Canadian spin-out EndoCeutics Inc. filed for an initial public offering, hoping to raise $75 million to fund upcoming Phase III trials of its lead products, though the price and number of shares have not yet been determined.

Upon completion of the offering, shares of EndoCeutics would trade on Nasdaq under the ticker "ENCX."

Founded last June as a wholly owned subsidiary of EndoResearch Inc, a privately held drug discovery company based in Quebec, EndoCeutics was created as a vehicle to finance late-stage development of programs assigned by EndoResearch. Fernand Labrie, founder of EndoResearch in 1985, is serving as president, CEO and chief scientific officer of EndoCeutics.

A portion of the proceeds from the IPO - about $8 million - will be used to satisfy the cash portion of costs to transfer rights to the product candidates from EndoResearch. The majority holding also will be issued an equity investment in EndoCeutics.

But most of the funds will support development activities of the two lead programs: dehydroepiandrosterone (DHEA) for treating vaginal atrophy, a condition that affects about half of all postmenopausal women, and acolbifene, a selective estrogen receptor modulator (SERM) for breast cancer.

The company expects to start a Phase III trial of DHEA in the first half of the year. A Phase III study of acolbifene is set to begin in the second half in patients with advanced stage breast cancer who haven't received prior hormone therapy.

Another Phase III study, scheduled to start in the second half of 2007, will be designed to test acolbifene in combination with DHEA as an alternative to traditional hormone therapy in postmenopausal women with vaginal atrophy.

In its prospectus, EndoCeutics estimates that $33 million would be needed to get those products through pivotal testing and regulatory submission, and anticipates having another $14 million on hand for miscellaneous costs associated with those trials, along with an additional trial being conducted in collaboration with Monash University in Australia.

If the IPO's price ends up falling short of expectations, a trend that has befallen many a biotech in the past few years, EndoCeutics said it would have to revise its operating plan.

The company, which has had no significant operations to date, posted a net loss of $1.8 million at the end of the second quarter and had no assets as of July 31, 2006. At that time, it had only 100 shares outstanding.

Pending positive Phase III trial results, EndoCeutics anticipates filing a new drug application for DHEA in 2008 and for acolbifene a year later. Pursuant to an agreement with parent company EndoResearch, Kenilworth, N.J.-based Schering-Plough Corp. holds an option to manufacture, market and distribute acolbifene for breast cancer. Upon the exercise of that option, EndoCeutics could be reimbursed for development costs and eligible for potential milestones and royalties.

Should the combination trials prove successful, the company anticipates conducting an additional uterine safety study, which would push that NDA to 2010. But that trial, along with another planned Phase III study of acolbifene, this one in advanced breast cancer patients previously treated with hormone therapy, will depend on additional financing opportunities. Both trials are anticipated to start in the second half of 2008.

Beyond its late-stage programs, EndoCeutics has a preclinical pipeline focused on endocrine-related disorders, such as acne, male pattern baldness, prostate cancer and benign prostate enlargement.

The company also has an early-stage program selective androgen receptor modulator (SARM) program in development for muscle atrophy and bone loss in aging men and women.Underwriters for the IPO include First Albany Capital, Oppenheimer & Co. and Stifel Nicolaus.