David Bautz: Hi, everyone, and welcome to the next episode of our CEO Fireside Chats. My name is David Bautz and I’m a senior biotechnology analyst here at Zacks Small Cap Research. Joining me today is Chris Schaber. He is the Chief Executive Officer of Soligenix, Inc. They are a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. The company operates two business segments. The specialized biotherapeutic segment, which is what we’re going to focus on today, along with the public health solutions segment. The stock trades on the NASDAQ under the symbol SNGX. Now, the company’s lead asset, HyBryte, is currently in a confirmatory phase three trial for the treatment of cutaneous T-cell lymphoma, or CTCL. The company also has two phase two trials ongoing for SGX302 for the treatment of psoriasis and SGX945 for the treatment of Behçet’s disease. Soligenix is a company that we have covered for a number of years here at Zacks and for which we currently have a $35 valuation. With that, I’d like to welcome Chris. Chris, thanks for joining me today.
Chris Schaber: David, thank you for having me. It’s always a pleasure.
DB: Let’s dive right in and get into HyBryte, for which Soligenix has already reported positive results from a phase three trial in CTCL and, as I mentioned, has initiated that second phase three trial. I was wondering if you could talk a little bit about what the strategy is with this second phase three trial and then how its design compares to the first phase three trial.
CS: Of course. With the first phase three, we treated double blind placebo control for six weeks and then at a crossover design where all patients received the drug and the health authorities wanted to see longer durations of comparative treatment. That’s what we were doing in the confirmatory study. Instead of that six weeks cycle, we call it, dosing twice a week for six weeks and then measuring the primary endpoint, we extended that duration of treatment to 18 weeks, twice a week for 18 weeks. Everything remains the same in the trial design with regard to inclusion, exclusion criteria, endpoint. We’re pretty confident in the potential success for this study moving forward. Now we’re actively enrolling, as you noted, in this study, and we expect top line results mid-2026. We may be able to adjust that based on how we see the enrollment going and probably in early third quarter of this year we’ll provide an enrollment update, let everyone know how things are going. But we expect enrollment in this study to be much quicker than the first study because we know this patient population so well, this disease so well.
CS: We’re working with all the key opinion leaders in the space in both US and Europe. I think we’re positioned very nicely with this particular program.
DB: Alright, sounds good. Yesterday actually, the company announced very encouraging interim data from the ongoing Investigator-Initiated Study of HyBryte and CTCL. I was wondering if you could talk a little bit about what the company has learned from that study and then maybe also along with the results that have been reported from the other supportive studies, and then how those supportive studies fit in with the overall goal of the CTCL program.
CS: We’ve learned quite a bit. What we’ve done in this Investigator-Initiated Study at University of Pennsylvania, is we are treating HyBryte twice a week for up to 54 weeks of treatment. We now know that longer duration treatment, and one thing’s very clear with the Investigator-Initiated Study, or IIS, it’s called, and the supported studies is with this particular therapy, it’s topical. You apply to the cancerous lesions on the skin, then you activate it with safe visible light to shrink those lesions. The one thing we know is the longer you treat, the better this therapy works. We’ve already had a cut of the Investigator-Initiated Study at 18 weeks that showed a very profound response of 75% using that same primary endpoint that we’re using in the Confirmatory phase three study. As you would imagine, given that we showed statistical significance in the first phase three in as short a time period as six weeks, we’re pretty confident in the outcome at 18 weeks of this study. For that reason, I think it gave us a lot of good information going into this replication study. It truly is a replication study that we’re conducting here that gives us quite a bit of confidence and again, a high probability of success in my opinion, for this particular program.
DB: Yeah, absolutely. In addition to CTCL, as I mentioned, you also have two other actively enrolling clinical trials, one for SGX302 and psoriasis, and the other SGX945 and Behçet’s disease. If you could update us where on those programs currently stand and then maybe if you could briefly talk a little bit about how SGX302 in particular is going to fit into the treatment landscape for psoriasis patients.
CS: Sure. Both studies are actively enrolling in their phase two studies. We expect top line results here later this year, sometime in the second half. So again, a lot of good data coming behind the Confirmatory phase three program. In particular with SGX302, it’s another topical therapy. It contains the same active ingredient that’s in HyBryte, so you’re applying it to plaques and patches of psoriasis patients on their skin and treating with visible light. And where it fits in nicely is in the safety profile, treating very early. When you look at not only psoriasis but CTCL, the therapies that are currently being used are extremely caustic, they’re chemotherapeutic agents, many systemic or they use ultraviolet A or ultraviolet B light, the equivalent of sunlight. The safety profile is pretty significant and not only CTCL, but especially psoriasis. For that reason, we think SGX302 or synthetic hypericin, the active ingredient fits very nicely in that front line or first line of treatment in psoriasis. That’s really what we’re focused on. In the phase two study, we’ve already announced, as you know, two cohorts of patients in that study that were positive and we’re expecting that final cohort of patient later this year that really is going to allow us to hopefully fine tune those endpoints and what we’d be doing moving forward in the next phase of study.
DB: Okay. Switching gears a little bit, let’s talk about the company’s current cash position. What is it? And then also, what is the company’s financing strategy given the overall current market conditions?
CS: They are interesting market conditions for sure. Our current cash takes us into the first quarter of 2026. Obviously, our focus being late-stage is first business development opportunities and we’re looking at all strategic options there that range anywhere from regional partnership to merger and acquisition. That’s something that’s a priority of ours. If we have to do a financing later, it would be sometime mid-year, this year, into the early 3Q currently is what we’re thinking. As you know, we’ve had a level of success in securing non-dilutive government funding in the past and over the years have brought in more than $60 million of non-dilutive funding to help manage our cash burn, extend cash runway, build out a robust pipeline. We have a number of grants, contracts in various phases of review or submitted that we’re hopeful we’ll get feedback there. But we kind of taken a multi-pronged approach here to extending our cash beyond where we have it today. That includes business development, non-diluted funding through grants and contracts and then, if need be, a very focused financing to get us over the finish line with the phase three confirmatory study.
DB: All right, sounds good. To wrap up, I’ll let you close. What do you think the top reasons are that Soligenix makes a good investment right now?
CS: There’s a number, I think one is that we do have an experienced, very seasoned management team, board of directors moving the company forward with a track record for success. I think it’s like any biotech, right. You look at the development risk profile and I think ours with the confirmatory phase three replication study provides a relatively low risk profile compared to many companies our market cap size. We’re very confident in the probability of success in this phase three study. We have a robust pipeline behind the phase three with multiple phase two studies actively enrolling data readout later this year. I think when you look at our current stock price market cap, it’s a good entry point, in my opinion, for investors to look at the company now given what we have coming down the road with some pretty significant catalyst in 2025 into 2026.
DB: Yeah, definitely, couldn’t agree more. Alright Chris, well thanks for your time and for all the information today. We look forward to the psoriasis and Behçet’s disease later on in the year along with some updates from the CTCL program. Thanks again for joining me.
CS: My pleasure. Thank you, David.
DB: Take care.
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