Soligenix Inc.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. The company maintains two active business segments: BioTherapeutics and Vaccines/BioDefense.
The BioTherapeutics business segment is developing a first-in-class photodynamic therapy (SGX301) utilizing topical synthetic hypericin activated with safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL), proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, and a novel innate defense regulator (IDR) technology, dusquetide (SGX942), for the treatment of oral mucositis in head-and-neck cancer.

Expert Comments:

Grant Zeng, Zacks Equity Research (8/1/16)
"Soligenix Inc.'s Dusquetide, a broad-spectrum, host-targeted therapeutic for the treatment of bacterial infections, would confer a number of unique clinical advantages including a reduced likelihood of generating resistance since the Innate Defense Regulator (IDR) directly targets the host, not the pathogen and treatment when antibiotics are contra-indicated. . .positive clinical activity in the Phase II study provides important Proof-of-Concept for the IDR. Soligenix' technology has the potential to provide adjunctive or stand-alone therapies for the broader antimicrobial/antibiotic antiviral, anti-inflammatory and anti-cancer markets."

Jason Kolbert, Maxim Group (7/18/16)
"Soligenix Inc.'s Dr. Lehrer co-invented the development of an Ebola vaccine using this approach previously, which had demonstrated proof of concept in primates. The heat-stable Ebola vaccine in the current study utilizes ThermoVax, which enhances protein stability and may be dose sparing (requires fewer vaccinations). . .the vaccine proteins are stable when heated to 104 degrees Fahrenheit over 12 weeks. Data in mice suggest comparable anti-ebola antibody production after just two doses of heat stabilized vaccine (vs. three doses of non-stabilized vaccine). . .ThermoVax has received multiple non-dilutive fundings from the National Institute of Allergy and Infectious Diseases."

Grant Zeng, Zacks Equity Research (7/18/16)
"Soligenix Inc.'s Dr. Lehrer has shown proof of concept efficacy with subunit Ebola vaccines in non-human primates. . .initial testing revealed that two doses of this new formulation is as effective as three doses of a non-stabilized vaccine in generating antibodies to Ebola, even after storage at 40 degrees Celsius for 12 weeks. . .application of ThermoVax may can avoid the need for cold-chain distribution and storage, yielding a vaccine ideal for use in both the developed and developing world."

Maxim Group biotech analyst Jason Kolbert notes "steady progress" is being made by Soligenix Inc., a small-cap biotech with programs addressing bioterrorism threats and a devastating side effect of cancer treatment, in his Q1/16 update on the company.
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Jason Kolbert, Maxim Group (6/7/16)
"Preliminary results from Soligenix Inc.'s SGX942 Phase 2 study in oral mucositis will be presented by Dr. Oreola Donini, Chief Scientific Officer and Dr. Richard Straube, Chief Medical Officer, at the Multinational Association for Supportive Care in Cancer conference in Adelaide, Australia, on June 25, 2016. . .the company is planning a pivotal Phase 2b/3 study. . .positive preliminary results from the SGX942 Phase 2 study set the stage for a Phase 2b/3 study. We are excited for the potential of this molecule to really have an impact in an area that represents a truly unmet medical need."

Grant Zeng, Zacks Small-Cap Research (5/16/16)
"Soligenix Inc. built a diversified pipeline targeting multiple indications. We are optimistic about its lead candidates SGX301 for CTLC and SGX942 for the treatment of oral mucositis. Soligenix's oral BDP is in various development stages. . .Soligenix is developing vaccines using its ThermoVax technology for biodefense."

Jason Kolbert, Maxim Group (5/12/16)
Soligenix Inc. reported Q1/16 results with total revenues of $2.6M. . .the company released positive data from the Phase 2 oral mucositis study with SGX942 this past quarter. SGX942's novel mechanism of action as an Innate Defense Regulator showed the potential to address all stages of oral mucositis disease progression. . .the positive preliminary results of the SGX942 Phase 2 study sets the stage for Soligenix to pursue partnerships for the Phase 2/3 study. We are excited for the potential of this molecule to really have an impact in an area that represents a truly unmet medical need."

Management Q&A: View From the Top
Christopher Schaber
With a robust pipeline of drugs in late-stage clinical trials and milestones on the horizon, it's no wonder Soligenix Inc.'s CEO, Dr. Christopher Schaber, holds an optimistic view of the company's future.
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More Expert Comments

Experts Following This Company

Jason Kolbert, Senior Analyst – Maxim Group
Jason McCarthy, Analyst – Maxim Group
Ross Silver, Co-Founder and Principal Analyst – Vista Partners
Grant Zeng, Senior Biotech Analyst – Zacks Investment Research, Zacks Small-Cap Research

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Investing Highlights
Two Phase 3 pivotal trials in CTCL and pediatric Crohn's disease and a Phase 2 trial in oral mucositis in head and neck cancer
Positive Phase 2 clinical data with SGX942 in oral mucositis in head and neck cancer patients
Up to $57M in government contract funding
catalyst Calendar