-----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, QsNAPjHzF5xq3y5lCPgMMg1HB7Gi5B10CzzbmLHYgocD1vHn8Wihn26JokFgNkS/ e2bJ2QnkzNgY0RFiqf4Tvg== 0000950129-08-002953.txt : 20080512 0000950129-08-002953.hdr.sgml : 20080512 20080512170952 ACCESSION NUMBER: 0000950129-08-002953 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080509 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080512 DATE AS OF CHANGE: 20080512 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: 08824607 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 h56809e8vk.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): May 9, 2008
Repros Therapeutics Inc.
(Exact name of registrant as specified in its charter)
         
Delaware
(State or other jurisdiction of
incorporation or organization)
  001-15281
(Commission File Number)
  76-0233274
(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 May 9, 2008 Repros Therapeutics Inc., a Delaware corporation (the “Company”), announced financial results for the first quarter ended March 31, 2008 and provided a clinical development program overview. Additional information is included in the Company’s press release dated May 9, 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 8.01. Other Information
     Repros Therapeutics Inc. announced in a press release today results from its pilot study of Proellex® in the treatment of uterine fibroids.
Item 9.01. Financial Statements and Exhibits
     c. Exhibits
     
Exhibit    
Number   Description
99.1
  Press Release dated May 9, 2008
99.2
  Press Release dated May 12, 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: May 12, 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 May 9, 2008.
99.2
  Press Release dated May 12, 2008

 

EX-99.1 2 h56809exv99w1.htm PRESS RELEASE exv99w1
Exhibit 99.1
Repros Therapeutics Inc. Reports First Quarter 2008 Financial Results and Provides
Clinical Development Program Overview
Live Conference Call, May 12, 2008, at 1:00 p.m. Eastern Time
THE WOODLANDS, Texas — May 9, 2008 — Repros Therapeutics (NasdaqGM: RPRX) today announces financial results for the first quarter ended March 31, 2008 and provides a clinical development program overview.
Financial Results
Total revenues which consisted of only interest income decreased 15% to $269,000 for the three-month period ended March 31, 2008 as compared to $318,000 for the same period in the prior year primarily due to lower cash balances.
Research and development expenses, including contracted clinical activities, regulatory affairs and general research expenses increased 104% to $6.2 million for the three-month period ended March 31, 2008 from $3.0 million for the same period in the prior year. The increased expenses are primarily due to an increase in our clinical and preclinical activities of $3.4 million, partially offset by a decrease in manufacturing activities of $349,000.
General and administrative expenses decreased 15% to $797,000 for the three-month period ended March 31, 2008 from $941,000 for the same period in the prior year. The decrease in expenses is primarily due to a decrease of $97,000 in non-cash stock compensation expense and a decrease in professional services of $51,000.
Net loss for the three-month period ended March 31, 2008, was ($6.7) million or ($0.52) per share as compared to a net loss of ($3.7) million or ($0.31) per share for the same period in 2007. We incurred increased expenses in the three-month period ended March 31, 2008 as compared to the same period in 2007 primarily due to increased clinical development activities during that period relating to our Proellex® clinical program.
As of March 31, 2008, we had cash, cash equivalents and marketable securities of approximately $19.6 million as compared to $25.9 million at December 31, 2007. As of March 31, 2008 we had 12,774,904 shares of common stock outstanding.
Clinical Development Program Overview
Proellex®
On March 31, 2008, we announced that the interim results from our ongoing 12-month Open Label Safety Extension Trial with Proellex for the treatment of symptoms associated with uterine fibroids showed that the occurrence of breakthrough bleeding associated with this class of compounds can be controlled successfully with repeated four-month cycles of treatment each followed by an off drug interval. At that time the trial had been underway for 15 months. We continue to gather additional safety data from this trial and at this time have not observed any unexpected safety findings relating to the use of Proellex. We expect to provide interim data relating to patients being treated with Proellex for symptoms associated with endometriosis from our ongoing U.S. Phase 2 trial before the end of the second quarter of 2008.
In the first quarter of 2008 we initiated the following clinical trials with Proellex: two 65-patient

 


 

registration Phase 3 Pivotal clinical trials as a pre-surgical short course (three-month) treatment of anemia associated with uterine fibroids: two 75-patient registration Phase 3 Pivotal clinical trials for the chronic treatment of symptomatic uterine fibroids and two 400-patient Open Label Safety Trials.
We continue to advance the activities relating to these trials and expect to see patient enrollment for some of these trials during the second quarter of 2008. Our goal is to file an NDA for Proellex near year-end 2008 for use as a pre-surgical three-month treatment of anemia associated with uterine fibroids.
Androxal®
We are on schedule to enter two clinical trials with Androxal by the end of the second quarter of 2008 which includes: one Phase 2b trial to treat men with low testosterone and adult-onset idiopathic hypogonadotrophic hypogonadism, or AIHH, with concomitant plasma glucose and lipid elevations and one Phase 2b trial in men with low testosterone levels wanting to improve or maintain their fertility and/or sperm function.
Live Conference Call Information
     Repros management will hold a conference call to provide an update on the company’s progress and to answer investor questions at 1:00 p.m. Eastern Time on May 12, 2008.
Conference Call Information
Domestic callers: 866-237-3252
International callers: 719-457-1018
Passcode: 379126
     A replay of the conference call will be available for 48 hours. To access the replay, dial 888-348-4629 (Domestic) and 719-884-8882 (International) and enter the passcode #379126. The replay will also be available on the Repros website, www.reprosrx.com approximately 24 hours after the call ends.
About Repros Therapeutics
Repros Therapeutics focuses on the development of oral small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.
Our lead drug, Proellex®, is a selective blocker of the progesterone receptor and is being developed for the treatment of symptoms associated with uterine fibroids and endometriosis. We are also developing Proellex as a short course pre-surgical treatment for anemia associated with excessive menstrual bleeding related to uterine fibroids. There is no currently-approved effective long-term orally administered 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 product candidate, Androxal®, is a single isomer of clomiphene citrate and is an orally active proprietary small molecule compound. We are developing Androxal for men with low testosterone and

 


 

adult-onset idiopathic hypogonadotrophic hypogonadism (“AIHH”) with concomitant plasma glucose and lipid elevations, all of which are components of Metabolic Syndrome. We are also 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.
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 additional capital in a timely manner and on acceptable terms or at all, 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 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.
[NOTE TO BOWNE-INSERT EXCEL SPREADSHEET HERE]
     
Contact:
  Joseph S. Podolski
 
  President & CEO
 
   
 
  (281) 719-3447

 


 

REPROS THERAPEUTICS INC. AND SUBSIDIARY
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands except per share amounts)
                 
    Three Months Ended  
    March 31,  
    2008     2007  
    (Unaudited)     (Unaudited)  
Revenues
               
Interest income
  $ 269     $ 318  
 
           
Total revenues
    269       318  
 
           
 
               
Expenses
               
Research and development
    6,166       3,028  
General and administrative
    797       941  
 
           
Total expenses
    6,963       3,969  
 
           
 
               
Net loss
  $ (6,694 )   $ (3,651 )
 
           
 
               
Net loss per share — basic and diluted
  $ (0.52 )   $ (0.31 )
 
           
 
               
Weighted average shares used in loss per share calculation:
               
Basic
    12,775       11,756  
Diluted
    12,775       11,756  
CONSOLIDATED BALANCE SHEETS
                 
    March 31,     December 31,  
    2008     2007  
    (Unaudited)          
Cash and cash equivalents
  $ 11,570     $ 1,779  
Marketable securities
    8,041       24,124  
Prepaid expenses and other currents assets
    863       479  
Fixed assets (net)
    43       47  
Patents (net)
    1,304       1,170  
 
           
Total assets
  $ 21,821     $ 27,599  
 
           
 
               
Accounts payable and accrued expenses
  $ 4,263     $ 3,539  
Stockholders’ equity
    17,558       24,060  
 
           
Total liabilities and stockholders’ equity
  $ 21,821     $ 27,599  
 
           

 

EX-99.2 3 h56809exv99w2.htm PRESS RELEASE exv99w2
Exhibit 99.2
Repros Therapeutics Inc. Announces That Proellex® Shows No Adverse Cardiac Effects In
A Pilot Trial
THE WOODLANDS, Texas—(BUSINESS WIRE) May, 12, 2008—Repros Therapeutics Inc. (NasdaqGM:RPRX) today released encouraging results from its pilot study of the potential for adverse cardiac events associated with administration of doses of Proellex up to four times higher than the intended marketed dose. The study was designed to assess the potential for QT prolongation, an indicator of potential adverse cardiac effects and a major safety consideration for the FDA.
Study Results
In preparation for conducting a thorough QT study (TQT), Repros has completed a pilot trial dosing healthy female volunteers for seven days with Proellex 200 mg. Formal QT studies are dosed for five days. This Proellex dose is 4 to 8 times the dose shown to be effective in our uterine fibroid and endometriosis trials. Subjects all had baseline electrocardiograms (ECGs) and blood tests for safety and were dosed with Proellex 200 mg daily for 7 days. ECGs were done at baseline and 2 hours after dosing on days 1, 3, 5, and 7. In addition Proellex pharmacokinetic assessments were performed at frequent intervals on Days 1 and 7 for 24 and 36 hours respectively. Analysis of the ECGs on days 1, 3, 5 and 7 of dosing showed that compared with baseline the change in QTc interval at 2 hours, which approximates the maximum blood concentration after dosing, was 0.20, - -2.71, 4.00 and -5.33 milliseconds (ms) respectively. Mean (SD) QTc intervals at baseline and Day 7 were 409.2 (11.34) and 406.67 (9.29) respectively. None of the measurements during treatment were statistically different from each other or baseline. Mean Proellex blood levels at 2 hours after dosing on Days 1 and 7 were 824 and 2121.7 ng/mL respectively. The increasing blood concentration over the 7 days of exposure is due to the fact that the compound has a half life of 17 hours. Despite this increase in Proellex concentration over 7 days the QTc did not change.
Dr. Andre van As, Chief Medical Officer of Repros commented, “Although this was a small pilot study to determine the highest tolerable dose of Proellex in preparation for the TQT study, the data showed that the QTc did not exceed 5ms at any time in the face of increasing blood concentrations. These blood levels are significantly higher than has been achieved with the highest dose we have used in clinical trials to date (50 mg), which suggests that Proellex has a good safety margin. In addition there were no other ECG abnormalities. ECGs from our other clinical studies, read by an independent cardiac reference laboratory, have shown no adverse effects or QTc prolongation. The fact that Proellex is very highly protein bound in the plasma (>97%) is important in determining its safety as this prevents the accumulation of drug in critical tissues such as the heart. The dose used in this study is four times higher than our highest intended marketed dose of 50 mg. We are proceeding with our planning for the TQT study.”
Background Information on QT Interval
Some non-antiarrhythmic drugs delay electrical repolarization of the heart muscle, an effect that can be measured as prolongation of the QT interval on a routine electrocardiogram (ECG). A delay in cardiac repolarization, and a prolongation of the QT interval, creates an electrophysiological environment in the heart muscle that favors the development of irregularities of heart rhythm, most significantly Torsade de Pointes (TdP), which can result in ventricular fibrillation leading to sudden death. Because of its inverse relationship to heart rate, the measured QT interval is routinely corrected by means of various formulae, to a value known as the QTc interval that is less heart rate dependent. The FDA has clear guidelines for

 


 

an extensive placebo and active controlled study to examine the effect of drugs on cardiac rhythm and this is referred to as a “thorough QT/QTc study” (TQT) which is conducted in healthy volunteers. Drugs that prolong the mean QT/QTc interval by >20 ms have a substantially increased likelihood of being pro-arrhythmic and therefore represent increased safety risk. On the other hand a QTc prolongation of 5ms or less is unlikely to be associated with arrhythmias.
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.
Our lead drug, Proellex®, is a selective blocker of the progesterone receptor and is being developed for the treatment of symptoms associated with uterine fibroids and endometriosis. We are also developing Proellex as a short course pre-surgical treatment for anemia associated with excessive menstrual bleeding related to uterine fibroids. There is no currently-approved effective long-term orally administered 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 product candidate, Androxal®, is a single isomer of clomiphene citrate and is an orally active proprietary small molecule compound. We are developing Androxal for men with low testosterone and adult-onset idiopathic hypogonadotrophic hypogonadism (“AIHH”) with concomitant plasma glucose and lipid elevations, all of which are components of Metabolic Syndrome. We are also 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.
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 additional capital in a timely manner and on acceptable terms or at all, 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 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
 
   
 
  (281) 719-3447

 

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