Company finds partner for cancer treatment product

TAMPA -- Oragenics Inc. is trading above a dollar for the first time since the end of March after the medical product acceleration company announced an expanded collaboration agreement with Intrexon Corp. to develop and market a new medication geared toward cancer patients.

The agreement is the third between Tampa-based Oragenics and Intrexon, and focuses on a treatment known as AG013 to help battle oral mucositis. The condition, primarily a side effect of cancer therapy affecting nearly 500,000 people a year, results in painful inflammation and ulceration of the membranes lining the oral cavity, throat and esophagus. Current treatments help alleviate the symptoms, but both Oragenics and Intrexon, a Maryland-based biological treatment manufacturer, say none of those treatments address the underlying pathology of the condition.

AG013 is an oral rinsing product that delivers a molecule known as trefoil factor 1, a class of peptides involved in protection of the gastrointestinal tissues against mucus damage.

Clinical trials of the treatment has shown it to be “safe and well tolerated,” Oragenics reported in a filing with the U.S. Securities and Exchange Commission. It's been granted “orphan drug” status in the European Union, meaning it's a treatment designed for a rare medical condition that might not have otherwise been developed because of limited profit potential. It's also potentially eligible to be fast-tracked through the U.S. Food and Drug Administration.

Oragenics, which trades on the New York Stock Exchange under the symbol OGEN, closed Friday ahead of the announcement at 77 cents a share, but jumped to $1.09 at Monday's close. After the announcement, Oragenics shares climbed higher, closing Wednesday at $1.40 -- 40% higher than the day before, in heavy trading.

Oragenics reported a loss of $1.3 million, or 4 cents per share, on revenue of just under $364,000 in the quarter ended March 31. That compares to a $1.6 million, or 5 cents per share, loss the year before on revenue of $215,000.

The agreement with Intrexon will give Oragenics exclusive worldwide license to develop products with Intrexon, including AG013. Oragenics will be responsible for funding the product development, conducting pre-clinical and clinical development of products and the manufacture and commercialization of the product.

Oragenics will then pay Intrexon 12% of net sales derived from AG013 and related treatments, after paying the company for a number of milestone events through the development process that range from $2 million to $10 million.