Clarity Pharmaceuticals Ltd. · ASX:CU6
Clarity Pharmaceuticals — Shareholder Meeting (November 2024)
21 slides from Clarity Pharmaceuticals's shareholder meeting presentation, Nov 20, 2024
Slide 1: Managing Director's presentation
Managing Director’s presentation Annual General Meeting 20 November 2024 Michelle Parker
Slide 2: Disclaimer
Disclaimer Introduction This presentation has been prepared by Clarity Pharmaceuticals Ltd (ACN 143 005 341) (Clarity or the Company) No representation, warranty or assurance (express or implied) is given or made in relation to any forward-looking and contains summary information about Clarity and t
Slide 3: Key FY24 highlights
Key FY24 highlights CLINICAL & REGULATORY OPERATIONS • Actively progressing 7 clinical trials + 1 IIT of Clarity’s three key • NorthStar manufacturing commercial scale Cu-67 and 67Cu- product areas SAR-bisPSMA final drug product under one roof for Phase I/II • 64Cu-SAR-bisPSMA Phase III diagnostic t
Slide 4: 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 5: Clinical stage assets in multiple cancers
Clinical stage assets in multiple cancers Clarity’s products are progressing through sponsored clinical trials in the U.S. and Australia Clinical development pipeline as of 20 November 2024 Current progress 12 month progress Note clinical development pipeline is indicative only, subject to review. A
Slide 6: SAR-bisPSMA
SAR-bisPSMA SECuRE - Phase I/IIa • Cohort 4 ongoing - 2 therapy cycles (12GBq) Targets the Prostate Specific Membrane Antigen • No DLTs observed to date (PSMA), present in the majority of prostate cancers • First 3 participants in Cohort 4 had reductions in prostate-specific antigen (PSA) levels fol
Slide 7: SAR-bisPSMA market opportunity
SAR-bisPSMA market opportunity PSMA based diagnostics SAR-bisPSMA aims to disrupt current diagnostic and therapeutic utilisation as a best-in-class • Current U.S. patient pool for PSMA-PET imaging is ~400k scans per agent for imaging and treating prostate cancer year between initial staging, suspect
Slide 8: Therapy program with 67Cu-SAR-bisPSMA
Therapy program with 67Cu-SAR-bisPSMA Trial highlights to date • Cohort 3 completed, now progressing the final 3 Trial overview patients in cohort 4 at 12GBq (Pluvicto dose capped at 7.4GBq) • Phase I/II study in mCRPC • First 3 participants in Cohort 4 had reductions in • Participants do not need t
Slide 9: PSA level reductions from 67Cu-SAR-bisPSMA single dose in heavily pre-treated mCRPC patients
67Cu-SAR-bisPSMA single dose leads to PSA reductions in heavily pre-treated mCRPC patients 78% PSA level reductions across different cohorts Response in PSA levels from 90 80 70 baseline (%) of patients showed reductions in 60 PSA levels >35% (cohorts 2 and 3) 50 44% 40 30 20 10 0 >PSA35 >PSA80 of p
Slide 10: Radiographic partial response and PSA80 following cycles of 67Cu-SAR-bisPSMA
Radiographic partial response and PSA80 following 2 cycles of 67Cu-SAR-bisPSMA (12GBq) Pre-67Cu-SAR- Post-cycle 2 of PSA reduction following 3 cycles of 67Cu-SAR-bisPSMA bisPSMA 67Cu-SAR-bisPSMA 200 Cycle 1 Cycle 2 Cycle 3 PSA level (ng/mL) 02 Apr 13 Jun 27 Aug 150 100 50 0 rPR 61% tumour volume 98%
Slide 11: 67Cu-SAR-bisPSMA has a favourable safety profile
67Cu-SAR-bisPSMA has a favourable safety profile Cohorts 1-3 (single dose): most adverse events (AEs) were lower Grade, with only 3/15 patients Cohorts 1-3 Grade 3 developing Grade 3 AEs (no Grade 4/5) Adverse event (AE) N = 15 (100%) • No AEs were related to 64Cu-SAR-bisPSMA Any drug-related AEs 3
Slide 12: Adaptive dosing leads to durable PSA response: EAP case report 1
67Cu-SAR-bisPSMA adaptive dosing leads to durable PSA response and disease control: EAP case report 1 Post-67Cu-SAR-bisPSMA PSA reduction following multi-doses of 67Cu-SAR-bisPSMA Pre-67Cu-SAR-bisPSMA (4 cycles x 4GBq) Tx break: Tx break: 6 months 14 months Cycle 1: Cycle 2: Cycle 3: Cycle 4: Cycle
Slide 13: Adaptive dosing leads to durable complete response: EAP case report 2
67Cu-SAR-bisPSMA adaptive dosing leads to durable complete response: EAP case report 2 • Complete anatomical response (CT; RECIST v1.1) PSA reduction following 2 cycles of 67Cu-SAR-bisPSMA • Complete molecular response (PET) Tx break: • Complete biochemical response (undetectable PSA) 3 months Cycle
Slide 14: Diagnostic program with 64Cu-SAR-bisPSMA
Diagnostic program with 64Cu-SAR-bisPSMA U.S. FDA Fast Track Designation (FTD) Trial overview • U.S. FDA granted FTD for 64Cu-SAR-bisPSMA • Phase III registrational trial in high-risk prostate cancer for PET imaging of PSMA positive prostate patients prior to undergoing radical prostatectomy and can
Slide 15: SAR-bisPSMA is safe and effective in detecting tumours in prostate cancer patients
SAR-bisPSMA is safe and effective in detecting tumours in prostate cancer patients Clinicians reported they would change their treatment plan in approximately 50% of patients due to 64Cu-SAR-bisPSMA scans, signalling a potential material improvement in patient care Patients with negative/equivocal S
Slide 16: Higher uptake and contrast in lesions on next-day imaging
Higher uptake and contrast in lesions on next-day imaging and detection of lesions in the 2mm range SUVmean and SUVmax in lesions TBR of lesions detected by detected by 64Cu-SAR-bisPSMA 64Cu-SAR-bisPSMA 30 150 Mean SUVmean and Mean TBR of lesions SUVmax in lesions 25 20 100 15 10 50 5 0 0 SUVmean SU
Slide 17: SAR-Bombesin
SAR-Bombesin COMBAT – Phase I/IIa therapy Targets the Gastrin Releasing Peptide receptor (GRPr), • 64Cu-SAR-BBN and 67Cu-SAR-BBN for which is present in a number of cancers, including identification and treatment of GRPr-expressing mCRPC in breast and prostate cancers patients who are ineligible for
Slide 18: SARTATE
SARTATE Targets the Somatostatin Receptor 2 (SSTR2), which is present in an aggressive childhood cancer, neuroblastoma, as well as neuroendocrine tumours (NETs), among other cancers CL04 – Phase I/IIa • 64Cu/67Cu-SARTATE theranostic clinical trial in high-risk neuroblastoma • Cohort 4 recently compl
Slide 19: Scaling manufacturing for commercial launch
Scaling manufacturing for commercial launch Clarity continues to strengthen and expand its manufacturing and supply chain footprint, creating additional capacity and flexibility to supply products to any state in the U.S. for upcoming and ongoing late-stage clinical trials Clinical Supply Drug manuf
Slide 20: Highly experienced team
Highly experienced team Clarity's management team has a diverse and in-depth level of expertise spanning corporate finance, management, clinical, Dr Alan Taylor Michelle Parker Dr Colin Biggin Eva Lengyelova operations, Executive Chairman CEO COO EVP – Clinical Development commercialisation and indu
Slide 21: Thank you
Thank you Contact details Dr Alan Taylor Michelle Parker Executive Chairperson Managing Director E: alan.taylor@claritypharm.com E: Michelle.Parker@claritypharmaceuticals.com
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