Organization, Operations and Liquidity

9 Months Ended

Sep. 30, 2012

Organization, Operations and Liquidity [Abstract]

Organization, Operations and Liquidity

NOTE 1 — Organization, Operations and Liquidity

Repros Therapeutics Inc. (the “Company”, “RPRX,” “Repros,” or “we,” “us” or “our”) was organized on August 20, 1987. We are a development stage biopharmaceutical company focused on the development of new drugs to treat hormonal and reproductive system disorders.

Our primary 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 of reproductive age with low testosterone levels. Androxal® treats the underlying mechanism that causes secondary hypogonadism and restores normal testicular function. On July 9, 2012, we announced that we reached an agreement with the Food and Drug Administration (“FDA”) for the design of the pivotal efficacy studies for Androxal® for the treatment of secondary hypogonadism. The pivotal studies are being conducted under a Special Protocol Assessment (“SPA”).

Proellex®, our product candidate for female reproductive health, is a new chemical entity that acts as a selective blocker of the progesterone receptor and is being developed for the treatment of symptoms associated with uterine fibroids and endometriosis. On October 8, 2012, we announced that the FDA has agreed to a reclassification of the full clinical hold to a partial clinical hold on low dose oral Proellex® to allow us to conduct a Phase 2 study in the treatment of endometriosis. We initiated this study in November 2012 and expect to complete enrollment in the second quarter of 2013. Additionally, the FDA has accepted an Investigational New Drug Application (“IND”) for vaginally delivered Proellex® and, as a result, we commenced a Phase 2 vaginal administration study for uterine fibroids in the first quarter of 2012 and intend to report final study results around year end 2012.

Our product development pipeline is summarized in the table below:

Product Candidate (Indication) Androxal®	Status	Next Expected Milestone(s)
Secondary Hypogonadism	Phase 3	Complete first Phase 3 pivotal study (Q2 2013) Complete open label safety study (Q4 2013) Complete DEXA study (Q1 2014)
Proellex®
Uterine Fibroids	Phase 2	Complete Phase 2 study (vaginal delivery) (Q4 2012)
Endometriosis	Phase 2	Initiate Phase 2 study (oral delivery) (Q4 2012)

 We also continue to maintain our patent portfolio of our phentolamine-based products for the treatment of sexual dysfunction and in order to create value from these assets in various ways which includes product out-licensing.

On February 1, 2012, we completed a registered direct offering to certain institutional investors, including certain existing shareholders, of 2,463,537 shares of our common stock at a price per share of $4.50. Net proceeds to us, after deducting placement agent's fees and offering expenses, were approximately $10.3 million.

On May 9, 2012, we announced that we held a meeting with the FDA to discuss the design of pivotal Phase 3 efficacy studies for Androxal® as well as the components of the overall drug development program required for a New Drug Application (“NDA”) submission. During this meeting we agreed with the FDA upon the registration requirements for Androxal® oral therapy for the treatment of secondary hypogonadism, including a safety database comprising of safety data for 100 subjects exposed to Androxal® for one year and 800 subjects exposed for six months, with a focus on overweight men under 60 years of age. The FDA further advised that a one year dual-energy X-ray absorptiometry (“DEXA”) study be conducted to ensure that there is no bone loss.

On July 9, 2012, we announced that we reached an agreement with the FDA for the design of the pivotal efficacy studies for Androxal® for the treatment of secondary hypogonadism. The pivotal studies are being conducted under a Special Protocol Assessment. The first pivotal study is fully enrolled in November 2012 and we have begun enrolling subjects into the second pivotal study. Additionally, we began enrolling men into a 500 subject open label safety study in June 2012 and began enrolling men into a one year DEXA study in the third quarter of 2012. Depending on study enrollment and the completion of other studies, we believe we may be able to submit an NDA in the first half of 2014.

At the end of July 2012, we satisfied our enrollment requirement of study subjects in the ongoing ZPV-200 Phase 2 study for the use of Proellex®-V, the proprietary vaginal delivery formulation of telapristone acetate, in the treatment of uterine fibroids and we intend to report the final study results around year end 2012. Additionally, we have begun enrolling subjects who completed the ZPV-200 study into a one year open label safety trial in order to begin collecting long term safety data which we expect the FDA to require in connection with the submission of an NDA.

On September 7, 2012, we completed a private placement of 2,145,636 shares of our common stock at a price per share of $11.00. Net proceeds to us, after deducting offering expenses, were approximately $23 million.

As of September 30, 2012, we had accumulated losses of $201.9 million, approximately $29.6 million in cash and cash equivalents, and our accounts payable and accrued expenses were approximately $1.8 million. We anticipate that our current liquidity will be sufficient to continue these planned studies into the second quarter of 2014; however, significant additional capital will be required for us to complete the development of our product candidates through NDA approval.We continue to explore potential additional financing alternatives (including corporate partnering opportunities) that would provide sufficient funds to enable us to continue to develop our two product candidates through NDA approval; however, there can be no assurance that we will be successful in raising any such additional funds on a timely basis or at all. The foregoing matters raise substantial doubt about our ability to continue as a going concern.