TALi Digital Limited (ASX:TD1) Managing Director Glenn Smith provides an update on the company’s software for the assessment and treatment of early childhood attention difficulties and its agreement with US company Akili Interactive, itself a prescription digital medicine company, to roll out software.
Just to begin, Clive has succinctly put that TALi Digital is a digital therapeutics business. So in short, what we’re doing is building next-generation products that are software that are delivered as medical treatments. And what we’re aiming to do in the initial stages of our rollout strategy is to target early childhood and children, particularly those with inattention and which may be symptomatic of conditions such as ADHD or autism spectrum disorder. So I’ll just run you through our slide deck right now.
Please take note of our forward-looking statements once you receive the presentation.
And as I said, we’re a listed Australian digital health business, currently capped around $40 million. We target attention during the early childhood and our initial product range is TALi TRAIN and TALi DETECT, and I’ll talk a little bit more about those soon.
We’re complimentary to existing therapies and detection in this area. So we can insert ourselves into current clinical practice and allow those products to be reimbursed in particular jurisdictions, such as in the US where we already have CPT codes. We have focus on ADHD and autism, but I’ll talk about our plans for mild cognitive impairment, which is a precursor to dementia, and talk about how our digital platform will evolve into that space. And we’ve recently announced a deal with a US-based company called Akili Interactive, where we will license our technology platform to Akili with expected milestone payments from that license agreement to be $51 million.
So we have about $2.7 million cash in hand at the end of June. And our clear strategy is to insert our products into clinical practice, seek reimbursement… And we have reimbursement and CPT codes in the US… but seek reimbursement into other jurisdictions. But we also have a nonmedical strategy as well for those markets where the digital health infrastructure isn’t yet available to deliver our products. And we have executed a partnership with The Times Group of India, India’s largest media conglomerate. They’ve invested US$2 million into us with another $5 million option investment. And what we’re doing there is targeting direct to consumers and also the education system there to roll out our particular programs whilst the digital health infrastructure catches up. So we have cash available to grow now; and through the licensing agreement with Akili, we have growth available to us.
So what we’re doing is ushering in the next generation of digital therapeutics. And why is that important? Well, what we do is work on the concept of neuroplasticity. And that’s when your brain is plastic, particularly early on in life, when the interventions can make the most dramatic difference to your brain function or brain health. And so we can effectively change the density of those neural connections and pathway, effectively rewire the brain through these digital interventions, testing and therapies. This is really important because this whole area of digital therapeutics, as I said, is software that’s now delivered as medical treatment. And there’s significant efficiencies to current clinical practice, which may be invasive or be pharmaceutical-based psychostimulants, which aren’t optimal for early childhood, as an example, or optimal for later-stage life as well. So this is a large and growing segment that’s really evolved in the last five years. And it’s circa about US$11 billion market, at now globally greater than $20 billion by 2025.
So what are we actually tangibly delivering? What you’re seeing on the screen is a personalised, game-changing experience for cognitive function and behavior. And we can deliver that through any device. You’re seeing a gamified application on your screen. That is our TALi DETECT product, our test that tests attentional capabilities in a child. And then we flow on to our TALi TRAIN program, which is actually a treatment for those attention deficits in those children. And so what we’re doing is we have a platform technology that is a set of algorithms based on science and research, and we’ve published all that data in peer-reviewed publications. To make it accessible, we’ve laid it over gamified applications, which you download from the iOS store or Google Play, that allow children to be tested and treated without them knowing they’re undergoing that particular treatment program.
So we’re delivering low-cost early detection and training platforms. So our first product TALi DETECT is 20 minutes, and that’s a test for attention deficits. And then our training program, TALi TRAIN, is a five-week intensive program that allows that child to receive treatment for the underlying inattention issue they have and gain other type of outcomes in terms of reduction on hyperactivity, focus improvements and numeracy skill improvements. All of what we do is evidence-based. Scientific research publications. Our TALi DETECT and TALi TRAIN programs are TGA cleared in Australia, FDA Class II in the US and CE Mark. And as I said, they have access to CPT codes in the US.
So where are we heading with this platform technology and why is this such an important area? Because mass non-invasive screening and diagnosis plus the treatment is critical. And so we’ve delivered out that target condition of inattention to begin with through our TALi DETECT and TALi TRAIN products. Now we’re focused on actual disease conditions, which will increase our ability to seek insurance payments and reimbursement in jurisdictions. Our Akili deal, which I’ll go to in a moment, allows us to target ADHD, really a large and significant market in… It’s significant issue in the US market. We also have an autism spectrum disorder program running in the company, as well as our mild cognitive impairment initiative. And as I said, it’s a precursor to dementia as we move forward.
So the scale of the opportunity in this cognitive or brain health area is enormous. We know there’s 136 million children globally with diagnosis of severe attention deficits. We know there’s a US$20 billion drug therapy market, which is currently psychostimulants delivered to children primarily or teenagers to suppress the symptoms, but not treat the underlying cause of the disease condition. And we know that areas such as autism spectrum disorder are rising dramatically in the US. 178% increase in prevalence since the year 2000. So this large and growing market is a significant opportunity to implement digital health initiatives, digital tests, digital therapeutics, particularly in a post-COVID environment where digital pharmacies and telehealth networks will be a primary care-delivery mechanism.
In this area of mild cognitive impairment, many of you may say, “So what?” Well, this precursor to dementia and Alzheimer’s is really critical because if you can early-intervene and early-detect, that allows for the delivery of preventative care, which means improved patient management and improved disease cost outcomes. That’s really significant because digital interventions can play a significant part in this mild cognitive impairment space. We know it’s a $300 billion-plus cost in the US and we know there’s a lot of spending and government funding in relation to Alzheimer’s and dementia in advanced economies. So this is a known market, a known quantity. And the delivery of digital interventions in this area will provide cost optimisation and improve patient outcomes.
So where are we targeting to leverage our technology platform? We have a wide patent base, which are issued in the US, Japan, Australia and other areas such as Europe. And what we’re doing is inserting our technology platform with partnering agreements and other commercial agreements so that we become a key ecosystem partner. So our tech platform and algorithm… Other people build on top of our platform with their applications. So this patent portfolio we have isn’t age-specific. So it’s not dedicated to early childhood; it actually spans all age ranges, which allows us to transfer our technology platform into other disease conditions and across age ranges.
So this deal with Akili is trans-relational for us. Akili is a leader in this global digital therapeutics area. They’re a US-based private business that recently raised $160 million through venture and pharma company funding. They have participants such as Shionogi in Japan, Temasek here out of Singapore and large VCs out of the valley. They currently have a product called EndeavorRx, which targets teenagers and our TALi products will target the three to eight. So the early childhood range. So that will allow both Akili and TALi to really service the family through that child’s life cycle. So we can capture the child early, provide care to them in delivery of digital therapeutics. And then that allows that child to progress through to other applications which Akili have or we may develop, so that we own the life cycle. And that’s very important for insurance coverage and large margins for this business as we go forward. That deal provides expected milestone payments of $51 million; they’re expected to commence from FY23, which is only 10 months away now. But during the current financial year, we will receive payments from Akili for the development work required to optimise the product in the US. And that’ll be receipted as revenue in our current financial year accounts.
This is a really exciting deal for us where we can tie up our technology platform, deliver our products directly with a proven player in market who has marketing and sales capability. And then we can build different applications through an existing channel of physicians and digital pharmacies in the US where we can increase our revenue as we go forward.
So as I said, we’ll be entitled to these royalty payments. Initially, we’ll focus on optimisation work and then FDA clearance in the FY23 period, which initiates the first $2 million payment. And then those future royalties are over top of those milestone payments. So for every time a child is tested and treated with our products, which can be multiple times for each child, we’ll receive a royalty payment. So very critical to creating us as a key participant in the ecosystem, but in an annuity revenue model for the business.
We know the market’s huge in the US. There’s six million children in there with ADHD. And so we know the near and present opportunity. Akili are in-market. Establish channels and marketing and sales networks. So we’ll be up to deliver out this significant opportunity in the near term.
So how are we progressing? Well, we’re building the blocks of partnerships and growth here. So we’re validating our technology and that’s been done through this Akili partnership where significant DD has been done only by Akili, but there are investors who are pharma companies and other technology businesses. We’re expanding our applications beyond the ADHD to autism spectrum disorder and mild cognitive impairment. We’re laying revenues through diversification. And I’ll talk about our nonmedical use partnership now in The Times Group, which compliments our medical use partnership in the US. And we’re expanding those negotiations, particularly in Japan and Korea, where we have confidential negotiations underway to secure further licensing agreements and commercial models as we go forward over the coming one to two quarters.
So The Times Group, as I said, is India’s largest media conglomerate, and they’ve invested an initial $2 million in us so we can expand our rollout in India for nonmedical use of our products. So direct to consumer and obtain government contracts in the education sector where it’s a large and well-funded and sophisticated education system in India. We can capture the middle-class in India. Of course, branch of Times Group own the middle class through their subscriber base. So we know all the details about what their spend patterns are on health and education products. And we’ll roll out this and increase this particular partnership from the October period on, as we increase our marketing spent in India.
So as I said, we commenced an early soft launch in April and moved to May with COVID. We pushed out our large scale marketing activities to October. That now is well on track as COVID is under control in India. And we’ll start our large print digital and TV advertising campaigns. We expect that to deliver large, growing revenues for our premium model of TALi.
So we’re going to leverage this US partnership to provide the foundation for other revenue. As I said, this Akili partnership provides validation. And then there’s a domino effect that allows us to execute further licensing agreement in other high-value markets, such as Japan, Korea, the UK, Europe, and Canada. And that will allow us to really submit our technology platform as a cornerstone tech in the ecosystem globally. So we’re really excited about this proven, evidence-based technology of TALi and how we’re going to expand our revenue base moving forward.
So just some investment highlights to close off. I’ve obviously talked about the large and growing market opportunity here as a $20 billion-plus market opportunity for us. What we need to understand about TALi is we’re evidence first and we’re a scientific-based company and clinical company. So everything we do is based in science, published research and regulatory clearance. We’re patented platform, and that’s going to be critical to initiating and closing out these additional agreements. We have clinical validation now, and we’ll continue to scale that. We’re a very scalable business model. We’re a digital technology company. So we can scale through assess models and insurance models in advanced economies. We’re an experienced team. We’ve got expansion potential and this US deal with Akili is transformational for what we do. So thank you for your time. If you’re of interest, please contact us with any further questions. But back to you, Clive.
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