-----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, OOs8O8ttyn8P+MvZEkuvRtMiP7u6/XL0mq8ONS3JwUYCXOOgC03RTF8Q7RkyWLbj AL6tK8ZBtsWEpIbFy27JuQ== 0000950129-08-001757.txt : 20080318 0000950129-08-001757.hdr.sgml : 20080318 20080317173323 ACCESSION NUMBER: 0000950129-08-001757 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080317 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080318 DATE AS OF CHANGE: 20080317 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: 08694257 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 h55038e8vk.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 17, 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 2.02   Results of Operations and Financial Condition
     On March 17, 2008 Repros Therapeutics Inc., a Delaware corporation (the “Company”), announced financial results for the year and fourth quarter ended December 31, 2007 and provided a clinical development program overview. Additional information is included in the Company’s press release dated March 17, 2008, which is attached hereto as Exhibit 99.1.
     The information in this Item 2.02 of this Current Report is being furnished pursuant to Item 2.02 of Form 8-K and, according to general instruction B.2. thereunder, the information in this Item 2.02 of this Current Report shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section. The information in this Item 2.02 of this Current Report shall not be incorporated by reference into any registration statement pursuant to the Securities Act of 1933.
Item 9.01.   Financial Statements and Exhibits
     c. Exhibits
         
Exhibit    
Number   Description
       
 
  99.1    
Press Release dated March 17, 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.
         
  Repros Therapeutics Inc.
 
 
Date: March 17, 2008  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 17, 2008.

 

EX-99.1 2 h55038exv99w1.htm PRESS RELEASE exv99w1
 

Exhibit 99.1
Repros Therapeutics Inc. Reports Fourth Quarter and Year End 2007 Financial Results and Provides
Clinical Development Program Overview
THE WOODLANDS, Texas — March 17, 2008 — Repros Therapeutics (NasdaqGM: RPRX) today announced financial results for the year and fourth quarter ended December 31, 2007 and provided a clinical development program overview.
Financial Results
Total revenues which consisted of only interest income increased 153% to $1.5 million for 2007 as compared to $596,000 for 2006 primarily due to an increase in marketable securities as a result of the completion of our public offering on February 5, 2007 in which we received approximately $33.1 million in net proceeds.
Research and development expenses, including contracted clinical activities, regulatory affairs and general research expenses increased 4% to $12.4 million in 2007 from $11.9 million in 2006. The increased expenses for 2007 are primarily due to an increase in our clinical and preclinical activities of $406,000, an increase of $312,000 in consulting fees, an increase of $243,000 in personnel costs, and an increase in non-cash stock option compensation expense of $127,000, partially offset by a decrease in manufacturing activities of $646,000.
General and administrative expenses decreased 3% to $2.8 million for 2007 from $2.9 million for 2006. The decrease in expenses is primarily due to a decrease of $156,000 in professional services.
Net loss for the three-month period ended December 31, 2007, was ($3.3) million or ($0.26) per share as compared to a net loss of ($5.4) million or ($0.54) per share for the same period in 2006 and was ($13.7) million or ($1.09) per share for the twelve-month period ended December 31, 2007 as compared to ($14.2) million or ($1.40) per share for the same period in 2006. The increase in loss per share for the three-month and twelve-month periods ended December 31, 2007 was primarily due to increased spending in our clinical development programs, personnel and an increase in non-cash stock option compensation expense.
As of December 31, 2007, we had cash, cash equivalents and marketable securities of approximately $25.9 million as compared to $6.7 million at December 31, 2006. As of December 31, 2007 we had 12,774,904 shares of common stock outstanding.
Clinical Development Program Overview
Proellex
In the first quarter of 2008 we filed an Investigational New Drug Application, or IND, for Proellex for a new indication, uterine fibroid induced anemia. During the first quarter of 2008 we also initiated the following clinical trials:

 


 

    Two 65 patient registration Phase 3 Pivotal clinical trials with Proellex for the short course treatment of uterine fibroid induced anemia
 
    Two 75 patient registration Phase 3 Pivotal clinical trials with Proellex for the chronic treatment of uterine fibroids.
 
    Two 400 patient Open Label Safety Trials with Proellex
We also have the following ongoing clinical trials with Proellex:
    U.S. Open Label Safety Trial, anticipate providing available safety trial data around the end of the first quarter 2008
 
    U.S. Phase 2 clinical trial with Proellex for the treatment of endometriosis, anticipate providing interim data late in the second quarter 2008
Androxal
We anticipate initiating the following clinical trials with Androxal in the second quarter of 2008:
    Phase 2b trial to treat men with adult-onset idiopathic hypogonadism, or AIHH, with concomitant glycemic and lipid elevations
    Phase 2b trial in men with low testosterone levels wanting to improve or maintain their fertility and/or sperm function
About Repros Therapeutics
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 anemia associated with uterine fibroids, two registration Phase 3 pivotal trials for the chronic treatment of uterine fibroids and two 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 anemia associated with uterine fibroids 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.
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 the second quarter of 2008. One of these trials will be in men with adult-onset idiopathic hypogonadotrophic 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 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. LH and FSH are the pituitary hormones that stimulate testicular testosterone and sperm production, respectively. 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.
REPROS THERAPEUTICS INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands except per share amounts)
                                 
    Three Months Ended     Twelve Months Ended  
    December 31,     December 31,  
    2007     2006     2007     2006  
    (Unaudited)     (Unaudited)                  
Revenues
                               
Interest income
  $ 352     $ 110     $ 1,508     $ 596  
 
                       
Total revenues
    352       110       1,508       596  
 
                       
 
                               
Expenses
                               
Research and development
    2,989       4,668       12,420       11,912  
General and administrative
    670       890       2,788       2,879  
 
                       
Total expenses
    3,659       5,558       15,208       14,791  
 
                       
 
                               
Net loss
  $ (3,307 )   $ (5,448 )   $ (13,700 )   $ (14,195 )
 
                       
 
                               
Net loss per share — basic and diluted
  $ (0.26 )   $ (0.54 )   $ (1.09 )   $ (1.40 )
 
                       
 
                               
Weighted average shares used in loss per share calculation:
                               
Basic
    12,775       10,151       12,524       10,147  
Diluted
    12,775       10,151       12,524       10,147  
CONSOLIDATED BALANCE SHEETS
                 
    December 31,     December 31,  
    2007     2006  
Cash and cash equivalents
  $ 1,779     $ 1,136  
Marketable securities
    24,124       5,600  
Other currents assets
    479       225  
Fixed assets (net)
    47       65  
Other assets (net)
    1,170       823  
 
           
Total assets
  $ 27,599     $ 7,849  
 
           
 
               
Accounts payable and accrued expenses
  $ 3,539     $ 4,059  
Stockholders’ equity
    24,060       3,790  
 
           
Total liabilities and stockholders’ equity
  $ 27,599     $ 7,849  
 
           
     
Contact:
  Joseph S. Podolski
 
  President & CEO
 
   
 
  (281) 719-3447

 

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