CEO: Dr. Chris Schaber
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About: Soligenix, Inc. is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Soligenix has two areas of focus: 1) a therapeutics segment dedicated to the development of products for orphan diseases and areas of unmet medical need such as cutaneous T-cell lymphoma, oral mucositis, pediatric Crohn’s disease, acute radiation enteritis, and 2) a vaccines/biodefense segment to develop vaccines and therapeutics for military and civilian applications in the areas of ricin exposure, acute radiation syndrome, and emerging and antibiotic resistant infectious disease.
WSA: Good day from Wall Street, this is Juan Costello, Senior Analyst from the Wall Street Analyzer. Joining us today is Dr. Chris Schaber, the CEO for Soligenix Incorporated. The company trades on NASDAQ and the ticker symbol is SNGX. Thanks for joining us today there Chris.
Dr. Chris Schaber: Thank you, Juan, thank you for having me.
WSA: Yeah, anytime. So starting off, please give us a brief overview of the company?
Dr. Chris Schaber: My pleasure. Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is currently an unmet medical need. We have two areas of focus here. We have a therapeutic business segment dedicated to the development of products for orphan diseases and areas of unmet medical needs such as Cutaneous T-Cell Lymphoma, oral mucositis and pediatric Crohn’s disease. We also have a separate vaccine biodefense business segment focused on developing vaccines and therapeutics for civilian and military applications in areas such as ricin exposure, acute radiation syndrome and emerging and antibiotic resistant infectious diseases.
WSA: So bring us of the speed there on some of the recent news highlights?
Dr. Chris Schaber: Sure, well, we have a number of recent news highlights. Most recently we provided an investor update letter that went out about January 25th. I think the letter which covers finance and development has been by and large positive and well received. The most important points outlined in that letter were that we are actively enrolling patients in two pivotal Phase III clinical trials that, if positive, have the potential to support regulatory approvals in areas of unmet medical needs.
The first is a novel photodynamic therapy for the first-line treatment of a rare cancer called Cutaneous T-Cell Lymphoma or CTCL. In treating this disease, which consists of cancerous lesions or tumors on the skin, we apply a proprietary topical drug called synthetic hypericin to these cancerous lesions followed by activation of the drug with a short course of safe visible fluorescent light, like you probably have above you in your office there, from a specialized light device. Here we’re looking to shrink the size of the lesions by 50% or greater.
The second Phase III study uses a new class of drugs referred to as Innate Defense Regulators or IDRs that modulate the bodies own innate defense system to treat disease. Our first in class drug here is called Dusquetide and it’s for treating the oral mucositis, which is ulcerations in the mouth and throat that is caused by chemo-radiation therapy in patients being treated for their head and neck cancers. Here, what we’re doing is administrating a short four minute IV infusion of Dusquetide periodically to potentially reduce the duration of severe oral mucositis as well as impacting other important measures like infection and survival.
Severe oral mucositis is defined as ulcers so painful that the patient can no longer eat and/or drink. So imagine the magnitude of that pain. Many of these patients are already on high doses of opioids for their head and neck cancer and the pain is still so severe that they cannot eat and/or drink. So the pain of cancer sore multiplied by a thousand … just very devastating.
WSA: Yeah, sounds horrible. And so what are some of those key trends that you’re focusing on right now in the healthcare space and particularly in your sector and how is the company positioning itself to capitalize?
Dr. Chris Schaber: Yes, as far as key trends in the healthcare sectors Soligenix is targeting, which are rare diseases of oncology, inflammation and biodefense I think the significant interest to support these areas continues from both investors and the US government especially where there remains unmet medical needs as is currently the case for diseases we’re pursuing. Therefore, I think our late-stage product candidates are well positioned moving forward with the opportunity for significant market potential assuming success.
WSA: And what are some of the main factors Chris that you feel make Soligenix unique from some of the other players in the sector?
Dr. Chris Schaber: I think there are probably two areas where I believe our company is unique. The first, which I already touched upon, is the fact that we’re developing in disease areas where there is a high unmet medical need with no real competition currently. For example, our synthetic hypericin photodynamic therapy has the potential to be the first FDA approved front-line treatment for Cutaneous T-Cell Lymphoma, which has received both FDA orphan drug and fast track designations.
There is currently no approved drug for oral mucositis and head and neck cancers. So Dusquetide has the potential to be the first approved here and has also received FDA fast track designation.
And we also have another product candidate called oral Beclomethasone Dipropionate or BDP that has a Phase III protocol cleared through the FDA to begin a clinical trial in mild to moderate pediatric Crohn’s disease, which I haven’t mentioned as yet. Oral BDP would potentially be another front-line treatment where there is no approved therapy currently. We have elected not to start this pivotal Phase III trial until we have secured additional funding or a partnership, but again, a program that has received orpahn and fast track designations from the FDA.
I think the second area where I believe we are unique is our success in securing non-dilutive government funding where we have bought in more than $40 million over the last several years across both our biotherapeutics and biodefense business segments. This includes an NIH contract award of up to 24.7 million that we are currently using to advance development of our novel heat stable Ricin Toxin vaccine called RiVax. Another area where Soligenix would potentially be the first approved vaccine to protect against lethal ricin toxin exposure, and again we have orphan drug designation here as well.
So we have multiple programs and/or product candidates funded in part or entirely by the US government where there are currently no approved drug therapies for the indications we’re targeting.
WSA: Great and perhaps you can walk us through your background and experience Chris and talk about some of the key management team there?
Dr. Chris Schaber: Sure, I won’t bore you with the full details given the limited time we have. But I’ve been in the pharmaceutical and biotech industry for over 27 years with a specific development and operational focus in rare diseases. I started my career in big pharma before moving into start-up development stage biotech companies where I continued to move into positions of increasing importance. I had the good fortunate of helping patients, having a number of drug successes along the way. I’ve also been around long enough to have experienced some disappointments as well, which I must say provided invaluable lessons as I advanced my career such as how to better prepare, design, execute and risk assess drug development programs, which I have applied moving forward. As you would imagine doing this line of work for 27 years now, I’ve had the opportunity to meet and/or work with some very bright experienced and passionate people, a number of which have joined the team here at Soligenix. Dr. Richard Straube is our Chief Medical Officer. Dr. Oreola Donini is our Chief Scientific Officer and Ms. Karen Krumeich is our Chief Financial Officer, to name a few.
There are more but I’ll stop there. It suffices to say that we have a very knowledgeable and dedicated team at Soligenix that has been doing this for a long time with a laser focus on quality execution of our develop programs to increase our probability of success.
WSA: Sure and so what are the main goals and milestones that you’re hoping to accomplish here over the next 6 to 12 to 18 months?
Dr. Chris Schaber: Sure, I think we have some very important and potentially transformational milestones in the next six to 12 to 18 months across our rare disease pipeline. We have our synthetic hypericin photodynamic therapy actively enrolling in a pivotal Phase III study for CTCL where we expect blinded interim results in 2018 and final results no later than the first half of 2019. The second is our new new chemical entity, Dusquetide, actively enrolling patients in a pivotal Phase III study in oral mucositis in head and neck cancer. We expect the blinded interim analysis to occur in the first half of next year with final results no later than the end of 2019.
And the third is in our biodefense business sector, where we are advancing our heat stable ricin toxin vaccine, RiVax, with further preclinical efficacy studies being conducted in 2018, which will potentially include results later this year. In parallel, we are also targeting the initiation of a Phase I/II clinical study of the vaccine in 2018. So as you’d imagine it’s a very busy and exciting time for the company with a number of key milestones this year and next. We believe we have positioned the company for significant growth in the relative near term, assuming we achieve the anticipated positive outcomes in our trials.
I’d also like to add that in the longer-term all of these product candidates have additional potential in broader indications which the company is planning pending positive outcomes with our current programs.
WSA: Certainly so it seems that you’re pretty confident there in the company’s future. And with that being said why do you believe investors should consider SNGX as a good investment opportunity today?
Dr. Chris Schaber: Sure, this is an important question for potential investors. I obviously think the future is extremely strong. As I noted earlier, given our stage of development with multiple shots on goal to mitigate risk, along with the current price point of the company’s stock, I think there is the potential for significant growth and upside assuming we achieve what we need to achieve in any one of our clinical or development programs.
I think I probably answered most of this but to summarize, given our stage of development in disease areas where there is a high unmet medical need and currently no approved therapies for our anticipated indications, along with the level of validation our pipeline has received from the US government through significant non-dilutive funding awards, as well as the continued business interest we garner, including a partnership we secured with Sciclone Pharmaceuticals for Dusquetide in the Greater China market, I truly believe we’re extremely undervalued and below many investors radars.
Think about it – Phase III data readouts in two cancer/cancer supportive care trials as soon as this year and next. To get to where Soligenix currently is today typically takes five to ten years of successful development and we’re now are a stone’s throw away. A very exciting time for us with the potential for meaningful and positive impact to first and foremost patients, but also to the stock price assuming a positive outcomes in any one of our trials.
WSA: Well, once again joining us today is Dr. Chris Schaber, the CEO for Soligenix Incorporated, which trades on NASDAQ, ticker symbol SNGX. Currently trading at $2.03 a share market cap is about $18 million. And we’d like to thank you for taking the time to join us today Chris and update our investor audience on Soligenix. It was great having you and look forward to future updates.
Dr. Chris Schaber: Well, Juan, thank you again for the time today. And obviously on our corporate website there is a lot of good information there, not only presentations but publications. I think anyone that’s potentially interested in learning a little bit more will find a lot of useful information there.