Attached files
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8-K - REPROS THERAPEUTICS INC. | v164475_8k.htm |
EX-10.2 - REPROS THERAPEUTICS INC. | v164475_ex10-2.htm |
EX-99.1 - REPROS THERAPEUTICS INC. | v164475_ex99-1.htm |
EX-10.1 - REPROS THERAPEUTICS INC. | v164475_ex10-1.htm |
Contact:
|
Joseph
S. Podolski
|
Chief Executive Officer
(281) 719-3447
Repros
Therapeutics Announces Settlement with Major Creditors
THE
WOODLANDS, Texas, October 30, 2009 – Repros Therapeutics (NasdaqGM:RPRX) today
announced that the Company has entered into a settlement agreement with its
major creditors for the large majority of the debt incurred associated with the
recently suspended Proellex® clinical
program.
Previously
the Company announced in early August 2009 that it had voluntarily suspended
dosing of all patients in its Proellex clinical trials. The FDA
subsequently notified Repros that the Proellex program was placed on full
clinical hold due to the observation of increased liver enzymes in a number of
patients treated with Proellex. These elevated liver enzyme
observations occurred during the time that the Company was attempting to raise
additional capital to fund its continued operations and the Proellex program in
particular. The liver enzyme issue resulted in a failure of the fund
raising activity and led to a situation where the Company had more debt than
cash. If this situation were to remain unresolved, Repros would face
bankruptcy.
The
creditor settlement allows for Repros to repay ten of its major creditors a
total of nearly $9 million of debt incurred during the execution of the Proellex
clinical studies. The creditors include clinical research
organizations, clinical investigator sites, clinical laboratories and a
manufacturer of clinical supplies. Repros will repay the debt with a
mixture of cash and unregistered stock. The unregistered stock is
priced at $1.10 which is the last transaction price of Repros stock at the close
of regular trading on Thursday, October 29, 2009. The settlement
calls for $2,849,051 to be paid in cash and $6,054,233 to be paid in
unregistered stock. Repros will use its reasonable best efforts to
register the stock in a timely fashion. The settlement also provides
for the dismissal with prejudice of pending lawsuits brought against Repros by
creditors participating in the agreement. In addition the Company is
concurrently attempting to resolve claims from approximately another 60 smaller
creditors that are owed a total of about $1.6 million.
Joseph
Podolski, Repros CEO, commented, “The last few months have clearly been
difficult times, not only for the Company and its shareholders, but also the
Company’s creditors. The creditor settlement and the recently
announced NIH amendment provide us with the opportunity to seek to obtain value
from the Proellex program.” He further noted, “The creditor
settlement is an important first step in addressing our balance sheet issues and
allows us to continue our Androxal® program
for the immediate future while we pursue additional financing and strategic
options. We have recently submitted a request for a Type C meeting
with the FDA to discuss our latest findings for Androxal.”
Mr.
Podolski continued: “We hope to determine with the FDA whether the previously
reported preservation of fertility while being treated for secondary
hypogonadism is a clinically relevant outcome which would allow for a clear
clinical path for Androxal, an oral treatment that restores testicular
function. There can be no assurances that the FDA will deem fertility
preservation during treatment as clinically relevant and sufficient to support
efficacy of the drug. Previously Repros showed Androxal to be non
inferior to Androgel when comparing circulating testosterone
levels. Androgel is a topical testosterone gel and the leading
testosterone treatment with reported US sales of over $400
million. Unlike Androgel or exogenous testosterone treatments in
general, Androxal does not suppress the hypothalamic-pituitary-testes axis as
evidenced by secretion of normal pituitary hormones as well as normalization of
testicular production of testosterone and sperm when hypogonadal men are
administered Androxal.”
About
Repros Therapeutics Inc.
Repros
Therapeutics focuses on the development of oral small molecule drugs for major
unmet medical needs that treat male and female reproductive
disorders.
Any
statements that are not historical facts contained in this release are
forward-looking statements that involve risks and uncertainties, including
Repros' ability to raise needed additional capital in the immediate future in
order for it to continue its operations on acceptable terms or at all, to settle
or otherwise resolve its outstanding liabilities resulting from the Proellex
clinical trials recently put on clinical hold, to successfully defend
itself against the recently-filed class action complaints, to continue to
maintain its listing on any Nasdaq trading market, whether a clear clinical path
for Androxal can be realized, the eventual outcome of the recent discussions and
correspondence with the FDA regarding the Proellex clinical trials currently on
clinical hold and whether clinical trials of Proellex may be resumed,
whether any safe and effective dose for Proellex can be determined, whether the
NIH license for Proellex can be maintained, and such other risks which are
identified in the Company's most recent Annual Report on Form 10-K and in any
subsequent quarterly reports on Form 10-Q. These documents are available on
request from Repros Therapeutics or at www.sec.gov. Repros disclaims any
intention or obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
For more
information, please visit the Company's website at
http://www.reprosrx.com.