UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) October 7, 2013
Repros Therapeutics Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-15281 | 76-0233274 |
| (State or other jurisdiction of incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
| 2408 Timberloch Place, Suite B-7 The Woodlands, Texas |
77380 |
| (Address of principal executive offices) | (Zip Code) |
Registrant's telephone number, including area code: (281) 719-3400
________________________________________________________________________________
(Former name or former address, if changed since last report)
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:
| [ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| [ ] | 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 October 7, 2013 the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
Exhibit 99.1. Press release dated October 7, 2013
SIGNATURE
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.
(Registrant) |
||
| October 7, 2013
(Date) |
/s/ KATHI ANDERSON
Kathi Anderson CFO |
| Exhibit Index | ||
| 99.1 | Press release dated October 7, 2013 | |
EXHIBIT 99.1
Key conclusions from the presentations:
THE WOODLANDS, Texas, Oct. 7, 2013 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc. ® (Nasdaq:RPRX) today announced that the Sexual Medicine Society of North America (SMSNA) has accepted key data on Androxal® for presentation at the annual meeting in New Orleans, Louisiana, November 21 – 24, 2013. The data presented are from subset analyses of the double-blind, placebo and active control Phase 2 and 3 studies.
One presentation describes the basic clinical profile of Androxal. Androxal acts at the level of the pituitary as a selective estrogen receptor modulator (SERM) to block the negative feedback of estrogen on the pituitary hormones, LH and FSH. Restoration of LH (secondary hypogonadal males have low levels) is shown to provide rapid and effective normalization of T levels without excursion outside the normal range. This profile is in contrast to the topical agents used in the protocol.
In addition, the second presentation demonstrates that preservation of FSH levels in Androxal treated patients ensures that there is no negative impact on sperm function. Once again, this is in contrast to the topical gels which have deleterious effects on spermatogenesis. Overall, this study shows that Androxal may provide effective therapy in men with secondary hypogonadism, particularly in those wishing to preserve fertility.
The final presentation examines the impact of Androxal on bone mineral deposition. Although it could be predicted due to its action as a SERM that Androxal would have an adverse effect on bone mineral deposition, this study shows that Androxal may actually have a beneficial effect.
Dr. Wayne Hellstrom, Professor of Urology and Chief of Andrology, Tulane University School of Medicine in New Orleans, stated, "Selection of all three analyses for presentation at the premier sexual health meeting in the US, shows the increasing interest that the urological community has in the management of hypogonadism. The data presented not only highlight the potential utility of Androxal but also the limitations of existing therapy."
About Repros Therapeutics Inc.®
Repros Therapeutics focuses on the development of small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.
Any statements made by the Company that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including the ability to have success in the clinical development of its technologies, the reliability of interim results to predict final study outcomes, the ability to protect its intellectual property rights 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 S. Podolski (281) 719-3447
President and CEO
Investor Relations:
Thomas Hoffmann
The Trout Group
(646) 378-2931
thoffmann@troutgroup.com