-----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, Rqjpd2Vm8+a44LFvOGx6wE8P2vCrS2cGm27syrHvOUcUYfg219eDOky/SLeRbdIe lkDnyiq8ANO/NZ9G75Qz6w== 0001144204-10-058906.txt : 20101110 0001144204-10-058906.hdr.sgml : 20101110 20101110122704 ACCESSION NUMBER: 0001144204-10-058906 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20101109 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20101110 DATE AS OF CHANGE: 20101110 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: 101178900 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 v201789_8k.htm
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): November 9, 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 2.02  Results of Operations and Financial Condition.
 
The information in this Item 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 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 of this Current Report shall not be incorporated by reference into any registration statement pursuant to the Securities Act of 1933, as amended.
 
On November 10, 2010, Repros Therapeutics Inc. (the “Company”) announced financial results for the third quarter ended September 30, 2010.  Additional information is included in the Company’s press release dated November 10, 2010.
 
A copy of the Company’s press release is attached hereto as Exhibit 99.1.  The foregoing description of the press release is qualified in its entirety by reference to the attached exhibit.
 
Item 8.01  Other Events.
 
On November 9, 2010, the Company issued a press release titled “Repros® Therapeutics Reports Outcome of Type B Meeting with FDA Regarding Androxal® in the Treatment of Secondary Hypogonadism.”  A copy of such press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.

Item 9.01  Financial Statements and Exhibits.
 
(d)  Exhibits.
 
Exhibit
 
Number
Description
   
99.1
Earnings Release dated November 10, 2010
   
99.2
Press Release dated November 9, 2010
 
 
 

 

SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
  Repros Therapeutics Inc.  
       
Date:  November 10, 2010
By:
/s/ Katherine A. Anderson  
    Katherine A. Anderson  
    Chief Accounting Officer  
       
 
 
 

 
 
EXHIBIT INDEX
 
Exhibit
 
Number
Description
   
99.1
Earnings Release dated November 10, 2010
   
99.2
Press Release dated November 9, 2010
 
 
 

 
 
EX-99.1 2 v201789_ex99-1.htm
Exhibit 99.1
 
Contact: 
Joseph S. Podolski
Chief Executive Officer
(281) 719-3447


Repros Therapeutics Inc.® Reports Third Quarter 2010 Financial Results
and Provides Corporate Update

THE WOODLANDS, Texas -- November 10, 2010 -- Repros Therapeutics Inc.® (NasdaqCM: RPRXD) today announced financial results for the third quarter ended September 30, 2010 and provided an update on corporate actions.

Corporate Update

On October 14, 2010, the Company effected a one-for-four reverse stock split of its common stock.  The split-adjusted shares of the Company’s common stock began trading on the Nasdaq Capital Market on October 15, 2010.  The one-for-four reverse stock split converted all shares of the Company’s common stock issued and outstanding, plus all outstanding stock options and the number of shares of common stock available for issuance under the Company’s approved stock plans.  The number of authorized shares of common stock was not affected by the reverse split.  The reverse split enabled the Company to meet the continued listing rules of the Nasdaq Capital Market.   All share and per share amounts have been retroactively adjusted to reflect the reverse stock split for all periods presented.

Financial Results

Net loss for the three month period ended September 30, 2010, was ($1.2) million or ($0.13) per share as compared to a net loss of ($10.2) million or ($2.64) per share for the same period in 2009.  The net loss for the nine month period ended September 30, 2010, was ($3.6) million or ($0.46) per share as compared to a net loss of ($25.9) million or ($6.77) per share for the same period in 2009.  As stated above, all share and per share amounts have been retroactively adjusted to reflect the reverse stock split for all periods presented.  The decrease in loss for both the three and nine month periods ended September 30, 2010 as compared to the same period in 2009 was primarily due to decreased expenses in clinical development for Proellex® and Androxal®.   In September 2010, the FDA notified us that the full clinical hold on Proellex had been revised to a partial clinical hold to allow us to run a single study to explore both safety and signals of efficacy in an escalating dose fashion.  We began dosing in the third quarter.  We are also currently conducting a Phase 2 trial for Androxal in the treatment of Type 2 diabetes in hypogonadal men.       

Research and development expenses, or R&D, decreased 91% or approximately $7.5 million to $736,000 for the three month period ended September 30, 2010 as compared to $8.3 million for the same period in the prior year.  Our primary R&D expenses for the three month periods ended September 30, 2010 and 2009 are shown in the following table (in thousands):
 
 
 

 
 
Research and Development
Three-months ended
September 30, 2010
 
Three-months ended
September 30, 2009
 
Variance
 
Change (%)
Operating and occupancy
$152
 
$1,551
 
($1,399)
 
(90)%
Payroll and benefits
159
 
344
 
(185)
 
(54)%
Androxal clinical development
163
 
64
 
99
 
153%
Proellex clinical development
262
 
6,323
 
(6,061)
 
(99)%
Total
$736
 
$8,282
 
($7,546)
 
(91)%

R&D expenses decreased 91% or approximately $19.8 million to $1.9 million for the nine month period ended September 30, 2010 as compared to $21.8 million for the same period in the prior year.  Our primary R&D expenses for the nine month periods ended September 30, 2010 and 2009 are shown in the following table (in thousands):

Research and Development
Nine-months ended
September 30, 2010
 
Nine-months ended
September 30, 2009
 
Variance
 
Change (%)
Operating and occupancy
$508
 
$2,026
 
($1,518)
 
(75)%
Payroll and benefits
421
 
1,170
 
(749)
 
(64)%
Androxal clinical development
177
 
775
 
(598)
 
(77)%
Proellex clinical development
844
 
17,794
 
(16,950)
 
(95)%
Total
$1,950
 
$21,765
 
($19,815)
 
(91)%

The decrease in R&D expenses is primarily due to the decreased clinical development expenses related to Proellex as a result of the discontinuation of all clinical trials in August 2009 due to the FDA’s clinical hold on Proellex.  R&D expenses were further decreased by the decreased clinical development expenses related to Androxal due to the completion of a Phase 2b proof-of-concept clinical trial in 2009.   Additionally, payroll and benefits expenses decreased due to reduced headcount and the salary reduction program put in place in August 2009 and revised in May 2010.

General and administrative expenses, or G&A, decreased 73% to approximately $533,000 for the three month period ended September 30, 2010 as compared to $2.0 million for the same period in the prior year.  Our primary G&A expenses for the three month period ended September 30, 2010 and 2009 are shown in the following table (in thousands):

General and Administrative
Three-months ended
September 30, 2010
 
Three-months ended
September 30, 2009
 
Variance
 
Change (%)
Payroll and benefits
$155
 
$767
 
($612)
 
(80)%
Operating and occupancy
378
 
1,195
 
(817)
 
(68)%
Total
$533
 
$1,962
 
($1,426)
 
(73)%
 
 
 

 
 
G&A payroll and benefits expenses include salaries, bonuses, relocation expense, severance costs, non-cash stock option compensation expense and fringe benefits.  Included in payroll and benefits expense is a charge for non-cash stock option expense of $79,000 for the three month period ended September 30, 2010 as compared to $266,000 for the same period in the prior year.  Additionally, salaries for the three month period ended September 30, 2010 were $68,000 as compared to $307,000 for the same period in the prior year.  The decrease in salaries is primarily due to a decrease in headcount and the salary reduction program put in place in August 2009 and revised in May 2010.

G&A operating and occupancy expenses, which include expenses to operate as a public company, decreased 68% to $378,000 for the three month period ended September 30, 2010 as compared to $1.2 million for the same period in the prior year.  The decrease is primarily due to a decrease in professional services.

G&A expenses decreased 57% to approximately $1.8 million for the nine month period ended September 30, 2010 as compared to $4.1 million for the same period in the prior year.  Our primary G&A expenses for the nine month period ended September 30, 2010 and 2009 are shown in the following table (in thousands):

General and Administrative
Nine-months ended
September 30, 2010
 
Nine-months ended
September 30, 2009
 
Variance
 
Change (%)
Payroll and benefits
$460
 
$1,862
 
($1,402)
 
(75)%
Operating and occupancy
1,312
 
2,264
 
(952)
 
(42)%
Total
$1,772
 
$4,126
 
($2,354)
 
(57)%
 
Included in payroll and benefits expense is a charge for non-cash stock option expense of $230,000 for the nine month period ended September 30, 2010 as compared to $711,000 for the same period in the prior year.  Additionally, salaries for the nine month period ended September 30, 2010 were $197,000 as compared to $870,000 for the same period in the prior year.  The decrease in salaries is primarily due to a decrease in headcount and the salary reduction program put in place in August 2009 and revised in May 2010.

G&A operating and occupancy expenses decreased 42% to $1.3 million for the nine month period ended September 30, 2010 as compared to $2.3 million for the same period in the prior year.  The decrease is primarily due to a decrease in professional services and consulting expenses.

Total revenues and other income increased to $85,000 for the three month period ended September 30, 2010 as compared to zero for the same period in the prior year and increased to $138,000 for the nine month period ended September 30, 2010 as compared to $4,000 for the same period in the prior year.  The increase for the three month and nine month periods ended September 30, 2010 was primarily due to an increase of $85,000 and $138,000, respectively, in non-cash other income related to debt relief from settlements with certain vendors in the second and third quarters of 2010.

As of September 30, 2010 we had 8,930,057 shares of common stock outstanding.
 
 
 

 

Liquidity, Capital Resources and Going Concern Uncertainty

As of September 30, 2010, we had cash and cash equivalents of approximately $4.2 million as compared to $1.9 million as of December 31, 2009.  The amount of cash on hand is not sufficient to fund each of the clinical trials currently planned for our two drug candidates, Proellex and Androxal.  Based on these planned clinical trials, we will need to raise additional capital no later than the first quarter of 2011.  Our Annual Report on Form 10-K for the year ended December 31, 2009 includes an explanatory paragraph in the report of its independent registered public accounting firm that there is substantial doubt about Repros’ ability to continue as a “going concern”.  Repros also received a similar going concern opinion for the years ended December 31, 2008 and 2007.

On February 12, 2010, we entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Ladenburg Thalmann & Co. Inc. (“Ladenburg”), pursuant to which we may issue and sell from time to time through Ladenburg, as sales agent and/or principal, shares of our common stock having an aggregate offering price of up to $10 million (the “ATM Shares”).  As of September 30, 2010, we have sold 2,448,572 ATM Shares at a weighted average share price of $2.77, for proceeds of approximately $6.4 million, net of expenses.  Between July 1, 2010 and August 4, 2010, we have sold an aggregate of 277,164 ATM Shares at a weighted average share price of $1.51, for proceeds of approximately $401,000, net of expenses.   Pursuant to General Instruction I.B.6. of Form S-3, we may not sell more than one-third of the aggregate market value of our common stock held by non-affiliates during a period of 12 calendar months immediately prior to, and including, the date of such sale of such common stock.   Due to this limitation, we announced on August 3, 2010 that we have suspended this ATM offering of Company securities.
 
About Repros Therapeutics Inc.

Repros Therapeutics Inc. 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 have the partial hold on Proellex® lifted and to determine a safe and effective dose for Proellex, maintain its listing on the NASDAQ Capital Market, raise needed additional capital on a timely basis in order for it to continue to fund its operations and pursue its development activities, 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)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited and in thousands except per share amounts)
 
   
Three Months Ended
   
Nine Months Ended
 
   
September 30,
   
September 30,
 
 
2010
   
2009
   
2010
   
2009
 
Revenues and other income
                       
Interest income
  $ -     $ -     $ -     $ 4  
Other income
    85       -       138       -  
Total revenues and other income
    85       -       138       4  
                                 
Expenses
                               
Research and development
    736       8,282       1,950       21,765  
General and administrative
    533       1,962       1,772       4,126  
Total expenses
    1,269       10,244       3,722       25,891  
                                 
Net loss
  $ (1,184 )   $ (10,244 )   $ (3,584 )   $ (25,887 )
                                 
Net loss per share - basic and diluted
  $ (0.13 )   $ (2.64 )   $ (0.46 )   $ (6.77 )
                                 
Weighted average shares used in loss per share calculation:
                               
Basic
    8,875       3,876       7,763       3,821  
Diluted
    8,875       3,876       7,763       3,821  
 
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited and in thousands)
 
 
 
September 30,
   
December 31,
 
   
2010
   
2009
 
                 
Cash and cash equivalents
  $ 4,216     $ 1,886  
Other currents assets
    211       177  
Fixed assets (net)
    9       12  
Other assets (net)
    1,131       885  
Total assets
  $ 5,567     $ 2,960  
                 
Accounts payable and accrued
               
expenses
  $ 1,354     $ 2,398  
Stockholders' equity
    4,213       562  
Total liabilities and
               
stockholders' equity
  $ 5,567     $ 2,960  

 
 

 
 
EX-99.2 3 v201789_ex99-2.htm
Exhibit 99.2
 
Contact:
Repros Therapeutics Inc.
Joseph Podolski (281) 719-3447
President and Chief Executive Officer


REPROS® THERAPEUTICS REPORTS OUTCOME OF TYPE B MEETING WITH FDA REGARDING ANDROXAL® IN THE TREATMENT OF SECONDARY HYPOGONADISM
 FDA agrees in general with Androxal development program and recommends Phase 2B study in men naïve to testosterone treatment before moving to Phase 3 Special Protocol Assessment

THE WOODLANDS, Texas – November 9, 2010 – Repros Therapeutics Inc.® (NasdaqCM:RPRXD) today reported on the outcome of a Type B meeting held with the FDA to discuss two Phase 3 protocols for the use of Androxal® in the treatment of secondary hypogonadism in men. The FDA opined that a Phase 2B study in men with secondary hypogonadism but naïve to testosterone treatment would provide for a more solid data base for design of Phase 3 studies and eventual approval of such studies under an SPA. The FDA did note “the Division agrees in general with the outline of your program for the development of enclomiphene” (Androxal).  They further stated that if the Company moved to Phase 3 at this time it would do so at its own risk.

The FDA accepted the notion of secondary hypogonadism associated with aging as an appropriate population. They suggested that the next study be conducted in men naïve to testosterone treatment or off testosterone treatment for at least six months. They felt that this population would exhibit a more consistent profile at baseline.  As outlined in the Company’s submitted protocols the FDA requested that the trial consist of four arms; placebo, two doses of Androxal and topical testosterone. At baseline the men should exhibit morning testosterone less than 250 ng/dl.  They further noted that the endpoints should consist of total testosterone and sperm counts at the end of study compared to baseline.

The Company agreed with the FDA comments and noted it would analyze the previously completed ZA-003 study for the subset of men with morning testosterone less than 250 ng/dl and submit the data.  Repros previously performed this assessment and found a statistically significant improvement in morning testosterone and no deterioration of follicle stimulating hormone, an important pituitary hormone controlling spermatogenesis, in Androxal-treated men. However, in the men on topical testosterone, 26 out of the 41 men that completed three months of dosing exhibited follicle stimulating hormone levels below the reference limits for the hormone, with 17 below the lower limit of detection.

The FDA also noted that 24 hour assessment of testosterone is the preferred method for assessing response for topical testosterone preparations.  The Company noted that it had previously conducted 3 studies in which 24 hour testosterone levels were obtained and unlike topical testosterone, morning testosterone was the maximum concentration observed consistent with the normal circadian rhythm in men. The Company agreed to combine the three studies into one analysis for FDA review.
 
 
 

 

“We are pleased with the overall outcome of the Type B meeting with the FDA,” Joseph Podolski, President and CEO of Repros commented.  “Although the FDA did not agree with our proposal for moving into Phase 3 trials under an SPA at this time, they clearly stated that they are in support of our intended development program for Androxal in treating men with secondary hypogonadism.  We are encouraged with the progress we have made with the FDA in moving this drug candidate toward eventual commercialization.  We also believe that the data we plan to provide the FDA from our prior studies, together with the anticipated results from this Phase 2B study, should be sufficient to move this drug into SPA reviewed Phase 3 trials without any additional costs or delays from our original proposed development plan.”

Repros has an issued patent teaching the use of Androxal in restoration of testicular function and has pending patent applications that deal specifically with the drug’s ability to impact glycemic control.

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 have the partial hold on Proellex® lifted and to determine a safe and effective dose for Proellex, maintain its listing on the NASDAQ Capital Market, raise needed additional capital on a timely basis in order for it to continue to fund its operations and pursue its development activities, 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.
 
 
 

 
 
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