Ann: Half Yearly Report and Accounts, page-33

ANY OTHER IDEAS?

I don’t read the market well so I don’t know what might have upset her/him!

1) THE NEUROBLASTOMA TRIAL(CLO4)

I shared some things already and I saw another informative post so I will limit myself a bit on this one. I will, however, remind us that, as a dose determination study, what happened should not concern shareholders. Its part of the design.
I also think its worth noting that the choice of subjects to trial (including in SECURE) puts these early trials in some potentially market scaring situations! Remember the number of failed lines of therapies (a badge of honour - ok!), as well as the 93-year-old man (another badge of honour!)!
Just as day follows night, soon enough and even by chance, something bad will happen to someone on our trials! In a sense, and for shareholders who fear every adverse effect, the Phase 3 trials will target better - lower risk early stages of disease.
BUT I am glad that these very sick patients are getting access to these therapies. It would be a blow and shame if companies excluded these patients, or chose to use sub-optimal dosing so as to stay safe, while administering marginally effective doses that lead to minimal benefit - creating resistance and and unnecessary failed treatments! Its a long story so i will stop here.
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2) DELAYS IN GETTING TO REVENUE?

CLARIFY is our most advanced trial, and this ‘specific’ report did not give an update on trial progress. The Clinical Trials website has February 2025 as the end date.

• However, the report did hint at some delays when the company says it is looking to submit both the CLARIFY data and AMPLIFY data for FDA approval AT THE SAME TIME! AMPLIFY has not started, and we do not know when it’s actually going to start! So, that creates quite some uncertainty, I think. Noting too that we haven't even been told about the 50% recruitment! That all but confirms there are delays in CLARIFY.
• Contrast this with previous interviews (since May 2024), where, whenever Alan was sort of pushed about commercialisation, he said “we are aiming to have that product in the market in a “couple of years”! I know that “couple” means different things to different people, but in some, its 2: so, target 2026! Not gonna happen! Noting that this was always during conversations where he clearly showed his preference for a takeover, so the commercialisation seemed to be his Plan B.

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3) DIVERTING ATTENTION?

Is Clarity turning its focus more towards (and prioritising) OTHER stuff instead of pushing towards FDA approval? In this report, Clarity do indicate that SARTATE and BOMBESIN products in particular, will dominate the news flow this year!

A turn towards the other products is a bullish move in some way (it helps prove the platform technology - good particularly if a takeover becomes a reality). But, in the short to medium term, that won't get Clarity to revenue. What if NOBODY LOVES US!




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4) SECURE
I agree - the trial got a bit more complicated. BUT - if we listen to Shaemus Gleason, we my be even more convinced about the move to expand the trial in the way they did. It sets Clarity up for a move towards challenging for FIRST LINE position in a large group of patients.


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IN CONCLUSION
I think Clarity have basically stretched the timelines - quite a long way! So, for people wanting to cash out soon - that doesn’t look like it will happen soon!
Long term - great!