-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, N1RAOKf9xiWFyocp8KG/1bVXhzdn+6Txrq+vnBhPPWuWIr9PASvYX13ilS2Zi/+M y42jDAdVfw2gkwl6couxkg== 0001144204-10-001306.txt : 20100111 0001144204-10-001306.hdr.sgml : 20100111 20100111131841 ACCESSION NUMBER: 0001144204-10-001306 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20100111 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100111 DATE AS OF CHANGE: 20100111 FILER: COMPANY DATA: COMPANY CONFORMED NAME: REPROS THERAPEUTICS INC. CENTRAL INDEX KEY: 0000897075 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 760233274 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-15281 FILM NUMBER: 10519642 BUSINESS ADDRESS: STREET 1: 2408 TIMBERLOCH PL STREET 2: SUITE B-7 CITY: WOODLANDS STATE: TX ZIP: 77380 BUSINESS PHONE: 2817193400 MAIL ADDRESS: STREET 1: 2408 TIMBERLOCH PLACE B-7 CITY: THE WOODLANDS STATE: TX ZIP: 77380 FORMER COMPANY: FORMER CONFORMED NAME: REPROS THERAPEUTICS INC DATE OF NAME CHANGE: 20060503 FORMER COMPANY: FORMER CONFORMED NAME: ZONAGEN INC DATE OF NAME CHANGE: 19930208 8-K 1 v171073_8k.htm Unassociated Document

 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.  20549
 
FORM 8-K
 
Current Report Filed Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
 
 
Date of Report
(Date of earliest event reported): January 11, 2010
 
 
Repros Therapeutics Inc.
(Exact name of registrant as specified in its charter)

Delaware
001-15281
76-0233274
(State or other jurisdiction of
incorporation or organization)
(Commission File Number)
(I.R.S. Employer Identification No.)
2408 Timberloch Place, Suite B-7
The Woodlands, Texas  77380
(Address of principal
executive offices
and zip code)
 
(281) 719-3400
(Registrant’s telephone
number, including area
code)
 


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2 below):

o           Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o           Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o           Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o           Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 
 

 
 
Item 8.01  Other Events.
 
On January 11, 2010, Repros Therapeutics Inc. (the “Company”) issued a press release titled “Repros Shelf Registrations of Stock are Effective.”  The press release also contained an update on the Company's various development programs.  A copy of such press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01  Financial Statements and Exhibits.
 
(d)  Exhibits.
 
Exhibit
Number
 
Description
99.1
Press Release dated January 11, 2010 
                                        
 
 

 

SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
  Repros Therapeutics Inc.  
     
Date:  January 11, 2010    
       
 
By:
/s/ Joseph S. Podolski
 
   
Joseph S. Podolski
 
   
President and Chief Executive Officer
 
       
 
 
 

 
 
EXHIBIT INDEX
 
Exhibit
Number
 
Description
99.1
Press Release dated January 11, 2010 
 
 
 

 
 
EX-99.1 2 v171073_ex99-1.htm Unassociated Document
Exhibit 99.1
 
REPROS SHELF REGISTRATIONS OF STOCK ARE EFFECTIVE
Company Updates Status


THE WOODLANDS, Texas – January 11, 2010   Repros Therapeutics Inc. (NasdaqGM:RPRX) today announced that the two previously filed shelf registration statements (S-3’s) are now effective. The first S-3, which became effective on January 7, 2010, registers stock that was issued to resolve previous creditor debt. The second S-3 is a universal shelf registration that allows the Company to issue up to $20 million worth of Repros preferred stock, common stock or warrants to acquire securities.

The Company recently submitted to the FDA a new IND for Androxal® for the treatment of Type II diabetes in men experiencing secondary hypogonadism. The potential for this indication was first exhibited in a retrospective analysis of data obtained from men exhibiting elevated fasting glucose levels during a previously conducted study of Androxal in men with low testosterone due to a hypothalamic-pituitary defect commonly known as secondary hypogonadism. Androxal exhibited a positive impact (reduction) of fasting glucose levels while neither testosterone nor placebo had effects to a similar degree. Repros is presently awaiting an FDA response. Additionally the Company has submitted a briefing package to the FDA regarding the impact of Androxal on sperm counts in men undergoing treatment for low testosterone with the goal of developing Androxal for the treatment of secondary hypogonadism in men wishing to preserve fertility during treatment for their hypogonadal state.  The Company expects to interact with the FDA regarding both filings later this month.

The Company is also completing its analysis of the liver toxicity issues associated with Proellex® and anticipates submitting data along with a request for a Type C meeting during February of 2010. The Company believes that a safe and effective oral dose of Proellex can be realized. Preliminary analysis of available data suggests that a 12.5mg dose of Proellex or lower will not impinge on the 95% confidence level of exposures exhibited by the highest dose (50mg), at which there was a significant impact on liver enzymes. Significantly, the 12.5mg dose was statistically different regarding level of exposure than even the 25mg dose. These observations are now undergoing rigorous analyses by a reputable third party technical organization before the information is submitted to the FDA. In previous Phase II studies with a 12.5mg dose of Proellex, both statistically and clinically significant results were achieved when assessing key symptoms of uterine fibroids, and in the case of endometriosis no statistical difference was observed comparing the 12.5 mg dose to a GnRH agonist when viewed from the perspective of pelvic abdominal pain. However, there can be no assurances that the current third party assessment will yield similar results or that the FDA will view the Proellex findings meaningful regarding the lifting of the current clinical hold.

Joseph S. Podolski, President and CEO of Repros noted, “The last quarter of 2009 has been especially difficult for everyone associated with the Company. This has been particularly true for our creditors and shareholders. During the last three months we have reduced expenses, resolved a significant percentage of our debt and continue to make modest progress on our technologies.  The effectiveness of our new universal shelf registration statement provides Repros with several customary vehicles to raise additional working capital in order to allow us to continue to pursue our technical programs in a timely fashion.”

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 maintain its listing on the NASDAQ Global Market or qualify for moving its listing to the NASDAQ Capital Market, raise needed additional capital on a timely basis in order for it to continue its operations, have success in the clinical development of its technologies,  successfully defend itself against the class action complaints;  the occurrence, timing and outcome of any meetings with the FDA, whether clinical trials of Proellex may be resumed, whether any safe and effective dose for Proellex can be determined, whether a clear clinical path for Androxal can be determined 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.

Contact:
Repros Therapeutics Inc.
Joseph Podolski (281) 719-3447
President and Chief Executive Officer
 
 

 
 
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