Clarity Pharmaceuticals Ltd. · ASX:CU6
Clarity Pharmaceuticals — Shareholder Meeting (November 2023)
27 slides from Clarity Pharmaceuticals's shareholder meeting presentation, Nov 23, 2023
Slide 1: Managing Director's presentation – Annual General Meeting
For personal use only Managing Director’s presentation Annual General Meeting 23 November 2023 Dr Colin Biggin
Slide 2: Disclaimer
Disclaimer Introduction For personal use only 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 informati
Slide 3: 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 For personal use only ASX code: CU6 Proprietary Global leader in Significant supply, SAR Techno
Slide 4: Clarity – The Copper Theranostics Company
Clarity – The Copper Theranostics Company For personal use only SAR Technology Targeted Copper Theranostics are the next- generation disruptive platform in Radioisotope Copper isotopes for Positron Emission radiopharmaceuticals that employ the “perfect Tumour Tomography (PET) imaging (64Cu) or thera
Slide 5: Why Copper?
Why Copper? The physical properties of copper-64 and copper-67 have optimal characteristics for global commercialisation For personal use only 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 lif
Slide 6: Current industry challenges
Current industry challenges For personal use only Combined with a history of supply issues Additional demands on existing supply as industry grows Time sensitive products with Inability to control short shelf-lives the entire supply chain Reliance on ageing Manufacturing Complex international nuclea
Slide 7: Clarity's TCTs Solution
Current industry challenges For personal use only Clarity’s TCTs Solution Additional demands on existing supply as industry grows Global scale commercial Time sensitive capacity for diagnostics Inability to control products with and therapeutics short shelf-lives the entire supply chain 100% control
Slide 8: Key FY23 highlights
Key FY23 highlights For personal use only CLINICAL OPERATIONS • Actively progressing seven clinical trials of • Commercial scale Cu-67 now being Clarity’s three key product areas routinely supplied exclusively to Clarity by NorthStar Medical Radioisotopes • 1st Phase III diagnostic trial commencing
Slide 9: Three core product areas in US clinical trials
Three core product areas in US clinical trials Clarity has potential to address multiple oncology indications with unmet needs through a range of products and their For personal use only applications. These include large indications, such as prostate and breast cancers, as well as small and orphan i
Slide 10: Clinical development in multiple cancers
Clinical development in multiple cancers Clarity’s products are progressing through sponsored clinical trials in the US and Australia For personal use only Clinical development pipeline as of 23 November 2023 Note clinical development pipeline is indicative only, subject to review. All US studies ar
Slide 11: SAR-bisPSMA clinical trials
SAR-bisPSMA SECuRE - Phase I/IIa Targets the Prostate Specific Membrane Antigen For personal use only • Recruiting in 12GBq therapy cohort (PSMA), present in the majority of prostate cancers • 100% of participants in cohort 2 (8GBq) had a PSA decrease of >80% from a single therapy cycle PROPELLER -
Slide 12: SAR-bisPSMA market opportunity
SAR-bisPSMA market opportunity For personal use only PSMA based diagnostics SAR-bisPSMA aims to disrupt current diagnostic and therapeutic utilisation with a best-in-class • Current US patient pool for PSMA-PET imaging is ~355k agent for imaging and treating prostate cancer scans per year between in
Slide 13: Not all PSMA targeting agents are created equal
Not all PSMA targeting agents are created equal For personal use only 64Cu/67Cu Superior performance of SAR-bisPSMA compared to monomer SAR-PSMA Radioisotope Cage SAR “chelator” securely SAR-bisPSMA has higher holding the radioisotope Targeting uptake in tumours and strong Molecules retention compar
Slide 14: 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. For personal use only Significant market opportunity to displace currently approved products, which are set to generate > US$1Bn in 2023. Lantheu
Slide 15: 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 For personal use only imaged from 1 hour to >24 hours post administration 64Cu-SAR-bisPSMA PET has the ability to image both on the day of
Slide 16: Therapy program with 67Cu-SAR-bisPSMA
Therapy program with 67Cu-SAR-bisPSMA For personal use only Currently recruiting into cohort 3 in the US-based study Trial highlights to date • Now recruiting in cohort 3 at 12GBq dosing Trial overview (Pluvicto dose capped at 7.4GBq) • Phase I/II study in mCRPC • One third of patients in cohort 1 h
Slide 17: 67Cu-SAR-bisPSMA therapy
67Cu-SAR-bisPSMA therapy Phase I/II SECURE trial in mCRPC : For personal use only 64Cu-SAR-bisPSMA PET/CT imaging before and after a single cycle of 8GBq 67Cu-SAR-bisPSMA Cohort 2 PSA decrease following (n=3) single therapy cycle 1 >95% PSA 47.2 May 23 2 >99% 3 >80% Considerable reduction in uptake
Slide 18: SAR-Bombesin
SAR-Bombesin Targets the Gastrin Releasing Peptide receptor (GRPr), For personal use only which is present in a number of cancers, including breast and prostate cancers COMBAT – Phase I/IIa therapy • 1st therapy patient treated in October 2023 SABRE – Phase II • 50% recruitment milestone in July 23
Slide 19: SAR-Bombesin lesion detection
SAR-Bombesin Lesion detection by 64Cu-SAR-BBN in PSMA- negative/equivocal biochemical recurrent PC For personal use only 18F-DCFPyl PET/CT (Pylarify) 64Cu-SAR-BBN PET/CT Day 1 64Cu-SAR-BBN PET/CT Day 2 Single pelvic lymph node uptake seen on 64Cu SAR-BBN on both Day 1 and Day 2. A subsequent biopsy
Slide 20: Metastasis detection of biochemical recurrent PC by 64Cu-SAR-BBN
Metastasis detection of biochemical recurrent PC by 64Cu-SAR-BBN For personal use only 68Ga-PSMA-11-negative or equivocal PET/CT PET CT 64Cu-SAR-BBN Fused, MIP and CT (left to right) images from 68Ga-PSMA-11 64Cu-SAR-BBN (top) and PSMA (bottom) PET, of a patient demonstrating a left subpleural lesio
Slide 21: SARTATE
SARTATE Targets the Somatostatin Receptor 2 (SSTR2), which For personal use only is present in an aggressive childhood cancer, neuroblastoma, as well as Neuroendocrine Tumours (NETs), among other cancers CL04 – Phase I/IIa • Cohort 3 was completed in July 2023 • Safety Review Committee recommendatio
Slide 22: Neuroblastoma therapy with 67Cu SARTATE
Neuroblastoma therapy with 67Cu SARTATE For personal use only CL04 trial is a 67Cu-SARTATE peptide receptor radionuclide CL04: 64Cu/67Cu SARTATE Phase I/IIa trial in high- therapy administered to paediatric patients with high-risk, risk neuroblastoma in the US with up to 34 patients relapsed, refrac
Slide 23: Manufacturing
Manufacturing Scaling manufacturing for commercial launch Patient doses in numbers For personal use only In the last 12 months: Significant milestones • 200 diagnostic doses • 34 therapy doses PETNET Solutions Inc, a Large-scale rhodotron Siemens Healthineers production of 67Cu now Company being use
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 For personal use only create new products and new IP Broad Patent Portfolio Discovery Engine Platform Protection Select high value cancer targets •
Slide 25: Highly experienced team
Highly experienced team Clarity's management team has a diverse and in-depth level of For personal use only expertise spanning corporate finance, management, operations, commercialisation and industry • Development, approval and launch of 1st approved radiopharmaceutical therapy product for prostate
Slide 26: Accelerating clinical progress
Accelerating clinical progress For personal use only PROPELLER CLARIFY CLARIFY Full results Phase III trial Phase III 50% published commences recruitment PSMA Dx Au PSMA Dx US/Au PSMA Dx US/Au SECuRE Advance to cohort COMBAT COBRA 4 (multi-dose) Advance to cohort 2 PSMA Tx US BBN Tx US COMBAT Toplin
Slide 27: Thank you
Thank you For personal use only Contact details Dr Alan Taylor Dr Colin Biggin Executive Chairman Managing Director E: alan.taylor@claritypharm.com E: colin.biggin@claritypharm.com
Clarity Pharmaceuticals — Shareholder Meeting (November 2023) on 6ix