By Mark Terry
Repros is a development-stage biopharma company. Its focus is on oral small molecule drugs for male and female reproductive health. One product candidate is enclomiphene for secondary hypogonadism. Another is Proellex for uterine fibroids and endometriosis.
On Nov. 13, the company reported its third-quarter financials. The net loss for the three-month period was $1.6 million or $0.04 per share compared to a net loss of $4.2 million of $0.17 per share for the same period in 2016. The company indicated the loss was due to decreased clinical development expenses related to Proellex and enclomiphene, as well as a decrease in research-and-development payroll and benefits expenses and legal expenses.
The net loss for the nine-month period was $9.7 million compared to $3.2 million for the same period the year before. The company reported cash and cash equivalents of about $1.8 million as of Sept. 30, 2017.
Under the deal, a subsidiary of Allergan, which is headquartered in Dublin, Ireland, will buy all the outstanding shares of Repros common stock via a cash tender offer of $0.67 per share. The company’s stock is down about 65 percent year-to-date. At the beginning of 2017, shares traded for about $1.37 per share and on Dec. 11 were trading for $0.47 per share. Shares jumped about 40 percent at the news of the acquisition to about $0.65 per share.
The Houston Business Journal reports, “The acquisition comes about eight months after Repros named a new top executive. Dr. Larry Dillaha was named president and CEO in April after serving as the interim in the position since February. The drug company’s former president and CEO, Joseph Podolski, left the position ‘to pursue other interests,’ per a previous release.”
On July 17, Repros reported that the U.S. Food and Drug Administration (FDA) had given preliminary feedback about its Proellex clinical development program. The program was to remain on a partial clinical hold. The FDA was reviewing the liver function safety data and indicated the company would need to pull together a large pre-approval safety data base to continue forward.
At the same time, the company announced that it had submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for enclomiphene to treat secondary hypogonadism in September 2016. As part of the ongoing review process, Repros was filing responses to the EMA in this year’s third quarter.
“We are appreciative of the preliminary feedback received from the FDA and expect further clarification from the FDA in the coming weeks on our Proellex development program,” Dillaha said in a statement at the time. “Our discussions with the FDA, and their guidance that a large safety data base will be required to continue the development of Proellex, indicate that a much larger clinical trial, with associated time and cost requirements, would be necessary.”