Clarity Pharmaceuticals (ASX:CU6) Releases Q4 Activity Report
Financial Performance
Clarity Pharmaceuticals ended the December quarter with a cash position of $111.2 million, including $11 million receivable for the FY24 research and development tax incentive. Net operating cash outflows were $18.0 million, providing a cash runway through mid-2026.
Clinical Trials Progress
The SECuRE trial advanced cohort 4, with all three participants showing reductions in prostate-specific antigen (PSA) levels following doses of 12 GBq of 67Cu-SAR-bisPSMA, the largest drop being 98.2%. Additionally, patient case studies demonstrated complete and durable responses to multiple cycles of 67Cu-SAR-bisPSMA.
Regulatory Milestones
Clarity received Fast Track Designation from the U.S. FDA for 64Cu-SAR-bisPSMA for PET imaging in prostate cancer patients with biochemical recurrence. Positive feedback was also received for the AMPLIFY Phase III trial.
Market Achievement
In December 2024, Clarity entered the ASX200 index, recognising its growth from Australian science benchwork to a top 200 ASX company in just three years.
Executive Appointments
Michelle Parker was appointed Chief Executive Officer, bringing over 20 years of industry experience. Dr Colin Biggin continues as Chief Operating Officer, focusing on manufacturing and supply chains.
Research and Development
Clarity expanded its pipeline with SAR-bisFAP, a fibrobast activation protein-targeted radiopharmaceutical, and secured manufacturing agreements with Nucleus RadioPharma and SpectronRx to support ongoing and future Phase III trials.
Executive Comments
Dr Alan Taylor, Executive Chairperson, stated, “The news is especially timely as Clarity is actively preparing to commence recruitment for our second registrational trial, AMPLIFY, in the coming months. The FTD will allow us to work closely with the FDA to facilitate the development process and accelerate the approval of what could become a best-in-class diagnostic.”
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