CU6 - Clarity Pharmaceuticals

Country Lad said:

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

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If there is further discussion it should definitely be in the Men's Health thread to avoid taking this thread off topic. However, as it stands I don't think any posts from this thread need to be moved as I don't think it's really gone too far off topic yet.

But if it's a discussion you'd like to expand on and discuss further then yes, please move it to the other thread.

Highlights
• Launch of fully underwritten equity raising of $121 million (before costs), at $2.55 a share
• The offer will comprise an institutional placement to raise approximately $101 million, and a 1 for 33 pro-rata accelerated non-renounceable entitlement offer to eligible Clarity shareholders to raise approximately $20 million
• Post completion of the Offer Clarity will have a pro-forma cash balance of $153.2 million (net of costs of the offer) and expects to be funded for its current clinical program through to early 2026
• Clarity now has the funding in place to continue to develop its best-in-class portfolio of radiopharmaceuticals and progress towards a number of significant milestones in its therapeutic and diagnostic product pipeline
• The capital raising provides Clarity with a strengthened balance sheet at a time when there has been significant M&A activity and strong strategic interest in radiopharmaceutical assets.

CU6 making another break-out and has bolted higher again. CU6 is NOT a copper miner!

peter2 said:

CU6 making another break-out and has bolted higher again. CU6 is NOT a copper miner

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Clarity shares are up 75 per cent in the past month after it revealed that the first prostate cancer patient dosed with two cycles of its revolutionary drug, known as 67Cu-SAR-bisPSMA, achieved a complete response to treatment.

The patient, suffering metastatic castration-resistant prostate cancer, had previously failed hormone therapy, an investigational agent and chemotherapy.

The five-year survival rate for metastatic CPRC is currently only 30 per cent.

“Having that dramatic response is incredible because we have built the product from scratch,” CEO Dr Alan Taylor says of the trial, known as SECuRE. “We hope to replicate this remarkable result in many patients, and confirm the favourable safety profile of this agent.”


"Our goal has been to be the most successful homegrown life sciences company that hasn’t had to rely on venture capital. Every one of our private and public funding rounds has been done with ordinary equity.”

The latest in April was a fully underwritten equity raising of $121m, the first since its IPO, taking the company’s cash position to a healthy $150m.

Its shareholders include Argo Investments, Antares Capital, Thorney Technologies and the Perennial Future of Healthcare Fund.

Funding from the capital raising will support ongoing research and development, and the clinical trials of Clarity’s therapeutic and diagnostic products in Australia and the United States.

Clarity now has five open investigational new drug applications with the FDA, covering all six current clinical stage products that have received clearance to proceed to clinical trials.

It has also received approvals from the US Food and Drug Administration for two orphan drug designations and two rare paediatric disease designations.

now $6.30 ... has risen from 2 bucks this CY

Country Lad said:

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

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Dona Ferentes said:

now $6.30 ... has risen from 2 bucks this CY

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I have had a good run with this from 86 cents and topping up now and then.
HOWEVER, it is now capitalised at about $2.5 billion without an approved product in the market. I think it has outpaced its real value so we have parted company.

This will help when they get the product to market:
The US Centers for Medicare & Medicaid Services (CMS) published a decision to start separate payments for specialised diagnostic radiopharmaceuticals.

“This is a major win for the molecular imaging industry, promising relative price stability and continued patient access to radiopharmaceutical diagnostics ” said Wilsons analyst Dr Shane Storey.

This will benefit both TLX Telix and CU6 Clarity Pharmacueticals.

Telix’s CEO for precision medicine Kevin Richardson says the ruling, which applies to outpatients, will “provide certainty for patients and physicians seeking access to safe and effective diagnostic radiopharmaceuticals”.

He says it will also encourage investment in new imaging agents “as there is a clear commercial pathway to recouping the investment.”

The ruling potentially also could benefit Clarity Pharmaceuticals (ASX:CU6). Clarity is at phase III stage of trialling developing a copper-isotope based prostate imaging agent. With a longer half-life, this agent could enable detection of additional lesions not apparent on day one.

“The ruling] brings price stability for incumbents and therefore nullifies opportunities to grab opportunistic adoption or market share ” Dr Storey says.

Clarity’s new “pan-cancer” radiopharmaceutical​

By Adrian Tan |

Clarity Pharmaceuticals (ASX:CU6) has expanded its cancer treatment pipeline with the development of a novel radiopharmaceutical called "SAR-bisFAP". This new product is designed for both diagnosis and treatment, and has possible "pan-cancer opportunity".

What's in a name?
Radiopharmaceuticals combine two components: a radioactive isotope and a targeting molecule. The targeting molecule directs the isotope to a specific site in the body, like a cancer cell or a tumour, while the isotope can be used to destroy or diagnose (for instance, they can be seen by a PET scan). The isotope decays over time, becoming non-radioactive and being cleared from the body.

The "SAR" in SAR-bisFAP refers to Clarity's "Specific Activity Radiopharmaceutical" platform, which allows copper isotopes (copper-64 for imaging and copper-67 for therapy) to be efficiently attached to a targeting molecule.
The "FAP" stands for "Fibroblast Activation Protein". This is a type of protein found on fibroblasts (a type of connective tissue cell) associated with cancer. FAP is present in a wide range of cancers, including breast, colorectal, pancreatic, lung, brain and ovarian cancers, but it isn't usually found in healthy tissue.
"Bis" refers to the fact that SAR-bisFAP has two binding sites. It can attach to two FAP molecules at once, which provides better ability for SAR-bisFAP to bind and stay bound. In Clarity’s preclinical trials, SAR-bisFAP showed 8x greater retention and 4x greater uptake compared to industry-standard compounds like FAPI-46.

Next steps
The company is conducting additional investigations to enable a Phase I clinical trial, which could start in late 2025. Clarity’s development of SAR-bisFAP follows the success of its SAR-bisPSMA product for prostate cancer.

I've been following this for a while but don't hold. It's getting to where I'm tempted to take a position.

in the S&P/ASX200 as of early Dec

though there's been a bit of a sell-off

.
market cap close to $1.5B

covered by the smaller end of town

One of my picks for the 2025 competition.

2024 was stellar until the last quarter. The trend isn't good now and it may not find support until it gets to around $3.

Nevertheless, biotechs are a roller coaster and it could take off again on one announcement. I like the work that the company is doing and management at ARG are believers too.

I don't hold but will look to get in when I have some confidence that the downtrend is broken.

The FDA has granted Fast Track Designation for 64Cu-SAR-bisPSMA for positron emission tomography imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions in patients with biochemical recurrence (BCR) of prostate cancer following definitive therapy.

This milestone builds on Clarity’s earlier receipt of an FTD for 64Cu-SAR-bisPSMA in patients with suspected metastasis of prostate cancer who are candidates for initial definitive therapy. These 2 FTDs enable the Company to accelerate the development of its comprehensive diagnostic program with this product.

I thought CU6 might drift down to $3, but the price has stabilised over the last fortnight and this announcement helps.

I'm a holder now, in at $4.16. As with any biotech, I'm prepared to lose my capital on this, if that's the way it goes.

the buzz from last week's fast-track news wore off.



Quarterly came out on 31/01
Cash Position
The Company’s cash position at the end of the December quarter was $111.2 million, with a further $11 million receivable
for the FY24 research and development tax incentive. Net operating cash outflows for the December quarter were $18.0 million. This combined funding of circa $122 million is expected to provide cash runway through to mid-2026.

... lots of molecules, lots of science, lots of trials, lots of data gathered. Lots of news