Why Soligenix Should Be Successful (OTC:SNGX.OB)

Written by Michael Vlaicu

Tuesday, 06 October 2009 15:22

Soligenix, Inc. (Public, OTC:SNGX) is an engaging company. Is it any wonder that the government also favours it by pouring in grants and funding for it's programs?

It stands tall amongst the other struggling small cap biotechs, and even after changing its company info from DORB Pharma (OTC:DORB.OB) to Soligenix (OTC:SNGX.OB), it remains ahead of the pack while the others are still searching to make a name for themselves.

After profiling the company the first time around, I felt it was necessary to paint a more clear picture as to what really makes this company not just a valuable investment, but rather a great one at that. The true potential lies in the company’s liquidity and ability to fund R&D, clinical trials and other important distributional aspects that many other small biopharmas lack. Many investors also may be aware of the main product OrBec which tends to be the company’s standout, however it is important you are also tunned to Soligenix’s BioDefence side of the table. The main scope or aim for this analysis is derived from the company’s conference call at the Rodman & Renshaw convention, where this article will depict and restate the potential target markets and current state of the company within the present and future. With the vaccine market set to double within the next five years, and products with market potentials in excess of $500M, this current state of $51.9M market cap won’t last much longer as investors begin to dig up this undiscovered story.

What’s important to note about this company, is that due to the fact that they have already submitted an NDA, they do not need to resubmit it — thus making FDA approval process significantly faster and more focused. The NDA is in place, and they simply have to respond to an action letter, so with that response which is class II, it is a 6 month review cycle.

For those who are new to this company, we suggest you read the company profile here.

Presentation at Rodman & Renshaw

Christopher J. Schaber, Ph.D., President and Chief Executive Officer, presented at the Rodman & Renshaw 11th Annual Global Investor Health-care Conference on Thursday, September 10, 2009 in the Spellman Salon of the New York Palace Hotel, New York.

*Press play to listen

Key Highlights of the Conference

Potential for exponential growth with approval of OrBec
Positive confirmatory phase III trial cleared by FDA & EMEA
Clean cap structure with no debt or preferred stock oustanding
Completed $30M partnership for North America with Sigma-Tau Pharmaceuticals
OrBec addresses potential $200M GVHD market, as well as $500M for treatment of other diseases/complications
Biodefence side is funded entirely by government grant money
Worldwide leader in Ricin toxin vaccine development
Not only treating acute GVHD, but also aiming to prevent it in a phase II study which will be completed by year end
Experienced management team – see here for more details
Acute GVHD has unmet needs, no treatments currently approved
OrBec has obtained track Oprhan status from the FDA
Risk and Benefit Analysis of OrBec: Significant reductions in mortality thus far, far better safety than placebo
Trials done at multiple centers with 129 patients for phase III, prior to the confirmatory one
Have experience with filing NDA, stated FDA required additional information and a confirmatory phase III
Went through highly informative assessment with the FDA very similar to previous trial with 166 patients
Partnerships throughout the world with the ability to generate revenue once OrBec is approved
Marketing partnership already established aimed at distributing to Canada, USA, and Mexico
35% Royalty on net sales that comes back to Soligenix
$10M in milestones, with $1M expected upon enrollment of first patient which is imminent
Other products: Radiation, Prostate Cancer, and Crohn’s Disease have potential markets in excess of $500M

Rivax vaccine for Ricin: Threat is real
In 2008 Ricin exposure in Las Vegas motel
In 2007 FBI terrorism report, Ricin and Anthrax posed biggest concerns as forms Bioterrorism attacks
World leader in Ricin vaccine R&D
Received in excess of $11M in NH funding to date

Overall Sentiment
Vaccines are quickly becoming an attractive investment option because the market will double during the next five years, because the products aren’t readily reproduced by competitors and because of the investment required to build vaccine plants, Viehbacher said. News source here

What you have in Soligenix is a company with really diversified portfolio with a Biotherapeutics, and a Biodefence side, which is highly funded by investors, institutions and government grants. This makes them stand apart from many other small biotechs which are struggling with cash burn and ongoing conerns towards future operations. A little patience can go a long way with this FDA play.

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Disclosure: Long SNGX

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