After ditching a planned private raise, Utah's Lipocine is looking to the boiling public market for biotechs, filing an S-1 for $11.5 million to fund its oral testosterone replacement therapy (TRT).
The company's lead product is LPCN 1021, a Phase III-ready TRT Lipocine believes can unseat the messy testosterone gels that currently dominate the market. Over the summer, Lipocine executed a reverse merger that put it on OTC markets and came coupled with a $38 million private placement, and now the company needs another $11.5 million to get LPCN 1021 into late-stage trials, targeting the fourth quarter of this year for initiation. In September, the company hired a placement agent to raise $8.4 million in a private offering to close the funding gap but later abandoned that effort, seeing more promise in going the public route.
Lipocine believes its proprietary drug delivery technology will bring success for LPCN 1021 where others have failed, and, if all goes according to plan, the company would have final Phase III results on the drug by 2015. That would likely put it behind Clarus Therapeutics and its CLR-610, an oral TRT already in the midst of Phase III study, but potentially ahead of Repros and its similar Androxal, as the FDA has taken issue with some of that drug's late-stage results.
As it stands, patients in need of testosterone replacement are largely left with unpleasant, erratic injectables or messy topical gels tied to troubling compliance rates. More than 60% of hypogonadal men discontinue all TRT treatments within 6 months, according to Lipocine, and only 41% stick with transdermal therapies after that timeframe.
Lipocine will spend the majority of its haul on LPCN 1021, meanwhile developing LPCN 1111, a next-generation oral TRT in the proof-of-concept phase, and LPCN 1107, a Phase I drug targeting preterm birth.
- read the S-1