Interview with Memphasys (ASX:MEM) CEO Alison Coutts

Memphasys (ASX:MEM)

We talked with Memphasys CEO Alison Coutts about new uses for MEM’s unique protein separation technology and progress with the core application in improving IVF outcomes. Horse owners may be benefiting from Memphasys’ work soon.

Full transcription below.

 

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Transcription

 

Stuart: Hello, and welcome to Stocks Down Under. My name is Stuart Roberts, and I’m one of the cofounders of our publication. And joining me on Tuesday the 17th of May, 2022, is Alison Coutts, who’s the CEO of Memphasys, ASX:MEM. Alison, good afternoon.

Alison: Good afternoon, Stuart.

Stuart: It’s been a story of continued progress for Memphasys. You were built, obviously, on the Felix device, which has some utility in terms of improving outcomes in IVF. But as we’ll talk about in a second, it’s much more than that. Now, in the meantime, you’ve recently got ISO 13485.

Alison: Yeah, well it’s been… Wait, wait. It’s not been formally issued yet. We’ve passed the audit. We’re just waiting for the formal issue sort of thing.

Stuart: Yeah. All right. No mean feat, whether it’s been formally issued or not. How difficult a process was it to get that ISO qualification?

Alison: Oh, it’s absolutely frightful. You should ask somebody who’s been through it. It’s like mountains of policies and procedures and documents. I mean, you name it. Every aspect of doing anything like a Felix device. Covers design and development, manufacturing, packaging, labeling, marketing, post-market surveillance, remedial action, risk analysis. And it’s all gotta be absolutely ordered, and at the touch of a finger when you’re asked.

Stuart: Right. So, basically, you’ve now got a functioning and well-running quality system, for medical devices, which is up to muster with any regulatory agency.

Alison: That’s right. And it’s not specific to the Felix alone. It’ll stand us in really good stead for the Felix, but any device that is Felix-like will be also part of this same process.

Stuart: Right. Now…

Alison: We’ve got a quality management system.

Stuart: Yes. So, we’ve now got best practice on the device. And you’ve been talking to some pretty engaged people, who are opinion leaders in their field. Talk to us about some of the relationships you’ve built over the last year or so, in order to spread the word on Felix.

Alison: Fortunately, when, before COVID, we went and traveled to various big shows, big IVF events overseas. There are three, and we got to meet a lot of key opinion leaders around the world. And some of them were introduced to us by John Aitken who’s the guy…we actually now employ him, but he’s number one in the world in anything to do with andrology. And key opinion leaders, actually, when we wanna have a meeting with them, they know that we’re associated with John, they wanna know us too, which is marvelous.

And so, that’s how we got to know a number of them. Not all of them, but a number of them. And they’ve been really, really valuable to us. They’re all around the world. They’re the guys who set the standards for everybody else to follow in anything to do with IVF.

Stuart: Right. Now, as someone who’s followed the Memphasys story for a little while, it was very pleasing to see that potentially, the technology which lies at the core of Felix and all you do is useful as a diagnostic for oxidative stress, and you’re prioritizing that…

Alison: Ah. That’s an interesting observation, Stuart, and I won’t go there, because I won’t… That’s interesting IP-wise. We just leave it there? There’s some little tricks that I don’t want to divulge.

Stuart: All right. So, if everyone blocks their ears, you can tell me all about it, right?

Alison: No, no. All I’ll say is that oxidative stress is huge. And it’s not just, actually, for anything infertility, it’s usually behind infertility in one form or another, male and female, but it’s behind anything like diabetes or heart attacks, strokes, cancers [crosstalk 00:03:54]

Stuart: All our neurological conditions?

Alison: Oh, everything. Like, it’s all about inflammation, and imbalance in your oxidative state, you know?

Stuart: Right.

Alison: I won’t go into the biochemistry, but, complex, but it’s a core biological thing, and this is kind of like a bit of a Holy Grail for a lot of…I mean, [inaudible 00:04:16] fertility, a lot of fertility clinics to…or not just clinics, but people who are really interested in research, they’ve been some really elusive to get a point-of-care diagnostic, that is quick, and sensitive, accurate. It’s hard. And John is a supreme [inaudible 00:04:36] biochemist, and he’s been working on this for a while. And what we’ve got, all I can say, because I’ve gotta be very careful about what I say, is that we’ve got…it’s about a…it’s like a fulcrum, and you’ve got oxidation or reduction, and you just wanna have a nice balance between the two. If you’re out of balance, either way, you’re in trouble, and a lot of people are. So, but you wanna measure it at the point of care. And we’ve got a, we’re very close to developing an assay that measures both sides of the fulcrum, and works out the balance all in one pop, and it’s probably minutes versus if you were trying to work on the known biochemistry, it would be hours. So, [crosstalk 00:05:24]

Stuart: Right. So, I mean, this is just important for Memphasys. This is a breakthrough of world-breaking consequence, right? People have been looking for this for years.

Alison: absolutely, potentially. I mean, I’ve done a lot of chemistry in my life. I’m nowhere near like John, but I tell you what, this is pretty special. And John’s very confident that he can pull it off, and he says he’s got a proof of concept in one side of the fulcrum with, even working with semen. That was as of today, and the other side, he’s managed to get oxidative states, but not with body fluids. But he’s confident he’ll get it. And I think this would be huge.

Stuart: That’s great. [crosstalk 00:06:04]

Alison: The thing is that, you might say, “Oh, look, I’ll just take antioxidant.” You know, like, “I’ll get something from the chemist.” Well, one is that is it the right sort of dose, and level of concentration that you need? You have no idea. As I said, before, it’s like taking insulin. You think you’ve got diabetes, but you don’t have any clue.

Stuart: Right.

Alison: And you might actually overdose or underdose, because you don’t know your oxidative state. And this is the thing that you need in order to determine what to take and when.

Stuart: Well, that’s exciting. But in the meantime, you’ve got something that’s a little bit closer to hand, with some more data you can talk about. Turns out that your SAMSON product is performing particularly well, where you’ve got some data on race horses, but it’s applicable to horses generally. Tell us [inaudible 00:06:53] about the latest news.

Alison: [crosstalk 00:06:53] Well, yeah. Look, bear in mind that this is retrospective data, knowing, you know, what the results were, and then getting an algorithm to fit, which is always easier than prospective, like, new pairings of stallions and mares. So that was what we wanna do next. But based on the retrospective data, we were able to predict pregnancy, by just using the semen from a stallion, whether it’s a standardbred or a race horse. With a race horse, of course, you know that they’re not allowed to be bred artificially, so they’ve gotta actually mount the mare. But, and so, you use a dismount sample, and I won’t go into how you collect those, but fortunately, we had a expert from a university doing all of that at the stud, and we were able to predict with high degree of accuracy, just using the semen sample and some other statistics about the individual horses, such as stallion and mare age, etc., getting an algorithm together, and working out, within an hour of the fertilization event, the likelihood of pregnancy, to a high level of accuracy.

Whereas, if you were looking to see how likely the event would be to create a pregnancy, otherwise, you would have to wait 14 days, or so, for an ultrasound, by which time the mare might have been outside of her season, the estrous cycle. You have to get, sometimes, the stallion on the mare, back together. That’s logistically difficult sometimes. If you know that that thing is likely not to have taken, you could potentially bring the stallion back, maybe he needs to rest a bit, and have another service. Or, for AI, you give another dose. And this is terribly important in, for high value of pairings, not just for any old horse out in the field, but for high-value, performance horses, it’s fairly important to get pregnancy within a season, and to also do it as soon as the season starts as possible, because every day of extra growth gives you more value. Because, of course, you know, horses all have the same birthday.

Stuart: Now, obviously, you’ve gotta run a prospective study of that. Have you lined up the relevant site, in order to run this [crosstalk 00:09:11]

Alison: No. Look, the two studs that participated are really, really keen, and very curious. They rear, wonderful. They’ve really been very cooperative. We will reach out to others, but right now, we are focused… It’s not easy to…I’m sorry. It’s not hard to recruit the studs, actually. But what we’re busy doing is making a better device to take to the field, because the first one was a bit of a clunker, but it served its purpose. The next one’s not gonna be the complete, final one, but it will be good enough, if it works, I told them, prospectively, that we could potentially have some commercial sales from it, and then we’ll fine tune it later. But we wanna make sure that it works on a prospective sample, not just retrospective, before we go and, you know, fine tune it that much. So, that’s where we’re going.

Stuart: Well, and just great. I mean, for those investors who just know of Memphasys as the Felix device, sure, it’s Felix, but we’ve got a heck of a lot of interesting stuff piled up behind that, which could potentially create more shareholder value than [crosstalk 00:10:18]

Alison: [crosstalk 00:10:18] oxidative stress is actually… I mean, we’re talking with other IVF clinics, and [inaudible 00:10:25] leaders, and, one in particular, hugely well-serviced, with…they’re doing stem cells and all sorts of things, and huge equipment overseas. Oxidative stress is one of their number one programs. This is a really, really big one. But don’t forget, also, Felix, because there’s enough there. That’s a good little device. You know, it’s taking a while to get the sales, but we’re selling a medical treatment, and, you know, it’s going pretty well. It performs well, but it’s just, it takes time. And we actually underestimated how long it would take.

Stuart: Yeah, and let’s face it, we had a pandemic as well, so that slowed down all sorts of technology [crosstalk 00:11:08]

Alison: and we did have a little hiccup in the development, which we’ve recovered from, that wasn’t, it wasn’t great. And then, the pandemic was an extra thing, but we’ve put the running shoes on, we’re back, and, you know, we’re doing a lot. Which, hopefully, you’ll see soon.

Stuart: Well, shout out to Professor John Aitken, the legend from the University of Newcastle, and hats off to you, Alison, and your team.

Stuart: Keep up the good work.

Alison: Thanks very much, Stuart.