Soligenix, Inc.

(Public, OTC:SNGX)

Soligenix truly is a magnificent company, its no wonder the government also favours it so much by pouring in grants and funding. 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, StocksHaven Investments 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 of 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: Short term position in SNGX

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A young and savvy, yet experienced and accomplished investments mogul since ‘01; Michael has amassed a fortune as a private self investor. Recently starting his own successful blog and turning it in to a corporation — MIV Investments Inc., a company offering advice to thousands of people worldwide and attracting contracts from various reputable sources. His articles and publications have been linked to Forbes, CNN Money, Reuters, Bloomberg, and many other top worldwide mainstream media sources.

Michael Vlaicu

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