Slide 1: Company Overview
Company Overview BIOSHARES 25 July 2023 Otto Buttula – Executive Chairman
Slide 2: Disclaimer
Disclaimer 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 or undert
Slide 3: Company Overview
Company Overview Capital Structure Share Price Chart ASX Code RHY Share Price (at 18 July 2023) $0.47 Shares on Issue 219.8 M Unlisted Options 12.9 M Market Capitalisation $109 M Cash in bank (31 March 2023) $6.8M Top 20 Shareholders 41% Board and Management Otto Buttula Trevor Lockett Lou Panaccio
Slide 4: Agenda
Agenda • Rhythm Biosciences – Our Goal • The Burden of Colorectal Cancer • ColoSTAT® - a simple screening alternative • Clinical Data • Historical Challenges • Rhythm’s 12 Month Focus • Rhythm’s Long-term Focus 4
Slide 5: Our Company's Goal
Our Company’s Goal “ Rhythm Biosciences is committed to saving lives through early detection of cancers using simple and accurate diagnostic technology ” Early detection is critical to improving patient outcomes and reducing the global burden of cancer; Developing alternative screening solutions for
Slide 6: Burden of Colorectal Cancer
BURDEN OF COLORECTAL CANCER Colorectal cancer (CRC) is treatable and often curable, yet is the second leading cause of cancer death globally CRC is a progressive disease in which epithelial cells in the colon or rectum grow out of control2 Global burden in 2020: 1.93 million new cases and ~940,000 d
Slide 7: Participation in CRC screening remains suboptimal
Participation in CRC screening remains suboptimal despite national programmes being in place in many countries worldwide Market Population Age – Screening Screening Screening Unscreened Screening Screening Incidence Population Method Participation Population/ Population Opportunity of CRC Rate Oppor
Slide 8: Blood tests, such as ColoSTAT, are preferred over FIT
Blood tests, such as ColoSTAT®, are preferred by patients over FIT as they provide a more acceptable way to participate in testing Blood-based tests are preferred over faecal tests (FIT) by 78–94% of people who are offered CRC testing1-5, with ease and convenience being the main reasons for their pr
Slide 9: ColoSTAT - patented in countries
ColoSTAT® - patented in 21 countries U.K. U.S. France Belgium Australia Luxembourg N.Z. Austria Spain Italy Sweden Finland Germany Liechtenstein Norway Japan Netherlands Denmark Switzerland Ireland Brazil Portugal EXTERNAL USE 24 July 2023 9
Slide 10: ColoSTAT - test kit explained
ColoSTAT® - test kit explained ColoSTAT® - indicated to screen adults, aged 40 to <85, at average risk for developing CRC. The test measures 5 specific biomarkers in the blood that either increase/decrease in concentration when CRC tumours are present. ELISA Assay Plate Optical Density (OD) Analyse
Slide 11: ColoSTAT - simple four step procedure
ColoSTAT®* - simple four step procedure 1 Standard blood draw at laboratory / collection centre (with referral) Blood sample 2 analysed at laboratory 3 Result sent to GP 4 GP follow-up with patient *currently not approved for use in Australia EXTERNAL USE 11
Slide 12: Our Clinical Data
Our Clinical Data - prospective, multi-centre study to evaluate the clinical performance of the ColoSTAT® for the detection of CRC1 Study Design Results • The primary endpoint was to evaluate • ColoSTAT® met the primary endpoint and ColoSTAT® performance compared to showed a high-sensitivity blood t
Slide 13: ColoSTAT - development journey
ColoSTAT® - development journey ColoSTAT® is expected to increase participation, leading to earlier detection ColoSTAT® Sensitivity Performance • Accurate ColoSTAT® obtains a qualitative likelihood of CRC presence based on 85% 5 protein biomarker levels in the blood, compared to FIT (detects 80% blo
Slide 14: Strategic Pillars and Direction
Strategic Pillars and Direction DISRUPTIVE TECHNOLOGY • An alternative to current screening methods through a well-established ELISA based technology. GLOBAL CAPABILITY • Manufacturing capability for our target markets. • Increase production capacity with further international and local CMOs. COMMER
Slide 15: Historical Challenges
Historical Challenges ➢ Test development - combining 5 different biomarker immunoassays into one kit • transitioning from research to commercial. ➢ Pandemic impact on: • Study recruitment; and • Manufacturing scale up. ➢ Market awareness: • Blood-based vs current screening methods, which have been i
Slide 16: Rhythm's 12 Month Focus
Rhythm’s 12 Month Focus ➢ FY’24 commercial sales – initially focused on ~1% of addressable market. ➢ UK market launch: • Establish ColoSTAT® as an alternative to FIT; • Developing partnerships with key labs for growth; and • Maximising sales revenue through the private market • Over 61% of CRC detec
Slide 17: Platform Technology Expansion – Stage 1
Platform Technology Expansion – Stage 1 Stage 3 Stage 1 Stage 2 Design & Stage 4 Stage 5 Initiation: Formulation: Development: Final Validation: Product Launch Opportunity and Concept and Verification, Product Launch & Post-Launch Risk Analysis Feasibility Validation, & Clinical Preparation Assessme
Slide 18: Rhythm's Long-term Focus
Rhythm’s Long-term Focus ➢ Establish ColoSTAT® as test of choice in CRC. • Expand test in diagnosis of advanced adenomas. ➢ Increase participation rate in CRC testing and reduce late diagnosis. ➢ Market awareness, widen CRC screening participation in individuals aged 40 and above. ➢ Machine agnostic
Slide 19: Thank you
Thank you
Slide 20: References
References Slide 5 1. Xi Y, Xu P (2021), Global colorectal cancer burden in 2020 and projections to 2040, Translational Oncology, 14(10), 101174,doi:10.1016/j.tranon.2021.101174 Epub 2021 Jul 6 2. Center for Disease Control and Prevention (CDC). Colorectal cancer, available at: https://www.cdc.gov/c