When it comes to having a diversified portfolio of orphan status and FDA Fast Track allotted drugs in the pipeline, perhaps no company is doing a better job than Soligenix (OTCQB:SNGX). When I first spoke to the CEO of this company Chris Schaber in May, my jaw nearly dropped by the amount of success this company could attain in just a few months to a few years time in comparison to the tiny market cap it is currently being valued at. What gives SNGX such an extreme gold star in my opinion is not just the fact that 6 of its 10 development programs are either orphan status approved or FDA fast track awarded, but that the company could have primary endpoint data in clinical trial for two significant drugs in the second half of 2014.
A Massive Portfolio
In looking at SNGX's pipeline below, we see a great deal of diversity ranging from Biodefense drugs, Cancer, Crohn's Disease, Graft vs. Host disease and specialty vaccines. In the space of Biodefense SNGX is bringing to the table treatments for anthrax, ricin toxin and radiation toxicity. Similar to stem cell company Cytori (CYTX) which has received funding contracts from the U.S. government agency BARDA (Biomedical Advanced Research And Development Authority) SNGX is also a prime candidate for receiving further contracts from this agency as well in acute radiation syndrome. In speaking with SNGX's CEO Dr. Schaber, it was discussed that SNGX is currently in talks with the Department of Defense and that 2013 could likely bear positive news for the company in terms of receiving a government contract for their Ricin vaccine, Rivax™. Rivax has currently been awarded orphan drug status by the FDA.
Nuclear Disasters and Weapons of Mass Destruction
In regards to SNGX's Anthrax vaccine, Thermovax™ Dr. Schaber informed me that the company is currently in talks with various non-profit organizations as well as pharmaceutical companies in regards to partnering with Thermovax™ and that a new deal could potentially come to light in the not too distant future. Yet the most interesting biodefense drug in SNGX's pipeline in my opinion is its treatment for radiation poisoning, Orbeshield™. If you remember Chernobyl, Fukushima or any of the other nuclear disasters/attacks that have destroyed the health of hundreds of thousands of people across the globe, then you can understand why a drug that combats the radiation poisoning resulting from these incidents has massive value. In the event that there is another disaster of this nature, which is likely, then Orbeshield™ could potentially save and treat an entire city or country of people who have fallen victim to radiation poisoning. In terms of the U.S. there are currently 65 nuclear power plants in operation which contain a total of 104 nuclear reactors. In terms of the planet a total of 430 nuclear power plant reactors exist. The Fukushima accident was the result of just one reactor malfunctioning. In my opinion there is no question that we will see at least one if not several more nuclear power plant accidents in the next decade of which Orbeshield™ would be under massive demand. SNGX is also looking to market Orbeshield™ to protect the gastrointestinal tract following lethal dose radiation exposure such as from a potential nuclear attack resulting from terrorism or war.
Cancer and Crohn's
In the space of Oncology SNGX is currently working on a drug to treat Oral Mucositis for patients of Head and Neck Cancer. Mucositis affects approximately 40% of patients who receive radiation and/or chemotherapy and is a life threatening major unmet medical need. Apparently the FDA is in favor and support of SNGX's efforts in this treatment as just this Monday SNGX announced receipt of Fast Track Designation for clinical trials regarding this treatment. Phase II results for the company's next trial for this drug are expected in the second half of 2014.
In terms of SNGX's efforts in combating pediatric Crohn's, the company recently completed a Phase 1 study and is in the process of preparing for a Phase II/III trial for a new treatment which potentially has less toxicity than the current standard therapy Prednisone. This drug has also received FDA Fast Track as well as Orphan Drug Status. This trial is expected to have results in the second half of 2014 as well.
In looking at why SNGX is so massively undervalued in comparison to the large markets it is entering, the sole reason appears to be the risk factor of a further dilution. While there is no question that the possibility of this exists, the company is still only comprised of about 12 million outstanding shares in total and could be eligible for other alternatives of funding. These avenues consist of partnering one of its trials with another pharma or business, receiving further government contracts like the $9.4 million award they previously received for Thermovax™ or receiving funding from a non-profit. There is also an S-1 that the company has filed, which could position the company for a financing in the not too distant future. My personal opinion is that at some point before the year's end we will see SNGX awarded a BARDA contract for Orbeshield™ based on the growing necessity the drug addresses. The bottom line remains, if you're looking for a pharma company with a massive pipeline of niche drugs, two of which are positioned to be initiated by year end with primary endpoint data in 2014, then SNGX is definitely worth considering. In a follow up article we'll take a look at SNGX's new Ricin Vaccine as well as a billionaire pharmaceutical entrepreneur who has shown a keen interest in what SNGX is bringing to the table.