All right. Good morning, all. Thank you very much for joining Vitrafy Life Sciences FY 2026 annual results presentation. I'm Tim Sharpe, your host this morning for this year's annual results presentation. We are also joined by Managing Director and CEO, Brent Owens, and Chief Financial Officer, Simon Martin, who will present this year's financial results. If you do have any questions throughout the presentation, please utilize the chat function located at the bottom of the Zoom platform. We will hold all questions to the end of the presentation, where we will have a Q&A session with both Brent and Simon. Right now, I'd like to hand over to Mr. Brent Owens, Managing Director and CEO, to present the results. Brent, over to you. Brent, your microphone's not working.
How's that now?
Perfect.
Great. Thank you, Tim. Thank you all for joining, appreciate another year of support, where we present the financial year 2026 results. Where I would say, I was reflecting on this last night, how would I summarize the year? Obviously we've got the tagline there of, "A year of delivery, positioned for scale," but I do think it was quite transformational. What I mean by that, when I assess, let's say, the milestones that we achieved over the year, I reflect back to where we were at the end of FY 2025. As an example, in the market, we only had one partnership with the U.S. Army completing phase I. We didn't have really a U.S. team at all, and no product available in market.
Where we were, was quite a fair way back from where we sit today, which is really exciting because we have been very focused, and we did set ambitious goals, as we should. I think by and large, we've achieved a very large portion of them and learnt from a few others as well, which you can see displayed on screen there. What I'm really excited about, and what the team's been getting much more excited about as we've seen more and more traction in this space, is how the blood market's been evolving. I'll spend a little bit more time on that later in the presentation, but that is something that we've seen and been somewhat surprised by with the speed of that progress. Moving into a little bit more of the highlights specifically. Overall, I'd summarize it as scientific validation with commercial momentum.
One of the biggest highlights for the year was no doubt the platelets results that we achieved with the U.S. Army. We completed the phase II in vitro study with the United States Army Institute of Surgical Research, where we saw results achieving 94.4% when compared to the standards of about 50% in Europe, and then 75% for fresh platelets in the U.S. using Vitrafy's very novel protocol with no washing. That is a real step change in outcomes and our first big validator at scale. That's actually really important for multiple reasons.
I will spend more time on this again, but that was done with the military. Our strategy has always been to start with the military and then transition that into the civilian market. These results really did open that door much wider. We're seeing a lot of progress in that space, which we'll come back to later in the presentation. Building on that, the partnerships. Again, we started the financial year with the agreement with the U.S. Army. We've now expanded that into the civilian market in human health, which we're seeing a lot of traction in. Importantly, we've signed the agreement with the global partner in animal reproduction, which again, is revenue generating as well, we've seen that growth quite strong over the past 12 months.
The exposure that we're seeing in the collection sites in the civilian market has grown substantially from where we were to where we are, that is something we're also going to focus on throughout FY 2027. Importantly, that's only possible if you've got product available, working, and in market. We have transitioned from where we were 12 months ago in the early design stages into development and manufacturing, achieving our first commercial release of research- use only devices that are being used, and now scaling up that manufacturing ahead of medical device registration later this calendar year. We have had some really great learnings from deploying those early devices that we've applied those learnings learnt from and strengthened how we're going about it moving forward too, which is always an important piece to the puzzle. From a revenue perspective, we have seen strong growth.
Contracted revenue's over AUD 1 million now, seeing strong growth in that from the animal reproductive site in Tasmania. A big focus for the year was to build out a really deliberate, structured team in the U.S. The foundations of that are almost set, but there is further build-out to do. I'll come back to that a little bit later in the presentation because there is an important piece to the evolution of building out the U.S. team as well. Just breaking down that a little bit further, it was the results with the U.S. Army that did transition the company from where it was to where it is today in many ways. If I cast back when we engaged with the Army, part of that approach was to start with the military. We thought that that would unlock the civilian market.
We achieved the phase I results, I think, just prior to this time last year, which started those conversations. It was certainly the phase II results that really turned the dial in that space, and achieving the 94.4% result is really a step change in outcomes and something that we see as being a big change to the way that the structure and the process of the blood market works. We're really looking forward to taking that forward more fulsomely. Again, what it did open and unlock was more of that civilian market and signing agreements and partnerships with Vitalant, which is one of the larger players in the U.S. civilian blood market.
Most recently in the last couple of weeks with Hoxworth Blood Center, we're starting to see growth in that civilian blood market. C apturing that market share will also be a big focus for the next financial year. Moving forward from that, in cell and gene therapy, an area that I would say is much more sophisticated from a really granular level with what you need to do from a marketing perspective. Over the year, we did have an important milestone that was achieved in that space. We had our first product release, which may sound insignificant, but it is quite important. We did attend Advanced Therapies Week in the United States, where we had our own equipment and team, which you'll see a photo of later in the presentation. We did demonstrate the technology to the cell and gene therapy industry.
From that, again, that was our first proper marketing exercise. We have seen a lot of pipeline development in that space. T he industry probably went through a bit of a lull as there was a lot of changes in government and markets, but it has started to pick back up as well. We have got really progressed conversations in that space in the pipeline, and we're expecting conversion in that space moving forward as we're not precluded from growing that market now as it stands too. More to come in that space throughout the year. Strong building of our brand and positioning within the industry over the last 12 months too. In animal reproduction, as I was saying earlier, one of the big milestones is securing the partnership with one of the global leaders in animal reproduction, representing about 50% of the global animal market.
Over the term, we not only executed that agreement, but we've commenced the works within that agreement. Machines that we built, the first ones off the manufacturing line, we sent over to France, and the team have been working closely with IMV Technologies on doing that work, which is broken down into bovine and aquaculture. That work will continue throughout the next few months ahead of some planned works in the northern hemisphere later in the calendar year. That is generating revenue, and we are invoicing that under that monthly recurring fee that we've described as the revenue model, which is really exciting. Again, the intent with the partnership with IMV is to create a joint go-to-market offering as a global offer to the animal reproductive market so that we don't have to build a whole team and try and go head-to-head with them as well.
Beyond that, we have seen strong revenue growth when we compare where we were last year just in the Huon and Tassal work in Tasmania. You can see there that that's gone effectively in a 150% increase from where it was last year that we expect to continue moving forward as well. All of that is only useful if we have product in market. Last year, I think we finished the full year concluding or getting close to concluding the design phase, moving into some of the early manufacturing work. Through this year, we have completed that development work and built out a batch of units. I think we're at 10 units now, and there's about another 15 to come in the very near term.
We have ramped that up, taken it through design, taking it through development, building out the research- use only units, which we'll be deploying commercially, and also using for medical device purposes for that milestone. That's been really important. Those units were deployed to IMV, as we mentioned, and also using for medical device purposes. We have had some learnings from those early releases which we've applied to the future designs to make further improvements and enhancements of the equipment. A few learnings there ahead of the expected medical device clearance later in this calendar year as well. Very closely supporting the hardware is obviously the software, which we call LifeChain. Through the period, we not only built that infrastructure and security system, we also made that compliant with 21 CFR Part 11, which is an expected regulatory standard in the U.S. software healthcare sector.
That's actually really important, not just from a marketing perspective, but a security perspective as well. Good milestones in the product development space, very much on track, and a lot of learnings applied with that, ahead of a further milestone later this year. Just breaking that down one step further. The regulatory pathway for us is broken really into three phase from the device perspective. As I mentioned, we achieved the milestone of building the research- use only units. That is devices that we've been building and using currently, commercially, and for the medical device process. We've now entered into the second phase of that work on our regulatory pathway, which is called validation and verification work. That's broken really into two sections. One is an engineering component. Does the device perform how it's described? Is it safe to use? All of those different things.
Then there's the biological testing to go with it. Is it achieving the performance of the biological material that's required by the FDA? That's the work that will continue through the first half of FY 2027, ahead of our medical device registration as a Class 2 510(k) exempt device that we're expecting again before Christmas this year. With that, we're continuing to work very closely with industry across military, civilian, and government with the FDA directly on how we further unlock more biological material and frozen materials available in market, such as the red blood cell program that I'll speak to in a moment. Good milestones achieved on product and near-term milestones ahead in that space. Whilst we're doing that in parallel, we are ramping up manufacturing as well. We did have an approach to manufacturing earlier in the year, and we are scaling that up.
We've built about 10 units already. We've got a further 15 coming. What's really important right now is to ensure that we've got U.S. operations and manufacturing all established and set up so that we can scale to meet the future commercial demand that we're expecting. One of the risks that we face is not having that in place and getting a high demand and not able to fulfill it. We're getting ahead of that, and we're building up that U.S. manufacturing capability now so that we can meet anticipated demand as well. That's both a ramp-up for use, but also preparation for the phase after that during FY 2027, which closely aligns to having U.S. operations in full. Over the year, we have set the foundations. We've built some really highly skilled, highly experienced team members.
Notably over the year, Tim Costello, who sort of joined, who's in the middle of that picture, who's very experienced on the commercial side. Then most recently from a scientific side, we have Dr. Heather Pidcoke, who was actually from the U.S. Army Institute of Surgical Research, and worked very extensively within industry in the U.S . Now building that out further is something that we'll focus on in FY 2027, continue to expand that team. I am expecting by the end of this financial year that we have full U.S. operations across all departments that we've spoken about to complement everything that we've been doing. With that, I'll also be relocating to the U.S. on a full-time basis pretty much straight away. That's something that we've been working towards and have now locked in. That's all good to go.
With that comes a location. Onboarding, training facility, demonstration sites, all of those different things is what we've got currently and looking to more strengthen that moving forward as well in a centralized location. A lot happening in that space. I will hand it over now to Simon to go through a bit of the financials.
It would be helpful. Thank you, Brent. I'm going to quickly run through the financials. You'll have seen these. Some of the highlights obviously are we are seeing revenue going up in animal. A large part of that is through IMV and of course the work we're doing in Tasmania in aquaculture. Our industry growth grant income keeps coming through. We're expecting about another AUD 400,000 in the first half of 2027 to close that out. That's been successful. In terms of costs, which is where I'm sure the eye turns to, we had about AUD 6 million worth of consulting, and materials costs come through the product management line. Obviously, this will dissipate a bit as we move into production. There is still more design and development that will be ongoing, but that was an important part of the investment this year.
We are ramping sales and marketing, particularly as we grow the U.S. Brent's already talked about the headcount, so that will continue to grow from here. Operations costs do include some expenditure on the first Guardion units. We will be capitalizing those going forward, and I'll come to that in a minute. The early units we have expensed because they are more in test mode than anything else, and that will change going forward. If I change to the balance sheet, we're really pleased and thank you for all of those who participated in the recent capital raising, including the SPP. We had AUD 41.2 million in cash in term deposits at the 30th of June, and we actually received the following week another AUD 2 million under the SPP, which was a great vote of confidence from you all. Thank you.
We have started capitalizing a small amount of the Guardion devices, which are actually components of the next build. It's about AUD 500,000 in the year just gone. There will be more coming. We're expecting at the moment, subject to some more work, that they will be depreciated over five years. Movements in the issued capital you can see result from the capital raise. On to cash flow. Our expenses have grown, as I said before, hence the payments to suppliers, and you can see there the net proceeds from capital raising. We have got a bunch of money on deposit. You can see the movements through term deposits and that small amount that we've capitalized.
I am really pleased with where we finished the year, and that sets us up really well for the transition to scale manufacturing in the U.S. and building out the team. Back to you, Brent.
Thank you. For those that have been part of the story and the journey for a little longer, you may recall that we've gone through a bit of a process of refinement and prioritization, which is an important thing. One of the best parts about Vitrafy's long term is the amount of applications our technology can be applied to, but that's also got its risk as well. We have to remain really focused and really deliberate with what we do, not just for the short term, but how it connects to the medium and the long term, and we spend a lot of time on that. Over the year, what's become really obvious is the critical market need that requires change now, including catalysts that are forcing that change to occur.
We probably entered FY 2026 with more of a level playing field across animal cell and gene therapy and blood. Certainly throughout the year, with market dynamics and with the results and the milestones that we achieved, the blood market certainly has taken a different level of engagement, speed, and opportunity for the company. The simplest way to describe it is really just the dynamics of supply and demand. The supply is constantly constrained, and the demand is constantly rising. I won't go through the verbatim details on the screen, but as an example, I encourage those online to have a look at the American Red Cross's LinkedIn in the past week. As recently as I think five or six hours ago today, there is a national blood crisis looming with them, and it's all back to the supply side.
The dynamic is changing, and there is urgent need for making changes because it's not a band-aid solution, it's a structural challenge that needs to be addressed. That's a really important, simple, I guess, issue that's coming up. What the American Red Cross posted, this was actually extracted from their post just a few days ago, is that blood crisis due to lack of supply. I don't say that lightly because the second sentence that went with it was, it's only the second time that this has ever occurred in the U.S. in its 150-year history of operating. That was in July 2026. That emphasizes how big of a problem this is, and it's a structural one. For us, there's all of these different layerings of problems that are emphasizing the need for cryopreservation- type solutions that Vitrafy are aiming to address.
Even little things like this demand side and just looking at that widening gap that's occurring from the supply to the demand. It's getting bigger, and it's getting quite rapidly bigger as well. This thesis for us of on-demand moving to inventory is a really important one. For those who listened in to the Vitalant announcement when that partnership was secured, we spoke a little bit about some of the structural challenges that the market is facing. One is the red blood cell market and the end-of-life technologies that are occurring in that space. There is a deadline to that that there needs to be a replacement in market. Because of the work that Vitrafy's done over the years, the blood network has been coming to us to try and solve that problem.
That is a structural problem that no band-aid's going to be able to sustainably fix from what we're aware of. That's the work that we're focusing on in one space. The second is in the platelet space with only up to seven-day shelf life and constant high levels and percentages of waste that costs over a couple of hundred million dollars per year. That's again an issue that's constant, continuous, and growing, that the use of cryopreservation, if you can retain the quality, as we've demonstrated that we could, could address this core issue. Layering that even further, we see, and our thesis is that we can turn from what is currently an on-demand perishable product, which has constantly got supply challenges and increasing in demand, into more of a stable, consistent inventory so that you can have delivery of product as you need it, when you need it.
Which is important for the civilian market, absolutely. It's also important for military applications and stockpiling as well, such as mass casualty events and preparedness for war or a national interest. The way that we've gone about addressing that, there's obviously some luck that's gone into it because of the end-of-life technologies, but it's because of the work that we've done over the last few years that's landed us in this position that people are coming to us to try and solve the problem. If you cast back to, I guess, FY 2024, where we engaged with the military, we completed the phase I last year and the phase II in vitro work this year, where we got that step change in result.
During that period, that's where the civilian interest started and the phase II results is where it increased, and then the announcement of the red blood cell end-of-life technologies, that's where it really accelerated. Now starting to unlock that civilian market, firstly with Vitalant, secondly with Hoxworth most recently, and now in FY 2027 for us, our goal and objective and focus is to further expand that spread across the U.S. civilian and military market. Our goal is to capture that. What we see the outcome from that being, amongst capturing the blood network, is unlocking the raw material of cell and gene therapy as well, because that is a core part of the supply chain that is at the same location. For us, it's very much a one solution, multiple uses.
You can use our technology for the red blood cell work, you can use our technology for the platelets work, and you can also use our technology for the area of cell and gene therapy with one solution and multiple uses. How you could see that evolve. For us, the U.S. blood network operates very differently to how it does in Australia. It's really broken up into three core areas. The market split has the American Red Cross having a big portion. The Blood Centers of America, which is, I guess, a member body, has another big portion, and then there's a few independents to go with it. Underneath the Blood Centers of America banner, that's where groups such as Vitalant and Hoxworth and Versiti, and the ones you can see displayed on screen are located.
For us, you can see on the graph on the right there that's the percentage of the blood collection market in the U.S. that we now have under partnership, which is a great start in a very short period of time. What we're focused on in 2027 and beyond is to capture that balance in the gray box there that are made up of those independent centers, the American Red Cross, and the balance within BCA as well. How that ties into FY 2027 more broadly, well, we need to transition from where we're currently at from a product perspective into securing that medical device registration. Again, we're in that process now. We're expecting that before the end of calendar year as well, and a lot of work is going into that.
Expanding on that slightly, the partners that we have are actually really important for that reason as well. To do that work in an accelerated way here in Australia is really quite challenging because you need access to high volumes of blood, the skills, the competencies, the environments, and equipment to be able to do all of that testing. Fortunately for us, the partners that we've got, and more that we're expecting, can do that work with us and for us. A lot of that is in kind, which we're very grateful for, which is an important piece to the actual relationship, but also for our FDA process as well. Expecting that in the first half of the year. Building on that, we want to start seeing and expect to start seeing commercial agreements coming through for cell and gene therapy as well.
There'll be more of the ones and twos, to use a cricket analogy, rather than fours and sixes, but that's an important one to validate the market opportunity and the revenue model that goes with it. That's an important one. What I'll be focused on in the very near term is, again, moving over to the U.S., securing our site in that location on a permanent basis, and building out that U.S. capability. That's across the core functions of the business as it sits today. Primarily building out the commercial team is the initial focus even further, and I'll be working on that straightaway, as well as the U.S. manufacturing capability. Our ability to not just do what we're doing today, but anticipation of demand coming through at high volumes, we need to be ready to go.
A big focus for the first half of the year is to get that up and going and being prepared for what is to come later in that financial year as well. A lot to look forward to. Summarizing the year from my perspective, a lot has changed. It's a very materially different business where we sit today at these results to where we were last year at those results. The process has been good and deliberate, and moving forward we're equally as focused to execute again as we did through this year as well. Tim?
Excellent. Thank you, Brent. Thank you, Simon. I would like now to invite all investors to ask any questions they may have around the FY 2026 results via the Q&A function down at the bottom of the Zoom platform. Just to kick us off, Brent, with a couple of questions. You highlighted the American Red Cross' public declaration around the blood crisis. How does that public declaration reflect some of the anecdotal conversations and feedback that the company has been having over the last six months, and how does that impact your confidence about the future?
It's a good question. I would say it's recurring, and it's just emphasizing the problem. Simon and I have spent a bit of time in the U.S. together. I've also spent time there in different meetings with everyone from the FDA to the industry to military. The same conversations are in all of those different forums, and that is the problem of supply and demand. How do we secure up an inventory to be able to meet the demand? Seeing those announcements from the American Red Cross, there's an element of shock, but not surprise as well because of the conversations that we've been having. I just didn't realize it was that bad where they're talking about national crisis for the second time in history. That's a big problem.
In terms of the land and expand strategy that the company has stated in terms of securing the blood collection network, how has securing Vitalant, which is the second-largest blood collection network, and Hoxworth, which is the oldest collection network in the U.S., sort of validated the market appetite, but also given confidence about securing the balance of the blood collection networks in the U.S.?
Can you just do the front half of that again? I'm just interested.
Securing Vitalant, t he second-largest blood collection network in the U.S., and Hoxworth, the oldest, how has that impacted your confidence around the strategy?
Well, I come back to my slide on the phase II in vitro study on platelets. Blood is blood, whether it's with the biggest party or the oldest party. It's all the same product. The data that we generated, the validation that we got, I'm expecting that with more parties, beyond just one of the biggest and one of the oldest, t hey are quite advanced in terms of innovating, and I refer to Vitalant in that space. They are known to be leaders, so I'm not surprised in that area. They do influence the market more broadly, so having a partner like that is a really important piece to the puzzle. It's because of the work that we had done that enabled that to occur. If we hadn't have done the work with the military, I'm highly confident that we wouldn't be talking about it right now.
Excellent. Thank you. A question from the audience. Tristan Hatcher asks, w ith the end of legacy technology, are there any competitors in this space also aiming to build out replacement for this legacy technology? Specifically referencing the RBC structural issue.
From a structural perspective, we're not aware. There's different, let's say, band-aid approaches that I'm sure that different people are working on, that we've heard that people are working on. From a structural perspective, I'm not aware of any competitors that are racing hard at that space. That being said, because of the size of the problem and the scope of the problem, and the importance of needing a solution, I think it would be naïve to think that no one's trying, or that there isn't other things happening in the background. That being said, I would say that where we're at from both who we've secured as partners, but also the engagement that we're having across industry, government regulators, that we're pretty well ahead in that space would be my summary and opinion on that.
Excellent. Thank you. In terms of competitors, how does Vitrafy's technology compare to those emerging competition? In particular, how does the data from the USAISR platelet study reflect that competitive advantage?
Well, I think there's a few different things to say competitive advantage. One is we talk about building an ecosystem end to end. That not only yields a superior quality outcome, which is sort of the core, which is addressing what we believe is the core problem, enabling that stockpiling and inventory-based approach. By doing it the way that we're doing it, aiming to grow it and develop it is, I think that we just continue to strengthen that competitive moat. That's not just from an intellectual property perspective, but also locking in with our customers as well. Providing the best customer experience from the user side, but also playing back the learnings, the data, the value that we get for continuous improvement. Where we are today, we're only going to get better at tomorrow. I think that that strengthens the competitive advantage.
That's not just for one product. I would say that's across all products.
Excellent. Thank you, Brent. A follow-up on the CGT side of things from Paddy Cockerell. Is your growing U.S. blood market presence assisting with engagement on the CGT side?
Say that again, sorry.
Is your growing U.S. blood market presence assisting with engagement on the CGT side?
Absolutely. T here's probably two core parts of the supply chain for cell and gene therapy that we're focused on. One is the CDMO, which is effectively the manufacturer of that drug product. The other part is the raw material that supplies the CDMO. In most cases, or in many cases, the raw material supplier that sells that product to the CDMO is often a blood center. It's not always the same location as where, say, platelets and red blood cells are collected, but in many cases, it's the same companies that are doing it. By capturing the blood center network, an outcome of that could be capturing the raw material side of the cell and gene therapy network as well.
If you think about where we're focusing and prioritizing some of our marketing spend and efforts, it's addressing that CDMO side in cell and gene therapy, because that's not connected to the raw material collection side that we're capturing through blood.
Excellent. Thank you. A question for Simon. The successful capital raising early this year provided the company plenty of funding to support the growth. How do you think about the funding future of the company, and in particular, how it will assist the company setting up operations in the U.S.?
Thanks, Tim. That's a good question. Clearly, we're really pleased with the support we received, and obviously, that is very important as we move to the U.S. In fact, in talking with supply partners, they want to know that we're capitalized well to afford the spend. They want to know that based on our forecast and delivery of equipment, that we can meet those financial commitments. That's been a real tick and a real boon in building those relationships and giving them confidence, not only in that we've got a great product, but that we're financed well enough to deliver it. That's the first thing. The second thing is, this is because of the model, we are consistent in saying this is a service model and there is a capital up front.
It is a short payback with sub- 12 months on the capital outlay, but it does still require some capital up front. As we move further into profiling demand, we can see, particularly in the blood space, and to a reasonable extent the CGT, that they're high credit quality and it will come down to terms. We would anticipate going forward being able to layer a mix of debt and equity as required. For the short term, we have plenty of cash, thank you to your support, and we'll continue to assess capital needs and supply as we go.
Excellent. This is a bit of a follow-up there, another question from the audience, Simon, around the company's intentions of listing in the U.S. How do you think about operational setup versus corporate establishment and listing requirements here versus in the U.S. for the company moving forward?
Thanks, Tim. Look, our capital is primarily sourced from Australia for now. I suspect that will stay that way for some time yet. Really what we assess is what is the cost of capital, how much capital do we need, and what's the best source, cheapest source, and on the best terms. If there was an advantage to moving our listing or having a dual listing, we would look at it. At this stage, that's not on the horizon, but it's something we will consider in the fullness of time, I suspect.
Excellent. Thank you, Simon. Question for you, Brent. Based upon the growth seen with the Huon and Tassal partnerships in FY 2026, how do you think about the animal opportunity more broadly and, in particular, with IMV over this FY 2027 year?
We've got that contracted revenue across 2026/2027, approximately AUD 1 million. That'll keep rolling through. We've got the monthly recurring coming through from IMV at the moment. We've got contracted work from Huon and Tassal in early calendar year 2027, I should say. What I would be keeping an eye out for is, what's probably the more important part in that is, working together with IMV to determine what the future larger scale could look like. The contracted piece is interesting, but during the year, I think determining what that longer-term, bigger picture could look like if we think it's viable is what would be more interesting. That I'd see probably in the back end of the financial year.
As a follow-up to that, Brent, the strategy with animal reproduction and partnering with one of the biggest, if not the biggest participant in the market globally, how do you think about that and what it enables in terms of resource allocation to human health in the U.S.?
Obviously, the strategy that we tried to bring in was the one that we've executed on. That is not trying to build a sales team on the ground across all the different priority markets, which is a global thing, to be able to acquire customers, let's say. We wanted to have a global partner who we could do it with because it is a consolidated industry. IMV would be the perfect partner in that space. That's why we went with them. That's proving out to be quite a good choice. We're working well together. It's a good partnership. We're working through assessing how that scales and how we go to market together. That's the work that we're doing at the moment. We don't intend to do what I just described we didn't want to do moving forward either.
We don't want to build a big team to be able to service that market. The type of deal that we would be looking at in this space and working with IMV on is probably more about how do we limit our resource build to capture that market together. That's some of the work that we'll do. What we want to keep our focus on and building resource to execute is the U.S. human health market. We see that as being the biggest, and whilst animal is really important, we don't want to lose sight of building our resource and focus area on the U.S. blood market primarily.
Excellent. Thank you. One final question from the floor. Then we'll call it a day. Just a quick update on the status of the device regulatory approval with the FDA, any sort of key markers to look out on, given the value inflection point that will present in the first half of this financial year.
We're building out units at the moment. That's expected to be before the end of calendar year, that FDA registration clearance. The work that we're doing right now is broken into verification, which is kind of like engineering work, and then validation, which is more about biological material and user requirements. That work will be done here in Australia as well as in the U.S . Some of that work will be done in kind with our partners in the blood space. We are expecting progress in the first half of this financial year.
Brent, Simon, thank you very much for taking the time to present this morning to all our investors and audience. Thank you very much for making the time this morning. If you do have any follow-up questions or would like further information around anything, please reach out to the company via our investors inbox, which is investors@vitrafy.com. Other than that, thank you very much for attending the FY 2026 financial year results, and have a great day. Thank you.
Thanks, everyone.