Syntara Limited (SNT) Earnings Call Transcript & Summary

This morning from Pharmaxis is Gary Phillips. Gary, good morning.

Good morning, Andrew.

Good to see you, Gary. Look, some news this morning here, but firstly, you and I have spoken a number of times here in recent weeks concerning a number of drugs within the Pharmaxis portfolio.

Just stepping back. Can you put a bit of context on this? What's the overall strategy here at Pharmaxis?

Yes. So Pharmaxis, a company -- we're focused on information and fibrosis, and we're a drug development company. So we have a lot of assets that are in the clinical stage of -- ready to go into clinical studies with patients. And I think that's one of the unique features of Pharmaxis and the other being the drug development team, which have delivered us those 5 drugs, I think, in the last 5 or 6 years. So those 2 things together, we are focusing on 2 drugs. The first one is an antifibrotic, which works in several cancer indications. And we're doing a study in bone cancer at the moment, which we've talked about before. That drug has got a lot potentially in other cancers as well. The second drug that we're focusing on is this one in scarring, which was the subject of the announcement yesterday. And then, of course, the third leg to our strategy is that we are also somewhat unique in that we have a manufacturing business, and we're shipping drug around the world for an FDA-approved drug, mannitol, in 2 different forms, Bronchitol and Aridol, and that's a source of nondilutive cash coming into the company that funds our drug development pipeline.

This collaboration here with Professor Fiona Wood in Perth, what's the objective?

Well, the collaboration has gone on for a number of years, and I'm sure many of the people watching this will have heard of Fiona Wood. She's a world-famous surgeon, a plastic surgeon, and deals particularly with patients with burns. But probably many of you might not be quite so aware that her team over in Perth do a lot of work in the basic research behind wound healing and scarring. And when they heard that we had a drug which blocked lysyl oxidase enzymes, they were very interested because there's 2 of this family of enzymes which are heavily upregulated in skin, and they're responsible for the cross-linking of fibers that the body puts into a wound when it's trying to heal itself. And the enzyme, of course, is cross-linking in those fibers, which causes the scarring and the strength in the scar. Now that's a good thing, but when it gets out of hand and you get too much of that enzyme, then you get scars which then cause -- can cause problems, which then we don't really know what to do with. So Fiona Wood's group have had this vision for a long time of having scarless wound healing, so being able to close the wound, heal it and make it strong again but not lead to an excessive scarring process afterwards. So they've done a lot of preclinical work and a lot of different models to look at that, and they were very encouraged by the result. Indeed, our drug does block those enzyme in the skin, and in their models, we significantly reduced the scarring process. So they believe there's real clinical applications for that, and that, of course, kicked the relationship and the collaboration with her and her group to the next level where we started to go into the clinic and into patients.

And you've finished the Phase I healthy volunteer study. What were the main findings?

So the Phase I is -- like with all drug development, the Phase I is generally to show safety, and you're looking at things like blood levels of the drugs. But in this case, we're dealing with a drug which we are applying topically in a cream to the skin. So the first thing we want to see is what's the tolerability of the formulation. There's lots of things we can put on our skin and people become allergic to. You get rashes. So is the formulation well tolerated? And indeed, in this case, it was. We're then looking to see does the drug penetrate the skin. The skin is a great device that our bodies have for actually keeping us waterproof and stopping things going in. So of course, in this case, we're trying to get a drug into the skin to help. So we can take in these healthy patients. We can take small punctures of skin, and then we take them back to the lab, and we test them to see whether the drug is actually penetrated. Is it going where we need it to in order to impact the scarring process? And again, we found that it was, and it did so in a dose-dependent fashion. So as we increased the concentration of the drug in the cream that we were applying, the level of inhibition of the enzymes we're targeting increased. So that's good. And then the last thing we're looking at is what level of drug actually goes through the skin and then gets into the blood system and circulates around the body. We prefer that was really low because, obviously, if you can get a high target levels of drug in the skin and low in the body, then you've got what's a very safe drug. You're localizing the action of it just to the skin. And again, we achieved that with the Phase I. We saw very low levels of drug in the blood. So that was overall a really positive thing.

And so you say these positive results have now triggered the next steps. What are those?

So the -- Fiona Wood's group, again, we're -- it's a close collaboration with them. They've been advising us on which of the patients they think can benefit in these early stages. And the real driver of the next study is to try and find a patient group with a scar where we think we can show in a relative short period of time whether the drug works or not. And so the first group of patients we're trialing is in patients that have got an established scar, so this is a scar that's been there for probably more than a year. It's stable as a scar. And we're going to apply the cream into those patients, and then we're going to look at a variety of things. Again, safety. So this will be a study probably that goes on for about 3 months. We're going to be looking at safety, and then we will also be looking at the scar structure and the scar appearance as well to try and see that. And then the other group of patients which Fiona Wood's group is interested in are patients with burns. So this goes to the core of her medical practice over in Perth. And again, patients with burns, they often have surgery. They have skin grafts. And then they -- some of them have a very aggressive scarring process after that. And the scars that form as a result of the surgery are -- often cause both appearance issues. There's a huge impact on patients' quality of life from the -- just from the appearance of the scars that they've got. It's obviously psychologically quite difficult to overcome the damage it's caused but then also functional as well. So these scars can contract. They can restrict movement. So we're going to look at those group of patients a little bit further down the track as well. So 2 groups of patients, and we hope that the study with the established scars will kick off quite soon and certainly in the next quarter. So we're really looking forward to that working more with that group in Perth and pushing that forward.

It's the 1st of September tomorrow, Gary. Hard to believe it's come around fast. But what's in store for Pharmaxis as far as news between now and the end of the year?

So, yes, it really goes back to that strategy we talked at the beginning. So the study that we've got in bone cancer, that's coming to the end of its dose-escalation phase. So we were trialing 3 doses there, each one larger than the last in a group of patients with bone cancer, again, looking to see -- looking for safety and looking to see whether the drug was inhibiting the enzyme. And the third of the 3 dose cohorts is due to finish quite soon. So hopefully, before the end of the year, we'll be announcing the completion of that phase and going on to the next phase, which is a 6-month study, where we'll really look to see whether the drug is working in those patients. So that's going to be a source of a lot of news flow between now and the end of the year. Then, of course, there's this scarring drug that we're doing with Professor Fiona Wood's group. That one, it will -- hopefully, we'll be reporting after the completion of the Phase I, which we announced yesterday, the start of the next stage, which is going into patients. So those 2 drugs, focusing on those, making sure we can get them through, and both of those drugs should deliver clinical trial efficacy and safety results before the end of next year. So yes, it's going to be a busy time at Pharmaxis.

Certainly plenty of news coming up. Gary, good to see you. Thanks very much.

Thanks very much, Andrew. Pleasure to talk to you, as always.