cosmetic procedures last year, including roughly $7 billion on surgical aesthetic procedures and $5 billion on non-surgical aesthetic procedures.
Neothetics anticipates that early adopters will come from the estimated 2 million Americans who are already getting cosmetic injectable therapy like Botox or dermal fillers.
The company plans to conduct two pivotal trials next year, with top-line data expected at the end of 2015. If the trials are successful, Neothetics says it will file a new drug application in the second half of 2016, under a regulatory option known as 505(b)(2) for modifications to drugs previously approved by the FDA.
Under a sweeping investment plan reached in 2012, Domain and Rusnano MedInvest now hold a majority stake in Neothetics. The initial S-1 filing does not disclose the exact percentage of their ownership stake, apparently because Neothetics plans to convert an array of warrants, debt, and preferred stock into slightly more than 50 million shares of common stock just before its IPO.
Neothetics says it also has granted rights to LIPO-202 and related technologies to NovaMedica, a Russian business co-owned by Domain and Rusnano, which plans to develop the drug for use in Russia, Ukraine, Belarus, Georgia, and eight other Eastern European countries.
As promising as it might seem, Neothetics still faces a number of hurdles that are detailed in its IPO filing. Aside from the countless number of things that can go wrong in late-stage clinical trials, the company says other risks include:
—Neothetics has never been profitable, and had an accumulated deficit of $66.8 million at the end of September. The company says it expects to keep losing money for the next several years.
—The market is highly competitive and new technologies are rapidly evolving. While liposuction remains the primary treatment for reducing subcutaneous fat, Neothetics expects to also compete with FDA-approved medical devices that reduce fat cells using freezing, ultrasound, and laser technologies. Neothetics acknowledges that Kythera also could eventually become a competitor.
—A loss in legal protections for its proprietary technologies. Neothetics says “a law firm representing one or more unidentified third parties” has formally asked the U.S. Patent and Trademark Office to review some of the company’s key patent claims. The patent office has granted the request with respect to one patent, and a decision is pending with regard to another patent.
