Cardiol Therapeutics Inc. (CRDL) September 2026 Conference Transcript

Good morning, everyone. My name is Brandon Foulkes. I'm one of the equity research analysts here at HC Wainwright and thank you very much for joining us at our global investment conference. Next up, we have a fireside discussion with Cardale Therapeutics and joining me from Cardale is the medical officer, Andrew Hamer. David, Andrew, thank you very much for joining us.

Thanks for inviting us.

Thank you.

You know, David, I think it's important maybe just to give you a a minute or two or however long you want to just introduce Cardiol where Cardiol is today and where you see the company in 12 to 24 months just given you know how significant that could be so Cardiol Therapeutics is an organization focused on developing anti-inflammatory strategies for cardiovascular disease heart disease primary focus is on rare heart disease but we also ambitions for a next-stage asset to go more broadly into mass market indications our lead program is in recurrent pericarditis which is now being well characterized with an in-market drug that's generating approximately a billion in sales so it's a it's a growing market it's causes significant impacts on folks quality of life and we're approaching completion of enrollment in the pivotal phase three program we have also have a focus on a second stage asset addressable to heart failure where the data from our phase two global archer trial has really provided strong encouragement to push forward with that asset and over the next 12 to 24 months horizon we see reading out a pivotal phase three program, taking our next stage asset in heart failure into clinical development and pursuing subject outcomes, obviously, in the Maverick program, pursuing a new drug application for which we have been awarded the orphan designation by the FDA for the entire pericarditis landscape of which recurrent pericarditis is a large subgroup.

Fantastic. Thank you very much. And I'm going to dive straight in to Maverick, you know, and you talked about enrollment, right? Can you just walk us through where enrollment is today? You know, what is the remaining patients sort of, you know, what is left in terms of the enrollment that needs to be taking place to meet that guidance of 1Q data readout?

And just perhaps on that, any color from the path of last patient in to top line data? uh so i'll leave the path from last patient into top line data for future guidance uh once the database is locked out in terms of enrollment we have guided the public we've advised that we were 75 enrollment some time ago we have an infrastructure of 20 pre-eminent pericardial disease centers throughout the united states additional centers are coming on board as well so we could have an infrastructure up to 24 centers. Our target enrollment by the end of this month is 110 patients, and we have not revised that. So that's what I can tell you is in the public domain. Everything else you'll have to wait for.

All right.

Gives me enough, right?

We're on track. I read through from that, so thank you. I do want to talk about the powering, right, and the trial mechanics of Maverick. Like, you know, can you just walk us through the powering of that and how we should think about kind of the data and what it's designed to show?

Well, we can be confident in the placebo event rate because it's very well established that the placebo event rate in this trial will be 75% recurrences and over a two- to three-month period. We have a 24-week period that the trial runs for. and we've powered for a 90% power for a 40% relative risk reduction. That is an assumption, therefore, that the active arm will have an event rate of 45% or less compared to the 75% of the placebo arm. That is a very clinically meaningful reduction. Our pilot trial would suggest that we should do much better than that, but it's important to be conservative with your powering.

You talk about that 75% being well established. You know, is there any risk to this trial if we see anything different? You know, I guess how sensitive is the trial if we were to see something different in the placebo oil?

We have looked at other connotations of event rates. And we also, you know, and we're comfortable with where things are sitting at. Any trial is sensitive to event rate. and we do state in our protocol that we will be monitoring event rate and there may be some flexibility in number of patients enrolled depending on that. But right now we're comfortable with what we're seeing.

And even the real world evidence or the feedback we're receiving from some of the largest pericardial disease centres in the world is suggesting the event rate remains at that or higher.

And I believe there's an overlap period, right, when patients are placed on Codal, Oryx, or placebo while Rolonicept is withdrawn. You know, Hush, is there any risk we should think about in terms of timing of the recurrence of that 75%? I guess any risk in that withdrawal period? And if so, you know, if an event occurs in that overlap period, how is it treated?

If an event occurs in that overlap period, that the patient cannot be assessed for the primary endpoint because the primary endpoint is from the time of last dose of Rolonicept. So we're comfortable that it's very, very unlikely anybody to have an event in that period because they're on their Rolonicept, which is a very effective drug. The reason for the good overlap is because whilst Rolonicept it does continue to have effects for two to three weeks after its last dose. Some patients have had recurrences quite early, if you look at the observational data. So while 75% get to 75% at two to three months, and the average time tends to be around eight weeks after the last dose that patients have their recurrences, it's a variability. So having a good 10 to 16 days overlap is important to make sure that you've got a really good exposure to our drug before you've withdrawn the IL-1 blocker.

Very helpful. And if we think about the phase two data, obviously, you know, it looked really good. Can you just talk about, though, what gives you the greatest confidence from that phase two data in terms of that it will translate here? and, you know, especially are there any endpoints, whether it be, you know, the primary or any other secondaries or any measures you think are most translatable and others that are perhaps a bit more variable?

Well, the pilot trial was very much designed upon the pilot trial for Rolonicept and primary endpoints was the eight-week point of reduction in pain and CRP. But the most important thing for the feasibility of the phase 3 trial is the extension period to that pilot where we withdrew all background therapy down to monotherapy of cardiol Rx. We were very pleased to see that CRP remained low, the pain levels remained low and what's most important is comparing their historic event rate prior to trial enrolment when 40% of patients are on corticosteroids, 80% on colchicine and they were having 5.8 events per year. That comes down to the weaning and monotherapy period of the extension where we saw 0.9 events per year. As said, that would suggest we'd get a much better result than a 40% relative risk reduction in Phase 3, but we don't want to underpower the trial and we don't want to miss a clinically relevant reduction.

It's definitely the annualized event rate that is the most important observation from Phase 2.

And, you know, staying along that theme, moving to Maverick what does I guess firstly you know a clinically compelling Maverick result look like and you know is a commercially compelling Maverick readout any different to the clinical you know I guess what I'm saying is are there any secondary endpoints you think are particularly relevant for the commercial perspective here especially you know to give physicians confidence to use the product. And I'll leave it at that before the follow-up.

What the specialists are telling us is that anything over, anything in the, even the 35% reduction in event rates would be overwhelmingly adopted into clinical practice. And in fact, the architect and the principal investigator for the trial, Paul Kramer from Northwestern, in a recent KOL call suggested that he would adopt such a medication into his practice at a much higher percentage than even we internally were forecasting. So couldn't be, to Andrew's point, I think the trial is very conservatively powered relative to the observations in phase two, because for that primary reason, we don't want to miss a treatment effect. And so I think we've done, you know, we've worked with the FDA, we've worked with the experts in the field to set this trial up for maximal chances of success, and that's what we look forward to.

And when we do think about the trial design, understanding exactly why you chose this patient population while you're coming off Rolonicept, right, Right. If we think about the commercial opportunity and those discussions you're having with KOLs, are they viewing the product and the readout in Maverick as using Cardale RX post-Rolandisept in their practice or earlier in line where we think there's a tremendous opportunity as well before going into an R1?

I'd say both. I mean, you can look at the low-hanging fruit in the market as an off-ramp to Rolonicept, but the mechanism of relapse or the pathophysiology that leads or the biology of relapse is the same irrespective of if it's tapering from IL-1 therapy or your first episode for that matter or non-response to any line of therapy. We are, it is simply an enrichment strategy, so we've selected patients at the highest risk for relapse. We put the drug to a tough test, but to make the study efficient. And I think it's also important that we are following in the footsteps of another drug that went through the same path. We have a very similar phase two program and a very similar design in phase three. And that's what the FDA has already approved down those lines. So we're not going into a path of unknown from a regulatory treatment point of view.

And certainly the experts and the prescribers, which is the people that are enrolling this trial in the US, they very much are looking at this as, you show benefit in the off-ramp benefit, you will be replacing corticosteroids in the treatment paradigm. And the FDA have had very specific discussions with them about that as well, and they perceive exactly what David says, the pathophysiology is the same across the whole spectrum of pericarditis, and therefore the indication would be across the spectrum.

Okay, fantastic. And you do talk about, you did touch on the FDA and the FDA, there is precedent for this.

Anything you want to say on your interactions with the FDA to date, and whilst maybe early on a label perspective, but that this enrichment strategy has the potential to drive can't really comment on anything more than we've already discussed we had a we've discussed publicly that we had a very successful end of phase two meeting we presented the design the design we're aligned with the FDA with respect to this design subject outcomes of course supporting a prevention of recurrence label and in fact if you look at the run-in period of the Rhapsody trial that led to the approval of Rolonicep, Arcalist, our run-in period is essentially the same. So the question we're answering is the same, and that led to a prevention of recurrence label for Arcalist. So we see no reason that our label wouldn't be the same.

Yeah, and if you want to Google enrichment strategies-FDA, you'll see an entire guidance, which is very key to how we've designed the trial and functioning the trial, and gives us huge confidence that the FDA both understands but also encourages and sets out guidelines for how to enrich a trial which we've followed.

And I think it's also important the architects of this trial is the same experts in pericardial disease that designed the studies for the Rolonicep program.

Fantastic. I do want to just touch on, and if you don't mind walking us through the medical as well as payer value proposition here, right? I know you've sort of talked about price in the past, you know, especially if we assume that there is a big market ahead of an IL-1. Can you just help us think through that medical but also payer value proposition here for Cardinal RX?

So I think from a medical perspective, they're looking for a drug that is more accessible, oral, more convenient for patients, more accessible from a price point of view, and then when you look at the pricing side of the equation, we've done extensive work with payers. Obviously the market precedent is a very expensive medication and we were very encouraged by the pricing the studies resulted in. It's actually a striking premium to what we had been anticipated. So I think the value proposition for our drug is it can be dispensed out of larger points of care through specialty pharmacies, more convenient for patients, more accessible, and most importantly, potentially disease-modifying. So there could be a path off the drug. So for a payer's perspective, they're not signing up to a perpetual commitment to a profoundly expensive medication. Our drug will be more attractively priced, more accessible for patients, and potentially there will be a way off the drug much faster than the immune suppression strategies.

Fantastic. And I do want to touch on the rest of your portfolio because it's not just Commoday or Rx. in recurrent pericarditis. But I do want to just stay on the commercial theme quickly. Can you talk us through the options you will have to commercialize this drug, right, and the ability to potentially self-commercialize an orphan drug indication in recurrent pericarditis, but then also how there may be additional indications that you could build out a commercial organization, should you wish?

There's lots of precedents for both. so there's precedence for strategic partnerships uh revenue sharing um outright licensing and going it alone so this is a highly specialized field uh there's a specialized clinic set up throughout the united states to care for these patients it is an infrastructure that can be detailed by a reasonable size sales force like sub 100 uh detailing reps for example and that is within the realm of possibilities for an organization to grow into we see ourselves as a drug discovery development company first and foremost that is our area of expertise we haven't built out a commercial expertise but other organizations that started out as drug development discovery companies did morph into those commercial enterprises in rare disease for highly tactical strategic marketing efforts so you know the board will assess all of those in due course, and we'll pick the best pathway forward for ultimately commercializing the drug.

Fantastic. And I do want to move to CRD38 because it's obviously a very interesting program. Can you just let us know how developed is that product profile today, and what should we be watching out for over the next 12 months in terms of news flow from that program?

Over the next 12 months, you should be watching out for that drug to go into first-in-man, so clinical development. So it is preclinical going through the IND enabling work because it is a reformulation. It is the same as the lead molecule, but it's a reformulation of the lead molecule. Therefore, the IND enabling work has to be repeated for good reason. And we are working our way through that process. And we see that really the interest in that molecule becoming exponential on the readout of the pivotal phase three Maverick program, because the molecule is the same we just have a more elegant efficient way to deliver it in a sub-q format hopefully once monthly for chronic mass market conditions that are orders of magnitude larger than the rare diseases such as heart failure so that's um and i think all of that comes together around the phase three readout next year and you've seen you no doubt have observed some of these high profile challenges with the other immune suppressing strategies, the anti-IL-6 strategy. So I think early 27 could be a time of great interest in a non-immune suppressing, potentially once-monthly therapeutic profile that addresses inflammation and fibrosis in heart disease.

Fantastic. And, you know, I do want to just touch on, you know, the broader potential of Cardale RX, right? I think we've had some data this year. You know, if Maverick were to read out positively, how do we think about balancing potentially partnering in CRD 38, you know, taking Maverick forward, or Cardale RX forward in recurrent pericarditis, but also maximizing the potential of the molecule Cardale Rx in other orphan indications. Should we think about continued development of Cardale Rx into other indications?

I think you can. I mean, the ARCHER data points to multiple other areas of heart failure medicine or cardiac disease, the largest of which is heart failure itself. So I think you could think of potentially the drug being deployed in persistent myocarditis patients once in market with a label for recurrent pericarditis. I think you could even envisage it going. There was a very provocative question asked in that KOL call with Paul Kramer, could you ever see this first line? and paul kramer's response was i like the way you're thinking so i leave it at that well i think that's a great place to leave it david andrew thank you very much appreciate your time