Clarity Pharmaceuticals Ltd. · ASX:CU6
Clarity Pharmaceuticals — Jefferies Biotech Summit (May 2022)
35 slides from Clarity Pharmaceuticals's conference presentation, May 27, 2022
Slide 1: Investor Presentation
Investor Presentation Developing the next-generation of radiopharmaceuticals to improve treatment outcomes for children and adults with cancer Dr Alan Taylor, Executive Chairman Dr Colin Biggin, Managing Director, CEO 27 May 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 summary
Clarity summary Clarity Pharmaceuticals is a clinical stage radiopharmaceutical company developing next-generation products to address the growing need for better diagnostics and treatments in oncology • Proprietary SAR Technology: a true platform technology that can drive out a range of radiopharma
Slide 4: Radiopharmaceutical sector transactions
Radiopharmaceutical sector transactions The radiopharmaceutical market is niche and highly acquisitive Completed Phase 3 with Lutathera® in Sep Licensed PSMA-617 after Phase 2a for ~USD14 million Bayer acquired Algeta ASA for 2015, market entry was early 2018 upfront with additional milestones and r
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 Radioisotope Copper isotopes used, for example, in Positron Emission Tomography (PET) Tumour imaging (64Cu) or
Slide 6: 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 7: Three core product areas in clinical trials
Three core product areas in clinical trials Clarity has potential to address multiple oncology indications with unmet needs through a range of products and their applications. These include large indications, such as prostate and breast cancers, as well as small and orphan indications, such as neuro
Slide 8: Targeted clinical development strategy
Targeted clinical development strategy Develop Position products for Focus on high products to Target the large Advance both rare and quality clinical maximise US market for diagnostics to large sites and opportunity in first product market first indications with experienced current approvals high u
Slide 9: Clinical development in multiple cancers
Clinical development in multiple cancers Clarity’s products are progressing through clinical development in the US and Australia. Clinical development pipeline as of 27 May 2022 Note clinical development pipeline is indicative only, subject to review. All US studies are conducted under IND 9
Slide 10: Clinical Update
Clinical Update
Slide 11: US prostate cancer in numbers
US prostate cancer in numbers 1:8 US men will develop 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 Currently investigated in
Slide 12: 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 13: 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 14: 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) 14
Slide 15: SAR-bisPSMA diagnostics
SAR-bisPSMA diagnostics Two Phase III trials required for registration in prostate cancer: one in the pre-definitive treatment and one in the biochemical recurrence (BCR) setting. Clarity is expecting to commence these registrational trials in 2023. PROPELLER: PET Imaging of participants with confir
Slide 16: 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 17: SAR-Bombesin: A pan-cancer target
SAR-Bombesin: A pan-cancer target SAR-Bombesin is a highly targeted pan-cancer theranostic radiopharmaceutical being to identify and select patients for subsequent treatment of their cancers that express GRPr SAR-Bombesin 64Cu SAR-Bombesin is retained in the tumours while quickly clearing from the p
Slide 18: SAR-Bombesin in prostate cancer
SAR-Bombesin in prostate cancer Detection of PSMA-negative prostate cancer SAR-Bombesin was able to locate tumours in PSMA-negative prostate cancers that are not visible with approved PSMA diagnostics • ~10% of prostate cancer patients do not express PSMA • PSMA negative prostate cancer patients wil
Slide 19: SAR-Bombesin clinical development
SAR-Bombesin clinical development ASCO 2022 Annual Meeting Abstract: 3092 | Poster: 82 C-BOBCAT: Results to be published at the Future milestones 2022 ASCO Annual Meeting in June • 64Cu SAR-Bombesin diagnostic IND expected 1H 2022 First-in-human pilot trial assessment of the • Initial US diagnostic
Slide 20: 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) Current clinical development High Accuracy • 64Cu SARTATETM for the man
Slide 21: SARTATE™ Clinical trials
SARTATE™ Clinical trials SARTATE™ CLO4: 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™
Slide 22: Overcoming Environmental & Supply Challenges
Overcoming Environmental & Supply Challenges
Slide 23: 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 68Ga and 18F • Regional availability issues • Limited scope for future upscaling • Little patient flexibility with 3-12 hour product shelf life • No opportunity for d
Slide 24: 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 177Lu 67Cu • Relies on antiquated, • Commercially unreliable and available high government powered rhodotron subsidised nuclear with a small reactor in
Slide 25: Targeted Copper Theranostics
Targeted Copper Theranostics Clarity’s solution to theranostic isotope supply threats The environmental considerations of TCT • No reactors • As the number of patient treatments increases, • No time sensitive international supply chains environmental factors will impact the selection of theranostic
Slide 26: Milestones & Inflection Points
Milestones & Inflection Points
Slide 27: Significant milestones achieved over last financial year
Significant milestones achieved over last financial year FY2021/22 has been an extraordinary year where Clarity achieved several transformational milestones and advanced the clinical development of our TCT • 26 May 22 - Dr Neal Shore joins Clarity’s Clinical Advisory • 2 December 2021 - Clarity and
Slide 28: Inflection points over next 12 months
Inflection points over next 12 months Open IND for 1st patient SARTATETM High activity Recruitment Dx imaged Cu-67 complete BBN Dx US production PROPELLER PSMA Dx 1st patient Advance online cohort 1 Recruitment to cohort 3 Open IND Advance to SECuRE complete CL04 BBN Tx 50% cohort 3 PSMA Tx COBRA SA
Slide 29: 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 Discovery Engine Select high value cancer targets Generate and radiolabel compounds (peptides and/or antibodies) 64C
Slide 30: Clarity Team
Clarity Team
Slide 31: Highly experienced leadership team
Highly experienced leadership team Clarity's management team has a diverse and in-depth level of expertise spanning corporate finance, management, operations, commercialisation and industry Dr Alan Taylor Dr Colin Biggin Dr Matt Harris Michelle Parker Dr Jennifer Rosenthal Shaemus Gleason David Gree
Slide 32: Board of Directors
Board of Directors Clarity’s board has extensive capital markets, radiopharmaceutical and broader life sciences experience Dr Alan Taylor Rosanne Robinson Dr Chris Roberts Dr Thomas Ramdahl Dr Gillies O’Bryan-Tear Mr Robert Thomas Executive Chairman Non-Executive Director Non-Executive Director Non-
Slide 33: Clarity's Advisory Board
Clarity’s 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 Dr Andrei Iagaru Dr Neal Shore Prof Paul Donnelly The E
Slide 34: Summary
Summary Global leader in Targeted Copper Theranostics (TCT) Extensive pipeline of TCTs based on 64Cu for diagnosis and 67Cu for therapy TCTs address the current manufacturing and logistical limitations in the growth of radiopharmaceuticals TCT are scalable, sustainable and dependable Broad a
Slide 35: 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
Clarity Pharmaceuticals — Jefferies Biotech Summit (May 2022) on 6ix