Resonance Health Ltd · ASX:RHT
Resonance Health — Corporate Update (October 2026)
31 slides from Resonance Health's corporate update, Oct 28, 2026
Slide 1: MRI Liver Fibrosis Device Clinical Trial Preliminary Results Webinar
ASX Announcement – 28 October 2026 MRI LIVER FIBROSIS DEVICE CLINICAL TRIAL For personal use only PRELIMINARY RESULTS WEBINAR Resonance Health Ltd (Resonance or Company) (ASX: RHT) has today released “Preliminary results of MRI Liver Fibrosis Device clinical trial investor presentation”, enclosed wi
Slide 2: Liver fibrosis results open GLP-1 biomarker opportunity
rsonal use only P R EL I M I NA R Y EP O C ST U D Y R E S UL T S | O C T OB E R 20 2 6 Liver fibrosis results open GLP-1 biomarker opportunity FibrosisAssessment: non-invasive MRI liver fibrosis software as a medical device Andrew Harrison | MD & CEO Dr Wenjie Pang | Chief Scientific Officer Resonan
Slide 3: Important notice and disclaimer
I M P O R T AN T NO T I CE Important notice and disclaimer Preliminary results. Liver fibrosis results are preliminary and not yet Market estimates and economics. Market sizes, pricing, trial sizes and rsonal use only independently verified, based on 50 subjects from a single site scan volumes are i
Slide 4: A fibrosis signal from standard MRI
AT A GLANCE A fibrosis signal from standard MRI Preliminary EPoC read-out: 50 biopsy-confirmed subjects scanned at 3T, against liver biopsy rsonal use only 0.82 93.5% US$0 951 AUROC, significant Specificity, advanced Added hardware or Obesity and overweight fibrosis (≥F2) fibrosis (≥F3) software tri
Slide 5: The opportunity
rsonal use only 01 The opportunity Why liver fibrosis matters in GLP-1, metabolic and obesity trials Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026 4
Slide 6: Fibrosis stage is what trials and payers need to know
L I V E R F I B RO S I S 1 0 1 Fibrosis stage is what trials and payers need to know Advanced fibrosis (≥F3) rsonal use only Significant fibrosis (≥F2) Any fibrosis (≥F1) F0 F1 F2 F3 F4 No fibrosis Portal or perisinusoidal Portal and periportal Bridging fibrosis Cirrhosis What FibrosisAssessment Tod
Slide 7: Biopsy gates MASH trials, and most fail it
THE NEED Biopsy gates MASH trials, and most fail it Invasive and imprecise rsonal use only 70–80% of patients screened for MASH trials fail screening, Needle biopsy, an imperfect reference standard, carries procedural risk, samples a tiny fraction of the liver and is subject to sampling and reader v
Slide 8: Three structural tailwinds
W HY NO W Three structural tailwinds Independent forces converging on the capabilities Resonance Health has spent 20 years building rsonal use only 01 02 03 Liver disease prevalence MASH diagnostics demand GLP-1 trial explosion 1.5B+ 2 951 people living with chronic liver disease FDA-approved MASH t
Slide 9: One MRI visit, the full GLP-1 read-out
T H E G L P - 1 B I OM A R KE R O P P O R T UN I T Y One MRI visit, the full GLP-1 read-out rsonal use only Liver fat CLEARED Fibrosis is a key endpoint HepaFatScan® / Smart® Fibrosis is a key biomarker endpoint in GLP-1, metabolic and obesity trials, particularly following the FDA Liver iron approv
Slide 10: Standard MRI in, fibrosis read out
H O W F I B R O S I S AS S E S S M E N T W O R KS Standard MRI in, fibrosis read out Scan rsonal use only 1 Standard sequences on any modern 1.5T or 3T scanner. No contrast injection, no added hardware, no site software. Upload 2 DICOM images sent securely through the core-lab workflow used for Ferr
Slide 11: The results
rsonal use only 02 The results Preliminary results from the extended proof-of- concept study (EPoC) Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026 10
Slide 12: DEVIMLA extended study: what was analysed
S T U DY D ES I G N DEVIMLA extended study: what was analysed Development and Validation of Multiparametric MRI for Non-Invasive Measurement of Liver Fibrosis and Activity Study Biopsy stage distribution, n = 50 rsonal use only 68 adults with biopsy-confirmed chronic liver disease at sites in Malays
Slide 13: Unlocking fibrosis signal from standard MRI
P R E L I M I N A RY RE S U L T S Unlocking fibrosis signal from standard MRI Significant fibrosis (≥F2) Advanced fibrosis (≥F3) rsonal use only 40 F2–4 vs 10 F0–1 19 F3–4 (incl. one F2–3) vs 31 F0–2 AUC AUC 0.820 0.788 95% CI 0.674–0.940 95% CI 0.631–0.908 Sensitivity (30/40) Sensitivity (11/19) 75
Slide 14: What the numbers say, and what they don't yet
I N T E R P R ET A T I O N What the numbers say, and what they don’t yet rsonal use only Small cohort, wide A real signal Expands the 2022 PoC intervals The model separates fibrosis stages well The 2022 PoC (AUC 0.92, n = 27) With 10 F0–1 subjects, specificity for ≥F2 above chance, at both threshold
Slide 15: Towards a greater AUROC, without a new study
M O D E L DE V E L O P M E N T Towards a greater AUROC, without a new study The current result represents an early stage of model development rsonal use only NOW NEXT THEN First-pass model Refined model Locked and validated Intentionally limited parameters, 50 Ongoing analysis and Every improvement
Slide 16: Where it sits
rsonal use only 03 Where it sits Access, positioning and the market opportunity Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026 15
Slide 17: FibrosisAssessment versus MRE and FibroScan
P O S I T I O N I NG FibrosisAssessment versus MRE and FibroScan FibrosisAssessment (MRI) MR elastography (MRE) FibroScan (VCTE) rsonal use only Driver hardware, sequence and Dedicated ultrasound device and Added equipment at site None: standard MRI sequences software licence probes Capex per site U
Slide 18: Mass access at zero capex for imaging sites
A C CE S S A N D C A PE X Mass access at zero capex for imaging sites rsonal use only FibrosisAssessment: no added US$0 hardware or software at the imaging site ~50,000 US$75k–150k MRE: per scanner, for driver hardware, sequence and MRI scanners worldwide software licence FibroScan: per device, plus
Slide 19: FibrosisAssessment completes the liver read-out
T H E G L P - 1 I M A G I N G PR O T O C O L FibrosisAssessment completes the liver read-out Metabolic and obesity MRI trial endpoints, grouped by region, from one imaging session and one ISO 13485 core lab rsonal use only HEART WHOLE BODY Paracardiac fat epicardial + pericardial volume IN DEV Total
Slide 20: Three markets, entered in sequence
S T R AT E G Y Three markets, entered in sequence US context: ~460,000 diagnosed F2–F3 MASH patients under specialist care; 6.7M rsonal use only adults with MASH and ≥F2 fibrosis; 267 MASH trials recruiting. STAG E 3 | POST-CO VERAG E Reimbursed diagnostics STAG E 2 | POST-CLEA RA NCE Payer coverage
Slide 21: Illustrative investigational-use economics per trial
E C ON O M IC S Illustrative investigational-use economics per trial Revenue = price per scan × patients × MRI visits rsonal use only Indicative economics for three prevalent trial types Revenue per trial (US$M) Paired MRI Revenue at $6.0M Trial type Patients Scans biopsy visits US$900–1,500* cases
Slide 22: Path to FDA
rsonal use only 04 Path to FDA Twenty years of SaMD development and regulatory clearance Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026 21
Slide 23: Twenty years of SaMD development and clearance
T R A CK R E C O RD Twenty years of SaMD development and clearance FibrosisAssessment follows the path Resonance has taken with its regulatory-cleared SaMDs rsonal use only FerriScan® CLEARED FerriSmart® CLEARED HepaFatScan® CLEARED Core-lab liver iron concentration; AI-trained, automated real-time
Slide 24: From preliminary results to an FDA submission
R E G U L A T O R Y P A T HW A Y From preliminary results to an FDA submission rsonal use only We are here 1 2 3 4 5 6 Complete the Model v2 FDA Pre- Investigational Pivotal validation Submit and clear EPoC Submission use All 68 subjects, Refine on data Agree intended use, Paid analysis in Locked mo
Slide 25: What to watch over the next months
C A T AL Y S T S What to watch over the next 12 to 24 months rsonal use only FibrosisAssessment The GLP-1 imaging protocol Full EPoC analysis Muscle quality endpoints to market results for all 68 enrolled subjects completing the obesity-trial imaging protocol Model refinement VAT/SAT automation live
Slide 26: A very encouraging step, with a clear path to improve
I N T HE I R W O R D S A very encouraging step, with a clear path to improve rsonal use only “These preliminary results are a very encouraging step “A clear fibrosis signal was identified at 3T consistent with the towards commercialising the FibrosisAssessment device in 1.5T proof-of-concept result,
Slide 27: Key risks
KEY RISKS Key risks Clinical validation: Preliminary results may not be confirmed in Model refinement: Planned refinements may not improve rsonal use only the full and final EPoC analysis or in validation. performance as expected. Regulatory: The FDA pathway (510(k) or De Novo), timing and Data righ
Slide 28: Summary
Summary A real fibrosis signal from standard MRI: AUROC 0.82 for ≥F2, in rsonal use only 1 line with FibroScan, and 0.79 for ≥F3. 2 Achieved at 3T in a challenging, heterogeneous cohort, from a first-pass model. 3 Refinement uses data already collected: no additional data or new study needed. 4 No h
Slide 29: Glossary
A P P EN D I X Glossary AUROC (AUC) Area under the ROC curve: ability to separate two groups VCTE (FibroScan) Vibration-controlled transient elastography: an ultrasound- rsonal use only across all cut-offs (0.5 = chance, 1.0 = perfect). based liver stiffness device. Sensitivity Proportion of biopsy-
Slide 30: Disclaimer and forward-looking statements
DISCLAIMER Disclaimer and forward-looking statements This presentation has been prepared by Resonance Health Ltd (“Resonance Health” or “Company”) and contains forward-looking statements that are rsonal use only based on current expectations and beliefs and are subject to numerous factors and uncert
Slide 31: A trial beachhead inside a much larger market
A D DR E S S AB L E M A R KE T A trial beachhead inside a much larger market Liver fibrosis assessment, annual market by stage rsonal use only W ID ER LI VE R MA RK ET S ~US$140M ~US$1.3B $23B US$60–100M a year a year hepatic fibrosis market a year (2026) $40B+ CL I NI CA L T RI AL S , GL OB AL US ,