Rhythm Biosciences Limited · ASX:RHY
Rhythm Biosciences — Investor Presentation (February 2024)
20 slides from Rhythm Biosciences's investor presentation, Feb 21, 2024
Slide 1: Rights Issue Investor Presentation
Rights Issue Investor Presentation Restoring value, by enhancing ColoSTAT® in alignment with updated regulatory and customer requirements February 2024 ASX: RHY
Slide 2: Disclaimer
Disclaimer ASX: RHY This presentation has been prepared by Rhythm Biosciences Limited (Rhythm) and is provided for general information purposes only. No party other than Rhythm has authorised or caused the issue of this document, or takes responsibility for, or makes any statements, representations
Slide 3: Corporate Overview
Corporate Overview ASX: RHY Corporate Snapshot Board and Management ASX Code RHY Otto Buttula Share Price (at 16 Feb 2024) $0.135 Executive Chairman • Extensive financial, investment, IT and biotech experience Shares on Issue 221.1 M • Co-Founder and CEO of IWL (ASX: IWL); Founder / former CEO of In
Slide 4: Colorectal Cancer and ColoSTAT®
Colorectal Cancer and ColoSTAT® ASX: RHY Colorectal Cancer (CRC) Barriers to overcome and improve participation rate include: Colorectal cancer (CRC) is a progressive disease associated • “Old Persons’ Disease” with increased risk of mortality and substantial healthcare • Cultural barriers and socie
Slide 5: ColoSTAT® - Simple Four Step Procedure
ColoSTAT®* - Simple Four Step Procedure ASX: RHY 1 Standard blood draw at laboratory / collection centre (with referral) Blood sample analysed at laboratory, utilising ColoSTAT® kit & algorithm 2 3 Result sent to GP 4 GP follow-up with patient *currently not approved for use in Australia 21 February
Slide 6: Our Clinical Data
Our Clinical Data ASX: RHY Prospective, multi-centre study to evaluate the clinical performance of the ColoSTAT® for the detection of CRC1 Results • ColoSTAT® met the primary endpoint and showed a high-sensitivity blood test for CRC detection. Primary Endpoint • ColoSTAT® may provide an Study Design
Slide 7: ColoSTAT® Patented in Over 20 Countries
ColoSTAT® Patented in Over 20 Countries ASX: RHY U.K. U.S. France Belgium Australia Luxembourg Austria Spain Italy Sweden Finland Germany Liechtenstein Norway Japan China Netherlands Denmark Switzerland Ireland Brazil Portugal 21 February 2024 EXTERNAL USE 7
Slide 8: Market Entry Focus
Market Entry Focus ASX: RHY Market Population Age – Screening Screening Screening Unscreened Screening Testing Incidence Population Method Participation Population/ Population Opportunity of CRC Rate Opportunity (40 to <85 yrs) (40 to <85 yrs) Europe 133.5 mill FIT, 455.1 mill 38% 82.8 mill 192.9 mi
Slide 9: Strategic Review Revealed Potential Barriers
Strategic Review Revealed Potential Barriers ASX: RHY ◦◦◦◦◦◦◦◦◦◦◦◦◦ ◦◦◦◦◦◦◦◦◦◦◦◦◦ x5 Test Development: five different biomarker immunoassays into one kit ◦◦◦◦◦◦◦◦◦◦◦◦◦ ◦◦◦◦◦◦◦◦◦◦◦◦◦ • Labour intensive procedure, prone to human error and higher assessment costs Kit production costs increased and proc
Slide 10: Key Decisions as a Result of the Strategic Review
Key Decisions as a Result of the Strategic Review ASX: RHY RUO The currently produced ColoSTAT® kits will be Appointment of a suitably qualified used for Research Use Only (RUO) and no Chief Executive Officer commercial sales IVDR Engagement of a US based Contract Follow on benefits are expected as
Slide 11: Updated & Simplified ColoSTAT® Kit
Updated & Simplified ColoSTAT® Kit ASX: RHY Optimally, moving from: • 5 plates to a single plate • 5 reagents to a single reagent kit Multiplex Planar Reduced Cost – Materials, Packaging based ELISA and Transport Reduced Chance of Human Error Embraces Increased Automation and Efficiency Redu
Slide 12: Regulatory Submission Pathway
Regulatory Submission Pathway ASX: RHY TGA CE / CA IVDD IVDR • ARTG applications withdrawn March 23 • Self-declared product • Marketing authorisation in Europe, • To be assessed by regulators • TGA assessor feedback internally audited, external review completed UK and New Zealand (notified body) • C
Slide 13: ColoSTAT® Update Process
ColoSTAT® Update Process ASX: RHY PHASE 1 PHASE 2 PHASE 3 PHASE 4 PHASE 1 Feasibility Iterative Design & Design Verification Design Validation & ofFeasibility New Kit Characterisation and Transfer Commercialisation 3 - 6 Weeks Design eQMS -Determine -Initial assay & reagent -Verify all assay -Design
Slide 14: Platform Technology Expansion Pipeline
Platform Technology Expansion Pipeline ASX: RHY Stage 3 Stage 4 Stage 5 Stage 1 Stage 2 Design & Development: Final Validation: Product Launch & Initiation: Opportunity Formulation: Concept Verification, Validation, & Product Launch Post-Launch and Risk Analysis and Feasibility Clinical Trials Prepa
Slide 15: Non-renounceable Rights Issue Offer
Non-renounceable Rights Issue Offer ASX: RHY Key details of the Offer Offer to Eligible Shareholders 3 New Shares for every 10 Shares held at the Record Date at the Issue Price plus • 1 Option for every 2 New Shares subscribed under the Offer. • New ASX Listed Option to purchase a Share with an exer
Slide 16: Indicative Timetable of Rights Issue
Indicative Timetable of Rights Issue ASX: RHY Important dates* Record Date (to determine Entitlement of Eligible Shareholders to participate in the Offer) Thursday, 22 February 2024 Opening Date of Rights Issue Offer - Dispatch of the Prospectus and Entitlement & Acceptance Form to Eligible Sharehol
Slide 17: Use of Funds
Use of Funds ASX: RHY Use of funds* Complete new product development of ColoSTAT® Complete new manufacturing of kits in North America. Up to $1.50m Re-submit for regulatory approvals for CE Mark and TGA Completion of renewed regulatory submissions (CE Mark and TGA), utilising external experts. Up to
Slide 18: Theoretical Value of Options
Theoretical Value of Options ASX: RHY Rights Issue Offer Discount Current share price (as at 16 February 2024) $0.1350 $0.40 Rights Issue offer $0.1000 Discount 25.9% Discount vs Volume Weighted Average (VWAP) Share Price (ASX) 10 day VWAP - discount 22.9% # $0.1224 30 day VWAP - discount 20.4% # $0
Slide 19: Thank You!
HH RHYTHM BIOSCIENCES Thank You!
Slide 20: Appendix – Rights Issue: Theoretical Option Value
APPENDIX 1 – Rights Issue: Theoretical Option Value* ASX: RHY Theoretical Option Value – 2 year Summary Share price - 16 February 2024 (P) $0.1350 Value of Call (31 Mar 2026) $0.0602 Exercise price of option (EX) $0.2000 New Share Rights Price $0.1000 Exercise period in years (t) – 31-03-26 2.00 The
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