External broker reports(aggregated public sources), Wilsons Advisory

Wilsons Advisory

External broker reports(aggregated public sources)

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Equity Bottom-Up

Clarity Pharmaceuticals Ltd / Equity Bottom-Up

<div><div><div><ul><li>Clarity have provided an update regarding their SeCuRE trial – the PSMA theranostic trial assessing the identification and treatment of metastatic, castrate-resistant prostate cancer (mCRPC) using Clarity’s 64Cu/67Cu-SAR-bisPSMA targeted copper theranostic (TCT) pair.</li><li>The release of the early data reveal is positive – there were no safety issues reported with 67Cu (at a 4GBq dose level), meaning that the trial can progress to Cohort 2 (utilizing an 8GBq dose).</li><li>Importantly, even with the lower dose used in Cohort 1, there is already evidence of clinical</li></ul></div></div></div><p><em>Content is external broker report sourced from online content aggregator through publicly available sources and is displayed below for general informational purposes only. Refer full disclaimer below.</em></p>

Clarity have provided an update regarding their SeCuRE trial – the PSMA theranostic trial assessing the identification and treatment of metastatic, castrate-resistant prostate cancer (mCRPC) using Clarity’s 64Cu/67Cu-SAR-bisPSMA targeted copper theranostic (TCT) pair.The release of the early data reveal is positive – there were no safety issues reported with 67Cu (at a 4GBq dose level), meaning that the trial can progress to Cohort 2 (utilizing an 8GBq dose).Importantly, even with the lower dose used in Cohort 1, there is already evidence of clinicalContent is external broker report sourced from online content aggregator through publicly available sources and is displayed below for general informational purposes only. Refer full disclaimer below.

Clarity Pharmaceuticals (CU6) - First Look at 67Cu Therapy Data

<ul><li>We maintain our OVERWEIGHT rating on Clarity Pharmaceuticals and risked price target of $1.22/sh.</li><li>Clarity have unveiled further detail from their Phase I/II PROPELLER trial with their prostate cancer diagnostic asset - 64Cu-SAR-bisPSMA.</li><li>Clarity announced in December the trial hit its primary endpoints, however today we see further detail regarding the safety profile and accuracy of the diagnostic versus the new standard of care (68Ga-PSMA-11). </li></ul><p><em>Content is external broker report sourced from online content aggregator through publicly available sources and is displayed below for general informational purposes only. Refer full disclaimer below.</em></p>

We maintain our OVERWEIGHT rating on Clarity Pharmaceuticals and risked price target of $1.22/sh.Clarity have unveiled further detail from their Phase I/II PROPELLER trial with their prostate cancer diagnostic asset - 64Cu-SAR-bisPSMA.Clarity announced in December the trial hit its primary endpoints, however today we see further detail regarding the safety profile and accuracy of the diagnostic versus the new standard of care (68Ga-PSMA-11). Content is external broker report sourced from online content aggregator through publicly available sources and is displayed below for general informational purposes only. Refer full disclaimer below.

Clarity Pharmaceuticals (CU6) - Clarity’s Copper Play Stacks up Vs New SOC

<ul>
<li>Clarity have announced that PROPELLER, their Phase I diagnostic trial assessing 64Cu-SAR- bisPSMA in detecting prostate cancer, has met all primary and secondary endpoints.</li>
<li>As outlined in our most recent note, this trial represents a significant de-risking point for the company, validating the use of their SAR copper platform, and, transitioning the company into a pivotal trial stage in 2023, with Clarity confirming start of a pivotal Phase III for this diagnostic asset next year.</li>
<li>Full data on 64Cu SAR-bisPSMA will be released at the American Society of Clinical Oncology (ASCO) Genitourinary (GU) Symposium in February 2023.</li>
</ul>
<p><em>Content is external broker report sourced from online content aggregator through publicly available sources and is displayed below for general informational purposes only. Refer full disclaimer below.</em></p>


Clarity have announced that PROPELLER, their Phase I diagnostic trial assessing 64Cu-SAR- bisPSMA in detecting prostate cancer, has met all primary and secondary endpoints.
As outlined in our most recent note, this trial represents a significant de-risking point for the company, validating the use of their SAR copper platform, and, transitioning the company into a pivotal trial stage in 2023, with Clarity confirming start of a pivotal Phase III for this diagnostic asset next year.
Full data on 64Cu SAR-bisPSMA will be released at the American Society of Clinical Oncology (ASCO) Genitourinary (GU) Symposium in February 2023.

Content is external broker report sourced from online content aggregator through publicly available sources and is displayed below for general informational purposes only. Refer full disclaimer below.

Clarity Pharmaceuticals (CU6) - Propulsion of Value with Positive Topline Results

<div><div><div><ul><li>We maintain our OVERWEIGHT rating on Clarity Pharmaceuticals with a revised price target of $1.22/sh.</li><li>We view the upcoming release of Clarity’s Phase I/II PROPELLER trial results for their 64Cu-SAR-bisPSMA in prostate cancer diagnosis as a de-risking event, with clear signals towards a positive outcome.</li><li>The readout represents an important step in Clarity’s development to a) verify the efficacy of their coupled SAR-copper technology; and b) transition the company into ‘pivotal- trial stage’, as Clarity move closer towards unlocking revenue to support longer-term programs. </li></ul></div></div></div><p><em>Content is external broker report sourced from online content aggregator through publicly available sources and is displayed below for general informational purposes only. Refer full disclaimer below.</em></p>

We maintain our OVERWEIGHT rating on Clarity Pharmaceuticals with a revised price target of $1.22/sh.We view the upcoming release of Clarity’s Phase I/II PROPELLER trial results for their 64Cu-SAR-bisPSMA in prostate cancer diagnosis as a de-risking event, with clear signals towards a positive outcome.The readout represents an important step in Clarity’s development to a) verify the efficacy of their coupled SAR-copper technology; and b) transition the company into ‘pivotal- trial stage’, as Clarity move closer towards unlocking revenue to support longer-term programs. Content is external broker report sourced from online content aggregator through publicly available sources and is displayed below for general informational purposes only. Refer full disclaimer below.

Clarity Pharmaceuticals (CU6) - PROPELLED to Upgrade

<ul><li><span data-sheets-value='{"1":2,"2":"Content is external broker report sourced from online content aggregator through publicly available sources and is displayed below for general informational purposes only. Refer full disclaimer below."}' data-sheets-userformat='{"2":33281,"3":{"1":0},"12":0,"18":1}'>Over the weekend, in a 16-0 vote, the FDA’s Oncologic Drug Advisory Committee (ODAC) decided Y-mAbs therapeutics’ omburtamab (commercialized as OMBLASTYS®) had not provided sufficient evidence to conclude improvement in overall survival for the treatment of central nervous system (CNS)/leptomeningeal metastasis from paediatric neuroblastoma. </span></li><li><span data-sheets-value='{"1":2,"2":"Content is external broker report sourced from online content aggregator through publicly available sources and is displayed below for general informational purposes only. Refer full disclaimer below."}' data-sheets-userformat='{"2":33281,"3":{"1":0},"12":0,"18":1}'>The PDUFA date had been set for November 30 2022, following BLA submission in April this year. </span></li><li><span data-sheets-value='{"1":2,"2":"Content is external broker report sourced from online content aggregator through publicly available sources and is displayed below for general informational purposes only. Refer full disclaimer below."}' data-sheets-userformat='{"2":33281,"3":{"1":0},"12":0,"18":1}'>Omburtamab represented the potential expansion of Y-mAb’s neuroblastoma treatment offering following FDA approval of their DANYELZATM drug in 2020. </span></li></ul><p><em>Content is external broker report sourced from online content aggregator through publicly available sources and is displayed below for general informational purposes only. Refer full disclaimer below.</em></p>

Over the weekend, in a 16-0 vote, the FDA’s Oncologic Drug Advisory Committee (ODAC) decided Y-mAbs therapeutics’ omburtamab (commercialized as OMBLASTYS®) had not provided sufficient evidence to conclude improvement in overall survival for the treatment of central nervous system (CNS)/leptomeningeal metastasis from paediatric neuroblastoma. The PDUFA date had been set for November 30 2022, following BLA submission in April this year. Omburtamab represented the potential expansion of Y-mAb’s neuroblastoma treatment offering following FDA approval of their DANYELZATM drug in 2020. Content is external broker report sourced from online content aggregator through publicly available sources and is displayed below for general informational purposes only. Refer full disclaimer below.

Clarity Pharmaceuticals (CU6) - FDA No-Go for Y-MAb’s Neuroblastoma Drug

Australia

Clarity Pharmaceuticals Limited operates as a radio-pharmaceutical company. The Company focuses on the developing targeted therapies for the treatment of cancer and other serious diseases. Clarity Pharmaceuticals serves customers worldwide.

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Clarity Pharmaceuticals Ltd (CU6 AU)

Clarity Pharmaceuticals (CU6) - First Look at 67Cu Therapy Data

The release of the early data reveal is positive – there were no safety issues reported with 67Cu (at a 4GBq dose level), meaning that the trial...

Wilsons Advisory

Clarity Pharmaceuticals (CU6) - Clarity’s Copper Play Stacks up Vs New SOC

Clarity have unveiled further detail from their Phase I/II PROPELLER trial with their prostate cancer diagnostic asset - 64Cu-SAR-bisPSMA.

Wilsons Advisory

Clarity Pharmaceuticals (CU6) - Propulsion of Value with Positive Topline Results

Clarity have announced that PROPELLER, their Phase I diagnostic trial assessing 64Cu-SAR- bisPSMA in detecting prostate cancer, has met all primary...

Wilsons Advisory

Clarity Pharmaceuticals (CU6) - PROPELLED to Upgrade

We view the upcoming release of Clarity’s Phase I/II PROPELLER trial results for their 64Cu-SAR-bisPSMA in prostate cancer diagnosis as a de...

Wilsons Advisory

Clarity Pharmaceuticals (CU6) - FDA No-Go for Y-MAb’s Neuroblastoma Drug

The negative outcome isn’t the first for Y-mAbs. The BLA for omburtamab was originally submitted to the FDA in August 2020.

Wilsons Advisory

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