Clarity Pharmaceuticals Ltd. · ASX:CU6
Clarity Pharmaceuticals — Investor Presentation (March 2024)
47 slides from Clarity Pharmaceuticals's investor presentation, Mar 26, 2024
Slide 1: Fully underwritten A$121M capital raise
Fully underwritten A$121M capital raise Developing the next-generation of radiopharmaceuticals to improve treatment outcomes for children and adults with cancer Dr Alan Taylor, Executive Chairperson Dr Colin Biggin, Managing Director and CEO 26 March 2024
Slide 2: Important Notice and Disclaimer
Important Notice and Disclaimer Introduction Forward looking statements This presentation (Presentation) is dated 26 March 2024 and has been prepared by The information contained in this Presentation is given for illustrative purposes only Clarity Pharmaceuticals Ltd (ACN 143 005 341) (ASX: CU6) (Cl
Slide 3: Important Notice and Disclaimer
Important Notice and Disclaimer No representation, warranty or assurance (express or implied) is given or made in The general information in this Presentation has been prepared without taking into relation to any forward-looking statement by any person (including any of the account the investment ob
Slide 4: Important Notice and Disclaimer
Important Notice and Disclaimer Distribution limited No warranty This Presentation has been prepared for publication in Australia and may not be To the maximum extent permitted by law, neither Clarity nor any of its respective released to US wire services or distributed in the United States. This Pr
Slide 5: Important Notice and Disclaimer
Important Notice and Disclaimer Joint Lead Manager Parties Market and industry data and other information Bell Potter Securities Limited (ACN 006 390 722, AFSL 243 480) and Wilsons Certain market and industry data and other information used in this Presentation may Corporate Finance Limited (ABN 65
Slide 6: Executive Summary
Executive Summary Raising A$121m to fully fund the company’s current clinical programs until early CY26 • Clarity is a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer. Company & • Clarit
Slide 7: Corporate Snapshot
Corporate Snapshot Proprietary Global leader in Significant supply, Clarity Pharmaceuticals is a clinical stage SAR Technology: a true Targeted Copper logistical, dependability radiopharmaceutical company developing next-generation platform technology Theranostics (TCTs) and scalability benefits pro
Slide 8: SAR-bisPSMA
SAR-bisPSMA Superior performance of bisPSMA compared to monomer PSMA 64Cu/67Cu Radioisotope Cage SAR “chelator” securely bisPSMA has higher uptake in holding the radioisotope Targeting tumours and strong retention Molecules compared to PSMA monomers Two PSMA binding motifs Significant anti-tumour ef
Slide 9: Next-generation SAR-bisPSMA diagnostic is coming
Next-generation SAR-bisPSMA diagnostic is coming Improved uptake of SAR-bisPSMA may support better diagnosis compared to first-generation PSMA PET agents. Significant market opportunity to displace currently approved products, which are set to generate > US$1.1Bn in 2023 Lantheus: PYLARIFY® (18F-DCF
Slide 10: 67Cu-SAR-bisPSMA in mCRPC: Now in cohort 4 (SECuRE)
67Cu-SAR-bisPSMA in mCRPC: Now in cohort 4 (SECuRE) 64Cu-SAR-bisPSMA PET/CT imaging before and after two cycles of 8GBq of 67Cu-SAR-bisPSMA • No Dose Limiting Toxicities with single cycles at 12GBq • Now in multi-dose (12GBq cycles) cohort 4, two doses with up to four doses agreed by Safety Review C
Slide 11: 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 22 March 2024 Note clinical development pipeline is indicative only, subject to review. All US studies are conducted under Investi
Slide 12: Strong Strategic Interest in Radiopharmaceutical Assets
Strong Strategic Interest in Clarity’s copper platform, strong prostate pipeline and therapeutic and diagnostic efficacy data Radiopharmaceutical Assets represents an attractive opportunity to grow a significant radiopharmaceutical franchise in Date Target Acquirer Acquisition Main asset oncology an
Slide 13: Key upcoming milestones
Key upcoming milestones Dx = Diagnostics Tx = Theranostics 13
Slide 14: Offer Summary
Offer Summary
Slide 15: Offer Summary
Offer Summary Clarity is conducting a fully underwritten capital raising of approximately A$121 million comprising an institutional private placement and a pro rata accelerated non-renounceable entitlement offer (together, the ‘Offer’) • A fully underwritten capital raising of approximately A$121 mi
Slide 16: Sources and Uses of Funds
Sources and Uses of Funds Sources of Funds A$m The funds raised under the Offer will be used Estimated Cash Reserves at Offer Date 28.1 to advance Clarity’s clinical portfolio and strengthen its balance sheet Offer 121.0 R&D Tax Incentive (FY23-FY25) 10.1 • Post completion of the Offer, Clarity will
Slide 17: Offer Timetable
Offer Timetable Announcement of underwritten offer Tuesday, 26 March 2024 Placement & Institutional Entitlement Offer Opens Tuesday, 26 March 2024 Announcement of results of Placement and Institutional Entitlement Offer and recommence trading of shares on ASX Thursday, 28 March 2024 Record date for
Slide 18: Company Overview
Company Overview
Slide 19: Clarity – The Copper Theranostics Company
Clarity – The Copper Theranostics Company SAR Technology Targeted Copper Theranostics are the next- generation disruptive platform in Radioisotope radiopharmaceuticals that employ the “perfect Copper isotopes for Positron Emission pairing” of copper-64 (64Cu) and copper-67 (67Cu) Tumour Tomography (
Slide 20: Why Copper?
Why Copper? The physical properties of copper-64 and copper-67 have optimal characteristics for global commercialisation Diagnostic radionuclides Therapeutic radionuclides Copper-64 Gallium-68 Fluorine-18 Copper-67 Lutetium-177 Half life 12.7 hours 1.1 hours 1.83 hours Half life 2.6 days 6.7 days Ty
Slide 21: Three key product areas
Three key product areas SAR-bisPSMA SAR-Bombesin SARTATE ED Diagnostic | rheanot | Diagnostic Theranostic Diagnostic = oa a os = COBRA SABRE - DISCO (recruitment ty (recruitment closed) i (recruitment closed)
Slide 22: Prostate cancer
Prostate cancer Two product areas: bisPSMA & Bombesin Four products for diagnosis and therapy
Slide 23: 64Cu-SAR diagnostics
64Cu-SAR diagnostics
Slide 24: Copper brings significant additional advantages
Copper brings significant additional advantages Beyond the supply chain advantages of a 12.7 hour half-life PET imaging agent, SAR-bisPSMA allows patients to be imaged from 1 hour to >24 hours post administration Cu-64 SAR-bisPSMA PET has the ability to image both on the day of administration and at
Slide 25: SAR-Bombesin
SAR-Bombesin SAR-Bombesin in PSMA- SAR-Bombesin targets Gastrin negative prostate cancer Releasing Peptide receptor (GRPr) that is overexpressed in a number of • Phase II Positron Emission Tomography (PET) imaging trial of participants with PSMA- cancers including prostate, breast, negative biochemi
Slide 26: 67Cu-SAR therapeutics
67Cu-SAR therapeutics
Slide 27: Metastatic castration-resistant prostate cancer
Metastatic castration-resistant prostate cancer Clarity is conducting two theranostic clinical trials in mCRPC with two products to treat PSMA-positive, PSMA- negative lesions and those with low PSMA expression SAR-bisPSMA SAR-Bombesin • Phase I/IIa study of 64Cu/67Cu-SAR-bisPSMA for identification
Slide 28: SECuRE cohort 1 - 4GBq dose level
SECuRE cohort 1 - 4GBq dose level 28
Slide 29: US FDA Expanded Access Program
US FDA Expanded 4GBq of 67Cu-SAR-bisPSMA over 4 cycles Access Program • Additional therapy cycles of 67Cu-SAR- bisPSMA at the lowest 4GBq dose level have been requested under the US FDA Expanded Access Program (EAP) • Early data indicates positive effects • SPECT-CT images (on the right) demonstrate
Slide 30: SECuRE cohort 2 - 8GBq dose level (single cycle)
SECuRE cohort 2 - 8GBq dose level (single cycle) • No Dose Limiting Toxicities with single cycle at 8GBq • The first 2 participants are exhibiting a PSA reduction of greater than 95% and the last participant is showing a drop of greater than 80% • Significant reduction in uptake of the diagnostic do
Slide 31: SECuRE cohort 3 – 12GBq dose level (single dose)
SECuRE cohort 3 – 12GBq dose level (single dose) • Participant from cohort 3 showing reduction in uptake of 64Cu-SAR-bisPSMA in prostate cancer lesions. The participant was treated with ADT, ARPI, chemotherapy and 2 investigational agents prior to enrolling in the SECuRE study (PSA 270.9 ng/ml at st
Slide 32: The Supply Differentiator
The Supply Differentiator
Slide 33: Current industry challenges Combined with a history of supply issues
Current industry challenges Combined with a history of supply issues Additional demands on existing supply as industry grows Time sensitive products with Inability to control short shelf-lives the entire supply chain Reliance on ageing Manufacturing Complex international nuclear reactor fleet outage
Slide 34: Current industry challenges Clarity's TCT Solution
Current industry challenges Clarity’s TCT Solution Additional demands on existing supply as industry grows Global scale commercial Time sensitive capacity for diagnostics Inability to control products with and therapeutics short shelf-lives the entire supply chain 100% control of end- 48-hour shelf-
Slide 35: Next-generation theranostics provide solutions to the challenges with current-generation radiopharmaceuticals
Next-generation theranostics provide solutions to the challenges with current-generation radiopharmaceuticals Opportunities with 64Cu (half-life = 12.7h) Opportunities with Rhodotron produced 67Cu • Can be mass produced on cyclotrons with solid targetry • Commercially available • Every US zip code c
Slide 36: Summary
Summary Global leader in Targeted Copper Theranostics (TCTs) • Exciting efficacy and safety data to date with therapy and imaging • Extensive pipeline of TCTs based on 64Cu for diagnosis and 67Cu for therapy • Multiple therapeutic and diagnostic trials in progress, including a Phase III registration
Slide 37: Risk Factors & Foreign Selling Restrictions
Risk Factors & Foreign Selling Restrictions
Slide 38: Risk Factors
Risk Factors The Company does not generate revenue and does not have a product that is capable of generating revenue without completing clinical trials and obtaining regulatory approvals. The Shares carry no guarantee of profitability, dividend payments, returns of capital or an increase in the shar
Slide 39: Risk Factors
Risk Factors The Company will need to obtain ongoing approvals from the United States Food and Drug Administration (FDA) in the United States, the Therapeutic Goods Administration in Australia and the European Medicines Agency in Europe in order to run its studies and clinical trials in those jurisd
Slide 40: Risk Factors
Risk Factors The Company currently has title to a number of key patents and patent applications in respect of the technology that forms the basis of a number of its product candidates. The success of the Company is therefore partly dependent on the Company’s ability to continue to obtain and maintai
Slide 41: Risk Factors
Risk Factors The Company does not have its own facilities from which to manufacture its products and it therefore relies on third parties for the supply of the critical materials that are necessary for the manufacture of its product candidates. These third parties include suppliers of radioisotopes,
Slide 42: Risk Factors
Risk Factors The Company relies on third parties to produce and manufacture its product candidates. Manufacturing radiopharmaceutical product candidates is a complex process, and contract development and manufacturing organisations (CDMO’s) are typically in high demand. The Company’s product candida
Slide 43: Risk Factors
Risk Factors If there are any adverse results in the clinical trials of the Company’s product candidates or in the clinical trials of the Company’s competitors that are Lack of acceptance of developing similar products, or any negative publicity with respect to the safety or efficacy of radiopharmac
Slide 44: Risk Factors
Risk Factors Due to the innovative nature of the Company’s products, the Company is exposed to the risk of product liability claims arising from defective products or products that are no longer viable, even where the Company has received prior regulatory approval. If the Company is subject to any p
Slide 45: Exchange rate risk
Risk Factors The Company’s functional currency is the Australian dollar. A considerable proportion of the Company’s costs are incurred in foreign currencies, especially the US dollar. The Australian dollar value of foreign currency denominated costs will be affected by changes in currency exchange r
Slide 46: Taxation
Risk Factors The acquisition and disposal of Shares will have tax consequences, which will differ depending on the individual financial affairs of each investor. All potential investors in the Company are urged to obtain independent legal, financial and taxation advice about the consequences of acqu
Slide 47: Foreign Selling Restrictions
Foreign Selling Restrictions This Presentation does not constitute an offer of New Shares in Clarity in any jurisdiction in This Presentation has been given to you on the basis that you are an “institutional investor” or which it would be unlawful. In particular, this Presentation may not be distrib
Clarity Pharmaceuticals — Investor Presentation (March 2024) on 6ix