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CLARITY PHARMACEUTICALS 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 ) .
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Disclaimer Introduction This presentation has been prepared by Clarity Pharmaceuticals Ltd (ACN 143 005 341) (Clarity or the Company) and contains summary information about Clarity and the business conducted by it as at 10 August 2026. The information in this presentation is for general informational purposes only, does not purport to be complete or comprise all information which a shareholder or potential investor may require in order to determine whether to deal in Clarity shares. It should be read in conjunction with the Company’s IPO prospectus and other periodic and continuous disclosure announcements lodged with the ASX. This presentation is not a prospectus, product disclosure statement or other disclosure document for the purposes of Chapter 6D or Part 7.9 of the Corporations Act 2001 (Cth) (Act) or other offer document under Australian law or the law of any other jurisdiction, including the United States. Although reasonable care has been taken to ensure that the facts stated in this presentation are accurate and the opinions expressed are fair and reasonable, none of Clarity, nor its advisers (Advisers) nor their respective affiliates, related bodies corporate (as defined in the Act) or securityholders and their respective directors, officers, employees, partners, representatives, consultants, agents or advisers (each a Limited Party and together, the Limited Parties) make any representation or warranty to, or takes responsibility for, the content of this presentation, and nothing contained in this document is, or may be relied upon as, a promise or representation, whether as to the past or future. To the maximum extent permitted by law, the Limited Parties disclaim all liability and responsibility (including without limitation any liability arising from fault or negligence) for any direct or indirect loss or damage which may arise or be suffered through use or reliance on anything contained in, or omitted from, this presentation. Forward looking statements The information contained in this presentation is given for illustrative purposes only and should not be relied upon as (and is not) an indication of Clarity’s views on future performance or condition. Past performance cannot be relied upon as an indicator of future performance. This presentation contains certain forward-looking statements. The words “forecast”, “estimate”, “like”, “anticipate”, “opinion”, “believe”, “expect”, “project”, “predict”, “intend”, “propose”, “should”, “could”, “may” and other similar expressions are intended to identify future earnings, financial position and performance of Clarity. You are cautioned not to place undue reliance on these statements. These forward-looking statements are based on estimates, projections and assumptions made by Clarity about circumstances and events that have not yet taken place. Although due care and attention has been used in the preparation of these statements, such forward-looking statements are based on numerous assumptions regarding Clarity’s present and future business strategies and the political, regulatory and economic environment in which Clarity will operate in the future, and are subject to change without notice. Statements about market and industry trends, which are based on interpretations of current market conditions, may not be reasonable, and are not guarantees or predictions of future performance. Actual results from any clinical trial may vary from any result that is anticipated. Under no circumstances will anything in this presentation create an implication that there has been no change in the affairs of the Company since the date of this presentation. The actual results or performance of Clarity may be materially different from the results or performance expressed or implied by such forward-looking statements. No representation, warranty or assurance (express or implied) is given or made in relation to any forward-looking statement by any person (including any of the Limited Parties). In particular, no representation, warranty or assurance (express or implied) is given that the occurrence of the events expressed or implied in any forward- looking statement in this presentation will actually occur. Subject to any continuing obligations under applicable law, the Company expressly disclaims any obligation or undertaking to provide any updates or revisions to any forward- looking statements in this presentation to reflect any change in expectations in relation to any forward-looking statement or any change in events, conditions or circumstances on which any statement is based. Not an offer or financial product advice The information contained in this presentation is for informational purposes only and should not be considered, and does not contain or purport to contain, an offer, invitation, solicitation or recommendation with respect the purchase or sale of any securities in Clarity (Securities) nor does it constitute legal, taxation, financial product or investment advice. The general information in this presentation has been prepared without taking into account the investment objectives, financial situation or particular needs of any particular person. This presentation does not constitute an advertisement for an offer or proposed offer of Securities. Investors must undertake their own independent investigations, consideration and evaluation. Neither this presentation nor any of its contents will form the basis of any contract or commitment and it is not intended to induce or solicit any person to engage in any transaction nor is it intended to be used as the basis for making an investment decision. This document does not constitute any part of any offer to sell, or the solicitation of an offer to buy, any securities in the United States or to, or for the account or benefit of, any “US person” as defined in Regulation S under the US Securities Act of 1993 (Securities Act). Clarity recommends that potential investors consult their professional advisors as an investment in Clarity is subject to investment and other known and unknown risks, some of which are beyond the control of Clarity or its directors and therefore any investment is considered to be speculative in nature. Market and industry data and other information Certain market and industry data and other information used in this presentation may have been obtained from research, surveys or studies conducted by third parties, including industry or general publications. Neither the Company nor its representatives or its advisers have independently verified, or can assure investors as to the accuracy of, any market or industry data or other information provided by third parties or industry or general publications. Photographs and diagrams used in this presentation that do not have descriptions are for illustration only and should not be interpreted to mean that any person shown in them endorses this presentation or its contents or that the assets shown in them are owned by the Company. Diagrams used in this presentation are illustrative only and may not be drawn to scale. General Statements made in this presentation are made only as at the date of this presentation. The information in this presentation remains subject to change without notice. The Company may in its absolute discretion, but without being under any obligation to do so, update or supplement this presentation. Any further information will be provided subject to the terms and conditions contained in this Disclaimer. Products All products discussed in this presentation are investigational only and are not approved by the US Food and Drug Administration (FDA) or Therapeutic Goods Authority (TGA, Australia).
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Clarity’s Vision: from Australia’s benchtop to blockbuster 3 Building Australia's most successful pharmaceutical biotech from intellectual property (IP) derived from the benchtop of Australian science Discovery in Australia’s leading research organisations, generating strong IP Clinical development to the highest standard of scientific rigour Commercialisation into blockbuster markets with high unmet needs
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Australian science that created pharmaceutical blockbusters 4 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 Venclexta Targeted cancer therapy for blood cancers like Chronic Lymphocytic Leukemia and Acute Myeloid Leukemia USD 1.3Bn in 2025 Origin: Walter and Eliza Hall Institute Commercialisation: AbbVie and Roche/Genentech Gardasil HPV (Human papillomavirus) vaccine for the prevention of cervical, anal and genital cancers USD 8.9Bn in 2023 Origin: University of Queensland Commercialisation: CSL & Merck (MSD) Relenza Anti-viral medication to treat and prevent influenza ~USD 1.0Bn in 2009 Origin: Monash University, ANU CSIRO & Biota Commercialisation: GlaxoSmithKline (GSK) NEXT CHAPTER 64Cu-SAR-bisPSMA Targeted Copper Theranostics, PSMA PET diagnostics Multi-billion Market size prediction for 2030+ Aiming to join Australia’s blockbuster club Origin: Collaboration between University of Melbourne and Clarity Development: Ojjaara Oral medication to treat myelofibrosis USD 835M 2025 Origin: Ludwig Institute for Cancer Research Melbourne Commercialisation: GlaxoSmithKline (GSK) Sources: Company Financial Reports - Merck MSD for Gardasil (2023), Abbvie for Venclexta (2025) and GlaxoSmithKline for Relenza (2009). https://www.datainsightsmarket.com/reports/momelotinib-1148805 for Ojjaara. This may be a non-exhaustive list. Revenues shown for context only; not a forecast of Clarity’s results. “Multi-billion” refers to the total future potential prostate-specific membrane antigen (PSMA) positron emission tomography (PET) diagnostic market.
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Dual PSMA targeting Unique dimer with two targeting molecules leads to increased tumour uptake and retention Copper isotopes (64Cu/67Cu) Myriad benefits ideally suited for today's radiopharmaceutical market SAR-bisPSMA • Proprietary SAR Technology • Optimised targeting • Same product for imaging & therapy • Improved patient management • First differentiated PSMA diagnostic • Broad impact in patient care • Manufacturing & supply advantages 5 Multiple proprietary positions 1. Composition of matter on chelator that securely holds copper 2. Composition of matter on SAR- bisPSMA dual targeting agent
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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 of serious conditions. 6 Diagnostic: 64Cu-SAR-bisPSMA Therapy: 67Cu-SAR-bisPSMA PET imaging of PSMA-positive prostate cancer lesions in: Patients with suspected metastasis who are candidates for initial definitive therapy; Patients with biochemical recurrence of prostate cancer following definitive therapy Treatment of adult patients with PSMA-positive metastatic castration- resistant prostate cancer (mCRPC) who have been previously treated with an androgen receptor pathway inhibitor (ARPI). 1 2 3
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SAR-bisPSMA diagnostic market opportunity 7 PSMA-based diagnostics: Significant market opportunity • By 2030 the PSMA PET market is expected to grow to >700k scans per year, representing a US market potential of >US$3Bn/year • As PSMA PET use expands to additional patient populations in 2030+, the market is expected to continue to grow to US$5-6Bn • 2025 US Centres for Medicaid and Medicare Services (CMS) reimbursement changes favour the long-term potential of the best- in-class PSMA PET agent $43 $527 $855 $1,060 $990 $- $101 $324 $509 $621 $- $200 $400 $600 $800 $1,000 $1,200 2021 2022 2023 2024 2025US Sales ($M USD) – PSMA PET Diagnostics* Pylarify Illuccix *US sales for Locametz, Posluma and other PSMA PET diagnostics are not publicly available. Data pulled from Telix and Lantheus press releases and investor reports. SAR-bisPSMA aims to disrupt current diagnostic and therapeutic utilisation as a potential best-in-class agent for imaging and treating prostate cancer
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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 innovation Australia Germany US Germany Innovator University of Melbourne / Clarity collaboration German Cancer Research Center (DKFZ), Heidelberg Johns Hopkins University Technical University of Munich (TUM) Clinical development sponsor Clarity Academia Progenics/Lantheus Blue Earth Diagnostics Patent Active No patent protection Active Active Targeting moiety Bivalent targeting PSMA Monovalent targeting PSMA Monovalent targeting PSMA Monovalent targeting PSMA Isotope half-life 64Cu (12.7 h) 68Ga (1.1 h) 18F (1.8 h) 18 F (1.8 h) Product shelf-life Up to 48 h 4-6 h 10 h 10 h Imaging window (post-administration) 1 to 30 hrs 50 to 100 min Start at 1 h Start at 1 h Sensitivity 40% (prespecified primary endpoint not met) 40% (prespecified primary endpoint not met) 27% (prespecified endpoint not met) Specificity 95% (prespecified primary endpoint not met) 98% 95% 1. Hope T et al., JAMA Oncol. 2021;7;(11):1635-1642. 2.GOZELLIX® (gallium Ga 68 gozetotide injection) prescribing information. FDA; 2025. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219592s000lbl.pdf. 3.Pienta KJ et al Osprey J Urol. 2021;206(1):52-61. 4. PYLARIFY TRUVU® (piflufolastat F 18) prescribing information. FDA; 2026. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220089Orig1s000lbl.pdf. 5. Surasi DS el al LIGHTHOUSE Eur Urol 2023;84:361-370. 6. POSLUMA® (flotufolastat F 18) prescribing information. FDA; 2023. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216023s000lbl.pdf. * Primary endpoints related to the registrational trials in the pre-prostatectomy setting respective to each product. Source: FDA Center for Drug Evaluation and Research, Multi-Discipline Review Differences in study design and patient populations preclude direct cross-trial comparisons. 64Cu-SAR-bisPSMA data on file. Starting image acquisition more than 90 minutes after injection may adversely impact imaging performance4Delayed imaging with 68Ga-PSMA-11 beyond 100 minutes not approved by FDA2
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9 Sensitivity remains a major limitation of currently approved PSMA PET agents Primary Endpoints* Sensitivity# Specificity# 68Ga-PSMA-111 40% 95% 18F-rhPSMA-7.32 27% 95% 18F-DCFPyL3 40% 98% None of the pivotal studies used for the registration of the currently FDA-approved PSMA PET agents met their predefined sensitivity primary endpoint • The 68Ga-PSMA-11 pivotal study did not meet either its sensitivity or specificity primary endpoint • The 18F-rhPSMA-7.3 and 18F-DCFPyL registrational studies did not meet their sensitivity and consequently co-primary endpoints The combination of low sensitivity and variability across clinical trials highlights the need for head-to-head studies to identify the PSMA PET agent of choice *Primary endpoints related to the registrational trials in the pre-prostatectomy setting respective to each product. Source: FDA Center for Drug Evaluation and Research, Multi-Discipline Review. #Sensitivity and specificity presented as reported in the published pivotal studies for each product. Differences in study design and patient populations preclude direct cross-trial comparisons. 1. Hope T et al. JAMA Oncol. 2021;7:1635-1642. 2. Surasi DS et al. Eur Urol. 2023;84:361-370. 3. Pienta et al. J Urol. 2021;206:52-61.
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10 Higher uptake and prolonged retention 10 Zia et al., 2019. Ang.Chem Considerably improved binding and internalisation 64/67Cu-SAR-bisPSMA177Lu-PSMA-617* 18F-DCFPyL* 18F- rhPSMA-7.3* 68Ga-PSMA-11* 64Cu-PSMA-I&T 18F-PSMA1007 Monovalent SAR-PSMA vs. SAR-bisPSMA Monovalent Bivalent Bivalent * FDA-approved products
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CLARIFY - Phase III in pre-prostatectomy1 • Registrational Phase III imaging trial of participants with high-risk prostate cancer prior to radical prostatectomy using 64Cu-SAR-bisPSMA • Recruitment ongoing AMPLIFY – Phase III in BCR2 • Registrational Phase III imaging trial with 64Cu-SAR-bisPSMA in prostate cancer patients with biochemical recurrence (BCR) • Recruitment completed, study ongoing SECuRE - Phase I/IIa in mCRPC3 • Theranostic trial for treatment of patients with mCRPC with 67Cu-SAR-bisPSMA • Dose Escalation (Phase I) successfully completed recruitment • Cohort Expansion (Phase II) recruitment ongoing at 8 GBq dose level (enzalutamide combination allowed) SAR-bisPSMA 11 PROPELLER – Phase I in pre-prostatectomy4 • First-in-human PET imaging trial of participants with confirmed prostate cancer using 64Cu-SAR-bisPSMA in Australia • Study completed, results released COBRA – Phase I/II in BCR5 • Phase I/II PET imaging trial of participants with BCR of prostate cancer following definitive therapy using 64Cu-SAR-bisPSMA in the US • Study completed, results released Co-PSMA - Phase II Investigator-Initiated Trial in BCR6 • Led by Prof Louise Emmett at St Vincent’s Hospital Sydney • Phase II head-to-head comparison of 64Cu-SAR-bisPSMA vs. 68Ga-PSMA-11 product for the detection of prostate cancer recurrence • Study completed, results released Ongoing trials Completed trialsCompleted trials Extensive clinical development program in the pre-prostatectomy and biochemical recurrence settings 1. NCT06056830. 2. NCT06970847. 3. NCT04868604. 4. NCT04839367. 5. NCT05249127. 6. NCT06907641
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SAR-bisPSMA: building a comprehensive body of evidence 12 Patients 750+ across trials and compassionate use access Scans performed 1,500+ 64Cu-SAR-bisPSMA same- day and/or next-day imaging Trials 6 Phase I to registrational Phase III and investigator- initiated trials Countries 2 Australia and USA Patient, scan, trial , and country figures reflect cumulative data as of July 2026; of the 6 trials, 3 remain ongoing. Data on file.
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SOC PSMA PET SOC PSMA PET SOC PSMA PET SOC PSMA PET SOC PSMA PET Median 20.5 days (2-50) between both scans Within 60 days of Day 1 Within 60 days of Day 0, up to 180 days follow-up Median 2 days (IQR 1-8) between SOC and 64Cu PET3 Within 60 days of Day 1, up to 180 days follow-up 64Cu-SAR-bisPSMA PET 64Cu-SAR-bisPSMA PET 64Cu-SAR-bisPSMA PET 64Cu-SAR-bisPSMA PET 64Cu-SAR-bisPSMA PET Exploratory endpoints • Number of lesions detected • Tracer uptake • Tumour-to-background ratio Exploratory endpoints • Lesion detection Post-hoc analysis • Lesion detection Primary endpoint • Mean number of lesions detected per patient Exploratory endpoint • Lesion detection 64Cu-SAR-bisPSMA PET vs. SOC* PSMA PET Performance of 64Cu-SAR-bisPSMA PET vs. SOC PSMA PET assessed in all trials * Standard-of-care (SOC) PSMA PET includes 68Ga-PSMA-11 and 18F-DCFPyL; IQR: interquartile range. 1. Data on file. 2. Khan et al. Eur Urol. 2026;89:512-520. doi: 10.1016/j.eururo.2026.03.001. 3. Interval between 68Ga-PSMA-11 PET and 64Cu-SAR-bisPSMA same-day PET. Intra-patient head-to-head comparison for confidence in decision making 1 1 1 1 13 Co-PSMA 2
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64Cu-SAR-bisPSMA in Pre-definitive Treatment Settings: PROPELLER CLARIFY
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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 • Primary endpoints: safety – incidence and severity of adverse events (AEs) and serious AEs following administration of 64Cu-SAR-bisPSMA; efficacy – proportion of 64Cu-SAR-bisPSMA PET/CT scans assessed as True Positive or False Negative for primary prostate cancer as confirmed by histopathology • Exploratory endpoints include intra-patient head-to-head comparisons of the diagnostic performance of 64Cu-SAR-bisPSMA vs. 68Ga-PSMA-11 Additional eligibility criteria apply. ISUP: International Society of Urological Pathology; PC: prostate cancer; PLND: pelvic lymph node dissection; RP: radical prostatectomy. ClinicalTrials.gov identifier: NCT04839367. Screening Period 68Ga-PSMA-11 PET/CT imaging performed 64Cu-SAR-bisPSMA sequential administration (100, 150 and 200 MBq: 1:1:3 ratio) Same-day imaging PET/CT acquisition at 3 ± 1 h post-injection Safety assessments RP with PLND/ histopathology Verification of 64Cu-SAR-bisPSMA PET/CT findings Day -35 to -1 Day 1 Day 5 to 28 Up to Week 11 Key eligibility criteria (n=30) • Participants with untreated, histologically confirmed adenocarcinoma of the prostate electing to undergo RP with PLND • Intermediate- to high-risk PC characterised by: • Clinical Stage ≥ T2b or ISUP Grade Group ≥ 3 or prostate- specific antigen (PSA) ≥ 10 ng/mL 15
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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 64Cu-SAR-bisPSMA68Ga-PSMA-11 68Ga-PSMA-1164Cu-SAR-bisPSMA 2-3x more uptake and contrast More lesions identified Left images: concordant lesions (same patient). Maximum standardised uptake value (SUVmax), mean standardised uptake value (SUVmean), tumour-to-background ratio (TBR): 2-3x increased values in 64Cu-SAR- bisPSMA vs. 68Ga-PSMA-11 PET (p<0.001). Right images: pelvic lymph node identified by 64Cu-SAR-bisPSMA but not by 68Ga-PSMA-11 (prostate cancer confirmed by histopathology). Lengyelova & Emmett et al. PROPELLER study. ASCO, 2023. ClinicalTrials.gov identifier: NCT04839367. 16 Improved diagnostic performance of 64Cu-SAR-bisPSMA compared to 68Ga-PSMA-11 on same-day imaging Higher number of lesions identified 2-3 times higher uptake and tumour-to-background ratio
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0 10 20 30 40 50 60 Number of lesions 64Cu-SAR-bisPSMA identified more total number of lesions than 68Ga-PSMA-11* 64Cu-SAR-bisPSMA identifies more lesions on same-day imaging vs. 68Ga-PSMA-11 17 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 *Averaged across all readers, all participants; †Averaged across all readers, participants with discordant lesions only are presented. ClinicalTrials.gov identifier: NCT04839367. 1.3-fold increase 38 49 68Ga-PSMA-11 64Cu-SAR-bisPSMA 2.7-fold increase 0% 20% 40% 60% 80% 100% 68Ga-PSMA-11 64Cu-SAR-bisPSMA 27% 73% Among participants with discordant lesion findings, 64Cu-SAR-bisPSMA detected more lesions in more participants than 68Ga-PSMA-11† Percentage of participants with more lesions identified by either of the tracers
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*** Denotes p<0.0001 as assessed by two-sided Wilcoxon signed-rank test on the comparison of the two imaging methods. Values wer e derived from the average of medians from each reader. The lesions were averaged for each patient so that each patient contributes once to the summary statistics. Lengyelova et al. PROPELLER study. ASCO, 2023; ClinicalTrials.gov identifier: NCT04839367. Data on file. 64Cu-SAR-bisPSMA shows higher lesion uptake and TBR vs. 68Ga-PSMA-11 on same-day imaging 64Cu-SAR-bisPSMA scans were associated with statistically significant: • Higher SUVmax • Higher SUVmean • Higher tumour-to-background ratio 0 10 20 30 40 50 60 70 80 SUVmax SUVmean TBR Standardised Uptake Value 68Ga-PSMA-11 64Cu-SAR-bisPSMA 2.5-fold increase *** 2.6-fold increase *** 2.7-fold increase *** 18
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64Cu-SAR-bisPSMA PET outperformed 68Ga-PSMA-11 PET in this head- to-head comparison in pre-prostatectomy patients based on: 19 • Higher lesion detection: Greater total number of lesions and higher percentage of participants with more lesions • Better image quality: Higher tracer uptake and improved background contrast • Favourable tolerability: Well tolerated in all 30 participants with only a single related AE of Grade 1 dysgeusia (metallic taste) reported 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 ClinicalTrials.gov identifier: NCT04839367. Data on file.
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CLARIFY Phase III trial: recruiting Registrational trial in participants with high-risk prostate cancer prior to undergoing radical prostatectomy and pelvic lymph node dissection Additional eligibility criteria apply. NCCN: National Comprehensive Cancer Network. ClinicalTrials.gov identifier: NCT06056830. Screening Period 64Cu-SAR-bisPSMA (200 MBq) Same-day imaging PET/CT acquisition at 1-4 h post-injection Next-day imaging PET/CT acquisition at 24 ± 6 h post-injection Post-Histopathology Follow-Up Period Verification of 64Cu-SAR-bisPSMA PET/CT findings by Standard of Truth Day -28 to 1 Day 1 Day 2 Until Day 90 Key eligibility criteria (n=383) • Untreated, histopathology-confirmed adenocarcinoma of the prostate • High-risk or greater PC defined by NCCN Guidelines as: • Clinical Stage ≥ T3a or • Grade Group ≥ 4 or • PSA > 20 ng/mL • Proceeding to RP with pelvic lymph node dissection PLND Safety Call Day 7 (±4 days) • Primary endpoint: Co-primary endpoints of sensitivity and specificity of 64Cu-SAR-bisPSMA PET compared to Standard of Truth, assessed independently for same-day and next-day imaging • Exploratory endpoints include intra-patient head-to-head comparisons of the diagnostic performance of 64Cu-SAR-bisPSMA vs. SOC PSMA PET agents 20
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64Cu-SAR-bisPSMA in biochemical recurrence: COBRA AMPLIFY Co-PSMA
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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 COBRA Phase I/II trial: completed Additional eligibility criteria apply. ClinicalTrials.gov identifier: NCT05249127. Key primary endpoints • Incidence and severity of treatment-emergent AEs and Serious AEs following the administration of 64Cu-SAR-bisPSMA • Assessed independently for same-day and next-day imaging: Correct detection rate (CDR) defined as the proportion of true-positive participants out of all scanned participants who had at least one evaluable reference standard datapoint Key eligibility criteria (n=50) • Confirmed adenocarcinoma of the prostate with subsequent definitive therapy • Suspected recurrence of PC based on rising or detectable PSA • Negative or equivocal findings for PC on conventional imaging per SOC within 60 days prior to Day 0 Screening Period 64Cu-SAR-bisPSMA (200 MBq; 5.4 mCi) Same-day imaging PET/CT acquisition at 1-4 h post-injection Next-day imaging PET/CT acquisition at 24 ± 6 h post- injection Follow-Up Period Verification of 64Cu-SAR-bisPSMA PET/CT findings by Reference Standard* Day -28 to 0 Day 0 Day 1 Day 90 and 180† (±15 days) Safety Visit Day 7 (±2 days) *Composite Reference Standard (histopathology, conventional imaging and PSA levels following radiation therapy) †Day 180 visit as only applicable for participants who were deemed negative or equivocal for PC recurrence at Day 90 22
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More lesions and patients with a positive scan identified by 64Cu-SAR-bisPSMA on next-day imaging 64Cu-SAR-bisPSMA Same-day imaging Nex-day imaging *Average increase across readers of 82% (from same to next-day imaging). Ranges across the readers for the total number of lesions detected: 53–80 on same-day vs. 82–153 on next-day imaging. Full Analysis Set: 42 patients. †Average increase across readers of 34% (from same to next-day imaging). Detection rate (DR) range across the readers on same-day imaging was 44–58% (95% confidence interval [CI] 30–71.8), increasing on next-day imaging to 58–80% (95% CI 43.2–90). AEs: One related AE reported across the trial population (grade 2 worsening of type II diabetes, resolved). Images are displayed at maximum intensity projection. Nordquist et al. COBRA. EANM, 2024. ClinicalTrials.gov identifier: NCT05249127. Data on file. 0 20 40 60 80 100 120 140 Same-day Next-day 0% 10% 20% 30% 40% 50% 60% 70% 80% Same-day Next-day The number of lesions identified by 64Cu-SAR-bisPSMA increased by 82%* % of 64Cu-SAR-bisPSMA PET-positive participants increased by 34%† 129 70 71% 53% 64Cu-SAR-bisPSMA PET showing positive lymph nodes in the pelvic, extra-pelvic (retroperitoneal) and lesions in the prostatic bed regions Number of PSMA(+) lesions Percentage of PSMA(+) participants Imaging timepoint Imaging timepoint Next-day imaging identified additional lesions compared to same-day imaging 23
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24.1 140.3 0 50 100 150 Same-day imaging Next-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 Figure 1. Pelvic lymph nodes showing uptake of 64Cu-SAR-bisPSMA on next-day imaging. Blue arrow: lymph node size 3.8 mm x 4.4 mm, SUVmean 20.6, SUVmax 22.1 and TBR 130.1. Green arrow: lymph node size also 3.8 mm x 4.4 mm, SUVmean 11.9, SUVmax 12.8 and TBR 75.3. Red arrow: lymph node showing 64Cu-SAR-bisPSMA uptake (>5 mm). Maximum Intensity Projection. Mean SUVmean and SUVmax in lesions Mean TBR of lesions Figure 2. SUVmean/max and TBR comparing same-day and next-day imaging. Average increase across 3 readers. The SUVmax, SUVmean and TBR were assessed in up to 25 lesions per patient on each 64Cu-SAR-bisPSMA scan. Ranges across the readers for same-day and next-day imaging, respectively: SUVmean 6.6-9.9 and 14.7-15.8; SUVmax 13.9-14.0 and 22.2-33.4; TBR 23.2-25.4 and 118.1-181.7. TBR = SUVmax of the lesions / SUVmean of the gluteus region. >80% increase in mean SUVmean and SUVmax (same-day vs. next-day imaging) >5x increase in mean TBR (same-day vs. next-day imaging) 8.5 13.915.1 26.1 0 5 10 15 20 25 30 SUVmean SUVmax Same-day imaging Next-day imaging SUVmean and SUVmax in lesions detected by 64Cu-SAR-bisPSMA Tumour-to-background ratio (TBR) of lesions detected by 64Cu-SAR-bisPSMA 64Cu-SAR-bisPSMA PET Same-day imaging Next-day imaging TBR ClinicalTrials.gov identifier: NCT05249127. Data on file. 24
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64Cu-SAR-bisPSMA identifies lesions months before currently approved PSMA PET agents Number of lesions identified by 64Cu-SAR-bisPSMA and SOC PSMA agents 0 10 20 30 40 50 60 Same-day imaging Next-day imaging Up to 6 months later 26 53 20 64Cu-SAR-bisPSMA SOC PSMA Number of lesions Graph: Average number of lesions identified by the readers on same-day, next-day imaging (64Cu-SAR-bisPSMA) or SOC PSMA PET (68Ga-PSMA-11 or 18F-DCFPyL) in a subset of 20 participants with follow-up SOC PSMA PET: 26.3, 52.7 and 20, respectively. Median number of days between Day 0 and the follow-up SOC scan: 73.5 (range 29-180). Images: retroperitoneal lesion detected by 64Cu-SAR-bisPSMA on next-day imaging (confirmed by all 3 readers). 68Ga-PSMA-11 scan performed 176 days post-Day 0 (175 days post-Day 1) did not show uptake of tracer. Nordquist et al. COBRA. EANM, 2024. ClinicalTrials.gov identifier: NCT05249127. Data on file. 64Cu-SAR-bisPSMA detects lymph node missed by 68Ga-PSMA-11 (SOC PET performed ~6 months later) 64Cu-SAR-bisPSMA Next-day imaging 68Ga-PSMA-11 175 days later Prostate cancer in lymph node confirmed via histopathology at Day 190 No lymph node involvement was detected 25
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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 participants were identified as PSMA-positive on next-day imaging, increasing from 53% to 71%, representing a 34% increase versus same-day imaging (average across readers) Over 80% higher tracer uptake in lesions and >5x higher contrast on next-day imaging enabled the detection of small lesions, including lesions in the 2 mm range In a subset of participants, 64Cu-SAR-bisPSMA identified 53 lesions on next-day imaging versus 20 lesions detected by SOC PSMA PET performed up to 6 months later, demonstrating the ability of 64Cu-SAR-bisPSMA to detect recurrent disease earlier 64Cu-SAR-bisPSMA: closing the diagnostic gap in prostate cancer recurrence ClinicalTrials.gov identifier: NCT05249127. Data on file. 26
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AMPLIFY Phase III trial: recruitment completed with 232 patients dosed and imaged Screening Period 64Cu-SAR-bisPSMA injection (200 MBq) Same-day imaging PET/CT acquisition at 1-4 h post-injection Next-day imaging PET/CT acquisition at 24 ± 6 h post-injection Follow-Up Period Verification of 64Cu-SAR-bisPSMA PET/CT findings by Reference Standard* Day -60 to 1 Day 1 Day 2 Up to Day 180 Key eligibility criteria (n=220) • Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy. • Rising or detectable PSA level after definitive therapy. - Post-radical prostatectomy: detectable or rising PSA that is ≥ 0.2 ng/mL with confirmatory PSA that is ≥ 0.2 ng/mL or - Post-radiation therapy, cryotherapy, or brachytherapy: increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir. • Primary endpoint: Co-primary endpoints of participant-level correct detection rate (CDR) and region- level positive predictive value (PPV), assessed independently for same-day and next-day imaging† • Exploratory endpoints include intra-patient head-to-head comparisons of the diagnostic performance of 64Cu-SAR-bisPSMA vs. SOC PSMA PET agents Additional eligibility criteria apply. †Assessed by three independent, blinded, central readers. Investigational products only. ClinicalTrials.gov identifier: NCT06970847. * Composite Reference Standard (histopathology, PSA levels after loco-regional therapy, or follow-up conventional scans) Registrational trial of participants with BCR of prostate cancer at sites in the US and Australia 27
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This prospective single-arm imaging trial enrolled 50 participants and evaluated the comparative performance of 64Cu-SAR-bisPSMA vs. 68Ga-PSMA-11 Co-PSMA Phase II investigator-initiated trial: completed Key Exclusion • Prior salvage radiotherapy • ADT currently or within prior 12 months • Prior systemic therapy for PC SOC Modalities Salvage Rx, biopsy, additional imaging Screening Same-day imaging 1-4 hours post-injection Next-day imaging 24 hours post-injection 64Cu-SAR-bisPSMA (200 MBq) Follow-up Primary objective: • To compare the detection rate of PC lesions per participant, between 64Cu-SAR-bisPSMA and 68Ga-PSMA-11 PET/CT Key secondary objectives: • To compare the diagnostic accuracy of 64Cu-SAR-bisPSMA vs. 68Ga-PSMA-11 PET/CT using a composite standard of truth • To evaluate the magnitude of clinical management change when using 64Cu-SAR-bisPSMA additional to standard of care imaging (68Ga-PSMA-11) • To evaluate PSA response following salvage Rx by 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT imaging parameters 68Ga-PSMA-11 within 3 weeks of 64Cu-SAR-bisPSMA PET Median of 2 days (IQR: 1-8) Same camera time (2 min per bed position) Key Eligibility • Prior radical prostatectomy (confirmed adenocarcinoma of PC) • Rising PSA 0.2 – 0.75ng/mL • No prior salvage radiotherapy • Under consideration for salvage fossa radiotherapy Management Impact Questionnaire (initial) Management Impact Questionnaire (post-64Cu-SAR-bisPSMA PET) Investigator-initiated trial (IIT) conducted by Prof Louise Emmett, St Vincent’s Hospital (Sydney, Australia). Rx: radiotherapy. NCT06907641, Khan et al. Eur Urol. 2026;89:512-520. doi: 10.1016/j.eururo.2026.03.001. 28
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Co-PSMA: Improved diagnostic performance with next-day 64Cu-SAR-bisPSMA PET vs. 68Ga-PSMA-11 in early BCR* 29* Patients with confirmed BCR following radical prostatectomy with a PSA 0.2-0.75 ng/mL; Khan S, et al. Co-PSMA trial. Eur Urol. 2026; https://doi.org/10.1016/j.eururo.2026.03.001 Khan et al. Eur Urol. 2026;89:512-520. doi: 10.1016/j.eururo.2026.03.001 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 0.48 1.26 0.0 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 Mean number of lesions per participant 68Ga-PSMA-11 64Cu-SAR-bisPSMA Mean difference 0.78; Ratio 2.63 (both p < 0.0001) 18/50 (36%) 39/50 (78%) 0 5 10 15 20 25 30 35 40 45 Number patients positive 68Ga-PSMA-11 64Cu-SAR-bisPSMA 24 63 0 10 20 30 40 50 60 70 Total lesions identified 68Ga-PSMA-11 64Cu-SAR-bisPSMA
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Co-PSMA: 64Cu-SAR-bisPSMA detected more lesions per patient and a higher true positive rate than 68Ga-PSMA-11 30 * True positive rate was derived from a composite reference standard as defined in Khan et al., European Urology. 2026;89:512-520. doi: 10.1016/j.eururo.2026.03.001 Adapted from Khan et al., European Urology 2026 Nodal lesion Local recurrent lesion Next-day 64Cu-SAR-bisPSMA PET scan identified 4 lesions vs. 1 lesion with 68Ga-PSMA-11 64Cu-SAR-bisPSMA 68Ga-PSMA-11 0% 10% 20% 30% 40% 50% 60% 70% 80% 71% 29% 68Ga-PSMA-11 64Cu-SAR-bisPSMA True positive rate* 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 (95% CI: 0.56-0.94) for 68Ga-PSMA-11
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*Patients with confirmed BCR following radical prostatectomy with a PSA 0.2-0.75 ng/mL. LN: lymph node; fossa RTX: surgical fossa radiotherapy; SBRT: stereotactic body radiation therapy. Khan et al., Eur Urol 2026;89:512–520; doi: 10.1016/j.eururo.2026.03.001 55% (12/22) changed from observation to targeted radiation therapy 40% (9/22) changed radiation fields 14% (3/22) added SBRT 18% (4/22) added ADT 68Ga-PSMA-11 of participants with planned active management 66% 64Cu-SAR-bisPSMA of participants with planned active management 90% 45/50 (90%) 5/50 (10%) 34/50 (66%) 17/50 (34%) Observation Active therapy 44% of patients (22/50) underwent a treatment change based on the 64Cu-SAR-bisPSMA scans Co-PSMA: Next-day 64Cu-SAR-bisPSMA PET drove treatment change in more participants with early BCR* in comparison to 68Ga-PSMA-11 31
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64Cu-SAR-bisPSMA outperformed 68Ga-PSMA-11 in all measured parameters 32 64Cu-SAR-bisPSMA vs. 68Ga-PSMA-11 demonstrated: • Higher number of patients with a positive scan • Higher true positive rate • Higher number of lesions • Higher number of anatomical regions with tracer uptake • Higher rate of change in treatment plan • Same scanning times (approximately 2 min/bed position) • Median time between 68Ga and 64Cu scans: 2 days (IQR 1-8) 64Cu-pos. (78%) 64Cu-neg. (22%) Participant-level detection of prostate cancer by tracer 64Cu-SAR-bisPSMA 68Ga-pos. (36%) 68Ga-neg. (64%) 68Ga-PSMA-11 “(…) whenever we can detect more lesions in the lower PSA ranges, we can eventually, as the Co-PSMA study shows, change the way we manage prostate cancer, (…)” Dr Alberto Briganti, Editor-in-Chief, European Urology journal, European Urology Podcast* * 26 June 2026; https://www.youtube.com/watch?v=g4B7A6JxcZY
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Real World Evidence Compassionate Use Program cases
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Closing the diagnostic gap: real-world 64Cu-SAR-bisPSMA lesion detection after negative SOC PSMA PET Background Key findings • Ten patients with BCR of PC and negative/equivocal SOC PSMA PET (68Ga-PSMA-11; 18F-DCFPyL) who accessed 64Cu-SAR-bisPSMA via SAS/EAP were imaged • Most recent PSA before 64Cu-SAR-bisPSMA range: 0.10 – 13.3 ng/mL • All patients received ~200 MBq of 64Cu-SAR- bisPSMA, with PET imaging performed on the same- day and/or next-day post-injection • Follow-up and monitoring for adverse events was undertaken Therapeutic Goods Administration (TGA, Australia) Special Access Scheme (SAS) and US FDA Expanded Access Program (EAP) cases; Data on file. An unmet need persists for improved PSMA imaging, despite availability of SOC PSMA PET agents 80% 8/10 patients had lesions detected with 64Cu-SAR-bisPSMA Total of 19 lesions identified on next- day imaging Management change after positive 64Cu-SAR-bisPSMA Clinical treatment change Targeted radiotherapy 8/8 4/8 Negative 64Cu-SAR-bisPSMA findings occurred below the BCR-confirmatory threshold (<0.2 ng/mL) PSA levels 0.10 and 0.19 ng/mL Safety profile: one Grade 1 (mild) fatigue event, which resolved 34
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64Cu-SAR-bisPSMA PET detects disease missed by Siemens Biograph Vision Quadra Data on file. Image: Siemens Biograph Vision Quadra. Source: https://www.siemens-healthineers.com/en-us/molecular-imaging/pet-ct/biograph-vision-quadra Background • Five patients with BCR of PC (PSA 0.3 – 13.3 ng/mL) • Prior negative SOC PSMA PET/CT (68Ga-PSMA-11 and/or 18F-DCFPyL) using the Siemens Biograph Vision Quadra • 64Cu-SAR-bisPSMA PET/CT via compassionate use at 1-4 hours (same-day imaging) and 24-30 hours (next-day imaging) post-injection Key findings 64Cu-SAR-bisPSMA imaging was positive in all patients For the 6 lesions identified on both same-day and next-day: Same-day imaging Next-day imaging Mean SUVmax 4.0 ± 1.6 7.6 ± 3.3 0 4 8 12 Same-day imaging Next-day imaging Number of lesions detected lesions detected on next-day (n=12) compared to same-day (n=6) imaging2X more Increased 64Cu-SAR-bisPSMA uptake with delayed imaging 64Cu-SAR-bisPSMA led to treatment management changes in all 5 patients 35
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Case highlight: 64Cu-SAR-bisPSMA detected lesions only 24 days after a negative 18F-DCFPyL PSMA PET on Siemens Biograph Vision Quadra Patient with BCR Negative 18F-DCFPyL* Same-day imaging Next-day imaging Localised recurrent lesion Bone lesion Change in management Same-day Next-day *70 yr old patient with BCR following radical prostatectomy. Data on file. 64Cu-SAR-bisPSMA detected 4 lesions 24 days 36
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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 SOC PSMA PET was negative or equivocal Lesions were missed or remained equivocal with SOC PSMA PET agents, even when delayed imaging was performed on advanced cameras such as the Biograph Vision Quadra 64Cu-SAR-bisPSMA identified lesions in all patients who had a negative/equivocal scan using SOC PMSA PET agents imaged on the Biograph Vision Quadra 64Cu-SAR-bisPSMA findings changed clinical management in every patient with a positive scan Summary of real-world evidence cases Data on file. 37
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38 Separating signal from noise: addressing competitive claims Competitive claim What the data show Takeaway Co-PSMA population is only relevant to a subset of the market because value depends on 24- hour imaging • 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 PROPELLER showed 2-3x higher lesion uptake and contrast and 1.3x more lesions vs. 68Ga-PSMA-11 • Delayed imaging adds optional clinical value by allowing higher lesion uptake and background washout, supporting improved lesion detection • Other Clarity trials do not impose an upper baseline PSA limit, supporting applicability across broader clinical settings Flexible imaging window supports both routine workflow and enhanced detection when clinically valuable Change in management data are survey-based and therefore not meaningful evidence • Management impact questionnaires are recognised endpoints in diagnostic imaging studies because the purpose of imaging is to inform treatment decisions • 64Cu-SAR-bisPSMA led to substantial management impact: 44-48% of participants had a change in planned management (Co-PSMA and COBRA) • In Co-PSMA, active management was planned in 90% of cases following 64Cu-SAR-bisPSMA PET vs. 66% after 68Ga-PSMA-11 PET Clinical impact is demonstrated by measurable changes in planned treatment, not just lesion counts Detecting more lesions has limited value; the real value is moving from no detection to some detection • This claim disregards the role of accurate staging in personalised prostate cancer care, including decisions between metastasis-directed therapy and systemic therapy • In Co-PSMA, treatment changes included altered radiation fields, stereotactic body radiotherapy and added androgen deprivation therapy • Regarding the point of “from ‘no’ to ‘some’ lesions”, 64Cu-SAR-bisPSMA more than doubled the number of participants with a positive scan: 78% vs. 36% with 68Ga-PSMA-11 (Co-PSMA) More accurate detection can change both whether patients are treated and how treatment is targeted Lesion detection and clinical impact Data on file.
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39 Separating signal from noise: addressing competitive claims Competitive claim What the data show Takeaway Improved camera technology makes the difference, not the agent • Published prospective evidence supporting improved detection using current PSMA PET agents with advanced cameras, particularly at low PSA, remains limited to support this claim • Real-world cases show SOC PSMA PET can remain negative/equivocal even when advanced cameras are used; 64Cu-SAR-bisPSMA detected recurrent disease in a series of similar cases (to be presented at EANM 2026) • If camera technology improves lesion detection, it may also further enhance the performance of 64Cu-SAR-bisPSMA The available evidence supports agent differentiation rather than attributing results solely to camera technology Next-day imaging will not be a major part of the market • 64Cu-SAR-bisPSMA offers next-day imaging leading to higher lesion uptake and background washout enabling improve detection rate and the detection of small lesions • The value proposition is flexibility with high sensitivity: patients can be imaged on either day, but next-day imaging provides higher diagnostic confidence • This positions next-day imaging as a clinical advantage rather than a workflow limitation Delayed imaging is an option that can extend clinical utility, not a restriction on use Longer scans create a throughput disadvantage, with next-day imaging creating workflow challenges • In Co-PSMA, camera time was the same for 64Cu-SAR-bisPSMA and 68Ga-PSMA-11: 2 minutes per bed position • Clinicians have reported that an optimised clinical workflow can actually improve operational efficiency, with patients simply attending for injection on one day, and returning for imaging on the following day – streamlining back-to-back (in sequence) scanning sessions The workflow argument is addressable, and the cited Co- PSMA scan time with potential increased operational efficiency does not support a major throughput disadvantage Camera technology and clinical workflow Data on file.
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40 Separating signal from noise: addressing competitive claims Competitive claim What the data show Takeaway The value is only at the late imaging timepoint • 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 imaging performance at 2-4 hours, with 1.3x more lesions identified vs. 68Ga-PSMA-11 • PROPELLER also showed lesion uptake and contrast were 2-3x higher for 64Cu-SAR-bisPSMA vs. 68Ga-PSMA-11. • COBRA showed that the detection rate on same-day 64Cu-SAR-bisPSMA PET was 70% vs. 60% for SOC PSMA PET, which was performed up to 6 months after the 64Cu-SAR-bisPSMA PET (indicating the ability of 64Cu-SAR-bisPSMA to detect recurrent disease earlier) • This demonstrates that differentiation is not limited to 24-hour imaging The evidence supports clinical flexibility, with same- day proven performance and added value from next-day imaging Delayed imaging is a narrow niche rather than a broad advantage • COBRA and Co-PSMA support improved lesion detection with next-day 64Cu-SAR-bisPSMA imaging • 64Cu-SAR-bisPSMA identified lesions in 78% of participants vs. 36% with 68Ga-PSMA-11 (Co-PSMA) • The true positive rate was 71% for 64Cu-SAR-bisPSMA vs. 29% for 68Ga-PSMA-11 (Co-PSMA) • COBRA showed that the detection rate on next-day imaging was 90% vs. 60% for SOC PSMA PET, which was performed up to 6 months after the 64Cu-SAR-bisPSMA PET (indicating the ability of 64Cu-SAR-bisPSMA to detect recurrent disease earlier) • Across the evidence base, next-day imaging adds clinical value with further improved diagnostic performance Next-day imaging is positioned as a differentiating clinical option with solid evidence to improve diagnostic performance The value of delayed imaging Data on file.
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41 Separating signal from noise: addressing competitive claims Data on file. 1. Hope T et al., JAMA Oncol. 2021;7;(11):1635-1642. 2, 4 and 6: FDA-approved Prescribing Information. Accessed on 20 June 2026. 3. Pienta KJ et al Osprey J Urol. 2021;206(1):52-61. 5. Surasi DS el al LIGHTHOUSE Eur Urol 2023;84:361-370. * Primary endpoints related to the registrational trials in the pre-prostatectomy setting respective to each product. Source: FDA Center for Drug Evaluation and Research, Multi-Discipline Review Differences in study design and patient populations preclude direct cross-trial comparisons. Competitive claim What the data show Takeaway Clarity will be late (5th) to market, making meaningful share gains difficult • The current competitive landscape has limited differentiation among approved PSMA PET agents with similar structural and isotopic characteristics • Commercial uptake is not determined by order of entry alone; clinical value and differentiation can change adoption dynamics • 64Cu-SAR-bisPSMA is positioned as a differentiated agent, rather than another similar (“me-too”) PSMA PET product • The differentiators include dimeric PSMA targeting, longer copper-64 half-life, sarcophagine chelator, extended shelf-life, wider imaging window and broad geographic coverage • The clinical proposition is supported by robust evidence from PROPELLER, COBRA and Co-PSMA • Phase III CLARIFY and AMPLIFY are intended to generate the pivotal evidence to support broad clinical adoption Commercial success is driven by clinical differentiation and value, not simply order of market entry Differentiation and market uptake 64Cu-SAR-bisPSMA 68Ga-PSMA-111,2* 18F-DCFPyL3,4* 18F-rhPSMA-7.35,6* Targeting moiety Bivalent targeting PSMA Monovalent targeting PSMA Monovalent targeting PSMA Monovalent targeting PSMA Isotope half-life 64Cu (12.7 h) 68Ga (1.1 h) 18F (1.8 h) 18 F (1.8 h) Product shelf-life Up to 48 h 6 h 10 h 10 h Imaging window (post-administration) 1 to 30 hrs 50 to 100 min 1 h 1 h Sensitivity 40% (prespecified endpoint not met) 40% (prespecified endpoint not met) 27% (prespecified endpoint not met) Specificity 95% (prespecified endpoint not met) 98% 95%
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42 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 PET to be particularly helpful and am interested in participating in your Cu 64 trial. I understand that there is a centre close by involved already, but I would like to explore recruiting and treating in the private sector where I am based.” Australian treating clinician “The results (of the 64Cu-SAR-bisPSMA PET) were beyond my expectations. Three tumours were found and I underwent targeted external beam radiation. (…) I am currently symptom-free and hope to remain like this for a long time. It certainly demonstrates the importance of this agent for patients like me.” Patient in BCR, with a negative SOC PSMA PET using state-of-the-art camera
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67Cu-SAR-bisPSMA therapy in prostate cancer SECuRE
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SECuRE Phase I/IIa trial: recruiting 67Cu-SAR-bisPSMA +/- enzalutamide 4 GBq Cohort 1 8 GBq Cohort 2 12 GBq Cohort 3 Cohort 4 12 GBq (2 + 2 additional cycles) Recruitment ongoing (n=24) Dose Escalation: Pre/Post-taxane Cohort Expansion: Pre-taxane 1 cycle Up to 4 cycles Up to 6 cycles 8 GBq (2 + 4 additional cycles) Additional eligibility criteria apply. ADT: androgen deprivation therapy. ClinicalTrials.gov identifier: NCT04868604. 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 Dose escalation phase: completed Cohort expansion phase: currently recruiting Patient population • Patients with progressive mCRPC despite previous treatment with ADT and ARPI • Patients with PSMA-expressing lesions per 64Cu-SAR-bisPSMA PET/CT A subset of participants in the Cohort Expansion phase will receive 67Cu-SAR-bisPSMA with enzalutamide (an ARPI) Key primary objectives • Safety and tolerability of 64/67Cu-SAR-bisPSMA • To determine the maximum tolerated or maximum feasible single dose as well as the recommended dose for two administrations of 67Cu-SAR-bisPSMA • Efficacy in terms of PSA and radiographic response 44
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Patient characteristics: heavily pre-treated patient group with most having bone metastasis 45 Cohort 1 (N=6) Cohort 2 (N=3) Cohort 3 (N=6) Cohort 4 (N=7) Cohort Expansion (N=16) Total (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 (66.7%) 4 (66.7%) 4 (57.1%) 6 (37.5%) 17 (44.7%) Other 0 0 1 (16.7%) 0 2 (12.5%) 3 (7.9%) Baseline* PSA (ng/mL) Mean (SD) 1532.27 (3029.7) 104.28 (155.7) 368.84 (547.9) 606.65 (1351.1) 38.71 (47.2) 449.39 (1396.5) Median 333.73 29.33 110.96 42.00 22.01 37.34 Min-Max 0.7-7684.2 0.3-283.2 34.3-1329.5 3.9-3655.8 0.0-156.7 0.0-7684.2 Number of Previous Anticancer Regimens 2 0 0 0 0 1 (6.3%) 1 (2.6%) 3 0 0 0 0 1 (6.3%) 1 (2.6%) 4 0 1 (33.3%) 0 0 1 (6.3%) 2 (5.3%) 5 0 0 0 0 1 (6.3%) 1 (2.6%) >5 6 (100%) 2 (66.7%) 6 (100%) 7 (100%) 12 (75.0%) 33 (86.8%) Preliminary analysis. Final results are pending completion of the trial. ClinicalTrials.gov identifier: NCT04868604. Data cut-off: 20 Jul 2026. Data on file.
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Safety overview: most adverse events were mild/moderate, indicating a favourable safety profile of 67Cu-SAR-bisPSMA 46 • Only 2 related Grade 3 AEs were reported in one participant (lymphocyte and white blood cell count decreases, 5%) • No Grade ≥4 were reported • Participants receiving 8 GBq dose generally developed a lower prevalence and severity of related AEs compared to the overall trial population The table shows the 5 most common related AEs from the Cohort Expansion Phase. Correspondent prevalence and severity of the same AEs are shown for all participants who received 8 GBq cycles. Preliminary analysis. Final results are pending completion of the trial. ClinicalTrials.gov identifier: NCT04868604. Data cut-off: 20 Jul 2026. Data on file. Most common related adverse events (AEs) regardless of severity Cohort Expansion (N=16) All Participants at 8 GBq cycles (N=19) n (%) Grades 1/2 Grades 1/2 Dry mouth 8 (50%) 9 (47)% Nausea 8 (50%) 8 (42%) Anaemia 4 (25%) 4 (21)% Neutrophil count decrease 4 (25%) 4 (21%) Fatigue 4 (25%) 5 (26%) Among participants who received 8 GBq cycles (Cohort 2 and Cohort Expansion), the most common related AEs were gastrointestinal and haematological disorders, with the majority being mild (Grade 1) and transient
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High PSA response rates across 8 GBq participants (Cohort 2 + Cohort Expansion) 47 Key response rates 63% PSA50 response 26% PSA90 response Pooled 8 GBq (Dose Escalation + Cohort Expansion) Mean (median) number of treatment cycles 0% 10% 20% 30% 40% 50% 60% 70% 80% PSA25 PSA50 PSA75 PSA90 Percentage of participants 74% 63% 53% 26% 2.2 (2.0) 2.3 (2.0) 2.3 (2.0) 2.2 (2.0) Response rates across participants (8 GBq cycles) PSA response categories and mean number of treatment cycles Preliminary analysis. Final results are pending completion of the trial. ClinicalTrials.gov identifier: NCT04868604. Data cut-off: 20 Jul 2026. Data on file.
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67Cu-SAR-bisPSMA 8 GBq leads to PSA reductions and complete responses/undetectable disease in mCRPC participants 48 PSA90 in 26% of 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 CR: complete response. *CR/undetectable disease represents no evidence of disease by RECIST, bone scan and/or PSA assessment, which were evaluable in 16 out of 19 participants (evaluable for radiographic assessment). Total of 7 participants with CR/undetectable disease include one participant from Cohort 2 (who achieved CR following a second cycle of 67Cu-SAR-bisPSMA under Expanded Access Program), 2 from Cohort 4 and 4 from the Cohort Expansion phase. Disease control: CR/undetectable disease + partial response + stable disease. †Most frequently reported related AEs (n=19): dry mouth 9 (47%), nausea 8 (42%), fatigue 5 (26%), anaemia 4 (21%), decreased neutrophil count 4 (21%). Preliminary analysis. Final results are pending the completion of the trial. ClinicalTrials.gov identifier: NCT04868604. Data cut-off: 20 Jul 2026. Data on file. PSA50 in 63% of participants CR/Undetectable disease in 31% of evaluable participants* Treatment cycles CR/undetectable disease Disease control Safety profile 74% received up to two cycles of 8 GBq of 67Cu-SAR-bisPSMA Median: 2.0 Range: 1 – 4 Mean ± SD: 2.1 ± 1.0 5 of 16 evaluable participants (31%) in the combined 8 GBq cohorts Total of 7 participants achieving CR/undetectable disease across the overall 67Cu-SAR-bisPSMA program, all dose levels. 81% of evaluable participants (n=16) for radiographic assessment Complete response or undetectable disease: 31% (n=5) Stable disease: 50% (n=8) Most related adverse events were mild (Grade 1) and transient † Majority were gastrointestinal and haematological disorders. Two Grade 3 events (lymphocyte and white blood cell count decreases) in 1 participant. No Grade ≥4 related events were reported.
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67Cu-SAR-bisPSMA 8 GBq leads to undetectable disease in mCRPC (assessed by PSA and imaging) 49 Patient A: 64-year-old man with bone metastases. Coloured arrows (left image) indicate metastatic bone lesions within each region: red – skull; blue – ribs and sternum; orange – spine; green – pelvis. Related AEs: mostly transient, mild (Grade 1) and non-haematological AEs were reported. The participant reported having excellent quality of life following the treatment. Total number of cycles administered: 4. Second image from the left: no evidence of disease. Patient B: 76- year-old man with metastatic nodal lesions (arrows, third image from left, “Baseline”). Left image: no evidence of disease. Related AEs included altered taste, dry eyes, eye pain, salivary gland soreness and anaemia (all resolved except anaemia). No renal AEs have been reported to date. Images are shown as maximum intensity projections. Last follow-up for both patients: Post-67Cu-SAR-bisPSMA (2 x 8 GBq) Baseline (Bone metastasis) Post-67Cu-SAR-bisPSMA (2 x 8 GBq) Baseline (Nodal metastasis) Patient A Patient B Cohort Expansion • No evidence of disease reported following the administration of 3 or fewer cycles of 67Cu-SAR-bisPSMA • All adverse reactions were mild or moderate • Participants remained with no evidence of disease at last follow-up Preliminary analysis. Final results are pending completion of the trial. ClinicalTrials.gov identifier: NCT04868604. Data cut-off: 20 Jul 2026. Data on file.
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SECuRE 50 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, including complete response/undetectable disease in 31% of participants (5/16 evaluable participants for radiographic assessment) and disease control in 81% of those receiving 8 GBq Seven participants across the overall 67Cu-SAR-bisPSMA program achieved complete response and/or undetectable disease Favourable safety profile with most treatment-related adverse events being Grade 1 and transient, no related Grade ≥4 adverse events reported, and only two related Grade 3 events occurring in a single participant 67Cu-SAR-bisPSMA 8 GBq cycles show strong anti-tumour efficacy with a favourable safety profile in mCRPC Preliminary analysis. Final results are pending completion of the trial. ClinicalTrials.gov identifier: NCT04868604. Data cut-off: 20 Jul 2026. Data on file.
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64Cu-SARTATE clinical development in NETs
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SARTATE SARTATE is a next-generation, highly targeted theranostic radiopharmaceutical. It is being developed for diagnosing, staging and subsequently treating cancers that express somatostatin receptor 2 (SSTR2). Clarity is prioritising the development of SARTATE into early commercialisation with a focus on neuroendocrine tumours (NETs) imaging in the first instance. • Based on the data from the DISCO and CL01 trials, a registrational Phase III study of 64Cu-SARTATE in NETs is in planning. • As a pivotal trial, its final results are intended to support an application to the US FDA for approval of 64Cu- SARTATE as a new diagnostic imaging agent in NETs. *Hicks R et al. First-in-human trial of 64Cu-SARTATE PET imaging of patients with neuroendocrine tumours demonstrates high tumor uptake and retention, potentially allowing prospective dosimetry for peptide receptor radionuclide therapy. The Journal of Nuclear Medicine. 2019. 52 SAR chelator Cage securely holding the radioisotope SSTR2-binding moiety Targeting agent SSTR2 Expressed on NET lesions 64Cu Diagnostic radioisotope Phase I CL01* trial Phase II DISCO trial Phase III registrational trial - in planning Clinical trials with 64Cu-SARTATE in NETs 52
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DISCO Phase II trial: completed Prospective, single-arm, non-randomised, blinded-review study in participants with known or suspected gastroenteropancreatic NETs (GEP-NETs) Additional eligibility criteria apply. MRI: magnetic resonance imaging; FDG: fluorodeoxyglucose. ClinicalTrials.gov identifier: NCT04438304. Primary objective To compare the diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis Key Eligibility Criteria • Known diagnosis of GEP- NET or suspicion of GEP- NET based on axial imaging (CT and/or MRI and/or FDG) and/or biochemical evidence of NETs • Pre-study 68Ga- DOTATATE PET/CT scan performed within 5 weeks of 64Cu-SARTATE administration Screening Period 64Cu-SARTATE (200 MBq; 5.4 mCi) Same-day imaging PET/CT scan at 4 ± 1 h post-injection Next-day imaging PET/CT scan at 20 ± 4 h post-injection Follow-Up Period Verification of 64Cu-SARTATE PET/CT findings by Standard of Truth Day -35 to -1 Day 0 Day 1 Up to 12 months 68Ga-DOTATATE PET at ~1 h post-injection 53
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64Cu-SARTATE: improved lesion detection and greater sensitivity vs. 68Ga-DOTATATE 68Ga-DOTATATE 64Cu-SARTATE Image: representative case of one participant from the DISCO trial showing improved lesion detection and lower liver background with 64Cu-SARTATE (same-day imaging) vs. 68Ga-DOTATATE. PET: maximum intensity projections. Top images, PET; lower images, PET/CT fusion. Arrows show lesions clearly identified against low liver background with 64Cu-SARTATE. *Lesion numbers & sensitivity expressed as the means across readers at 4 h 64Cu-SARTATE imaging. Similar results were observed with 24 h 64Cu-SARTATE. †Nine related TEAEs were observed in 7 participants (Grade 1: abnormal feces = 1; diarrhoea = 3; feces discolored = 1; nausea = 2; chest discomfort = 1; Grade 2: rash = 1). [NCT04438304] ~2x more foci (441 vs. 228, respectively) Higher sensitivity (discordant lesion-level) (95.1% vs. 5.0%, respectively; P<0.001) Majority of adverse reactions were Grade 1 and self-limiting† High foci-liver SUV ratio (Foci mean SUVmax 44; Liver mean SUVmean 5; Mean ratio 11)* 64Cu-SARTATE vs. 68Ga-DOTATATE* 64Cu-SARTATE 54
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64Cu-SAR-Bombesin
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Detection of extensive metastatic disease by 64Cu-SAR-Bombesin in a participant with BCR of prostate cancer (not identified in the baseline and follow-up SOC scans using 18F-DCFPyL). SAR-Bombesin Targets the Gastrin Releasing Peptide receptor (GRPr), which is present in a number of cancers, including breast and prostate cancers SABRE ClinicalTrials.gov identifier: NCT05407311 56 • Phase II PET imaging trial of participants with PSMA-negative BCR of prostate cancer using 64Cu-SAR-Bombesin. • Topline data showed that 64Cu-SAR-Bombesin was safe, well tolerated and effective at detecting prostate cancer in BCR patients. • The trial enrolled 53 patients. 64Cu-SAR-Bombesin identified lesions in approximately 35% and 28% of participants on same-day and next-day imaging, respectively (average across readers). Forty-nine lesions in total were identified on 64Cu-SAR-Bombesin PET/CT scans (average across readers and imaging days). • Despite biopsy not being SOC for this patient population, approximately 16% of participants were biopsied in the study. All lesions assessed by histopathology were positive for prostate cancer (100% true-positive rate). SABRE – Phase II
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Discovery Pipeline
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Comprehensive pipeline from discovery to late-stage development 58 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 planned to be conducted in the US. Pipeline assets as of 5 Aug 2026. Data on file.
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Robust IP driving the Discovery program 59 Clarity’s proprietary SAR Technology platform can be used in conjunction with any number of targeting ligands to create new products and new IP SAR Technology platform Select high value cancer targets Generate and radiolabel compounds (peptides and/or antibodies) 64Cu imaging in tumour models 67Cu efficacy studies in tumour models High value clinical candidates: SARTATE, SAR-bisPSMA, SAR-Bombesin, etc. Discovery Engine • Granted and new chelator patents used in further developing lead and back-up products Platform Protection • Maintenance of pending applications for potential continuation or divisional filings on existing important patents • New patents filed on lead and back-up compounds Product Protection • New chelator patents used in future discovery products • New patents filed on novel treatment regimes for radiopharmaceutical applications Pipeline Protection • Manufacturing and formulation patents • New patents filed on manufacturing processes Manufacturing & Process Protection Broad Patent Portfolio
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64/67Cu-SAR-bisFAP 60 Clarity is developing 64/67Cu-SAR-bisFAP as potential pan-cancer theranostic targeting fibroblast activation protein (FAP). FAP is highly expressed in a broad range of cancers (e.g. breast, colorectal, pancreatic, lung, brain and ovarian cancers), but only minimally in healthy tissue. Clarity developed and assessed two versions of the FAP-targeted product: SAR-FAP and a dimeric version, SAR-bisFAP. 64Cu-SAR-FAP vs. 64Cu-SAR-bisFAP • Tumour uptake and 24-hour retention of 64Cu-SAR-bisFAP was higher than that of 64Cu-SAR-FAP and indicates potential for therapeutic benefit using copper-67. • Pre-clinical efficacy studies have shown the therapeutic potential of 67Cu-SAR-bisFAP compared to an industry benchmark,177Lu-FAP2286. Improved pre-clinical efficacy of 67Cu-SAR-bisFAP vs. 67Cu-SAR-FAP and industry comparator 64Cu-SAR-FAP and 64Cu-SAR- bisFAP PET/CT images in U87MG glioblastoma tumour- bearing mice at 1 hour. Supportive data shows higher uptake and longer retention of 64Cu-SAR-bisFAP compared to 64Cu-SAR-FAP. 64Cu-SAR-FAP 1 hour 64Cu-SAR-bisFAP 1 hour De Franco, et al. World Molecular Imaging Congress, 2025. Based on the results from completed pre-clinical studies, Clarity is progressing the SAR-bisFAP theranostic product into human clinical studies with a focus on the diagnostic in the first instance
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64/67Cu-SAR-trastuzumab SAR Technology SAR chelator(s) securely holding the copper radioisotope used for PET imaging ( 64Cu) or therapy (67Cu) Trastuzumab (biosimilar) Binds to HER2 expressed by cancer cells which the RIT can target Radioimmunotherapy (RIT) utilises antibodies to deliver therapeutic radionuclides to tumour tissue. Conjugating the SAR Technology to trastuzumab has shown: • High selective uptake in HER2-positive cancer cells lines1 • Clear visualisations of HER2-positive tumours by PET imaging1 PET/CT Imaging of 64Cu-SAR-trastuzumab Preclinical PET/CT images of mice bearing HER2- positive SKOV3 xenograft tumours 24 hours (left) and 48 hours (right) after administration of 64Cu-SAR-trastuzumab. 24 hours Rudd et al., Chem Sci., 2025, 16, 3998-4005 Mean tumour volume (left) and survival probability (right) of mice bearing HER2-positive SKOV3 xenograft tumours following a single dose of either 4.5, 6.7 or 9.0 MBq of 67Cu- SAR-trastuzumab, saline (vehicle) control or unlabelled SAR-trastuzumab (cold antibody) control. Data are shown as mean ± SEM, n = ≥ 9 at day 0. 67Cu-SAR-trastuzumab reduces tumour growth and prolongs survival in pre-clinical model 48 hours 61 Clarity intends to conduct a Phase I/IIa theranostic study in HER2-positive cancer patients
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Extended shelf-life and imaging window vs. Cu-64 Ga-68 F-18 0 10 20 30 40 50 60 PSMA diagnostic product characteristics Imaging window (h) Typical shelf-life (h) Half-life (h)Imaging window (hours) Typical shelf-life (hours) Half-life (hours) Trinity Partners Analysis 2024 Base Capacity Total Addresable Market 0 500,000 1,000,000 1,500,000 2,000,000 2,500,000 Current contracted base capacity vs. market size Abundant copper-64 capacity ready for commercial launch Pylarify TruVu, Posluma and Gozellix FDA approved product information. Accessed on 27 March 2026. 64Cu-SAR-bisPSMA information: data on file. 62
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Highly experienced team Clarity's management team has a diverse and in-depth level of expertise spanning corporate finance, management, clinical, operations, commercialisation and industry • Development, approval and launch of the first approved radiopharmaceutical therapy product for prostate cancer (Xofigo) • Decades of experience spanning across science, nuclear medicine/PET and pharmaceutical industries • Investment banking experience focused on the life sciences sector Dr Alan Taylor Executive Chairperson Michelle Parker CEO and MD Dr Colin Biggin Chief Operating Officer Shaemus Gleason EVP - Operations Dr Othon Gervasio Chief Medical Officer Dr Ellen van Dam Chief Scientific Officer David Green Chief Financial Officer Robert Vickery Company Secretary Eva Lengyelova EVP – Clinical Development 63 Mary Bennett Head of People and Culture Juliane Foley VP Regulatory Affairs 63 Chris Horvath Chief Commercial Officer
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Thank you