Diagnosing autism and ADHD from a smartphone

BlinkLab Limited (ASX:BB1) Non-Executive Chairman Brian Leedman discusses transforming smartphones into diagnostic tools.

Manny Anton: Hello. I'm Manny Anton for the Finance News Network, and today I'm talking with BlinkLab (ASX:BB1). BlinkLab, trading under the ASX code "BB1", has a market capitalisation of approximately $25m. BlinkLab is a pioneering neuroscience company that turns ordinary mobile phones into devices for conducting neurobehavioral evaluations. The company's technology enables remote and rapid testing to aid research on neurodevelopmental and neurodegenerative conditions such as schizophrenia, autism, ADHD and various forms of dementia.

Joining us today is BlinkLab Chairman Brian Leedman. Brian, welcome back to the network.

Brian Leedman: Manny, thank you for having me.

Manny Anton: Excellent. Let's start with a little background. Now, the last time we spoke, the last time you were on the network, you were involved with ResApp Health. How did that go?

Brian Leedman: Well, that was just a terrific outcome. I mean, you dream of these sorts of outcomes when Big Pharma comes along and says, "We'll buy you." And we never even got to the revenue stage of the company and we were simply acquired. Of course, it's up to shareholders to decide whether the company should be acquired or not. But certainly as a director of the company and a founder, I was very proud to take that offer to the shareholders, and it was such a terrific return for the investors, including myself. It was a fantastic event.

Manny Anton: And you've moved on something new now. So, you're focused on BlinkLab. Can you tell us a little bit about BlinkLab, about the company, its business. Now, you recently listed, of course?

Brian Leedman: Yeah. Well, BlinkLab, like ResApp, is a digital healthcare company. So, we're always intrigued about what a smartphone can do in terms of a diagnostic tool. And ResApp used signatures in the sound of a cough to diagnose respiratory disease on a smartphone, and BlinkLab uses your facial reflexes that are automated. It's an automatic response to diagnose early-stage autism or ADHD or potentially a whole range of other neurological disorders. But, in our focus market, in children that are very young, certainly younger than what they're currently diagnosed, which is typically around five or six. But I would argue that these children, they're already displaying behaviours that are problematic, which the parents are concerned about. They go through a process, they get diagnosed, it costs thousands and thousands of dollars, the NDIS is spending so much money on it. But imagine if you could diagnose these kids at one and a half to two years old with an automated reflex response that's stimulated by the phone, and how you respond to that test captured by the phone on the forward facing camera can accurately diagnose whether they have autism or ADHD at an age for when they're diagnosed, can actually start treatment that will be disruptive to their lives and also for their caregivers. And we all know that the earlier you can diagnose anybody with anything, the better the clinical outcome for that patient. That's BlinkLab.

Manny Anton: How big is the market for this technology?

Brian Leedman: Well, one of the slides that I use in the presentation, and we're here for a conference at the moment, but the market size for autism in diagnosis and treatment in the US alone is about $700 billion.

Manny Anton: Wow.

Brian Leedman: So, it's a huge cost. And we also know, in NDIS, they're spending something in the order of $25 or $26 billion in NDIS. But the biggest expenditure within NDIS is in children with autism. So, our technology can allow children to be diagnosed much earlier through this biomarker, and that's the key thing here. This is an actual biomarker, just like a blood test, that is a test to show whether you've got autism. And it would be taken up by the medical fraternity. They would use it on a per-diagnosis basis, obviously following regulatory approval. And then we will find our place in that multi-billion-dollar market.

Manny Anton: And how difficult would it be to get that regulatory approval?

Brian Leedman: Well, I mean, regulatory approvals are not easy, and we've already done substantial clinical testing through our partnership with Princeton University, where the technology was developed, exclusively licensed to BlinkLab. They've already done over 8,000 patients to diagnose in terms of getting that algorithm as good as we can make it.

Now we're doing a — or we will be doing, I should say — an FDA registration study in the United States. It'll take about 12 months. We're enrolling over 500 patients. And the outcome of that study will determine whether we get FDA approval. If we get FDA approval, then we'll be able to market the product in the United States, and we can also get a reimbursement code because it'll be the parents who are effectively paying for it.

I don't know the pricing of it yet, but we'll call it a couple of hundred dollars a test, bring that cost down as a result of reimbursement, and then you're into this massive market.

And by the way, it may not just be that commercialising through revenues. That might be one model. Another model is like what happened to ResApp Health. You know, big pharma and Pfizer, digital healthcare division, their fastest-growing division within that huge company, they saw the opportunity to acquire the technology and commercialise it themselves. Could that potentially happen to BlinkLab? Absolutely. Maybe even Apple Health. They're the fastest-growing division within Apple, and this is a very cool application for diagnosing an illness using a smartphone. Lots of data in that as well. So, these are all potential commercial outcomes for our investors.

Manny Anton: Okay. You're talking very much about autism or you have up till now, so it seems that autism is clearly front and centre. The other conditions…

Brian Leedman: Well, ADHD is the other key face for us. And, of course, we know that the ADHD market is multiple sizes bigger than the autism market in terms of prevalence. So, again, the early diagnosis of autism is the same for ADHD. That blink response that we're generating using the smartphone is the same for every person, regardless of age. It's just that I believe personally that… I've got friends and friends of friends who've been diagnosed with ADHD in their 30s, 40s or 50s. Now, that might explain a lot of things in their lives. You know, why their marriage broke up or why they behave the way they do. It's sort of a gratifying thing to know what's wrong with you. But I don't think you can actually do much for them. You're not going to change their personalities or behaviours given that they're already adults, right? And the same thing can be said for little kids, that by the time they're five or six, their behaviours are largely entrenched in their little personalities. But imagine if we get them at one and a half to two, be able to diagnose them and then treat them, and then you can totally transform their lives, for their caregivers and for themselves. And the cost for the healthcare system as well. I'm not saying we're going to save the healthcare system money, but we're certainly going to make the expenditure of that money far more effective. And I think that's what we want as a society. We want to be able to treat these people and we want to be able to give them a better outlook on life through that treatment. And that can only be done through early diagnosis and early intervention.

Manny Anton: And you've talked about the FDA. Obviously the US is the elephant.

Brian Leedman: Sure.

Manny Anton: What about ex the US? Have you had much luck out there or…?

Brian Leedman: Well, remember, as you pointed out at the start, we only listed in April.

Manny Anton: Right.

Brian Leedman: So, although we've made terrific announcements, associated with major partnerships like with Columbia University and Erasmus University in Europe, and there's other… There's been great announcements of partnerships. But the key for us is going to be doing those regulatory studies. The FDA one you've just mentioned, that's forthcoming, but there will also be an Australian TGA study. And that's a key one for me, because I feel like albeit that the Australian market is not a huge market, it is a market where our investors are. And I know from my experience with ResApp Health, when we went through clinical trials in Australia, we captured the investor imagination by having those Australian trials. We generate a lot of media as well in terms of the six o'clock news. And this is a sort of story that really bides itself well for that sort of market. But I think you do need an Australian trial to achieve those aims. And, you know, we're an Australian company. We're not an American company, we're not a Dutch company. We're an Australian company. And I want to do clinical trials in Australia for that market as well.

Manny Anton: Going forward, then, what are we looking for, say for the remainder of '24 and into '25 — what are the key bits of news that we should be expecting?

Brian Leedman: Yeah, so as I mentioned, the announcements to date have been with prestigious partnerships with major universities, major hospitals. That's terrific. But what the market is really waiting for is the regulatory study. That's the one that's going to get you before the FDA, that's going to help you design your clinical trial, and they're going to advise us. You need so many hundreds of patients, you need to have a regional distribution so that you manage to get different types of creeds and cultures. And whether that makes a difference in people's autism or ADHD, whether they be Hispanic or African American or Cauca… Whatever. All those bases have to be covered. That clinical trial has to start. And it is scheduled to begin in this second half. And that will be the catalyst for, I think, the real growth in the company, because if you're not in a clinical trial, you're not in the game. And so these clinical trials are beginning very soon, certainly in this half of the year. I can't be more specific and I can't name names, but I do know that they're very close to being completed in terms of getting those trials underway. And then we become a really interesting company, and I'm really excited about being able to get out and tell the story of the company as we've progressed into regulatory studies.

Manny Anton: And is there any timing, do you think, around that? Have you got a sense for what…

Brian Leedman: I can't be pressed…

Manny Anton: No, I know you can't be…

Brian Leedman: ..into anything other than in this half of the year.

Manny Anton: Right.

Brian Leedman: And remember, we listed in April.

Manny Anton: Yep.

Brian Leedman: I know that shareholders, they get excited and it's like, "Are we there yet?" But we have a plan. My big saying in all the companies that I've been involved in is do what you say you're going to do in the timeframe you say you're going to do it in. And if you stick to that rule, you will be rewarded. And the companies that fail to achieve that are the ones that get left behind. And so I'm really focused on that. We have a great plan. I've got a great team of people around me. And I think that the opportunities are truly exciting. And I hope to replicate the success of my previous companies.

Manny Anton: Fantastic. Brian, thank you for your time today, and we hope to get you back maybe in six months' time, or when we've got a bit more news and you can give us an update then.

Brian Leedman: I'd love to share it with you.

Manny Anton: Fantastic. Until then.

Brian Leedman: Thank you.