Soligenix (OTCQB:SNGX) is gearing up for a phase 2 trial for oral mucositis in head and neck cancer, which was granted fast-track designation by the FDA.
A phase 2 and 3 trial is also in the works for its pediatric Crohn’s disease program, after participants successfully passed through the first phase.
In a research note, Brean Capital, which has a "buy" rating and $5.00 price target on the stock, said these are the two key programs to keep an eye on.
The stock is surging ahead nearly five per cent late Tuesday Morning and is on a 145 per cent tear so far this year.
The phase 2 oral mucositis drug will only take place in the U.S. and will enroll approximately 75 head and neck cancer subjects with oral mucositis.
Soligenix, a clinical stage biopharmaceutical company which focuses on advancing drugs with multi-million dollar market potential, said on Monday it believes its current cash holdings will cover its capital expenditures into the first quarter of 2015.
As of June 30, the end of its second quarter, the company more than doubled its cash and equivalents to $8.1 million, which Brean calls Soligenix's "most important financial metric."
Working capital came to to $6.9 million at the end of the latest period, also more than doubling as a result of proceeds from the company's registered public offering worth a little more than $7.1 million.
Soligenix reported grant revenue in the second quarter of $0.6 million and also has about $2.3 million in active grant funding still available for its associated research programs through 2014 and has plans to submit additional grant applications.
In July, Soligenix entered into a personalized medicine collaboration with SciClone Pharmaceuticals for its oral mucositis clinical program. According to the deal, Soligenix received access to SciClone’s oral mucositis clinical and regulatory data library in exchange for commercialization rights in China.
The company has caught the eye of life sciences billionaire Randal Kirk with its development of a treatment for high-priority government biothreat melioidosis, a contagion which has the potential for widespread dissemination through aerosol.
In May, the company signed an exclusive worldwide collaboration agreement with Kirk's Intrexon, which last week completed a hugely successful IPO, for the development of a treatment for the disease.
For the quarter that ended June 30, Soligenix's revenue dropped to $0.6 million from $0.8 million a year ago, while its net loss increased to $3.4 million, or 28 cents per share, from $1.0 million, or 9 cents per share, in the year earlier period. The latest period included non-cash charges of $2.1 million, relating to expenses tied to the collaboration with Intrexon and a $0.6 million charge related to the change in the fair value of its warrants.
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