CU6 - Clarity Pharmaceuticals

[System]

Clarity Pharmaceuticals is a clinical stage radiopharmaceutical company developing next-generation products to address the growing need for the use of radiopharmaceuticals in oncology.

Clarity is a global leader in Targeted Copper Theranostics (tct), developed with its proprietary SAR Technology platform. TCT are the next-generation disruptive platform in radiopharmaceuticals that employ the "perfect pairing" of copper-64 (64Cu) and copper-67 (67Cu) for diagnosis and therapy. TCT deliver a compelling combination of high accuracy and high precision in the treatment of a range of cancers, as well as providing supply and logistical advantages over current theranostics. TCT provide a highly efficacious, scalable, and cost-effective way to expand radiopharmaceuticals into the global oncology market.

Clarity was incorporated on 8 April 2010 and is headquartered in Sydney, Australia and has subsidiaries in Belgium and the US. As it is a clinical stage company, Clarity does not currently generate any revenue.

It is anticipated that CU6 will list on the ASX during August 2021.

Clarity Pharmaceuticals - Radiopharmaceutical Therapies and Diagnostics

Clarity is a clinical stage company developing products to address the growing need for the use of radiopharmaceuticals in oncology.

www.claritypharmaceuticals.com

 

[Dona Ferentes]

Listing date	25 August 2021 #
Contact details	Clarity Pharmaceuticals - Radiopharmaceutical Therapies and Diagnostics Clarity Pharmaceuticals is a radiopharmaceutical company focused on the treatment of serious diseases in adults and children. www.claritypharmaceuticals.com Ph: +61 2 9209 4037
Principal Activities	Clarity is a clinical stage radiopharmaceutical company developing next-generation theranostic (therapy and imaging) products, based on its platform SAR Technology.
GICS industry group	TBA
Issue Price	$1.40
Issue Type	Ordinary Fully Paid Shares
Security code	CU6
Capital to be Raised	$92,000,000
Expected offer close date	10 August 2021
Underwriter	Fully underwritten. Jefferies (Australia) Pty Ltd and Bell Potter Securities Limited (Joint Underwriters and Lead Managers)

still open !!

 

[noirua]

Clarity Pharmaceuticals (ASX:CU6) treats first patient in therapeutic prostate cancer trial

Clarity Pharmaceuticals (ASX:CU6) has dosed its first patient in its therapeutic prostate cancer trial.

themarketherald.com.au

Clarity Pharmaceuticals (CU6) has dosed its first patient in its therapeutic prostate cancer trial.

The study is a therapeutic phase of Clarity’s SAR-bisPSMA theranostic clinical trial, dubbed SECuRE, which is investigating targeted copper theranostics (TCTs) in patients with metastatic castrate-resistant prostate cancer.

 

[Country Lad]

That's interesting, no posts for a year. I was sure I had posted charts previously as I have a personal interest in its trial progress (and share price of course). Broke out again today.

 

[Country Lad]

That's interesting, no posts for a year. I was sure I had posted charts previously as I have a personal interest in its trial progress (and share price of course). Broke out again today.

For the non P&F people

 

[peter2]

Great break-out from triple bottom (Green arrow in your chart). Not on my trading radar due to low daily volume. Good up trend.

 

[Country Lad]

Great break-out from triple bottom (Green arrow in your chart). Not on my trading radar due to low daily volume. Good up trend.

I am happy with the volume.

338,000 daily average over the past 40 days
365,000 daily average over the past 30 days
456,000 daily average over the past 20 days and
723,000 daily average last 10 days.

262 million on issue

 

[peter2]

Reviewing my chart, I agree with you. There was sufficient volume being traded when both my setups were triggered.

$120K - 600K/d is sufficient for a position in a possible trend trade like CU6. For swing trades I prefer >$600K/d to be traded.

 

[Country Lad]

Phase 3 Trial commences

Highlights

• First patient safely dosed in the pivotal Phase III 64Cu-SAR-bisPSMA diagnostic trial, CLARIFY.
• The aim of the CLARIFY trial is to detect regional nodal metastases in participants with prostate cancer prior to
radical prostatectomy.
• Final results from the CLARIFY trial are intended to provide sufficient evidence to support an application to the
FDA for the approval of the 64Cu-SAR-bisPSMA product in pre-prostatectomy patients.

I would pick this one for the 2024 comp if I was participating.

 

[Dona Ferentes]

still going ... $2.11

since listing, has made back what it lost and 50 per cent on top

 

[Dona Ferentes]

still going ...
.....since listing, has made back what it lost and (more)

now with a $600 million market cap

.
spending a bit:

.
I noticed Argo have a position now (not in their Top20 though)

 

[Country Lad]

Interesting that there has been little interest in this one except for @peter2 and @Dona Ferentes. Lots of discussion's bout many of the train wrecks people are holding. Must be me and the the P&F charts that puts people off.
This one has been a +3 bagger for me in a reasonably short time.
Announcement today - good trial results and will be going onto Phase 3 trials

 

[Country Lad]

Announcement

https://announcements.asx.com.au/asxpdf/20240215/pdf/060f8rvvv0sc0r.pdf

 

[peter2]

After missing out on the best time to buy I've really tried to ignore this chart.
Thanks @Country Lad for the reminder that I can be such a stubborn fool. BO-NH >1.50, BO-NH >1.75, BO-NH >2.17, BO-NH >2.50

One of the best up trends in the ASX.

 

[Country Lad]

After missing out on the best time to buy I've really tried to ignore this chart.
Thanks @Country Lad for the reminder that I can be such a stubborn fool. BO-NH >1.50, BO-NH >1.75, BO-NH >2.17, BO-NH >2.50

One of the best up trends in the ASX.

Sorry @peter2 I didn't mean to trigger your regret. I thought you had entered this. I have outlined my system/technique a number of times here.
Interestingly, when I outlined the system to a couple of new members on our private group (why I haven't been here since November) using VEE as an example they saw it as a mechanical system - triggers hit BUY, stop hit SELL. Sorry a bit off topic - should discuss it elsewhere.

 

[peter2]

No concerns from me for your chart reminder. My scans show me the boxes and high volume bullish bars whenever they form and there's been a lot of them in the CU6 chart. It's my lack of consistent application that irks me the most. I do have a bias against pharma companies and this is the reason for my refusal to buy at the correct time.

 

[Dona Ferentes]

as mentioned by the nonurban bloke

Clarity is a global leader in next-generation radiopharmaceuticals with its Targeted Copper Theranostic (TCT) platform of products. Clarity’s products use the “perfect pairing” of copper isotopes, copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy, which deliver a compelling combination of high accuracy and high precision in the treatment of a range of cancers.

SAR-Bombesin targets the gastrin releasing peptide receptor (GRPr), a receptor present across a range of cancers, including breast and prostate cancers.
SARTATE targets the somatostatin receptor 2 (SSTR2), which is present in an aggressive childhood cancer, neuroblastoma, as well as neuroendocrine tumours (NETs), among other cancers.
SAR-bisPSMA has been optimised with two targeting agents that bind to prostate specific membrane antigen (PSMA), which is present in the majority of prostate cancers.

Clarity’s three core products, SAR-bisPSMA, SAR-Bombesin and SARTATE, each contain a different targeting agent and bind to different receptors that are present on different cancer cells. The three theranostic products are in clinical development for both diagnosis and treatment of various cancers and address unmet clinical needs. In addition to these core products, SAR Technology is used in Clarity’s Discovery Program, which explores new targeting agents, thereby creating new TCTs to expand the existing platform.

.
need to get my head around some of this

 

[Country Lad]

as mentioned by the nonurban bloke

need to get my head around some of this

@Dona Ferentes, the article below may help (the emphasis is mine for clarity). In a nutshell, Cu6 is developing products for the earlier and better detection of various cancers by PET scans. The lead product is for the detection of the spread of prostate cancer which most men will develop even if they die with it and not of it. In many cases even the removal of the prostrate may not have stopped the spread.

Currently, early detection of its spread to lymph nodes and other parts of the body is not possible with standard PET scans and by the time it is detected, treatment may not be effective. Phase III trials have started.

Cu6 is also developing other products for the early detection of other cance


Clarity Pharmaceuticals Ltd (ASX: CU6)

Clarity Pharmaceuticals share price has been on a positive run since late 2023. The share price increased 52.6% from 31 December 2023 to 29 February 2024 and is up 229.5% over the 12-months to 29 February 2024.

Clarity Pharmaceuticals is a clinical stage radiopharmaceutical company developing next generation products to address the growing need for better diagnostics and treatments in oncology through its Targeted Copper Theranostic (TNT) platform.

The Company has a strong balance sheet, with over $37.9 million in cash as at 31 December 2023. The addition of the RDTI of ~$10 million is expected to provide a cash runway into late 2024.

The Company has a number of ongoing clinical trials for its three core products, SAR-bisPSMA, SAR-Bombesin and SARTATE, each of which contain a different targeting agent and bind to different receptors that are present on different cancer cells.

In December 2023, the Company dosed the first patient in the Phase III CLARIFY trial. The trial is a non-randomised, open-label trial that will include 383 participants. The aim of the trial is assess the diagnostic performance of 64Cu-SAR-bisPSMA PET
to detect prostate cancer within the pelvic lymph nodes. The CLARIFY study is investigating if delayed imaging allows for improved disease detection. The longer half-life of 64Cu may not only allow the detection of additional cancerous lesions on delayed imaging but also provide a timely supply of products covering a broad geographic area and flexibility for the scheduling of patients.

According to the Company, currently approved diagnostic products have low sensitivity, meaning some lesions may remain undetected. Clarity’s SAR-bisPSMA product was developed in response to this issue. The dual PSMA targeting agent and delayed imaging feature have the potential to improve product uptake and retention in prostate cancer lesions.

In February, the Company announced the initial results of the Phase 1/2 COBRA trial, which showed that the Company’s SAR-bisPSMA is safe and effective in detecting tumours in prostate cancer patients with biochemical recurrence. In trial participants where the standard of care imaging was unable to detect any lesions, up to ~60% had lesions identified by same-day 64CU-SAR-bisPSMA imaging and up to 80% on next-day imaging, with high specificity.

The possibility of performing next-day imaging is a feature not available to currently approved PSMA-targeted PET products and unique to 64Cu-based SAR diagnostics due to the optimal half-life of 64Cu and the ability of the SAR Technology to prevent leakage of copper isotopes from the radiopharmaceutical in-vivo. The COBRA trial confirmed the benefits of delayed imaging in this patient group as more lesions and more patients with a positive scan were identified on next-day imaging. These results have seen the Company commence plans for a Phase III trial.

 

[Dona Ferentes]

@Dona Ferentes, the article below may help (the emphasis is mine for clarity). In a nutshell, Cu6 is developing products for the earlier and better detection of various cancers by PET scans. The lead product is for the detection of the spread of prostate cancer which most men will develop even if they die with it and not of it. In many cases even the removal of the prostrate may not have stopped the spread.

Currently, early detection of its spread to lymph nodes and other parts of the body is not possible with standard PET scans and by the time it is detected, treatment may not be effective. Phase III trials have started.

Cu6 is also developing other products for the early detection of other cance


Clarity Pharmaceuticals Ltd (ASX: CU6)

Clarity Pharmaceuticals share price has been on a positive run since late 2023. The share price increased 52.6% from 31 December 2023 to 29 February 2024 and is up 229.5% over the 12-months to 29 February 2024.

Clarity Pharmaceuticals is a clinical stage radiopharmaceutical company developing next generation products to address the growing need for better diagnostics and treatments in oncology through its Targeted Copper Theranostic (TNT) platform.

The Company has a strong balance sheet, with over $37.9 million in cash as at 31 December 2023. The addition of the RDTI of ~$10 million is expected to provide a cash runway into late 2024.

The Company has a number of ongoing clinical trials for its three core products, SAR-bisPSMA, SAR-Bombesin and SARTATE, each of which contain a different targeting agent and bind to different receptors that are present on different cancer cells.

In December 2023, the Company dosed the first patient in the Phase III CLARIFY trial. The trial is a non-randomised, open-label trial that will include 383 participants. The aim of the trial is assess the diagnostic performance of 64Cu-SAR-bisPSMA PET
to detect prostate cancer within the pelvic lymph nodes. The CLARIFY study is investigating if delayed imaging allows for improved disease detection. The longer half-life of 64Cu may not only allow the detection of additional cancerous lesions on delayed imaging but also provide a timely supply of products covering a broad geographic area and flexibility for the scheduling of patients.

According to the Company, currently approved diagnostic products have low sensitivity, meaning some lesions may remain undetected. Clarity’s SAR-bisPSMA product was developed in response to this issue. The dual PSMA targeting agent and delayed imaging feature have the potential to improve product uptake and retention in prostate cancer lesions.

In February, the Company announced the initial results of the Phase 1/2 COBRA trial, which showed that the Company’s SAR-bisPSMA is safe and effective in detecting tumours in prostate cancer patients with biochemical recurrence. In trial participants where the standard of care imaging was unable to detect any lesions, up to ~60% had lesions identified by same-day 64CU-SAR-bisPSMA imaging and up to 80% on next-day imaging, with high specificity.

The possibility of performing next-day imaging is a feature not available to currently approved PSMA-targeted PET products and unique to 64Cu-based SAR diagnostics due to the optimal half-life of 64Cu and the ability of the SAR Technology to prevent leakage of copper isotopes from the radiopharmaceutical in-vivo. The COBRA trial confirmed the benefits of delayed imaging in this patient group as more lesions and more patients with a positive scan were identified on next-day imaging. These results have seen the Company commence plans for a Phase III trial.

thanks CL,

pertinent and relevant... having recently, like many with BPH, gone through the investigation process.

First a UTI , with discomfort and bleeding , and antibiotics, referral, ultrasound, bloods, then MRI and then PET, identified lesion, monitor and etc. Seems to have settled down and not malignant. Another follow-up next month.

PET was useful as I'd had prior melanomas excised and no current exhibition. It's now 18 months, so anything that can shorten or narrow down the diagnosis would be useful.

 

[Country Lad]

thanks CL,

pertinent and relevant... having recently, like many with BPH, gone through the investigation process.

First a UTI , with discomfort and bleeding , and antibiotics, referral, ultrasound, bloods, then MRI and then PET, identified lesion, monitor and etc. Seems to have settled down and not malignant. Another follow-up next month.

PET was useful as I'd had prior melanomas excised and no current exhibition. It's now 18 months, so anything that can shorten or narrow down the diagnosis would be useful.

@Dona Ferentes, my Gleeson score was 4+3 so on watch only with regular PSA blood tests. Likely die with it, not of it. The prostrate PET scan is specifically for the PSM antigen (prostate-specific membrane antigen) and doesn't show up any other type of cancer including the melanocytes. I had the full body PSMA PET scan which showed only the lesions in the prostate and not the lung cancer. Of course the probability of prostate cancel increases substantially with age.

This should probably be in the Men's Health topic, particularly if there is to be further discussion. @Joe Blow ????