Clarity Pharmaceuticals Ltd. · ASX:CU6
Clarity Pharmaceuticals — Bell Potter Healthcare Conference 2022
26 slides from Clarity Pharmaceuticals's conference presentation, Nov 9, 2022
Slide 1: Bell Potter Healthcare Conference 2022
Developing the next-generation of radiopharmaceuticals to improve treatment outcomes for children and adults with cancer Bell Potter Healthcare Conference 2022 Dr Alan Taylor, Executive Chairman Dr Colin Biggin, Chief Executive Officer 9 November 2022
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 ASX Code: CU6 Significant Proprietary SAR Technology: Global leader in supply, log
Slide 4: Radiopharmaceuticals: Market overview
Radiopharmaceuticals: Market overview Global Oncology Market 2021 Global Oncology Market 2031 US$286 Bn US$~25 Bn US$~1.3 Bn US$600 Bn US$6.3 Bn US$35 Bn US$ ~5 Bn US$~10 Bn Global Oncology Global radiopharmaceuticals Radio-diagnostics Radio-therapeutics 2021 2031 Global oncology market US$ 286 Bill
Slide 5: Growth drivers
Growth drivers Radiopharmaceuticals have shown significant growth potential both diagnostically and therapeutically and companies, similar to Clarity, have proven to be very profitable Positive changes have driven Big Pharma interest in the space Re-imbursement Novartis Pricing (Pluvicto >US$
Slide 6: Current industry challenges
Current industry challenges Combined with a history of Creates challenges supply issues for prescribers Additional demands on existing supply as industry grows Work to be done to convince oncologists that there is a safe, dependable and Inability to control Time sensitive reliable source of the enti
Slide 7: Clarity's TCTs address the current industry challenges
Clarity’s TCTs address the current industry challenges Clarity Pharmaceuticals is a clinical stage radiopharmaceutical company with a mission to develop next- generation products that improve treatment outcomes for children and adults with cancer Proprietary SAR Technology platform enables Targeted
Slide 8: Clarity - the perfect pairing to address current challenges
Clarity - the perfect pairing to address current challenges Copper-64 (half-life = 12.7 hours) Copper-67 (half life = 2.6 days) • Mass produced on cyclotrons • Optimal half-life for peptide-based therapy • Every US zip code covered from 1 location • Commercially available high powered rhodotron for
Slide 9: Proprietary SAR Technology platform
Proprietary SAR Technology platform Theranostic radiopharmaceuticals have four main elements: a radioisotope, cage, linker and targeting ligand and are administered intravenously Radioisotope Copper isotopes used, for example, in Positron Emission Tomography (PET) Tumour imaging (64Cu) or therapy (6
Slide 10: Global leader in Targeted Copper Theranostics
Global leader in Targeted Copper Theranostics Clarity’s SAR Technology is used to develop the next generation of radiopharmaceuticals that employ the “perfect pairing” of copper-64 (64Cu) for diagnosis and copper-67 (67Cu) for therapy Diagnostic Therapeutic Positron emission from 64Cu at Beta partic
Slide 11: Dual development strategy
Dual development strategy SAR Technology enables a synergistic development of stand-alone diagnostics as well as paired theranostics Diagnostics based on 64Cu Theranostics based on 64Cu/67Cu Dx revenue pays for late-stage • Broad market opportunities Tx clinical development • High precision, high ac
Slide 12: Clinical Development
Clinical Development
Slide 13: Three core product areas in clinical trials
Three core product areas in clinical trials Clarity has an active clinical development program in multiple oncology indications with unmet needs through a range of products and their applications. The SAR platform is also used in our SAR-DISCOVERY program which has significant synergies with the exi
Slide 14: 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 9 November 2022 Note clinical development pipeline is indicative only, subject to review. All US studies are conducted under IND 1
Slide 15: SAR-bisPSMA: Pre-clinical data
SAR-bisPSMA: Pre-clinical data SAR-bisPSMA is ideally suited for a theranostic radiopharmaceutical ‘bisPSMA’ The term “bis” is High uptake and retention in tumour used to denote the presence of two 120 Preclinical biodistribution identical but 80 study demonstrating high Rapid kidney clearance of se
Slide 16: SAR-bisPSMA therapy in prostate cancer
SAR-bisPSMA therapy in prostate cancer PET scans in a patient with metastatic castrate-resistant prostate cancer imaged over multiple timepoints between 1 and 72 hours post administration of 64Cu SAR-bisPSMA (Normalised Voxel Intensity) 16
Slide 17: SAR-bisPSMA diagnostic in untreated, confirmed prostate cancer
SAR-bisPSMA diagnostic in untreated, confirmed prostate cancer Comparison of 68Ga PSMA-11 (image left) to Clarity’s 64Cu SAR-bisPSMA (image right) in the same patient 68Ga PSMA-11 (~200MBq) 64Cu SAR-bisPSMA (~200MBq) 68Ga PSMA-11 (~200MBq, left) vs. 64Cu SAR-bisPSMA (~200MBq, right) in the same pati
Slide 18: SAR-bisPSMA therapy in prostate cancer
SAR-bisPSMA therapy in prostate cancer SECuRE: Systemic Copper theranostics in prostate cancer • Phase I/IIa study of 64Cu/67Cu SAR-bisPSMA for identification Preliminary imaging results from the dosimetry phase and treatment of PSMA-expressing metastatic castrate resistant prostate cancer (mCRPC) 6
Slide 19: SAR-bisPSMA diagnostics
SAR-bisPSMA diagnostics PSMA diagnostics are set to become a blockbuster market with >$1.1B in the US Pre-definitive treatment setting Biochemical recurrence (BCR) setting Compares 64Cu SAR-bisPSMA to 68Ga PSMA-11in participants with Investigates the safety and tolerability of 64Cu SAR-bisPSMA as we
Slide 20: SAR-Bombesin – a pan cancer product
SAR-Bombesin – a pan cancer product GRPr is a receptor that is overexpressed in a number of cancers including prostate, breast, colon, gastric, glioma, pancreatic, small cell lung and non-small cell lung cancer, as well as renal cell cancer SAR-Bombesin was able to locate tumours in PSMA-negative pr
Slide 21: SAR-Bombesin in PSMA-negative prostate cancer
SAR-Bombesin in PSMA-negative prostate cancer SABRE: Copper-64 SAR-BBN in Biochemical Recurrence of prostate BOP IIT: Copper-64 SAR Bombesin in Prostate Specific Membrane Antigen cancer (PSMA) negative Prostate Cancer The primary objectives of the trial are to investigate the safety and Assesses the
Slide 22: SARTATE™
SARTATE™ SARTATE™ CL04: 67Cu-SARTATE™ Peptide Receptor Radionuclide DISCO: Diagnostic Imaging Study of Copper-64 SARTATE using PET on Therapy Administered to Pediatric Patients With High-Risk, Relapsed, patients with known or suspected NETs Refractory Neuroblastoma 64Cu/67Cu SARTATE™ Phase I/IIa tri
Slide 23: Inflection points over next 12 months
Inflection points over next 12 months Dx = Diagnostics Tx = Theranostics BBN Tx 1st patient treated SECuRE BBN Tx BBN Tx US Advance to Open IND cohort 2 COBRA SABRE PSMA Phase III BBN Tx US PSMA Tx US Recruitment 50% recruitment Pivotal study complete BBN Dx US commences COBRA PSMA Dx US PSMA Dx US
Slide 24: 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 25: 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 Dr Alan Taylor
Slide 26: 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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