Clarity Pharmaceuticals Ltd (ASX:CU6)
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Apr 28, 2026, 4:10 PM AEST
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AGM 2024

Nov 19, 2024

Alan Taylor
Executive Chair, Clarity Pharmaceuticals

Hi. Welcome, everybody. Before we get started, great to see. What a room, look at this. What's going on? Must have been a good year. It's fantastic to see so many people here in the room. Obviously, there'll be quite a few people online as well listening to my voice. For those, I'm wearing a suit today, just so everyone knows who I am up here as well.

Not usually my usual black t-shirt, as you know. Now, we've got the Clarity ones that look very official in my black t-shirt. But let's get this show on the road, shall we? Welcome to our annual general meeting. We're obviously of Clarity Pharmaceuticals. We're holding this as a physical meeting only. We have provided guest access to the web platform of our share register.

Link Market Services Limited attendees on that line will be able to hear proceedings but cannot participate in the business of the meeting, so hopefully, they had the opportunity, obviously, to vote earlier. Before we begin with formalities, I would like to acknowledge the Gadigal People of the Eora Nation as the traditional custodians of this country, certainly this and the land we're on.

It actually says it right here as well on this desk, and the reason for that is, obviously, Clarity is born and bred in Redfern, this Redfern precinct, which we are today, as a proud member of our community as well, which has a long history and strong cultural ties to our Indigenous brothers and sisters, and is a flourishing, obviously, urban center for our Indigenous community, and we're, as I said, a very—we love being part of this community.

I've been part of it for all of my life. But some introductions. I'd like to introduce, obviously, our board. Chris Roberts is there. Colin Biggin as an executive director. We've got Rosanne Robinson. And we've got Michelle Parker. We have an absentee, Thomas Ramdahl. It's a ridiculous time in the morning for him. But he did make an earlier meeting today, just so people know.

But he's obviously dialing in from Norway. Obviously, Thomas is from that previous very famous radiopharmaceutical company, Algeta, which Colin was as well, and a few other of our team. So I just want to make an apology. Some of you may know Robert Vickery. He's our company secretary. He's unfortunately had a death in the family late last week and can't make it today. And he sends his apologies. I'd also like to introduce, though, David Green, our CFO, who's here.

Louise Worsley, who's been our auditor, actually from the beginning, and then rested, and then back again, had a long-term association with us. I have to work through some formalities. I apologize for this. It's less exciting than the real story. But notice of the meeting was duly given, and the meeting has been properly convened. Please note that only shareholders, proxy holders, or shareholder corporate representatives may vote at today's meeting.

Only shareholders that have registered on site at the meeting as a shareholder and proxy holders may ask questions during the meeting. Now, this is something we bend the rules around. If someone's made the effort to come here, I know there's a couple of people who aren't shareholders who just love coming to our AGMs. If you'd like to ask a question, I'm not going to stop you. Okay? We're open to questions.

We're one of those companies that we love transparent dialogue, clearly. There were no shareholder questions received prior to the cutoff time prescribed in the notice of meeting. I would appreciate if all mobile phones could be turned on silent. That's okay. And recording devices and cameras must not be used during the meeting. I note there is a quorum present, and I declare the meeting open.

So the agenda today, we like, as I said, we're going to obviously have plenty of opportunity for you to ask questions during today's meeting. I'm sure there's plenty, given the year we've had. But the agenda today, obviously, I'm going to say some words. You know that. I'm going to give the chairperson's address. Obviously, an executive in this organization has been here for a while, so I'll be sharing my views.

Our CEO, Mish, will be coming up and sharing our clinical program. We'll try not to go into too much. I'll try and talk less and Mish present less because we provide, as you know, lots of information. All the time, I'm forever giving podcasts at this point in time, explaining where we are, our clinical trials, and where we were. I did two in front of the camera yesterday.

People saw those at, obviously, Bell Potter, and I was on Ausbiz yesterday morning, talking about that anti-vaxxer in the U.S. for a brief while. But we can comment on that probably later, and then we'll have questions prior to voting, formal business, which includes the resolutions of the meeting, which is a little bit laborious. I apologize, but I'm sure we'll get through it.

In accordance with the company's constitution and as set out in the notice of meeting, we have determined that voting on each of the resolutions will be conducted by a poll rather than a show of hands. We adopted these procedures to ensure that the views of as many shareholders as possible are represented at the meeting. Following my address and our CEO's address, general business questions will be taken, so let me begin.

Obviously, Clarity, and this is sort of the official we provided this morning. I'm going to ad lib a little bit so it's not so laborious as well, and hopefully, people have had an opportunity to read before, if not after, and continue to ask questions, but good morning, everyone. Welcome to our fourth annual general meeting as an ASX-listed company. Yes, it's only been four years. It's been certainly an exciting period of time.

We obviously, the last year itself, going through what was obviously what was considered the nuclear winter of biotech, we find ourselves now in a very good position in where we sit. Now, given our origins and certainly where we are in Redfern, but also where we are listed in Australia, we're excited to now become the largest ASX-listed pharmaceutical biotechnology company by capitalization, built purely from the benchtop of great Australian science.

Now, when I've been saying this recently, I've been getting feedback that there's this company called CSL. Some of you may have heard of it. It's a big pharma company, well-intended pharma. And CSL is a wonderful Australian biotech company. There's no doubting that.

But if people know its history, its origins, it actually was started up as a government entity to provide blood products for the first 70 years of its existence, and then obviously spun out and listed on the ASX in the 1990s. Very different model than the one we're suggesting here, which is the translation of Australian science from the benchtop, which is where Clarity is. It started off with a couple of provisional patents and now where we are today.

I think everyone should be proud of that situation: our team, our shareholders who have supported us for a long time, our board, everyone involved in that. Our formula for achieving this goal has been relatively simple, reinforced obviously by a hard work ethic. It's been particularly difficult this year.

It looks good as a share price, but understanding the amount of work that goes into something like this and dedication of what is still a relatively small team, but really, what's driven it is an unwavering focus on delivering great science, which I am personally really, really proud of as a company, and what really has clearly differentiated us from our peers in the radiopharmaceutical field, the SAR technology that underpins that targeted copper theranostic platform was invented and developed in Australia, firstly at ANU by a gentleman called Professor Alan Sargeson some 70 years ago, but then obviously got in the hands of Professor Paul Donnelly, who we're very close to, and tomorrow night, just for interest, we're heading to University of Melbourne to celebrate what has been an outstanding translational story, and obviously, we continue to work closely with Paul and his group.

And there'll be a nice video coming out as part of that at the end of the week, which we'll put on LinkedIn. People can have a look. The relationship continues to lead to the development of many existing products, including our lead product, SAR-bisPSMA, which has really been a driver this year, as you know. And it's been done clearly at the benchtop and not that long ago.

And this product obviously overcomes the shortfalls of the current generation of PSMA targeting products. And I know that annoys some Australian companies and overseas companies when we say that. So this incredible collaboration and our science-centric approach have led to some incredible outcomes for patients in recent times. Our work is not done. It's not done by any means at this point in time, but we're ready.

The focus on science leaves us in a very unique position, having developed our products from scratch and with a deep understanding of the products of our competitors because we've gone head-to-head in our clinical trials. We have an absolute insight into how our products perform. And nothing states this more than our announcement this week regarding our work, obviously, with Louise Emmett at St. Vincent's Hospital.

Even though our stock price fell 15% for some reason, and we'll get to the bottom of that, we're excited because we want to go head-to-head with these products. And Louise is a fantastic KOL, globally renowned, and part of the cohort of other people on our scientific advisory board, including all of the SARTATE and the like. We're very proud to work there. I'm out of that precinct.

If people don't know, I did my PhD at the Garvan Institute across the road, so very proud to be going back and supporting her and her work. She's already worked on a few trials, so this will be led by Professor Louise Emmett herself, and she'll be evaluating the performance of our product, Copper-64 SAR-bisPSMA, in comparison to the standard of care Gallium-68 PSMA-11 product for the detection of prostate cancer recurrence.

Professor Emmett has been a member of Clarity's scientific advisory board since 2022. At the time, we were the only board she joined, by the way. She did due diligence for pretty close to a year. I kept asking and asking, and eventually she said yes and is deeply embedded in Australia's multidisciplinary clinical development and cancer research efforts, and we look forward to continuing to work with her.

We've worked with her non-stop at the moment. She's been part of a lot of our clinical trials to date. She understands that product very, very well, particularly how it compares to Gallium-68 PSMA-11 and her role in PROPELLER. So importantly, though, this provides access to what we consider to be a best-in-class diagnostic to more men suffering from prostate cancer in Australia, and particularly in our own city of Sydney.

With the R&D, and this has been a bit of an issue of late, I've had emails approaching me and asking me, "Well, you're a Sydney-based company. Why don't you give access to your product to people in Sydney?" So as a Sydney boy through and through, that did touch the heart a little bit. And obviously, this is a first step in doing that and obviously generating fantastic data for our clinical trials.

With the R&D tax incentive and significantly lower costs for clinical trials run in Australia than in the U.S., it is a very low cost for true head-to-head data to clearly differentiate ourselves in what is the largest prostate imaging market currently for PSMA agents and which are failing patients in detecting early disease, which is this BCR market. We receive requests for access to our PSMA products almost daily, and we're deeply saddened when we cannot provide these products to patients in need of better diagnostics.

We hope that through the Cu-PSMA trial, we can meet some of these demands locally and help improve cancer outcomes for patients close to our home. In the meantime, we're swiftly progressing Phase III clinical trials with that product, two of them with Copper-64 SAR-bisPSMA, really to change the paradigm of prostate cancer if you followed that information.

I'm sure everyone in this room reads our announcements and has been following that development. And it really is, this product is extraordinary from first diagnosis to identifying recurrent disease. Our CLARIFY trial is progressing well in patients with confirmed prostate cancer, pre-prostatectomy, pre-therapy. And in October, the U.S. FDA provided positive guidance, obviously in the BCR and the AMPLIFY trial Phase III in patients with biochemical recurrence of prostate cancer.

We plan to commence patient recruitment into AMPLIFY early next year. And we're expecting that one to run fairly quickly, given, as I mentioned before, the high need for patients who start to have rising PSA but undetectable disease. And certainly looking to show in a phase three clinical trial, something similar that we're looking to show here with this CUPSMA, that we can pick up lesions far earlier and far smaller.

As we're aiming here with Louise, hopefully producing some curative outcomes for men, which is something we should be all heading towards. This data was most recently selected. Certainly, the data from our PSMA work is top-rated oral presentation at EANM Congress 2024, one of the most prestigious conferences in nuclear medicine space. We also recently received the U.S. FDA Fast Track designation for the use of our product.

This is despite having products already in the market. And you get this. It was really designed to expedite the development of regulatory review of novel drugs and paves the way for a potentially faster process to bring this product to market. We hope this will allow us to bring our next-generation diagnostic to patients in need of novel imaging options sooner. This, you will see, is a common thing for us.

We'll be looking at other diseases as well that we're progressing and looking for regulatory milestones such as this and others to fast-track our products to market. In our theranostic SECURE trial, does anyone not know the SECURE trial? Hopefully, they do. Everyone in this room should know it, so SAR-bisPSMA, we've seen incredible data, and I'll let Mish touch on some of that, but I've voiced that in many podcasts and the like.

They're all available on our website, but it's been an incredible outcome to date, and in the multidose cohort four that we are hoping to complete early next year before moving into the cohort expansion phase trial, the safety data generated in the trial so far is excellent, particularly when we compare it to some competing products with no dose-limiting toxicities reported to date.

Our oldest patient, we did detail that because we had a fast moving of the actual safety review committee. They just wanted to get on with the trial, and we had that older patient who was 93 years old and had a history of prostate cancer for over a quarter of a century, failing multiple lines of therapy prior to entering the SECURE study.

Even in this patient, the only adverse event he experienced was, as you probably know, moderate nausea after the first dose, and that was after completing two doses of 12 GBq. There was nothing after that, which was fantastic. While the dose escalation phase is focused on evaluating safety of the product, that's correct. This is a dose escalation, single dose, and now we're doing multidose. It's only meant to be safety, but I know everyone's keen on the efficacy side of that.

Preliminary efficacy data at this moment is impressive. We're seeing excellent responses in patients who have been heavily pretreated prior to receiving Copper-67 SAR-bisPSMA, sometimes having battled their cancer for over a quarter of a century, as we discussed here, with little to no options left of treatment in their disease, and it's been certainly one of the treating clinicians there, Dr. Luke Nordquist, has been very vocal even in our announcements about how wonderful that was, particularly for the patient who had a complete response. Importantly, these responses appear to be durable.

We'll show some of that data again today, which we've shown recently in our announcements, with some patients experiencing the maximum effect from the treatment months to years after being administered with Copper-67 SAR-bisPSMA, based on the data from the previous cohorts of the SECURE trial and two case studies, obviously, where people have received multiple doses of the product under the U.S. FDA Expanded Access Program.

It was good. I don't know if anyone listened to the Bell Potter presentation yesterday, but John HESTA asked a great question there. What's the mechanism of that? And there's obviously an immunological effect, which leads to that because the radiation has gone, that continued fall in the size of the lesion, and then the opportunity to redose at later dates. And we'll show some of that data today.

You're across that. Even hearing, you can ask some really good questions in relation to that. Now, actually, we're well into, obviously, this last cohort, the completing cohort four and reporting additional data. All three remaining slots in this cohort have now been allocated with three patients already dosed because you know how fast we move into these clinical trials. There's actually a lineup of patients for that with their initial cycle of 12 GBq already given. This data will inform the next stages of our clinical development program, including cohort expansion of the SECURE trial and a subsequent phase three trial, which we're looking forward to doing.

With our unique bisPSMA agent now progressing in both diagnostic and therapeutic indications, as well as our preclinical program, which we keep a little quiet at this point in time, and that'll start to come out shortly, combining the benefits of this molecule with alpha-emitting isotope of actinium-225, patients throughout the entirety of the prostate cancer journey may benefit from this extraordinary molecule.

All of these individual indications, namely imaging and pre-prostatectomy and BCR patients, as well as therapy, are blockbuster markets individually for the PSMA-targeted products, with an estimated combined market value of approximately $10 billion-$15 billion by 2030. Not a bad target to look at with a product like ours.

Although there is so much excitement around SAR-bisPSMA, Clarity has a pipeline of promising assets in development, both in the clinic with SAR-bisPSMA, SAR-Bombesin, and SARTATE progressing in theranostic and diagnostic trials, as well as in preclinical development. Given our strong patent position, everyone probably knows we're around about 30 patent families.

We started off with two provisionals in the beginning, 11 years ago, proprietary SAR technology, and our dedicated focus on science and collaboration. We continue to generate an infinite number of TCTs we can generate, sorry, an infinite number of TCTs addressing indications with huge unmet need, and we'll continue exploring the possibilities of this approach. I'd like to extend my utmost thanks to our small but extremely driven and dedicated team who are all united.

Obviously, we have a great cause behind our company, this important mission of improving treatment outcomes for children and adults with cancer, and who continue to deliver outstanding results as we progress our pipeline of products from the benchtop to the clinic. We have grown from no employees, yes, I remember that day very well, 11 years ago, to 62 highly educated and committed team members across Australia and the U.S. today.

And we continue to attract the world's best talent. Some of our current team members have been working at the company now for many years, some even for over a decade, all driven by our important mission. Recognizing the importance of our team, we're committed to promoting training and developing all of our team members throughout the year. We've promoted approximately 15 people internally, despite growing as well quite considerably.

One important promotion, obviously, was Mish taking on the role of Chief Executive Officer after growing an exceptional leadership team over the last six years, leading the growth of the largest group within Clarity and the like. Our colleague, obviously, Colin, is now leading the operations, still part of our board, still a very important part of our group and an important part of role within Clarity, obviously, in radiopharmaceuticals, the logistics and supply chain as well.

We've grown our senior executive team, as you would note, to reiterate our focus on two important areas of our business, our clinical development and our people, with the addition of Eva Lengyelova, who's the Executive Vice President of clinical development, writes up all of our protocols and the like, and a very, very important part of our group.

Also Mary Bennett, who's recently joined us, actually earlier this year, has been fantastic, Mary. And she heads People and Culture. As we grew, we realized we had to be a little more focused on our people because they weren't all sitting in a room here together, squashed in a little startup venue here at Redfern.

They're around the world, and Mary's come on and done a terrific job. Dr. Othon Gervasio is obviously our Chief Medical Officer just there. And Matt Harris comes back as the Chief Scientific Officer, which is good. Matt, a lot of you may know, was here in the beginning, and now taken over that role again as Chief Scientific Officer, heavily involved, works very closely with me on looking at all these new product opportunities, which we're kind of excited about.

At the board level, there have been a number of changes as well. Clarity's not an executive director. Rob, obviously, resigned earlier this year after fairly long. I've known Rob for many, many years. Thank you again for your service at Clarity. In line with the announcement dated 16 January, non-executive director, Dr. Chris Roberts, sitting there, has been appointed chair of the audit risk committee and joined the nomination remuneration committee.

Thomas, as I mentioned before, he's joined the audit risk committee as well. Fellow non-executive director, Rosanne Robinson, if people don't know her as well, come up and meet, took the role of lead independent director.

With these changes, Clarity remains on track towards its goal of maintaining gender balance at board and senior executive levels, really to represent our team and also to be in accordance with the 40/40 vision initiative led by Hester and the Australian Council of Superannuation Investors. We grew organically with not a focus on gender.

We just ended up having north of 70% of our team being female who were highly driven. I'll touch on that in a second. The initiative here of this scheme is seeking to achieve greater balance in executive leadership roles across ASX 300 companies. I just want to remind everyone we met that this year.

By 2030, having that implemented, diversity at all levels of our company is highly important to us as we believe that the unique skills and talents of our directors, officers, employees, contractors, consultants are essential for certainly an innovative company like ours. It's important to note that all of the progress and important milestones Clarity has achieved to date were accomplished by a team that is over 70% female, with the substantial majority of our team being incredibly bright and driven women who underpin our success in next-generation radiopharmaceuticals.

We'll continue to ensure this is reflected at all levels of our company, making sure that we have that balance between all parts, including board and senior levels. Clarity has continued to deepen its commitment to ESG practices over the year and will be releasing our next ESG report later this year.

We'll be providing that report to shareholders shortly. From our very humble beginnings, only a little more than a decade ago, from a very small office in this very building, if you remember where we were, jammed up there, we can actually have a site visit if anyone wants to, where we are today in Redfern. Our team and our shareholders have built, as I mentioned before, about the size, but it's the sixth largest. We're the sixth largest biotech or medtech company, so life sciences company listed on the ASX, which, once again, a great achievement, having recently broken into the ASX 300 with a high likelihood of ASX 200 inclusion shortly, if people have been following that.

Given these exciting developments and rapid growth, there is now a high level of corporate governance expected of us as we're growing up and from some shareholders and obviously the proxy advisors who advise a number of our shareholders. While we understand the importance of the government's guidelines, obviously, Clarity remains a relatively small and pre-revenue company despite our size of capitalization by employee size.

We operate in a highly specialized field with unique requirements where retention of talent is paramount. While we strive to comply with all governance recommendations in due course, and some of those are not having an executive chair, just so you know, some of them are not Chris to sell some of his shares to make sure he's not independent to break the 5%. I'm sure you'd react really badly if Chris started selling his shares.

So our view at this point in time is obviously at present, we're going to take the most appropriate way to achieve our common objective is through a pragmatic approach over time. So we'll start looking at that more pragmatically and start looking at our board and those sorts of things, which the proxy advisors focus on quite rightly.

The objective, though, to be frank, we are looking to reach is no small feat as we endeavor to build the most successful biotech ever that was derived purely from the benchtop of Australian science and become the most successful radiopharmaceutical company in the history of our field, supported by a united and experienced team of employees, directors, collaborators in order to together improve treatment outcomes for children and adults with cancer.

And if you think that's out of the way or bullish or the like, you should have seen 11 years ago when I had the same dream. So we're not that far away from that level of success as we stand today with an incredible team. We remain highly confident about our technology products, team, and strategy as we enter Financial Year 2025 with the powerful momentum of exceptional data and the radiopharmaceutical sector being center stage of the massive oncology market, generating multi-billion dollar mergers and acquisitions with over $130 million in receivables.

Clarity is well funded and on track to maximize the value of our company while delivering on our ultimate goal of improving treatment outcomes for children and adults with cancer around the world. We thank our shareholders for our support. I know a lot of you personally, obviously, those are online and those are here.

We're proud, obviously, to grow the company and supporting you and us for their support and look forward to reporting our progress. As you know, we'd like to do that in the updates very transparently all the time as we continue along this exciting phase of our journey. I'm sure you're sick of my voice by now. It's certainly annoying me. So I'm going to ask someone else to come up. I'm going to ask Mish to come up, our CEO, to provide more detail around our clinical and operational progress. Thank you.

Michelle Parker
CEO, Clarity Pharmaceuticals

Thanks, Alan. And hi, everyone. It's great to be here today. Before I kind of launch into the presentation, I might just give a brief overview of my background. Some new faces in the room. Not everyone knows me yet. I started my career over 20 years ago as a Nuclear Medicine Technologist.

Did that for a number of years before moving to Novartis in industry in the world of clinical operations. That opened my eyes to industry, to leadership, to building and growing teams. I was there for 10 years in the Australian business. Left there; the team was about 45 people that I was kind of overseeing and running all the global clinical trials for the Australian affiliate.

Six and a half years ago, I was introduced to Clarity and haven't looked back. Love the story, love what we're doing here, and have had some amazing opportunities along the way. Really grateful to be here today talking to all of you and seeing where we can take this. Clarity has again had a successful year with a number of key highlights seen across the business.

We have remained focused on delivering on our clinical regulatory and operational milestones, progressing our clinical programs, and strengthening operational capabilities as we move through late-phase clinical trials and towards commercialization. I will touch on the specifics throughout this presentation, but at the core of what we do, and as Alan mentioned, we simply cannot achieve these successes without the dedication and perseverance of our team.

The past year has seen the team grow to 62 associates across all functions, both in the U.S. and Australia. And as Alan mentioned, we continue to recognize outstanding performance with promotions and have strengthened the leadership team, welcoming Eva and Mary to the senior executive team, as well as aligning several roles for existing team members. We remain in a strong financial position with a healthy cash balance as we drive our pipeline forward.

We continue to progress our clinical programs across our core products, SAR-bisPSMA, SAR-Bombesin in prostate cancer, and SARTATE in neuroblastoma and neuroendocrine tumors. We saw some trials complete and close out this year, as well as new studies enter our trial pipeline. Just touching briefly on this pipeline slide, which really provides an overview of where we are today with each of our clinical programs and progress to be made over the next 12 months.

All trials continue to advance well, with SAR-bisPSMA being our most advanced product. We are also focused on advancing our discovery program through preclinical development. Here is a snapshot of our busy PSMA program. We have seen some really encouraging preliminary data come out of the SECURE study. Alan touched on some of that in his address.

I'm going to delve into that a little bit more, showing some visuals to perhaps what he was talking to. The SECURE study is advancing through dose escalation. I will come to more details about that shortly. We have ramped up activities for our first Phase III clinical trial, CLARIFY, with recruitment ongoing and also receiving fast-track designation for patients prior to initial definitive therapy. This is certainly one of the highlights of the year.

COBRA, our Phase II diagnostic study in biochemical recurrence of prostate cancer, read out earlier this year with positive results. This formed the basis of our end-of-phase meeting with the FDA to discuss the trial design for our next phase three study, AMPLIFY, in this indication.

We are supporting an investigator-initiated study led by Professor Louise Emmett, who is looking at our product, apologies, at how Copper-64 SAR-bisPSMA compares to standard of care Gallium-68 PSMA-11. So in terms of market potential for SAR-bisPSMA, this continues to grow with the recent CMS reimbursement changes in the U.S .favoring the long-term potential of the best-in-class PSMA agent.

On the therapy side, market potential will continue to grow as we move into earlier lines of therapy and Pluvicto reach blockbuster status this year in the post-chemo setting. So SECURE. I think Alan said everyone in the room knows SECURE. So I'm not going to actually go over the trial design as planned because I'm sure you all know about that. So I'll just kind of touch on the key highlights for this year.

We completed cohort three this past year. We are progressing the final three patients in cohort four, where we're assessing multiple doses at 12 GBq per dose. No dose-limiting toxicities have been observed in the trial to date. We are seeing strong PSA declines. With the first three participants all seeing a reduction in PSA levels, the largest being 98% to date. At the completion of this cohort, we will be looking to move to the cohort expansion study pending safety evaluation from the Safety Review Committee.

So just to touch on that a little bit more and more of the data, focusing on the PSA reductions in the single-dose cohorts of the patients treated with a single dose of copper-67 SAR-bisPSMA in cohorts two and three, almost 80% saw a reduction in PSA of greater than 35%, while in almost half of the patients, a reduction of greater than 80% was seen.

This actually prompted some clinicians to request additional doses for their patients under the U.S. Expanded Access Program. And I'll discuss these a little later. So the information on this slide is preliminary data from cohort four. If we look at the images on the left and the regions highlighted in red, they outline areas of extensive lymph node disease in the chest and abdomen, both before and after therapy, following two cycles of the copper-67 SAR-bisPSMA.

Visually, you can see a reduction in tumor burden. And when we did some preliminary analysis on this, we showed a 61% reduction in tumor volume. The patient has also seen their PSA reduced by almost 98% and a radiographic partial response per RECIST assessment criteria. We're looking forward to seeing more data. I think this is really remarkable and more data to come out of this cohort very soon, hopefully. In terms of safety, to quote Alan, excellent safety profile that we've seen.

To summarize this slide, cohorts one to three saw most adverse events reported as low-grade, and only three of the 15 patients enrolled in these cohorts developing grade three adverse events. No adverse events were related to Copper 64, and no grade four or grade five adverse events were reported.

Cohort four is also looking similar at the last update, with almost all events mild or moderate, and the majority of these either resolved or improving at the last assessment, so over the next couple of slides, I just wanted to show some more of the data coming out of the two patients that received their first therapy cycle on SECURE and additional therapy cycles under the Expanded Access Program, following requests from their treating clinicians.

This patient on the screen was enrolled in cohort one, our lowest dose level at 4 GBq , and the starting point for our dose escalation. They had multiple metastases in the bone, and these are kind of pointed to by the blue arrows on the screen there, and as you can see, a reduction in uptake of the Copper-64 SAR-bisPSMA following the four cycles of therapy.

That's the image on the right following the four cycles. Around 14 months after the fourth dose, there were new bone lesions that appeared on the imaging. These are the red circles you can see on the screen. This, coupled with rising PSA, led to the administration of a fifth therapy cycle at a dose of 8 GBq . The last update, the patient's PSA is falling, and it's now been over two years since the patient first received Copper-67 SAR-bisPSMA. I'm pretty excited by that. As with this, which is this image here was one of the images that got me all teared up when I first saw this. This update here is showing a durable complete response in a patient who last year received two therapy cycles of 8 GBq .

The patient had a complete anatomical response per RECIST on CT scan, a complete molecular response on PET imaging, which is the images you're seeing here, and a complete biochemical response with undetectable PSA. It has been 17 months since the patient first received therapy as part of the SECURE trial and 13 months with undetectable PSA.

So this is just a snapshot. I hope this data shared really brings as much enthusiasm for you as it does us and shows you the potential to offer patients improved treatment options. These two case reports, along with the SECURE data, will help inform potential next studies and as we look to start planning our phase 3. So moving on to the diagnostic with Copper-64 SAR-bisPSMA.

Huge achievement for Clarity this year was the FDA granting us Fast Track Designation for patients in prostate cancer who were candidates for initial definitive therapy. A big win for us as promising results seen to date were assessed by the FDA and considered this product to be addressing a serious condition with significant unmet need and shows an advantage over other available therapies.

Fast Track Designation is designed to expedite the development and review of novel drugs, which can lead to faster product review. We commenced our first registrational Phase III study, CLARIFY, this past year in high-risk prostate cancer patients scheduled to undergo radical prostatectomy and pelvic lymph node dissection. We are looking at both same-day and next-day imaging in this study, and recruitment is ongoing and looking to complete this study as quickly as possible.

Shifting to our second indication, earlier this year, we released positive results of our COBRA trial, confirming 64Cu-SAR-bisPSMA is safe and effective in detecting prostate cancer lesions in patients with biochemical recurrence. A few key takeaways from this 50-patient study looking at both same-day and next-day imaging. The study detected 82% more lesions on next-day imaging compared to same-day imaging.

If we look at the images here on the left, we can see a high number of lesions in the area surrounded by the red dashes in the next-day imaging. What we also found is 34% more patients had a positive scan on next-day imaging. The images on the right show a clear pelvic lymph node detected on next-day imaging. This is the image on the far right that was not seen by the standard of care Pylarify scan and first-day imaging.

One other extremely important result for this study is that approximately 50% of clinicians said that they would change their treatment based on our scan with Copper-64 SAR-bisPSMA. This really is truly remarkable and has the potential to have a real impact on improving patient care, so this is a busy slide. I'm not going to go into it too much, but just really simply wanted to say that what we saw was an 80% increase in uptake in our product in lesions on next-day imaging, and in addition to this, lesion contrast increased by almost five times on next-day imaging. These characteristics all contribute to improved detection of lesions and better patient outcomes, setting us ahead of the rest with this product.

The results of this study form part of the package submitted to the FDA to support the end-of-phase meeting informing our next phase three study design in this indication, which is the AMPLIFY study. Preparation is well underway. We're not slowing down, and we're really excited to bring this trial to patients in the new year. Moving on to Bombesin, which is also focused in prostate cancer. Our COMBAT theranostic study in metastatic castrate-resistant prostate cancer, who are ineligible for Pluvicto, is also in a dose escalation cohort expansion study design similar to SECURE.

This study is progressing through the dose escalation phase across five sites in the U.S., and we presented this study at two conferences earlier this year, ASCO GU and SNMMI. All patients have now completed the follow-up period for the SABRE study.

This is our imaging study using Copper-64 SAR-Bombesin in patients with biochemical recurrence of prostate cancer who were PSMA negative. Data review and analysis is ongoing, and the initial data readout is anticipated for quarter one next year, and the third trial in our Bombesin program is BOP, which was an investigator-initiated study conducted by Professor Louise Emmett.

This study completed and was recently published in the Journal of Nuclear Medicine. SARTATE, so just a quick update on SARTATE. CL04 is our dose escalation cohort expansion theranostic trial in high-risk neuroblastoma. Continues to progress through the dose escalation with cohort four recently completing. Our diagnostic program in neuroendocrine tumors is also wrapping up as final patients completing the follow-up period. We will then commence the data analysis and initial data readout expected around the middle of next year.

Key focus area for Clarity has been expanding the manufacturing and supply chain footprint as we move to late-phase clinical trials and beyond. Our clinical supply agreement with NorthStar for the production of Copper-67 SAR-bisPSMA builds on the existing supply agreement we have for Copper-67. This agreement uniquely provides large-scale manufacturing of both therapeutic isotope and finished product under one roof and ready for shipment to clinical sites.

The integrated approach for manufacturing offers significant logistical, manufacturing, and environmental advantages. We also signed an agreement with TerraPower earlier in the year for the supply of actinium, which means we're well positioned to develop and advance our new target alpha particle therapy program. The recent announcements with SpectronRx and Nucleus RadioPharma further strengthen our capabilities to supply product for SAR-bisPSMA clinical programs.

The slide I will finish on is Clarity's management team, each bringing diversity in thinking and experience across all functions and leading the team to continued successes and prepare for more exciting times ahead. Thank you.

Alan Taylor
Executive Chair, Clarity Pharmaceuticals

Okay, this is when we get to rest and you get to speak. I'm guessing there's a lot of questions out there. We do have, obviously, an official part of this process of obviously voting on all the different resolutions and the like, but there's a lot of people turned up today. So let's get the mics out to some questions. Who's first? Really? Come on. You've made the, oh, there we go. Philip. Adam, Philip. There we go.

Thanks, Phillip Ajji. Is it too early to form a view about the dosage design that you're going to go forward with, either a larger single initial dose or multiple lower doses, or is it still too early to form a view about where that's headed?

The data's been great. You've seen the data. The important things that we've seen, and I think 12 GBq are safe, so we're looking at going at that at this point in time unless we see something coming out of the multi-dose. The key question, and we've raised it a few times, all of this data, all of the views of our KOLs are that adaptive dosing is far better for the patient than having one dose after the other, as you can imagine.

Now, we had the complete response in that patient. Dosing that patient with more radiation will have no additional therapeutic benefit, as you can see, because there's no tumor there, but it'll drive side effects. So instead of giving another four doses, an adaptive regime would be, "Let's go on a treatment holiday.

Let's wait for a period of time, and let's treat when PSA starts to go out." Now, we've got evidence already with our 4 GBq patients where we recently gave 8 GBq, and we're looking to get the updated PSA data on there, but you've already got nearly a 50% drop with a single dose. Adaptive dosing makes so much sense.

The OS, I can say with absolute confidence, OS overall survival in these patients will increase significantly having adaptive dosing. It just makes so much sense. That's the only part that at the moment we're obviously forming an opinion based on data, as you know how we work at Clarity, generate the data first, but it's all pointing towards adaptive dosing as opposed to all the other dosing schedules that you're talking about. Adam, come on.

Adam Beasley
Investor, Smarter Capital

Michelle. For the back of the room to hear. Adam Beasley from Sparta Capital. Alan, thank you very much for your presentation. Michelle, nice to have heard you speak for the first time. I love the use of the word enthusiasm, and there is a lot to be enthusiastic about, so that resonated strongly with me. Could you maybe just give us a little bit more detail around this head-to-head trial that Louise Emmett's going to be conducting at St. Vincent's? It's very exciting, up against the standard of care. Can you just talk us through a little bit more around the clinical trial and enrollment and when we should see some data on that?

Alan Taylor
Executive Chair, Clarity Pharmaceuticals

Yeah, that's a good one because the enthusiasm on that is very high because for several reasons. We've already done some head-to-head data. Propeller was head-to-head with that same product, Gallium-68 PSMA-11. And you saw the data on same-day imaging. That was same-day imaging comparison, and we're picking up lesions outside of the prostate, which is very important in a pre-prostatectomy setting.

But we're asking a much bigger question now, and we're doing it with Sydney men who suffer from prostate cancer. When you have rising PSA, it's suggestive of disease. As soon as you start to get that, so you have a prostatectomy, your PSA drops to zero or near zero, and you wait, and you get measured all the time. It's the most informed market on prostate cancer because they'll always go back, get their scan because they've already had cancer.

They don't want cancer to come back. As soon as you see that PSA starting to rise, at the moment, there's a sensitivity issue with the current PSMA agents. We've seen in COBRA and PROPELLER how our product competes against Gallium and Fluorine, the fluorinated product as well. And what we want to do is ask a massive question.

Louise is big on massive questions. If we can pick up the lesions much earlier, at two millimeters, instead of waiting until they grow and disperse through the body, we have a really small window of opportunity of potentially having curative outcomes. That is a ma

ssive step. And so we're going to ask that big question. Firstly, are we confident of finding the lesions earlier? Yes, yes, I am. Yes. Are we able then to directly treat?

Yes, we can treat them because you can actually direct it because you have a good image to target. So we're incredibly excited to do that. And it's head-to-head. We know how good the other product is. We've been measuring ourselves against that other product for the last six, seven years. And as I tell people, the reason why we have such confidence, we have absolute vision of the competitors.

We made our product the same as the others in the first instance. And as you've probably heard me say before, ours was as equally as bad as theirs. So we made that better product. And this is what we'll be celebrating tomorrow night with Professor Paul Donnelly, who made the product and compared ourselves preclinically or in cells how we compete against the monomers.

Now to see it working in therapy, sorry, in this sort of in patients, in humans, and to do this in our own backyard of Sydney and to do a 50-patient trial, which we have an issue, yes. Yes, the issue is there's a lineup already. You'll see that recruit very quickly, and you'll see that data roll out next year. That's how fast this will travel.

So everybody knows this is the largest market in this imaging space, and this is where people have repetitive images trying to find their lesions. This is an area that we can disrupt quite significantly with these current agents. We know what we're up against. A tumor will start small before it's large. This is all logical and reasonable, isn't it? So PSA starts to increase. It's small.

We want to find that lesion as early as possible, treat with whatever means we have, potentially it's external beam radiation. At that point in time, that's what we'll be looking at with Louise, and hopefully, in these patients, we may have curative outcomes or at least better treatment at the early stage so we can get longevity of outcome. If we're nipping it in the bud instead of it growing and metastasizing, these patients will live longer.

Adam Beasley
Investor, Smarter Capital

Sorry about my enthusiasm on that. Okay. Thank you.

Roger. Silvers tream, your shareholder. So with that, good news about that comparative study with Professor Emmett. How come the share market went down? The share price went down 15% or 22%.

Alan Taylor
Executive Chair, Clarity Pharmaceuticals

Yeah. Roger. Firstly, nice to meet you. I'm Alan. And what I've realized in this gig, and because I've been in the markets now for some quarter of a century, some things are out of our control. And the things we can control, and you would have seen post the IPO, our share price fell even further than that, and we had no control of what was going on.

You know what was affecting us then? Rising interest rates. Nothing to do with us. We have money in the bank. It's favorable for us having rising interest rates. And what we did was we stuck to our knitting. We delivered the outcomes. Now, where are we? I'm sure a lot of people would have liked to have bought. Some of you probably did at AUD 0.40, AUD 0.50, AUD 0.60. But people tell me they're very smart, and they were selling at that time.

Okay? What was Monday? Were they listening to Robert F. Kennedy Jr.? Is there an anti-vax mentality?

Nothing to do with vaccines, so.

Nothing to do with vaccines.

Yeah. And when we saw it, there were two million shares traded, two and a half million shares traded. And I was working closely with the bankers, and a lot of the bankers informed me, "We don't know what's going on. It's not the Australian shareholders, and it wasn't our U.S. investors, to my knowledge." But I'll get a better understanding of that, Roger, in the coming weeks.

We keep a very close eye on our register, mainly not for this sort of behavior, but to look at CREEP, if you know what CREEP is. Looking at the CREEPs, trying to build positions in our share registry. But we'll get a better understanding of what that's about. But it might be that. There's so many things going on at the moment. Trump, the markets are volatile. We saw the U.S. down on Friday. Why was Clarity specifically hit?

This is a very positive announcement. Who else would do a head-to-head unless you were highly confident, particularly with a clinician that knows your product, who uses Gallium PSMA 11 all the time, so knows both products very well? And who would do that?

Either a madman, and that could be possible, by the way, or people who are very confident in the outcomes of this trial to deliver the meaningful outcomes that we're looking to produce. So I can't explain everything about markets, but let's bounce back a little bit. And we have AUD 130 million in the bank, and maybe it was a buying opportunity.

Eva Lengyelova
EVP of Clinical Development, Clarity Pharmaceuticals

Just going back to Adam's question just before, in terms of the imaging study, how do you think about the standard of truth, given you're picking up small lesions, many more as well? And so is it possible to actually biopsy every single one, or what's the discussion with the FDA being like?

Alan Taylor
Executive Chair, Clarity Pharmaceuticals

So, [uncertain], they're two different things. One is the trial here, which we're actually going to be zapping the lesions and the like. The one in the U.S. is the Phase III clinical trial. Othon, do you want to comment on that? Or Eva? Eva, do you want to come up? Obviously. Maybe just one tick. We'll get a mic.

Eva Lengyelova
EVP of Clinical Development, Clarity Pharmaceuticals

Yeah. So we are definitely expecting to pick up a lot of lesions, especially on the next-day imaging. And it's just not clinically feasible or practical to biopsy every single lesion. And the verification of the lesions in this study, in the registrational study, will happen on a patient level and then a region level. So we will have three specific regions that we will need to verify if they are positive on the COBRA.

And yes, ideally, we would want the clinicians to biopsy the lesion, but they have some discretion as to what lesion to biopsy within those regions that were positive. So hopefully, they will sort of biopsy the ones that are mostly accessible and also meet certain size criteria. Absolutely, it's not possible to biopsy a lesion that is like a millimeter small.

But we have other sort of standard of truth in the bank besides biopsy. So we will look at correlative imaging as well. And the clinician can choose also to treat the patient with focal therapy. And in that case, we would be measuring PSA decline. So if the lesion was irradiated, even if it's very small and the PSA starts to go down, that would mean the patient is true positive. So that's another way how we would validate the lesions.

Alan Taylor
Executive Chair, Clarity Pharmaceuticals

Yeah, and so we'll have direct comparisons, actually, to those other phase three clinical trials that were carried out in similar contexts with a real push, though, for biopsy as many patients as we can.

Ellen van Dam
Chief Scientific Officer, Clarity Pharmaceuticals

Hi, Alan.

Alan Taylor
Executive Chair, Clarity Pharmaceuticals

Hey, Ellen.

Ellen van Dam
Chief Scientific Officer, Clarity Pharmaceuticals

I have some really great data on the Copper- 67, SAR-bisPSMA. You said you were planning for the phase three trial. Do you expect that you have to go head-to-head with Pluvicto in that trial?

Alan Taylor
Executive Chair, Clarity Pharmaceuticals

No, no. We'll go head-to-head with standard of care. We can't rely on Pluvicto's supply, can we really? Imagine being reliant on that.

Ellen van Dam
Chief Scientific Officer, Clarity Pharmaceuticals

What about what the regulators tell you to do, though?

Alan Taylor
Executive Chair, Clarity Pharmaceuticals

Yeah. Well, the regulator won't push a head-to-head trial without. So we won't do a head-to-head with Pluvicto. You know the issues here are actually crossover in these trials is probably the biggest issue. So watching out for crossover. Crossover is your patients jumping onto your drug when it's not working for them in the control group. But we have some clinicians keen for us to go head-to-head.

Some of those might have a lot of experience with Pluvicto, particularly with the phase three clinical trial and then in clinical practice. And they've told us, "Go head-to-head." That wouldn't be a smart move necessarily for us because it'd slow down the trial. But we can't wait. We can't wait, and you're getting measures along the way. Remember the potential for intra-measures of OS, RPFS, and the like, and look what's out there, Alan.

The PSMA-I&T, the POINT Lantheus nonsense when they dose less than expected a better response because they didn't do a phase two clinical trial properly to actually measure the kidney dose. So the phase three trial then was limited, and it failed. And POINT sat there in front of me and said, "This is going to work so much better because you dose less, you get a better response." And I was looking at them going, "No, you don't." And they didn't. It was a stupid thing to do.

And who's paying for it now? Eli Lilly, POINT, and Lantheus. And Novartis are suing them because they're using PSMA-I&T. So it's a fun time. We're not that. We're SAR-bisPSMA. We're a different molecule, different treatment regimen. And we're not doing four microdoses thinking we're going to get a better outcome.

Thank you. Glenn Turner, shareholder.

I know you, Glenn. What are you telling me that for?

Michelle, the two words I picked up on in your address were remarkable and excited. But my question, Alan, is to you to say, in the wider context of the radiopharmaceutical market, perhaps a few words on that and how it's moved in the last 12 months. And then also, the last slide in Michelle's presentation was about other areas, possibly other cancers. Again, if you could link that in with Clarity and with the wider pharmaceutical market.

I thought it was our team. I thought it was our team was the last slide. You're just testing me, Glenn. I'm glad I passed that one. But I'll comment on both of those. Yes, what an amazing market. Everyone's seen it. The last year. We touched on one, POINT getting acquired for $1.4 billion for a generic product, two generic products. That were underdosed.

That lead product was underdosed. It was a poor deal. Lantheus licensed it. This is how desperate people were for assets. Lantheus licensed it for $250 million upfront. And that product is unlikely to make it to market. So fascinating position. But Eli Lilly wanted a footprint. They've got a warehouse. And they've now spent about $2 billion in trying to do something without any products.

Eli Lilly, I'm sure you all know who Eli Lilly is, but by size, they're the biggest pharma company on earth making thin people thinner at this point in time, and it's an incredible position that they're in to build out, and they need to do something. I think that's great.

Novartis are desperate at the moment trying to maintain their position and are doubling down on different positions trying to maintain that radiopharma dominance because everyone knows it's going to be the fastest-growing area over the next decade, then you look at Fusion acquisition by AstraZeneca. A very early stage, I said I&T, the same generic with Actinium asset, was in phase one, was acquired for $2 billion. Incredible, but had a warehouse at that time, so AstraZeneca have a warehouse and no products as they stand today. I think the key ones haven't even moved yet.

We have patent cliffs around the corner. 2028, and Philip, you heard me talk about it last night. Patent cliffs of pharma companies are dramatic over the next few years, and there's no sustainable positions. Big pharma is desperate to do that, and we're seeing it. I'll tell you what's really interesting, and I'll share with you. It's not just the therapy market now. The recent changes to CMS make the diagnostic radiopharma market a blockbuster market for many, many years to come.

Everyone's worried. And obviously, part of the drive we're talking about on Monday with the view that they're trying to reduce pricing in the U.S., which would have had a feedback on all of the pharma companies. CMS changes are sustainability in radiopharma particular to charge $4,000-$5,000 for an imaging agent. That means prostate, a blockbuster area for the future.

It relates to efficacy and intellectual property. What do we have? Efficacy. We're showing that efficacy. We're in phase three clinical trials. We have IP. Just composition of matter on that product's out to about 2038. That's a long time generating lots of income like that. Then we've got Bombesin, and we've got other assets, and we've got this. I'm going to now feed into your next question.

We've got a plethora of opportunities that we're looking at at the moment. Matt's leading that, as you know Matt very well, Glenn. We're working very hard at this point in time with our preclinical team developing these new assets. Now, I'm a little bit coy on which ones they are. We've come out with this PSMA with actinium at this point in time. Do we think actinium is going to be better than Copper 67?

The Copper 67 data is amazing. It's incredibly safe, and we've seen highly effective. Actinium is another beast. We've got some people who are Actinium alpha people, as we've used that before, who have worked with alphas before. Alphas are incredibly difficult to work with when you're trying to put them in a human.

They're fine working with a mouse. The mouse data looks great, and then you just kill the mouse. Humans, you want to live a little longer. The alphas cause all sorts of side effects that we're seeing at the time, particularly with these targeted therapies. We think we're in a really good space for our theranostic paradigm of Copper 64 and 67. But we'll add alphas where required. Now we'll develop in that preclinical three products.

We'll have an alpha strategy, beta strategy, and an imaging strategy, which, as I said, is a blockbuster area. And some of those products will come out shortly. We're filing some abstracts, and we'll release to market some of that data. Any more? No? We're going to hang around anyway at the back, and we've got our team here to catch up with afterwards.

Why don't we get through the formalities quickly, and then we can round this out. So business of the meeting. Procedural matters. As mentioned, voting on each resolution will be conducted by a poll. I now declare the poll open. As chair of the meeting, finally, I can also give mine, which

is good. Okay. 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.

You can cast your vote by filling out a yellow paper voting card. You will have received an attendance card when you registered on arrival. If you have a yellow voting card, you are voting shareholder, proxy holder, or corporate representative and have chosen to vote using a paper voting card. You are also entitled to speak at this meeting.

If you have a blue card, you're 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 entitled to speak at this meeting. That's a bit rude, isn't it? As I said, I'm sorry. Why don't we do this, Ayla? Okay. Sorry. I'm not even doing this properly. Is that okay? Okay.

If you have any questions, please see a Link Market Services team member at the registration desk outside this room. If anyone with a yellow or blue card wishes to speak again with like four red people, okay, please raise your hand. Anyway, reserve the right as chairperson 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 of this poll will be announced as soon as possible after this meeting. Items of business. We'll now move to the formal items of business for this meeting. The first one, financial reports. The first item of business is to receive and consider the financial report, the director's report, and the independent auditor's report of the company for the financial year ended 30 June 2024.

All shareholders can view these in the company's annual report on the company's website. Shareholders are not required to vote on this item. Louise Worsley, if you want to put your hand up, yep, from our auditors, Grant Thornton is available to take any questions in relation to the financial report, director's report, or independent auditor's report. Are there any questions?

Sorry, Louise. I knew you were anticipating some. Okay. Okay. Next one. Okay. We can see who runs this company, see? Told you. Okay. Resolution one, remuneration report. That the adoption of the company's remuneration report forming part of the company's annual report for the financial year ended 30 June 2024 be and is hereby approved for the purposes of section 250R(2) of the Corporations Act 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 the directors of the company. Are there any questions received for this item? All good. There wasn't any. Okay. The proxy votes go again. The proxy votes received in relation to this resolution are now shown on the presentation slides on your screen.

If you're registered and wish that today, please select for or against abstain next to the resolution one on your paper voting card. Next. Yep. Okay. Next one, election of director, Rosanne Robinson, who's been here for a very, very long time now. The second item of business in the notice of meeting is to consider the re-election of Rosanne Robinson as director of the company.

Put your hand up, I guess, Rosanne, so everyone knows who you are. 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. Obviously, Rosanne has been here since the initial ANSTO involvement in the company at the startup point of this company.

Has been a director all the way through that process, all the way through the IPO, and is a very favored member of our team. So any questions in relation to that? No. Okay. The proxy votes received in relation to this resolution are now shown on the presentation slides on your screen. If you're registered and wish to vote today, please select for or against or abstain next to the resolution. Okay. Next is Colin Biggin.

So the third item of business in the notice of meeting is to consider the re-election of Colin Biggin 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 entitled to vote on the resolution. Obviously, Colin and I and the team have been working very close together for a long time now as well.

And Colin's involvement in the company has been very important to us. And obviously, having that transparency, the key here is transparency of the important logistics side with our non-executive directors and the rest of the board. Are there any questions received? Items of business. Am I in the right spot here? Ayla, see, I'm slipping behind. Okay.

So then 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 me. Do I have to keep saying that all the time? But okay. Okay. Next one. Ratification of prior placement of shares. The fourth item of business in the notice of meeting is to consider the ratification of the prior issue of shares 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 votes cast by shareholders present and entitled to vote on the resolution. This resolution is subject to certain voting exclusions, which are set out in the notice of meeting. Clearly, capital is very important for life sciences companies.

I'm guessing everyone is very sensible, obviously, in this and aware of that. Yep. You like to ask questions? Yeah. You did that calculation specifically for the time, and I think it was specifically over. Right? Which was at the time a discount for those prices at the time. What was the thinking behind that? Did you think that we could do it at a premium?

Yeah. Why don't we ask some of the people involved? Michael, do you want to answer that? Why we did a particular pricing? We've got our bankers here. Why don't we ask them? Why don't we put them on the spot? I agree with you. Why don't we do it at such a discount? I'm a shareholder. What's going on? Perhaps we can take it offline. Wilsons want to say something? Yeah, yeah. Good question, by the way. Why? It is a good question.

I think, obviously, it was a significant capital raising for the company, and we wanted to attract not only the volume but the right investors into the deal. And so being able to do that does typically require a discount. But the discount involved was very much a market rate and no greater or lesser than many other transactions of similar scale. I don't want to label it too much.

When I look at all these other capital raisings where they require an underwriter, that kind of argument makes sense. But when there's a two or three or six-time average subscription, and you're not allocating it to specific investors that you think would be good on the register, you're giving it in proportion to their bids, then that kind of response doesn't really address it. In fairness to that, though, we weren't six times oversubscribed. Even if we do. Yeah.

If you remember, so to give some feedback on the situation, because I had a misspent youth as an investment banker, and I just wanted to put them under pressure right now to see how they'd react. You remember our share price actually spiked and came back, and we found ourselves in a little bit of a susceptible position.

I'll give you the run-through of certainly what my thinking was at the time. Because the discount actually on the last prevailing price wasn't that bad. I think it was about 11%-12%, something like that, which was good in the market. There was one recently got away for a 40% discount, I think. What we were doing, there was a lot of things going on at that time, and we were deep into March. If you remember, this year was a weird April.

The entirety of the East Coast had school holidays for the entirety of April. So remember, we had that thing in New South Wales, which was the second half of April. Everybody knows, do not do capital raisings during school holidays because fund managers all have kids. Okay? And I remember that back from my day. And so we actually had to shut off a lot of things going on. We launched that capital raise on the Wednesday.

We would have had in the quarterly readout, we would have been in the 20s millions of dollars. Okay? But we knew. We knew what the market was trying to say and what was happening. But then you have to instigate a capital raise and see what that demand's right. We did it quickly in that context because we had to do it before the break off for Easter.

The implementation that yes, there was a negotiation, but are we looking at the difference might have been AUD 0.05 and you would have lost some shareholders and that sort of prevailing amount because that was certainly in the market demand. When that started to come in and someone cornerstones at a particular amount, then everyone jumps in.

But you need that first group to move or first movers to move in. So the context of a capital raise is that there has to be a first mover, a cornerstone player, as you know, and then you have fast followers. If there's not that cornerstone, then you may not have a deal. That pricing wasn't too bad, and then that fit into not a six times oversubscribed too. It was more in the context of about two to three was the number after the first mover. Does that help?

Yep. Okay. These bankers are hopeless. Why don't I just do the job then?

Ellen van Dam
Chief Scientific Officer, Clarity Pharmaceuticals

Onto the register as well. So that's also helped the stability in the share price since and helped it grow, who have capacity to buy more.

Alan Taylor
Executive Chair, Clarity Pharmaceuticals

Yeah. But I hope shareholders always ask that question of us. People have been here since the beginning. Glenn, it's been front of mind for mine. I am a shareholder. Everyone knows. It'll come up shortly, probably. And it should be front of mind. We should be doing capital raisings that are accretive and drive value within our company. The first capital raising was done at AUD 1, which was a comparative price when I joined of AUD 0.05. Next one was AUD 0.10. Next one was about 20-something cents in comparison to where we are today. But I agree with you.

We should be driving value for all of our shareholders. And pricing and dilution are significant points. As you've seen, that capital raise went okay, and our share price has done all right since. But what becomes the negotiation? And we can probably play around with AUD 0.05 on that, but we weren't going to get it. It wasn't going to be done at a premium. Is that okay? And I'm happy to answer more questions on that if these bankers can't.

But obviously, having this availability of stock, this is what this question is about. Having availability of stock for a company like ours that doesn't generate revenue is incredibly important to have that availability to drive that out. Depending on how markets go and where our share price goes, keeping that important thought.

We're AUD 130 million in the bank at this point in time, but we'll continue to monitor to see how things go because life sciences need lots of money. So thank you for your question. The proxy votes received in relation to this is this? Yes. In relation to this resolution are now shown on the presentation slides on your screen. If you're registered and wish to vote today, please select for or against or abstain next to the resolution four on the paper. Okay. Okay.

The next one, resolution five, approval of issue of securities under the company's equity incentive plan. The fifth item of business in the notice of meeting is to consider the approval of the issue of securities under the company's equity incentive plan. 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 are set out in the notice of meeting. Some words on rationale of ESOP. We've had a broad ESOP since the beginning. If you wonder why people are working around the clock and delivering these miracle outcomes, it's because they feel like they're owners of the company.

I don't know if I have to explain that much more to the group that is here, but it's benefited, obviously, from that hard work and dedication of the team, which is strongly aligned to shareholder value. Are there any questions received on this item? Did that make sense? Great. When people rub their eyes, scratch their head, it looks like it's going to be a question, so we're good, are we? Yep. Okay.

The proxy votes received in relation to this resolution are now shown on the presentation slides on your screen. If you're registered and wish to vote today, please select yes, for, against, or abstain next to resolution five on your paper. Okay. Okay. The remaining items of business relate to my election and the issue of options to executive directors. Given my personal interest in the resolutions, I wish to ask our independent director, Rosanne Robinson, as Lead Independent Director. Thanks, Rosanne.

Michelle Parker
CEO, Clarity Pharmaceuticals

Okay. So resolution number six. The sixth item of business in the notice of meeting is to consider the issue of options to Dr. Alan Taylor, our Executive Chair. 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 are also set out in the notice of meeting. Are there any questions in relation to this resolution?

Okay. Thank you. The proxy votes received in relation to this resolution are now shown on the screen. If you are registered and wish to vote today, please select for, against, or abstain next to resolution six on your voting card. So we now move on to resolution seven. The seventh item of business in the notice of meeting is to consider the issue of options to Dr. Colin Biggin, who is our 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 are set out in the notice of meeting. Are there any questions for this item of business? The proxy votes received in relation to this resolution are now shown on the presentation. 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.

We now move on to resolution number eight. The eighth item of business in the notice of meeting is to consider the issue of options to Ms. Parker, our Chief Executive 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 are also set out on the notice of meeting.

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 the screen. If you are registered and wish to vote today, please select for, against, or abstain next to resolution number eight on your paper voting card. I now invite Alan back to resume his duties as chair of the meeting.

Alan Taylor
Executive Chair, Clarity Pharmaceuticals

Okay. Let's try and get through this last bit quickly. The next issue of options, obviously, to Dr. Chris Roberts, Non-Executive Director, been here for a long time now since that second capital raise that we did many, many years ago. So the ninth item of business in the notice of meeting is to consider the issue of options to Dr. Chris Roberts. 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 are set out in the NOM. Are there any questions? There we go. Is that okay? I get up here and it's a mess straight away. I don't know. Okay.

The proxy votes received in relation to this resolution are now shown on the presentation slides on your screen. If you're registered and wish to vote today, please select for, against, or abstain next to resolution nine on the paper. Resolution 10, Dr. Thomas Ramdahl, who's also been with us for a while, the ex-CEO of Algeta, that successful radiopharmaceutical company many years ago. The tenth item of business in the notice of meeting is to consider the issue of options to Dr. Thomas Ramdahl.

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. The resolution is subject to certain voting exclusions, which are set out in the notice of meeting. Any questions in relation to Thomas?

No. Okay. The proxy votes received in relation to this resolution are now shown on the presentation slides on your screen. If you're registered and wish to vote today, please select for, against, or abstain in the resolution 10 on your paper. Okay. Next is issue of options to Rosanne. The eleventh item of business in the notice of meeting is to consider the issue of options to Ms. Rosanne Robinson. 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 are set out in the notice of meeting I've commented on Rosanne before. Any questions? We're good. 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 11 on your paper. Okay. Next is renewal of proportional takeover provisions. The twelfth item of business in the notice of meeting is to consider the renewal of the proportional takeover provisions that are contained in the company's constitution. Information on this resolution is set out in the explanatory memorandum in the NOM.

The resolution is a special resolution which requires at least 75% of votes cast by shareholders present and entitled to vote on the resolution. Has anyone got any questions in relation to that? Because we've got people far more educated than me on this in the room. It's basically to protect shareholders. So it's in your favor to do that, our favor, our favor as a group to implement that change.

Any questions? No. Okay. The proxy votes received in relation to this resolution are now shown on the presentation slides on your screen. If you're registered and wish to vote today, please select for, against, or abstain next to resolution 12 on your paper. The next is the amendment to constitution.

The thirteenth item of business is to consider an amendment to the constitution to increase the issue capital and securities issued for monetary consideration under the company's equity incentive plan from 5% to 10%. Information on this resolution is set out in the explanatory memorandum in the NOM. The resolution is a special resolution which requires at least 75% of votes cast by shareholders present and entitled to vote on it.

I discussed the rationale of a broad-based ESOP before. Any questions on that? No. Okay. The proxy votes received in relation to this resolution are now shown on the presentation slides on your screen. If you're registered and wish to vote today, please select for, against, and abstain next to resolution 13 on your paper. Please be close to the end. Great. Okay. So great. Okay.

So we have now dealt with all the items of business in the notice of meeting. The polls will be closed once this meeting ends, and Link Market Services Limited, as returning officer, will count the votes from the poll. And I think there's some representatives here if anyone's got any of those. And I have my little yellow card here.

The results of this meeting will be reported as soon as possible and will also just be displayed on our website. On behalf of the board I can finish off on that. On behalf of the board, obviously, and once again, it's been an incredible year, and it's been an incredible opportunity with all of our shareholders. Some may be more recent, but some have actually done the hard yards and grown our company with us over many, many, many years.

Thanks for being part of that journey, and we look forward to continuing to fight the good fight. Thank you, everybody. Let's close the meeting. Yeah. Thanks. Thanks so much.

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