Clarity Pharmaceuticals Ltd (ASX: CU6), a clinical-stage radiopharmaceutical Company specialising in targeted copper theranostics, has reported steady operational progress across its diagnostic and therapeutic programs for the quarter ending 31 December 2025. The Company closed the period with a robust $226.2 million cash balance, supporting its transition toward late-stage clinical development and eventual commercialisation.
Clarity Pharmaceuticals continues to scale its copper-based theranostic platform as multiple late-stage trials progress. (Source: Clarity Labs)
The quarter featured advancement across Clarity’s key programs, SAR-bisPSMA, SARTATE, and SAR-Bombesin, as well as new developments in its manufacturing supply chain and discovery pipeline. With multiple Phase III trials underway and an additional registrational study scheduled to begin in 2026, the Company continues to position itself as a frontrunner in next-generation radiopharmaceuticals.
Key Findings / Results
Clarity’s quarterly report highlights significant milestones across clinical, regulatory, and operational domains.
Quarterly Highlights
- Cash position of $226.2 million as at 31 December 2025.
- SECuRE Phase II interim data support progression toward Phase III.
- Co-PSMA trial achieves primary endpoint ahead of March 2026 EAU Congress presentation.
- Registrational 64Cu-SARTATE Phase III trial cleared to commence in 2026 following FDA agreement.
- Supply agreement with Nusano to secure large-scale copper-67 production starting in 2026.
- Positive preclinical results for SAR-bisFAP, a next-generation pan-cancer theranostic.
These achievements consolidate the Company’s position relative to global peers in the radiopharmaceutical sector, particularly as Clarity’s copper-based isotopes offer advantages over widely used gallium- and lutetium-based agents, which face supply and scalability constraints.
Economic and Strategic Benefits
The Company’s progress aligns with rising global demand for radiopharmaceutical diagnostics and therapies, especially in prostate cancer and neuroendocrine tumours (NETs). With the US prostate cancer diagnostic market estimated at US$2 billion annually, and forecasts exceeding US$3 billion by 2029, Clarity’s dual copper-isotope approach continues to attract investor interest.
Executive Chairperson Dr Alan Taylor said the Company’s data continues to validate its scientific strategy and commercial potential:
Executive Chairperson Dr Alan Taylor. (Source: AFR)
“The quality and significance of the data we are generating underline the benefits of our targeted copper theranostic platform. With three Fast Track Designations from the FDA, we are moving steadily toward bringing best-in-class products to market.”
Taylor added that strengthening the copper-67 supply chain was “critical to scaling reliably and cost-effectively” to meet future commercial demand.
Resource & Exploration (Clinical Development) Updates
SAR-bisPSMA Program — Prostate Cancer
Clarity’s lead theranostic, SAR-bisPSMA, is progressing across several trials:
- SECuRE (Phase I/IIa):
Interim results in the Cohort Expansion Phase show strong PSA response rates among participants with metastatic castrate-resistant prostate cancer (mCRPC), including one patient achieving undetectable PSA and no radiological evidence of disease after three cycles. The agent continues to demonstrate a favourable safety profile, with most adverse events graded mild to moderate. - AMPLIFY (Phase III):
Recruitment continues for this 220-patient diagnostic trial assessing 64Cu-SAR-bisPSMA in biochemical recurrence (BCR) of prostate cancer. - CLARIFY (Phase III):
The Company’s first registrational trial, targeting high-risk prostate cancer patients undergoing radical prostatectomy, also continues recruitment. - Co-PSMA (Phase II IIT):
The investigator-initiated study achieved its primary endpoint, demonstrating significantly higher detection rates of PSMA-positive lesions using 64Cu-SAR-bisPSMA compared with standard-of-care 68Ga-PSMA-11. Full data will be presented at the European Association of Urology (EAU) Congress in March 2026.
SARTATE Program — Neuroendocrine Tumours (NETs)
Following a successful End of Phase meeting with the US FDA, Clarity will commence a registrational Phase III trial of 64Cu-SARTATE in 2026. Earlier Phase II (DISCO) results demonstrated:
- Approximately double the lesion detection of SOC 68Ga-DOTATATE.
- Statistically significant sensitivity improvements across multiple regions.
- A favourable safety profile, with only minor adverse events reported.
Discovery Pipeline — SAR-bisFAP
Clarity continues expanding its early-stage pipeline. SAR-bisFAP, a dual-targeting FAP-directed theranostic, showed:
- Superior tumour targeting and retention in preclinical glioblastoma models.
- Improved therapeutic efficacy compared with both monomeric FAP agents and industry benchmarks.
Market & Strategic Context
Radiopharmaceuticals represent one of the fastest-growing segments in oncology, driven by the demand for more precise, personalised cancer therapies. However, scalability remains a key challenge across the industry. Clarity’s copper-based products—especially given the longer half-life of copper-64 and the scalable accelerator-based production of copper-67—offer a competitive advantage in both manufacturing and distribution.
The newly signed supply agreement with Nusano, alongside existing partnerships with NorthStar and Idaho Accelerator Centre, provides Clarity with a diversified and resilient supply chain as it prepares for potential commercial roll-out.
With nine quarters of funding runway and multiple pivotal trials advancing, Clarity remains well-positioned to transition from a development-stage biotech to a commercial radiopharmaceutical manufacturer.
FAQs
- What is the main highlight from Clarity Pharmaceuticals’ December 2025 quarter?
Clarity advanced multiple late-stage trials across its SAR-bisPSMA, SARTATE, and SAR-Bombesin programs, strengthened its copper-67 supply chain, and ended the quarter with a strong $226.2 million cash balance.
- What clinical trials are currently in Phase III?
Three Phase III programs are active or commencing:
- AMPLIFY – 64Cu-SAR-bisPSMA in biochemical recurrence of prostate cancer
- CLARIFY – 64Cu-SAR-bisPSMA in high-risk prostate cancer pre-surgery
- SARTATE Phase III (NETs) – approved to begin recruitment in 2026
- What were the key findings from the SECuRE Phase II trial?
Interim results showed strong PSA response rates, including one participant achieving undetectable PSA and no detectable disease on imaging, with a favourable safety profile.
- Why is the Co-PSMA study significant?
The investigator-initiated trial reported that 64Cu-SAR-bisPSMA detected significantly more PSMA-positive lesions in low-PSA patients compared with the standard-of-care 68Ga-PSMA-11. Full data will be presented at EAU 2026.
- What progress has been made in neuroendocrine tumour (NET) imaging?
The SARTATE program is advancing to a registrational Phase III trial after Phase II DISCO data showed substantially higher lesion detection than SOC 68Ga-DOTATATE.
- Why is copper-67 supply important for Clarity?
Copper-67 is essential for therapeutic radiopharmaceuticals. Clarity secured additional supply through a partnership with Nusano, supporting scalability as the Company moves toward commercialisation.
- How strong is the Company’s financial position?
Clarity held $226.2 million in cash at the end of the quarter, equal to approximately nine quarters of operating runway.
- What is Clarity’s broader strategy in the radiopharmaceutical market?
Clarity aims to deliver next-generation copper-based theranostics that improve imaging accuracy, enhance treatment precision, and overcome global isotope supply limitations.
- What is the significance of the FDA Fast Track Designations?
Clarity has three Fast Track Designations for SAR-bisPSMA, two diagnostic and one therapeutic, which may accelerate regulatory review and commercial timelines.
- What new developments emerged from Clarity’s discovery program?
SAR-bisFAP, a dual-targeting fibroblast activation protein theranostic, showed improved tumour targeting and survival outcomes in preclinical models, reinforcing pipeline depth.
