Clarity Pharmaceuticals Ltd. · ASX:CU6
Clarity Pharmaceuticals — Investor Presentation (August 2026)
64 slides from Clarity Pharmaceuticals's investor presentation, Aug 10, 2026
Slide 1: Pipeline and Clinical Update
Pipeline and Clinical Update Dr Alan Taylor Executive Chairperson Aug 2026 All Clarity products mentioned in this presentation are investigational products and not approved by the US Food and Drug Administration (FDA).
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: Clarity's Vision: from Australia's benchtop to blockbuster
Clarity’s Vision: from Australia’s benchtop to blockbuster Building Australia's most successful pharmaceutical biotech from intellectual property (IP) derived from the benchtop of Australian science Discovery in Australia’s Clinical development to the Commercialisation leading research highest stand
Slide 4: Australian science that created pharmaceutical blockbusters
Australian science that created pharmaceutical blockbusters Blockbuster status, i.e. more than US$1 billion in annual sales, is a milestone only a few products originated from Australian science have ever reached Gardasil Venclexta Relenza Ojjaara NEXT CHAPTER HPV (Human Targeted cancer therapy Anti
Slide 5: SAR-bisPSMA
SAR-bisPSMA Multiple proprietary positions 1. Composition of matter on chelator that securely holds copper • Proprietary SAR Technology 2. Composition of matter on SAR- bisPSMA dual targeting agent • Optimised targeting • Same product for imaging & therapy • Improved patient management • First diffe
Slide 6: Three FDA Fast Track Designations granted
Three FDA Fast Track Designations granted Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range o
Slide 7: SAR-bisPSMA diagnostic market opportunity
SAR-bisPSMA diagnostic market opportunity SAR-bisPSMA aims to disrupt current diagnostic and therapeutic utilisation as a potential best-in-class agent for imaging and treating prostate cancer PSMA-based diagnostics: Significant market opportunity • By 2030 the PSMA PET market is expected to grow to
Slide 8: Australian innovation challenging the PSMA PET standard
Australian innovation challenging the PSMA PET standard 64Cu-SAR-bisPSMA 68Ga-PSMA-111,2* 18F-DCFPyL3,4* 18F-rhPSMA-7.35,6* Country of origin of the Australia Germany US Germany innovation University of Melbourne / German Cancer Research Technical University of Innovator Center (DKFZ), Heidelberg Jo
Slide 9: Sensitivity remains a major limitation of currently approved PSMA PET agents
Sensitivity remains a major limitation of currently approved PSMA PET agents None of the pivotal studies used for the registration of the currently FDA-approved PSMA PET agents met their predefined sensitivity primary endpoint Primary Endpoints* • The 68Ga-PSMA-11 pivotal study did not meet either i
Slide 10: 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* 68Ga-PSMA-11* 64Cu-PSMA-I&T 18F-PSMA1007 Considerably improved binding and internalisation 10 * FDA-approved products Zia et al., 20
Slide 11: SAR-bisPSMA clinical development program
SAR-bisPSMA Extensive clinical development program in the pre-prostatectomy and biochemical recurrence settings Ongoing trials Completed Completed trials trials CLARIFY - Phase III in pre-prostatectomy1 PROPELLER – Phase I in pre-prostatectomy4 • Registrational Phase III imaging • First-in-human PET
Slide 12: SAR-bisPSMA: building a comprehensive body of evidence
SAR-bisPSMA: building a comprehensive body of evidence 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 trials 12 P
Slide 13: 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-PSMA 1 1 1 2 1 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 of Day 1, With
Slide 14: 64Cu-SAR-bisPSMA in Pre-definitive Treatment Settings
64Cu-SAR-bisPSMA in Pre-definitive Treatment Settings: PROPELLER CLARIFY
Slide 15: 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 Screening Key eligibility criteria (n=30) Period 64Cu-SAR-bisPSMA 68Ga-PSMA-11 sequential admi
Slide 16: 64Cu-SAR-bisPSMA yielded higher tumour uptake and detected more lesions than 68Ga-PSMA-11
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 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 lesions identified t
Slide 17: 64Cu-SAR-bisPSMA identifies more lesions on same-day imaging vs. 68Ga-PSMA-11
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 64Cu-SAR-bisPSMA identified more total Among participa
Slide 18: Higher lesion uptake and TBR vs. 68Ga-PSMA-11
64Cu-SAR-bisPSMA shows higher lesion uptake and TBR vs. 68Ga-PSMA-11 on same-day imaging 80 2.7-fold 68Ga-PSMA-11 increase 64Cu-SAR-bisPSMA *** 70 64Cu-SAR-bisPSMA scans were Standardised Uptake Value 60 associated with statistically 50 2.5-fold significant: increase *** • Higher SUVmax 40 2.6-fold
Slide 19: 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 64Cu-SAR-bisPSMA PET outperformed 68Ga-PSMA-11 PET in this head- to-head comparison in pre-prostatectomy pa
Slide 20: CLARIFY Phase III trial: recruiting
CLARIFY Phase III trial: recruiting Registrational trial in participants with high-risk prostate cancer prior to undergoing radical prostatectomy and pelvic lymph node dissection Screening 64Cu-SAR-bisPSMA Safety Post-Histopathology Key eligibility criteria Period (200 MBq) Call Follow-Up Period (n=
Slide 21: 64Cu-SAR-bisPSMA in biochemical recurrence
64Cu-SAR-bisPSMA in biochemical recurrence: COBRA AMPLIFY Co-PSMA
Slide 22: 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 Screening 64Cu-SAR-bisPSMA Safety Key eligibility criteria Follow-Up Period Period (200 MBq; 5.4 mCi) Visit (n=50) Ne
Slide 23: 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 Same-day imaging Nex-day imaging The number of lesions identified by % of 64Cu-SAR-bisPSMA PET-positive 64Cu-
Slide 24: Higher uptake and contrast on next-day vs. same-day imaging
Higher uptake and contrast in lesions on next-day vs. same-day imaging allows for detection of lesions in the 2-millimeter range 64Cu-SAR-bisPSMA PET SUVmean and SUVmax in lesions Tumour-to-background ratio (TBR) of detected by 64Cu-SAR-bisPSMA lesions detected by 64Cu-SAR-bisPSMA Same-day imaging N
Slide 25: 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 64Cu-SAR-bisPSMA and SOC PSMA agents 68Ga-PSMA-11 (SOC PET performed ~6 months later) 60 53 64Cu-SAR-bisPSMA Next-day imaging Prostate 50
Slide 26: 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 Next-day imaging increased lesion detection by 82%, with the total number of identified lesions increasing from 70 to 129 (average across readers) More participan
Slide 27: AMPLIFY Phase III trial: recruitment completed
AMPLIFY Phase III trial: recruitment completed with 232 patients dosed and imaged Registrational trial of participants with BCR of prostate cancer at sites in the US and Australia Screening 64Cu-SAR-bisPSMA Key eligibility criteria (n=220) Period injection (200 MBq) Follow-Up Period • Histologically
Slide 28: 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 Management Impact Management Impact Key Eligibility Questionnaire Questionnaire (initial) (post-6
Slide 29: Co-PSMA: Improved diagnostic performance vs. 68Ga-PSMA-11 in early BCR
Co-PSMA: Improved diagnostic performance with next-day 64Cu-SAR-bisPSMA PET vs. 68Ga-PSMA-11 in early BCR* 64Cu-SAR-bisPSMA detected 2.6x more lesions per patient than 68Ga-PSMA-11 Number of lesions per participant Total number of lesions Participants with a positive scan Mean difference 0.78; Ratio
Slide 30: 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 vs. 0.75
Slide 31: Co-PSMA: Next-day PET drove treatment change in more participants
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 66% 90% of participants with planned active of participants with planned active management management 17/50 (34%) Observation 5/50 (10%) 34/5
Slide 32: 64Cu-SAR-bisPSMA outperformed 68Ga-PSMA-11 in all measured parameters
64Cu-SAR-bisPSMA outperformed Participant-level detection of prostate cancer by tracer 68Ga-PSMA-11 in all measured parameters 64Cu-SAR-bisPSMA 64Cu-SAR-bisPSMA vs. 68Ga-PSMA-11 demonstrated: • Higher number of patients with a positive scan • Higher true positive rate • Higher number of lesions • Hi
Slide 33: Real World Evidence
Real World Evidence Compassionate Use Program cases
Slide 34: Real-world lesion detection after negative SOC PSMA PET
Closing the diagnostic gap: real-world Key findings 64Cu-SAR-bisPSMA lesion detection after negative SOC PSMA PET 8/10 patients had lesions detected with 64Cu-SAR-bisPSMA An unmet need persists for improved PSMA imaging, 80% Total of 19 lesions identified on next- despite availability of SOC PSMA PE
Slide 35: 64Cu-SAR-bisPSMA PET detects disease missed by Siemens Biograph Vision Quadra
64Cu-SAR-bisPSMA PET detects Key findings disease missed by Siemens 64Cu-SAR-bisPSMA imaging was positive in all patients Biograph Vision Quadra Background 2X more lesions detected on next-day (n=12) compared to same-day (n=6) imaging • Five patients with BCR of PC (PSA 0.3 – 13.3 ng/mL) 12 Number o
Slide 36: Case highlight: lesions detected 24 days after a negative 18F-DCFPyL
Case highlight: 64Cu-SAR-bisPSMA detected lesions only 24 days after a negative 18F-DCFPyL PSMA PET on Siemens Biograph Vision Quadra 64Cu-SAR-bisPSMA detected 4 lesions Same-day imaging Next-day imaging Patient with BCR Negative 18F-DCFPyL* Same-day 24 days Next-day Change in management Localised r
Slide 37: Summary of real-world evidence cases
Summary of real-world evidence cases 64Cu-SAR-bisPSMA: confirming outcomes in real-world cases seen in the clinical trial setting There is a need for a more sensitive PSMA PET agent despite the availability of current SOC PET agents 64Cu-SAR-bisPSMA identified lesions in 8 out of 10 patients whose S
Slide 38: Separating signal from noise: addressing competitive claims
Separating signal from noise: addressing competitive claims Lesion detection and clinical impact Competitive claim What the data show Takeaway • Same-day imaging remains clinically relevant: Co-PSMA showed similar same-day detection rate with 64Cu-SAR-bisPSMA (34%) vs. 68Ga-PSMA-11 (36%), while PROP
Slide 39: Separating signal from noise: addressing competitive claims
Separating signal from noise: addressing competitive claims Camera technology and clinical workflow Competitive claim What the data show Takeaway • Published prospective evidence supporting improved detection using current PSMA PET agents with advanced cameras, particularly at low PSA, remains limit
Slide 40: Separating signal from noise: addressing competitive claims
Separating signal from noise: addressing competitive claims The value of delayed imaging Competitive claim What the data show Takeaway • Co-PSMA showed that 64Cu-SAR-bisPSMA at 1 hour performed similarly to 68Ga-PSMA-11 (detection rate 34% vs. 36%, respectively) • PROPELLER showed improved same-day
Slide 41: Separating signal from noise: addressing competitive claims
Separating signal from noise: addressing competitive claims Differentiation and market uptake Competitive claim What the data show Takeaway • The current competitive landscape has limited differentiation among approved PSMA PET agents with similar structural and isotopic characteristics • Commercial
Slide 42: High demand for effective diagnostic PSMA PET agents
High demand for effective diagnostic PSMA PET agents that lead to high patient impact “I am a high-volume prostate cancer surgeon, with many of my patients in the higher risk category. I have been operating on these patients for many years and routinely do nodal dissection. I have not found Ga 68 PE
Slide 43: 67Cu-SAR-bisPSMA therapy in prostate cancer: SECuRE
67Cu-SAR-bisPSMA therapy in prostate cancer SECuRE
Slide 44: SECuRE Phase I/IIa trial: recruiting
SECuRE Phase I/IIa trial: recruiting Phase I/IIa, dose-escalation, dose-finding and cohort expansion theranostic trial of 64/67Cu-SAR-bisPSMA for identification and treatment of participants with mCRPC 12 GBq 8 GBq Patient population (2 + 2 additional cycles) (2 + 4 additional cycles) 12 • Patients
Slide 45: Patient characteristics: heavily pre-treated patient group
Patient characteristics: heavily pre-treated patient group with most having bone metastasis Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort Expansion Total (N=6) (N=3) (N=6) (N=7) (N=16) (N=38) Location of Metastases Bone 6 (100%) 2 (66.7%) 4 (66.7%) 5 (71.4%) 10 (62.5%) 27 (71.1%) Lymph Node 1 (16.7%) 2
Slide 46: Safety overview: mostly mild/moderate adverse events
Safety overview: most adverse events were mild/moderate, indicating a favourable safety profile of 67Cu-SAR-bisPSMA Most common related adverse events (AEs) regardless of severity Cohort Expansion All Participants at 8 GBq (N=16) cycles (N=19) n (%) Grades 1/2 Grades 1/2 Among participants who recei
Slide 47: High PSA response rates across 8 GBq participants
High PSA response rates across 8 GBq participants (Cohort 2 + Cohort Expansion) Pooled 8 GBq (Dose Escalation + Response rates across participants (8 GBq cycles) Cohort Expansion) 80% 74% 70% Percentage of participants 63% 60% Key response rates 53% 50% 40% 63% 30% 26% PSA50 response 20% 10% 26% 0%
Slide 48: 8 GBq leads to PSA reductions and complete responses in mCRPC
67Cu-SAR-bisPSMA 8 GBq leads to PSA reductions and complete responses/undetectable disease in mCRPC participants A total of 19 participants have received 67Cu-SAR-bisPSMA at 8 GBq (Cohort 2 and Cohort Expansion phase), which demonstrated anti-tumour effect and favourable safety profile PSA50 in 63%
Slide 49: 8 GBq leads to undetectable disease in mCRPC
67Cu-SAR-bisPSMA 8 GBq leads to undetectable disease in mCRPC (assessed by PSA and imaging) Cohort Expansion Patient A Patient B Baseline Post-67Cu-SAR-bisPSMA Baseline Post-67Cu-SAR-bisPSMA (Bone metastasis) (2 x 8 GBq) (Nodal metastasis) (2 x 8 GBq) • No evidence of disease reported following the
Slide 50: SECuRE summary
SECuRE 67Cu-SAR-bisPSMA 8 GBq cycles show strong anti-tumour efficacy with a favourable safety profile in mCRPC High PSA response rates at 8 GBq, with PSA reductions ≥25%, ≥50%, ≥75% and ≥90% observed in 74%, 63%, 53% and 26% of participants, respectively Evidence of deep anti-tumour activity, inclu
Slide 51: 64Cu-SARTATE clinical development in NETs
64Cu-SARTATE clinical development in NETs
Slide 52: SARTATE
SARTATE SAR chelator Cage securely holding the SARTATE is a next-generation, highly targeted theranostic radioisotope radiopharmaceutical. It is being developed for diagnosing, staging and subsequently treating cancers that express 64Cu somatostatin receptor 2 (SSTR2). Clarity is prioritising the Di
Slide 53: DISCO Phase II trial: completed
DISCO Phase II trial: completed Prospective, single-arm, non-randomised, blinded-review study in participants with known or suspected gastroenteropancreatic NETs (GEP-NETs) 64Cu-SARTATE Key Eligibility Criteria Screening Period Follow-Up Period (200 MBq; 5.4 mCi) • Known diagnosis of GEP- NET or sus
Slide 54: 64Cu-SARTATE: improved lesion detection vs. 68Ga-DOTATATE
64Cu-SARTATE: improved lesion detection and greater sensitivity vs. 68Ga-DOTATATE 68Ga-DOTATATE 64Cu-SARTATE 64Cu-SARTATE vs. 68Ga-DOTATATE* ~2x more foci (441 vs. 228, respectively) Higher sensitivity (discordant lesion-level) (95.1% vs. 5.0%, respectively; P<0.001) 64Cu-SARTATE High foci-liver SUV
Slide 55: 64Cu-SAR-Bombesin
64Cu-SAR-Bombesin
Slide 56: 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 th
Slide 57: Discovery Pipeline
Discovery Pipeline
Slide 58: Comprehensive pipeline from discovery to late-stage development
Comprehensive pipeline from discovery to late-stage development Clarity’s products are progressing through various company-sponsored clinical trials in the US and Australia CLARIFY and AMPLIFY are being conducted in the US and in Australia. SECuRE is being conducted in the US. SARTATE Phase III is p
Slide 59: 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 60: 64/67Cu-SAR-bisFAP
64/67Cu-SAR-bisFAP • Tumour uptake and 24-hour retention of 64Cu-SAR-bisFAP was higher than that of 64Cu-SAR-FAP and indicates Clarity is developing 64/67Cu-SAR-bisFAP as potential pan-cancer potential for therapeutic benefit using copper-67. theranostic targeting fibroblast activation protein (FAP)
Slide 61: 64/67Cu-SAR-trastuzumab
64/67Cu-SAR-trastuzumab Radioimmunotherapy (RIT) utilises antibodies to deliver Trastuzumab SAR Technology (biosimilar) SAR chelator(s) securely therapeutic radionuclides to tumour tissue. Conjugating the SAR Binds to HER2 holding the copper Technology to trastuzumab has shown: expressed radioisotop
Slide 62: Abundant copper-64 capacity ready for commercial launch
Extended shelf-life and Abundant copper-64 capacity imaging window ready for commercial launch Current contracted base capacity vs. PSMA diagnostic product market size characteristics 2,500,000 vs. F-18 2,000,000 Ga-68 1,500,000 Cu-64 1,000,000 0 10 20 30 40 50 60 500,000 Imaging window Typical shel
Slide 63: Highly experienced team
Highly experienced team Clarity's management team has a diverse and in-depth level of expertise spanning corporate finance, management, clinical, operations, commercialisation Dr Alan Taylor Michelle Parker Dr Colin Biggin Eva Lengyelova and industry Executive Chairperson CEO and MD Chief Operating
Slide 64: Thank you
Thank you
Clarity Pharmaceuticals — Investor Presentation (August 2026) on 6ix