Clarity Pharmaceuticals Ltd. · ASX:CU6
Clarity Pharmaceuticals — Bell Potter Healthcare Conference 2021
27 slides from Clarity Pharmaceuticals's conference presentation, Nov 10, 2021
Slide 1: Bell Potter Healthcare conference
For personal use only Bell Potter Healthcare conference Dr Alan Taylor, Executive Chairman Dr Colin Biggin, Managing Director 10th November 2021
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 business highlights
Clarity business highlights Superior theranostic products using proprietary SAR Technology platform, achieving superior For personal use only 1 imaging and highly precise and accurate therapy Multiple products in clinical development, complemented by two Investigational New Drugs 2 (INDs) and two Ra
Slide 4: Overview
Overview Clarity Pharmaceuticals (the “Company”) is a clinical stage radiopharmaceutical company developing next- generation products to address the growing need for radiopharmaceuticals in oncology For personal use only Targeted Copper Theranostics (“TCT”) Radiopharmaceutical company with highly Cl
Slide 5: Clarity's proprietary SAR Technology platform
Clarity’s proprietary SAR Technology platform Theranostic radiopharmaceuticals have four main elements: a radioisotope, cage, linker and targeting ligand and are administered intravenously For personal use only Radioisotope Copper isotopes used, for example, in Positron Emission Tomography (PET) Tum
Slide 6: Supply and manufacturing advantages of copper
Supply and manufacturing advantages of copper The supply and manufacturing process of copper radioisotopes gives Clarity’s theranostic products an advantage in the commercialisation phase, enabling an efficient and streamlined distribution model For personal use only Copper-64 (64Cu) Copper-67 (67Cu
Slide 7: Clinical supply of ready-to-use TCT
Clinical supply of ready-to-use TCT Development of robust manufacturing network for current and future US product supply For personal use only Growing our TCT manufacturing footprint in the USA Washington Uni St Louis Evergreen Theranostics, NJ • Ready-to-use copper-64 and copper-67 based products c
Slide 8: Clinical supply of ready-to-use TCT
Clinical supply of ready-to-use TCT Development of robust manufacturing network for current and future US product supply For personal use only Growing our TCT manufacturing footprint in the USA Washington Uni St Louis Evergreen Theranostics, NJ • Ready-to-use copper-64 and copper-67 based products c
Slide 9: Clinical benefits of the copper isotope "perfect pair"
Clinical benefits of the copper isotope “perfect pair” High Accuracy High Precision For personal use only Achieved by only treating those patients Achieved by using the same targeting molecule with the same chemical who show product uptake in the tumour element inside the chelator in the diagnostic
Slide 10: Clarity's clinical development pipeline
Clarity’s clinical development pipeline Clarity’s products are progressing through Phase I and Phase II clinical trials with two open IND applications that received clearance to proceed to clinical trials from the FDA, two RPDDs and two ODDs from the FDA For personal use only Clinical development pi
Slide 11: US prostate cancer in numbers
US prostate cancer in numbers 1:8 US men will develop For personal use only 2nd prostate cancer in their lifetime most common cancer in US men 34,130 men will die annually of >3.1M prostate cancer in the US living with prostate cancer today in US 248,530 new cases of >200,000 prostate cancer in Curr
Slide 12: SAR-bisPSMA: Pre-clinical data
SAR-bisPSMA: Pre-clinical data SAR-bisPSMA has ideal product characteristics for a radiopharmaceutical ‘Bis-PSMA’ For personal use only High uptake and retention in tumour The term Bis is used to denote the 120 Preclinical biodistribution presence of two 80 study demonstrating high Rapid kidney clea
Slide 13: SAR-bisPSMA: Current clinical trials
SAR-bisPSMA: Current clinical trials For personal use only SECuRE: Systemic Copper theranostics in PROPELLER: PET Imaging of Participants With prostate cancer (NCT04868604) Confirmed Prostate Cancer (NCT04839367) A Phase I/IIa study of 64Cu SAR-bisPSMA and 67Cu SAR- A Phase I multi-centre, blinded r
Slide 14: SAR-bisPSMA mCRPC therapy
SAR-bisPSMA mCRPC therapy Preliminary imaging results from the dosimetry phase of the theranostic SECuRE clinical trial For personal use only PET scans in a patient with metastatic castrate-resistant prostate 64Cu SAR- Comparison of 1h 64Cu SAR- cancer imaged over multiple timepoints between 1 and 7
Slide 15: SAR-Bombesin in prostate cancer
SAR-Bombesin in prostate cancer Detection of PSMA-negative prostate cancer (PC) For personal use only 68Ga PSMA-11 (top) images of a PSMA-negative 68Ga PSMA-11 (top) images of a PSMA- patient with clinical signs of PC (a rising PSA score of negative patient with history of PC (a rising PSA • ~10% of
Slide 16: SAR-Bombesin: A pan-cancer target
SAR-Bombesin: A pan-cancer target SAR-Bombesin is a highly targeted pan-cancer theranostic radiopharmaceutical being developed for identifying and selecting patients for subsequent treatment of their cancers that express gastrin releasing For personal use only peptide receptor (GRPr) 64Cu SAR-Bombes
Slide 17: SAR-Bombesin in metastatic breast cancer
SAR-Bombesin in metastatic breast cancer C-BOBCAT: Recruitment closed For personal use only First-in-human pilot trial assessment of the C-BOBCAT: One hour post 64Cu-SAR-Bombesin administration in a breast diagnostic value of 64Cu SAR-Bombesin PET/CT cancer patient imaging for staging of hormone pos
Slide 18: SARTATE – next generation theranostic
SARTATE™ – next generation theranostic SARTATE™ is a highly targeted theranostic radiopharmaceutical which is being developed for diagnosing, staging and subsequently treating cancers that express somatostatin receptor 2 (SSTR2) For personal use only High Accuracy Target benefits High Precision • Ta
Slide 19: SARTATE: Clinical trials
SARTATE™: Clinical trials SARTATE™ CL04: 67Cu-SARTATE™ Peptide For personal use only Receptor Radionuclide Therapy Administered to DISCO: Diagnostic Imaging Study of Copper-64 Pediatric Patients With High-Risk, Relapsed, SARTATE using PET on patients with known or Refractory Neuroblastoma (NCT 04023
Slide 20: SARTATE regulatory milestones
SARTATE™ regulatory milestones Clarity has reached several regulatory milestones and approvals from the US FDA including the award of two Rare Paediatric Disease Designations (RPDD) which may potentially allow the company to access two Priority For personal use only Review Vouchers (PRVs) • Open US
Slide 21: Clarity's Discovery Program
Clarity’s Discovery Program Clarity’s SAR Technology platform can be used in conjunction with any number of targeting ligands to create new products For personal use only Select high value cancer targets Generate and radiolabel compounds (peptides and/or antibodies) 64Cu imaging in tumour models 67C
Slide 22: Robust Intellectual Property position
Robust Intellectual Property position Clarity has a broad patent portfolio protecting its Clarity’s proprietary SAR Technology platform, existing products, Discovery Program, and Manufacturing and Process protection For personal use only Broad patent protection Broad Patent Portfolio Clarity has a
Slide 23: Inflection points to Q4 2022
Inflection points to Q4 2022 >50% For personal use only recruitment Recruitment FPFV BBN US DISCO complete Dx US manufacture PROPELLER expansion Advance Advance Advance 1st PSMA Tx to Cohort 2: to Cohort 3: to Cohort 4: NB Tx PSMA Tx PSMA Tx Q4 2021 Q1 2022 Q2 2022 Q3 2022 Q4 2022 Recruitment Dosime
Slide 24: Board of Directors
Board of Directors Clarity’s board has extensive capital markets, radiopharmaceutical and broader life sciences experience Dr Alan Taylor Dr Colin Biggin Rosanne Robinson Dr Chris Roberts Dr Thomas Ramdahl Dr Gillies O’Bryan-Tear Mr Robert Thomas Executive Chairman Managing Director Non-Executive Di
Slide 25: Clarity's Scientific Advisory Board
Clarity’s Scientific Advisory Board Clarity’s advisory board comprises global thought leaders with extensive capabilities, expertise and experience in developing radiopharmaceuticals For personal use only Prof Oliver Sartor Prof Richard Wahl Prof Jason Lewis Prof Andreas Kjaer Prof Paul Donnelly Pro
Slide 26: Summary
Summary For personal use only Global leader in Targeted Copper Theranostics (TCT) Highly differentiated pipeline of TCT based on 64Cu for diagnosis and 67Cu for therapy TCT address the current manufacturing and logistical limitations in the growth of radiopharmaceuticals TCT are scalable, sust
Slide 27: Contact details
Contact details For personal use only Dr Alan Taylor Dr Colin Biggin Executive Chairman Managing Director E: alan.taylor@claritypharm.com E: colin.biggin@claritypharm.com Alan has been instrumental in the growth of Clarity Colin has over 15 years of radiopharmaceutical over the last seven years, lea
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