Lumos Diagnostics Holdings Limited (LDX) Earnings Call Transcript & Summary

Good morning, everyone. My name is Sam Lanyon, Chair of Lumos Diagnostics Holdings Limited, and it's my pleasure to welcome you all to our Annual General Meeting of Shareholders. I would like to start by acknowledging and paying respect to the traditional custodians of the land, wherever those participating at this meeting are located. Today's meeting is being held in a virtual format allowing shareholders and their representatives to participate via the webinar forum. And as such, we may experience some time lag, and this may cause delay in your questions or comments coming to our attention. So stick with us. I further advise that the company has complied with the relevant requirements to convene this meeting and that a quorum is present. As the time is now 9:03, I formally declare the meeting open. I'm joined through the webcast today by my fellow directors, CEO, Doug Ward; and our Non-Executive Directors, Catherine Robson, Bronwyn Le Grice, Larry Mehren. Our auditor, Alan Finnis, representing William Buck is also in attendance and will make himself available during the meeting to answer any questions on the accounts at the appropriate time. Also, our CFO, Barrie Lambert; and Company Secretary, Tracy Weimar, are in attendance today. The Notice of Meeting has been given in accordance with the company's constitution, and copies are available for you on the company's website and the share registry's online voting site. Unless there are any objections, I intend to take the notice of this meeting and attached explanatory statement sent to the shareholders as read. As previously advised, this is a virtual meeting, and shareholders will be able to participate via a live web of the meeting, ask questions and cast, submit direct votes at the appropriate times whilst the meeting is in progress. The format of today's meeting will be a brief Chair address from myself and a presentation from Doug with an update on the company and its current operations. Both of these have been released to the ASX this morning. A Q&A, voting and poll procedure explanation from our Company Secretary, Tracy, will then follow; a Q&A session in relation to the company's operations, followed by consideration of the formal business on today's agenda; and a final Q&A session for the shareholders on the formal business for today. As this is a virtual meeting, shareholders will be able to ask questions and cast direct votes at the appropriate times whilst the meeting is in progress. Questions received during the meeting, which are of a similar nature, will be grouped and answered at the appropriate time. If you have any questions which you feel were not addressed at today's meeting, we invite shareholders to contact the company via phone or e-mail. I'll now move to our formal -- to my formal Chair address. Dear shareholders, welcome to Lumos Diagnostics' 2024 Annual General Meeting. My name is Sam Lanyon, and I am the Non-Executive Chair of the company. Reflecting on the past year, I'm pleased to address you on behalf of the Board. Alongside my fellow members, I'm encouraged by the company's progress under the leadership of our CEO and Managing Director, Doug Ward and his team. Over the last 2 years, they've shown strong commitment to being a solid foundation for Lumos' growth. We're now seeing the results of these efforts, positioning us for a very promising future. During this period, Lumos has made significant progress securing regulatory clearances for our flagship diagnostic products, FebriDx and ViraDx, launching them commercially and achieving initial sales. We've also successfully secured funding to support our goals. Importantly, our financial and operational position has strengthened further through a key intellectual property and development agreement with Hologic, a global leader in women's health solutions. In particular, I want to highlight 2 major product clearances received in the United States for FebriDx and ViraDx. FebriDx is our innovative rapid point-of-care diagnostic test, providing health care professionals with the ability to differentiate bacterial from nonbacterial infections quickly and reliably, addressing a pressing health care need in infection management. ViraDx, on the other hand, is our rapid test for COVID-19, Flu A and Flu B, which enables the timely identification of viral infections essential for patient care during flu season. Achieving these clearances from the FDA demonstrates our team's collective capability and expertise across research, development, regulatory compliance and quality assurance. Building a strong market presence for these products, especially in the United States has been essential. Our team has ramped up production and established distribution channels, even with the challenges of entering the U.S. 2023/'24 flu season later than we would have liked. This progress demonstrates our operational flexibility and commitment to making essential diagnostic tools widely accessible in the health care market. Our partnership with Hologic is another cornerstone of our growth trajectory. Since beginning in FY '23, this collaboration has expanded, recently resulting in intellectual property and development agreements to support Hologic's next-generation fetal fibronectin, fFN, prebirth -- preterm birth test. This partnership underscores our joint commitment to advancing women's health diagnostics and our ability to meet high industry standards. Lumos' financial position was bolstered by a USD 10 million IP payment from Hologic with an additional $0.7 million received from milestone achievements so far and another USD 4 million expected as we advance the fFN product development. As Doug Ward joined the Board this year, his role has been instrumental in aligning strategic direction and operational focus alongside our valued Board members, Larry, Catherine and Bronwyn. I look forward to his continued contributions in this dual role as he leads Lumos through its next phase of growth. Surely, in his CEO address, Doug will discuss operational progress, provide additional insights on our road map for the coming year and beyond. We also want to acknowledge the support of you, our shareholders. Last month, we successfully completed an AUD 10 million capital raise. This funding will help us conduct a clinical trial to expand FebriDx to a CLIA-waived label in the U.S., broadening our market reach substantially as well as support new product development and our working capital needs. I'll extend gratitude to the participating shareholders, including new supporter Tenmile and long-time investor Ryder Capital. Looking ahead, I'm confident in the solid foundation we've established. These not only provide financial stability but a platform to continue developing innovative products and new partnership opportunities in specialized health care segments. We're particularly excited to commence exploring new market opportunities in rapid point-of-care tests in the women's health market. With these foundations, my belief is that the broader market will begin to recognize the value of this business and its bright future, which in turn will drive shareholder value. In conclusion, I extend my sincere gratitude to the Lumos team for their hard work and expertise, to my fellow Board members for their insights, and to our shareholders for their support in our mission. Thank you, and I look forward to the journey ahead. Doug?

Good morning, everyone. It's terrific to be with you today to give you a quick update on the company. Thank you, Sam, for doing your address. We greatly appreciate that, and thanks for the whole Board for your support throughout the year. Likewise, I also want to extend my thanks to all of our shareholders as well. We do sincerely appreciate all of your support over the past year and continue to rely on that support as we go forward; and then finally, just to say thanks to the entire Lumos Diagnostics team. We're 50-plus strong individuals working on the team now, and I think they've just done a wonderful job over the past 15 months to deliver all of the achievements that we've been able to bring forward. So Sam spoke to all of these pretty much, but I just wanted to once again reiterate the key milestones that we've been able to achieve over the last 15 months if you will. So for full year '24 as well as first quarter here in '25, I tell you, I'm thrilled with where we are as a business right now and in the positive outcomes that we've had starting with the Hologic agreement, which we signed up just under $15 million for that IP agreement and so forth. I'm going to talk a little bit more about that specifically, where we are in that process and even probably more important to clarify expectations around the future opportunity because it's very bright in regard to that opportunity with Hologic. So I want to touch base on that. Likewise, FebriDx and ViraDx, to get both of those cleared early last year in the fiscal year was terrific and then start to sell that product and here in the U.S. starting in January, really is a positive momentum builder for the company. I'm going to talk a little bit about both products, where we are with ViraDx as well as the flu season here in the U.S. as well as the ongoing opportunity with FebriDx in the key trial that we have coming up. Relative to the financials overall and just say, hey, I thought we had a terrific year and a very, very good quarter 1 as well this year. So sales were up significantly for the quarter, year-on-year here in '25 versus '24. And overall, our cash position is much improved, both from a standpoint of year-end 2024 and ending the year with $6.5 million. But then also, as Sam said, having the capital raise for AUD 10 million coming in as well early in this fiscal year has put us in a very good position going forward. Lastly, I'll just speak a little bit to the BARDA partnership that we signed. Overall, that's an USD 8.3 million opportunity for non-diluted funding for the company. Right now, we're working on the first stages of that, which are support for the CLIA waiver study for FebriDx. And that's about a USD 3 million non-diluted funding to go toward that. And I'll speak a little bit more about that otherwise in the presentation. And now I'm going to ask Barrie, if he doesn't mind, because I want him to get some credit here. I get to go out and talk about all the great stuff that we do, but to be fair, I think Barrie has done a wonderful job in helping us manage our position from a financial standpoint, both in terms of driving our revenue line, getting us into a nice cash position and doing the capital raise. So he's going to speak to the next 2 slides, and then I'll come back and talk more about the products.

Thanks, Doug. Just want to recap, I guess, on a few points that Sam and Doug have already made on the FY '24 results and a little bit on the capital raise as well, so just 2 slides from me. Got 3 charts here on this slide. So one on the left is revenue by quarter going back to Q1 FY '24 through to the most recent quarter, Q1 FY '25. Chart in the middle's the revenue mix and then the cash flow on the far right there on that chart. So just recapping again. So revenue for FY '24 was $11.1 million, okay, which is up 6% on FY '23, which, in my opinion, was a really good result considering the slow start to the year. You can see that in the chart there on the top left. Q1 and Q2 were a little bit slow and then strong Q3 and Q4 driven obviously by the Hologic project wins and the IP agreement, and also the flu season in the U.S. started to kick in, in those quarters. The Services revenue for FY '24 was $9.9 million, strong contributions from Hologic and probably around -- between 10 and 20 other projects we're doing for customers as well in the service business. Products revenue for FY '24 was $1.2 million, which was actually up 289% on the prior year, so a great result getting those 2 products cleared. ViraDx, we started preparing for the sale season and the flu season in the U.S. around sort of November, December period, so that only came to market partway through the year. And FebriDx in the U.S. really only came on to market in January of '24, so as Sam mentioned, a little bit late in the flu season but great to get those clearances and get started with commercializing those products. Net cash flow for FY '24 was actually an outflow of $0.4 million, which was an incredible improvement over the previous year of FY '23, which was an outflow of $11.6 million, obviously supported by the agreements with Hologic, which made a strong contribution to cash flow. First quarter of FY '25, product sales were up 200% on the prior comparable period in Q1 of FY '24, driven a lot by ViraDx, and given the products have now been on market for a few months, we're getting some traction with customers there. I made a comment around pro forma cash at the bottom there after the capital raise. So pro forma cash at the end of September, if we include all the proceeds from the capital raise, would be USD 9.8 million. Next slide. Thanks. And just a couple of comments on the capital raise. And once again, my thanks to all shareholders who supported the capital raise, in particular, Tenmile and Ryder Capital as well. So that was completed over September, October, an ANREO, accelerated rights offer, AUD 3.1 million under the institutional and $6.9 million under the retail entitlement component. I think most shareholders would know Tenmile is part of Tattarang Group, which is the investment vehicle for Andrew and Nicola Forrest. Post the capital raise, their holding in the company is 19.9%. And we also had strong support from Ryder Capital, who have been with the company for many years, and their holding increased from 5.3% to 17%. And just a couple of comments on the use of funds. Proceeds from the capital raise, we put towards a FebriDx CLIA waiver trial in the U.S.; initiate some development on a new product in the women's health space, which Doug will talk about shortly; put some sales and marketing, which we need to put behind ViraDx and FebriDx in the U.S.; and also to support the Service business with those projects and general working capital. You can see the split there on the right-hand side. So I think that's it for me, Doug. I'll pass back to you.

Barrie, thank you very much. Really appreciate all the hard work you're doing to make all of that happen for us. So thank you. So next slide, please. I have 3 slides on product updates for you all. Let's talk about FebriDx, first of all. And listen, I want to take a second and just speak to expectation about what it takes to bring the product to market within the U.S. just for a minute as well as what is that opportunity once we fulfill the obligations for the FDA clinical trial to try to get the FDA clearance for this for CLIA waiver. Let me explain that, in the U.S. specifically, which is the largest point-of-care market in the world, right, this is going to be a tremendous opportunity for us once we have CLIA waived. It's a great opportunity right now, but it also has some limitations, meaning we can only sell to what are called moderate complex laboratories to utilize this test. That limits our access to the market to about 18,000 locations here in the U.S., which is a nice opportunity, but what -- the key part that I'd like to just make sure that people are aware of is understanding how those sites actually work. These are typically associated with hospitals, and therefore, they have very clear, what are called, clinical care pathways on how they treat for acute respiratory infections. In that setting, they had clear guidelines that they follow, and they're pretty rigorous in doing that. We are in the process of, right, trying to introduce arguably one most unique and highly differentiated tests and helpful test to change the practice of medicine, FebriDx, right, into that market. So to introduce that product in there, it does take a little bit of education, experience and proving its clinical value and its economical value to get placed into those guidelines into care pathways. We are slowly moving that forward. So as we do that, we are signing up dealers and distributors and [ DMO ] groups and so forth, which gives us the opportunity when they want to place orders to meet those -- that demand. So it will take a little bit of time to get this test put in, okay, into that regulated market in that care pathway. So I just wanted to make sure that I was setting expectations around that as we're announcing that we turn on Thermo Fisher or MediGroup and so forth. They do place initial orders with us, but those are relatively small orders, I would say. And until we start getting repeat orders, I think what you can expect is just a steady growth of that product but not a significant ramp of that product here in the first year until we get -- after CLIA waiver, okay? And as I said, we now have BARDA non-dilutive funding to help us achieve that CLIA waiver, to help pay for that. We are starting that study in the month of December, first patient in. We hope to have that completed, say, around the April standpoint. And I can say, right, this -- the big risk to this is you need a flu season. And I can say -- and this is going to have an impact on our next slide called FebriDx as well, our next product, our flu, COVID test. Flu season in the U.S. right now is about 6 weeks behind from where it was last year. So if you get on to the CDC website and look up like flu or influenza map, you can see by state what the incident of infection is and you can compare year-on-year and so forth. Right now, the only place in the U.S. that is a -- what's called a hot area is Washington, D.C., the District of Columbia right now. The rest are low incident rate. Now that changes quickly once we start to get colder weather, people move inside, and then you have the holidays and so forth with Thanksgiving here in the U.S. this month and then Christmas next month, where there's a lot more, right, people closer together and infection growth tends to grow rapidly. So just wanted to give you a flavor. That's the only risk on our study for BARDA, is if that flu season is a little bit longer, it could take us a little bit more time to do that. So in regard to ViraDx, listen, we had a great first quarter for that product. We had about 300,000, I think, in sales -- product sales in quarter 1, which is actually terrific. Now again, what those orders are, are stocking orders, which come in anticipation of flu season. Now what we're waiting for is flu season to start. So then those kits will go out to the treatment centers, and then we'll start to replenish. And then it starts to snowball very quickly. So I would say relative to sales for products, a key thing to watch or expectation of ramp and so forth, especially for ViraDx will be the flu season here in the U.S. So you guys can keep track of that, if you wish, on the CDC, and then you can have -- understand what kind of expectation we might have there. Okay. Next slide. And then as we've talked about with our new proceeds that have come into the company, hey, we love ViraDx and FebriDx as products, meeting the needs of the customers, but what we really want to do is go after a segment of the market with new products that will be, right, labeled and branded for Lumos for the point-of-care environment. And as we've communicated before, we plan to really focus on the women's sexual health business. Okay? Right now, we do sell a Binx product that we're one of their dealers and distributors into the women's health market. It's Chlamydia, gonorrhea that we sell for that. But as -- right now, what we're doing is we started the development of our own tests. We're not telling people what that is yet only because we don't want anybody to come in and try to do that before we get it done because it's going to be a terrific product, and it's an unmet need in the market today that, I think, we're well positioned to address. So more to come on this, especially once we get started into our clinical trial for this product. Now I'd like to talk a little bit about our services business. Next slide, please. So we're talking about Hologic here, is the biggest project that we have to date, right? We signed that significant agreement, the 2 significant agreements with Hologic. Just things are going according to plan there. We've met Phase I of the product, right? We build that. We received the receipts for that as well. For Phase II, we're halfway through that. We've completed the first part of that. And now we're in progress here for the second, and that's probably, let's say, within a couple of months away from finalizing. And simultaneously, we'll be working on Phase III moving that, which is, obviously, that part is also broken up into smaller segments as well. I think there's like, I want to say, 6 or 7 segments to that project. So as we complete that, right, we'll be billing against the remaining $3.7 million that's left in that contract and then getting that cash in the door. Next slide, please. So the final item to talk about here is just expectation around, well, what's next. Fine. We signed the IP agreement, and we have this initial feasibility work for $4.7 million. Well, what we're looking at is we have 3 more legs to this fFN project. Okay? We'll be signing an agreement to do verification, validation, okay, which would be the next stage of development. When that's completed, the product will then go into a clinical study, and we'll support Hologic's plan to deliver on that clinical study that has to be done. And then we will be the manufacturer of both the instrument and the test for Hologic, and we'll be providing those products going forward to meet their replacement need, right, as we swap out their old product for our new generation product and for new customers going forward. So that will bring us ongoing revenue and margin going forward, manufacturing that and meeting that. And then lastly, right, the agreement does contemplate, well, they also want to put additional tests onto that instrument. So we expect to do that in the future as well. Next slide. So now as I said, Hologic is the largest, but we do about a dozen projects, services agreements a year. So I just thought I'd highlight a few of those. One, we've recently announced, right, the Burnet initiative, where we are working with them to bring an ALT test, so it's a liver function test if you will. And we'll be providing both the manufacturing of that reagent test and also the instrument for that test as well. We signed that here this quarter -- or last quarter, I should say. And we'll be doing that work over the next 9 to 12 months to bring in close to $0.7 million to $1 million in revenue for us here this year. Two other projects, I'll just speak to just to give you an idea of type of work we do but also what different industries we're associated with here. So we're working with Aptatek Biosciences. This is a PKU test. If you've ever looked at a can of Coke or Diet Coke or anything, you see that, hey, there's PKU. You got to be careful. Anyways, we have developed a home test with them to develop a home test, PKU test, so very, very interesting opportunity around that. And then the other is Huvepharma, which, right, we're working with them to take a look at developing products, especially for antibiotics in feed of animals, right? I'm sure you've gone to the grocery store and you say, hey, these are antibiotic-free chickens or lamb or whatever. Well, they need a great point-of-care test to do that, and we are actually manufacturing that product. We developed it in the past, and now they're starting to use this more and more and need us to be their contract manufacturer for this product going forward. So that's just a little bit of flavor for some of the work and great work that the team is doing on bringing products, not just doing the services work but also trying to turn that into then sustainable revenue as a manufacturer of those products in the future. So again, we'll just summarize with these are the 4 priorities right now for the company, right? We'll continue to drive FebriDx and ViraDx into the market. We'll do that ourselves. And certainly, we'll look to sign distributors up and also we'll look to partner in tests that can be bundled together with our products that we could take that forward. Number two, we want to expand that market significantly. Right now, in the -- in a moderate complex environment, 18,000 sites, geographical sites, that we could go to. With CLIA waiver, that becomes like 280,000 sites. And it's much easier to impact that care pathway, can be changed much easier in the CLIA waiver environment versus the moderate complex environment. We'll continue to drive our relationship with Hologic and our other services partners and look to grow that part of the business. And then lastly, very, very excited about the prospect of starting work on our own women's health product portfolio going forward. So that kind of wraps up what I wanted to give everyone a quick summary on the last 15 months, terrific work by the entire team with the support of the Board and obviously our investors. So I'm really, really pleased to be in front of you all today and look forward to any questions that you guys have.

Thank you, Doug. I will now pass over to our Company Secretary, Tracy, who will outline the Q&A voting and poll procedure for today's meeting.

Thank you, Sam. As mentioned earlier, shareholders will be able to ask questions and cast votes at the appropriate time during the meeting. Please note that when logging a question via the webinar facility, we may experience some time lag, and this may cause some delay in your questions coming to our attention. We encourage you to lodge them as early as you can. There are 2 ways of submitting questions during the meeting, via text and via an audio facility. [Operator Instructions] With regard to the poll procedure, we will be opening voting at the commencement of the formal business section of the meeting so that your votes may be cast. For those proxy holders, shareholders and authorized corporate representatives who are entitled to vote, you will be able to do so via the webinar poll. A voting box will appear on your screen at the launch of the poll. Please submit your votes on each of the resolutions when the poll is opened. It is important to note that if you have lodged a proxy form and voted prior to the meeting, you do not need to vote again at this meeting unless you wish to change your proxy instruction. For proxy holders, you will have a summary of proxy votes, which detail the voting instructions, if any, for the items of business. By completing the voting via the webinar poll, when instructed to vote in a particular manner, you are deemed to have voted in accordance with those instructions. Where the Chair has been appointed proxy on behalf of the shareholder, Sam Lanyon, as Chair of the Meeting will be voting in favor of all the resolutions. When the poll is declared open, a poll window will appear on your screen. To vote, simply select the direction in which you would like your vote to be cast and the selected option will be marked. To submit your votes, please click on the submit button. You will have the ability to change your vote up until the time the voting is closed. Voting on all resolutions is allowed up until the time the poll is closed. So Sam, that covers the logistics of questions and voting. I'll now hand back to you.

Thank you, Tracy. We will now address shareholder questions which were submitted prior to today's meeting and any received in relation to the business operations just presented by Doug. Tracy, did we receive any written questions or does any shareholder wish to ask a general question about the business?

We have received some questions via the text facility in the webinar. And I'll start with the first one from [ Andrew Blair ], which says, back in January, it was mentioned that most stockists made their purchases by September for the upcoming U.S. flu season. How have sales progressed for FebriDx in line with that previous advice? And why did the quarterly not specifically address this?

So I think some of that question was actually answered in some of Doug's presentation regarding stocking sales for ViraDx. I think Doug mentioned 300,000. But maybe, Doug, do you want to add any more color to that question?

Yes, absolutely. Yes. Thanks for the question. So yes, to clarify, the initial orders that are placed are stocking orders that the dealers or distributors take. They normally will start to take those, let's call it, in the September time frame, around there. And then as flu season hits, okay, and let's say that's October. In this case, it's not. It's -- now we're mid-November, and it still hasn't hit yet here in the U.S. But if it was in October, the docs would start to say, "Okay. Send me -- I want to buy FebriDx or ViraDx." In most cases, it's going to be ViraDx, right. So send me the product and then they'll start to use it. And as the distributor's inventory goes down, they'll start to reorder. And then, right, it's just a feedback loop from there that, right, as docs use product, distributors will continue to send more inventory into the docs as they order it, and then we will continue to supply those distributors the products. So that's how it works. We actually will get most sales, as you saw from back on Slide 8, if you -- I think it's Slide 8, of the financials, you would have seen the quarterly product sales and you would have seen that, I think, the largest number was for Q3, I believe. So the reason for that is our Q3 is January, February, March. That's when flu season was its heaviest here in the U.S. last year. So we had people placing orders through their distributors that we were selling to, and we were filling those use orders, right, that were there in January, February and March. And then it started to come down significantly. So we actually had a number of stocking orders in Q1, which we felt great about. And I would say, typically, you would think that we have a good Q2 for us, right, which is the October, November, December. But so far, we're not having flu season yet. So I think we're going to be delayed in when will we really see that ramp. Is that going to be in Q2, which was a hope if flu season was normal or early. It looks like it's delayed, so you'll probably see that ramp more in the Q3 time frame for us. So I hope that answers the question.

All right. So there's another question online. Tracy, do you want to read that one out?

Sure. So we've got a question from [ David Smithers ], and it says, could you please reiterate the key time lines over the next 12 to 18 months, in particular, expected receipt of the CLIA waiver and consequent achievement of optimal sales levels for both present point-of-care products. Could you also give us your feel for the broad level of sales that you expect?

Yes. So I think, David, I'll get Doug to talk back through the time lines. And I do believe there's another question coming up of a similar nature. We're just going to remember that this is early stages for our business. We're bringing new point-of-care products to market, and sometimes it takes a while for it to become -- for us to become an overnight success. So we're not providing guidance at this point in time in terms of expected sales revenue and things like that. But we do expect to be giving regular updates, like Doug just provided an update today in terms of sales of ViraDx by way of example. But Doug, did you want to touch on that CLIA waiver time line's point of view just in terms of general ideas as to submission and potential clearance?

Yes, absolutely. Thank you for the question. So time line for FebriDx and CLIA waiver, so we have been working with BARDA over the last, I'd say -- I guess, it's been about a month since we announced, a month, maybe a little bit more, working with them in setting up. Now that we are working with the government institution like BARDA, they now get a say, right? We have meetings with them every other week now to go through our plan, right, in a very robust manner with them, and they actually have a say in those plans, especially around when we can initiate things and so forth. So we plan to initiate first patient in, in December. Okay? Don't know quite yet what week that is. I know there's a meeting yet this week face to face with BARDA on the trial, to get that started, but that will start in December. We have to achieve 120 bacterial-positive patients. That's the key highlight. Now to do that, our math says, geez, we're going to have to test people with symptoms. We probably have to test about, let's call it, 600 patients in order to get that 120, right? Now we'll do that across a number of sites. And like I said earlier, if the accrual rate is consistent with what it was the last time we did our clinical study and there is a good robust flu season here in the U.S., we expect that we'll probably be done with that study, let's say, near the April time frame. We would then take the results to that with BARDA and so forth. We'd submit that to the FDA for clearance, right? That would then -- we anticipate that, that can take up to 180 days. Okay? So that would put us at the very start, again, let's call it, around -- if it's month 4 or 5 plus 6, right, you're getting close to the October-November time frame of when that would be cleared by the FDA if things go in the way that we're thinking they will go. Hopefully, that answers your question on the time line.

That's the subsequent, obviously, flu season too, right, there, Doug. So in terms of the approval, around about then.

Yes. I would just say, Sam, that if the accrual rate is a little bit slower than what we want or the flu season is not, then probably what we will do -- and we've kind of, right, as with all things, right, yes, if your plan -- your first plan and you have to have plan, right, 2, 3, 4, as anything that you work on, so we do have the anticipation that if there are any headwinds against us, we could try to get more sites onboard. So by bringing more sites onboard, right, you could pick up more patients and you have to do more testing, right, because then instead of, say, the 600, if flu -- if the accrual rate was much less, we might have to do 800 patients, right? But we try to keep our time frame over the flu season by doing more sites. So these are the kind of the anticipated challenges that you just have to prepare for and have your contingency plans.

Thank you, Doug. There's one more question, I believe, Tracy.

There's one more question from [ Barry Henderson ]. As you mentioned, it is -- you touched on it briefly earlier but for completeness, given the optimism inherent in the Chairman's, CEO's and CFO's addresses, could you please give us some guidance for revenue and/or cash flow in the coming year?

Yes. It's sort of related to my answer before, but I might expand a little bit more. In my Chair address, I used the word solid foundation. And so the optimism is coming from a feeling that with -- under Doug's leadership, we've got the company in its right size, shape, structure and able to create opportunities and work on those opportunities as they come up. So I think the optimism is positive because we're seeing what solid foundations do to the business. So we've had some quarters where we've had positive cash flow. We've had things where we've been able to gear up sales like the ViraDx sales going into the next flu season. And so I think there's just a general feeling both at management and the Board that we're in a really good position to make the most of the opportunities as they come up. Now that said, when you start to look forward, and as I said before, is -- takes a while to become an overnight success. We realize there's still risk in this business. We realize that from a sales perspective, things can and not necessarily work on the time lines that you want, like Doug just talked about with the CLIA waiver for instance. In terms of non-dilutive funding, you've got to achieve milestones in order to get the next tranche. And so because of all of these things, whilst we're optimistic, I don't think we're at the position where we want to be setting and the company doesn't provide guidance, as I said, and we don't want to be out there providing that sort of detail just now. Now as we build into success, then obviously, as a company, we need to look at whether we do provide guidance, but at this point in time, we do not. So I think, Tracy, that's -- is that...

There are no other questions at this time, Sam.

Okay. So we move on to the formal business. So firstly, if you have any question on any of the items of business, please follow the questions procedure, which was previously outlined. We will address your questions after the last resolution. Before opening the poll, I wish to remind shareholders that the poll will remain open for additional time after we've considered all resolutions to allow our shareholders sufficient time to complete their voting. I now move to the first item of business as set out in the Notice of Meeting, which is to receive and consider the financial report of the company and the related reports of the directors and the auditors for the year ended 30th of June 2024. These items contained in the annual report, so I'll ask that they be taken as read. The annual report is available on the company's website. The Corporations Act requires the accounts and reports to be put before shareholders at the Annual General Meeting. However, except as set out in resolution 1 to be considered later, there is no requirement for a vote of members to be taken on them. I note no written questions to the auditor under section 250PA of the Corporations Act were received by the cut-off date 5 business days before this meeting. Questions may be directed through myself to the auditor in relation to the conduct of the audit, the audit report, the company's accounting policies or the independence of the auditor. As this matter does not require a vote, we will now move on to receipt of the electronic notice under the Corporations Amendment (Meetings and Documents) Act 2022. Shareholders are also asked to consider the electronic communications notice in accordance with the Corporations Amendment as specified under the Meetings and Documents Act 2022, the Amendment Act. As this matter also does not require a vote, we will now move to the formal business of today's meeting. I'll refer you to resolution 1, which is to consider the adoption of the remuneration report forming part of the directors' report for the financial year ended 30th of June 2024. The remuneration report is set out in the directors' report in the company's 2024 annual report. The remuneration report sets out the company's remuneration arrangements for the directors and key management personnel of the company. The vote on this resolution is advisory only and does not bind the directors or the company. Full details of received proxy results are outlined in the presentation on your screen. I move that shareholders consider and if thought fit, pass the ordinary resolution. Moving on to the next resolution. As this resolution is in relation to myself, I will pass the Chair to Catherine Robson to conduct the resolution.

I now refer to resolution 2, which seeks approval of the reelection of Sam Lanyon as a Director of the company. Mr. Lanyon's profile has been provided on Pages 8 and 9 of the explanatory statement. Full details of received proxy results are outlined in the presentation on your screen. I move that shareholders consider and if thought fit, pass the ordinary resolution. I'll now pass back the Chair role to Sam to conduct the remainder of the formal business.

Thanks, Catherine. I now refer to resolution 3, which seeks to approve to issue 2.743 million fully paid ordinary shares to Mr. Doug Ward or his nominee in relation to his FY '23 bonus payment. All details of received proxy results are outlined in the presentation on your screen. I move that shareholders consider and if thought fit, pass the ordinary resolution. I now refer you to resolution 4, which seeks the approval to issue 5.337 million restricted shares to Mr. Doug Ward or his nominee in relation to his FY '24 finance payment. Full details of received proxy results are outlined in the presentation on your screen. I move that the shareholders consider and if thought fit, pass the ordinary resolution. I now refer you to resolution 5, which relates to the ratification of prior issue of 62,196,034 unlisted options to the sub-underwriters, Tenmile Ventures Pty Ltd and Ryder Capital Limited as part of their underwriters' agreement in relation to the company's entitlement offer as announced to the ASX on the 4th of September 2024. Full details of received proxy results are outlined in the presentation on your screen. I move that the shareholders consider and if thought fit, pass the ordinary resolution. I now refer you to resolution 6, which seeks approval to renew the company's long-term incentive plan. Full details of the received proxy results are outlined in the presentation on your screen. I move that shareholders consider and if thought fit, pass the ordinary resolution. I now refer you to the final item of business, resolution 7, which seeks approval to refresh the company's 10% placement facility. Full details of the received proxy results are outlined in the presentation on your screen. As this resolution is a special resolution, it requires 75% of votes cast to be in favor in order to be deemed passed. I move that shareholders consider and if thought fit, pass the special resolution. We ask all shareholders to now take this time to complete your votes as we will close the poll after addressing shareholder questions. We will now go to shareholder questions. Tracy, did we receive any written questions or does any shareholder wish to ask or comment on any of today's formal business?

We have no open questions at this time, Sam.

As there are no further questions, we will now provide shareholders with an additional 30 seconds for poll voting to be completed. I'll pause. [Voting]

Okay. Sam, I think we've -- I can see the votes have come through.

Okay. Great. This concludes the Q&A session of this meeting, and I now declare the poll is closed. We welcome shareholders to contact the company via phone or e-mail if you have any questions, which you feel were not addressed at today's meeting. The company has not received notice of any other business. Since the poll is now closed and there is no other business that can be brought forward at this meeting, I declare this meeting is closed. After your votes have been counted, the results of the poll will be announced to the ASX later today. We thank you for your attendance, and we look forward to your continued support.