Forum Topics CU6 CU6 CEO Meeting

Pinned straw:

Added 3 months ago

The interview with Dr Taylor is now up, and the transcript is here CU6 Transcript 2025.pdf

Clearly the products in development, SAR-bisPSMA in particular, have a huge potential market, and (taking Alan at face value) minimal competition, with medium term commercial opportunity (~2 years or so). He was very keen to stress the big picture stuff, but I didnt do a great job at pinning him down on more specific stuff.

It's great that have some clear air in terms of their immediate funding, and the enthusiasm is clear, but from the outside I have a lot of trouble assessing the odds, magnitude and timing of success -- let alone whether the $1.2b market valuation is fair or not.

Other than to guess that *if* their tech is as good as is pitched, and they dont experience any major executional blunders, then yeah, it's probably worth a lot more than it is today. But even then it'll be a couple of years before much of that is clear, and no doubt one or two more raising along the way.

Anyway I think it represents exciting potential, but for now it'll sit in my "too hard basket".

Here's the AI summary:

Company Overview

  • Clarity is an Australian biotech focused on next-generation cancer diagnostics and therapies using copper isotopes.
  • Originated from University of Melbourne research, now in late-stage clinical trials.
  • Core programs target prostate, breast, and neuroendocrine cancers.

Flagship Program: Prostate Cancer (SAR-bis PSMA)

  • Built a bispecific molecule (SAR-bis PSMA) that outperforms first-generation PSMA agents.
  • Advantages:
  • Greater sensitivity (detects smaller lesions earlier).
  • Longer half-life isotope (Copper-64, 12.7 hours vs 1–2 hours for current agents).
  • Enables central manufacturing, broad distribution, and flexible imaging windows.
  • Market Opportunity:
  • Current PSMA diagnostic market ≈ US$2B.
  • Clarity estimates potential > US$5B.
  • Large unmet need: ~600,000 US patients with recurrent prostate cancer cannot be imaged using current standards.

Clinical & Regulatory Progress

  • Running two Phase 3 diagnostic trials (Clarify and Amplify).
  • Received three FDA fast-track designations (two diagnostic, one therapeutic).
  • Conducting head-to-head clinical trials vs current standard (Gallium PSMA) – early results show 2–5x stronger tumour-to-background ratios.
  • Therapy side: Copper-67 isotope for targeted radiotherapy.

Funding & Financial Position

  • Recently raised ~$200M at a premium, adding to ~$280M cash reserves.
  • Prior raises (IPO $92M, 2023 $121M).
  • Current market cap ≈ $1.2B.
  • Funds to complete Phase 3 trials and prepare for commercialization.
  • Quarterly R&D spend ≈ $16M, mostly on clinical trials (not manufacturing).

Commercialisation Strategy

  • 2-year horizon to potential market entry, pending trial success and FDA approval.
  • Partnering with established manufacturers (e.g., Spectrum) – Clarity will not produce isotopes itself.
  • High-margin product: pricing guidance around US$5,000 per dose.
  • Focused first on prostate cancer, while maintaining pipeline in breast cancer and neuroendocrine tumours.

Market & Competition

  • Current competitors (e.g., Lantheus, Telix) rely on short half-life isotopes with poor sensitivity.
  • Clarity believes its product is differentiated and defensible (patent life 13–14 years).
  • Acknowledges risk of new entrants but sees little direct competition near-term.

Capital Markets & Strategy

  • Dr Taylor emphasised adaptability and resilience, not reacting to short-term share price moves.
  • Notes biotech volatility: external market events and index movements can drive share price swings unrelated to fundamentals.
  • Strategy is to stay focused on core programs, push through clinical milestones, and prepare for revenue generation.

Key Takeaways

  • Clarity is transitioning from R&D to commercialisation, with strong confidence in its lead prostate program.
  • The company has a large cash buffer, global partnerships, and regulatory support.
  • If successful, SAR-bis PSMA could redefine prostate cancer imaging and therapy, addressing a multi-billion-dollar market with significant unmet need.


mikebrisy
Added 3 months ago

@Strawman I thought this was a really interesting discussion today.

I felt your frustration trying to clarify the manufacturing piece. I get the cyclotron and the 3rd party manufacuturing piece, but I wanted him to explain better how the targeting agent, the linker, and the chelating agent are synthesised, and then the 64Cu added to it, all to achieve a consistent product. I'd hoped he'd have stepped us through the manufacturing and supply chain in some more detail. To me, he made it sound like you just stand next to a cyclotron and mix it all up at room temperature and there you go. I get that the manufacturing is straighforward (relatively), not core to their capability. and outsourced. But it was a bit frustrating that we couldn't get any insights into that piece.

After all, $TLX have failed to get approval for Zircaix because of chemistry, manufacturing and controls ... so even if the science and efficacy is all good, the supply chain can stop you getting a product FDA-approved in this business.

For me , $CU6 is a simple idea, and Alan did a really great job of explaining this today.

The radiopharmaceutical industry in diagnosis of several forms of prostate cancer is established. It is already worth $2bn focused on the US with 3 products in the market. F-18 (Pylarify and Posluma) and Ga-68 (Illuccix/Gosellix ($TLX); and Locametz). These are well known to have high-specificity but low sensitivity.

Because of its longer half-life, "background" 64Cu can get flushed out of the system (and in particular the bladder which is adjacent to the prostate), leading to a higher contrast for the product that binds to lesions (with binding itself aided by the bivalent targeting agent ... two binding points instead of one in the competitors). At a simple, conceptual level, the $CU6 product is fundamentally superior. Or that's the $CU6 Story,... and it makes sense to me.

IF THIS IS PROVEN in the current parallel Phase III trials, which are set against the standard of care, then absent some adverse finding (which I am unable to foresee - not the same thing as saying it won't happen!), not only will $CU6's 64Cu product quickly become preferred to the 68Ga and 18F products, it will also likely be applicable to large portions of the total Prostate cancer market, that the incumbents don't work for. (This is Alan's $5bn TAM, that he gave examples of.)

Again, I had some frustration here with the lack of detail on supply chain from Alan. Afterall, with the short half-life $TLX have invested a lot in their fully integrated model. They have to, because they have less time to get the product into the patient. Equally, this appears to be giving them advantages over their current competitors who have had supply chain problems competing for the last supply chain assets - which Alan referred to.

But of course, Alan makes a great point. Are $TLX just talking up the advantge of their integrated strategy and making a competitive virtue of it, because they don't have a choice, given their half-life? I liked Alan's remark that do you really care about a few hours of inconvenience, given what's at stake?

Now to the investment case: what might happen, looking at newsflow out over the next 2 years, in the success case for $CU6?

64Cu-Sar-Bis-PSMA will be commercialised and over a 2-5 year period grow to be a multi-$-billion product. The share price of $CU6 will soar, because the platform will be proven and - even though not all follow-up products will succeed - they will be relatively de-risked, and there are enough "bullets in the chamber", that Alan will be able to fill the development pipeline quickly, given operating cashflows. (This was at the heart of your question about how many horses do they choose to back at one time. The approval of 64Cu-Sar-Bis-PSMA transforms that equation, not only because of the funding but also because of the de-risking of the science/efficacy.)

In short, in the success case, $CU6 will over the course of 2-3 years become what $TLX is today,... growing from the $1.2bn company to a c. $5bn company. The upside is 4x in 2-3 years.

And what of $TLX. Well, there's the rub,...If it can't pull through Zircaix and Pixclara, and if the therapeutics don't progress successfully, it's SP will be destroyed. It will go from a $4.6bn comany to a $1-2bn company or worse.

So, overall, I've decided the category of Radiopharma Cancer Diagnostics is going to be a winner, with therapy as the upside. I've also decided that some combination of $CU6 and $TLX will be in the mix of the long term winners, with reasonable confidence (>70%). Either one or the other or both.

The questions for me then are: a) how much capital to allocate overall to this play (Answer 5% max, cost base) and b) the allocation between $CU6 and $TLX, which is news dependent (and aided when the market does dumb things, which you discussed with Alan.) At the moment I am about 5:1 $TLX:$CU6, but I expect this to change as my view on the two business's prospects develop. At this stage I still see $CU6 as speculative, as there might not be a business here at all (although I give that only a 30% likelihood). However, that could change quite quickly and so I want to keep on top of this, for sure. Certainly, Alan has nearly all the chips riding on 64Cu-sar-bis-PSMA diagnostic imaging. He's close to All In on that, and I sense he is seeing a much higher chance of success. If I really believed him today, my weighting to $CU6 would be higher. But of course he is biased. He has to back his company because he doesn't get to play anyone else's hand.

So, I find this a really fascinating time. Of course, there is every indication that for $TLX Zircaix will come good, and maybe even Pixclara in time, which would decouple $TLX's success from $CU6 to some extent. But both products are now in an unwelcome, prolonged uncertainty. So the rest of the $TLX pipeline becomes even more important. Of course, my dream scenario is that both $TLX and $CU6 "win", but perhaps that's only a 50% likelihood.

Anyway, I'm rambling now. Lots of food for thought from today's meeting!

23

edgescape
Added 3 months ago

Had a chance to catch up and this meeting with Alan was quite interesting.

Given they have patents on their products, do they CU6 have to disclose fully the whole manufacturing process even at a very high level?


11

mikebrisy
Added 3 months ago

@edgescape I'm not sure there is any disclosure requirement. However, in this and other industries, firms usually give some indication as to the nature of their operations and the key phyiscal and contractual assets. But to be fair to Alan, there is quite a bit disclosed in the Annual Report.

Here's what I got my Library Assistant (aka Notebook) to extract:


=====================================================

Clarity Pharmaceuticals has made several disclosures regarding its manufacturing process and supply chain for 64Cu-sar-bis-PSMA, emphasizing its strategy to establish a dependable, scalable, and cost-effective commercial network for this diagnostic product.

Here are the key disclosures:

Summary from the FY25 Annual Report

Clarity Pharmaceuticals has strategically built a robust manufacturing and supply chain network for 64Cu-SAR-bisPSMA by securing agreements with key partners like SpectronRx and Nusano, leveraging the inherent advantages of copper isotopes, such as longer shelf-life and environmentally preferred production methods, to enable scalable, dependable, and cost-effective commercialization.

Manufacturing Process & Agreements:

Commercial Manufacturing Agreement with SpectronRx: In June 2025, Clarity entered into a Commercial Manufacturing Agreement with SpectronRx for 64Cu-SAR-bisPSMA. This agreement enables on-demand commercial-scale manufacturing of both copper-64 and 64Cu-SAR-bisPSMA under one roof at SpectronRx's facility in Indiana, with central distribution across the US.

Expanded Production Capacity: SpectronRx's Indiana facility is planned to expand its production capacity to up to 400,000 patient-ready doses of 64Cu-SAR-bisPSMA annually by the time of commercialization. The agreement also includes an option to expand production into additional sites throughout the US, which would substantially increase manufacturing capacity in regional hubs.

Foundation of Agreements: This commercial manufacturing agreement builds upon a previous 64Cu-SAR-bisPSMA Clinical Manufacturing Agreement signed with SpectronRx in October 2024, and an earlier Master Services Agreement (MSA) and associated Supply Agreement for the copper-64 isotope.

Enhanced Product Formulation: Prior to the commencement of the Cohort Expansion Phase of the SECuRE trial, Clarity rolled out an improved 67Cu-SAR-bisPSMA product formulation (which also applies to the SAR-bisPSMA platform). This enhanced formulation allows for room temperature stability, supply, and scalability, which are crucial for late-stage clinical trials and streamlined commercial-scale manufacture.

Supply Chain for Copper-64 Isotope:

High-Volume Commercial-Scale Agreement with Nusano: In April 2025, Clarity signed a high-volume commercial-scale agreement with Nusano, Inc. for the supply of the copper-64 isotope. Nusano's 190,000 square-foot facility in West Valley City, Utah, is expected to begin isotope production in 2025, with copper-64 supply planned to commence in 2026.

Nusano's Production Capabilities: Nusano's accelerator-based proprietary technologies are designed for cost-effective mass production of copper-64, with the facility capable of producing more than 1,000 Ci (37,000 GBq) of copper-64 per day at capacity. This translates to over 18,000 patient doses per day at 200 MBq per dose, with a 48-hour shelf-life. Nusano is also developing in-house production of nickel-64, the target material for copper-64 manufacturing.

Supply Agreement with The University of Queensland (Australia): In March 2025, Clarity entered into a Supply Agreement with The University of Queensland (UQ) at the Australian Institute for Bioengineering and Nanotechnology (AIBN) for the supply of the diagnostic copper-64 isotope in Australia. This agreement provides additional capacity and expands manufacturing capabilities in Australia, supporting Australian sites participating in Clarity's clinical trials, including the registrational Phase III trials AMPLIFY and CLARIFY, and the Investigator-Initiated Trial, Co-PSMA.

Advantages and Environmental Benefits of 64Cu-sar-bisPSMA Supply Chain:

Longer Shelf-Life: Copper-64, the diagnostic imaging isotope used in 64Cu-SAR-bisPSMA, has an ideal half-life of 12.7 hours, facilitating a significantly longer product shelf-life of up to 48 hours. This is a major advantage over current-generation radiodiagnostics like gallium-68 (half-life ~1 hour) and fluorine-18 (half-life ~2 hours), which have acute supply restraints due to their shorter half-lives.

Centralized Manufacture and Wider Distribution: The longer shelf-life allows for centralized manufacture and broad distribution from a single cGMP facility, reducing the need for an extensive and expensive network of cyclotrons, generators, and radiopharmacies located close to imaging sites. This capability has the potential to reduce disparities in prostate cancer care and ensure patient access regardless of geographic location.

Reduced Waste and Carbon Footprint: The extended shelf-life minimizes the risk of product expiry before administration, thereby reducing waste. It also enables patient doses to be provided in the morning and remain viable all day, eliminating the need for frequent courier travel between radiopharmacies and reducing the carbon footprint of the supply chain.

Environmentally Preferable Production: Copper-64 production is non-uranium sourced and does not result in long-lived radioactive waste products.


My Assessment

This is all pretty consistent with what Alan said at a 40,000 ft view (as @Strawman describes it).

However, what I've learned from this is that their NDA package for the Chemistry Manufacturing and Controls module, will have to show equivalence across sites particlarly if there are differences between the clinical trials supply chain and the commercial supply chain. This is an area where $TLX have come unstuck with the Zircaix NDA. The outsourced suppliers will also have to pass their GMP inspections - again, the $TLX suppliers copped a couple of 483s, which can be minor of very, very problematic depending on what was found.

I guess the Zircaix experience (and my own battle scars from early in my pharmaceuticals manufacturing career) triggered me a little yesterday, in that I felt that Alan didn't really engage much on the manufacturing and supply chain question. It is not so much that he had an obligation to make a disclosure, but more about his ability to characterise the risk in that part of the business. Coming as he does from a clinical research and financial services background, I guess I have a question on how on top of the manufacturing and supply chain he is, and I felt a little let down that the quality of his response left that as an open question for me.

It is not something I am unduly worried about. But it was just a missed opportunity. But maybe - given his evident tendency to be dismissve of retail investors - he didn't think for one moment that some of us might be hanging on his words!

18

Strawman
Added 3 months ago

I really do hate the term "retail investor". It's not always intended, but it has such a derogatory tone about it.

Like we poor hapless fools could never muster the discipline and rigour one finds among the 'sophisticated' investor class, let alone the necessary depth of understanding required to judge a business and its prospects..

25

mikebrisy
Added 3 months ago

@Strawman really? You didn't show it ... (not).

12

lowway
Added 3 months ago

Thanks for posting your summary of today's meeting with Alan Taylor @Strawman. I'll definitely set aside enough time tomorrow to listen to the full CEO interview as I have a personal interest in this area as a previous patient/user of Gallium 68 & F18 DCFPyL for PSMA PET scans. Posted this in a previous forum post for $TLX by our resident SM gurus @mikebrisy.

I'll be watching the progress of 64Cu-Sar-Bis-PSMA with great interest as anything that improves the half-life and efficacy of tests for various cancers (particularly prostate and RCC) will be huge winner if it passes the regulatory phases effectively.

16

edgescape
Added 3 months ago

@Strawman @mikebrisy

The Telix CEO Christian Behrenbuch was also indirectly dismissive of retail investors too. In one announcement I believe was the commercial launch of Illucix he thanked the support of institutional investors. Err what about me when there was a 30% drawdown after the CR got pulled in last minute that was used for the launch of Illucix!

In addition there was one call when I think it was the ASA asked when Telix would pay out dividends and Christian replied "We don't do that sort of thing" or something along those lines!

Unfortunately that's the reality and we small fish have to get used to it.

Anyway I have a reduced percentage holding in Clarity but that's because some of my small cap stocks have now overtaken it (I won't name here for sake of relevance but you can probably guess which ones they are). So much for large caps anchoring the smaller companies! Really is amazing when you think about it that Clarity is still around $1bn market cap yet my personal holding is small in comparison.

14

Tom73
Added 3 months ago

Thanks for the summary and organising the interview @Strawman , very interesting and has prompted me to place an order for a small amount at $3.00 to complement my recent TLX small position.

Regarding Alan’s attitude to retail investors (and most biotechs in phase 2+), I have to say it’s totally rational and realistic for what they are trying to do and what most retail investors represent, which are under resources and informed for the Biotech space. The amount of effort required to pander to that segment of the market is just not worth it, especially as has previously been pointed out, when we want our CEO’s to focus more on running the company rather than selling to investors (even considering that for Biotech’s this is a much of the job).

I have been heavily involved with a Biotech start-up for a bit over 2 years now, it’s lead asset is a Prostate Cancer treatment and I have experienced first hand how immature the Australian capital markets are when it comes to Biotech’s. Even the so called professionals and VC boarder on amateurish, while the Angel investor groups which is the “retail investor” equivalent are enthusiastic and often will have some exceptionally well qualified biotech member (like here on SM), they are in general badly suited to the space and can provide only a small fraction of the capital required to advance through clinical studies.

For context, I am very impressed by Alan’s ability to raise $200m at $4.20 recently in Australia. While executed quickly, that would have been the result of a very long development of an institutional or lead investor base. If he had invested as much of his and the companies time on retail investors it would have been at the detriment of the company and all shareholders.

I don’t like the term retail investors or connotations it provides as a blanket term, but quite frankly there is some truth to the heuristic of it, particularly in very technical or complex investment areas where the distinction is warranted.

So @edgescape and others, don’t take offense to being unfairly lumped in with and dismissed as retail investors. Instead celebrate that we are in an overlooked and undervalued part of the market that we can have an edge in if we do the work that is needed and share our knowledge as we do on SM.


17

Strawman
Added 3 months ago

Fair comment @Tom73, and I certainly don't think biotech CEOs should spend too much time trying to sell the story to "mum and dad" investors.

But if you are going to do engage with retail, at least have the decency to answer good faith questions without all the hand waiving.

I don't want to make a mountain out of a mole hill. It's not that big a deal in the grand scheme of things. Its just a bit of a pet hate of mine.

19

edgescape
Added 3 months ago

I think we should just be grateful Alan Taylor took time to speak with us and answer some questions. It does show he has some time for non institutional investors no matter what we think.

15

mikebrisy
Added 3 months ago

@edgescape I totally agree.

If I ever express a dissatisfaction with answers or information shared in a CEO meeting, it is in the context that I am always hoping to get a lot out of them, and so will sometimes call out a missed opportunity.

If I put myself in the shoes of the CEO, it must be hard to understand at what level to pitch their answers. This is especially true in businesses that are technically complex and removed from everyday experience (such as biotech).

Having said that, I think Alan understands from his previous visit to the "Strawman Star Chamber" that this community has a reasonable proportion of members who take a deep and long term interest in their holdings. And so, I just had hoped for better and more.

But your point stands. And despite my grumbles, I got a lot out of the meeting and would hope he will come back in a year's time.

18