AGM Presentation 24 November 2021 ASX:RHY A transformative and predictive cancer diagnostics technology company 2 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 undertakings in this presentation . This presentation is not intended to be relied upon as advice to investors or potential investors and does not take into account the investment objectives, financial situation or needs of any particular investor . Rhythm makes no warranty or representation (express or implied) as to the accuracy, reliability or completeness of the information contained in this presentation . Specifically, several matters referred to in the presentation remain under investigation and are subject to change or even elimination, depending on further research and investigation . Further, any opinions (including any forward - looking statements) expressed in this presentation are subject to change without notice . Rhythm and its directors, officers, employees, advisers and agents shall have no liability (including liability to any person by reason of negligence or negligent misstatement) for any statements, opinions, information or matters (express or implied) arising out of, contained in or derived from or for any omissions from this presentation, except liability under statute that cannot be excluded . This presentation, including the information contained in this disclaimer, does not form part of any offer, invitation or recommendation in respect of shares, or an offer, invitation or recommendation to sell, or a solicitation of any offer to buy, shares in the United States, or in any other jurisdiction in which, or to any person to whom, such an offer would be illegal . This presentation may include forward - looking statements . Forward - looking statements are only predictions and are subject to known and unknown risks, uncertainties and assumptions, many of which are outside the control of Rhythm . Actual values, results or events may be materially different to those expressed or implied in this presentation depending on a range of factors . Given these uncertainties, recipients are cautioned not to place reliance on forward - looking statements . No representation or warranty (express or implied) is made by Rhythm or any of its directors, officers, employees, advisers or agents that any forecasts, projections, intentions, expectations or plans set out in this presentation will be achieved . Disclaimer 3 Introduction Rhythm’s initial product, ColoSTAT ® is a simple , low - cost blood test for the early detection of colorectal cancer for global mass - market screening. IP protection secured in all major international jurisdictions. 4 Company Overview Board and Management Otto Buttula Glenn Gilbert Trevor Lockett Lou Panaccio Eduardo Vom Chairman Chief Executive Officer Executive - Director Non - Executive Director Non - Executive Director • Extensive financial, investment and biotech experience . • Co - Founder and CEO of IWL (ASX : IWL) ; Founder / former CEO of Investors Mutual . • Formerly a Director of Imugene (ASX : IMU) and Chairman of Investorfirst, now HUB (ASX : HUB) . • Chairman of HITIQ (ASX : HIQ), Non - Executive Director of Oncosil Medical (ASX : OSL) . • Former Head of Global Sales, Marketing and BD at Medical Developments Int . (ASX : MVP) . • Various leadership positions at CSL (ASX : CSL) . • Strong Legal, IP & Operational management . • Broad international business experience . • Former Theme Leader Colorectal Cancer and Gut Health CSIRO . • Leader – Personalised Health Group CSIRO . • Inventor on seven commercially - licensed patent families . • Chairman Avita Medical (ASX : AVH) . • Director Sonic Healthcare (ASX : SHL) . • Chairman NeuralDX . • Non - executive Director Unison Housing . • Former CEO Melb Pathology & Monash IVF . • Co - Founder & Executive Director Planet Innovation . • Director Atmo Biosciences . • Former VP Innovation, Genetic Technologies . • Various senior leadership positions Vision BioSystems . Capital Structure ASX Code RHY Share Price ( at 23 November 2021) $1.74 Shares on Issue 208.8 M Unlisted Options 16.8 M Market Capitalisation $363 M Cash in bank (30 September 2021) $7.7 M Top 20 Shareholders 46% $0 $1,000,000 $2,000,000 $3,000,000 $4,000,000 $5,000,000 $6,000,000 $7,000,000 9-Mar-20 16-Mar-20 23-Mar-20 30-Mar-20 6-Apr-20 13-Apr-20 20-Apr-20 27-Apr-20 4-May-20 11-May-20 18-May-20 25-May-20 1-Jun-20 8-Jun-20 15-Jun-20 22-Jun-20 29-Jun-20 6-Jul-20 13-Jul-20 20-Jul-20 27-Jul-20 3-Aug-20 10-Aug-20 17-Aug-20 24-Aug-20 31-Aug-20 7-Sep-20 14-Sep-20 21-Sep-20 28-Sep-20 5-Oct-20 12-Oct-20 19-Oct-20 26-Oct-20 2-Nov-20 9-Nov-20 16-Nov-20 23-Nov-20 30-Nov-20 7-Dec-20 14-Dec-20 21-Dec-20 28-Dec-20 4-Jan-21 11-Jan-21 18-Jan-21 25-Jan-21 1-Feb-21 8-Feb-21 15-Feb-21 22-Feb-21 1-Mar-21 8-Mar-21 15-Mar-21 22-Mar-21 29-Mar-21 5-Apr-21 12-Apr-21 19-Apr-21 26-Apr-21 3-May-21 10-May-21 17-May-21 24-May-21 31-May-21 7-Jun-21 14-Jun-21 21-Jun-21 28-Jun-21 5-Jul-21 12-Jul-21 19-Jul-21 26-Jul-21 2-Aug-21 9-Aug-21 16-Aug-21 23-Aug-21 30-Aug-21 6-Sep-21 13-Sep-21 20-Sep-21 27-Sep-21 4-Oct-21 11-Oct-21 18-Oct-21 25-Oct-21 1-Nov-21 8-Nov-21 15-Nov-21 22-Nov-21 $0.00 $0.50 $1.00 $1.50 $2.00 $2.50 Volume Share Price Share Price Chart 5 Globally, Colorectal Cancer is currently the 3 rd largest cancer by volume with 1 . 9 million new cases diagnosed annually and 2 nd largest cause of cancer related deaths . Source : 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. DIAGNOSIS BY STAGE GLOBAL BURDEN 1.93 million new cases ~940,000 deaths COLORECTAL CANCER RISK FACTORS CURRENT TESTING & SCREENING REGIME Early detection is key to survival In most countries, screening is recommended for those aged between 50 - 74 years old, with the primary method being a faecal test (FIT), which is designed to test only for blood in the stool . >90% Colorectal Cancer 6 Key Achievements FY’21 Technology Performance Global Capability Clinical Trial – Study 7 Quality and Regulatory Commercialisation • Technical validation of four final adjunct biomarkers supporting the key lead biomarker for ColoSTAT ® ; • Stable and reproduceable; and • Ongoing enhancements – AI Learning, Lifestyle Risk Factors. • Global manufacturer, Biotem appointed to manufacture ColoSTAT ® ; and • Initial third - party commercial analytical test work completed. • Study 6 completed - Sensitivity of 84% at Specificity of 95%; and • Confirms very high accuracy - 33% better than market standard. • Patents now secured in all major jurisdictions; • US market entry initiated – IchorDX Inc; and • Government and partner discussions commenced. • 11 clinical trial sites operational; • Patient recruitment phase completed; and • Well understood path for regulatory approvals. • ISO 13485 certification maintained (assessed annually); and • Initial TGA (Australia) application submitted and accepted. 7 ColoSTAT ® - What Is It? How Does It Work? Blood collected via a simple, routine blood draw. ColoSTAT ® could be added to the standard panel of referred tests a GP completes for routine and annual check ups. Detects protein biomarkers in the blood that are indicative of an increased likelihood of presence of colorectal cancer. The result is sent to the patient’s doctor for review & assessment if further action is required i.e., colonoscopy. ColoSTAT ® Test - Kit Algorithm Low cost assay format which is designed to integrate seamlessly with existing pathology lab infrastructure ColoSTAT ® will analyse & consolidate individual biomarker results simultaneously, using its developed algorithm, to provide an indication of the likelihood of presence of colorectal cancer. ColoSTAT ® Technology Sample Result How it works ColoSTAT® detects colorectal cancer – not just blood in faeces . 8 ColoSTAT ® Performance 63% 72% 77% 84% 40% 45% 50% 55% 60% 65% 70% 75% 80% 85% FIT (80ug/g) Market Standard CSIRO R&D 2003-2016 Rhythm Prototype January 2021 Rhythm Study 6 March 2021 ColoSTAT Sensitivity Performance Comparison • Highly accurate ColoSTAT is 33% more accurate at detecting colorectal cancer than the current market standard Faecal Immunochemical Test (FIT). 2 • Low Cost and Simple Protein biomarker led delivers a cost - efficient simple blood test that is suited to global mass market screening programs. • Detects Cancer Disruptive technology that detects the presence of cancer in the blood whereas current FIT based testing regimes only detects the presence of blood in a stool sample. • Preferred A blood test is preferred as a more acceptable way to participate in testing. 92% specificity 95% specificity “83% of unscreened participants prefer a blood test over a faecal test” 1 1 9. Osborne, J. , Wilson, C. , Moore, V. , Gregory, T. , Flight, I. and Young, G. (2012) Sample preference for colorectal canc e r screening tests: Blood or stool?. Open Journal of Preventive Medicine, 2, 326 - 331. doi: 10.4236/ojpm.2012.23047. 2 Symonds EL, Pedersen SK, Baker RT, Murray DH, Gaur S, Cole SR, Gopalsamy G, Mangira D, LaPointe LC, Young GP.A Blood Test for Methylated BCAT1 and IKZF1 vs. a Fecal Immunochemical Test for Detection of Colorectal Neoplasia. Clinical and Translational Gas troenterology (2016) 7, e137; doi:10.1038/ctg.2015.67. 95% specificity 95% specificity 9 Market Opportunity / Addressable Market Colorectal Cancer Screening Market Population Number of people over 50 years of age eligible for screening Country Screening participation Addressable population United States 63% 94 million Europe 38% 231 million China 19% 397 million Japan 38% 42 million Australia 41% 7 million Total 771 million people US EU CN JP AU Potential to reach ~1 billion people when the screening age is lowered to 45 years old US$38 billion addressable screening value in priority markets 1 $350M $2.1Bn $20Bn $12Bn $4.7Bn 1 Based on 2021 data calculated as Eligible Screening Population (771 million) x Example Test Cost (US$50). RHY revenue may var y . 10 Australia – Growth of CRC in younger age groups 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 1990 1995 2000 2005 2010 2015 2020 Melanoma of the Skin Brain Colorectal Bone Cervix Other soft tissue Acute lymphoblastic leukaemia Non-hodgkin lymphoma Acute myeloid leukaemia 25 – 29 years old 40 – 44 years old 30 – 34 years old 45 – 49 years old 35 – 39 years old 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 1990 1995 2000 2005 2010 2015 2020 Melanoma of the Skin Brain Colorectal Bone Cervix Other soft tissue Acute lymphoblastic leukaemia Non-hodgkin lymphoma Ovary 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 1990 1995 2000 2005 2010 2015 2020 Melanoma of the Skin Brain Colorectal Liver Cervix Other soft tissue Pancreas Non-hodgkin lymphoma Ovary 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 1990 1995 2000 2005 2010 2015 2020 Melanoma of the Skin Brain Colorectal Liver Cervix Other soft tissue Pancreas Unknown primary Ovary 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 1990 1995 2000 2005 2010 2015 2020 Melanoma of the Skin Brain Colorectal Liver Cervix Oesophagus Pancreas Unknown primary Ovary Colorectal Cancer is the #1 cause of death in 25 - 34 year old’s . Top 2 cause of cancer related deaths below the age of 50. Source: Australian Institute of Health and Welfare (AIHW). Cancer data in Australia - Cancer rankings data visualisation. - data - in - australia/contents/cancer - rankings - data - visualisation 11 Unique Opportunity To Add Significant Value Seamless alignment across the entire value chain providing broader benefits for the health system Blood test is the preferred testing method. Cheaper testing leads to higher availability. Reduction in unnecessary colonoscopy procedures. Reduction in unnecessary procedures. Technology fits existing pathology infrastructure. Test managed via a doctor referral. Increased participation in screening. More lives saved. Reduced economic & societal burden. Reduced claims costs. Increased member engagement. More resources and beds available to prioritise urgent cases. No additional equipment or training required. More relevant contact with patients for better health outcomes. Patients Government Health Insurers Health System Laboratories GP/Doctors 12 On Track For Future Milestones Clinical Trial (Study 7) • Commenced remaining clinical trial tasks; • Reduced variability in cost and time with patient recruitment completed; and • On track for final clinical report for H1CY’22 Regulatory Distribution Market Entry • Identify key sales, distribution & diagnostic companies for partnering; and • Explore commercialisation pathways for ColoSTAT ® in various global jurisdictions. • CE Mark submission and approval expected in late 2021; and • Progression of TGA (Australia) regulatory application post clinical trial (Study 7) on track for H1CY’22. • Advance USA / European / Australian / China / Asia / ROW market entry strategies. Platform Technology Expansion • Development of platform technology opportunities for other cancers commenced. 13 The Team In Action! note: photos represent part of the entire lab team. Some team members were not present on the day these photos were taken. 14 Summary Disruptive and transformative technology Significantly cheaper and easier to administer Globally addressable market Performance better than market standard Manufacturing & Patents secured Initial revenues targeted for 2022 15 Glenn Gilbert CEO, Rhythm Biosciences +61 3 8256 2880
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