Clarity Pharmaceuticals Ltd. · ASX:CU6
Clarity Pharmaceuticals — Investor Presentation (September 2021)
32 slides from Clarity Pharmaceuticals's investor presentation, September 2021
Slide 1: Company Briefing
Company Briefing Dr Alan Taylor, Executive Chairman Dr Colin Biggin, Managing Director September 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 1 imaging and highly precise and accurate therapy Multiple products in clinical development, complemented by two Investigational New Drugs 2 (INDs) and two Rare Paediatric Disease
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 Targeted Copper Theranostics (“TCT”) Global leader in Targeted Copper Theranostics (TCT) Clarity us
Slide 5: Industry Overview
fCLARITY Industry Overview
Slide 6: Theranostic radiopharmaceuticals
Theranostic radiopharmaceuticals Theranostics is the combination of both therapeutic and diagnostic radiopharmaceuticals in the one platform Theranostics The Five Pillars of Cancer Care and Precision Therapy Theranostics is the next generation of “Precision Therapy” in cancer care The diagnostic
Slide 7: Theranostics in practice
Theranostics in practice Theranostic approach increases the probability of treatment success by selecting patients that demonstrate uptake of the diagnostic agents to visualise their cancer prior to therapy DIAGNOSIS (Copper-64) Patients are imaged with a PET camera, which THERAPY (Copper-67) allows
Slide 8: Cancers that Clarity is currently focused on
Cancers that Clarity is currently focused on Diverse asset portfolio addressing both large and orphan market opportunities across diagnostics and therapies Pan Cancer Neuroblastoma Neuroendocrine Tumours Prostate Cancer (e.g. breast and prostate) (NB) (NETs) 1 in 8 women will be 1 in 8 men will be 8
Slide 9: Company Overview
Company Overview
Slide 10: 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 Radioisotope Copper isotopes used, for example, in Positron Emission Tomography (PET) Tumour imaging (64Cu) or
Slide 11: Clarity's superior chelator
Clarity’s superior chelator Until now, the utilisation of copper radioisotopes has been hampered by the inability to hold the isotopes in a suitable cage – Clarity’s chelator addressed this issue Comparison of Clarity’s superior chelator vs. other chelators Comparison of Clarity’s 64Cu SARTATE vs. 6
Slide 12: 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 Copper-64 (64Cu) Copper-67 (67Cu) Isotope production I
Slide 13: Clinical benefits of the copper isotope "perfect pair"
Clinical benefits of the copper isotope “perfect pair” High Accuracy High Precision Achieved by only treating those patients Achieved by using the same targeting molecule with the same chemical who show product uptake in the tumour in element inside the chelator the diagnostic PET scan Diagnostic Th
Slide 14: Clarity's clinical products
Clarity’s clinical products SAR Technology platform 1 2 3 SARTATE™ SAR-Bombesin Pan Cancer SAR-bisPSMA (e.g. breast and Prostate Cancer Neuroblastoma Neuroendocrine prostate cancers) (NB) Tumours (NETs) Theranostic Diagnostic Theranostic Theranostic 14
Slide 15: 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 Review Vouchers (PRVs) • Open US FDA IND for 64/67Cu SA
Slide 16: SARTATE – next generation theranostic
NB SARTATE SARTATE™ – next generation theranostic NETs SAR-Bombesin SAR-bisPSMA SARTATE™ is a highly targeted theranostic radiopharmaceutical which is being developed for diagnosing, staging and subsequently treating cancers that express somatostatin receptor 2 (SSTR2) Target benefits CL01 Trial: Su
Slide 17: SARTATE CL04: 64/67Cu SARTATE
NB SARTATE SARTATE™ CL04: 64/67Cu SARTATETM NETs SAR-Bombesin SAR-bisPSMA Theranostic trial in neuroblastoma High Accuracy Phase I/IIa Conducting a 64Cu/67Cu SARTATE™ Phase I/IIa trial in neuroblastoma in the US with up to 34 patients (NCT 04023331) Multi-centre, dose-escalation, open label, non
Slide 18: SARTATE CL04: 64/67Cu SARTATE
NB SARTATE SARTATE™ CL04: 64/67Cu SARTATETM NETs SAR-Bombesin SAR-bisPSMA Theranostic trial in neuroblastoma High Precision Phase I/IIa Conducting a 64Cu/67Cu SARTATE™ Phase I/IIa trial in neuroblastoma in the US with up to 34 patients (NCT 04023331) Multi-centre, dose-escalation, open label, no
Slide 19: SARTATE CLS07: 64Cu SARTATE
NB SARTATE SARTATE™ CLS07: 64Cu SARTATETM NETs SAR-Bombesin SAR-bisPSMA Phase II NETs diagnostic DISCO Diagnostic Imaging Study of Copper-64 SARTATE (DISCO) using PET on patients with known or suspected NETs (NCT 04438304) Assessing the performance of imaging agent 64Cu SARTATETM in participants w
Slide 20: SAR-Bombesin: A pan-cancer target
NB SARTATE SAR-Bombesin: A pan-cancer target NETs SAR-Bombesin SAR-bisPSMA 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 peptide receptor (GR
Slide 21: SAR-Bombesin in metastatic breast cancer
NB SARTATE SAR-Bombesin in metastatic breast cancer NETs SAR-Bombesin SAR-bisPSMA C-BOBCAT First in human pilot trial assessment of the diagnostic value of 64Cu SAR-Bombesin PET/CT C-BOBCAT: One hour post 64Cu-SAR-Bombesin administration in a breast imaging for staging of hormone positive breast can
Slide 22: SAR-Bombesin in metastatic prostate cancer
NB SARTATE SAR-Bombesin in metastatic prostate cancer NETs SAR-Bombesin SAR-bisPSMA Detection of PSMA-negative mCRPC 64Cu SAR-Bombesin (top) and 68Ga PSMA (bottom) PET/CT images of the same patient with clinical signs of prostate cancer (a rising PSA score of 0.16). A suspected tumour is The left
Slide 23: SAR-bisPSMA: Prostate cancer
NB SARTATE SAR-bisPSMA: Prostate cancer NETs SAR-Bombesin SAR-bisPSMA SAR-bisPSMA has ideal product characteristics for a radiopharmaceutical ‘Bis-PSMA’ High uptake and retention in tumour The term Bis is used to denote the 120 Preclinical biodistribution presence of two 80 study demonstrating high
Slide 24: SAR-bisPSMA: SECuRE & Propeller
NB SARTATE SAR-bisPSMA: SECuRE & Propeller NETs SAR-Bombesin SAR-bisPSMA 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-cen
Slide 25: 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 Select high value cancer targets Generate and radiolabel compounds (peptides and/or antibodies) 64Cu imaging in tumour models 67Cu efficacy studies in
Slide 26: 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 Clinical development pipeline Robust clinical
Slide 27: Recent milestones
Recent milestones YTD 2021 milestones Clarity has reached significant milestones in its clinical Feb 2021 - Assignment of certain patents from the University processes since the beginning of 2020, with a number of of Melbourne (previously licensed to Clarity) important developments achieved in 2021
Slide 28: 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 Broad patent protection Broad Patent Portfolio Clarity has an extensive patent por
Slide 29: The growth of radiopharmaceuticals in the US
The growth of radiopharmaceuticals in the US Radiopharmaceuticals are expected to grow strongly over the next 20 years, as a result of expansion of the user base who can prescribe radiopharmaceuticals and a positive US reimbursement environment Expansion of the user base who can prescribe Additional
Slide 30: 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 31: 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 Prof Oliver Sartor Prof Richard Wahl Prof Jason Lewis Prof Andreas Kjaer Prof Paul Donnelly Prof Dale Bailey Principa
Slide 32: Contact details
Contact details Dr Alan Taylor Dr Colin Biggin Executive Chairman Managing Director Ph: +61 (0)413 871 165 Ph: +61 (0)473 536 205 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 t
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