Pinned straw:
@topowl I think this is a very good question, and as a holder of an initial small RL position in $CU6, I'll give my view.
By way of background, I began to take in interest in $CU6 shortly after taking an initial position in $TLX earlier last year, and learning more about radiopharmaceuticals and some of the unique features of the $CU6 platform. The $CU6 Strawman meeting came at a helpful time, although immediately after the meeting, based on what I knew at the time, I felt that $CU6 was too speculative for me. However, in the intervening period from October to January, I deepened my knowledge of the Radiopharmaceutical sector in general, on $TLX and $CU6 another products. And as the $CU6 price came off early this year, I took a small position around $3 and $4.
(Note although my SM portfolio says I have 1.9% in $CU6 and 2.1% in $TLX, my RL position is very different, at 3.7% $TLX and 0.5% $CU6. Important to recognise that I take less care with my SM portfolio weightings than in RL, and I tend to show bigger SM holdings of higher risk businesses, as a general rule because I have certain large holdings in RL that I don't hold in Strawman, but which I always list on my Profile!)
Having been involved in biotech and pharma for many years, it is clear that SP's are very news-flow and milestone-driven. It really can be a bad idea to buy stocks in pre-revenue companies on the back of good news and as part of SP momentum, simply because these events can create a lot of forth that blows off when the news flow dies down. (I'll stop opining on price mechanics, because there are plenty on this forum who are much better qualified to comment on technical price action and how to interpret it.)
I invest on fundamentals (with an eye to momentum, to help consider timing). So, where do we stand on the fundamentals of $CU6?
Revenue and Approved Products = 0. No Change.
Here's the development portfolio (picture below), as presented in the November AGM. No change.
And importantly, we still do expect very significant newsflow during the course of 2025.
But that newsflow could be negative, trial milestone might fail, products might be abandoned, and new capital required to keep the show going. You have to have your eyes open when investing in pre-revenue biotech, no matter how much early successes have been lauded!
So what information have we had since the AGM, when the SP was around $7?
Here's a summary.
$CU6 Developments Since the 2024 AGM
Regulatory Milestones:
- FDA Fast Track Designation: In February 2025, the U.S. Food and Drug Administration granted Fast Track Designation for Clarity's ^67Cu-SAR-bisPSMA, targeting metastatic castration-resistant prostate cancer (mCRPC). This designation facilitates expedited development and review processes, underscoring the potential of Clarity's therapeutic agent.
Clinical Trial Progress:
- SECuRE Trial Update: The SECuRE trial, assessing ^67Cu-SAR-bisPSMA in mCRPC patients, reported that 92% of pre-chemotherapy participants experienced a reduction in prostate-specific antigen (PSA) levels exceeding 35%. This promising outcome led to the initiation of the Cohort Expansion Phase at an 8 GBq dose level.
Pipeline Expansion:
- Breast Cancer Focus: Clarity expanded its pipeline to include ^64/^67Cu-SAR-trastuzumab, targeting HER2-positive breast cancer. Pre-clinical studies demonstrated significant tumor reduction and improved survival rates in models treated with ^67Cu-SAR-trastuzumab compared to standard trastuzumab therapy.
Strategic Partnerships:
- Copper-64 Supply Agreement: In March 2025, Clarity secured a supply agreement with The University of Queensland for copper-64 isotopes. This collaboration ensures a consistent supply for clinical trials, particularly for ^64Cu-SAR-bisPSMA, enhancing Clarity's theranostic programs.
My Assessment
I think the adverse SP movement in recent months is down to three factors:
- The SECURE update, while from my reading a reasonably positive update, perhaps didn't hold the blow away results some were expecting
- As we move into Q2, froth blows off in the absence of major newsflow. That's a very, very common pattern.
- The market more generally has turned against high risk stocks, in the current correction
Do I think $CU6 was overvalued at $7? Maybe, maybe not. Do I think it is undervalued today? Maybe, maybe not. The point is, the risk around $CU6 is very high depending of a large number of highly uncertain outcomes. Across the development portfolio I consider there is promising evidence that one or more of its products will be successful in delivering a commercial diagnostic product, with a lower likelihood of success in achieving a therapeutic drug.
Importantly, the news flow since the AGM has not been so positive so far as to cause me to increase my very small holding. The SECURE trial update was fairly neutral to mildly positive in my assessment on the risk-reward profile of that trial, and the other announcements do not materially change my view on value.
All that said, I am considering adding some more $CU6 at the current prices, in the context of my overall pharma/biotech portfolio. Basically, because of progress elsewhere in the portfolio, I am open to adding some more development risk (perhaps another 0.5% in RL) and $CU6 is looking quite attractive to me at the moment to do that.
Disc: Held in RL and SM