Clarity Pharmaceuticals Ltd. · ASX:CU6
Clarity Pharmaceuticals — Shareholder Meeting (November 2022)
18 slides from Clarity Pharmaceuticals's shareholder meeting presentation, Nov 24, 2022
Slide 1: Managing Director's presentation
Managing Director’s presentation Annual General Meeting 24 November 2022 Dr Colin Biggin
Slide 2: Disclaimer
Disclaimer Introduction No representation, warranty or assurance (express or implied) is given or made in relation to any forward- This presentation has been prepared by Clarity Pharmaceuticals Ltd (ACN 143 005 341) (Clarity or the looking statement by any person (including any of the Limited Partie
Slide 3: Clarity in a nutshell (ASX:CU6)
Clarity in a nutshell (ASX:CU6) 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, logistical, SAR Technolo
Slide 4: Targeted clinical development strategy
Targeted clinical development strategy Develop Focus on high Position products Target the large Advance products for quality clinical to maximise US market for diagnostics to both rare and sites and opportunity in first product market first large indications experienced current treatment approvals w
Slide 5: SAR Technology platform
SAR Technology platform SAR Technology Radioisotope Copper isotopes used, for example, in Positron Emission Tomography (PET) Tumour imaging (64Cu) or therapy (67Cu) A proprietary, highly specific and highly stable bifunctional cage (chelator) with a superior ability to retain copper isotopes within
Slide 6: Three distinct products built on SAR Technology
Three distinct products built on SAR Technology Each product area can be a diagnostic or a therapeutic SAR-bisPSMA SAR-Bombesin SARTATETM Targets cancers Targets cancers Targets cancers that express that express that express Prostate Specific Gastrin Releasing Somatostatin Membrane Peptide receptor
Slide 7: Key FY22 highlights
Key FY22 highlights OPERATIONAL CORPORATE FINANCIAL • Actively progressing seven • Strengthened leadership team: • Strong cash balance of $84.7 clinical trials of Clarity’s three ‐ New CSO, Dr Jeff million as at 30 September 2022 key product areas Norenberg • R&D tax incentive for FY22: ‐ New CFO, M
Slide 8: SAR-bisPSMA
SAR-bisPSMA Targets the Prostate Specific Membrane Antigen SECuRE - Phase I/IIa (PSMA), present in the majority of prostate cancers • Recruitment completed for imaging stage • Advanced to therapy stage with 67Cu SAR-bisPSMA in the US PROPELLER - Phase I • Reached full recruitment in July 2022 • Top-
Slide 9: SAR-Bombesin
SAR-Bombesin Targets the Gastrin Releasing Peptide receptor (GRPr), which is present in a number of cancers, LATEST NEWS including breast and prostate cancers COMBAT- Phase I/II therapy • IND application approval received in November 2022 from the US FDA for 67Cu SAR-BBN in PSMA-negative prostate ca
Slide 10: SARTATE
SARTATE Targets the Somatostatin Receptor 2 (SSTR2), which is present in an aggressive childhood cancer, neuroblastoma, as well as Neuroendocrine Tumours (NETs), among other cancers CL04 - Phase I/IIa • Safety Review Committee recommendation to continue dose escalation phase, opening cohort 3 • Coho
Slide 11: Clarity on clinicaltrials.gov
Clarity on clinicaltrials.gov More details on all our clinical trials are online Strong focus on US clinical sites, leading cancer centres and investigators 11
Slide 12: 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 24 November 2022 Note clinical development pipeline is indicative only, subject to review. All US studies are conducted under IND
Slide 13: Enabling universal access to PET imaging with 64Cu & next-generation therapeutics
Enabling universal access to PET imaging with 64Cu & the next generation of therapeutics with 67Cu 64Cu (half-life = 12.7h) 67Cu (half-life = 2.6 days) • Can be mass produced on cyclotrons with solid targetry • Commercially available high powered rhodotron with a small footprint • Every US zip code
Slide 14: Manufacturing
Manufacturing Continuing to build out the large supply chain for TCTs New collaborations Patient doses in numbers In the last 12 months: • 108 diagnostic doses • 21 therapy doses In the last 3 months: Production of a range of Large scale ready-to-use TCTs for production of Cu-67 • 48 diagnostic dose
Slide 15: 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 16: Highly experienced team
Highly experienced team Clarity's management team has a diverse and in-depth level of expertise spanning corporate finance, management, operations, commercialisation and industry • Development, approval and launch of 1st approved radiopharmaceutical therapy product for prostate cancer (Xofigo) Dr Al
Slide 17: Accelerating clinical progress
Accelerating clinical progress Dx = Diagnostics BBN Tx Tx = Theranostics 1st patient treated SECuRE BBN Tx COBRA BBN Tx US Advance to PSMA Phase III SABRE Open IND Recruitment cohort 2 Pivotal study 50% recruitment BBN Tx US complete PSMA Tx US commences BBN Dx US COBRA PSMA Dx US PSMA Dx US 50% rec
Slide 18: Thank you
Thank you Contact details Dr Alan Taylor Dr Colin Biggin Executive Chairman Managing Director E: alan.taylor@claritypharm.com E: colin.biggin@claritypharm.com
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