A simple production process. This year has seen us continue to strengthen and expand our manufacturing and supply chain footprint in preparation for our commercial launch. We've engaged with Nusano on copper-67 supply. Their accelerator-based technology is well-suited for high-volume mass production of isotope. We're also looking at Nusano for supply of commercial-scale volumes of copper-64, and SpectronRx will provide high-volume commercial-scale manufacturing of both copper-64 as well as copper-64 SAR-bisPSMA under one roof, with the ability to produce up to 400,000 patient-ready doses per year by the time of commercialization. I want to really finish up acknowledging our team. If I could fit everyone's picture on this slide, then I would, because we really could not achieve what we do without the dedication and tenacity of everyone in this organization.
Not every day is easy, but we approach every challenge with an open mind and determination just to get it done, working together to make it happen. Thank you also to everyone that supports Clarity. We have achieved a tremendous amount already, but I continue to look forward to advancing our pipeline and our products reaching as many patients as possible. Thank you.
Okay, now the fun bit. We get to hear from you. Question time from our shareholders that we love and appreciate. There are some mics that will go around. You have to speak into the mic because there are some shareholders listening in in this process as well. Please, hands up.
Thank you. In the notice of meeting, I saw that there was information on the performance criteria for the options, and they were based around total shareholder performance, but I did not see anything on the performance measures for short-term incentives. Can you tell us a bit about that?
You know what? I'm not the best person because I actually received that. Rosanne, do you want to have a comment on that? Do you want to come up here, or is that fine to talk into that mic? Yeah.
Typically, we don't publish that information prior to the completion of the financial year. That is set up at the commencement of the financial year. Most of it is around our commercial goals and our clinical milestones, including supply chain. They're commercially sensitive, hence why we don't put anything in that notice of meeting.
Okay.
Peter, do you have a question?
Thanks, Alan. Congrats to the board and to you all. Is this working?
Robert, is that working? Do we know? It is, yeah. Cool.
In my opinion, the stock market focus has been very heavily on the diagnostic recently. Congrats on the success of that trial, and we're all looking forward to hearing more detail. My question's about the therapy side of the developments. In particular, I think you mentioned that the NETs trial, or you're considering moving to a phase III registrational study in NETs. Can you expand on that? Have you met with the FDA on that as yet?
Maybe some people are quite tired today from that, but the answer is yes. It's not the therapy, though. It's the diagnostic trial. Michelle showed that phenomenal data in DISCO, and our goal is to get that product to market ASAP. It's a smaller market, less interesting to some, maybe some shareholders, because it's only a few hundred million dollars U.S., but an exciting opportunity for us. What we went head-to-head with there is DOTATATE with Gallium, which is otherwise known as NetSpot, which dominates that market, 70%-80%. The other product is actually a copper product, but they've used a chelator that leaks, and when copper leaks, it goes to the liver. You saw that's where all the METS were.
We see that as less of an issue for us, and we wanted to go head-to-head then with the market leader in the space, and you saw the difference between us and the market leader. We will be doing the level of the size of the clinical trial is nothing like the prostate cancer trials, are a much smaller sample size, but just to get that product to market ASAP, because we know that will be taken up by clinicians, given the significant difference between us and standard of care. We're excited about it. If that didn't come across, we're still excited about that. We think that's a great product. We also think Bombesin has a role to play, but SARTATE is something right now that we want to move into phase III clinical trials next year.
Just a quick question in regards to the SECuRE trial. You announced phase patient was dosed in the expansion phase seven months ago. At what stages are you guys going to provide an update? Are you waiting for the whole cohort to be enrolled before providing an update?
Yeah, we'll probably wait for a significant milestone. We've got a safety review committee approaching early next year. It's quite interesting that firstly, good to see you again. It's quite interesting that when we run trials, people somewhat, and maybe it's how life sciences works in Australia, people expect a different result that comes out of what is a very similar trial. Remember that eight-gigabecal cohort was phenomenally efficacious. It was the first time we had a complete response when we dosed at what we thought was going to be an efficacious level of radiation, obviously, dosage. The safety profile was fantastic. We actually have built in something that's very different too, because when we were selecting the dose for this trial, there were two key questions brought forward. Do we want to be an alpha destroyer?
We hit harder and then potentially have an increase in AEs, or do we want to be a Pluvicto buster? Our vote is a Pluvicto buster. We think Pluvicto is a good product. It's got a good market share, but we want to be better than that. We chose particularly eight gigabecquerels, and we have a little bit of a treatment window of anywhere between six and 13 weeks. It is a single arm. When we get a relative level of data available, we'll announce that to the market. We can do that because it's our trial. It's an IIT. When we had 12 out of 13 patients have such a significant PSA reduction off, predominantly those were single dose that were pre-chemo, maybe it's the same.
Let's get that data to you, which is a relevant data sample, but it's recruiting at this time and recruiting well. We expect to give an update probably early next year. People are asking about the therapy, actually, because I thought the therapy was lost in the diagnostic discussion as it was over here.
Follow-up question. In terms of, I guess, how the trial was designed, is it powered to perhaps utilize the FDA accelerated approval pathways?
Which trial? The SECuRE trial?
The SECuRE trial, yeah.
Yeah, that would be fantastic. We've already got the fast-track designation. We need more data for breakthrough, and we're generating that data as we speak. This is an expanded cohort as a phase II. Once we generate all of that data, we'll speak to the FDA as far as any other way to accelerate our products to market. You know we've been relatively successful at achieving those milestones, but we need more data with SECuRE to prove that out.
Is there a chance that you don't have to do a phase III trial and you can get approval based on either the current phase II- A or expanding that further and say, "I can roll in another 20 or 30 patients"?
Yeah, it's a good question. The size of the sample size of the phase III, because we would expect to do a phase III, is potentially smaller if we have a stronger response. I'm just telling you something logical there. Now, we have to measure what that response is and to see how it represents against a product which is in the market. Now, we've got the PSMA4 data. If you follow the PSMA4 data, it's not bad, but the AEs would be at a level that we would think to be rather unacceptable. This is probably why we've received fast-track designation for that therapy product to see whether we can do it better.
Now, we planned, and obviously, I've been in the Australian life sciences market for not as long as some people like Chris and the like and others, but for the last quarter of a century. I've seen some of the missteps of Australian life sciences companies where they do a phase III, which is different to the phase II. We have no plans to do that. We have to generate more data, obviously, as a phase II, but when we move into a cohort in phase III, we expect it to be the same at this point in time. We've spent a lot of time on dose optimization, which a lot of people haven't done. We've done this dose escalation component. We've dose optimized. Now we have to do multi-dosing at this point in time to generate data about safety and efficacy.
Given all that work we've done, we're expecting a good outcome. If that continues to be the case, then that cohort would be exactly the same. It would just be a larger amount of patients under the same treatment regime. We expect it, as I said, to be a phase III, but it's hoping to be a smaller phase III than, say, the Pluvicto phase III, which was 700-odd patients. If we can do a smaller patient population and get meaningful statistical outcomes, then that's great. We just have to generate a little more data, meaningful data at that dose at this point in time. Does that answer that? Yep?
Yeah.
Yeah, perfect.
Alan, two or three years ago, as I recall, Clarity made an announcement about that you'd gained access to click c hemistry, as you know, subject of a Nobel Prize. I'm very promising, but I haven't heard anything from you since. Is that something you're still looking at?
Yeah, we are. We're looking at ways to make it a little bit better at this point in time. We're running a diagnostic trial, and it was hard to recruit as purely a diagnostic trial, but we love the pre-targeting concept. The issue around the pre-targeting is actually not yet, at this point in time, not the click chemistry, but finding something that we can utilize that stays on the outside of the cell. So we still have a preclinical program in that space of pre-targeting, but it's a complex thing or a complex question that we have to answer. We're hoping it works. We're hoping it thrives, and we're continuing to look at these new targets at this point in time. It's a little bit different.
Did you see when we're doing the BIS PSMA that all that the focus was all that internalization, first binding, and then all of that internalization? We got great internalization, then something like pre-targeting doesn't work. We have to find quite a unique targeting moiety that stays on the outside of the cancer for a longer period of time. We can image then a couple of days later, and then we treat, and it's trying to make these antibodies safer. At this point in time, we're still in that preclinical model and not developing a theranostic at this point in time in humans until we get that science right. Not an area. I think it's quite an interesting space, but it's going to take a little bit to evolve.
The treatment paradigm itself is a little more complex, but there's a few people looking at it, and we think we've got a little bit of a head start on others. Okay. Is there more questions? Yep.
Hello, Alan. I am just wondering, you mentioned about wanting Clarity to be bigger than CSA earlier today. I was wondering, in the long run, do you plan to keep Clarity Pharmaceuticals in its current form, or would you be considering takeovers from big pharmaceutical companies?
Yeah, it's a good question. The space is a little bit hot, as you know, and it looks like we discussed that there was a little bit of a shake-up, obviously, when the Trump administration moved in. There were discussions with the FDA and pricing, and Big Pharma then sort of shifted to a focus on trying to sort out whether their products are going to be sold at a premium or not or wherever. There was sort of a retraction from the amount of M&A that was occurring. We're seeing that started to turn around. Certainly, the biotech indexes have started to improve. There was a great transaction even from Johnson & Johnson in the prostate cancer space just last week. That dynamic now seems to be alive and well again.
For us, we think at this point in time, and you've probably heard some of my videos, we want to stick to our knitting. We're excited about the opportunity that is only a couple of years away in a big diagnostic space where we see the competition as being quite lax. Our ability to drive shareholder value is quite significant to do that. We're all guns are blazing for that. Let me tell you, I'm an old-fashioned investment banker, and it's always important to have all options on the table. I think the door needs to be always open for those conversations. It's becoming more and more relevant in the diagnostic and theranostic space that the amount of money Novartis is currently spending in this space means this is an exciting area to be in.
There is probably only one relevant pharma company in the space at this point in time, which means others have to follow on. We saw what we thought was quite a ridiculous transaction when BMS took RayzeBio that showed the desperation just over a year, a year and a half ago. That, obviously, with the changing dynamic that happened in the U.S., sort of shut off for a period of time. That does not mean radiopharma is not a hot space today. It does not mean that these big pharmas do not want to get into the space. They certainly do. We have even seen Eli Lilly put a toe in the water in the space with the acquisition of POINT, and those assets did not progress anywhere. Now they are heading down the road of Bombesin, which is quite interesting as an early asset. We think it is exciting.
We think it's exciting to keep those doors open. We think it's exciting at the end of the day for Clarity to be the largest takeout. The largest takeout of a pre-revenue company in Australia was Viralytics, which Robert Vickery was part of, the CFO of, and he's doing Viralytics 2.0 right now. That was AUD 500,000,000. Our capitalization is what, AUD 1.3-1.4, depending on the day, AUD 1.5 billion as a pre-revenue company. If we can maximize value for shareholders in the opportunity of a takeout as opposed to building our company and commercializing, then obviously, we would talk to all of our shareholders and see whether that was the right thing for us to do.
I'm excited to see where radiopharma is right now, and I think there's great opportunities, whether it's that way to progress or just take the product to market and generate the best part of $5 billion just in the U.S. alone for a diagnostic with good margins. That's hard to say no to these days, isn't it? Okay. Any more questions there? No? We might get down to the actual business of the meeting, if that's okay with everybody. Okay. As mentioned, voting on each resolution, it's the important part here, will be conducted by a poll. I now declare the poll open. As Chair of the meeting and as detailed in the notice of meeting, I will vote. We're authorized all undirected proxies in favor of each resolution. I've just done that as I sat down earlier.
You can cast your vote by filling out a yellow paper voting card. You will have received an attendance card when you registered here. Now, this is a little boring, and I apologize for that, but it's procedural. If you have a yellow voting card, you are a voting shareholder, proxy holder, or corporate representative and have chosen to vote using a paper voting card, you're also entitled to speak at this meeting. If you have a blue card, you are a non-voting shareholder. While you're entitled to ask questions and make comments, you are not entitled to vote at this meeting. If you have a red card, you are a visitor and are not entitled to speak or vote at this meeting. That's a bit harsh, isn't it? As I said, anyone can speak. I'm not holding that off.
If you have any questions, please see a MUFG Corporate Markets team member who are here in the room at the registration desk, actually just outside most of them, but some of them in. If anyone with a yellow or blue card wishes to speak, please raise your hand at any time. I reserve the right as Chair to rule questions as not pertaining to the AGM or out of order. Votes will be counted by Link after the meeting closes. The results, obviously, will be posted and announced as soon as possible after this meeting. We'll now move to the formal items of business for this meeting. The first item is to receive and consider the financial report, the Director's report, and independent auditor's report of the company for the last financial year. All shareholders can view these in the company's annual report on the company's website.
They're also outside, I saw earlier, if you need one. Shareholders are not required to vote on this item, obviously, but we do have Louise here, as mentioned before, our auditor. Grant Thornton is available to take any questions in relation to financial report or director's report or independent auditor's report. Are there any questions on that at this time? All good. Okay. The next is the adoption of the company's remuneration report forming part of the company's annual report for the financial year last year ending 30 June 2025. Being is hereby approved for the purposes of Section 250(2) of the Corporations Act 2001 and for all other purposes. Information on this resolution is set out in the explanatory memorandum in the NOM. If you have any questions for the board, please submit them now.
If you haven't already done so, please note that this resolution is advisory only and does not bind directors of the company. If there's any questions at this point in time, I know there was a question earlier on that. All fine. Okay. The proxy votes received in relation to this resolution are now shown on the presentation slides on your screen. If you are registered and wish to vote today, please select for, against, or abstain for that. We'll now move to the next item of business. The second item of business in the notice of meeting is to consider the re-election of Dr. Chris Roberts as Director of the company. Information on this resolution is set out in the explanatory memorandum in the NOM. The resolution requires a simple majority of votes cast by shareholders present and entitled to vote on the resolution.
This is a spot where I get to say some things about Chris. Obviously, Chris, if you don't know Chris, he's probably one of the, or if not the, most outstanding person in the life sciences space. Spent a lot of time on ResMed's board. If you don't know ResMed, then I don't know why you're investing in Clarity because you probably don't know Australian biotech or devices. He was also the CEO of Cochlear for many, many, many, many years and certainly a fantastic asset to us on this board. We had a little bit of an interesting discussion with one of four proxy advisors who said to vote against Chris, retaining his position on the board because he, like you, dug in his pocket and grabbed some money and bought some shares in the company.
For a period of time, that was a little bit over 5% of the company and now is not. They decided that it's best that Chris isn't on the board. I strongly disagree with that. That has resulted in, obviously, some people voting against a small cohort of those players. Hopefully, they can find me a plan B if that goes ahead. Obviously, I'm strongly in favor of this. We do not always see eye to eye, and that's the basis of having a board. I've never met, certainly, a fantastic person on our board. Are there any questions in relation to this item? Is that a question?
No, we're good. Okay. Okay. The proxy rates are up there now. Resolutions are now shown on the presentation. If you are registered and wish to vote, you know the deal. Okay. The next is re-election of Thomas Randahl. Is to consider re-election of Thomas as a director of the company. Information on this resolution is set out in the explanatory memorandum in the NOM. The resolution requires a simple majority of votes cast by shareholders present and entitled to vote on the resolution. We've known Thomas now for a few years. He was part of Algeta. He was the CEO of Algeta from the beginning and was obviously through the takeout of that by Bayer. He's worked very closely with Colin and Seamus and some others of the group. He's got very unique insight into the radiopharma space, and he's a terrific person.
Any questions on that from anybody? All good. Okay. He owns a little less shares, so did not come across as an issue for the proxy advisors, which is good. The proxy votes are now shown on the presentation slides on your screen. If you are registered and wish to vote today, please select for, against, or abstain. The next is the ratification of prior placement of shares. The fourth item of the business of the meeting is to consider the ratification of the prior issue under a private placement to institutional investors. Information on this resolution is set out in the explanatory memorandum in the NOM. The resolution requires a simple majority of shareholders. This resolution is subject to certain voting exclusions, which are set out in the notice of meeting. We are a pre-revenue company.
Being able to transact quickly and efficiently gives us options and puts us in a very strategic position to execute, obviously, capital raisings in a small amount of time. I think we executed the last capital raising in a couple of hours on a Friday morning, and we're able to raise AUD 203 million. It's a refreshing of that 15%. We're not raising money today. We're not raising money tomorrow. I must say the Monday of that week, Monday morning of that week, I didn't know we were raising AUD 200 million that week either. This gives us an opportunity to execute quickly and efficiently if it's in the benefit of, obviously, all of us as shareholders. Are there any questions in relation to this item?
Where does the AUD 4.20 capital on the basis of the last major raise? How do you answer for management to determine the purposes of this resolution?
This was actually this is the last placement. So we're looking to yeah, that's all. It's not about the next capital raise. Obviously, we like accretive share prices for our capital raisers. This is just in relation to the voting of this to free up that 15% again. That's all. Okay. The proxy relation to this resolution are now shown on the presentation slides. If you're registered, obviously, you can vote. The remaining items of business, actually, I'm conflicted here related to the executive directors, obviously. I'm going to ask Rosanne, who heads up our Nomination and Remuneration Committee, to take this from here.
Read the slide.
Yeah.
Thanks, Alan. Okay. Resolution number five is the issue of options to Dr. Alan Taylor, our Executive Chair. The fifth item of business in the notice of meeting is to consider the issue of options to Dr. Taylor. Information on this resolution is set out in the explanatory memorandum in the NOM. The resolution requires a simple majority of votes cast by shareholders present and entitled to vote on the resolution. This resolution is subject to certain voting exclusions, which were set out in the notice of meeting. Are there any questions received in relation to this item of business?
Oops. Proxy votes received in relation to this resolution are now shown on the presentation slides on your screen. If you are registered and wish to vote today, please select for, against, or abstain next to resolution number five on your voting card. We now move on to resolution number six, which is the issue of options for Ms. Michelle Parker, our Chief Executive Officer and Managing Director. The information on this resolution is set out in the explanatory memorandum of the NOM. The resolution requires a simple majority of votes cast by shareholders present and entitled to vote on the resolution. This resolution is subject to certain voting exclusions, which are also set out in the NOM. Are there any questions in relation to this item of business?
The proxy votes received in relation to this resolution are now shown on the presentation slides on your screen. If you are registered and wish to vote today, please select for, against, or abstain next to resolution number six on your voting card. Resolution number seven, our seventh item of business, is in relation to the issue of options for Dr. Colin Biggin, Chief Operating Officer. Information on this resolution is set out in the explanatory memorandum in the NOM. The resolution requires a simple majority of votes cast by shareholders present and entitled to vote on the resolution. This resolution is subject to certain voting exclusions, which were also set out in the NOM. Are there any questions received for this item of business? Yes.
Yes. How was the exercise price determined?
It was the five-day VWAP prior to the awarding of the options for the new financial year.
A premium to that five-day VWAP at the end of the financial year. They're always issued at a premium.
On the 1st of July, then is it a market price or?
Yes.
Yeah.
Yep.
Discuss it. We have a broad-based CSOP, so it's important for all of our team because all options get issued as a one-July price. It's a five-day VWAP, and it's always a premium to the five-day VWAP. There are no tax consequences and those sorts of things. It's just that the price moves sometimes up or sometimes down from one-July. Last year, we've got the issue that they were priced a lot higher, and the share price moved down from one-July. This year, we've got, obviously, a little bit of a benefit that it went up slightly.
When you say the premium to the five-day.
Yeah. The exercise price is above the VWAP of the time. I think the number's usually 20% premium to the VWAP volume weighted. So they're always issued out of the money.
Yeah. Okay.
Yep. I tell you, the reason why we do it one-July, our team then sometimes get the benefit from tax selling from shareholders that do not care about our stock. They get a little bit of a better deal because these are the people actually running the company, actually managing the company.
Just also to add to that, that the options are subject to certain performance criteria. Okay. Proxy votes received in relation to this resolution are now shown on the presentation slides on your screen. If you are registered and wish to vote today, please select for, against, or abstain next to resolution number seven on your paper voting card. I now invite Alan back to resume the proceedings.
Okay. We have dealt with all items of business in the notice of meeting. Before I close, obviously, people have made the effort to come. This is the last chance to ask questions in this forum. Is there any outstanding questions from anybody? It might be good if you have a mic because there are shareholders that are online.
Why did we?
It's not on.
It sounds like it's not on, but it is.
Oh, yeah. Here we go.
Why did we have an income tax expense this year when you've got unused income tax losses?
Let's get someone who loves tax, and that's I'm only a simple scientist, so.
Just in brief, because we have an entity in the U.S. that lets us hire staff there, and we're paying their expenses plus a premium, they have a tax expense in the U.S.. That tax expense was fully related to the revenue of the U.S. company. The money that we're, the income that they earn from us paying them to manage our operations over there. Does that answer your question?
Did that answer your question?
Okay. I like your eye for detail, though. That's excellent. Okay. Okay. We're going to be outside as well. Have a think about that. David's here as well. We've got our CFO, Aila, as part of our finance team just answered. We can do that. Are you comfortable with that?
Yeah.
Sorry, one last question. I'm fine. I'm probably okay without the mic.
Oh, no.
Ask for the paper.
Thank you. Thanks, Alan. Michelle made reference to the head-to-head trials and the primary endpoint results that came out and an upcoming international conference. Do we have a date on that international conference at all? Not at this time, no.
It'll come out in due course once, obviously, it's been accepted.
Okay. All right.
The process of any sort of scientific conference is that data's prepared, lodged as an abstract. It's either accepted or rejected, and then we know which conference that is. At this point in time, we're expecting it to be early next year. I know there's been a debate about ASCO GU. It's unlikely to be ASCO GU, but something probably around about that, around about that first quarter timing.
Europe? U.S.?
That's a good question. I don't know at this point in time. Yeah. Let's not rule out Europe because there's a couple of big conferences there as well.
Alan, congratulations and other that's terrific results and great prospects. You're getting so much closer to commerciality. Just wondered, anything happening in terms of patient cost recovery? I'm using the wrong terms. In the U.S., under all these changes that Kennedy is introducing with NIH and other social welfare type things?
We're in a little bit of a unique space in this radiopharm area of diagnostics. The price is far greater for a diagnostic scan with a product like ours. When we're looking at that, we're looking at $4,000, $5,000, $6,000, which makes that market massive. If any people listen to Dr. Oliver Sartor as part of the Canaccord who are here today, Canaccord interview with Maddie, who's a fantastic analyst at Canaccord. Oliver stated, "There's a million men today suffering from biochemical recurrence, and about 600,000 of them will fail standard of care today." That's a massive market opportunity when you consider $5,000 a dose. We don't see any problems with that pricing at this point in time. We've seen some competition in the fluorinated space because they make the same products on the same cyclotrons and go to the same patients.
We don't view our product as an opportunity to go in at a discounted price and to take the market. We spent a lot of time producing a superior product. We're showing that now in multiple clinical trials. We're running the phase III clinical trials. Our goal is not a discounting model. It's a premium model and to sell our product at a premium. We've had the calling. We've had men wanting to travel from the U.S. to Australia to get imaged. That is every week. We've got men calling out trying to get access to our products. Best opportunity, obviously, these clinical trials at this time. We've provided our product under special access and EAP on a few occasions. Finding people's lesions, we find, is the most important thing for a cancer diagnostic. These cancer diagnostics fail more than half the time. That's our market.
Is it a tax question?
No. The operations in the U.S., are they 100% subsidiary company, standalone subsidiary company?
Yes, it is. Yeah.
Okay. That might answer the tax question.
Okay. Okay. As I said, our finance team are going to be here afterwards if you want to ask further details. On that note, the polls will be closed once this meeting ends. MUFG Corporate Markets as returning officer will count the votes from the poll. The results of this meeting will be reported as soon as possible, as I mentioned before, and will also be displayed on our website. On behalf of the board and obviously our management, thank you to everyone who attended, all the shareholders that made an effort to be here today, and all those listening in, and declare the meeting closed. Thank you. Thanks very much.