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Study Update

Jun 24, 2025

Brad O'Connor
CEO, Cogstate

Lion delivering highly sensitive, standardized digital assessments of cognition. Today, Cogstate's an essential partner for pharmaceutical and biotech companies worldwide. We're helping to power advances in clinical research with evidence-backed technology that delivers unprecedented accuracy and operational efficiency. It's a pretty exciting time for Cogstate. Most of you probably will have seen the earnings update that we released yesterday. We've been able to deliver really strong revenue and profit growth backed by strong cash flows over the last five years. We're uniquely positioned at the intersection of increasing investment in R&D in central nervous system diseases, as well as advanced data analytics and artificial intelligence. I'm going to introduce to you today a range of presenters, including Anthony Costello, who's the CEO of Medidata, Rachel Colite, who's at Cogstate, our Executive Vice President of Clinical Trials, and Pam Ventola, who's our Chief Science Officer.

Finally, I'll just say that this webinar is being recorded, and at the moment, everyone's in a listen-only mode. We do, however, encourage questions, and we're going to try and get through our prepared materials relatively quickly, so you can ask some questions at the end of the session. There's a Q&A icon at the bottom of your screen, which will allow you to ask some questions. For those who are unaware, Cogstate partnered with Medidata, or we announced this in November of last year, November of 2024, but it's been a partnership that's been some time in the making. Cogstate- Medidata have worked for some months before the announcement to work through the ways in which we would work together, what the opportunity was, how we would connect from a technology point of view and pass data back and forth, etc.

I'm really pleased to be able to introduce to everyone Anthony Costello. Anthony's the CEO of Medidata, and over a relatively short period of time, has become a really good friend of Cogstate, and I'm really pleased that he's able to join us today. Welcome, Anthony.

Anthony Costello
CEO, Medidata

Thanks, Brad. I'm really happy to be here. Thanks for having me.

Brad O'Connor
CEO, Cogstate

What we're going to do to start with is Anthony's going to take us through some background in respect of Medidata. I'm sure that for a lot of investors, you might not be familiar with Medidata. You're going to take us through some background with Medidata, really talk about why Medidata is interested in central nervous system diseases, and within that context, why they've partnered with Cogstate. With that, I'm going to hand over to Anthony. We're going to bring up some slides to take you through and help from a visual point of view. Anthony, over to you.

Anthony Costello
CEO, Medidata

Thank you very much. Again, welcome to everyone. Thanks for being here today. I'm going to do my best to describe a little bit about who Medidata is and kind of our positioning in this broad clinical trials landscape, and then we'll get to the significance of the partnership with Cogstate as it is quite a strategically significant partnership for us. First of all, for those of you that may not be as familiar with the way the clinical research industry works, there are tens of thousands of clinical trials around the world that run every year across a plethora of different therapeutic areas from phase I trials, phase II, phase III for both pharmaceutical, biotech, and also medical device companies.

Medidata is the largest player in that ecosystem, providing technology that facilitates the conduct of those trials and the data capture, ingestion, and ultimately the analysis that tells a customer of ours whether or not their drug is working and they can go to regulators for approval of that drug. What you see on the screen here is our mission, kind of the mission statement that we live by here at Medidata, that we see ourselves at the nexus of supporting innovative new therapies being developed, the biology side of that development from our customers, and then we provide the technology to help accelerate those clinical research programs.

We see ourselves as powering these smarter treatments, new molecules and new drugs and medical devices, all the way through a pretty complex pipeline of clinical development in order to come out the other side as a regulatory-approved commercial therapeutic that can be prescribed to patients. We want to accelerate this process as much as we can, and we see ourselves powering those treatments so that ultimately people around the world can live healthier lives taking those new drugs. If you go to the next slide, we've had a huge influence on this industry over the years. Medidata is about a 26-year-old company now, and at any given point in time, we're running somewhere in the neighborhood of 8,000 ongoing clinical trials. This is a huge majority of the world's clinical research exposure at any point in time.

We capture about 200 million data points across our platform on a daily basis. If you look at the impact of how our piece of the clinical research puzzle kind of fits together, you can see that it is a pretty significant impact. Over 62% of all new drugs approved by the FDA since 2015, so over the last 10 years, have been approved and studied in some way across the Medidata platform. Just in the last couple of years, last year, 72% of FDA drug approvals used Medidata and 86% of oncology approvals. In any way you slice this, we are a big contributor to what we like to think of as kind of the mechanics of making clinical research work and getting these drugs approved for patients. Next slide, please.

One of the ways that we measure our impact is by looking at what the industry analyst community is saying about Medidata compared to many of the other technology players in this space. As you know, the clinical trial space is actually pretty small compared to all of healthcare, but it is a huge space in and of itself, supporting a lot of different technology partners, many of whom have similar product lines and are all looking to the pharmaceutical industry and the medical device industry as their customers. It is very important to us to be able to rank highly in a number of different categories. You can see a few of the key categories here where the industry analyst groups evaluate Medidata compared to the competition: electronic data capture, decentralized trials, clinical trial management, and analytics platforms.

I'll talk a little bit more about what each one of these means. Over the last year or two, we have been ranked in the leadership position in all four of these categories, which really tells you that we are a trusted platform, not just a niche player that might provide one or even two of these different aspects of our clinical trial platform, but more of a platform player that can be ranked in a leadership position across all four of these, really kind of meaning that Medidata is a platform that can be trusted by our customers and also by the patients who are obviously donating their data and their own clinical trial experience to trusted entities like Medidata in order to run a trial or to be on a trial that we're helping to run.

If I break these categories down just for a second, because later in our conversation, I think this will become a little bit more important as you try to understand why Cogstate and Medidata are in such an important partnership and also why we're both so focused on the CNS market. In this context, electronic data capture is really meant to describe all different types of data acquisition. Think about on a clinical trial, you're a regular patient under care of at least one provider, oftentimes many providers. You might have multiple different institutions that you see. You might have a primary care doctor. You might have multiple specialist physicians. You might have had surgery in one place, but you get your regular care in another place.

This paradigm leads to health records that are dispersed all over, and patients seldom actually have a grip on where all their health data resides, much less their ability to kind of pull it together and make it available for a research study. When we say electronic data capture, we're talking about a complex set of technologies that help patients and our pharmaceutical customers pull all those data points together so that in the context of a clinical trial, the data can more easily be evaluated. When you do a clinical trial, you have to understand every single thing that happens to that patient during the time that they're ingesting an investigational product.

The biggest aspect of getting to those data clarity, those data answers as fast as possible, is to be able to just assemble the data in a place that makes it possible to digest and to see a signal as quickly and as efficiently as possible. Electronic data capture comprises a huge portion of what our business does, and we're certainly excited to be ranked as the top electronic data capture provider in the industry. Moving on to decentralized trials is a little bit more nuanced, but our industry over the last several years has really begun to understand how much burden clinical trials place on patients, and we've looked for ways to mitigate that burden as much as we can.

One of the most important ways to reduce patient burden is to allow patients to provide their own data from their real life or their home environment. We have developed many different technologies that allow patients to provide their own data through a smartphone or patients to wear some sort of wearable sensor device on their body somewhere that provides continuous data 24/7 during a clinical trial. We have even built mechanisms for patients to use our photography capabilities to take pictures at home of things like body rashes or even health ID cards and upload them to our system. Things like signing consent documentation that we can use their data can now be done directly from the patient at home.

All of these capabilities minimize the burden for a patient on a trial and therefore make it more likely that a patient will register to participate in a trial, which becomes the fundamental building block of running these trials in an expeditious way, just getting enough patients to enroll that you can meet the statistical power of that research study. Decentralization, think of as a more modern set of technologies meant to reach out to patients more in their real lives, something that's near and dear to the core strategy that Cogstate has always had as well, and I hope you can see that overlap. Clinical trial management systems, I'll spend a little bit less time on, but this is a set of technology primarily used by our customers and partners to measure and manage the ongoing mechanics and their own work staff around clinical trial.

There are many different functional groups that participate on the pharmaceutical side in order to run one of these trials, and CTMS systems are used to measure the output of those teams to make sure that the tasks of the clinical trial are being done on time and that if you have difficulties in certain hospital sites or certain geographies around the world, you can highlight those as quickly as possible and make the reparations that are necessary before the study suffers too much. I will end with clinical data and analytics platforms, and think about this as infrastructure. This is really the network infrastructure, the cybersecurity, the way that we manage and handle data, control it across multiple different regulatory environments.

The laws of governing patient data in China, France, Italy, Germany, the U.S., and Russia are all very, very, very different, and it takes quite a complex set of network infrastructure to be able to accommodate the global research studies that we do that recruit patients in all of these countries, but have certain considerations country by country for how those data are stored and protected. Again, just to finish up on this slide, the industry analysts have ranked us as a leader in all four of these areas, and these really are four critical areas for our business and for all of our partnerships. Okay, next slide.

One of the most important strategies that Medidata has adopted over the last couple of years is we've taken our 35 individual product lines and we've combined them all into a much simpler and much smaller set of what we call experiences. Again, 35 products collapsed into three experiences that you see here. The patient experience, which is really all about any technology a patient keeps in their pocket during a clinical trial and pulls out in order to provide information to us or to receive information from us about what they need to do on that research study.

The data experience is really the bulk of the things that I talked about a few minutes ago, all of the data capture, all of the decentralization, and any of the mechanics that we use to randomize patients to different study arms or to collect data directly from their hospital systems or directly from them at home. Finally, the study experience, which is a way that we are re-envisioning the clinical trials of the future, leaning very heavily into simulating those trials and trying to predict the outcome of a certain study design before we actually start exposing real humans to those investigational products. The study experience is our most futuristic way that we envision our strategy, that our customers will ultimately completely simulate a clinical trial before the first patient is dosed. Today, it's quite the opposite.

Today, we dose patients right away on a trial design, and then we endlessly modify that trial along the way to overcome certain inefficiencies that are built into that study that we just did not have the foresight to anticipate ahead of time. A huge expense goes into designing bad studies and then learning along the way how to modify those trials. Many of you may know that about 90% of clinical trials fail during the research process from phase I to phase III. It takes 10 or sometimes even more new drug trials in order to get one drug out the end of the process and into actually a prescribed medication that is approved by the regulators.

What we're trying to do with the study experience is really change those odds and create the chance that more like two or three or four out of 10 of those products could make it through a process or could be killed much earlier in the process before they become very costly if the drug simply doesn't work. We need to try to anticipate that in simulations ahead of a trial before we spend big dollars and big ethical risk exposing patients to a drug that's not going to bring them any clinical benefit. Okay, next slide, please.

The other big important part of our strategy, and I think something that we're very excited to be pursuing with Cogstate as a partnership, is we have developed over the last 10 years an AI program that's really quite specialized, focused on the tens of thousands of research studies that Medidata has done historically and leveraging the data rights agreements that we have, both to use operational data. How did the study run? How did it work? How much did it cost? Which hospitals were successful at recruiting patients? Which hospitals were not? That's all the operational data that we have the ability to leverage in our AI program. For many trials, we actually have the clinical data rights to leverage for our AI program. Experience and user interface on our platform.

What you're looking at on this slide is a very specific modernized patient experience meant to be very user-friendly for patients because we know that they have 50 different apps on their phones that are very modern, and they're used to that experience every day. They can't run into a clinical trial pharmaceutical app that looks like it was built in 1995. We have really worked hard and invested a lot of money to update our platform user experience for patients and to make them feel like what they do on a clinical trial is really nicely aligned with all the rest of the apps that they use in their regular life with the same kind of considerations around their data privacy and security.

This becomes critical in our Cogstate partnership because a lot of the effort that's gone into our partnership with Cogstate is looking for ways that we can better address patients along their cognitive journey and to find better ways to engage them such that we get better adherence, we get better engagement from them, which clearly is a precursor to understanding what might be happening in their cognitive decline. That heavy engagement both on the clinical trial and then for some of our larger initiatives with Cogstate to reach outside of just pure clinical trials and to start to look for new ways to bring brain health front and center in the healthcare industry.

All of these things will require as kind of a fundamental building block that there is trust in us, patient trust in Medidata, patient trust in Cogstate, and a user experience that gives patients the confidence to provide that engagement and those sensitive data to us as their partners.

Brad O'Connor
CEO, Cogstate

Anthony, just before you jump into the focus on central nervous system diseases and how we're working together, I think just a few things that might sort of help bring this to life for the audience. Obviously, Medidata is a leader in the industry and a huge company. I think one of the things that always resonates with me is when you talk about the 35 different products down into these three different experiences, it's a really broad offering that you've built up over 20+ years now. It's a big team too, right?

I mean, across the globe, how many employees in Medidata bringing this to life?

Anthony Costello
CEO, Medidata

Yep, Medidata's got about 4,000 employees.

Brad O'Connor
CEO, Cogstate

Yeah, so it's an enormous team trying to bring all this to life. It's not just, I think it's easy to bracket it as electronic data capture, but it's everything from the patient experience through to the clinician experience and everything in between and really acting as a critical aspect in terms of that for the sites, for the sponsors, for the patient in terms of that management of the data. You touched a little bit on the work that you're doing around AI, but critically to that is the access to this breadth of data that you have, right?

Anthony Costello
CEO, Medidata

Yep, that's right. I think, as I mentioned, the foundation of our AI success so far has been these data rights agreements that we share with customers have been in place for years. We built an AI program almost a decade ago to start exploring that very special, I'll even say unique data set, 10 million or 11 million patients that have been through a clinical trial where all of the data are cleaned and groomed and source verified and essentially pristine data ready for delivery to the regulators is very different than most of the AI programs that you'll see out there based on real-world data that comes clean or not so clean out of real-world evidence or even health record systems where there isn't that same focus on data cleanliness.

It's a highly specialized data set with a bunch of highly specialized AI algorithms built on top that are meant to facilitate the next clinical trial based on the 35,000 previous clinical trials. That's the model that we've intended to build.

Brad O'Connor
CEO, Cogstate

The leaders across the industry in that regard. I think that the logical then step as we get to the next slide is to think about then what the commercial. I also had a view that we're certainly seeing, and we've shared this with our investors, a tailwind in terms of investment in central nervous system diseases. That goes from Alzheimer's disease right through to a range of different diseases.

Pam Ventola is going to sort of, after this, try and bring that to life for us a little bit outside of Alzheimer's disease because I think a lot of investors will be familiar with what we're doing in Alzheimer's disease, but it's across a range of different central nervous system diseases. I think this is where it all really comes together in terms of the work that's occurred over, say, the last year in terms of bringing the Cogstate- Medidata partnership together. It's only been going for a number of months, but we're really proud of how this partnership's progressing, Anthony.

Anthony Costello
CEO, Medidata

Yeah, exactly. There's a lot of detail on this slide. I won't try to walk through the whole thing.

The take-home message here is we've put a lot of infrastructure in place to be able to go to market quickly with a unified message and with a lot of joint effort around pipeline development. We're seeing, again, the early signs that that could pay off big. We've got dramatic growth in the pipeline. We're winning deals. We're building infrastructure to be able to turn those proposals around faster and faster and faster. We're getting the kind of industry recognition that you really need to have, especially in a newer partnership, in order to get more chances to bid on more studies. Winning awards and getting recognized, the kind of PR side of this is really important in order to drive customers to the point of thinking, "I'm going to run a CNS trial. I've been hearing a lot about this Medidata-Cogstate partnership.

Let me throw the proposal to them and see what they come back with. That building a snowball effect there is how we build the pipeline faster and turn this partnership into something that's really, I think, quite innovative, but also quite lucrative for both of us.

Brad O'Connor
CEO, Cogstate

As Anthony mentioned, the key aspect of this is the working culture between the two firms. When we set out to partner together, Medidata were really open with Cogstate about wanting to draw on our expertise to make sure that the technology solution was really fit for purpose. We've been really impressed with the product and how that has advanced. We really do see this as sort of, it's best of breed in terms of the product. Really excited about that.

We're going to let Anthony have a rest for a minute now, and we're going to bring on Pam Ventola, who's just coming. Pam's our Chief Science Officer, and Pam's got a couple of examples of just how we're working in central nervous system diseases outside of Alzheimer's disease. We've specifically focused outside of Alzheimer's disease because we have another webinar coming up at the start of August where we're going to talk a lot about Alzheimer's disease. In this hour, what we wanted to do is spend some time talking about other indications, but really bring to life for you, hopefully, the ways in which Cogstate works in these indications and the range of services and technology that we provide to our customers. Pam, I'll hand over to you.

Pam Ventola
CSO, Cogstate

Great, thanks . As Brad said, I wanted to highlight how, again, to build on what Anthony said, are building momentum in broader indications. One is with rare disease trials. I pulled out a case example for you today where we're working with a small biotech company on a rare neurodevelopmental disorder. These rare neurodevelopmental disorders are genetic syndromes. They have global impacts on usually the child. There's deficits, impairments in cognition, motor skills, language skills, behavior. Sometimes there's seizures and sleep problems. I mean, these are quite devastating conditions. Our science, as a field, has taken us to the point where we're now having gene therapies that are being in development and even available for these patients and their families. That's what I wanted to highlight here as an example of how we work in this space.

When you have a gene therapy for a rare disease, your goal is not to address a symptom. I mean, your goal is to move the needle on this syndrome. You want to change lots of aspects, lots of symptoms at the same time because you're really having a mechanism that's kind of at the root of the problem at the genetic level. That's different than what sometimes we'll see with a small molecule, not always, but often, where they're trying to get a symptom. They're trying to reduce seizures or improve sleep. Here, we really, again, want to take a broad view and really help these patients as a whole. That is challenging, though, because we don't have easy ways to measure change in syndromes.

Cogstate got involved early on in this example where we helped them write their protocol, really helped them with their schedule of assessments, what endpoints they're going to use, how they're going to use them, the frequency. What came to light here, as it does very, very often in rare disease, is that we don't have a great endpoint, kind of commercially available for them that captures the heterogeneity and the full clinical presentation. We helped the company make one. We made our endpoints for this trial. We did a lot of work developing it and supporting its validation, meaning, was it clear? Could people understand it? Was it measuring what we thought it would measure? Was it sensitive to change? Kind of the things that are really critical when we think about assessing change in a clinical trial. We did multiple interactions.

We had many, many interactions with the FDA to kind of align on this. I mean, we made a new endpoint. To align on this, and it's their primary endpoint in their phase III trial, the FDA aligned with that, agreed with that. Also, though, wanted an endpoint that was something the patient themselves did. The endpoint that we developed was an interview with the caregiver using clinical judgment. We took our new endpoint, and then we added the Cogstate Digital Battery, and those became our co-primary endpoints. The trial is now, it's ongoing. We're doing the reader training, so we're teaching the clinicians how to administer and score these scales. Also within this trial, we're doing central rating, which means we have Cogstate clinicians that are collecting the data on the study endpoints.

It helps ensure consistency and accuracy because we have a small team of really specialized clinicians that can do this. The point here, just to draw on, is Cogstate's, I would say, uniquely positioned in this space. I mean, we have very deep scientific expertise in rare disease. We got into this space early on, kind of in the field. We have brought that deep scientific expertise to our operational teams, and we have this kind of niche area that we're working in. I think as a company, we feel just really proud of this and kind of honored to be in this space. A lot of these biotechs are started by families. They start small companies, and they might get bought.

Large pharma might take over, but there's a sense of kind of commitment in rare disease that I think is somewhat unique to this space, and that's not lost on us at Cogstate. Go to the next slide. Just going to a completely different market area outside of rare disease, but to give you a sense of the scope and breadth of what we're doing. We're moving into psychiatric disorders. Just wanted to highlight some of the psychedelic therapies we're working in as well. We're newer in this space. The key competitors right now are probably Signant and Clario, are probably our most strongest competitors. We're definitely strongly entering the market, and we were recently awarded a multi-trial program from a large pharmaceutical company in psychiatric, in a range of different psychiatric indications.

One of the aspects of supporting these kinds of trials that's really critical is ensuring data quality. It's critical in all trials. In psychiatric trials, it's of heightened importance. What Cogstate can offer to this process is we have a suite of data visualizations, really sophisticated kind of graphs and figures that sponsors can view to see all of their endpoints. They are interactive dashboards where they can filter on different variables, see across patients over time, by country, all sorts of different ways that they can get insights into their data real-time. We also have algorithmic monitoring approaches that allow us to detect error. It's all about detecting error.

We can, as Anthony talked about in his section as well, use these advanced analytics, these machine learning approaches to detect error now in the data, but also predict sites and raters that are going to make error. We can develop these variables around site and rater risk. We also have the capabilities to really drill down and look at specific source documents and comment on specific raters. Central rating as well, as I mentioned with the rare disease, is also critical in psychiatric trials, particularly when there is an effect of the drug. If that is the vision that you can tell by seeing the person, you might be able to know if they are on drug or not. Central rating comes into play there to ensure blinding.

That's something else that we offer where the Cogstate clinicians are doing the visits remotely with the patients to help ensure blinding. Overall, it gives you a sense.

Brad O'Connor
CEO, Cogstate

That's excellent. I think the key takeaway there for our investor audience is really just to understand that, as Pam mentioned, moving into these psychiatric trials is a big market opportunity for Cogstate. It's expansion of the indications we're working in. I think it's also really important to note that it is 7:40 in the evening here, which is why Pam's got a cleaner working behind her, which is excellent. Just going above and beyond. Thank you. We're going to move across now to Rachel Colite. As I mentioned before, Rachel is Executive Vice President of our clinical trials business. Rachel essentially runs our entire clinical trials operation. She has both sales and operations reporting into her.

What Rachel's going to do is just talk about what the market opportunity looks like for Cogstate and why it is we win in this area. Rachel, over to you.

Rachel Coite
EVP of Clinical Trials, Cogstate

Yeah, thank you, Brad. We'll talk quickly just about why we win in these studies that Pam and Anthony have described and also some of the investments we're focused on making to further that competitive position for Cogstate and the Medidata partnership. First, the first thing that contributes to that unique value proposition is our proprietary technology. Many investors and sponsors will know us for our digital cognitive tests where we have a large suite of digital assessments that assess a broad range of domains. They are scientifically validated, highly scalable, easy to deploy, all the things that you need in order to deliver clean and reliable data in clinical trials.

They're designed for both in-clinic and remote use. That's been something that when we invested in that technology and that capability a number of years ago, it was first used in many of our research and academic collaborations. Clinical trial sponsors had not really adopted those extensively until the 2020 COVID era where we started seeing more decentralized trial methods being utilized. Now we're seeing it pretty extensively, at least in part, aspects of the trial, whereas Anthony described, we're trying to impact patient burden. In our case, sometimes it also helps impact data quality. Our tests are really ideal for that use case. That's really been helpful in driving adoption in certain use cases, particularly pre-screening and where you're trying to go after a really large set of patients. They're accepted globally by regulators. I think that's really critical and differentiated.

We have large longitudinal data sets and a number of indications that have really helped demonstrate the application of these tests and the reliability of the tests. Those have been used in a number of regulatory submissions in numerous jurisdictions. That gives sponsors the trust they need to adopt the tests. In addition to our cognitive tests, we also have proprietary technologies that help us support the data quality, as Pam described, for all the other assessments, all the other clinical assessments in the CNS trials. CNS trials tend to have a large number of clinical outcome assessments. The average phase three AD trial has 15 measures across different aspects of disease. We have developed this proprietary technology that allows us to oversee that endpoint data quality for all those clinical assessments.

This includes strategically sampling which assessments will get reviewed, and then triaging the materials, the recordings, the source materials out to the right clinicians to do those reviews. That is a big aspect of how we bring technology to the unique challenges of CNS trials today. The next aspect of why we win, I think, is our global experience. It is unparalleled in areas like rare disease and pre-symptomatic Alzheimer's disease, and then developing in additional areas like psychiatry, narcolepsy, where we are seeing a lot of growth at the moment. These are areas where our digital endpoints were included for many years. We have a long history of supporting psychiatric trials with respect to the measurement of cognition, but now the way that we are expanding is through that support of all the other clinical assessments and symptom severity assessments in those trials.

It is really exciting to see these other aspects of our capabilities being leveraged in new ways and new areas. Today, we are a trusted partner for hundreds of clinical trials. We work with all 10 of the top 10 pharmaceutical sponsors by R&D spend. We are really a trusted partner in many of these studies. We have proven scientific expertise to manage all the different aspects of data quality. As Pam described, we get involved at the trial design phase in many instances. It is such a great opportunity for us to get to help shape smarter trials and help really inform the endpoint selection that goes well beyond Cogstate tests. We do the training and monitoring of those hospital sites and all the way through to data analysis.

That scientific expertise is really a major part of what sets us apart in terms of our global experience. Finally, we have the operational infrastructure to help support that on a global scale. Between the technology and our network of clinicians, where we have over 300 clinicians in 50 languages, that's how we bring the operational and the technological capabilities to drive endpoint data quality in late-phase global programs, which is really what's needed for some of the larger and most impactful studies that we work on. Another reason that we win is our ability to provide that data analytic capability that Pam described.

It's one of the larger investments we've made in recent years where we've invested in a really modern and sophisticated data lake and then have spent a tremendous resource establishing all the appropriate data pipelines to get the data where we need it procured and cleaned in order to visualize that for sponsors in the ways that help connect through to our data quality monitoring programs. We're taking the analytic approaches to do the large-scale monitoring of different values in the trial that can be risk indicators, quality risk indicators, and we use that to more strategically sample which visits, which assessments need that human review, where a second neuropsychologist will often do a review of the work of the first neuropsychologist.

That data infrastructure and our ability to provide that real-time data visualization for what's happening within the trial with respect to these quite risky and error-prone CNS assessments, it's a really important aspect of how we're differentiated today. Just a little focus on, I know we may expand on this in the Q&A as well, where we are making some focused investments in future innovation is in the area of deepening our partnership integrations. Our partnership with Medidata has been tremendously fruitful and effective in terms of being able to put together a joint capability that's truly integrated. What we brought to market with that partnership has some really unique capabilities and integrations that drive endpoint data quality, but there's still more that we can do in that partnership.

I think there's a lot we're planning in terms of how we'll leverage AI together for even more advanced approaches to how we're thinking about endpoint data quality and then deepening integrations about how we deliver our digital cognitive tests through a single workflow and a single platform. The other ways that we are investing in technology with respect to AI in particular is thinking about improving how we deliver training and monitoring. CNS has really error-prone, subjective, noisy endpoints, and we want to change that. We are leveraging AI to help raters train in a better way, get a more experiential training in terms of how they practice, and also in terms of how we're detecting and picking up that error that Pam described. The third way is with respect to talent.

We're really making focused investments in those new therapeutic indications where we're investing in bringing on the right scientific and medical subject matter experts to help really maintain that leadership position with respect to being science-led and maintaining that opportunity to be able to get involved at those earliest stages of trial planning where we can bring the right experts to the table to help support the sponsors as they think about how to plan and design smarter trials.

Brad O'Connor
CEO, Cogstate

Perfect. Thank you, Rachel. We're going to switch over to Q&A. As we're just compiling those questions, Rachel, I just want to start with just explore one of the things you were talking around the sort of digital disruption of endpoint data quality, which is where we're really focused. You've framed the tagline of usability is data quality with respect to the Medidata partnership.

You've been really closely involved in it as we've built out this joint offering. I just think it's probably helpful for people to understand how this partnership really works is to talk about that usability aspect and why that's so important in terms of data quality.

Rachel Coite
EVP of Clinical Trials, Cogstate

Yeah. With the Medidata platform, that's really when we talk about we manage the deployment of Cogstate measures and then all the other measures. Medidata facilitates all the other measures. That data capture front end is clinician-facing, it's site-facing, hospital-facing. That process in CNS in particular is really difficult for the clinicians. These are long assessments. They can be 30 minutes, 40 minutes long for a single test in Alzheimer's disease. There's a lot of manipulatives, a lot of back-and-forth, really long forms that have to be navigated.

The assessments and the judgment calls they have to make are really difficult. Making that experience for the sites as user-friendly as possible, baking in as much clinical guidance as possible, as many reminders as possible in a way that's easy to digest and to collapse and bring back up, these all feel simple and minor, but they're tremendously important when you think about improving the experience for the rater. When you can improve that experience for the rater, they're going to do a better job of giving a proper assessment, which is how these drugs get approved. These noisy subjective endpoints are the primary endpoints in these trials. It is tremendously important to think about how we can impact data quality at data capture. That is what we were so impressed with in working with the product development team at Medidata.

As they were thinking of how to build out a fit-for-purpose platform that had the unique capabilities to facilitate the collection of CNS endpoints, they were really, really receptive to making sure that we built something that could take our clinicians who were sitting there to inform that build. They really took their guidance to heart and built a capability that allows for ease of data collection. Some examples of that and what that looks like for the site is flexibility in terms of how they do their clinical note-taking. In some of the assessments, the clinicians have to document their clinical notes, and they have the option to do so by typing or writing into the tablet or dictating. They have this flexibility because we've heard some prefer different methods.

For some of them, it really slows them down to do one versus the other. This flexibility has been really helpful for having a streamlined site experience, which we know is so central to data quality.

Brad O'Connor
CEO, Cogstate

Yeah, it's perfect. Beck, have we got some questions from the audience?

Speaker 5

We do, Brad. The first one was in relation to an earlier slide that Anthony showed around the competitive environment. The question is, with the combined Cogstate- Medidata partnership, how has that strengthened that competitive differentiation?

Anthony Costello
CEO, Medidata

Yeah. I'll say a couple of things quickly because I know we don't have a lot of time left. First of all, I talked about the growth in the CNS space.

I don' t want to sound too repetitive, but there is no way to be a serious player in the CNS space and to take advantage of the increase in the kind of research dollars that are going there if you do not have a joint offering like this. You could try to do it all under one roof, or you could do it as a partnership, but you simply cannot win significant amounts of work in this space if you have one half of the equation, let's say the Medidata stack for running clinical trials, but you do not have the highly specialized cognitive battery that Cogstate brings or vice versa.

We formed the partnership really out of a recognition that it would take two of us together, kind of bringing together the chocolate and the peanut butter, if you will, to make the easiest path for customers who are going to see their own pipelines explode in this area, and they're going to have to do it with a stabilized set of trusted partners that they know can do this work with them.

Rachel Coite
EVP of Clinical Trials, Cogstate

Just to expand on that, Anthony, the install base with Medidata's Rave electronic data capture system, I think there's tremendous value for sponsors who have widely—the platform is widely adopted.

The ability to have any co-op platform for metadata that pipes right into Rave and then with the other CNS assessments all going into one place, I think it opens up tremendous opportunity for enhancing data quality monitoring when you have all that data in one spot, visualized in one spot. I think it's a tremendous differentiator and something that we're seeing a lot of interest from sponsors.

Speaker 5

Yeah. Great. Brad, the next question is a reference to the strong revenue growth in the second half and how much of that can be attributed to this partnership, or are you still sort of expecting to see significant upside from the partnership?

Brad O'Connor
CEO, Cogstate

Yeah, so it's a good question. The reality is that whilst Anthony mentioned we've executed sort of a small number of deals already, mostly over the last couple of months.

Really not much revenue represented in our June 25 numbers from this partnership. I think the opportunity in terms of revenue growth really falls into the next 12 months. That is exciting for us.

Speaker 5

Maybe just as a follow-on question to you, Anthony, and it is a nice segue, Brad, from what you have just said, is the Medidata integration of the adoption of Cogstate in its early stages, and how do you see that evolving?

Anthony Costello
CEO, Medidata

Yeah, I would say the partnership is in its early stages in the sense that we are only starting to see the market uptake of this joint offering. As Brad mentioned at the very top of the hour, this partnership has been months in the making.

Before we even get our first trial, we've got to put a lot of partnership infrastructure in place and go-to-market messaging and team dynamics and bidding processes and so on. I think what I think is advantageous about our positioning right now is that we've done a lot of the heavy lifting in the background to get ready to do study number one, but we're seeing a lot of pipeline development too. We're seeing pipeline development in the dozens of studies in the pipeline. As those start to come through as wins, then we're really, I think, going to reap the rewards of the back-end work that's been going on for a few months now.

Speaker 5

Fantastic. We're just going to squeeze one final question in. With Trump's cost-cutting measures on FDA, etc., do you see a slowing of clinical trial investment decisions so far?

Brad O'Connor
CEO, Cogstate

I'll jump in here first, but Anthony, interesting your view. From our perspective, we haven't really seen too much impact from this. We've been monitoring it closely in terms of decision-making and any slowdowns. From our perspective, we really haven't seen much in the way of slowdowns. Having said that, it's a fairly niche sort of pool where Cogstate's running hundreds of trials. Medidata's running thousands of trials. Anthony, interested in your view.

Anthony Costello
CEO, Medidata

Yeah. There's definitely a slowdown. It's been going on for a couple of years, and I think it's the consequence of a bunch of complex market dynamics. We had a slowdown during COVID. Then we had a massive bolus of trials after COVID. Then we had a run-off of those trials, and we went into kind of a tough economy where biotechs weren't getting a lot of investment, and that caused a slowdown.

There is certainly enough political uncertainty right now about where investments will land and how the new American regime views research and the pharmaceutical industry. All of that aside, whatever the catalyst may be, we're seeing fewer study starts in a year the last few years than in recent past history before that. Again, back to some of the metrics that I shared earlier, I think our goal, and certainly I think this is part of the philosophy behind the partnership here, is we want to give customers the fastest, most efficient way to run whatever trials they're going to run and to either get to a finished product that can be commercialized quickly or to be able to turn off that research project as quickly as possible because it doesn't work and those dollars should go somewhere else.

When the industry can't support the cost of its own research, it's got to downsize the number of trials. That's not good for any of us, but it's also not good for patients who are desperately waiting for these new therapies to come to market.

Brad O'Connor
CEO, Cogstate

Thanks, Anthony. Look, we're at the top of the hour, so we're going to call it there. We'll just remind everyone that this is the first in a series of investor events that we're running. On Tuesday, the 5th of August, we've got our next webinar. We're going to do a deep dive into Alzheimer's disease. That'll be immediately following the Alzheimer's Association International Congress, which is occurring in Toronto in the week prior to that. We expect to have some updates in terms of Alzheimer's disease research out of that.

A reminder that Cogstate's financial results for the year-end 30 June 2025 will be presented on the 22nd of August. We have our AGM on the 16th of October. Just to put into your diaries, on Friday, the 7th of November, we're going to be holding an in-person shareholder day in Melbourne. More information on each of those to come. We really thank you for your engagement. I want to thank Anthony especially for joining us. We're really pleased with this partnership and really thankful for his time. Rachel and Pam, thank you so much.

Rachel Coite
EVP of Clinical Trials, Cogstate

Yeah, thank you all.

Thank you.

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