Clarity Pharmaceuticals Ltd. · ASX:CU6

Clarity Pharmaceuticals — Drug & Device Conference (October 2026)

26 slides from Clarity Pharmaceuticals's conference presentation, Oct 13, 2026

  1. Slide 1: SAR-bisPSMA: A sensitive story

    rsonal use only SAR-bisPSMA: A sensitive story Drug & Device Conference Dr Alan Taylor Executive Chairperson 12 October 2026 For investor purposes only All Clarity products mentioned in this presentation are investigational products and not approved by the US Food and Drug Administration (FDA).

  2. 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

  3. Slide 3: Beyond positivity: measuring scan and product performance

    Beyond positivity: measuring scan and product performance Sensitivity, specificity and correct detection rate require a reference standard, detection rate does not REFERENCE STANDARD rsonal use only Sensitivity TP / (TP + FN) Disease Present Disease Absent If disease is present, is the scan positive

  4. Slide 4: Approved PSMA PET agents did not detect pelvic nodal disease in most patients

    Approved PSMA PET agents did not detect pelvic nodal disease in most patients with nodal metastases, based on FDA labels/pivotal studies No pivotal study of currently FDA-approved PSMA PET agents met their predefined sensitivity primary endpoint* rsonal use only Sensitivity is determined by histopat

  5. Slide 5: The sensitive topic of sensitivity

    The sensitive topic of sensitivity Detection rate and positivity rate are not the same as sensitivity CLAIMED CONFIRMED BY HISTOPATHOLOGY FDA PRESCRIBING INFORMATION rsonal use only Histopathology Positive Negative PET Positive 14 9 scan Negative 16 84 Total 30 93 Diagnostic Sensitivity Specificity

  6. Slide 6: Australian innovation challenging the PSMA PET standard

    Australian innovation challenging the PSMA PET standard 64Cu-SAR-bisPSMA 68Ga-PSMA-111-3* 18F-DCFPyL4-6* 18F-rhPSMA-7.37-9* Country of origin of the Australia Germany US Germany innovation rsonal use only University of Melbourne / German Cancer Research Technical University of Innovator Johns Hopkin

  7. Slide 7: SAR-bisPSMA Two Proprietary Positions

    SAR-bisPSMA Two Proprietary Positions 1. Composition of matter on chelator that securely holds copper • Proprietary SAR Technology 2. Composition of matter on • Optimised targeting SAR-bisPSMA dual targeting agent • Same product for imaging & rsonal use only therapy • Improved patient management • F

  8. Slide 8: Monovalent SAR-PSMA vs. SAR-bisPSMA Bivalent

    Monovalent SAR-PSMA vs. SAR-bisPSMA Bivalent Monovalent Bivalent 64/67Cu-SAR-bisPSMA 177Lu-PSMA-617* 18F-DCFPyL* Higher uptake and prolonged retention 18F- rhPSMA-7.3* rsonal use only 68Ga-PSMA-11* 64Cu-PSMA-I&T 18F-PSMA1007 Considerably improved binding and internalisation 8 * FDA-approved products

  9. Slide 9: SAR-bisPSMA: a body of evidence built for success

    SAR-bisPSMA: a body of evidence built for success rsonal use only Patients Scans performed Trials Countries 750+ 1,500+ 6 2 across trials and 64Cu-SAR-bisPSMA same- Phase I to Australia and USA compassionate use day and/or next-day registrational Phase III access imaging and investigator- initiated

  10. Slide 10: SAR-bisPSMA clinical development program

    SAR-bisPSMA clinical development program Ongoing trials Completed trials Completed trials rsonal use only CLARIFY - Phase III in pre-prostatectomy PROPELLER – Phase I in pre-prostatectomy • Registrational Phase III imaging • First-in-human PET imaging trial trial of participants with high-risk prost

  11. Slide 11: 64Cu-SAR-bisPSMA PET vs. SOC PSMA PET

    64Cu-SAR-bisPSMA PET vs. SOC* PSMA PET Performance of 64Cu-SAR-bisPSMA PET vs. SOC PSMA PET assessed in all trials Co-PSMA2 1 1 1 1 rsonal use only SOC PSMA PET SOC PSMA PET SOC PSMA PET SOC PSMA PET SOC PSMA PET Median 20.5 days (2-50) Within 60 days of Day 0, Median 2 days (IQR 1-8) Within 60 days

  12. Slide 12: PROPELLER Phase I trial: completed

    PROPELLER Phase I trial: completed First-in-human, dose-ranging study evaluating safety and preliminary efficacy of 64Cu-SAR-bisPSMA in participants with untreated, histopathology-confirmed prostate cancer rsonal use only Key eligibility criteria (n=30) Screening Period 64Cu-SAR-bisPSMA 68Ga-PSMA-11

  13. Slide 13: 64Cu-SAR-bisPSMA yielded higher tumour uptake and detected more lesions

    64Cu-SAR-bisPSMA yielded higher tumour uptake and detected more lesions than 68Ga-PSMA-11 on same-day imaging in first head-to-head trial rsonal use only Improved diagnostic performance of 64Cu-SAR-bisPSMA Higher number of 2-3 times higher uptake and compared to 68Ga-PSMA-11 on same-day imaging lesi

  14. Slide 14: 64Cu-SAR-bisPSMA identifies more lesions on same-day imaging

    64Cu-SAR-bisPSMA identifies more lesions on same-day imaging vs. 68Ga-PSMA-11 Prospective intra-patient comparison demonstrates that 64Cu-SAR-bisPSMA same-day imaging detects more lesions than 68Ga-PSMA-11 and outperforms it in most participants rsonal use only 64Cu-SAR-bisPSMA identified more total

  15. Slide 15: PROPELLER: First-in-human study

    PROPELLER: First-in-human study First study to demonstrate improved diagnostic performance of 64Cu-SAR-bisPSMA PET over SOC PSMA PET in detecting primary prostate cancer prior to prostatectomy rsonal use only 64Cu-SAR-bisPSMA PET outperformed 68Ga-PSMA-11 PET in this head-to-head comparison in pre-p

  16. Slide 16: COBRA Phase I/II trial: completed

    COBRA Phase I/II trial: completed Phase I/II trial assessing the safety and efficacy of 64Cu-SAR-bisPSMA in patients with BCR of prostate cancer and negative or equivocal SOC imaging rsonal use only Key eligibility criteria Screening 64Cu-SAR-bisPSMA Safety Follow-Up Period Period (200 MBq; 5.4 mCi)

  17. Slide 17: More lesions and patients with a positive scan on next-day imaging

    More lesions and patients with a positive scan identified by 64Cu-SAR-bisPSMA on next-day imaging 64Cu-SAR-bisPSMA Next-day imaging identified additional lesions compared to same-day imaging rsonal use only Same-day imaging Nex-day imaging The number of lesions identified by % of 64Cu-SAR-bisPSMA PE

  18. Slide 18: 64Cu-SAR-bisPSMA identifies lesions months before approved PSMA PET agents

    64Cu-SAR-bisPSMA identifies lesions months before currently approved PSMA PET agents Number of lesions identified by 64Cu-SAR-bisPSMA detects lymph node missed by rsonal use only 64Cu-SAR-bisPSMA and SOC PSMA agents 68Ga-PSMA-11 (SOC PET performed ~6 months later) 60 53 64Cu-SAR-bisPSMA Next-day ima

  19. Slide 19: 64Cu-SAR-bisPSMA: closing the diagnostic gap in prostate cancer recurrence

    64Cu-SAR-bisPSMA: closing the diagnostic gap in prostate cancer recurrence BCR patients with a negative/equivocal SOC scan at study entry rsonal use only Next-day imaging increased lesion detection by 82%, with the total number of identified lesions increasing from 70 to 129 (average across readers)

  20. Slide 20: Co-PSMA Phase II investigator-initiated trial: completed

    Co-PSMA Phase II investigator-initiated trial: completed This prospective single-arm imaging trial enrolled 50 participants and evaluated the comparative performance of 64Cu-SAR-bisPSMA vs. 68Ga-PSMA-11 rsonal use only Management Impact Management Impact Key Eligibility Questionnaire Questionnaire (

  21. Slide 21: Co-PSMA: Improved diagnostic performance with next-day 64Cu-SAR-bisPSMA PET

    Co-PSMA: Improved diagnostic performance with next-day 64Cu-SAR-bisPSMA PET vs. 68Ga-PSMA-11 in early BCR* Primary endpoint met: next-day 64Cu-SAR-bisPSMA PET detected 2.6x more lesions per participant than 68Ga-PSMA-11 (p < 0.0001) rsonal use only Number of lesions per participant Total number of l

  22. Slide 22: Co-PSMA: more lesions per patient and higher true positive rate

    Co-PSMA: 64Cu-SAR-bisPSMA detected more lesions per patient and a higher true positive rate than 68Ga-PSMA-11 Near-perfect inter-reader agreement: very high level of reliability in scan interpretation between different nuclear medicine specialists Kappa score of 0.94 (95% CI: 0.83-1.00) for 64Cu-SAR

  23. Slide 23: Co-PSMA: Next-day PET drove treatment change

    Co-PSMA: Next-day 64Cu-SAR-bisPSMA PET drove treatment change in more participants with early BCR* in comparison to 68Ga-PSMA-11 68Ga-PSMA-11 64Cu-SAR-bisPSMA rsonal use only 66% 90% of participants with planned active of participants with planned active management management 17/50 (34%) Observation

  24. Slide 24: Co-PSMA builds on head-to-head evidence, helping bridge the diagnostic gap

    Co-PSMA builds on head-to-head Participant-level detection of prostate cancer by tracer evidence, helping bridge the diagnostic gap 64Cu-SAR-bisPSMA rsonal use only Next-day 64Cu-SAR-bisPSMA PET outperforms 68Ga-PSMA-11 • Higher number of patients with a positive scan (78% vs. 36%) • Higher true pos

  25. Slide 25: CLARIFY and AMPLIFY: registrational Phase III trials

    CLARIFY and AMPLIFY: registrational Phase III trials designed to measure diagnostic performance against defined reference standards rsonal use only Topline data 1HCY2027 Topline data 1HCY2027 Pre-prostatectomy, high-risk prostate cancer (n=383) Biochemical recurrence (n=232) REFERENCE STANDARD REFER

  26. Slide 26: Thank you

    Thank you A\uo asn yeuosie

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