Clarity Pharmaceuticals Ltd. · ASX:CU6
Clarity Pharmaceuticals — Investor Presentation (March 2023)
39 slides from Clarity Pharmaceuticals's investor presentation, Mar 13, 2023
Slide 1: Shareholder Update
Shareholder Update Developing the next-generation of radiopharmaceuticals to improve treatment outcomes for children and adults with cancer Dr Alan Taylor, Executive Chairperson Dr Colin Biggin, Chief Executive Officer 13 March 2023
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 in a nutshell (ASX:CU6)
Clarity in a nutshell (ASX:CU6) Clarity Pharmaceuticals is a clinical stage radiopharmaceutical company developing next-generation products to address the growing need for better diagnostics and treatments in oncology ASX Code: CU6 Significant Proprietary SAR Technology: Global leader in supply, log
Slide 4: Radiopharmaceuticals: Market overview
Radiopharmaceuticals: Market overview Global Oncology Market 2021 Global Oncology Market 2031 US$286 Bn US$~25 Bn US$~1.3 Bn US$600 Bn US$6.3 Bn US$35 Bn US$ ~5 Bn US$~10 Bn Global Oncology Global radiopharmaceuticals Radio-diagnostics Radio-therapeutics 2021 2031 Global oncology market US$ 286 Bill
Slide 5: Growth drivers
Growth drivers Radiopharmaceuticals have shown significant growth potential both diagnostically and therapeutically and companies similar to Clarity have proven to be very profitable Positive changes have driven Big Pharma interest in the space • Re-imbursement • Pricing (Pluvicto >US$ 250k for 6 do
Slide 6: Targeted radiopharmaceuticals are becoming a new pillar of oncology
Targeted radiopharmaceuticals are becoming a new pillar of oncology Radiopharmaceuticals are systemic agents that can be used to diagnose and treat different types of cancer Targeted radiopharmaceuticals use special targeting agents which go to specific receptors on specific cancers. Delivering radi
Slide 7: Current industry challenges
Current industry challenges Combined with a history of Creates challenges supply issues for prescribers Additional demands on existing supply as industry grows Work to be done to convince oncologists that there is a safe, dependable and Inability to control Time sensitive reliable source of the enti
Slide 8: Current industry challenges
Current industry challenges 8
Slide 9: Clarity's TCTs address the current industry challenges
Clarity’s TCTs address the current industry challenges Clarity Pharmaceuticals is a clinical stage radiopharmaceutical company with a mission to develop next- generation products that improve treatment outcomes for children and adults with cancer Proprietary SAR Technology platform enables Targeted
Slide 10: Proprietary SAR Technology platform
Proprietary SAR Technology platform SAR Technology Theranostic radiopharmaceuticals have four main elements: a radioisotope, cage, linker Radioisotope and targeting ligand and are administered Copper isotopes used, for example, in Positron Emission Tomography (PET) intravenously Tumour imaging (64Cu
Slide 11: TCTs: A robust foundation for future growth
TCTs: A robust foundation for future growth Copper-64 (half-life = 12.7 hours) Copper-67 (half-life = 2.6 days) • Mass produced on cyclotrons • Optimal half-life for peptide-based therapy • Every US zip code covered from 1 location • Commercially available high powered rhodotron for • Patient flexib
Slide 12: Dual development strategy
Dual development strategy SAR Technology enables a synergistic development of stand-alone diagnostics as well as paired theranostics Diagnostics based on 64Cu Theranostics based on 64Cu/67Cu Dx revenue pays for • Broad market opportunities late-stage Tx clinical • High precision, high accuracy • Add
Slide 13: Clinical & Regulatory Development
Clinical & Regulatory Development
Slide 14: Three core product areas in clinical trials
Three core product areas in clinical trials Clarity has an active clinical development program in multiple oncology indications with unmet needs through a range of products and their applications. The SAR platform is also used in our SAR-DISCOVERY program which has significant synergies with the exi
Slide 15: Clinical development in multiple cancers
Clinical development in multiple cancers Clarity’s products are progressing through sponsored clinical trials in the US and Australia Clinical development pipeline as of 13 March 2023 Note clinical development pipeline is indicative only, subject to review. All US studies are conducted under IND 15
Slide 16: Regulatory Overview
Regulatory Overview Strong focus on the US FDA and first approvals in the US All six clinical-stage products under IND Two Orphan Drug Designations and two in the US Rare Paediatric Disease Designations Rare US FDA Rare Paediatric Disease Designation (RPDD) for: Theranostic Therapy Therapy 64Cu/67Cu
Slide 17: SAR Therapy
SAR Therapy 17
Slide 18: SARTATE in neuroblastoma
SARTATE in neuroblastoma SARTATE CL04: 67Cu-SARTATE Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk, Relapsed, Refractory Neuroblastoma CL04: 64Cu/67Cu SARTATE Phase I/IIa trial in high-risk neuroblastoma in the US with up to 34 patients Trial Design Status Mu
Slide 19: SAR-bisPSMA in prostate cancer
SAR-bisPSMA in prostate cancer 70 - 008 SECuRE: Systemic Copper theranostics in prostate cancer • Phase I/IIa study of 64Cu/67Cu SAR-bisPSMA for identification and treatment of PSMA-expressing metastatic castrate resistant prostate cancer (mCRPC) Comparison of 64Cu SAR-bisPSMA and 67Cu SAR-bisPSMA i
Slide 20: Images: Cohort 1 (4GBq dosage level)
Images: Cohort 1 (4GBq dosage level) 70 - 009 20
Slide 21: SAR-Bombesin in prostate cancer
SAR-Bombesin in prostate cancer GRPr is a receptor that is overexpressed in a number of cancers including prostate, breast, colon, gastric, glioma, pancreatic, small cell lung and non-small cell lung cancer, as well as renal cell cancer SAR-Bombesin was able to locate tumours in PSMA-negative prosta
Slide 22: 67Cu SAR-Bombesin in prostate cancer
67Cu SAR-Bombesin in prostate cancer 64Cu SAR-BBN in C-BOBCAT study COMBAT: Copper-67 SAR Bombesin in metastatic castrate resistant prostate cancer 64Cu SAR-Bombesin is retained in the tumours while quickly clearing from the pancreas in hormone positive metastatic breast cancer • A Phase I/IIa thera
Slide 23: SAR Diagnostics
SAR Diagnostics 23
Slide 24: Cu-64 will become the isotope of choice for PET imaging
Cu-64 will become the isotope of choice for PET imaging by overcoming the clinical and operational challenges with Ga-68 and F-18 based diagnostics Challenges with approved Ga-68 Solutions provided by Cu-64 based diagnostics and F-18 based diagnostics Ideal physical • Short half-life of Ga-68 and F-
Slide 25: SAR-bisPSMA diagnostic development
SAR-bisPSMA diagnostic development 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 registrational trials in 2023. Pre-definitive treatment Biochemical recurren
Slide 26: SPELLER
SPELLER e 1 multi-center diagnostic trial 64Cu-SAR-bisPSMA Anew frontier for prostate cancer imaging that is safe and efficacious for the detection of primary and secondary disease Pek for imaging PSMA-expr 1ed as the optimal dose for future trials bisPSMA as an imaging agent in biochemical
Slide 27: 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 28: SAR-bisPSMA diagnostic in untreated, confirmed prostate cancer
SAR-bisPSMA diagnostic in untreated, confirmed prostate cancer PET/CT demonstrated uptake of 64Cu-SAR-bisPSMA (F) in a left pelvic lymph node according to both readers and PC was confirmed via histopathology. Readers did not detect uptake in pelvic lymph nodes on the 68Ga-PSMA-11 PET/CT (E). Time be
Slide 29: SAR-bisPSMA diagnostics
SAR-bisPSMA diagnostics COBRA: Copper-64 SAR-bisPSMA in BCR prostate cancer • Phase I/II multi-centre, single arm, non-randomised study in up to 50 patients across the US • Investigates the safety and tolerability of 64Cu-SAR-bisPSMA as well as its ability to correctly detect recurrence of prostate
Slide 30: SAR-Bombesin in PSMA-negative prostate cancer
SAR-Bombesin in PSMA-negative prostate cancer SABRE: Copper-64 SAR-BBN in Biochemical Recurrence Trial design of prostate cancer • Multi-centre, single arm, non-randomised, open-label trial of 64Cu- labelled SAR-Bombesin in 50 participants. • Phase II Positron Emission Tomography (PET) imaging trial
Slide 31: SAR-Bombesin in PSMA-negative prostate cancer
SAR-Bombesin in PSMA-negative prostate cancer BOP IIT: Copper-64 SAR Bombesin in Prostate Specific Membrane Antigen (PSMA) negative Prostate Cancer • Assesses the safety of 64Cu-SAR-Bombesin and looks at the diagnostic potential across two different groups of men: • Participants with suspected bioch
Slide 32: SARTATE
SARTATE DISCO: Diagnostic Imaging Study of Copper-64 SARTATE using PET on patients with known or suspected NETs • Assesses the performance of imaging agent 64Cu SARTATE in participants with known or suspected gastroenteropancreatic NETs as a potential new way to help diagnose and manage NETs • Aims
Slide 33: Inflection points in the next 12 months
Inflection points in the next 12 months Dx = Diagnostics Tx = Theranostics PSMA Dx US BBN Tx US PSMA Tx US COBRA COMBAT PSMA Dx US BBN Dx IIT SECuRE Topline results COBRA 1st patient treated BOP Advance to Initial data Recruitment cohort 3 SARTATE Tx US released Cu-67 complete CL04 Large-scale PSMA
Slide 34: 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 Broad Patent Portfolio Discovery Engine Platform Protection Select high value cancer targets • Granted and new chela
Slide 35: Highly experienced team
Highly experienced team Clarity's management team has a diverse and in-depth level of expertise spanning corporate finance, management, operations, commercialisation and industry • Development, approval and launch of 1st approved radiopharmaceutical therapy product for prostate cancer Dr Alan Taylor
Slide 36: 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 Thomas Ramdahl Cheryl Maley Executive Chairman Non-Executive Director Non-Executive Director Non-Executive Director Ms Robinson brings extensi
Slide 37: 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 Medical oncologist and an internationally recognised expert in prostate cancer. He is the Laborde Professor f
Slide 38: Summary
Summary Global leader in Targeted Copper Theranostics (TCTs) • Extensive pipeline of TCTs based on 64Cu for diagnosis and 67Cu for therapy • Seven clinical trials and an IIT in development with Phase III clinical trials commencing from 2023 • TCTs address the current manufacturing and logistical lim
Slide 39: Thank you
Thank you Contact details Dr Alan Taylor Dr Colin Biggin Executive Chairperson Managing Director E: alan.taylor@claritypharm.com E: colin.biggin@claritypharm.com
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