Clarity Pharmaceuticals Ltd. · ASX:CU6
Clarity Pharmaceuticals — Investor Presentation (September 2024)
30 slides from Clarity Pharmaceuticals's investor presentation, Sep 18, 2024
Slide 1: Shareholder Briefing
Shareholder Briefing Developing the next-generation of radiopharmaceuticals to improve treatment outcomes for children and adults with cancer Dr Alan Taylor, Executive Chairperson 18 September 2024
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: Who is Clarity
Who is Clarity Senior Executive Team Non-Executive Directors Dr Alan Taylor, PhD Rosanne Robinson Our Team Executive Chairperson Non-Executive Director & Lead Our diverse team brings together many years of in- Michelle Parker Independent Director depth expertise spanning corporate finance, Chief Cli
Slide 4: Corporate Snapshot
Corporate Snapshot Clarity Pharmaceuticals is a clinical stage radiopharmaceutical company developing next-generation products to address the growing need for better diagnostics and treatments in oncology Proprietary Global leader in Targeted Significant supply, SAR Technology: a true Copper Therano
Slide 5: Clarity – The Copper Theranostics Company
Clarity – The Copper Theranostics Company SAR Technology Targeted Copper Theranostics are the next- generation disruptive platform in Radioisotope radiopharmaceuticals that employ the “perfect Copper isotopes for Positron Emission pairing” of copper-64 (64Cu) and copper-67 (67Cu) Tumour Tomography (
Slide 6: Why Copper?
Why Copper? The physical properties of copper-64 and copper-67 have optimal characteristics for global commercialisation Diagnostic radionuclides Therapeutic radionuclides Copper-64 Gallium-68 Fluorine-18 Copper-67 Lutetium-177 Half life 12.7 hours 1.1 hours 1.83 hours Half life 2.6 days 6.7 days Ty
Slide 7: SAR-bisPSMA
SAR-bisPSMA Two Proprietary Positions Dual PSMA targeting What's all the hype? 1. Composition of matter on chelator Unique dimer with two that securely holds copper targeting molecules leads 2. Composition of matter on SAR- to increased tumour uptake bisPSMA dual targeting molecule Precision Targeti
Slide 8: Monomer vs Dimer
Monomer vs Dimer • Pluvicto® Superior performance of bisPSMA compared • SAR-bisPSMA • Pylarify ® to monomer PSMA • 68Ga-PSMA-11 • 177Lu-PNT2002 Significantly better binding and internalisation 8 Zia et al., 2019. Ang.Chem
Slide 9: Monomer vs Dimer
Monomer vs Dimer • Pluvicto® Superior performance of bisPSMA compared • SAR-bisPSMA • Pylarify ® to monomer PSMA • 68Ga-PSMA-11 • 177Lu-PNT2002 68Ga-PSMA-11 64Cu-SAR-bisPSMA 9
Slide 10: SECuRE study design
SECuRE study design Phase I/IIa: safety and efficacy of 67Cu-SAR-bisPSMA in metastatic castrate-resistant prostate cancer (mCRPC) 12 12 12 12 Key eligibility criteria TBD TBD TBD TBD GBq GBq GBq GBq • Progressive mCRPC, prior 12 ADT and at least one ARPI GBq Cohort 4 Expansion cohort 8 (pre- or post
Slide 11: Complete response following cycles of 67Cu-SAR-bisPSMA (8GBq)
Complete response following 2 cycles of 67Cu-SAR-bisPSMA (8GBq) Multi-dose of 67Cu-SAR-bisPSMA under Expanded Access Program (EAP) • Complete anatomical response (CT; RECIST v1.1) PSA reduction following 2 doses of 67Cu-SAR-bisPSMA • Complete molecular response (PET) Cycle 1: Cycle 2: • Complete bio
Slide 12: 67Cu-SAR-bisPSMA single dose leads to PSA reductions in heavily pre-treated mCRPC patients
67Cu-SAR-bisPSMA single dose leads to PSA reductions in heavily pre-treated mCRPC patients 78% PSA level reductions across different cohorts Best response in PSA levels 90 80 from baseline (%) 70 of patients showed reductions in 60 PSA levels >35% (cohorts 2 and 3) 50 44% 40 30 20 10 0 >PSA35 >PSA80
Slide 13: SECuRE cohort - 4GBq dose level
SECuRE cohort 1 - 4GBq dose level 13
Slide 14: US FDA Expanded Access Program
US FDA Expanded 4GBq of 67Cu-SAR-bisPSMA over 4 cycles Access Program • Additional therapy cycles of 67Cu-SAR-bisPSMA at the lowest 4GBq dose level have been requested under the US FDA EAP • Early data indicates positive effects • SPECT-CT images (on the right) demonstrate a reduction in the intensi
Slide 15: 67Cu-SAR-bisPSMA (12GBq single dose) leads to PSA and tumour volume reductions – Cohort 3
67Cu-SAR-bisPSMA (12GBq single dose) leads to PSA and tumour volume reductions – Cohort 3 64Cu-SAR-bisPSMA PET - MIP 92% Pre-67Cu-SAR-bisPSMA Post-67Cu-SAR-bisPSMA PSA reduction achieved 8 weeks post-67Cu-SAR-bisPSMA Pre Tx Post Tx ∆ (%) PSA 270.9 20.8 -92.3 SUVmax 51.74 19.03 -63.22 Tumour 1,040.92
Slide 16: Two doses of 12GBq of 67Cu-SAR-bisPSMA lead to PSA and tumour volume reductions – Cohort 4
Two doses of 12GBq of 67Cu-SAR-bisPSMA lead to PSA and tumour volume reductions – Cohort 4 64Cu-SAR-bisPSMA PET 92% Post-cycle 2 of PSA reduction achieved post- Pre-67Cu-SAR-bisPSMA 67Cu-SAR-bisPSMA 2 doses of 67Cu-SAR-bisPSMA (PSA continues to decline) Pre Tx Post Tx ∆ (%) PSA 157.4 12.1 -92.3 SUVm
Slide 17: 67Cu-SAR-bisPSMA has a favourable safety profile
67Cu-SAR-bisPSMA has a favourable safety profile Cohorts 1-3 (single dose): most adverse events (AEs) were lower Grade, with only 3/15 patients Cohorts 1-3 Grade 3 developing Grade 3 AEs (no Grade 4/5) Adverse event (AE) N = 15 (100%) • No AEs were related to 64Cu-SAR-bisPSMA Any drug-related AEs 3
Slide 18: Dosimetry and clearance
Dosimetry and clearance Serial SPECT imaging after administration of therapy showed prolonged tumour retention of 67Cu-SAR-bisPSMA with non-tumour bound activity clearing rapidly via the kidneys. Dosimetry assessment in a participant from cohort 3 (12GBq). SPECT was performed at different timepoints
Slide 19: Next-generation SAR-bisPSMA diagnostic is coming
Next-generation SAR-bisPSMA diagnostic is coming Improved uptake of SAR-bisPSMA may support better diagnosis compared to first-generation PSMA PET agents. Significant market opportunity to displace currently approved products, which generated >US$1.1Bn in 2023 Lantheus: PYLARIFY® (18F-DCFPyL) US sal
Slide 20: 64Cu-SAR-bisPSMA led to 2-3x higher SUVmax/mean and TBR than 68Ga-PSMA-11
64Cu-SAR-bisPSMA led to 2-3x higher SUVmax/mean and TBR than 68Ga-PSMA-11 SUV SUVmax SUVmean Tumour-to-background ratio p<0.001 p<0.001 p<0.001 p<0.001 p<0.001 p<0.001 64Cu 68Ga 64Cu 68Ga 64Cu 68Ga Tracer Tracer 2.5x 2.6x 2.7x Tracer higher SUVmax higher SUVmean higher TBR Box plots shown from reade
Slide 21: Copper brings significant additional advantages
Copper brings significant additional advantages Beyond the supply chain advantages of a 12.7-hour half-life PET imaging agent, SAR-bisPSMA allows patients to be imaged from 1 hour to >24 hours post administration. 64Cu-SAR-bisPSMA enhanced performance could lead to considerable impact on treatment d
Slide 22: 64Cu-SAR-bisPSMA identifies lesions months before currently 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 68Ga-PSMA-11 64Cu-SAR-bisPSMA and SOC PSMA agents (SOC PET performed ~6 months later) 60 53 64Cu-SAR-bisPSMA Next-day imaging 50 Prostate
Slide 23: Higher uptake and contrast in lesions on next-day imaging and detection of lesions in the 2-millimeter range
Higher uptake and contrast in lesions on next-day imaging and detection of lesions in the 2-millimeter range SUVmean and SUVmax in lesions TBR of lesions detected by detected by 64Cu-SAR-bisPSMA 64Cu-SAR-bisPSMA 30 150 Mean SUVmean and Mean TBR of lesions SUVmax in lesions 25 20 100 15 10 50 5 0 0 S
Slide 24: Clinical development in multiple cancers
Clinical development in multiple cancers Clarity’s products are progressing through sponsored clinical trials in the US and Australia Clinical development pipeline as of 30 August 2024 Current progress 12 month progress Note clinical development pipeline is indicative only, subject to review. All US
Slide 25: 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 26: Current industry challenges with 68Ga & 177Lu; Clarity's TCT Solution with 64Cu & 67Cu
Current industry challenges with 68Ga & 177Lu Clarity’s TCT Solution with 64Cu & 67Cu Additional demands on existing supply as industry grows Global scale commercial capacity for Time sensitive diagnostics and products with Inability to control therapeutics short shelf-lives the entire supply chain
Slide 27: Next-generation theranostics provide solutions to the challenges with current-generation radiopharmaceuticals
Next-generation theranostics provide solutions to the challenges with current-generation radiopharmaceuticals Opportunities with 64Cu (half-life = 12.7h) Opportunities with Rhodotron produced 67Cu • Can be mass produced on cyclotrons with solid targetry • Commercially available • Every US zip code c
Slide 28: Strong strategic interest in radiopharmaceutical assets
Strong strategic interest in Clarity’s copper platform, strong prostate pipeline and therapeutic and diagnostic efficacy data radiopharmaceutical assets represents an attractive opportunity to grow a significant radiopharmaceutical franchise in Acquisition oncology and other indications Date Target
Slide 29: Summary
Summary Global leader in Targeted Copper Theranostics (TCTs) • Exciting efficacy and safety data to date with therapy and imaging • Extensive pipeline of TCTs based on 64Cu for diagnosis and 67Cu for therapy • Multiple therapeutic and diagnostic trials in progress, including a Phase III registration
Slide 30: Thank you
Thank you Contact details Dr Alan Taylor Executive Chairperson E: alan.taylor@claritypharm.com
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