourcroy, member of the
Company’s Board of Directors and former Medical Officer at the FDA’s Division of
Reproductive and Urological Products, has agreed to serve as Company’s Chief
Medical Officer on an as needed basis.
O
n
November 6, 2009, the Company received notification from the NASDAQ Stock Market
that it has not regained compliance with NASDAQ Listing Rules 5450(b)(2)(A) or
5450(b)(3)(A) and, as a result, its securities will be
delisted from the NASDAQ Global Market. Pursuant to the NASDAQ
procedural rules, the Company appealed such determination and on
December 3, 2009, an oral hearing was held to determine whether its
securities will continue to be listed on the NASDAQ Global
Market. At such hearing the Company requested that its
securities be moved to the NASDAQ Capital Market if the appeal is not
successful. On December 15, 2009, the Company received another notification from
the NASDAQ Stock Market that it has not regained compliance with NASDAQ Listing
Rule 5450(b)(2)(C), which further subjects the Company's securities to delisting
from the NASDAQ Stock Market as a result of the market value of its
publicly-held shares being below $15 million. The Company previously
addressed the deficiency associated with such Listing Rule in its December 3rd
oral hearing and is awaiting the decision from NASDAQ Listing Qualifications
Panel regarding such deficiency. There can be no assurance that our
appeal will be successful to remain on the NASDAQ Global Market or that the
Company will be allowed to move its securities to the NASDAQ Capital Market.
On
December 15, 2009, the Company also received notice from NASDAQ that its
securities did not meet the minimum $1 bid price requirement and that it
securities would be delisted if such price was not met, for 10 continuous
trading days, within six months of such letter. The Company
anticipates that it will have some developments relating to its product
candidates on or before such date that could result in the stock price moving
above $1 per share, however, there can be no assurance that such
result will be successful in achieving compliance with
such rule by such date .
On
November 12, 2009, Dr. Jaye Thompson was appointed to our board of directors and
to serve as a member of the audit committee of our board of
directors.
On
November 12, 2009, Mark Lappe resigned his position as a member of the Company’s
board of directors and chairperson of the board of directors. Nola E.
Masterson, a member of the Company’s board of directors since 2004, has been
appointed as chairperson of the Company’s board of directors.
On
November 16, 2009, our board of directors elected Joseph S. Podolski as
President of the Company.
On
November 17, 2009, our stockholders approved an amendment to our Restated
Certificate of Incorporation, as amended, to increase the number of authorized
shares of our common stock from 30 million to 75 million.
Settlement
with Trade Creditors
On
October 29, 2009, we entered into a Master Settlement Agreement and Releases
(the “Settlement Agreement”) with certain trade creditors, pursuant to which we
issued 5,361,194 shares of our common stock, at $1.10 per share, and paid
approximately $2.77 million in cash to such creditors as payment in full for our
then-outstanding liabilities of approximately $8.7 million and for the release
of the claims held by and the dismissal of the litigation commenced by such
creditors against the Company. On December 4, 2009, we filed a
registration statement on Form S-3 to register the resale of the shares of
common stock issued under the Settlement Agreement by such
creditors. Under the Settlement Agreement, we agreed to refrain from
selling any shares for any primary public offering or other offering of our
equity securities during the ten business days immediately following the
effective date of such registration statement, in order to provide such
creditors an opportunity to sell their shares issued under the Settlement
Agreement.
RISK
FACTORS
Investment
in our securities involves a high degree of risk. You should consider carefully
the risk factors in any prospectus supplement and in our Annual Report on Form
10-K for the fiscal year ended December 31, 2008, updates in Part II,
Item 1A of our Form 10-Q filings, and in our future filings with the
Securities and Exchange Commission, as well as other information in this
prospectus and any prospectus supplement and the documents incorporated by
reference herein or therein, before purchasing any of our securities. Each of
the risk factors could adversely affect our business, operating results and
financial condition, as well as adversely affect the value of an investment in
our securities.
FORWARD-LOOKING
INFORMATION
Some of
the statements contained (i) in this prospectus and any accompanying
prospectus supplement or (ii) incorporated by reference into this
prospectus are forward-looking statements within the meaning of Section 27A
of the Securities Act of 1933, as amended, or the Securities Act, and
Section 21E of the Securities Exchange Act of 1934, as amended, or the
Exchange Act, and are subject to the safe harbor created by the Securities
Litigation Reform Act of 1995. Examples of these forward-looking statements
include, but are not limited to:
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our
ability to continue as a going concern and to raise additional capital
before the second quarter of 2010 on acceptable terms or at
all;
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our
ability to successfully defend the recently filed class action
lawsuits;
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our
ability to maintain the Company’s listing on the NASDAQ Global
Market;
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whether
a clear clinical path for Androxal® can be
realized;
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the
removal of the current clinical hold on further clinical trials for
Proellex® by the Food and Drug Administration, or FDA, and the
reestablishment of safe dosing in clinical trials for
Proellex®;
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having
available funding for the continued development of Proellex® and
Androxal®;
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uncertainty
related to our ability to obtain approval of our products by the FDA and
regulatory bodies in other
jurisdictions;
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uncertainty
relating to our patent portfolio;
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market
acceptance of our products and the estimated potential size of these
markets;
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dependence
on third parties for clinical development and
manufacturing;
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dependence
on a limited number of key
employees;
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competition
and risk of competitive new
products;
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volatility
in the value of our common stock;
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volatility
in the financial markets generally;
and
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any
other risks and uncertainties described in the Company's filings with the
Securities and Exchange Commission.
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While
these forward-looking statements made by us are based on our current intent,
beliefs and judgments, they are subject to risks and uncertainties that could
cause actual results to vary from the projections in the forward-looking
statements. You should consider the risks below carefully in addition to other
information contained in this report before engaging in any transaction
involving our securities. If any of these risks occur, they could seriously harm
our business, financial condition or results of operations. In such case, the
trading price of our securities could decline, and you may lose all or part of
your investment.
In
addition, in this prospectus, any prospectus supplement and the documents
incorporated by reference into this prospectus, the words “believe,” “should,”
“predict,” “future,” “may,” “will,” “estimate,” “continue,” “anticipate,”
“intend,” “plan,” “expect,” “potential,” “continue,” or “opportunity,” or other
words and terms of similar meaning, as they relate to us, our business, future
financial or operating performance or our management, are intended to identify
forward-looking statements. Any forward-looking statement speaks only as of the
date on which it is made, and we undertake no obligation to update or revise any
forward-looking statement to reflect events or circumstances after the date on
which the statement is made or to reflect the occurrence of unanticipated
events. New factors emerge from time to time, and it is not possible for us to
predict which factors will arise. In addition, we cannot assess the impact of
each factor on our business or the extent to which any factor, or combination of
factors, may cause actual results to differ materially from those contained in
any forward-looking statements. Past financial or operating performance is not
necessarily a reliable indicator of future performance and you should not use
our historical performance to anticipate results or future period
trends.
USE
OF PROCEEDS
Unless
the applicable prospectus supplement states otherwise, the net proceeds we
receive from the sale of the securities offered by us under this prospectus will
be used for general corporate purposes.
DESCRIPTION
OF CAPITAL STOCK
Our authorized capital stock consists
of 75,000,000 shares of common stock and 5,000,000 shares of preferred stock, of
which 500,000 shares are designated the Series One Junior Participating
Preferred Stock. As of December 30, 2009, 25,538,598 shares of our
common stock, par value $0.001 per share, and no shares of our preferred stock,
were outstanding.
Common
Stock
The
issued and outstanding shares of common stock are, and the shares of common
stock that we may issue in the future will be, validly issued, fully paid and
nonassessable. Holders of our common stock are entitled to share equally, share
for share, if dividends are declared on our common stock, whether payable in
cash, property or our securities. The shares of common stock are not convertible
and the holders thereof have no preemptive or subscription rights to purchase
any of our securities. Upon liquidation, dissolution or winding up of our
company, the holders of common stock are entitled to share equally, share for
share, in our assets which are legally available for distribution, after payment
of all debts and other liabilities and subject to the prior rights of any
holders of any series of preferred stock then outstanding. Each outstanding
share of common stock is entitled to one vote on all matters submitted to a vote
of stockholders. There is no cumulative voting. Except as otherwise required by
law or our Restated Certificate of Incorporation, the holders of common stock
vote together as a single class on all matters submitted to a vote of
stockholders.
Our
common stock is currently listed on the NASDAQ Global Market under the symbol
“RPRX.”
Preferred
Stock
We may
issue shares of preferred stock in series and may, at the time of issuance,
determine the designations, preferences, conversion rights, cumulative,
relative, participating optional or other rights, preferences and limitations of
each series. Satisfaction of any dividend preferences of outstanding shares of
preferred stock would reduce the amount of funds available for the payment of
dividends on shares of common stock. Holders of shares of preferred stock may be
entitled to receive a preference payment in the event of any liquidation,
dissolution or winding-up of the Company before any payment is made to the
holders of shares of common stock. Upon the affirmative vote of a majority of
the total number of directors then in office, our board of directors, without
stockholder approval, may issue shares of preferred stock with voting and
conversion rights which could adversely affect the holders of shares of common
stock.
DESCRIPTION
OF WARRANTS
We may
issue warrants to purchase shares of common stock or preferred stock. Warrants
may be issued independently or together with any shares of common stock or
preferred stock and may be attached to or separate from such shares of common
stock or preferred stock. Each series of warrants
may be issued under a separate warrant agreement to be entered into between us
and a warrant agent. The applicable prospectus supplement will describe
the following terms of any warrants in respect of which this prospectus is being
delivered:
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the
title of the warrants;
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the
price or prices at which the warrants will be
issued;
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the
periods during which the warrants are
exercisable;
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the
number of shares of common stock or preferred stock for which each warrant
is exercisable;
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the
exercise price for the warrants, including any changes to or adjustments
in the exercise price;
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if
applicable, the date on and after which the warrants and the related
common stock or preferred stock will be separately
transferable;
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any
listing of the warrants on a securities exchange or automated quotation
system;
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if
applicable, a discussion of material United States federal income tax
consequences and other special considerations with respect to any
warrants; and
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any
other terms of the warrants, including terms, procedures and limitations
relating to the transferability, exchange and exercise of such
warrants.
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PLAN
OF DISTRIBUTION
We are
registering securities which may be sold from time to time after the date of
this prospectus. We may sell the securities through underwriters or
dealers, through agents, or directly to one or more purchasers. The securities
may be sold in one or more transactions at fixed prices, at prevailing market
prices at the time of the sale, at varying prices determined at the time of
sale, or at negotiated prices. One or more prospectus supplements
will describe the terms of the offering of the securities,
including:
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the
name or names of any agents or
underwriters;
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the
purchase price of the securities and the proceeds we will receive from the
sale;
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any
over-allotment options under which underwriters may purchase additional
securities from us;
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any
agency fees or underwriting discounts and other items constituting agents’
or 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 common stock or other
securities may be listed.
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Only
underwriters named in the prospectus supplement are underwriters of the
securities offered by the prospectus supplement.
If
underwriters are used in the sale, they will acquire the securities for their
own account and may resell the securities from time to time in one or more
transactions, including negotiated transactions, at a fixed public offering
price or at varying prices determined at the time of sale. The obligations of
the underwriters to purchase the securities will be subject to the conditions
set forth in the applicable underwriting agreement. We may offer the securities
to the public through underwriting syndicates represented by managing
underwriters or by underwriters without a syndicate. Subject to certain
conditions, the underwriters will be obligated to purchase all the securities
offered by the prospectus supplement if they are to purchase any of such offered
shares. Any public offering price and any discounts or concessions allowed or
reallowed or paid to dealers may change from time to time. We may use
underwriters with whom we have a material relationship. We will describe in the
prospectus supplement naming the underwriter, the nature of any such
relationship.
We may
sell the securities directly or through agents we designate from time to time.
We will name any agent involved in the offering and sale of the securities and
we will describe any commissions we will pay the agent in the prospectus
supplement.
We may
authorize agents or underwriters to solicit offers by certain types of
institutional investors to purchase the securities from us at the public
offering price set forth in the prospectus supplement pursuant to delayed
delivery contracts providing for payment and delivery on a specified date in the
future. We will describe the conditions to these contracts and the commissions
we must pay for solicitation of these contracts in the prospectus
supplement.
We may
provide agents and underwriters with indemnification against certain civil
liabilities, including liabilities under the Securities Act, or contribution
with respect to payments that the agents or underwriters may make with respect
to such liabilities. Agents and underwriters may engage in transactions with, or
perform services for, us in the ordinary course of business.
Any
underwriter may engage in overallotment, stabilizing transactions, short
covering transactions and penalty bids in accordance with Regulation M
under the Securities Exchange Act of 1934. Overallotment involves sales in
excess of the offering size, which create a short position. Stabilizing
transactions permit bids to purchase the underlying securities so long as the
stabilizing bids do not exceed a specified maximum price. Short covering
transactions involve exercise by underwriters of an over-allotment option or
purchases of the securities in the open market after the distribution is
completed to cover short positions. Penalty bids permit the underwriters to
reclaim a selling concession from a dealer when the securities originally sold by the
dealer are purchased in a short covering transaction. Those activities may cause
the price of the securities to be higher than it would otherwise be. If
commenced, the underwriters may discontinue any of the activities at any
time.
Our
common stock is quoted on the NASDAQ Global Market. One or more underwriters may
make a market in our common stock or other securities, but the underwriters will
not be obligated to do so and may discontinue market making at any time without
notice. We cannot give any assurance as to liquidity of the trading market for
our common stock or other securities.
Any
underwriters who are qualified market makers on the NASDAQ Global Market may
engage in passive market making transactions in the securities on the NASDAQ
Global Market in accordance with Rule 103 of Regulation M under the
Securities Exchange Act of 1934, during the business day prior to the pricing of
the offering, before the commencement of offers or sales of the securities.
Passive market makers must comply with applicable volume and price limitations
and must be identified as passive market makers. In general, a passive market
maker must display its bid at a price not in excess of the highest independent bid for such
security; if all independent bids are lowered below the passive market maker’s
bid, however, the passive market maker’s bid must then be lowered when certain
purchase limits are exceeded.
LEGAL
MATTERS
The
validity of the securities being offered hereby will be passed upon by Winstead
PC, The Woodlands, Texas. Jeffrey R. Harder, a member of the law firm
Winstead PC, beneficially owned as of December 8, 2009, an aggregate of
11,899 shares of our common stock. Mr. Harder also holds options to purchase
52,500 shares of our common stock.
EXPERTS
The
consolidated financial statements and management’s assessment of the
effectiveness of internal control over financial reporting (which is included in
Management’s Report on Internal Control over Financial Reporting) incorporated
in this prospectus by reference to the Annual Report on Form 10-K for the year
ended December 31, 2008 have been so incorporated in reliance on the report
(which contains an explanatory paragraph relating to the Company's ability to
continue as a going concern as described in Note 1 to the consolidated financial
statements) 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 Securities and Exchange Commission. We
have filed with the Securities and Exchange Commission a registration statement
on Form S-3 under the Securities Act with respect to the securities we are
offering under this prospectus. This prospectus does not contain all of the
information set forth in the registration statement and the exhibits to the
registration statement. For further information with respect to us and the
securities we are offering under this prospectus, we refer you to the
registration statement and the exhibits filed as a part of the registration
statement. You may read and copy the registration statement, as well as our
reports, proxy statements and other information, at the Securities and Exchange
Commission’s public reference room at 100 F Street, N.E., Room 1580,
Washington, D.C. 20549. You can request copies of these documents by writing to
the Securities and Exchange Commission and paying a fee for the copying cost.
Please call the Securities and Exchange Commission at 1-800-SEC-0330 for more
information about the operation of the public reference room. Our Securities and
Exchange Commission filings are also available at the Securities and Exchange
Commission’s website at http://www.sec.gov.
The
Securities and Exchange Commission allows us to “incorporate by reference”
information that we file with it, 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. Information
in this prospectus supersedes information incorporated by reference that we
filed with the Securities and Exchange Commission prior to the date of this
prospectus, while information that we file later with the Securities and
Exchange Commission will automatically update and supersede this information. We
incorporate by reference into this registration statement and prospectus the
documents listed below and any future filings we will make with the Securities
and Exchange Commission under Sections 13(a), 13(c), 14 or 15(d) of the
Securities Exchange Act of 1934, as amended, after the date of the initial
registration statement but prior to effectiveness of the registration statement
and after the date of this prospectus but prior to the termination of the
offering of the securities covered by this prospectus, except in each case for
information contained in any such filing where we indicate that such information
is being furnished and is not to be considered “filed” under the Securities
Exchange Act of 1934, as amended.
The
following documents filed with the Securities and Exchange Commission are
incorporated by reference in this prospectus:
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our
Annual Report on Form 10-K for the year ended December 31, 2008 filed
with the Securities and Exchange Commission on March 16,
2009;
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our
Quarterly Reports on Form 10-Q for the quarters ended March 31,
June 30, 2009 and September 30, 2009 filed with the Securities and
Exchange Commission on May 11, August 17, and November 9, 2009,
respectively, as amended by our Quarterly Report on Form 10-Q/A for the
quarter ended June 30, 2009 filed with the Securities and Exchange
Commission on August 18, 2009;
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our
Current Reports on Form 8-K (other than information furnished rather than
filed), filed with the Securities and Exchange Commission on January 13,
2009, January 27, 2009, February 3, 2009, February 24, 2009, March 9,
2009, March 12, 2009, March 16, 2009, March 17, 2009, March 20, 2009,
April 20, 2009, May 11, 2009, May 20, 2009, May 27, 2009, June 8, 2009,
July 2, 2009, July 8, 2009, July 10, 2009, July 23, 2009, August 3, 2009,
August 7, 2009, August 11, 2009, August 18, 2009, September 10, 2009,
September 21, 2009, September 30, 2009, October 14, 2009, November 3,
2009, November 9, 2009, November 10, 2009, November 17, 2009; November 19,
2009 and December 21, 2009, as amended by our Current Report on Form 8-K/A
filed with the Securities and Exchange Commission on December 22, 2009;
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
February 2, 1993, including all amendments and reports filed for the
purpose of updating such
information.
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Information furnished to
the Securities and Exchange Commission under Item 2.02 or Item 7.01 in
Current Reports on Form 8-K, and any exhibit relating to such
information, filed prior to, on or subsequent to the date of this prospectus is
not incorporated by reference into this prospectus.
We will furnish without
charge to you, upon written or oral request, a copy of any or all of the
documents incorporated by reference, including exhibits to these
documents. You should direct any requests for documents to Repros Therapeutics
Inc., Attention: Secretary, 2408 Timberloch Place, Suite B-7, The
Woodlands, Texas 77380. Our telephone number is
(281) 719-3400.