-----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, Bhu5j5jI9T/71S7fUp2+WRaW/W8zI1/LmPRMuNfRa2i3ohXB2us5t/5P4hkktgTv vznpjcx7QVmbIb+XNiPTgw== 0000950129-08-001694.txt : 20080314 0000950129-08-001694.hdr.sgml : 20080314 20080314113115 ACCESSION NUMBER: 0000950129-08-001694 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080313 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080314 DATE AS OF CHANGE: 20080314 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: 08688210 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 h54980e8vk.htm FORM 8-K - CURRENT REPORT e8vk
 

 
 
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): March 13, 2008
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 7.01. Regulation FD Disclosure
     Repros Therapeutics Inc. (the “Company”) announced today that it will report financial results for the quarter and year ended December 31, 2007, before the market opens on March 17, 2008. Repros management will hold a conference call to provide an update on the company’s progress and to answer investor questions at 12:00 noon CT on the same day. Investors can access the call by dialing 866-237-3252 (within the United States) or 719-457-1018 (International). The Passcode is 442473.
Item 9.01. Financial Statements and Exhibits
     c. Exhibits
     
Exhibit    
Number   Description
99.1
  Press Release dated March 13, 2008.

 


 

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.
         


Date: March 14, 2008
Repros Therapeutics Inc.

 
 
 
  By:   /s/ Louis Ploth, Jr.    
    Louis Ploth, Jr.  
    Vice President, Business Development
and Chief Financial Officer 
 

 


 

         
EXHIBIT INDEX
     
Exhibit    
Number   Description
99.1
  Press Release dated March 13, 2008

 

EX-99.1 2 h54980exv99w1.htm PRESS RELEASE exv99w1
 

Exhibit 99.1
REPROS TO REPORT FOURTH QUARTER AND FULL YEAR 2007 FINANCIAL RESULTS
ON MARCH 17, 2008
Live Conference Call, March 17, 2008, at 12:00 noon Central Time
     THE WOODLANDS, Texas, March 13, 2008 — Repros Therapeutics Inc. (NasdaqGM:RPRX) today announced that is will report financial results for the quarter and year ended December 31, 2007, before the market opens on March 17, 2008. Repros management will hold a conference call to provide an update on the company’s progress and to answer investor questions at 12:00 noon CT on the same day.
Conference Call Information
Domestic callers: 866-237-3252
International callers: 719-457-1018
Passcode: 442473
     A replay of the conference call will be available for 48 hours. To access the replay, dial 888-203-1112 (Domestic) and 647-436-0148 (International) and enter the passcode #7465017. The replay will also be available on the Repros website, www.reprosrx.com approximately 24 hours after the call ends.
     About Repros Therapeutics Inc.
     Repros Therapeutics focuses on the development of oral small molecule drugs for major unmet medical needs. We have a proven track-record of efficient and rapid advancement of our therapeutic candidates through clinical development.
     Our lead drug, Proellex®, is a selective blocker of the progesterone receptor and is targeted for the treatment of uterine fibroids, endometriosis and anemia associated with uterine fibroids. During the first quarter of 2008 we initiated two registration Phase 3 pivotal trials with Proellex as a pre-surgical short course treatment of uterine fibroid induced anemia, two registration Phase 3 pivotal trials for the chronic treatment of uterine fibroids and two long-term Open Label Safety Studies. In addition, we have an ongoing U.S. Phase 2 clinical trial underway for the treatment of endometriosis. Uterine fibroids, endometriosis and uterine fibroid associated anemia affect a significant number of women of childbearing age in the developed world. There is no currently-approved effective long-term drug treatment for uterine fibroids or endometriosis. In the United States alone, 300,000 women per year undergo a hysterectomy as a result of severe uterine fibroids. We have estimated the market opportunity addressed by Proellex to be in excess of $3 billion annually.
     Our second drug, Androxal®, is a single isomer of clomiphene citrate. Androxal restores normal pituitary response in men with secondary hypogonadism and normalization of testosterone and luteinizing hormone (LH) levels. Androxal is entering two Phase 2b clinical trials in Q2, 2008. One of these trials will be in men with adult-onset idiopathic hypogonadism (AIHH) with concomitant plasma glucose and lipid elevations, all of which are components of

 


 

Metabolic Syndrome. Recent published studies in older men show a link of low testosterone with higher incidences of insulin resistance, diabetes and consequently mortality rates. Based on a retrospective review of a recently completed six-month clinical trial of Androxal, our findings showed that Androxal therapy resulted in a significant reduction in mean glucose levels in men with a body mass index (BMI) >26 and glucose levels >104 mg/dL, an outcome not seen in the placebo or Androgel® arms of this study. The second Phase 2b Androxal trial to begin in the second quarter of 2008 will be in men of reproductive age with low testosterone levels who want to improve or maintain fertility/sperm function. We believe Androxal will be superior to the existing drugs used to normalize testosterone as only Androxal has the property of restoring both LH and follicle stimulating hormone (FSH) levels. FSH is the pituitary hormone that stimulates testicular sperm production. It is estimated that 13 million men in the United States are testosterone deficient.
Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Repros’ ability to have success in the clinical development of its technologies, the timing of enrollment and release of data in such clinical studies and the accuracy of such studies, limited patient populations of clinical studies to date and the possibility that final data may not be consistent with interim data, Repros’ ability to raise additional capital in a timely manner and on acceptable terms or at all 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:
  Joseph S. Podolski
 
  President & CEO
 
  The_Woodlands_1\38786\1
 
  (281) 719-3447

 

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