Clarity Pharmaceuticals (ASX:CU6) is off all time highs but is a $600m company! Is it the next Telix?

When we last wrote about Clarity Pharmaceuticals (ASX:CU6), in July last year, it was a multi-billion dollar company, less than 3 years after an IPO that valued the company at $350m.

In retrospect, that was kind of a kiss of death because it retreated back to $700m. So where to next for the company? Is it the next Telix Pharmaceuticals, or could it go even better? Well, to answer the latter question, that will all depend on whether or not it can get regulatory approval.

Clarity Pharmaceuticals (ASX:CU6) share price chart, log scale (Source: TradingView)

Introduction to Clarity Pharmaceuticals (ASX:CU6)

Clarity Pharmaceuticals is in the radiopharmaceutical space, where cancer therapies are radiation-based. So-called radiopharmaceuticals deliver treatment directly to the cells rather than the outside. This is the type of therapy employed by Telix, but also by Clarity.

Clarity’s technology is Targeted Copper Theranostics (TCT). Its technology platform has a bifunctional chelator (cage) at its heart that can bind and retain the copper isotopes used (in other words, stop them leaking into the body before reaching the cancer cells and causing damage to healthy cells).

The cage is linked to targeting a molecule that finds and binds tumour specific receptors on cancer cells. Unlike Telix, which focuses on multiple radioisotopes, Clarity has just two: Copper-64 and Copper 67.

Everyone knows the damage cancer does, but also that treatments such as chemotherapy can cause. The sad thing is that there has been little to no innovation in cancer treatments over the last few decades, even in spite of all the research done. But companies like Clarity provide hope.

It is impressive that it is still one of the ASX’s largest biotechs and went from nothing to something in a few years. Sure, it is no CSL, but CSL was a government entity for decades before being pritivised.

Why did shares go on a run during FY24?

Clarity’s products have shown impressive results. The most advanced asset is Clarify which is in a pivotal Phase 3 trial that is expected to support an FDA application for approval of the drug in pre-prostatectomy patients (i.e. patients with prostate cancer about to undergo a prostatectomy procedure).

The second is Cobra which unveiled data in February 2024 which showed that the drug was safe and effective in detecting PC lesions, supporting the company’s ambitions to undertake a Phase 3 trial there. And the third is Secure which is in a trial in metastic castrate-resistant prostate cancer. Again, there has been promising clinical data, and although Phase III is a while off, the trial was approved to advance to a new cohort with a higher dose level.

Also exciting investors have been multiple blockbuster M&A deals in the radiopharmaceutical space and consequent speculation Clarity Pharmaceuticals could be next. AstraZeneca bought Fusion for US$2.4bn, Eli Lilly bought Point Biopharma for US$1.4bn and Bristol Myers Squibb bought Rayze Bio for US$4.1bn. And all of these were when the target companies were where Clarity was – at the clinic. With few other radiopharmaceutical companies out there, and a cash balance of A$153.2m, you’d imagine a premium would need to be paid by any would-be buyer.

It is true that Telix was not bought out. But Telix went at it alone and has never looked back, consistently recording 9-figure sales each quarter (i.e. over US$100m). No doubt, it could be similar for Clarity. This is not just because there is a need for treatments, that consumers (either directly or indirectly via Medicare) would pay a premium for.

But also because this treatment could get to market fast. Copper-64 and Copper-67 can be supplied and produced faster and easier other competing radionuclides. Copper-67 for instance costs US$15m to supply and <18 months to scale. Lutetium-177, meanwhile, costs >US$1bn to scale and 10 years to supply, because they are produced by nuclear reactors.

Why has momentum gone out of the company?

Let’s take a look at what the company has done in the last 12 months. Among other things:

• It signed a clinical manufacturing agreement for Cu-64 with SpectronRx which will see that company make both the isotope and finished product at the latter’s facility on the north-west outskirts of Indiaianpolis,
• Appointed Michelle Parker as a Director, then promoted her to CEO one month later,
• Revceived positive feedback from the FDA on a proposed Phase 3 trial, to be called AMPLIFY; not to mention fast-track designation for Cu-64 for biochemical recurrance of prostate cancer,
• Received positive results in a Phase 2 SeCURE trial (in which 92% of pre-chemo participants saw a greater than 35% drop in antigen levels),
• Began a collaboration with St Vincent’s Hospital in Sydney to conduct a head-to-head trial of Clarity’s product in comparison to a standard of care product for prostate cancer, and
• Expanded its pipeline with a new radiopharmaceutical (SAR-bisFAP) as well as the use of CU-64/67 in breast cancer.

The Phase III AMPLIFY trial began in mid-May 2025, with the first clinical site being in Omaha. It will enrol 220 participants in the US and Australia. The timing was quite well with Joe Biden and Barnaby Joyce being diagnosed with prostate cancer, no doubt raising awareness about the disease. And the company began June announcing the results of a Phase II trial showing Cu-Sartate was safe and highly effective at diagnosing detecting lesions in patients with neuroendocrine tumours. Only a week later, it announced more Phase II results in its Sabre trial, showing it was effective in detecting prostate cancer recurrence in patients with negative SOC imaging.

Clearly it isn’t to do with a lack of progress – although maybe some investors expected the company’s trial to be faster. We think other external factors have had a greater impact on investors’ perception of the company. Beyond the impact of Trump’s tariffs on markets generally, investors would’ve been spooked by the unexpected failure of Opthea and the rejection of nuclear power by the Australian electorate. As true as all these are, these shouldn’t affect Clarity – it is conducting its trials in the US, mind you.

Conclusion

When you add it all up, Clarity Pharmaceuticals is in a great position, with clinical stage assets that have showed compelling data. Although the company still has some way to go to reach commercialisation, there is potential for further shareholder value to be created either through an M&A deal or through the company taking the treatments to market in its own right.

Consider that Telix has taken the latter route and is currently capped at >A$8bn. Although Clarity is less than a tenth of that, we imagine that if the company can have the success Telix has, the gap could shrink.

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