Clarity Pharmaceuticals Ltd. · ASX:CU6
Clarity Pharmaceuticals — Shareholder Meeting (November 2025)
24 slides from Clarity Pharmaceuticals's shareholder meeting presentation, Nov 25, 2025
Slide 1: Managing Director's Presentation
Managing Director’s Presentation Annual General Meeting 25 November 2025 Ms Michelle Parker
Slide 2: Disclaimer
Disclaimer Introduction This presentation has been prepared by Clarity Pharmaceuticals Ltd (ACN 143 005 341) (Clarity or the Company) No representation, warranty or assurance (express or implied) is given or made in relation to any forward-looking and contains summary information about Clarity and t
Slide 3: Key Highlights
Key Highlights • CLARIFY – registrational Phase III 64Cu-SAR-bisPSMA diagnostic trial in high-risk prostate cancer prior to radical prostatectomy. Final results from the trial are intended to support an application to the US Food and Drug Administration (FDA) for the approval of 64Cu-SAR-bisPSMA in
Slide 4: Clinical stage assets in multiple cancers
Clinical stage assets in multiple cancers Clarity’s products are progressing through sponsored clinical trials in the US and Australia Clinical development pipeline as of 25 November 2025 4
Slide 5: SAR-bisPSMA market opportunity
SAR-bisPSMA market opportunity PSMA-based diagnostics SAR-bisPSMA aims to disrupt current diagnostic and therapeutic utilisation as a potential best-in- • By 2030 the PSMA PET market is expected to grow to >700k scans per class agent for imaging and treating prostate year, representing a US market p
Slide 6: SAR-bisPSMA
SAR-bisPSMA Two Proprietary Positions Dual PSMA targeting What's all the hype? 1. Composition of matter on chelator Unique dimer with two that securely holds copper targeting molecules leads 2. Composition of matter on SAR- to increased tumour uptake bisPSMA dual targeting molecule Precision Targeti
Slide 7: Monomer vs Dimer
Monomer vs Dimer • Pluvicto® Superior performance of bisPSMA compared • SAR-bisPSMA • Pylarify® to monomer PSMA • Posluma® • 68Ga-PSMA-11 Significantly better binding and internalisation 7 Zia et al., 2019. Ang.Chem
Slide 8: SAR-bisPSMA
SAR-bisPSMA CLARIFY - Phase III • Registrational Phase III imaging trial of participants with high-risk prostate Targets the PSMA present in the majority of cancer prior to radical prostatectomy using 64Cu-SAR-bisPSMA prostate cancers • Fast-Track Designation granted by the US FDA • Recruitment ongo
Slide 9: 64Cu-SAR-bisPSMA in pre-prostatectomy
64Cu-SAR-bisPSMA in pre-prostatectomy PROPELLER trial showed improved diagnostic performance of 64Cu-SAR-bisPSMA compared to 68Ga-PSMA-11 on same-day imaging, including brighter and higher number of lesions identified as well as 2-3 times higher uptake and tumour-to- background ratio, favouring 64Cu
Slide 10: Registrational CLARIFY trial
Registrational CLARIFY trial Trial overview • Phase III registrational trial in high-risk prostate cancer patients prior to undergoing radical prostatectomy and pelvic lymph node dissection • Assessing same-day and next-day imaging of 64Cu-SAR-bisPSMA in this patient population • Recruitment is ongo
Slide 11: 64Cu-SAR-bisPSMA in biochemical recurrence
64Cu-SAR-bisPSMA in biochemical recurrence COBRA study identifies prostate cancer recurrence months before currently approved PSMA PET agents Number of lesions identified by 64Cu-SAR-bisPSMA detects lymph node missed by 68Ga-PSMA-11 64Cu-SAR-bisPSMA and SOC PSMA agents (SOC PET performed ~6 months l
Slide 12: Registrational AMPLIFY trial
Registrational AMPLIFY trial Trial overview • Phase III registrational trial in BCR of prostate cancer • Assessing same-day and next-day imaging of 64Cu-SAR-bisPSMA in this patient population • Recruitment is ongoing (total patients = 220) 1 2 3 4 Follow-up ↑PSA Same-day Next-day up to 52 weeks imag
Slide 13: Co-PSMA IIT achieves primary endpoint
Co-PSMA IIT achieves primary endpoint: Head-to-head trial of 64Cu-SAR-bisPSMA vs. 68Ga-PSMA-11 in low-PSA BCR Patient population Screening 64Cu-SAR-bisPSMA (200 MBq) Follow-up • Prior radical prostatectomy (confirmed adenocarcinoma of PC) 68Ga-PSMA-11 PET Same-day imaging Next-day imaging Salvage Rx
Slide 14: Therapy program with 67Cu-SAR-bisPSMA
Therapy program with Trial highlights 67Cu-SAR-bisPSMA • Dose Escalation completed, now recruiting into the Cohort Expansion phase (8 GBq). Trial overview • Favourable safety profile across all cohorts. • Phase I/II study in mCRPC • 68% of participants across all cohorts showed • Dose escalation fol
Slide 15: Three Fast Track Designations
Three Fast Track Designations Clarity has three US FDA FTDs for the SAR-bisPSMA agent Key benefits Indications • FTD is designed to expedite the development and regulatory review 64Cu-SAR-bisPSMA diagnostic product of novel drugs addressing serious • Granted two FTDs for PET imaging of PSMA-positive
Slide 16: SARTATE
SARTATE Targets the Somatostatin Receptor 2 (SSTR2), which is DISCO – Phase II present in NETs, among other cancers • A diagnostic imaging study of 64Cu-SARTATE using PET in patients with known or suspected NETs. • Topline data confirms that 64Cu-SARTATE is safe and highly effective compared to SOC
Slide 17: SAR-Bombesin
SAR-Bombesin Targets the Gastrin Releasing Peptide receptor (GRPr), SABRE – Phase II which is present in a number of cancers, including breast and prostate cancers • Phase II PET imaging trial of participants with PSMA-negative BCR of prostate cancer using 64Cu- SAR-Bombesin. • Topline data showed t
Slide 18: Robust IP driving the Discovery program
Robust IP driving the Discovery program Clarity’s proprietary SAR Technology platform can be used in conjunction with any number of targeting ligands to create new products and new IP Broad Patent Portfolio Discovery Engine Platform Protection Select high value cancer targets • Granted and new chela
Slide 19: 64/67Cu-SAR-bisFAP
64/67Cu-SAR-bisFAP • Tumour uptake and 24-hour retention of 64Cu-SAR-bisFAP Clarity is developing 64/67Cu-SAR-bisFAP as potential pan-cancer was higher than that of 64Cu-SAR-FAP and indicates theranostics targeting fibroblast activation protein (FAP). potential for therapeutic benefit using copper-6
Slide 20: 64/67Cu-SAR-trastuzumab
64/67Cu-SAR-trastuzumab Trastuzumab SAR Technology (biosimilar) SAR chelator securely Radioimmunotherapy (RIT) utilises antibodies to deliver Binds to HER2 holding the copper therapeutic radionuclides to tumour tissue. Conjugating the SAR expressed radioisotope used for Technology to trastuzumab has
Slide 21: Current industry challenges with 68Ga & 177Lu
Current industry challenges with 68Ga & 177Lu Clarity’s Solution with 64Cu & 67Cu Additional demands on existing supply as industry grows Global-scale commercial Time sensitive capacity for diagnostics products with and therapeutics Inability to control short shelf-lives the entire supply chain 100%
Slide 22: Scaling manufacturing for US commercial launch
Scaling manufacturing for US commercial launch Clarity continues to strengthen and expand its manufacturing and supply chain footprint ahead of US commercial launch Supply Agreement for Supply Agreement for Commercial Manufacturing copper-67 commercial-scale copper-64 Agreement for 64Cu-SAR-bisPSMA
Slide 23: Highly experienced team
Highly experienced team Clarity's management team has a diverse and in-depth level of expertise spanning corporate finance, management, clinical, Dr Alan Taylor Michelle Parker Dr Colin Biggin Eva Lengyelova operations, Executive Chairperson CEO and MD Chief Operating Officer EVP – Clinical Developm
Slide 24: Thank you
Thank you
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