Pre-commercial company $CU6 announced that the abstract for the upcoming conference presentation for the CoPSMA trial has bee released today.
ASX Announcement
The market has gotten a little excited over this with the SP up 17% at time of writing. So in this straw I set out my thoughts, having analysed the release.
TLDR: It is good news. On its own I judged the SP reaction to be overdone, however, that it maybe can be understood because I don't think the market is properly relfecting the risk value of the business. So a large jump in SP really only closes some of the gap IMHO.
First some background.
BACKGROUND: Where does this trial sit compared with $CU6’s own trials?
Co-PSMA is a small, investigator-led Phase II study conducted at a single centre that directly compared Copper-64 SAR-bisPSMA against the current standard Gallium-68 PSMA-11 in men with low prostate-specific antigen biochemical recurrence after prostatectomy. The investigator is Prof. Louise Emmett at St Vincent’s Hospital Sydney, and the paper will be given as an oral presentation at the upcoming European Association of Urology Congress.
Its purpose was to test whether Clarity’s product detects more true cancer lesions in a challenging early-recurrence setting. It provides head-to-head superiority data and clinical utility signals, but it is not a registration-enabling study.
CLARIFY and AMPLIFY, by contrast, are large, multi-centre, sponsor-run trials specifically designed to support regulatory approval. These are the leading trials that $CU6 is running, and through which it is aiming to commercialize Cu-64 SAR-bisPSMA. They are structured to meet formal regulatory requirements for diagnostic accuracy, reproducibility and statistical robustness across multiple sites and readers. While Co-PSMA strengthens the differentiation case, it is the outcomes from CLARIFY and AMPLIFY that will ultimately determine the likelihood of registration.
What is New in Today’s Release Compared with Earlier Announcements?
We have already had quite a bit of detail about these trial results released in December. So one key question is what, specifically, is new in today's release? And what bearing if any should have that have on valuation.
The new abstract release does not change the headline outcome that the Co-PSMA study met its primary endpoint, but it adds important quantitative detail.
It now discloses the precise magnitude of superiority over Gallium-68 PSMA-11, including exact lesion detection rates, confidence intervals, statistical significance, confirmed true positive rates, and - importantly - the proportion of patients whose treatment plans changed after imaging (this is likely to be a major consideration bearing on ultimate registration approvals, because the add value of a me-too diagnostic agent is whether or not is changes the treatment pathway).
This moves the disclosure from a general statement of statistical success to a clearly defined and robust effect size, strengthening the credibility of the superiority claim.
In terms of impact on the likelihood of eventual approval of Copper-64 SAR-bisPSMA, the data incrementally reduces clinical and differentiation risk but does not materially alter the regulatory pathway. Co-PSMA remains a small, supportive Phase II study rather than a pivotal registration trial. The results enhance confidence in diagnostic performance and potential commercial positioning, but regulatory success will ultimately depend on the larger, approval-directed studies.
My Overall Takeaway
The near term valuation catalysts lie primarily in AMPLIFY and CLARIFY, and so strictly, I'm not sure how much you can read across from this CoPSMA trial into those (I need to give this further thought and investigation). Of course, it does offer a promising sign for the eventual use of the diagnosis in low prostate-specific antigen biochemical recurrence after prostatectomy, but this will of course require its own registrational trial. So, if prior to today, we considered the likelihood of that pathway ulimtately being approved as 60%-65% (which is where I have it based on the December disclosures), then the incremental detail today perhaps nudges that up to 65%-75%.
Again, the optimist in me would like to read across that it strengthens the evidence base that 64Cu-SAR-bisPMSA is going to emerge as an important platform more generally for diagnosing prostate cancer across the lifecycle and across the patient journey. That's the super Bull thesis for $CU6, and it is why I hold $CU6. Today's news is one paragraph of one chapter of that thesis.
My more sober assessment is in contrast to Exec Chair Alan Taylor's more upbeat assessmentin the release. Of course he knows infinitely more than me, but I know that the pathway to realising material value here is long, and won't be straigtforward.
So, good news, but on its own, I don't think it is enough for me to increase my current holding. I continue to evaluate every new piece of data for this business, as it does have the potential to be an ultimate blockbuster and today is a supportive sign.
A HOLD for me.
Disc: Held (3% RL)
