Click Therapeutics and Software-Enhanced Drugs

Speaker 1:
Welcome to TD Cowen Insights, a space that brings leading thinkers together to share insights and ideas shaping the world around us. Join us as we converse with the top minds who are influencing our global sectors.
Charles Rhyee:
Hi, my name is Charles Rhyee, TD Cowen's healthcare technology and distribution analyst, and welcome to the TD Cowen Future Health Podcast. And today we're live from TD Cowen's 46th annual healthcare conference in Boston. Today's podcast is part of our ongoing series that continues TD Cowen's efforts to bring together though leaders, innovators, and investors to discuss how the convergence of healthcare technology, consumerism, and policy is changing the way we look at health, healthcare, and the healthcare system. And in this episode, we're discussing the role digital therapeutics can play in the consumerization of healthcare. And to help explore that topic, I'm here with Randall Stanicky, a CFO of Click Therapeutics, which is redefining modern medicine with patient-centric digital treatments. Randall, thanks for being here.
Randall Stanicky:
Yeah, no, Charles, great to be here with you.
Charles Rhyee:
Maybe just to start, when Click came to market over a decade ago, it was with the idea of using digital technology to impact physiology, and a lot has changed in the market over that time. Maybe you can talk through a little bit of Click's evolution from then to now.
Randall Stanicky:
The market's changed a lot. I mean, the one thing that hasn't changed actually is our strategy. We've set out to build a platform as opposed to some of the other companies you've seen that have come out with one product and tried to take that to market, our goal and strategy from the beginning was to build a platform. And by that, I mean, building digital mechanisms of action, so MOAs and digital tools. So if we compare that to traditional pharma, think like drug API ingredients and the technology, drug delivery technology. And within that platform now we've built up over the last decade a number of these MOAs and tools that we know are FDA validated, we know work, and we've now had three successful RCTs that we've run through FDA on the back of that.
And so what that does from our perspective is it gives us the flexibility. And we came out, as you know, our strategy was partnering with pharma on prescription digital therapeutics. And that's evolved over the last four or five years. Last year we announced the partnership with Medidata. So now we're providing clinical trial solutions to our partner with Medidata beyond just prescription digital therapeutics. And more recently, and I'm sure we'll talk about this, we partnered with Ultrahuman on the wearable side. So all of that off of the same platform that we've built out over the last decade, as you said.
Charles Rhyee:
Let's step back and talk first maybe about the partnership model. And obviously you have three RTTs that were successful with FDA. One of your early partnerships was with Otsuka for MDD. More recently, right? FDA has kind of put out some draft guidance around Peters. It seems to me that this could open up even more opportunities to partner with pharma. First, maybe talk about Peters, what Peters does and how Click SE fits into that.
Randall Stanicky:
Yeah. The prescription drug use related software guidance came out in 2023. And in a nutshell, it basically provided a roadmap for traditional drugs to combine with digital drugs. One or more successful RCTs against drug alone, and you effectively have a new label, new drug with a product now that could be arguably more efficacious if it's improving the primary endpoint, or in a lot of cases, adding secondary endpoints to label that might actually have a lot of clinical benefit and benefit for the patient. When that guidance came out, we saw that as a huge opportunity and we stepped back and said, look, this is likely the future. The FDA's provided the roadmap here and you've got a number of drugs that they work, but they don't work perfectly. They don't work as well as they could. And migraine's a great example where we have Statsig positive and cleared a migraine program where if we combine that with a CGRP or another migraine drug, we're all hitting the same primary endpoint reduction in monthly migraine days, different mechanisms of action.
So now you're looking at a bigger reduction on a combined basis. So on the back of that guidance, we termed something and trademarked something called software enhanced drugs, so SE. And I'm sure we've all heard of Adderall XR, the XR being the extended release. Well, in SE, in our SE lingo, drug SE, SE standing for software enhanced would be the Click component to that drug. And that's something that we've gotten a lot of traction on with pharma and where we're focused now on moving forward. I think there's a huge opportunity and over the next three to five years, this is going to be something that becomes a lot more prevalent across a lot of different therapeutic areas.
Charles Rhyee:
Yeah, that's really interesting. And earlier also, you talked about sort of a partnership with Medidata as well, which is obviously one of the leading software platforms used to run clinical trials. Maybe expand a little bit here also, what are you working on with Medidata?
Randall Stanicky:
Yeah, so it's a really interesting partnership. So they took down our series C last year. The entire series C provides validation and capital, but way beyond that is this partnership where we're now, you can call it cross-selling, but it's a lot more than that. So they have 150 reps globally. They have 1,300 life science customers, and so they're now selling our offering into their customer base, but we're now offering digital solutions within their clinical trial software offering. And so we're adding to their offering in what is, I think, adding significant benefit and value to their customers. And there's just so much that the two of us that we can do together. And so we're really excited to be working with Medidata and it's a global partnership and it's been going really well.
Charles Rhyee:
Besides partnering with pharma though, as you mentioned earlier, you talked about migraine as an example, you've already gotten FDA approval for a couple of your own PDTs, one for episodic migraine, another that you acquired for type two diabetes. For migraine, you've talked about looking to get also approved for an over-the-counter version. Maybe talk a little bit sort of the strategic thinking behind that.
Randall Stanicky:
Yeah. So we're the first ever digital therapeutic for episodic migraine to be cleared through FDA. And very excited about our data in our pivotal. We showed a reduction of a little over three monthly migraine days per month, but we also had some really good and secondary endpoints in terms of disability and quality of life. And those scores are important and they play right into the payer thinking because these are questionnaires where they specifically ask patients, "How many days of work did you miss with the last two weeks?" And so if you're a payer or an employer, that matters to you from a pharmacoeconomic perspective and so on. So very exciting data. We got cleared to your point last April for an RX and we've now filed with FDA for an OTC version.
And this is the first drug that we partnered on the wearable side with Ultrahuman. That deal was announced in January of this year. This is going to be, we think, a big opportunity. It's a global partnership, non-exclusive. We see more of these coming, and migraine is arguably the perfect product to take to the OTC arena. If you think about it, we are actually going to treat the patient before the patient becomes a patient. We're going to the user before they've entered the healthcare system. And obviously, our platform's able to support that with the OTC business that we're going to build out. We have the clinical trials business with metadata, and then the other side of that, we have the prescription business and the SC partnerships with pharma. So as you think about the whole continuum of the patient lifecycle, Click, our platform can help serve that. So that's exciting that we have that whole life cycle.
Charles Rhyee:
So maybe can you talk then a little bit more about what does that mean to be part when you partner with someone like Ultrahuman? A, you said it's not exclusive, so we can maybe expect more of these, but talk a little bit more what that integration means of Click and particularly with migraine. How does that help a patient before they become a patient? What is that tracking and how does that fit into what Click is doing here?
Randall Stanicky:
Yeah. I mean, it doesn't take a lot. You can look around and see how many people have rings and watches and bands on to understand that the wearables business is exploding. And in a way, all of these companies do the same thing. They provide the same or similar biometric data that's frankly a commodity. I mean, different watches, different bands, they look different, so there's differentiation there. The biometric data is arguably a commodity that you can get from a number of different players. And while that's interesting and helpful, nobody really tells you what to do with that data. Your sleep score is this, or you just are as this. But what we saw a huge opportunity is to come and be that company that takes that data and treats patients. And so if you think about the Ultrahuman partnership, we know based on our pivotal study that our migraine program can reduce migraines by three days per month based on our data. So we can treat patients already.
Charles Rhyee:
Can I ask real quickly, what does that compare to with CGRPs? How does the three days result compared to traditional therapy at the moment?
Randall Stanicky:
Well, they're all a little bit different. I mean, every studies, it's hard to compare. They're all structured a little bit differently, but focusing on reduction in monthly migraine days and you look to the spread versus placebo. I think the important thing for us is that we're Statsig against placebo. And so you have to really look at trial design and all of that to get a specific comparison. But the reality is that we hit that endpoint, that primary endpoint. And so if we can treat migrainers, and again, we're talking about a massive number of people globally, 14, 15% of the population, primarily women, 80% plus, women suffer from migraines. So our ability to treat, and even if you're on a CGRP or a migraine treatment, you're likely still having migraines. For most people, your migraine medication does not eliminate all of your migraines. So having another treatment of a different mechanism can be additive and improve that.
So when we partner with a wearable company, Ultrahuman or someone else, the opportunity is to treat these users on their migraine, but also take their biometric data that's personal, overlay that with their migraine history and their migraine landscape, and then personalize that so that we can understand stacking some of these biometrics that matter like sleep, HSR and others, we can intervene. Think of it as like a weather forecast. If you go into the app and you're looking at the resiliency, you can get a sense as to when you're likely at more risk to have a migraine. If we can help patients understand that and go in and intervene before they have the migraine, in addition to treating them, there's huge value for patients in that.
Charles Rhyee:
All right. So then last question then, what's next? What should we be looking out for this year then?
Randall Stanicky:
I'd say three things. Number one, as we think about these three different areas that we talked about, the prescription digital therapeutics, the partnership with metadata, and then the wearables and OTC, I'd say watch for more activity, business development activity out of all three. That's number one. There's some things that we're working on that are very exciting that hopefully we'll be able to talk about soon. Number two, and this is maybe more of a CFO answer coming for myself, but I spent the last part of last year helping transition the company into a SaaS revenue model. So as we start to think about some of the revenue recognition coming in 2026, we're excited to start transitioning some of that to SaaS.
And then I'd say the third thing, we didn't talk about this, but it's probably one of the most exciting aspects of our business right now for us is we're expecting to see clearance for our CT-155 schizophrenia drug for negative symptoms that's partnered with Boehringer Ingelheim, and we hit on Statsig. We're the first drug of any modality to hit on negative symptoms. It's been a graveyard for traditional drugs trying to hit this endpoint. And so that hopefully is, you're going to see that this year in the hands, literally, in the hands of patients, and that could be exciting. And I think two things to think with that. One, it's going to be a prime example of what digital can do that traditional drugs can't, improving the lives of patients with schizophrenia with negative symptoms. But two, I think, Charles, this is going to be the one analog that you're really going to want to point to when we think about digital therapeutics going forward.
Charles Rhyee:
Well, that's exciting to look forward to.
Randall Stanicky:
Yeah.
Charles Rhyee:
All right. Well, Randall, thanks for being with us today.
Randall Stanicky:
Yeah, thanks for having me.
Speaker 1:
Thanks for joining us. Stay tuned for the next episode of TD Cowen Insights.