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#Broker/Analyst Views
Added a month ago

The latest update from Wilsons with the change in pathway to market for those who are interested. Potential for a slow down in the Phase 3 results it seems.

Clarity Pharma Wilsons advisory 15 Feb 2024.pdf


Nessy

not held

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#Industry/competitors
Added 2 months ago

Good deep dive of the radiopharma landscape from the Frazis substack and where Clarity sits against other companies

https://fraziscapital.substack.com/p/clarity-pharmaceuticals

[Held]

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#Industry/competitors
Added 2 months ago

Looks like Telix is getting on the Cu64 bandwagon

I thought I'd post this to Clarity instead to start a discussion on how copper isotopes are being used external to Clarity

Latest slide from 08/01/2024  - JP Morgan Healthcare Conference Presentation

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Appears Telix is using Cu64 as the diagnostic agent with Ac225 as the therapy.

Only phase 1 trial so this is still early compared to some of Clarity's studies. But it does look like copper is getting some attention and could be a bit of a negative as now Clarity is no longer the go-to pharma for Copper diagnostics or even therapy.

[held]

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#Bull Case
Added 3 months ago

Received this note from Frazis Capital Partners for anyone not yet subscribed to his email updates

Clarity Pharmaceuticals

c1f33f69173f4e2b0b80657e0588ddeeb27a11.png

This is the most exciting company I’ve come across in Australia lately. Clarity has been steadily releasing data from patients treated with their copper therapies with late stage prostate cancer.

Clarity has been on a bit of a tear lately. If their data continues to hold, this is still early days, and it remains a fraction of the value of recent acquisitions in the space with early stage data.

I will send out a note on the space shortly.

Current players include Novartis, which entered the space through their US$2 billion acquisition of Endocyte, Lantheus, which offers a radiodiagnostic, and Telix which is rapidly gaining diagnostic share from Lantheus. The whole space itself is growing fast and expanding into new areas.

M&A activity has been intense.

Two days ago Bristol Myers Squibb bought RayzeBio for US$4.1 billion, with early stage data for their alpha-particle emitting Actinium-based radiotherapy targeting gastroenteropancreatic neuroendocrine tumors. The company is enrolling patients in a Phase III trial.

And Novartis paid $2 billion for Endocyte in late 2018 with only Phase II data. This has proved a big winner, with first year revenues for their first product Pluvicto forecast at over US$1 billion.

Point Biopharma, in partnership with Lantheus, was itself bid for by Eli Lilly for US$1.4 billion - again with only Phase II data. Last week Point’s data came in a little soft, leaving open space for new entrants like Clarity.

This is going to be a large market. In prostate cancer, the trend is towards increased monitoring and (where possible) fewer surgeries and hormone therapy, which involves the unwelcome side effects of incontinence, impotence, low testosterone and depression.

These companies are focused on heavily pre-treated patients. But the hope is that these targeted treatments, with their milder side effects, will move further up the treatment timeline, which could double or even triple industry revenues.

This will take time, given the high hurdle for changing standard-of-care, but is looking more likely than ever today.

In the meantime, a steady rise in the incidence of prostate cancer, combined with an increase in monitoring, suggests the market will expand significantly regardless.

In a space where companies with promising data are being acquired for billions of dollars, and Clarity’s early indications look best-in-class, the company’s post-runup US$340 million valuation looks cheap.

And just today (28 Dec 23) the share price reached an all time high of $2 before settling back down to $1.89

I presume the rally was on the back of coverage from this email update.

Michael Frazis of Frazis Capital Partners is known for ignoring financial metrics in favour of more unconventional measures of customer satisfaction, loyalty, addressable markets and ideas that involve cutting edge technology and science. His style is more inline with ARK invests Cathie Wood

For the record, I'm not as enthusiastic as Frazis on the growth of the PSMA market, I think the rise of drugs such as Ozempic could slow the rate of growth in Prostate Cancer and the underperformance from Lantheus and Telix is evidence of this. Frazis could be just a victim of wanting to catch the CU6 uptrend late in the cycle while ignoring his bad call on Paul Hopper's Radiopharm Theranostics.

[held]

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#Bull Case
Added 4 months ago

CU6 has really been on a tear recently

Apart from the latest report from Wilsons shared by @Bear77, there was also an earlier update on the SeCURE Therapy trial for Cohort 2. Although there were only results from 3 patients, the update on page 1 looked promising but as usual I brushed it off

The more significant part is on page 2 where I have highlighted the update where patients has had radiogland therapy with not much success but has showed progress in the SeCURE trial

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While the radiogland therapy is not named, we can probably guess that the one they could be referring to is either Novartis (Pluvicto) or maybe others from Lantheus (can't think of the name) or Telix (TLX591)

In either case, the news seems significant enough to justify the current rise.

However this is still early stage with only 3 patients tested (cohort 2). And still a "science experiment" with no revenue till 2026 and why I've held back on putting any more in CU6. Seems fairly priced now.

[held]


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#Broker/Analyst Views
Added 4 months ago
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#Bull Case
Added 4 months ago

Interesting to see Clarity getting bid today.

There was a Bell Potter conference a few days ago

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Milestones to look out for

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[held]

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#ASX Announcements
stale
Last edited 10 months ago

Clarity’s theranostic prostate cancer trial advances to cohort 2

Highlights

• Cohort 1 of the SECuRE trial has been completed in 6 participants with metastatic castrate-resistant prostate cancer (mCRPC) who received therapy with 67 Cu SAR-bisPSMA at the lowest dose level of 4GBq.

• No dose limiting toxicities (DLTs) have been reported in cohort 1.

• The Safety Review Committee (SRC) has recommended that the trial continues to cohort 2.

• Recruitment has opened at clinical sites in the United States (US) at the cohort 2 dose level of 8GBq and patients are currently in screening for all available slots.

• Additional therapy cycles of 67 Cu SAR-bisPSMA have been requested by clinicians under the US Food and Drug Administration (FDA) Expanded Access Program (EAP).

• Early data from the EAP indicates positive effects of the lowest dose of 67 Cu SAR-bisPSMA on lesions, demonstrated by SPECT-CT images, with reduction in Prostate Specific Antigen (PSA) levels

My Notes:

In summary Clarity SECuRE trial is jumping straight into developing therapy treatment instead of just imaging (Propeller trial) and doctors are requesting the therapy be placed into the EAP (Expanded Access Program).

However I'm not sure if Clarity would receive any sales from being admitted into the EAP. Maybe someone with more knowledge of this subject can clarify

Some scans below from the announcement:

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Clarity pipeline below although the SECURE trial needs updating after the recent announcement

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Probably good news for those who bought the IPO at 1.50

[held]

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