As
filed with the Securities and Exchange Commission on June 9, 2010
Registration
No. 333-
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
S-3
REGISTRATION
STATEMENT UNDER
THE
SECURITIES ACT OF 1933
Repros
Therapeutics Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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2834
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76-0233274
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(State
or other jurisdiction of
incorporation
or organization)
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(Primary
Standard Industrial
Classification
Code Number)
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(I.R.S.
Employer
Identification
Number)
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2408
Timberloch Place, Suite B-7
The
Woodlands, TX 77380
(281)
719-3400
(Address,
including zip code, and telephone
number,
including area code, of registrant's
principal
executive offices)
Joseph
S. Podolski
President
and Chief Executive Officer
Repros
Therapeutics Inc.
2408
Timberloch Place, Suite B-7
The
Woodlands, TX 77380
(281)
719-3400
(Name,
address, including zip code, and telephone number, including area code, of agent
for service)
Copies
to:
Jeffrey
R. Harder, Esq.
Winstead
PC
24
Waterway Avenue, Suite 500
The
Woodlands, TX 77380
(281)
681-5900
Approximate date of
commencement of proposed sale to the public:
From time
to time after the effective date of this Registration Statement.
If the
only securities being registered on this form are being offered pursuant to
dividend or interest reinvestment plans, please check the following
box. ¨
If any of
the securities being registered on this form are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act of 1933,
other than securities offered only in connection with dividend or interest
reinvestment plans, check the following box. x
If this
form is filed to register additional securities for an offering pursuant to
Rule 462(b) under the Securities Act, check the following box and list the
Securities Act registration statement number of the earlier effective
registration statement for the same offering. ¨
If this
form is a post-effective amendment filed pursuant to Rule 462(c) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering. ¨
If this
form is a registration statement pursuant to General Instruction I.D. or a
post-effective amendment thereto that shall become effective upon filing with
the Commission pursuant to Rule 462(e) under the Securities Act, check the
following box. ¨
If this
form is a post-effective amendment to a registration statement filed pursuant to
General Instruction I.D. filed to register additional securities or additional
classes of securities pursuant to Rule 413(b) under the Securities Act,
check the following box. ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “large accelerated filer,”
“accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act.
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Large
accelerated filer ¨
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Accelerated
filer þ
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Non-accelerated
filer ¨ (Do
not check if a smaller reporting company)
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Smaller
reporting company ¨
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CALCULATION
OF REGISTRATION FEE
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Title
of Each Class of Securities to be Registered
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Amount
to
be
Registered
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Proposed
Maximum
Offering
Price
Per
Share(1)
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Proposed
Maximum
Aggregate
Offering
Price(1)
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Amount
of
Registration
Fee(1)
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Common
Stock, par value $.001 per share
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294,671 | $ | 0.5169 | $ | 152,315 | $ | 11.00 | |||||||||
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(1)
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Estimated solely for the purpose
of calculating the registration fee pursuant to Rule 457(c) under the
Securities Act and based on the average high and low prices per share of
common stock on June 7, 2010 as reported on the Nasdaq Capital
Market.
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The
Registrant hereby amends this Registration Statement on such date or dates as
may be necessary to delay its effective date until the Registrant shall file a
further amendment that specifically states that this Registration Statement
shall thereafter become effective in accordance with Section 8(a) of the
Securities Act of 1933 or until the Registration Statement shall become
effective on such date as the Securities and Exchange Commission, acting
pursuant to said Section 8(a), may determine.
Information
contained herein is subject to completion or amendment. A registration statement
relating to these securities has been filed with the Securities and Exchange
Commission. These securities may not be sold nor may offers to buy be accepted
prior to the time the registration statement becomes effective. This prospectus
shall not constitute an offer to sell or the solicitation of an offer to buy nor
shall there be any sale of these securities in any jurisdiction in which such
offer, solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such jurisdiction.
Subject
to completion. Dated June 9, 2010.
PROSPECTUS
Up to 294,671 Shares
Common
Stock
From time
to time, certain selling stockholders of Repros Therapeutics Inc. (“the
Company”, "Repros," or "we," "us" or "our") may offer and sell up to 294,671
shares of common stock issued to such selling stockholders in connection with
the Settlement Agreements described in “Selling Stockholders”
below.
Our
common stock is quoted on the Nasdaq Capital Market under the trading symbol
“RPRX.” On June 7, 2010, the last reported sale price of our common stock on the
Nasdaq Capital Market was $0.49 per share.
The
selling stockholders may offer and sell any of the shares of common stock from
time to time at fixed prices, at market prices or at negotiated prices, and may
engage a broker, dealer or underwriter to sell the shares. For additional
information on the possible methods of sale that may be used by the selling
stockholders, you should refer to the section entitled “Plan of Distribution”
beginning on page 9 of this prospectus. We will not receive any proceeds
from the sale of the shares of common stock by the selling stockholders. We will
pay all expenses incurred in effecting the registration statement of which this
prospectus constitutes a part.
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, 2009, 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 ,
2010
Table of
Contents
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ABOUT
THIS PROSPECTUS
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1
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ABOUT
REPROS THERAPEUTICS INC.
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1
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RISK
FACTORS
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5
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FORWARD-LOOKING
INFORMATION
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5
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USE
OF PROCEEDS
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6
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SELLING
STOCKHOLDERS
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7
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PLAN
OF DISTRIBUTION
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9
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LEGAL
MATTERS
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10
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EXPERTS
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10
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WHERE
YOU CAN FIND MORE INFORMATION
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10
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PART
II INFORMATION NOT REQUIRED IN THE PROSPECTUS
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II-1
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SIGNATURES
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II-5
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POWER
OF ATTORNEY
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II-5
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INDEX
TO EXHIBITS
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II-7
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Opinion
of Winstead PC
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Consent
of PricewaterhouseCoopers LLP
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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 common
stock, nor do this prospectus and the accompanying supplement to this prospectus
constitute an offer to sell or the solicitation of an offer to buy common stock
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 common stock 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, whereby certain selling stockholders may offer to sell
up to 294,671 shares of common stock issued to such selling stockholders in
connection with the Settlement Agreements described in “Selling Stockholders”
below.
This
prospectus provides you with a general description of the securities the selling
stockholders may offer. We may provide a prospectus supplement to add, update or
change 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
Repros
Therapeutics Inc. ("the Company", "RPRX," “Repros”, or "we," "us" or "our") was
organized 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. As of March 31, 2010, we had
accumulated losses of $175.6 million, approximately $974,000 in cash and cash
equivalents, and our accounts payable and accrued expenses were approximately
$1.9 million. As of April 30, 2010, we had cash and cash equivalents
of approximately $4.0 million. The amount of cash on hand is not
sufficient to fund our future clinical trials of Androxal® and, if the current
FDA clinical hold on Proellex® is removed, 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 would provide sufficient funds
to enable us to continue to develop our two product candidates through
completion of clinical trials; 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 complete
development of either of our product candidates.
Our
current product pipeline (with the respective status of development) consists of
the following:
Androxal® (male reproductive
health):
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Completed
Phase 2b proof-of-concept trial in men being treated for low testosterone
levels who want to improve or maintain their fertility and/or sperm number
and function; and
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Our
Investigational New Drug Application, or IND, for the study of oral
Androxal® in the treatment of hypogonadal men with type 2 diabetes was
accepted by the FDA and, thus, we may initiate a Phase 2
trial.
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Proellex® (female reproductive
health): All ongoing clinical trial activities for Proellex® have been put on hold by
the FDA; however, we have recently filed for a limited removal of the clinical
hold in order to commence certain clinical trials of Proellex ® at a 12 mg or
lower dose level, following discussions with the FDA. On April 29, 2010 a
teleconference was held with the FDA to review the clinical hold status of
Proellex®. During the teleconference the FDA noted that it felt that not
all of their concerns were fully answered but opined that if the Company was
willing to modify the trial from a parallel design to an escalating dose design
the FDA would consider lifting the full clinical hold and place Proellex® on
partial clinical hold to allow the low dose trial to be conducted. The Company
agreed to modify the protocol and submitted the new design to the Agency on
April 30, 2010. There can be no assurances however that the FDA will find the
new design acceptable or that they will lift the full clinical
hold.
We also
continue to maintain our patent portfolio of our phentolamine-based products for
the treatment of sexual dysfunction and in order to create value from these
assets in various ways which includes product out-licensing.
1
Androxal®
Product
Overview
Our
primary product candidate, Androxal® (the trans isomer of clomiphene),
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 improve or maintain their fertility and/or sperm function while
being treated for low testosterone. In addition, we submitted a new IND to
the Division of Metabolic and Endocrine Products, or DMEP, for the investigation
of Androxal® as a potential treatment for type 2 diabetes. On February 1,
2010, we received confirmation from the DMEP that our new IND was accepted and,
as a result, we may initiate a Phase 2 trial, subject to available funding.Our
findings from a retrospective review of the clinical data from our
200 patient non-pivotal U.S. Phase 3 clinical trial showed that
Androxal® therapy resulted in a significant reduction in mean glucose levels in
men with glucose levels >104 mg/dL, an outcome not seen in the placebo or
AndroGel® arms of this study. There can be no assurance that clinical
trials performed for this new indication will be successful.
We
believe Androxal® may have advantages over current therapies for the treatment
of low testosterone due to secondary hypogonadism because it is designed as an
oral therapy that acts centrally to restore testicular function and hence normal
testosterone in the body, as compared to currently approved products that
simply replace diminished testosterone either through injections, nasal spray or
the application of a gel or cream containing testosterone over a percentage of
body area.
We
believe Androxal® will be superior to the existing administration of exogenous
testosterone products used to normalize testosterone as only Androxal® has the
property of restoring both LH and FSH levels. LH and FSH are the pituitary
hormones that stimulate testicular testosterone and sperm production,
respectively.
Testosterone
is an important male hormone. Testosterone deficiency in men is linked to
several negative physical and mental conditions, including loss of muscle tone,
reduced sexual desire, and deterioration of memory and certain other cognitive
functions. Testosterone production normally decreases as men age, sometimes
leading to testosterone deficiency. According to the Urology Channel,
recent estimates show that approximately 13 million men in the United States
experience testosterone deficiency. The leading therapy is AndroGel®, a
commercially available testosterone replacement cream marketed by Solvay
Pharmaceuticals for the treatment of low testosterone, which we believe has had
and continues to have significant sales in North America.
Based on
our own clinical trial screening data, we believe over 70% of men that have low
testosterone suffer from secondary hypogonadism, caused by failure of the
pituitary to provide appropriate hormone signaling to the testes, which we
believe causes testosterone levels to drop to the point where pituitary
secretions fall under the influence of estrogen. In this state, we also
believe that estrogen further suppresses the testicular stimulation from the
pituitary. These men are readily distinguished from those that have primary
testicular failure via assessment of the levels of secretions of pituitary
hormones (i.e., men with primary testicular failure experience elevated
secretions of pituitary hormones). Secondary hypogonadism is not relegated
only to older men although the condition becomes more prevalent as men
age.
Androxal®
is considered a new chemical entity by the FDA which means that the compound
will be required to undergo the full regulatory approval process. We must
still meet additional clinical requirements including pre-clinical, Phase 1,
Phase 2, pivotal Phase 3 trials and long-term Open Label Safety Studies as well
as other requirements. Although Androxal® is considered a new chemical
entity for purposes of requirements for approval, it is closely related
chemically to the drug, Clomid®, which is approved for use in women to treat
certain infertility disorders. The FDA has indicated that testicular
tumors, gynecomastia and adverse ophthalmologic events, which have been reported
in males taking Clomid®, are potential risks that should be included in informed
consent forms for our Androxal® clinical trials. We do not believe that
Androxal® will present with the same adverse events given its reduced half-life
in the human body as compared to Clomid®. In our preclinical studies and
our clinical trials to date, we have observed no evidence of any of these events
except for certain ophthalmologic events in our preclinical dog study at doses
significantly higher than those administered in the clinical
trials.
All
clinical trial results are subject to review by the FDA, and the FDA may
disagree with our conclusions about safety and efficacy. We caution that
the results discussed herein are based on data from non-pivotal trials and that
our Phase 2 trials, pivotal Phase 3 and long-term Open Label Safety Trial data
may not agree with these results which will be based upon significantly larger
and more diverse patient populations treated for longer periods of
time.
Secondary
Hypogonadism with Fertility Maintenance/Improvement
During
the second quarter of 2008, we initiated a 24-patient Phase 2b proof-of-concept
clinical trial (ZA-201) for a new indication 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 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 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.
2
Type 2 Diabetes
In April
2008, we submitted a White Paper, based on the results from a previously
conducted non-pivotal Phase 2 clinical trial (ZA-003) with Androxal® for the
treatment of testosterone deficiency due to secondary hypogonadism, to the
Division of Reproductive and Urology Products. The data we believe
demonstrated that in subjects with a serum glucose of greater than or equal to
105mg/dL, there was a statistically significant reduction in fasting serum
glucose and a higher response rate to treatment in the Androxal®-group than the
placebo or Androgel® groups. In November 2008, after the FDA reviewed this paper
we received guidance from them 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 in mellitus. In
December 2009, we submitted a new IND to the DMEP for the investigation of
Androxal® for such purpose. On February 1, 2010, we received confirmation from
the DMEP that our new IND was accepted and, as a result, we may initiate a Phase
2 trial, subject to available funding.
Proellex®
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® in our previous Phase 2 and 3 clinical trials to endometriosis and
uterine fibroids, respectively, 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. On April 5, 2010, we
announced that we requested that the clinical hold be lifted to conduct a single
study to determine the potential for developing a “low dose” oral anti-progestin
therapy based on telapristone acetate or Proellex®. On April 29, 2010 a
teleconference was held with the FDA to review the clinical hold status of
Proellex®. During the teleconference the FDA noted that it felt that not
all of their concerns were fully answered but opined that if the Company was
willing to modify the trial from a parallel design to an escalating dose design
the FDA would consider lifting the full clinical hold and place Proellex® on
partial clinical hold to allow the low dose trial to be conducted. The Company
agreed to modify the protocol and submitted the new design to the Agency on
April 30, 2010. 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, we 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®.
Other
Products
We
continue limited out-licensing efforts for our phentolamine-based product
candidates, including VASOMAX®, which had previously been approved for marketing
in several countries in Latin America for the treatment of male erectile
dysfunction under the brand name, Z-Max. VASOMAX® is currently on partial
clinical hold in the U.S.
Business
Strategy
Provided
we are able to obtain sufficient funds to continue our business, we plan to
initially 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 an acceptable corporate partnering opportunity will be
found.
3
Risks
Affecting Us
Our
business is subject to numerous risks as discussed more fully in “Risk Factors"
below. We plan to continue to utilize the current Equity Distribution
Agreement with Ladenburg to provide us with capital to fund our immediate and
short term needs and to explore other various financing alternatives. 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 future 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 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 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 March 31, 2010, we had accumulated losses of
$175.6 million, approximately $974,000 in cash and cash equivalents, and our
accounts payable and accrued expenses were approximately $1.9
million. As of April 30, 2010, we had cash and cash equivalents of
approximately $4.0 million. The amount of cash on hand is not
sufficient to fund our future clinical trials of Androxal® and, if the current
FDA clinical hold on Proellex® is removed, 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 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
We were
organized as a Delaware corporation in August 1987. 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.
4
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, 2009, 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, as necessary, on acceptable
terms or at all;
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our ability to successfully
defend the class action
lawsuits;
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our ability to maintain the
Company’s listing on the Nasdaq Capital
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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§
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uncertainty relating to our
patent portfolio;
|
|
|
§
|
market acceptance of our products
and the estimated potential size of these
markets;
|
|
|
§
|
dependence on third parties for
clinical development and
manufacturing;
|
|
|
§
|
dependence on a limited number of
key employees;
|
|
|
§
|
competition and risk of
competitive new products;
|
|
|
§
|
volatility in the value of our
common stock;
|
|
|
§
|
volatility in the financial
markets generally; and
|
|
|
§
|
any other risks and uncertainties
described in the Company's filings with the Securities and Exchange
Commission.
|
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 common stock 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.
5
USE
OF PROCEEDS
We will
not receive any of the proceeds from the sale of the shares by the selling
stockholders.
6
SELLING
STOCKHOLDERS
Between
November 30, 2009 and April 8, 2010, we entered into settlement agreements and
mutual releases (the “Settlement Agreements”) with certain of our creditors,
pursuant to which we issued an aggregate of 294,671 shares of common stock (the
“Settlement Shares”) and paid a certain amount in cash as payment in full for
our then-outstanding liabilities to such creditors. Pursuant to the Settlement
Agreements, we agreed to use our best efforts to prepare and file a registration
statement to register the sale of the Settlement Shares as soon as possible
following the date of each Settlement Agreement, to use our best efforts to have
such registration statement declared effective as soon as possible and to
maintain such registration statement until all such Settlement Shares registered
thereunder to such creditors have been sold or for a period of one year,
whichever comes first.
Pursuant
to the terms of the Settlement Agreements relating to such issuances, we filed a
Registration Statement on Form S-3, of which this prospectus constitutes a part,
in order to permit the selling stockholders to resell to the public any or all
of the shares of our common stock issued in connection therewith. When we refer
to the “selling stockholders” in this prospectus, we mean the entities listed in
the table below, as well as their transferees, pledgees or donees or its
respective successors.
The
following table, to our knowledge, sets forth information regarding the
beneficial ownership of our common stock by the selling stockholders as of June
7, 2010 and the number of shares being offered hereby by the selling
stockholders. The information is based in part on information provided by or on
behalf of the selling stockholders. Beneficial ownership is determined in
accordance with Rule 13d-3 promulgated by the Securities and Exchange Commission
under the Securities Exchange Act of 1934, as amended, or the Exchange Act, and
includes voting or investment power with respect to shares, as well as any
shares as to which the selling stockholders have the right to acquire beneficial
ownership within sixty (60) days after June 7, 2010 through the exercise or
conversion of any stock options, warrants, convertible debt or otherwise. Unless
otherwise indicated below, the selling stockholders have sole voting and
investment power with respect to their shares of common stock. The inclusion of
any shares in this table does not constitute an admission of beneficial
ownership by the selling stockholders. We will not receive any of the proceeds
from the sale of our common stock by the selling stockholders.
The
actual number of shares of common stock that may be sold by the selling
stockholders will be determined by the selling stockholders. Because the selling
stockholders may sell all, some or none of the shares of common stock which they
hold, no estimate can be given as to the number of shares of common stock that
will be held by the selling stockholders after completion of the sales. The
information set forth in the following table regarding the beneficial ownership
after resale of shares is based on the assumption that the selling stockholders
will sell all of their shares of common stock covered by this
prospectus.
|
Shares Beneficially
Owned Before Offering
(1)
|
Shares Offered
|
Shares Beneficially
Owned After Offering
(1)
|
||||||||||||||||||
|
Name
of Selling Stockholder
|
Number
|
Percent
|
Hereby
|
Number
|
Percent
|
|||||||||||||||
|
The
Coghlan Group, Inc.(2)
|
30,267 | * | 30,267 | — | — | |||||||||||||||
|
Pharmascan
LLC(3)
|
61,246 | * | 61,246 | — | — | |||||||||||||||
|
Ricerca
Biosciences LLC(4)
|
23,667 | * | 23,667 | — | — | |||||||||||||||
|
eResearch
Technology, Inc.(5)
|
73,554 | * | 73,554 | — | — | |||||||||||||||
|
Rapid
Medical Research, Inc.(6)
|
24,203 | * | 24,203 | — | — | |||||||||||||||
|
DaVita
Clinical Research, Inc.(7)
|
34,885 | * | 34,885 | — | — | |||||||||||||||
|
Seth
Herbst
|
23,424 | * | 23,424 | |||||||||||||||||
|
KABJA
Investment, LLC(8)
|
23,425 | * | 23,425 | — | — | |||||||||||||||
* Does
not exceed 1%.
(1) The
percentage of shares beneficially owned prior to the offering is based on
32,937,464 shares of our common stock issued and outstanding as of May 31, 2010
and the percentage of shares beneficially owned after the offering is based on
the same number of shares and assumes the issuance of the shares offered by each
particular selling stockholder.
(2) The
Coghlan Group, Inc. ("Coghlan") shares voting and dispositive power with Terry
H. Coghlan, who is the chief executive officer and controlling person of
Coghlan. Terry H. Coghlan may be deemed to beneficially own the
shares listed above. Coghlan's address is 1500 Business Park Drive,
Bastrop, Texas 78602.
(3) Pharmascan
LLC ("Pharmascan") shares voting and dispositive power with Yair Safriel, who is
the controlling person of Pharmascan. Yair Safriel may be deemed to
beneficially own the shares listed above. Pharmascan's address is
1201 Gulf Boulevard, Belleair Beach, Florida 33786.
7
(4) Ricerca
Biosciences LLC ("Ricerca") shares voting and dispositive power with Ricerca
Holdings II, Inc., who is the controlling person of Ricerca ("Ricerca
Holdings"), and SV Life Sciences, Bain Capital and Trinity Equity Investors, who
collectively are the majority shareholders of Ricerca
Holdings. Ricerca's address is 7528 Auburn Road, Concord, Ohio
44077.
(5) eResearch
Technology, Inc. ("eResearch") is a publicly-owned
company. eResearch's address is 1818 Market Street, Suite 1000,
Philadelphia, Pennsylvania 19103.
(6) Rapid
Medical Research, Inc. ("Rapid Medical") shares voting and dispositive power
with James E. Fahy, who is the controlling stockholder of Rapid
Medical. As controlling stockholder, Mr. Fahy may be deemed to
beneficially own the shares listed above. Rapid Medical's address is
3619 Park East Drive #300, Cleveland, Ohio 44122.
(7) DaVita
Clinical Research, Inc. (“DaVita”) is a publicly-owned
company. DaVita’s address is 601 Hawaii Street, El Segundo,
California 90245
(8) KABJA
Investment, LLC ("KABJA") shares voting and dispositive power with Keith Aqua,
who is a member and controlling person of KABJA. As a controlling
person, Mr. Aqua may be deemed to beneficially own the shares listed
above. KABJA's address is 14370 Halter Road, Wellington, Florida
33414.
8
PLAN
OF DISTRIBUTION
The
common stock to be offered and sold using this prospectus are being registered
to permit public secondary trading of such common stock by the selling
stockholders from time to time after the date of this prospectus. We will not
receive any of the proceeds from the sale by the selling stockholders of the
common stock offered by this prospectus. The aggregate proceeds to the selling
stockholders from the sale of the common stock will be the purchase price of the
common stock less any discounts and commissions. A selling stockholder reserves
the right to accept and, together with its agents, to reject, any proposed
purchases of common stock to be made directly or through agents.
The
common stock may be sold from time to time to purchasers directly by the selling
stockholders and their successors, which includes their transferees, pledgees or
donees or their successors, or through underwriters, broker-dealers or agents
who may receive compensation in the form of discounts, concessions or
commissions from the selling stockholders or the purchasers of the common stock.
These discounts, concessions or commissions may be in excess of those customary
in the types of transactions involved.
The
selling stockholders and any underwriters, broker-dealers or agents who
participate in the distribution of the common stock may be “underwriters” within
the meaning of the Securities Act. None of the selling stockholders has
represented to us that it is a broker-dealer or an affiliate of a broker-dealer.
If the selling stockholders are deemed to be underwriters, such selling
stockholders may be subject to certain statutory liabilities of the Securities
Act and the Exchange Act.
We will
pay all expenses of the registration of the common stock pursuant to the
Settlement Agreements, including, without limitation, Securities and Exchange
Commission filing fees and expenses of compliance with state securities or “blue
sky” laws; provided, however, that if the common stock is sold through
underwriters, broker dealers or agents, the selling stockholders will be
responsible for underwriting discounts or commissions or agent’s
commissions.
9
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 May 31, 2010, an aggregate of 20,999
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, 2009 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 common stock the
selling stockholders 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 common stock the selling stockholders 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:
|
§
|
our Annual Report on Form 10-K
for the year ended December 31, 2009 filed with the Securities and
Exchange Commission on March 15,
2010;
|
|
§
|
our Quarterly Report on Form 10-Q
for the quarter ended March 31, 2010 filed with the Securities and
Exchange Commission on May 10,
2010;
|
|
§
|
our Current Reports on Form 8-K
(other than information furnished rather than filed), filed with the
Securities and Exchange Commission on January 11, 2010, January 19, 2010,
January 26, 2010, January 27, 2010, February 2, 2010, February 8, 2010,
February 19, 2010, March 3, 2010, March 4, 2010, March 11, 2010, March 16,
2010, March 31, 2010, April 5, 2010, April 15, 2010, April 28, 2010, April
30, 2010, May 10, 2010, May 13, 2010 and May 18, 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 is
not incorporated by reference into this prospectus.
10
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.
11
PART
II
INFORMATION
NOT REQUIRED IN THE PROSPECTUS
Item 14.
Other Expenses of Issuance and Distribution
The
following table sets forth the estimated costs and expenses, other than the
underwriting discounts and commissions, payable by the registrant in connection
with the offering of the securities being registered. All the amounts shown are
estimates, except for the registration fee.
|
Securities
and Exchange Commission registration fee
|
$
|
11
|
||
|
Accounting
fees and expenses
|
20,000
|
|||
|
Legal
fees and expenses
|
20,000
|
|||
|
Printing,
transfer agent and miscellaneous expenses
|
10,000
|
|||
|
Total:
|
$
|
50,011
|
Item 15.
Indemnification of Officers and Directors
Section 145
of the Delaware General Corporation Law, or Delaware law, inter alia, empowers a
Delaware corporation to indemnify any person who was or is a party or is
threatened to be made a party to any threatened, pending or completed action,
suit or proceeding (other than an action by or in the right of the corporation)
by reason of the fact that such person is or was a director, officer, employee
or agent of the corporation, or is or was serving at the request of the
corporation as a director, officer, employee or agent of another corporation or
other enterprise, against expenses (including attorneys’ fees), judgments, fines
and amounts paid in settlement actually and reasonably incurred by him in
connection with such action, suit or proceeding if he acted in good faith and in
a manner he reasonably believed to be in or not opposed to the best interests of
the corporation, and, with respect to any criminal action or proceeding, had no
reasonable cause to believe his conduct was unlawful. Similar indemnity is
authorized for such persons against expenses (including attorneys’ fees)
actually and reasonably incurred in connection with the defense or settlement of
any such threatened, pending or completed action or suit if such person acted in
good faith and in a manner he reasonably believed to be in or not opposed to the
best interests of the corporation, and provided further that (unless a court of
competent jurisdiction otherwise provides) such person shall not have been
adjudged liable to the corporation. Any such indemnification may be made only as
authorized in each specific case upon a determination by the stockholders or
disinterested directors or by independent legal counsel in a written opinion
that indemnification is proper because the indemnitee has met the applicable
standard of conduct.
Section 145
further authorizes a corporation to purchase and maintain insurance on behalf of
any person who is or was a director, officer, employee or agent of the
corporation, or is or was serving at the request of the corporation as a
director, officer, employee or agent of another corporation or enterprise,
against any liability asserted against him and incurred by him in any such
capacity, or arising out of his status as such, whether or not the corporation
would otherwise have the power to indemnify him under Section 145. We
maintain policies insuring our officers and directors against certain
liabilities for actions taken in such capacities, including liabilities under
the Securities Act of 1933, as amended (the “Securities Act”).
Our
Restated Certificate of Incorporation and Restated Bylaws require us to
indemnify our directors to the fullest extent permitted under Delaware law or
any other applicable law in effect, but if such statute or law is amended, we
may change the standard of indemnification only to the extent that such amended
statute or law permits us to provide broader indemnification rights to our
directors. We must indemnify such officers and employees in the same manner and
to the same extent that we are required to indemnify our directors under our
Restated Certificate of Incorporation and Restated Bylaws. Our Restated
Certificate of Incorporation limits the personal liability of a director to us
or our stockholders to damages for breach of the director’s fiduciary
duty. Pursuant to indemnification agreements we entered into with
each of our directors, we are further required to indemnify our directors to the
fullest extent permitted under Delaware law and our Restated Bylaws; provided
that each such director shall enjoy the greater of (i) the advancement and
indemnification rights permitted under our Restated Certificate and Restated
Bylaws for directors and officers as of the date of such indemnification
agreement or (ii) the benefits so afforded by amendments
thereto.
II-1
Item 16. Exhibits and Financial
Statement Schedules
(a) Exhibits
|
Exhibit Number
|
Identification of Exhibit
|
|
|
3.1(a)
|
Restated
Certificate of Incorporation. Exhibit 3.3 to the Company’s
Registration Statement on Form SB-2 (No. 33-57728-FW), as
amended (“Registration Statement”), is incorporated herein by
reference.
|
|
|
3.1(b)
|
Certificate
of Amendment to Restated Certificate of Incorporation. Exhibit 3.1 to
the Company’s Current Report on Form 8-K dated May 1, 2006 is
incorporated herein by reference.
|
|
|
3.1(c)
|
Certificate
of Designation of Series One Junior Participating Preferred Stock
dated September 2, 1999. Exhibit A to Exhibit 4.1 to the
Company’s Registration Statement on Form 8-A as filed with the
Commission on September 3, 1999 (the “Rights Plan Registration
Statement”), is incorporated herein by reference.
|
|
|
3.1(d)
|
Certificate
of Amendment to Restated Certificate of Incorporation, dated as of
December 16, 2008. Exhibit 3.1(d) to the Company’s Current
Report on Form 8-K dated December 23, 2008 is incorporated herein by
reference.
|
|
|
3.1(e)
|
Certificate
of Amendment to Restated Certificate of Incorporation, dated as of
November 18, 2009. Exhibit 3.1(e) to the Company’s Current Report on
Form 8-K dated November 19, 2009 is incorporated herein by
reference.
|
|
|
3.2
|
Restated
Bylaws of the Company. Exhibit 3.4 to the Registration Statement is
incorporated herein by reference.
|
|
|
4.1
|
Specimen
Common Stock Certificate, $.001 par value, of the Company.
Exhibit 4.1 to the Registration Statement is incorporated herein by
reference.
|
|
|
4.2
|
Rights
Agreement dated September 1, 1999 between the Company and
Computershare Investor Services LLC (as successor in interest to Harris
Trust & Savings Bank), as Rights Agent. Exhibit 4.1 to the Rights
Plan Registration Statement is incorporated herein by
reference.
|
|
|
4.3
|
First
Amendment to Rights Agreement, dated as of September 6, 2002, between
the Company, Harris Trust & Savings Bank and Computershare Investor
Services LLC. Exhibit 4.3 to Amendment No. 1 to the Rights Plan
Registration Statement on Form 8-A/A as filed with the Commission on
September 11, 2002 is incorporated herein by
reference.
|
|
|
4.4
|
Second
Amendment to Rights Agreement, dated as of October 30, 2002, between
the Company and Computershare Investor Services LLC. Exhibit 4.4 to
Amendment No. 2 to the Rights Plan Registration Statement on
Form 8-A/A as filed with the Commission on October 31, 2002 is
incorporated herein by reference.
|
|
|
4.5
|
Third
Amendment to Rights Agreement, dated as of June 30, 2005, between the
Company and Computershare Trust Company, N.A. Exhibit 4.4 to the
Company’s Current Report on Form 8-K as filed with the Commission on
June 30, 2005 is incorporated herein by reference.
|
|
|
4.6
|
Fourth
Amendment to Rights Agreement, dated as of January 9, 2008, between the
Company and Computershare Trust Company, N.A. Exhibit 4.5 to the Company’s
Current Report on Form 8-K as filed with the Commission on January 10,
2008 is incorporated herein by reference.
|
|
|
4.7
|
Fifth
Amendment to Rights Agreement, dated as of October 10, 2008, between the
Company and Computershare Trust Company, N.A. Exhibit 4.6 to the Company’s
Current Report on Form 8-K as filed with the Commission on October 10,
2008 is incorporated herein by reference.
|
|
|
4.8
|
Form
of Rights Certificate. Exhibit B to Exhibit 4.1 to the Rights
Plan Registration Statement is incorporated herein by
reference.
|
|
|
5.1*
|
Opinion
of Winstead PC.
|
|
|
23.1*
|
Consent
of PricewaterhouseCoopers LLP, independent registered public accounting
firm.
|
|
|
23.2*
|
Consent
of Winstead PC (included in Exhibit 5.1).
|
|
|
24.1
|
Power
of Attorney (included in the signature
page).
|
* Filed
herewith.
II-2
Item 17.
Undertakings
The
undersigned registrant hereby undertakes:
(1) To
file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement:
(i) to
include any prospectus required by section 10(a)(3) of the Securities Act of
1933;
(ii) to
reflect in the prospectus any facts or events arising after the effective date
of the registration statement (or the most recent post-effective amendment
thereof) which, individually or in the aggregate, represent a fundamental change
in the information set forth in the registration statement. Notwithstanding the
foregoing, any increase or decrease in volume of securities offered (if the
total dollar value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the estimated maximum
offering range may be reflected in the form of prospectus filed with the
Securities and Exchange Commission pursuant to Rule 424(b) if, in the aggregate,
the changes in volume and price represent no more than a 20 percent change
in the maximum aggregate offering price set forth in the “Calculation of
Registration Fee” table in the effective registration statement;
and
(iii) to
include any material information with respect to the plan of distribution not
previously disclosed in the registration statement or any material change to
such information in the registration statement; provided, however, that
paragraphs (1)(i), (1)(ii) and (1)(iii) do not apply if the information required
to be included in a post-effective amendment by those paragraphs is contained in
periodic reports filed with or furnished to the Securities and Exchange
Commission by the registrant pursuant to section 13 or 15(d) of the Securities
Exchange Act of 1934 that are incorporated by reference in the registration
statement, or is contained in a form of prospectus filed pursuant to Rule 424(b)
that is part of the registration statement.
(2) That,
for the purpose of determining any liability under the Securities Act of 1933,
each such post-effective amendment shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of the
securities at that time shall be deemed to be the initial bona fide offering
thereof.
(3) To
remove from registration by means of a post-effective amendment any of the
securities being registered which remain unsold at the termination of this
offering.
(4) That,
for the purpose of determining liability of a registrant under the Securities
Act to any purchaser in the initial distribution of the securities, the
undersigned registrant undertakes that in a primary offering of securities of
the undersigned registrant pursuant to this registration statement, regardless
of the underwriting method used to sell the securities to the purchaser, if the
securities are offered or sold to such purchaser by means of any of the
following communications, the undersigned registrant will be a seller to the
purchaser and will be considered to offer or sell such securities to such
purchaser:
(i) Any
preliminary prospectus or prospectus of the undersigned registrant relating to
the offering required to be filed pursuant to Rule 424;
(ii) Any
free writing prospectus relating to the offering prepared by or on behalf of the
undersigned registrant or used or referred to by the undersigned
registrant;
(iii) The
portion of any other free writing prospectus relating to the offering containing
material information about the undersigned registrant or its securities provided
by or on behalf of the undersigned registrant; and
(iv) Any
other communication that is an offer in the offering made by the undersigned
registrant to the purchaser.
(5) That,
for purposes of determining any liability under the Securities Act of 1933, each
filing of the registrant’s annual report pursuant to section 13(a) or section
15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing
of an employee benefit plan’s annual report pursuant to section 15(d) of the
Securities Exchange Act of 1934) that is incorporated by reference in the
registration statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering
thereof.
(6) That: (i) for
purposes of determining any liability under the Securities Act of 1933, the
information omitted from the form of prospectus filed as part of this
registration statement in reliance upon Rule 430A and contained in the form
of prospectus filed by the registrant pursuant to Rule 424(b)(1) or
(4) or 497(h) under the Securities Act of 1933 shall be deemed to be part
of the registration statement as of the time it was declared effective; and
(ii) for the purpose of determining any liability under the Securities Act
of 1933, each post-effective amendment that contains a form of prospectus shall
be deemed to be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
II-3
Insofar
as indemnification for liabilities arising under the Securities Act of 1933 may
be permitted to directors, officers and controlling persons of the registrant
pursuant to the foregoing provisions, or otherwise, the registrant has been
advised that in the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the Securities Act of
1933 and is, therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment by the
registrant of expenses incurred or paid by a director, officer or controlling
person of the registrant in the successful defense of any action, suit or
proceeding) is asserted by a director, officer or controlling person in
connection with the securities being registered, the registrant will, unless in
the opinion of its counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in the Securities
Act of 1933 and will be governed by the final adjudication of such
issue.
II-4
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the registrant certifies that
it has reasonable grounds to believe that it meets all of the requirements for
filing on Form S-3 and has duly caused this registration statement to be signed
on its behalf by the undersigned, thereunto duly authorized, in The Woodlands,
Montgomery County, State of Texas, on June 9, 2010.
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REPROS
THERAPEUTICS INC.
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By:
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/s/ Joseph S. Podolski
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Joseph
S. Podolski
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President
and Chief Executive Officer
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POWER
OF ATTORNEY
KNOW ALL PERSONS BY THESE
PRESENTS , that each person whose signature appears below constitutes and
appoints Joseph S. Podolski as true and lawful attorney-in-fact and agent, with
full power of substitution and resubstitution, for them and in their name, place
and stead, in any and all capacities, to sign any and all amendments (including
pre-effective and post-effective amendments) to this registration statement and
any additional registration statements filed pursuant to Rule 462, and to
file the same, with all exhibits thereto, and other documents in connection
therewith, with the Securities and Exchange Commission (the “SEC”), and
generally to do all such things in their names and behalf in their capacities as
officers and directors to enable the Company to comply with the provisions of
the Securities Act of 1933 and all requirements of the SEC, granting unto said
attorney-in-fact and agent full power and authority to do and perform each and
every act and thing requisite and necessary to be done in connection therewith,
as fully to all intents and purposes as he or she might or could do in person,
ratifying and confirming all that said attorney-in-fact and agent, or their or
his or her substitutes or substitute, may lawfully do or cause to be done by
virtue hereof.
II-5
Pursuant
to the requirements of the Securities Act of 1933, this registration statement
has been signed below by the following persons in the capacities and on the
dates indicated.
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Signatures
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Title
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Date
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||
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/s/
Joseph S. Podolski
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President and Chief Executive Officer
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June
9, 2010
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||
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Joseph
S. Podolski
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and
Director
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|||
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/s/
Katherine A. Anderson
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Principal
Financial Officer and Chief Accounting
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June
9, 2010
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||
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Katherine
A. Anderson
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Officer
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|||
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/s/
Nola Masterson
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Chairman
of the Board
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June
9, 2010
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||
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Nola
Masterson
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||||
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/s/
Daniel F. Cain
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Director
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June
9, 2010
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||
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Daniel
F. Cain
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||||
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/s/
Jean L. Fourcroy, M.D., Ph.D., M.P.H.
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Director
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June
9, 2010
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||
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Jean
L. Fourcroy, M.D., Ph.D., M.P.H.
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||||
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/s/
Jaye Thompson, Ph.D.
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Director
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June
9, 2010
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||
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Jaye
Thompson, Ph.D
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II-6
INDEX
TO EXHIBITS
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Exhibit Number
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Identification of Exhibit
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|
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3.1(a)
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Restated
Certificate of Incorporation. Exhibit 3.3 to the Company’s
Registration Statement on Form SB-2 (No. 33-57728-FW), as
amended (“Registration Statement”), is incorporated herein by
reference.
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3.1(b)
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Certificate
of Amendment to Restated Certificate of Incorporation. Exhibit 3.1 to
the Company’s Current Report on Form 8-K dated May 1, 2006 is
incorporated herein by reference.
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3.1(c)
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Certificate
of Designation of Series One Junior Participating Preferred Stock
dated September 2, 1999. Exhibit A to Exhibit 4.1 to the
Company’s Registration Statement on Form 8-A as filed with the
Commission on September 3, 1999 (the “Rights Plan Registration
Statement”), is incorporated herein by reference.
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|
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3.1(d)
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Certificate
of Amendment to Restated Certificate of Incorporation, dated as of
December 16, 2008. Exhibit 3.1(d) to the Company’s Current
Report on Form 8-K dated December 23, 2008 is incorporated herein by
reference.
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3.1(e)
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Certificate
of Amendment to Restated Certificate of Incorporation, dated as of
November 18, 2009. Exhibit 3.1(e) to the Company’s Current Report on
Form 8-K dated November 19, 2009 is incorporated herein by
reference.
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3.2
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Restated
Bylaws of the Company. Exhibit 3.4 to the Registration Statement is
incorporated herein by reference.
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4.1
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Specimen
Common Stock Certificate, $.001 par value, of the Company.
Exhibit 4.1 to the Registration Statement is incorporated herein by
reference.
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4.2
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Rights
Agreement dated September 1, 1999 between the Company and
Computershare Investor Services LLC (as successor in interest to Harris
Trust & Savings Bank), as Rights Agent. Exhibit 4.1 to the Rights
Plan Registration Statement is incorporated herein by
reference.
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4.3
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First
Amendment to Rights Agreement, dated as of September 6, 2002, between
the Company, Harris Trust & Savings Bank and Computershare Investor
Services LLC. Exhibit 4.3 to Amendment No. 1 to the Rights Plan
Registration Statement on Form 8-A/A as filed with the Commission on
September 11, 2002 is incorporated herein by
reference.
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4.4
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Second
Amendment to Rights Agreement, dated as of October 30, 2002, between
the Company and Computershare Investor Services LLC. Exhibit 4.4 to
Amendment No. 2 to the Rights Plan Registration Statement on
Form 8-A/A as filed with the Commission on October 31, 2002 is
incorporated herein by reference.
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4.5
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Third
Amendment to Rights Agreement, dated as of June 30, 2005, between the
Company and Computershare Trust Company, Inc. (as successor in interest to
Computershare Investor Services, LLC). Exhibit 4.4 to the Company’s
Current Report on Form 8-K as filed with the Commission on
June 30, 2005 is incorporated herein by reference.
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4.6
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Fourth
Amendment to Rights Agreement, dated as of January 9, 2008, between the
Company and Computershare Trust Company, Inc. (as successor in interest to
Computershare Investor Services, LLC). Exhibit 4.5 to the Company’s
Current Report on Form 8-K as filed with the Commission on January 10,
2008 is incorporated herein by reference.
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4.7
|
Fifth
Amendment to Rights Agreement, dated as of October 10, 2008, between the
Company and Computershare Trust Company, N.A. Exhibit 4.6 to the Company’s
Current Report on Form 8-K as filed with the Commission on October 10,
2008 is incorporated herein by reference.
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4.8
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Form
of Rights Certificate. Exhibit B to Exhibit 4.1 to the Rights
Plan Registration Statement is incorporated herein by
reference.
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5.1*
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Opinion
of Winstead PC.
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23.1*
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Consent
of PricewaterhouseCoopers LLP, independent registered public accounting
firm.
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23.2*
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Consent
of Winstead PC (included in Exhibit 5.1).
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24.1
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Power
of Attorney (included in the signature
page).
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* Filed
herewith.
II-7