Taking advantage of a recent doubling in stock price, Repros Therapeutics Inc. is raising $35.9 million through a public offering of 2.6 million shares priced at $13.75 per share. Net proceeds are estimated at $33 million after fees and expenses. An additional 390,000 shares are available to cover any overallotments.
Repros' shares (NASDAQ:RPRX) dipped 67 cents to close at $13.75 on Wednesday. But last month the stock more than doubled, closing at $12.61 on Dec. 29 compared to $5.90 on Dec. 1.
"The stock actually went up on the road show, which is kind of an anomaly," Repros President and CEO Joseph Podolski told BioWorld Today.
The jump was driven by interim data reported from all three of the company's ongoing clinical trials with its two lead products, Proellex and Androxal.
Proellex selectively blocks the progesterone receptor in women, and Repros is conducting trials in patients with uterine fibroids and endometriosis. Interim data from 63 of 128 patients in an ongoing Phase II uterine fibroid trial demonstrated a statistically significant reduction in excessive menstrual bleeding, the primary endpoint. Patients also experienced a statistically significant improvement in quality of life. Full data are expected in mid-2007, and Repros plans to initiate a pivotal program by year-end.
In the endometriosis indication, interim data from 34 of 39 patients in an ongoing Phase II trial in Europe showed that treatment with the highest dose of Proellex, 50 mg, resulted in a statistically significant reduction in pain compared to treatment with Lupron (leuprolide acetate, TAP Pharmaceutical Products Inc.), the drug standard of care for endometriosis. Full data from the trial are expected in the third quarter, but in the interim, Repros plans to initiate a Phase II trial in the U.S. around the middle of the year.
About 8 million American women of childbearing age experience bleeding, pain and/or infertility from uterine fibroids or benign tumors, according to a research report from analyst David Martin at Dundee Securities Corp. Approximately 9 million women experience endometriosis. In both conditions, a safety concern is endometrial thickening, which can result in the need for surgery. Repros' interim data in uterine fibroid treatment showed no statistically significant change in endometrial thickness after three months of treatment. In the endometriosis trial, the interim data suggested an inverse dose-dependent relationship between treatment and the condition, with women receiving the higher dose achieving a nonsignificant reduction in endometrial thickness.
"We can protect against endometrial thickening through a combination of dosing and drug holidays," Podolski said, adding that the effects of Proellex seem to carry over during the holiday periods.
Repros' second product, Androxal, stimulates the pituitary gland to increase testosterone secretion from the testes. The product is being studied in a nonpivotal Phase III trial to treat testosterone deficiency resulting from secondary hypogonadism. After three months of treatment, interim data on 112 of 194 patients showed that Androxal restored testosterone levels to the normal range in more than 80 percent of patients. The data also established non-inferiority compared to Androgel (testosterone gel, Solvay Pharmaceuticals Inc.). Full data are expected in the third quarter, and Repros plans to begin a pivotal Phase III trial by the end of the year.
Repros did take small statistical penalties in exchange for conducting its interim analyses. The trials will now need to achieve p-values of less than or equal to 0.04 rather than 0.05, but Podolski said he was "unconcerned," considering the interim results had p-values several orders of magnitude smaller.
"The interim analyses sent a message to Wall Street," he said, making them worth the trade-off.
Repros, based in The Woodlands, Texas, has come a long way in the last few years. Once known as Zonagen Inc., the company suffered a series of setbacks in the late 1990s when the FDA placed a clinical hold on erectile dysfunction drug Vasomax. The hold was never lifted, causing the loss of partner Schering-Plough Corp., of Kenilworth, N.J. In January 2004, the company's stock traded under $2. (See BioWorld Today, Jan. 28, 2005.)
Today, Matt Kaplan, analyst with Punk Ziegel & Co., has a "buy" rating and a $25 dollar price target on the company.
Proceeds from the current financing, combined with the $9.9 million in cash and equivalents Repros had on hand as of Sept. 30, should carry the company through June 2008. Repros reported a third-quarter net loss of $3.6 million, or 36 cents per share, and a nine-month loss of $8.7 million, or 86 cents per share.
The current offering is expected to close Feb. 5, at which time Repros will have approximately 12.8 million shares outstanding. CIBC World Markets Corp. is serving as the sole book-running manager for the offering, with Punk, Ziegel & Co. acting as the co-lead manager and ThinkEquity Partners LLC as the co-manager.
In other financing news:
• Aradigm Corp., of Hayward, Calif., closed its previously announced public offering. The company generated net proceeds of approximately $33.3 million through the sale of 38 million shares including the overallotment. Punk, Ziegel & Co. served as the sole bookrunner and lead managing underwriter for the offering. Merriman Curhan Ford & Co. acted as co-manager. (See BioWorld Today, Jan. 26, 2007.)
• NanoMed Pharmaceuticals Inc., of Kalamazoo, Mich., completed the second close of its Series A financing. The first close occurred in July 2006, and the total amount raised was not disclosed. The SWMF Life Science Venture Fund, a $50 million venture fund dedicated to life science companies in the Kalamazoo region, was the primary investor. Concurrently, NanoMed announced it achieved a preclinical development milestone with its lead product, which is designed to overcome multidrug resistance in remission induction therapy in elderly acute myeloid leukemia patients.
• Symphogen AS, of Copenhagen, Denmark, added a €5 million (US$6.5 million) investment to its latest financing round, bringing the total amount raised to $85 million. The new funding came from Dutch venture capital fund Gilde Healthcare Partners and will help Symphogen advance Sym001, its lead recombinant human polyclonal antibody, into Phase I trials this year for the prevention of hemolytic disease in newborns and the treatment of idiopathic thrombocytopenic purpura.