Clarity Pharmaceuticals Ltd. · ASX:CU6
Clarity Pharmaceuticals — Investor Presentation (March 2022)
28 slides from Clarity Pharmaceuticals's investor presentation, Mar 3, 2022
Slide 1: Clarity Pharmaceuticals Investor Presentation
For personal use only Clarity Pharmaceuticals Investor Presentation Dr Alan Taylor, Executive Chairman 3 March 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 highlights
Clarity highlights 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 Radiopharmaceutical company with highly differentiated product portfo
Slide 4: Radiopharmaceutical sector transactions
Radiopharmaceutical sector transactions The radiopharmaceutical market is niche and highly acquisitive For personal use only Completed Phase 3 with Lutathera® Licensed PSMA-617 after Phase 2a for Bayer acquired Algeta ASA for IBA Molecular acquired in Sep 2015, market entry was early ~USD14 million
Slide 5: Overview
Overview Clarity’s mission is to improve treatment outcomes for children and adults with cancer Targeted Copper Theranostics (“TCT”) For personal use only Clarity uses a “perfect pair” of copper radioisotopes Positron emission Beta particle (β-) 67Cu SARTATETM (PET imaging) for 64Cu SARTATETM emissi
Slide 6: 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 7: Clinical Update
For personal use only Clinical Update
Slide 8: 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 9: 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 cl
Slide 10: SAR-bisPSMA therapy in mCRPC
SAR-bisPSMA therapy in mCRPC SECuRE: Systemic Copper theranostics in prostate Preliminary imaging results from the dosimetry phase of For personal use only cancer (NCT04868604) the theranostic SECuRE clinical trial Phase I/IIa study of 64Cu/67Cu SAR-bisPSMA for identification 64Cu SAR-bisPSMA Compar
Slide 11: SAR-bisPSMA therapy in mCRPC
SAR-bisPSMA therapy in mCRPC PET scans in a patient with metastatic castrate-resistant prostate cancer imaged over multiple timepoints For personal use only between 1 and 72 hours post administration of 64Cu SAR-bisPSMA (Normalized Voxel Intensity) 11
Slide 12: SAR-bisPSMA diagnostics
SAR-bisPSMA diagnostics Two Phase III trials required for registration: one in the pre-definitive treatment and one in the BCR setting For personal use only PROPELLER: PET Imaging of participants with COBRA: Copper-64 SAR-bisPSMA in confirmed prostate cancer biochemically recurrent prostate cancer P
Slide 13: SAR-bisPSMA diagnostic in untreated, confirmed prostate cancer
SAR-bisPSMA diagnostic in untreated, confirmed prostate cancer For personal use only 68Ga PSMA-11 (~200MBq, left) vs. 64Cu SAR-bisPSMA (~200MBq, right) in the same patient; time between serial imaging was 8 days. Standardised Uptake Value (SUVmax)* of the lesions were 6.5 and 6.3 for 68Ga PSMA-11 an
Slide 14: 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 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 0.16 ng/m
Slide 16: SAR-Bombesin clinical development
SAR-Bombesin clinical development C-BOBCAT: Recruitment closed in Future trials For personal use only October 2021 • 64Cu-SAR-Bombesin diagnostic trial in PSMA negative prostate First-in-human pilot trial assessment of the cancer patients to open in 1H2022 under an IND diagnostic value of 64Cu SAR-B
Slide 17: Development of TCT across the prostate cancer indications
Development of TCT across the prostate cancer indications Potential to move TCT earlier For personal use only in the treatment schedule TCT therapy Tumour volume and activity Pre-treatment BCR Once FDA approved, 64Cu based diagnostics can be broadly used to diagnose and manage prostate cancer PSMA +
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 Current clinical development High Accuracy • 64Cu
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: Supply and Logistics
For personal use only Logistics Supply and
Slide 21: Enabling universal access to PET imaging with 64Cu
Enabling universal access to PET imaging with 64Cu The future of PET radioisotope supply is dependable, scalable and customer focused For personal use only 68Ga and 18F • Regional availability issues • Limited scope for future upscaling • Little patient flexibility with 3-12 hour shelf life • No opp
Slide 22: Next generation of therapeutics with 67Cu
Next generation of therapeutics with 67Cu Eliminating dependency on the limited number of aging nuclear reactors for therapeutic radioisotope supply For personal use only 177Lu 67Cu • Relies on antiquated, • Commercially unreliable and available high government powered rhodotron subsidised nuclear w
Slide 23: Targeted Copper Theranostics
Targeted Copper Theranostics Clarity’s solution to theranostic isotope supply The environmental considerations of TCT For personal use only threats • As the number of patient treatments increases, • No reactors environmental factors will impact the selection of theranostic radiopharmaceuticals • No
Slide 24: Clarity Team
For personal use only Clarity Team
Slide 25: 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 26: 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 The
Slide 27: 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 28: 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 eight years, lea
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