*Two Pivotal Phase III studies for T-cell Lymphoma and Oral mucositis
*Enrollment milestone for SGX942
*Upcoming interim analysis for SGX942 in September
*Top-line final results for CTCL expected in 1Q 2020
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 for having me Juan.
WSA: Please provide us with an intro and overview of Soligenix for some of listeners that didn’t catch our previous conversation from last year?
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 biotherapeutic 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, funded entirely by the US government, focused on developing vaccines and therapeutics for civilian and military applications in areas such as ricin exposure and emerging and antibiotic resistant infectious diseases.
WSA: Can you talk about the recent progress on your two Phase 3 trials in which you just announced an update, and any other important news.
Dr. Chris Schaber: Sure. The two Phase 3 studies that we are continuing to actively enroll include cutaneous T-cell Lymphoma and the oral mucositis.
Briefly, our first Phase 3 trial for cutaneous T-cell Lymphoma (or CTCL) uses a novel photodynamic therapy for the first-line treatment of this rare cancer. In treating this disease, which consists of cancerous lesions or tumors on the skin, we apply a proprietary topical drug called synthetic hypericin to the 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. We refer to this combination drug-light therapy by the research name SGX301. The primary outcome in this trial is to shrink the size of the lesions by 50% or greater.
In October of last year, we announced the result of a positive interim efficacy analysis, and anticipate top-line final results in the 1Q 2020.
Our second Phase 3 study uses a new class of drugs referred to as Innate Defense Regulators that modulate the body’s own innate immune system to treat disease. Our first in class drug here is called Dusquetide, research name SGX942, and it’s for treating 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 4 minute IV infusion of SGX942 periodically to potentially reduce the duration of severe oral mucositis as well as impacting other important measures like infection and survival.
Just top provide a bit more clarity, 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 canker sore multiplied by a thousand … just very devastating.
For this study, we recently announced that we reached the enrollment of approximately 90 subjects, necessary for the independent Data Monitoring Committee to conduct the interim efficacy analysis, which we expect to announce in the September 2019 timeframe.
Briefly, I will just like to add that we recently issued an investor update letter that went out on April 23rd, which summarizes our recent highlights. For those interested in getting the complete update, I would recommend checking it out on our corporate website.
WSA: You also achieved an enrollment milestone for SGX942, what other progress can we expect over the next few months?
Dr. Chris Schaber: Again, probably the biggest upcoming milestone we will have in the next few months is that interim efficacy analysis for the SGX942 Phase 3 clinical trial in oral mucositis in the September timeframe, which we are quite excited about.
If we look beyond September, obviously the SGX301 Phase 3 clinical trial top-line data is fast approaching with a 1Q 2020 read-out expected.
And as always, we remain very active in our pursuit of non-dilutive government funding. We recently announced receiving about $600,000 from the state of NJ and expect there is the potential for some additional non-dilutive capital coming in 2019 that will assist with our cash runway.
WSA: You mentioned the upcoming interim analysis for SGX942 a couple times now. Can you tell us, what information will be coming from this analysis in September?
Dr. Chris Schaber: Of course. As I noted, there is a Data Monitoring Committee or DMC, independent of the Company, made up of one statistician and clinicians knowledgeable and experienced in treating oral mucositis in head and neck cancer. This Committee will be conducting a pre-specified interim efficacy analysis, in addition to the ongoing evaluation of the drug’s safety. For this Phase 3 study with SGX942, the DMC has the power to recommend continuation or termination of the study based on the evaluation of the unblinded data in approximately 90 subjects. Specific recommendations include stopping the study for overwhelming efficacy, stopping the study for serious safety concern, stopping the study for futility, continuing enrollment in the study at the pre-specified sample size, which for the SGX942 Phase 3 study is approximately 190 subjects, or re-estimating sample size up or down to maintain the study’s high statistical power.
It’s important to note that all participating subjects and study centers, as well as the Company, will remain blinded at all times. Therefore, any public disclosure by the Company following this interim efficacy analysis will be more high level, focusing on the DMC’s recommendation versus any specific data read-outs.
WSA: Can you talk about your patent position and what other areas of need you’re targeting?
Dr. Chris Schaber: I would say that our patent position is quite strong across our rare disease pipeline, ranging from composition of matter to method of synthesis and/or use claims. In addition, the majority of our product candidates also have orphan drug designation, which allows for a minimum of 7 years market exclusivity.
With regard to other areas of need we are targeting … In addition to CTCL and oral mucositis, we are targeting pediatric Crohn’s disease in our biotherapeutics business segment. In our biodefense business segment, we are targeting ricin exposure and emerging infectious disease.
WSA: What makes SNGX’s approach unique from that of some of the other players in the sector?
Dr. Chris Schaber: At a high level, I think there are two important elements that make us unique compared to other players. The first, is that we are operating in areas of high unmet medical need, in that there are currently no drug therapies approved for the indications we are pursuing – be it for CTCL, oral mucositis, pediatric Crohn’s or ricin exposure. The second, is that we have had a nice level of success in securing non-dilutive government funding to advance our rare disease pipeline, having secured in excess of $50 million to date … and expecting additional funding coming in the future.
WSA: Can you fill us in on your background as well as the rest of the key management team, as you’ve just had some recent additions.
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 29 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 29 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.
WSA: What are the main company drivers that investors should take note of?
Dr. Chris Schaber: Great question Juan! If potential investors remember nothing else, the main points to remember are:
- Soligenix is currently conducting two Phase 3 clinical trials in CTCL and oral mucositis with multiple data reads throughout 2019 and early 2020.
- The first … an interim efficacy analysis for oral mucostis expected in September 2019
- The second … top-line final results for CTCL expected in 1Q 2020; and
- The third … top-line final results for oral mucositis currently expected in 1H 2020, depending on the outcome of the interim analysis
WSA: Once again joining us today is Chris Schaber, CEO of Soligenix. The company trades on NASDAQ, ticker symbol SNGX, currently trading at $0.72 per share, market cap is about 13 million. Before we conclude, Chris, to recap some of your key points, why do you believe SNGX, represents a good investment opportunity today?
Dr. Chris Schaber: I truly believe we’re extremely undervalued and below many investors radars. 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 development programs.
Think about it – Phase 3 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 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 shareholders assuming a positive outcomes in any one of our clinical trials.
WSA: We certainly look forward to continuing to track the companies growth, and report on your upcoming progress, and we’d like to thank you for taking the time to join us Chris, and update our investor audience on Soligenix, it’s always great to have you on.
Dr. Chris Schaber: My pleasure, Juan, thank you for having me.