My key takeaways from the quarterly report:CLARIFY trial in Cu64 as a diagnostic for pre-prostratectomy PC patients is due to complete the phase 3 trials in Feb 2025 following which they will apply to FDA for marketing approval.Key differentiator: Next day imaging and little/ no adverse effectsCOBRA (BCR) - Clarity is currently preparing for an End of Phase meeting with the US FDA, scheduled for the quarter ending 30 September 2024. The purpose of an End of Phase meeting is to determine the safety of proceeding to Phase III, to evaluate the Phase III plan and protocols and the adequacy of current studies.Key differentiator: Next day imaging and little/ no adverse effects. Lesions up to 2mm detected (specificity)Ver aptly named and described in this section:“SUPPLY AND MANUFACTURING: THE GAME CHANGER FOR RADIOPHARMACEUTICALSTargeted Copper Theranostics (TCTs) hold a number of competitive advantages, including clinical benefits, which Clarity is actively exploring through its clinical program.However, the key differentiators, which hold promise of taking radiopharmaceuticals into the large oncology market, are the logistical, manufacturing and environmental advantages associated with the production of copper isotopes for diagnostic imaging (copper-64) and therapy (copper-67).”Cash in hand: $136.5 Mn (34 quarters of cash available)R&D: We have spent $10Mn in the last quarter and $38.5Mn in the last year. We would be expecting about $16Mn in R&D tax refund.
Any mistakes are mine. AIMO.
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NEURIZON THERAPEUTICS LIMITED
Michael Thurn, CEO & MD
Michael Thurn
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