Morning. How you going? Your audio is stuck.
Pardon? My audio okay or not?
Yeah. Well, let's go to Tim, just a note. You've got the AI tool that's automatically recording. We may need to update some of the, or trim some of the content prior to it being released to market, just 'cause it sort of starts from the very beginning.
Noted. Yep, that's done. I'll bring it up. Yep, that would be great. Thanks, Brent.
Mm.
Good morning, it's Tim Sharp here, Vice President of Strategy and Corporate Development at Vitrafy Life Sciences. Thank you very much, everyone, for joining us this morning. On today's call, we have CEO and Managing Director, Brent Owens, and CFO, Simon Martin, who will be giving an update on the Q2 quarterly activities report and Appendix 4C. So I'll now hand over to you, Brent, for an update to investors. Thank you.
Thanks, Tim, and thank you everyone for joining. Noting that we did catch up a couple of weeks ago, so I've already touched base this year, but for those that weren't on that call, Happy New Year, and welcome to Vitrafy's Q2 update. Where I would say that we closed out the end of the calendar year in a really strong position, and this year we've sort of used that momentum and really accelerated as well. Whilst this is the quarterly update, we do have a more extended presentation next week for the half year results as well, which will come across early next week. But I guess again, welcome.
For us, it has been quite meaningful over the past quarter, particularly with our first real material and validating strategic commercial agreement with one of the largest global players in animal reproduction. We did note that that was what we were aiming to achieve commercially as a first milestone, so that is a big achievement for the company, which I'll expand on in a moment. Beyond that, though, over the quarter, we also built our first batch of Guardian cryopreservation freezing devices, and we've sent, and one has now arrived in the United States as well, where we have now set up an office in Southern California with an operating laboratory as well. During that term as well, we also completed a board renewal.
So quite a bit of evolution of the company from the sort of management team setting up in the United States, but also at a board level too, with the appointment of Dr. Leigh Farrell , and most recently Dr. Jeannie as well, who've got deep experience in covering blood, defense, biotech, and biopharma as well, which is excellent additions to the board. We've commenced following the government shutdown, phase two of the work with the United States Army on blood platelets, and that program is progressing well, and we are expecting some results in the next quarter as well, which is something that we're really looking forward to. A critical milestone to enable some of that commercial activity as well.
Really strong balance sheet with over AUD 22 million in the bank, that will really enable us to double down on our business development, sales and marketing, commercial activities, primarily in the United States. And what we've been doing from a technology development perspective is setting up our commercial manufacturing capability in the United States as well, and looking to build the next round of devices, ahead of our medical device milestones that are coming too. So a lot of activity, and a lot of progress as well, which has been excellent. But first and foremost, IMV deal that we've done is the clear standout of the quarter, the first major commercial milestone for the company in line with our strategy.
IMV is one of the largest providers of animal reproductive material and equipment across the world in different species, covering bovine, porcine, aquaculture, all the different markets that we're focusing on. With that deal, we're looking at a 12-month exclusive arrangement where we will see clear revenue opportunities that equate to around AUD 480,000 in aggregated monthly fees. Then we will have further milestone payments to achieve over the term, which are really about preparing for the go-to-market launch. That's what we're focusing on, the co-development as a joint offering to the market, and that's the work that we'll be doing in this first 12-month period. We are expected, upon those milestones being hit, for much bigger, broader, longer-term commercial deals with IMV across the different species that we're working with.
So a very clear pathway to scaling, which is what we wanted to achieve as fast as possible, as broad as possible across the animal reproductive market. So a great strategic commercial agreement executed with IMV there, giving us the best chance of accelerating and capturing market share quickly. Just a note on that agreement as well, whilst IMV do, you know, up to sort of 400 million individual sperm straw units per annum, we have still got a specific carve-out for the aquaculture work that we're doing here in Australia, and we will be keeping that work ongoing and our relationships here in Australia, completed by Vitrafy too. So great milestone for the company with a clear path to scale.
Beyond that, some of the product and commercialization highlights over the quarter. Again, we did build our first batch of Guardian cryopreservation freezing devices. We have shipped and sent, and it has arrived and been commissioned in the United States, which will really support those sales and marketing activities. I will expand on that at the half-year results as well. It is quite an important step in our evolution and growth and momentum, gaining market traction in the States, in our primary markets being blood, cell, and gene therapy. You know, we've seen. We've been doing those business development efforts, and now we actually have a physical device that people can touch and feel and see, which is really critically important.
From there, we've also built out four further Guardian devices that are for commercial use as well, with further being progressed and built and manufactured along the way, which have been included in the original forecast too. And now we're continuing to invest in our U.S. manufacturing capability to meet the anticipated demand coming from both animal and human health in those markets that we're focusing on as a priority. With that, some of those human health markets do have a medical device requirement. We've really tried to accelerate commercial opportunities in the research market, which are big and large, but we also have a big goal to get that medical device certification, and we're trying to accelerate that as fast as possible.
We have now commenced that program, starting with some of the validation work that we need to do and verification on the device. So the early medical device pathway has now commenced as well, and we're expecting to have further registration at, on the Class II 510(k) exempt status for that device, in the first half of the next financial year too. Then there's the actual ability to execute commercial arrangements, and we've built out a really strong team in the United States for customer onboarding and customer success in its entirety to support those commercial agreements that we're anticipating and have progressed well through our funnel as well. So great momentum in that space. More generally, as I was mentioning, we do have a U.S. operation now, as we said, that we're going to build.
We've co-located at Planet Innovation in Southern California, where we've got a little office. We've also got a demonstration facility and a little lab too. So that's gonna really support not just sort of training and onboarding, but also demonstrations and walkthroughs too, and it's a really great location. So if anybody's over in Southern California, give me a yell, and we can show you through and do a technology demo. Further to that, as I said, we have gone through a board renewal process, as we evolve and take our next phase of growth and bolstering our capability, and we've got the sort of subject matter experts, and that started with Dr. Leigh Farrell, appointed as chair of the board, particularly with his background in blood and defense-related activities.
Dr. Jeannie, who has recently been appointed as a non-executive director, again, with similar experience, but much deeper on the biopharma, biotech side of it, and in particular, in the United States as well. So the combination of that board renewal, we feel like we're in a really strong position for our next phase of growth in those priority markets that we're focusing on in the United States, in blood, cell, and gene therapy too. On the financial highlights, we do remain really disciplined on how we spend and where we spend. We'll say that we are progressing in line with our expectations. We're expecting a couple of million dollars to come in moving forward. Oops, sorry, over the next term for the Industry Growth Fund.
We do have a strong cash balance of close to AUD 23 million. And based on the current outlook, with factoring in all of the things that I mentioned prior, we do have runway well into calendar year 2027 as well. So progressing in line with how we've said since really the IPO. Importantly, over the next six months, what are we going to be doing? Well, we do have the obviously the deal with, with IMV that we want to execute, and we've hit the ground running since signing that agreement and getting that underway to move with pace in line with what they also want to achieve.
Further to that, there are the human health pipeline opportunities across blood and cell and gene therapy that are progressing well, and converting those into commercial agreements and collaboration agreements is what we're expecting in the first half of this calendar year as well. Importantly, with that, to deploy that commercially in some of those areas, we want to make sure that we are securing our medical device registration to expand our addressable market, particularly in the United States. Also ensuring that we've got equipment to be deployed. We've been building our manufacturing capability with our partners in Planet Innovation, and now we want to move towards building a few more batches of devices to be able to meet the anticipated demand, too.
So quite a bit of activity happening in parallel, with the core focus being the execution and creation of new commercial agreements that we've got there. So a lot to look forward to. We'll also be, again, as I mentioned in the opening part of the conversation, presenting the half-year results, where we will expand on some of this, and in particular, some of the market development activities that we've been doing in the United States as well, which will be later next week or the middle of next week. But from there, thank you everyone for joining, and Tim, I'll hand it over to you for any Q&A.
Thanks, Brent. Just a quick reminder, if you do have any questions, please use the Q&A function at the bottom of the Zoom platform. There is one question here, Brent, relating to regulatory strategy and market expansion.
Mm-hmm.
Any work or plans for capturing opportunities elsewhere, such as Europe, the U.K. or Asia over the coming years?
Yes. It's a great question, and I would say there is a pipeline, that we want to achieve continuous market expansion. You know, there, there are big markets outside of the U.S., and we do have a strategy to be able to implement that. There's two responses, though, specifically. One is, there's a big market that can be captured without needing the medical device approval, so under the banner of how the device is being built now, and that's not just in the States, that's also other jurisdictions and markets. The second part is that we want to make sure that we're really focused, and we don't try and boil the ocean day one.
So whilst there are opportunities, and we do see market growth and expansion for sure, and there is a strategy to execute on that, both from a penetration but a regulatory perspective too, we want to make sure that we're crawling before we're sprinting and delivering on our primary market with focus, and that being the United States first.
Thanks, Brent. And a question for Simon. In terms of the cost, cost of goods, what's the sort of indicative of the price per machine from a manufacturing perspective? How's that going to change over the coming 12 months?
Yeah. So one of the tasks we've got that we're working on right now is looking at shifting manufacturing closer to the customer base. So one of the photos you saw possibly off to the right of the slide was Planet Innovation, where our office in the U.S. is. That's where we want to push manufacturing to. At the same time, we want to push the manufacturing cost down. So there's a big program over the next six months to lower the cost of manufacturing, looking at various alternatives to make that happen. Our goal is to push it down to a level where we think we can achieve a very high gross margin come year two.
We'll expand on this more in the second next week in the results as we talk about what we're driving to on each of those outcomes. But suffice to say, we're confident we can get it down to a level subject to pricing on inbound to a level where we can achieve the sort of margins we've been talking about over the last 12 months.
Excellent. Thank you, Simon. Just I'll give another 30 seconds for any further questions to be put into the Q&A function at the bottom of the Zoom platform. Just following up on Brent's earlier point, the company will be releasing its first half FY 2026 results on Wednesday, the 4th of February. We will also be hosting an investor webinar at 9:00 A.M. to go through the results and provide a bit of an outlook for the remainder of FY 2026 and beyond. So those details will be circulated not only via the ASX platform, but also via the social media channels of the website and Mailchimp. So if you do have any questions relating to the half-year results and any investor engagement, please do reach out to investors@vitrafy.com.
Noting that there's no further questions, we might call time on this webinar. Thank you all very much for taking the time this morning to join and listen to the Q2 quarterly update. This will be made available on the website for follow-up, and if you do have any further following questions, please reach out to either Simon or myself via the investors@vitrafy.com email address. Thank you very much for joining, and have a great day.
Thanks, everyone.