Conference Transcript - TTRX 2026-03-02

Stacey Koo, Analyst — TD Cowan

Okay. Well, good afternoon. Thanks for joining our 46th annual healthcare conference. I'm Stacey Koo, part of the biotech team with my colleague Ms. Shaw. It's my pleasure to introduce Bradley Burnham, CEO of Trend Therapeutics. Please take it away.

Bradley Burnham, CEO

Thank you. I'm just going to do a quick double check. Can everybody hear me okay? I've got sort of a microphone here. Are we good back there?

Stacey Koo, Analyst — TD Cowan

Okay.

Bradley Burnham, CEO

I just want to check the pointer. Okay. Thank you to Kallen. Thank you to everybody for being here. Thank you to Stacey for the questions that I know and the discussion that we're going to have. My name is Brad Burnham, as she mentioned. I'm founder and CEO of Turn Therapeutics. I'm just going to jump directly into the slides. So, the origin of Turn Therapeutics is probably different than a lot of pharma companies out I was actually a medical device rep for a decade. I was the pacemaker guy. I worked for St. Jude Medical, did the defibrillators, the pacemakers. the operating rooms. I managed a large team actually for a lengthy period of time, so I understand the commercial portion of medical sales very well because I actually was in it. I dealt with the back committees, I dealt with you know corporate accounts and reimbursements and whatnot. But the other thing is because you're in the hospital all the time, you're interacting with patients, one of those patients was very sick and I ended up getting septic with an organism called CRE. Those of you who know organisms, you know that's not a a good one to get. It's got a pretty high fatality rate. One of the symptoms of it is you get soft tissue infections about 25% of the time. And I had a series of abscesses over the course of five years, over 20 surgeries. And I became what could best be referred to as a chronic wound patient for a long time. I can keep going. Learned that our wound care products were not quite up to par at the time. And that's where the company started. They were putting things like honey on my wound and calling it advanced. So I set about trying to formulate my own product initially for myself. I found an API that is still the workhorse in GX03, which is the formula that we're going to spend a lot of time talking about today, in Europe. It is a novel polymer. It's a new chemical entity. It's never been utilized. It's an API in the U.S., so we get the NCE status. Problem was it was in a liquid state, and I wanted it in an ointment state. So I developed a process of actually fusing this liquid inside of an oil carrier without an emulsifier and it was obviously a great deal of trial and error. It was my mom's favorite thing to say that her son patented mixing oil and water but here we are and we call that process permafusion. Visually, if you could just imagine, I'm just gonna keep going even though the microphone is jumping in and out. The API's are suspended in these blueberries inside of a three-dimensional matrix of petrolatum and because of that suspension rather than dilution, we can use a very low ingredient weight overall and still achieve a very high bioavailability. So this is what we're going to talk the most about today. This is the lead asset that I developed actually originally as a wound care product for me. I have an extensive amount of experience with this product. I actually had an FDA clearance in wound care and I did some initial sampling and so we have a lot of actual human data and human uses to fall back on as far as the safety profile. But what we discovered over time is that it was good at a number of things. In particular, it's very good at things like dermatitis. And we will talk about the fact that it is an IL-36, IL-31 inhibitor. It is the first IL-36 inhibitor of its kind. It is a novel mechanism of action. It's also an IL-31 inhibitor, which is very important. We do have an active phase two as we speak, 114 to 120 patients. It's happening inside the United States. we're expecting both the interim assessment and the final data to read out in the first half of 26 so it's going to be a fun first half of the year of return so this is our pipeline as I mentioned moderate to severe eczema is active Q2 interim assessment then they'll probably be because it's an eight week treatment period kind of a short trigger before we see the the final top line so that's going to be a fun quarter we also have a phase 3 radionic mycosis drug with the recent updates with the FDA that of course could be a amended to a phase 2b slash 3 single registrational trial. Everybody's still sort of catching up a little bit on the new regulations. But it has a great deal of human data, and I can go into that in a bit. So I mentioned eczema. So I did not initially think to use the product in eczema. I take no credit for that. The doctors are very clever people with coming up with off-label uses for things. It made sense when they were putting it on severe eczema to me because these were patients that the biology of eczema had just progressed to the point that the skin was very injured. I mean, the real difference between moderate and severe eczema was just more injury to the skin, you know, more breaking, more infection likelihood. So they were using it initially in these wound clinics and skin clinics to try and heal these wounds, but what they were noting to me is the patients were getting significantly less itchy and reporting, hey, I want some more, it's helping my eczema. I had a theory that we were inhibiting what I like to call the epithelial distress cytokine. It is quite literally the first signal that the skin sends off in the case of barrier distress. So if you have too much staph colonization, if you have cold weather and it breaks, if you have a disruption, you know, in the force, if you want to use a cliche, the skin sends off this IL-36 signal and it starts that whole eczema cascade. You might notice th2 differentiation. Everybody's probably heard of IL-4 and IL-13 because of the biologics that act on them. That happens after IL-36 release. And then later on in the chain, we also get the IL-31 release, which is the patient discomfort, the itching signal. That's obviously a very important target to hit and sort of a hot one because it actually leads to a quality of life change. So I wanted to determine, validate whether or not this IL-36 theory was true. so we set about doing some in vivo studies in the first one we used a Johns Hopkins model by a gentleman the name of Lloyd Miller who was at Johns Hopkins at the time he's now at Johnson & Johnson he created sort of a seminal work on connecting IL-36 to eczema so we replicated his model we created an IL-36 environment we applied the product and we wanted to see if there was a clinical effect and in that particular case we had a 57% reduction investigator global assessment over seven days. So we now knew that at least there was a clinical effect in the NViva model. Now mechanistically, what was happening in terms of the actual cytokines? We ran a very large western blot cytokine analysis using tissue analysis, protein expression, and basically said what's happening in there? Which signals are being expressed? How much are we inhibiting them? We ran a pre-treatment model that was actually an NIH model that they used in candida aura studies, where we put ointment on the animals for four straight days, and then we induced, and we wanted to see in terms of a comparator which one was being reduced. Now if you see, we actually hit 36 alpha and 36 gamma. If you're familiar with these cytokines, you know that 36 gamma is strongly associated with psoriasis. Borenger-Engelheim's pustular psoriasis drug, in fact, acts on that. Eczema is alpha dominant. We also hit IL-31 downstream, a very significant portion of IL-31 and also IL-4. We have an extensive safety history on the product, as I mentioned, but of course you need to validate things with controlled clinical trials. So we sponsored a phase one study, a traditional RIPT study, ran, you know, repeat insult patch tests, over 53 patients, 580 plus applications under occlusion. So the Tegaderm, the saran wrap style dressings, we didn't have a single adverse event reported. This was not surprising to us because The formula has already been blessed as non-cytotoxic, non-irritating, non-sensitizing. It's a non-systemic, but it's nice to see it validated. And this is our phase two that is ongoing. We are now doing a moderate to severe eczema trial. This is happening in the U.S. It's got three PIs. It is enrolling on time and very well, especially with the winter enrollment surge. We did it as an adaptive trial whereby the interim committee, if you can imagine sort of a group of people where they swallow the key and hide behind a door. they look at the data and they say okay you can add some more n if you need to we recognize that dermatitis can actually have a high placebo effect with vehicles but we don't anticipate a futility we anticipate either keep going or keep going and potentially add a bit more patients either of which of course are a win we still are planning to read out probably in June I will say by the end of q2 primary endpoint is the the usual easy index eczema area severity index, change versus vehicle, secondary endpoints of IGA and itch score. I anticipate we will actually be equivalent to systemics, so that could be a fun quarter. As far as the model, it was actually a really smart analyst who told me to think about this. When a patient goes to the doctor for eczema, there's a traditional treatment model. They start with something topical, usually a steroid. It's a pretty big commitment to jump to these injectable systemics. Usually you want to try something as a first line, and right now the first lines are not great options in terms of safety and efficacy. Nobody wants to just slather steroids all over themselves. Doctors don't love prescribing JAK inhibitors with side effects warnings on the side. We actually think because we're non-systemic, non-sensitizing, non-irritating, and non-steroid that this could become first-line treatment for eczema. I just mentioned the topical milieu. I don't need to go over each one of these in detail. As far as the eczema market, I'm sure most people know it's a very large market. A fascinating random statistic, though, is I started looking at other countries, and they tier the countries in terms of bigger markets, first-tier, second-tier. The U.S. is actually a second-tier market for eczema. It turns out countries like Sweden, Norway, Denmark, they can have as high as a 34% eczema incidence because it's cold and because the barrier is under distress a lot and you get that IL-36 signal. So we're obviously exploring international marks as well. Quickly on the onychomycosis, another fun off-label, I'll call it program, that was brought to me, this time by the head of the American Podiatric Medical Association who We reached out and wanted to run a clinical trial on our product for tonial fungus. He had a theory that because we were a fat-based product with a broad-spectrum API that he could treat tonial fungus. He ran a 100-patient trial. This was an APMA study. It was in the journal. I can send the poster. He had 70% to 85% efficacy, which is incredibly high for tonial fungus. He did the nail clippings. He sent them out to a lab. I wanted to know why because that's just me. I don't like saying just because. I like to know why. So we ran an in vivo nail penetration study where they inoculated the nails with actually trichophyte and rubrum, the traditional organism that causes nail fungus. And we were one of the first topicals to actually penetrate the nail and kill the fungus. The current options for topicals are not fantastic, 6.5, 8.9, and 17.8. The last branded topical comes off of Patent in 2026 as sort of this cliff that everybody is seeing. so it is an interesting time to have a potential branded product in the toenail fungus market, which lacks almost any and all competition at this point. Just mentioned the topicals. You can see they are not cheap either, and people still, like, I sometimes call onychomycosis the last bastion of reimbursable vanity. This is a very deceptive TAM because only 15% of people actually go to the doctor to treat their toenail fungus because they sort of already know they're gonna have to take a pill Lamisil or the topicals out there aren't great so if you could actually open up that market a lot of people have toenail fungus I feel like you can throw a rock and any group I talked to you're gonna find a few people that have it so this is a massive untapped reservoir of patients I mentioned our science aisle 36 has a number of diseases associated with it it's sort of the golden goose to me of the cytokines it's the initiating punch of the inflammatory cycle. Also IL-31, given the quality of life and the other indications associated with itching. We have a very fun 2026 coming up. I mentioned this timeline. This deck will be online for people who want to review it again. This is probably something you're not used to seeing at conferences like this, which is our unbelievably low burn rate. That is not a typo. So because I built this company on a shoestring, literally built my own lab in the beginning I got used to outsourcing and vendors and choreographing and we still extensively use vendors to this day built this company entirely on family office money we've raised a total of 21 million dollars to this day and produced everything you're seeing right now when it came time to I'll say go toward our phase 3 trials or phase 2 is fully capitalized it was either go public via micro cap or direct list which we did in october and then utilize this fully capitalized phase two trial as an opportunity to actually approach institutional investors and so far right now it's actually it's working out we're doing pretty well extensive patent and protections seven families 17 issued patents current coverage through 37 we should be expecting further coverage in the late 2040s. I think this is my favorite slide. I call this the oracle slide. So I was acutely aware in the beginning that I knew nothing about the pharma industry. I knew how to sell pacemakers and program them. But I started just cold calling these brilliant people. One of the first ones was Arthur Golden. He's the senior most M&A lawyer at Davis Polk Wardwell. He's been a mentor of mine for at least half a decade, maybe more at this point. He's on our board. Andrew Dr. Jen Joss, CFO of Terns Pharma, which is very confusing because we're Terns sometimes. They raised a couple of dollars a few weeks ago or a month or so ago, and Calum was on Kent Kester, he's the head of CEPI. Martin Dewhurst was global head of McKinsey Life Sciences for seven years, head of McKinsey for 30 years. If you look at this book, we just hired Dr. Redfield, the former director of CDC, to help us with regulatory and policy. So we've got an incredible group of minds and brains that I get to reach out to. And that's the conclusion of the presentation, but if I could just end with not a lot of people knew about us because of that quote-unquote non-traditional way that I said we went public. And we hired an incredible PR person named Sasha DeMuni. She was with Bayer and she was a Bloomberg health reporter. And she sort of helped us frame the story much more for the institutional crowd. And now given that we have a novel mechanism of action, we've got potentially phase three trials in the next 12 months to start and active phase two, we really think we're well positioned for investment. So thank you. Does this work or is it just that?

Stacey Koo, Analyst — TD Cowan

So, what a very comprehensive update. Thank you. But maybe let's go to the MOA slide. I know you talked about the oil and water aspect of things.

Bradley Burnham, CEO

You mean the loop slide?

Stacey Koo, Analyst — TD Cowan

Yes, exactly.

Bradley Burnham, CEO

Sure.

Stacey Koo, Analyst — TD Cowan

So just talk about maybe, clearly you've done a lot of work to look at your drugs, but can we also talk about maybe the pathogenic skin bile burden?

Bradley Burnham, CEO

Absolutely.

Stacey Koo, Analyst — TD Cowan

The very dysfunctional piece of all that maybe pull off?

Bradley Burnham, CEO

So I mentioned a gentleman named Lloyd Miller before who was at Johns Hopkins. He had a theory that eczema was closely associated with excess bio burden in the skin, dysbiosis. You know, it feels like everything keeps coming back to the microbiome lately. So there is a strong connection with excess staph colonization in the skin, which tends to, in the literature's theory, tends to lead to that distress signal. There's also the chicken or the egg back and forth because you may get more staph because of the fact that you have a weakened skin barrier, which can be a genetic deficiency, but the fact that we are a nonsensitizing that also eliminates the dysbiosis because we can eliminate the staph burden as well as heal the skin barrier, it's a working theory that we may work from both sides, especially and including the staph bio-burden portion. You also talked about at the very end the IP protection that gets you out to 2040s, but maybe talk about the maybe the hurdle that you yourself face to try to bring this formulation forward the hurdle that I faced I mean trying to mix water inside of oil yeah it was it wasn't easy because of the fact that we have literally the world's first emulsifier free emulsion I think that's the best way that I could put it the uniquity the novelty of the patents a lot of it was what's not in it not just what's in it we were able to get composition and method protection though and we have additional patent families on the on on the indications such as onychomycosis. We have one pending for inflammatory skin disease, including the compositions as well. So we've spent more money on IP than any other aspect of this company. And I've never, I've become a little bit of an IP nerd actually. I've never liked it when people have a single family and then they keep filing continuation patent because I feel like somebody could throw a dart at that one family at the top and the whole tree could fall down. So we continued to file extensive additional families. So we do have seven patent families, including the method of mixing, as well as the composition.

Stacey Koo, Analyst — TD Cowan

Okay, understood. And, of course, we're now waiting for the mid-26 update in atopic dermatitis. But maybe talk about the level of de-risking you all have taken to pursue the moderate to severe patient population. So maybe speak to some of that off-label use you're seeing.

Bradley Burnham, CEO

I mentioned that it was in wound care in the beginning. The fun story behind that is that I literally got a 510K clearance at a Kinko's in Woodland Hills, California by myself. I submitted all the data via a folder that I got off the shelf there. So the FDA has actually cleared this formula in the past already for use on skin disease, including breech tissue because chronic wounds, diabetic ulcers, whatnot. It's not on the market for that, but I was able to actually sample it in this space extensively. Thousands and thousands of units have been used on patients. it's an fda registered product there's never been a single adverse event reported to the fda it's a public database so we have a huge amount of real world experience on the safety profile of this product so in terms of a lot of eczema to me is safety especially what the options are out there in terms of the the safety and efficacy so we're very confident on an efficacy that we could you know match some of the systemic drugs out there safety I really don't think anybody's gonna hold a candle to us okay and if you could go to the phase to design sure maybe walk through that adopted design where you are right now just a level set the outcomes of our we're expecting sure it is a one-to-one trial simple in that sense vehicle on one side active on the other moderate to severe is the inclusion double-blind randomized vehicle control to all of the fancy acronyms that we want the primary endpoint is called the eczema area severity index people have heard of the easy index before which is going to be are we better than the vehicle as an eight-week treatment period from enrollment to readout which matches actually the VATAMA treatment protocol we recommend two to three times a day in the trial since we're non systemic we anticipate real-world use could be more than that but of course for the trial recommending two to three times a day the secondary endpoints is the change in investigator global assessment sort of the traditional drop in two points which means you have to at least drop two and I think it should be to one or clear as what I believe the endpoints say and the itch assessment is literally how bad are you itching which to me is a very biological indicator of the eczema itself having breech tissue you know with no itching there could be the question of is this eczema or not if you have the breech tissue and the itching That's the indication of biological activity if that goes down.

Stacey Koo, Analyst — TD Cowan

So the number of patients that you're going to disclose, and we should expect all these updates to be also expected, all these different metrics to be.

Bradley Burnham, CEO

So we, the interim assessment will be conducted between 50 and 60 patients. We anticipate it will be probably about 51 patients. That will be the keep going, keep going, add a few patients for statistical precision or futility, that we anticipate to be in Q2, and then we also anticipate the top line in Q2.

Stacey Koo, Analyst — TD Cowan

Okay, understood.

Bradley Burnham, CEO

The top line will have all of these specific data points in there. The interim will just have thumbs up. You guys designed it well.

Stacey Koo, Analyst — TD Cowan

Understood. So when it comes to dermatology, and obviously you're going to talk about toenail fungus and the opportunity there, but are you thinking about anything else within dermatology when it comes to this? I'm guessing you're waiting for the results here, but let me talk about some of the other places where it could be leveraged.

Bradley Burnham, CEO

So I have a very strong interest in hydradenitis suprativa, and I've actually learned to say that correctly very fast, by the way. Hydradenitis suprativa is a bioburden-driven inflammatory disease of the skin that results in huge painful lesions all over the body for these patients. Very similar mechanism of action, IL-36-driven, bioburden-connected. according to the physicians that I've spoken to, the only things that really work right now are things like topical clandamycin and oral antibiotics. So there's a very large lack in that space and it's a huge quality of life and issue for the patients. Given that we hit IL-36 gamma, psoriasis is obviously on our radar. I like the fact that HA is a relatively large but very high need market. I was a patient for a long time so it has that appeal to me and and there's also really nothing else out there that targets the very similar MOA.

Stacey Koo, Analyst — TD Cowan

Okay. So as we think about maybe then beyond dermatology and your level of interest in toenail fungus, what kind of clinician target kind of sales force when you're thinking about maybe all the different indications?

Bradley Burnham, CEO

I think that this would be a derm sales force. I recognize that podiatry may be a podiatry, or I recognize that toenail fungus may be a podiatry sales force, so we're not against partnering that asset with another company or with a strategic sales force of some kind that already has that channel. But this is going to be a dermatology sale, and we're actively working toward developing relationships with dermatology, KOLs, bringing on staff that are in the dermatology space. But it was fun because we found out we were a great derm asset because people told us. So now we're almost backing into it, but it's really nice when you sort of have information on your own asset before you begin the trial.

Stacey Koo, Analyst — TD Cowan

To that point, what work are you doing nowadays to increase awareness in the dermatology community?

Bradley Burnham, CEO

We have trials and peer review as we speak that I got a chance to co-write. We're going to be at the academic conferences, the American Academy of Dermatology. We submitted an abstract for that. I'm also actively trying to hire people in the medical affairs space and build out the advisory panel with DERMS. Thankfully, Sasha and her partner, David Patti, have a ton of experience. david patty who's another person who works in our pr he ran the atopic derm marketing at leo so he's got a number of contacts in the space so we're very much leveraging our team that has a lot more experience in that space okay wonderful any last questions yes sir you mentioned that in my opinion can you repeat the question before the question was if they don't use it two to three times a day would that blunt the efficacy i will say that there are controls in the trial such as weighing the tubes to make sure that they are using the appropriate amount I do expect that using less of it and having more exposure to the elements or potentially irritating skin care items or whatnot might blunt it but I also don't know if they're applying it once and leaving it on the whole day it might have a ton of effect so we're doing our best to control that and we've had really good compliance thus far we we work extensively with our CRO weekly calls with the updates and the weighing has been in keeping with the eczema area severity index the size of the lesions and the people using it the appropriate amount thus far that does bring up I guess on my end one last question then from your trial what do you work how you working on keeping that control arm within historical rates how we work can sorry can you elaborate a bit more sounds like in your control arm you're just trying to make sure how do you how do you make sure that the stay within a control arm type of outcome kind of work are you doing with the CROs to make sure you're really maximizing the effect maximizing the effect of the asset we just designed the trial with a very heavy understanding of the fact that a vehicle such as ours would have a strong reduction in eczema I mean it's eczema you put an emulsion on somebody's skin it's going to make them feel better we we have enough information on the product with the way we built the trial that we just believe strongly the delta will be high enough wonderful any last questions thank you so much thank you stacy and thank you everybody for being here