Soligenix (SNGX) Up 56% on Forthcoming Data for First Potential Ricin Vaccine

The biggest gainer in Wednesday’s market has been Soligenix (SNGX), which traded as high as $5.08 this morning, almost doubling its $2.57 close on Tuesday. As of 2pm ET, shares are changing hands at a steady $4.10, still up 56% on the day, on volume of over 24 million shares – over 260x average daily trading volume.

Soligenix announced early this morning that results from its ricin toxin vaccine (RiVax) development program would be presented next week on April 25th at 2:15pm ET at the 20th Annual Conference on Vaccine Research in Bethesda, Maryland, and that “these findings are expected to facilitate the potential approval of RiVax under the FDA’s ‘Animal Rule’ and represent a significant step forward in the understanding of ricin toxin immunology.” The Animal Rule allows for approval of a product based on adequate and well controlled animal studies when traditional efficacy trials in humans are unethical or impractical.

No antidote currently exists for ricin poisoning. Ricin, naturally produced in the seeds of castor oil plants, is extremely toxic, interfering with a cell’s ability to make the proteins it needs, thereby destroying the cell. From the CDC: If ricin is ingested, initial symptoms typically occur in less than 6-12 hours include nausea, vomiting, and abdominal pain, and can rapidly progress to include severe dehydration and kidney and liver problems. If ricin is inhaled, initial symptoms may occur as early as 4-6 hours after exposure, likely to affect the respiratory system and can include difficulty breathing, shortness of breath, chest tightness, and cough. Death from ricin poisoning can take place within 36-72 hours of exposure.

Soligenix’s RiVax vaccine, when formulated with ThermoVax, the company’s proprietary vaccine heat stabilization technology, has demonstrated significantly enhanced thermostability and 100% protection in preclinical ricin aerosol challenge models. In collaboration with the New York State Department of Health and the laboratory of Nicholas Mantis, Ph.D., Soligenix has been investigating immune correlates of protection in sera of animals vaccinated with RiVax. The findings demonstrate that:

• The ThermoVax thermostabilization process significantly enhances the stability of the RiVax antigen
• Degradation in the antigen can be measured with specific monoclonal antibodies
• These same monoclonal antibodies can be used to probe the immune profile of vaccinated mice and primates and predict their survival to subsequent ricin exposure challenge.

Soligenix has multiple product candidates with FDA fast track and/or Orphan Drug designations in two areas of focus:

• BioTherapeutics for oncology and inflammation
• Vaccine/BioDefense for civilian and military use

Source: Soligenix Corporate Presentation, March 31, 2017

SNGX stock traded counter to most of the sector in Q4, coming under what we believe what tax loss selling pressure to close out the year. Shares found a floor in Q1 and had been building a base over the past 2 months before today’s dramatic move. Today’s move marks just a 38.2% Fibonacci retracement to the highs of last year, so there’s still a long way to go. But a press release like today’s signals extreme confidence in the ricin vaccine development and speaks well to the underlying fundamentals of the company’s overall clinical program.

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