Board Change • Apr 29
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Non-Executive & Independent Chairman Aaron Brinkworth was the last independent director to join the board, commencing their role in 2023. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Sep 25
Resonance Health Limited, Annual General Meeting, Nov 13, 2025 Resonance Health Limited, Annual General Meeting, Nov 13, 2025. New Risk • Sep 09
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: AU$14.9m (US$9.87m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 33% per year over the past 5 years. Market cap is less than US$10m (AU$14.9m market cap, or US$9.87m). Reported Earnings • Aug 31
Full year 2025 earnings released: AU$0.004 loss per share (vs AU$0 in FY 2024) Full year 2025 results: AU$0.004 loss per share (further deteriorated from AU$0 in FY 2024). Revenue: AU$11.2m (up 30% from FY 2024). Net loss: AU$1.73m (down AU$1.90m from profit in FY 2024). Over the last 3 years on average, earnings per share has increased by 12% per year but the company’s share price has fallen by 17% per year, which means it is significantly lagging earnings. Announcement • Aug 11
Resonance Health Limited to Report Fiscal Year 2025 Results on Aug 29, 2025 Resonance Health Limited announced that they will report fiscal year 2025 results on Aug 29, 2025 New Risk • Apr 07
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: AU$16.1m (US$9.72m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 15% per year over the past 5 years. Market cap is less than US$10m (AU$16.1m market cap, or US$9.72m). Minor Risk Share price has been volatile over the past 3 months (12% average weekly change). New Risk • Mar 03
New major risk - Revenue and earnings growth Earnings have declined by 15% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 15% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Market cap is less than US$100m (AU$23.0m market cap, or US$14.3m). Announcement • Feb 21
Resonance Health Limited to Report First Half, 2025 Results on Feb 28, 2025 Resonance Health Limited announced that they will report first half, 2025 results on Feb 28, 2025 New Risk • Nov 19
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Australian stocks, typically moving 20% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (20% average weekly change). Minor Risk Market cap is less than US$100m (AU$27.1m market cap, or US$17.6m). Announcement • Oct 07
Resonance Health Limited, Annual General Meeting, Nov 28, 2024 Resonance Health Limited, Annual General Meeting, Nov 28, 2024. Reported Earnings • Sep 03
Full year 2024 earnings released: EPS: AU$0 (vs AU$0.002 loss in FY 2023) Full year 2024 results: EPS: AU$0 (improved from AU$0.002 loss in FY 2023). Revenue: AU$8.80m (up 97% from FY 2023). Net income: AU$169.3k (up AU$949.7k from FY 2023). Profit margin: 1.9% (up from net loss in FY 2023). The move to profitability was driven by higher revenue. Over the last 3 years on average, earnings per share has fallen by 23% per year but the company’s share price has only fallen by 17% per year, which means it has not declined as severely as earnings. New Risk • Feb 05
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 48% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Revenue is less than US$5m (AU$4.5m revenue, or US$2.9m). Market cap is less than US$100m (AU$22.8m market cap, or US$14.8m). New Risk • Nov 17
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 48% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Revenue is less than US$5m (AU$4.5m revenue, or US$2.9m). Market cap is less than US$100m (AU$28.0m market cap, or US$18.2m). Announcement • Sep 29
Resonance Health Limited, Annual General Meeting, Nov 16, 2023 Resonance Health Limited, Annual General Meeting, Nov 16, 2023, at 10:00 W. Australia Standard Time. Announcement • Sep 05
Resonance Health Ltd Appoints Benjamin Carruthers as Chief Financial Officer, Effective October 2023 Resonance Health Ltd. announced that Mr. Benjamin Carruthers has been appointed as Chief Financial Officer (CFO) and is expected to commence the role in October 2023. Mr. Carruthers is a seasoned professional with over 20 years' experience in advisory, restructuring and turnaround in listed and private entities across a range of industries including mining and resources, services, retail, manufacturing, aquaculture and marine, education and training, and franchising. He brings extensive experience in M&A transactions, due diligence, modelling, and financial management. He holds a Bachelor of Commerce (Accounting & Finance), Bachelor of Arts (French) and is a Chartered Accountant. His most recent role was as General Manager at SFM Marine, and prior to that he was an Executive Director at Korda Mentha. Announcement • Sep 01
Resonance Health Limited Announces Resignation of Liesl Ellies as Joint Company Secretary Resonance Health Limited announced that Ms Liesl Ellies has resigned as joint Company Secretary, effective 31 August 2023. Mr. Mitchell Wells continues to serve as Company Secretary of Resonance in addition to serving as a Non- executive Director of the Company. Reported Earnings • Aug 31
Full year 2023 earnings released: AU$0.002 loss per share (vs AU$0.002 loss in FY 2022) Full year 2023 results: AU$0.002 loss per share (in line with FY 2022). Revenue: AU$4.51m (up 17% from FY 2022). Net loss: AU$780.4k (loss narrowed 32% from FY 2022). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 48 percentage points per year, which is a significant difference in performance. New Risk • Aug 31
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2022. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 38% per year over the past 5 years. Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Revenue is less than US$5m (AU$4.1m revenue, or US$2.6m). Market cap is less than US$100m (AU$25.4m market cap, or US$16.4m). Reported Earnings • Mar 03
First half 2023 earnings released: EPS: AU$0 (vs AU$0 in 1H 2022) First half 2023 results: EPS: AU$0 (in line with 1H 2022). Revenue: AU$2.16m (up 15% from 1H 2022). Net loss: AU$251.8k (loss widened 12% from 1H 2022). Over the last 3 years on average, earnings per share has fallen by 33% per year whereas the company’s share price has fallen by 29% per year. Announcement • Dec 21
Resonance Health Ltd Announces That It Has Lodged Provisional Patent Application in Relation to an Invention for the Detection and Assessment of Fibrosis in the Liver and Other Organ Resonance Health Ltd. advised that it has lodged a provisional patent application in relation to an invention for the detection and assessment of fibrosis in the liver and other organs, utilising non-invasive magnetic resonance imaging (MRI). Early detection and assessment of liver fibrosis is essential to managing and reversing liver disease progression. The current gold-standard for assessing the presence and progression of liver fibrosis is by way of liver biopsy, which involves the collection of a tissue sample from the patient using a needle, which is then analysed by a pathologist. Liver biopsies are not trivial procedures; they are invasive, can give rise to significant side effects (including pain, bleeding, infection, hospitalisation, and even death) and are unavailable for patients with comorbidity factors including blood clotting conditions and infections. Further, liver biopsies are slow and expensive as they require the involvement of multiple medical specialists and facilities, and they may be subject to significant sampling error. Current Non-Invasive Approaches to Liver Fibrosis: Several techniques exist that purport to indicate the presence of liver fibrosis utilising non-invasive or less- invasive procedures than liver biopsy. These include serum blood tests, ultrasound, and magnetic resonance elastography (MRE) methods and quantitative MRI methods. While these non-invasive methods may provide information as to the presence of liver fibrosis (particularly advanced fibrosis), there are a number of unresolved issues in relation to the accurate and reliable detection of fibrosis using these methods. In addition, the techniques are typically confounded by the presence of factors including liver iron level (or content), subcutaneous fat, ascites, liver fat, liver inflammation and others. Resonance Health has completed an initial proof-of-concept study of an analysis technique aimed at the identification and assessment of liver fibrosis (Initial Proof of Concept). The Initial Proof of Concept forms the basis of the invention that is the subject of the Provisional Patent Application. The Initial Proof of Concept study, which was conducted on a patient and control group of 30 subjects, indicates a strong capability to predict the absolute presence of liver fibrosis within the study population. Based on the extremely promising Initial Proof of Concept results Resonance Health is now undertaking an accelerated extended proof-of-concept study with an expanded study population (Extended Proof of Concept). Extended Proof of Concept: The objectives of the Extended Proof of Concept are to confirm the results of the Initial Proof of Concept, to further refine the study predictive models and to further assess the performance of predictive models and their capacity to distinguish between differing fibrosis grades. The duration of the Extended Proof of Concept is estimated to be 6 to 12 months. The Company is actively engaged with study partners to secure the study subjects required for the study and will update shareholders once the timelines for completion of this phase of the study are determined. Subject to the outcomes of the Extended Proof of Concept, the Company intends to explore collaboration opportunities with large pharmaceutical companies and clinical key opinion leaders (KOLs), who have expressed strong interest in the results of the Initial Proof of Concept and a desire to participate in such a collaboration. Board Change • Nov 16
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 2 experienced directors. 2 highly experienced directors. MD, Joint Company Secretary & Executive Director Mitchell Wells was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Oct 07
Resonance Health Limited, Annual General Meeting, Nov 24, 2022 Resonance Health Limited, Annual General Meeting, Nov 24, 2022. Reported Earnings • Oct 01
Full year 2022 earnings released: AU$0.002 loss per share (vs AU$0.001 profit in FY 2021) Full year 2022 results: AU$0.002 loss per share (down from AU$0.001 profit in FY 2021). Revenue: AU$3.85m (down 3.3% from FY 2021). Net loss: AU$1.14m (down 295% from profit in FY 2021). Over the last 3 years on average, earnings per share has fallen by 39% per year but the company’s share price has only fallen by 23% per year, which means it has not declined as severely as earnings. Reported Earnings • Aug 31
Full year 2022 earnings released: AU$0.002 loss per share (vs AU$0.001 profit in FY 2021) Full year 2022 results: AU$0.002 loss per share (down from AU$0.001 profit in FY 2021). Revenue: AU$3.86m (up 2.0% from FY 2021). Net loss: AU$1.14m (down 295% from profit in FY 2021). Over the last 3 years on average, earnings per share has fallen by 39% per year but the company’s share price has only fallen by 14% per year, which means it has not declined as severely as earnings. Announcement • Jul 25
FerriScan Now Available on 3 Tesla (3T) MRI Machines Resonance Health Ltd. advised that FerriScan®, its product, is now available for use on 3T MRI scanning machines. FerriScan® is internationally recognised by clinicians as the gold standard for the measurement of liver iron concentration ("LIC") for patients suffering iron overload disorders. This accurate MRI-based technique is non-invasive and eliminates the need for liver biopsies. FerriScan® is recommended in multiple clinical patient management guidelines and international standards of care. Since the Company's inception, Resonance Health has completed over 58,000 FerriScan® analyses to assist patients suffering iron overload disorders around the world. Until now, the FerriScan® service has only been available at MRI facilities with 1.5 tesla (1.5T) field strength MRI machines. The Company commenced studies aiming to adapt the FerriScan® acquisition protocol from 1.5T to 3T MRI scanners, which would allow for better usability of the FerriScan® service across a broader range of MRI machines. Resonance Health is pleased to advise that it recently successfully finalised the calibration of the FerriScan® protocol, with FerriScan® now commercially available for use in clinical trials and in the routine clinical management of patients, on both 1.5T and 3T MRI machines. 3T MRI machines offer advantages for clinicians and patients, including shorter scan times and greater image contrast compared with 1.5T MRI machines, and are growing in prevalence around the world. In the United States, 1.5T and 3T scanners are now being purchased in approximately equal numbers and dominate new sales, with 3T scanners already representing approx. 15% to 18% of total MRI scanners in Europe and North America. Announcement • May 02
Resonance Health Limited Appoints Liesl Ellies as Joint Company Secretary Resonance Health Limited announced that it has appointed Ms. Liesl Ellies as Joint Company Secretary, effective immediately. Following Ms. Ellies' appointment, Ms. Ellies, Mr. Nicholas Allan, and Mr. Mitchell Wells will be joint Company Secretaries and will share responsibility for communications with ASX in relation to Listing Rule matters under ASX Listing Rule 12.6. Board Change • Apr 27
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 2 experienced directors. 2 highly experienced directors. MD & Executive Director Mitchell Wells was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Feb 07
Resonance Health Limited Receives United States CPT Code Confirmation for Liversmart Resonance Health Ltd. has received confirmation from an independent US CPT Code Certifier that its LiverSmart medical device is eligible for up to two new US Current Procedural Terminology codes. The Company engaged the services of KarenZupko & Associates Inc., based in Chicago, Illinois, USA, to perform the review, which was conducted by Mr. Matthew Twetten MA MHCDS. KZA reviewed the Company's LiverSmart® User Guide, the 2022 CPT Professional Coding Guide published and maintained by the American Medical Association, and various materials relating to new CPT codes 0648T and 0649T which became effective on January 1, 2022. KZA recommends that CPT code 0648T applies when LiverSmart® is performed without other documented diagnostic liver imaging, and CPT code 0649T applies when additional diagnostic liver imaging is performed in the same scanning session. CPT Code Eligibility - Key Milestone Towards US Reimbursement for LiverSmart CPT codes are a set of codes, descriptions and guidelines maintained by the AMA and recognised by US government agencies and private insurers. They describe medical procedures and services performed by physicians and other healthcare providers for reimbursement by government payers such as Medicare and Medicaid, and private payers including private health insurers. The codes are used by physicians and healthcare providers for reporting and tracking medical services performed by healthcare providers. CPT codes generally start as Category III codes and, when there is sufficient reporting of the codes and adequate literature supporting efficacy, they can be upgraded to Category I which are widely accepted by third party payors. CPT code eligibility for medical devices, procedures, and services, are the first formal step into the US national reimbursement coding framework. The new Cat III codes can immediately be used by hospitals and MRI imaging centres in the United States when using LiverSmart®. Announcement • Dec 30
Resonance Health Limited Announces US FDA Clearance for LiverSmart Resonance Health Ltd. obtained 510(k) regulatory clearance from the United States Food & Drug Administration ("FDA"). The FDA clearance allows LiverSmart® to be commercially marketed and sold in the United States of America, which is the Company's largest customer base. LiverSmart® combines two existing FDA regulatory-cleared Resonance Health products, FerriSmart® and HepaFat-AI®, into a single multi-parametric MRI session, avoiding the need for multiple MRI appointments, and delivering a more complete and comprehensive assessment of a person's liver. An example of the LiverSmart® report is enclosed with this announcement at Annex A. Instead of obtaining individual FerriSmart® and HepaFat-AI® reports via separate scanner sessions, which adds to cost and inconvenience, patients and clinicians will soon be able to obtain both analyses at the same time with one referral, and in one consolidated report. Clinicians seeking both analyses will simply refer for a LiverSmart® assessment, by Resonance Health. Importantly, the Company believes that LiverSmart® may be eligible for two new US (Cat III) Current Procedural Technology ("CPT") codes published by the American Medical Association which become active in January 2022. The Company is awaiting definitive determination of LiverSmart's eligibility for these codes from a US certified CPT coder and believes that the FDA clearance may expedite this. Resonance Health will advise the market upon receipt of confirmation of code applicability. CPT codes are a national procedural coding set maintained by the AMA, and recognised by US government agencies, used to describe medical services for reimbursement by both government payers such as Medicare, Medicaid, and private payers including private health insurers. The codes are used by physicians and health care professionals for reporting and tracking medical services performed by healthcare providers. CPT codes start as temporary Cat III codes and, when there is sufficient reporting of the codes, they are upgraded to Cat I, at which point they become permanent and reimbursable. If LiverSmart® is eligible for the new codes, it will be another milestone in the pathway to widespread payer and insurer reimbursement in the US and will better facilitate LiverSmart® being reimbursed by private payers such as private health insurers, as well as Medicare and Medicaid. Announcement • Dec 20
Resonance Health Ltd Provides Update on its Antisense Oligonucleotide Project for Treating Viral Hepatitis Resonance Health Ltd. provided the following update on its Antisense Oligonucleotide ("ASO") project for treating viral hepatitis ("ASO R&D Project"). The ASO R&D Project is part of the Company's Molecular Medicine R&D workstream, which is led by Resonance Health's Dr. Sherif Boulos. The Company recently disclosed that its drug AS3 (re-named EX00A31; see Annexure A, item 1), targets cyclophilin A, a human protein essential to the growth of many clinically important viruses, including Hepatitis B, D and C. The Company announced that work in Dr. Nadia Warner's (HBV Pathogenesis Group Leader) laboratory demonstrated that EX00A31 significantly reduced Hepatitis B viral replication compared to control in a cell model of disease. Encouragingly, treatment also reduced the secretion of Hepatitis B surface antigen (HBsAg), a serum marker of active disease and a driver of immune suppression. The current results align with the Company's previous announcement that EX00A31 is well-tolerated, engages with, and downregulates its liver target by >96%, relative to control. Considering these important milestones, the Company is proceeding with the preclinical validation of EX00A31 in a humanized-liver mouse model of Hepatitis B infection. In that regard, the Company has signed a Research Services Agreement with Prof. Philip Mueleman (Liver Infectious Diseases Laboratory: University of Ghent, Belgium), a world leading expert in the testing of antiviral therapeutics. As part of this agreement, Prof. Mueleman will also test EX00A31 against Hepatitis C virus (HCV) in a humanized-liver mouse model, another serious and leading cause of viral hepatitis around the globe). The Company is confident that EX00A31 is a legitimateand promising therapy for the treatment of both HBV and HCV. Underscoring the broader clinicalapplicability of EX00A31, up to 8.4% of US patients with Chronic Hepatitis B (CHB) are also co-infected with HCV. The Company expects that both preclinical animal studies will be completed in the first half of 2022. Viral hepatitis affects over 2.3 billion people globally and is a leading cause of liver failure and cancer. More specifically, CHB is a life-long illness, affecting some 300 million people, including 230,000 Australians. Current treatments fail to eliminate the virus, leaving 40% at risk of an early death from liver-related complications. Aside from the serious morbidities associated with CHB, healthcare costs for a single patient are estimated at around USD 100,000 annually. Successful viral elimination will require a `multi-drug approach' that addresses 2 or more distinct viral pathways. As such, EX00A31 is an ideal co-treatment option precisely because it targets a human protein essential to viral replication, and not the virus directly. And as viruses inevitably mutate, drug resistance is far less likely to emerge against EX00A31 than it would against a direct acting antiviral (DAA). Thus, EX00A31 would act to improve viral clearance, while mitigating theemergence of drug resistance against the agent(s) it is combined with. Announcement • Nov 24
Resonance Health Limited Announces Filing of Two Patent Applications Resonance Health Limited announced that it has filed two additional Australian provisional patent applications covering the application of novel Antisense Oligonucleotides ("ASOs") for the treatment of human diseases ("Additional ASO Patent Applications"). The Additional ASO Patent Applications have been filed with IP Australia and they follow the Company's earlier filing of both Australian and international Patent Co-operation Treaty ("PCT") applications for the ASO R&D Project. The Additional ASO Patent Applications are a precursor to the filing of substantive PCT applications in due course which, if granted, will have a term of 20 years from the PCT filing date. The ASO R&D Project is part of the Company's Molecular Medicine R&D workstream which is led by Resonance Health's Chief Scientist of Molecular Medicine, Dr. Sherif Boulos. Previous updates on the ASO R&D Project have covered the Company's development of ASOs for an undisclosed target without mentioning the target by name. The Company can now disclose that the ASOs are targeting three key members of the `cyclophilin' protein family namely, cyclophilin A (CYPA), cyclophilin B (CYPB), and cyclophilin D (CYPD). Scientific research has consistently validated the medical importance of these proteins across multiple disease groups including microbial diseases, inflammatory disorders, metabolic and fibrotic disorders, neurodegenerative and cardiovascular disorders, and cancer. Reported Earnings • Oct 04
Full year 2021 earnings released: EPS AU$0.001 (vs AU$0.002 loss in FY 2020) The company reported a strong full year result with improved earnings, revenues and profit margins. Full year 2021 results: Revenue: AU$3.78m (up 3.0% from FY 2020). Net income: AU$585.9k (up AU$1.30m from FY 2020). Profit margin: 16% (up from net loss in FY 2020). Over the last 3 years on average, earnings per share has fallen by 15% per year but the company’s share price has increased by 51% per year, which means it is well ahead of earnings. Announcement • Sep 21
Resonance Health Ltd announces R&D Molecular Medicine ASON Project Results of Dosing Study Resonance Health Ltd. provides the following update that In demonstrating that AS3 is highly efficacious in a humanised-liver mouse model, the Company has achieved a significant milestone. On that basis, the Company has commenced discussions with an experienced academic team to develop a collaborative study with the objective of evaluating AS3 in a humanised-liver mouse model of Hepatitis B virus infection. The company hope to commence this work late 2021 or early 2022 for completion in the first half of 2022. Reported Earnings • Sep 01
Full year 2021 earnings released: EPS AU$0.001 (vs AU$0.002 loss in FY 2020) The company reported a strong full year result with improved earnings, revenues and profit margins. Full year 2021 results: Revenue: AU$4.02m (up 9.7% from FY 2020). Net income: AU$585.9k (up AU$1.30m from FY 2020). Profit margin: 15% (up from net loss in FY 2020). The move to profitability was primarily driven by lower expenses. Over the last 3 years on average, earnings per share has fallen by 15% per year but the company’s share price has increased by 64% per year, which means it is well ahead of earnings. Executive Departure • Jul 13
Chief Executive Officer Alison Laws has left the company During their tenure, earnings grew by 1,030% annually compared to the industry average of 17%. On the 2nd of July, Alison Laws was replaced as CEO by Mitchell Wells after 3.4 years in the role. As of March 2021, Alison still personally held only 9.09k shares (AU$1.0k worth at the time). Alison is the only executive to leave the company over the last 12 months. The current median tenure of the management team is 4.08 years. Under Alison's leadership, the company delivered a total shareholder return of 546%. Announcement • May 24
Resonance Health Limited Announces Filing of Patent Application Resonance Health Limited announced that it has lodged an international application under the Patent Co- Operation Treaty for the use of Antisense Oligonucleotides to target a human gene associated with viral, inflammatory, and malignant disease. The PCT Patent Application, which has been filed with IP Australia, seeks protection for a new method for treating viral, inflammatory, and malignant diseases. The Company's ASO project initially investigated the application of specific compounds for use in modulation of Hepatitis B virus In a preclinical cell model of HBV infection, the lead ASO demonstrated statistically significant viral suppression compared to a control ASO. Due to this promising data, a dosage study to test its effectiveness in a humanised liver mouse strain will soon commence. If successful, AS3's effectiveness in an HBV infection model using the same strain will then be assessed. Chronic Hepatitis B is estimated to affect 292 million people globally, including an estimated 230,000 Australians. Current life-long treatments do not eliminate HBV, and up to 40% of sufferers will develop serious clinical complications such as cirrhosis, liver failure and/or liver cancer. Aside from the human suffering, the healthcare cost of chronic HBV in the USA is estimated to be USD100,000 per patient per annum The ASO R&D project will now also investigate: The use of AS3 as an antiviral treatment for patients co-infected with HBV and Hepatitis C Virus and/or Immunodeficiency Virus Type 1; The use of AS3 for the treatment of serious inflammatory disorders, such as non-alcoholic fatty liver disease and in Hepatocellular carcinoma, wherein the drug's biological target has been found to be substantially expressed in patients with poor outcomes; Evidence implicates a possible role for the Company's drug-target in the life cycle of Coronavirus strains, including those responsible for severe acute respiratory syndrome such as SARS- CoV-2, the causative agent of COVID-19. The Company will explore this further. Announcement • May 17
Resonance Health Limited Provides Update on Its Antisense Oligonucleotide R&D Project for Treating Liver Related Diseases Resonance Health Ltd. provided the following update on its Antisense Oligonucleotide ("ASO") R&D project for treating liver related diseases ("ASO R&D Project"). The ASO R&D Project is part of the Company's Molecular Medicine R&D workstream, which is led by Resonance Health's Dr. Sherif Boulos. The ASO R&D Project was initially announced on 25 May 2020. Over the past twelve months the Company has completed lead optimization and early preclinical testing of ASO compounds targeting a human (host) protein essential to the lifecycle of numerous human viruses, including the Hepatitis B Virus ("HBV"). Following the design and testing of over 40 different ASO compounds, the Company has selected a lead compound for the ASO project and has named the compound AS3 ("AS3"). In a preclinical cell model of HBV infection, AS3 demonstrated statistically significant viral suppression compared to a control ASO. Chronic Hepatitis B is estimated to affect 292 million people globally, including an estimated 230,000 Australians. Current life-long treatments do not eliminate HBV, and up to 40% of sufferers will develop serious clinical complications such as cirrhosis, liver failure and/or liver cancer. Aside from the human suffering, the annual healthcare cost of chronic HBV in the USA is estimated to be USD 100,000 per patient (U.S. Medicare figures, 2015; cited by Robert Gish MD, Medical Director of the Hepatitis B Foundation). ASO therapeutics fall under the broader molecular medicine study of ribonucleic acid ("RNA") and deoxyribonucleic acid ("DNA") molecules. ASO therapeutics have the benefits of high target specificity and potency. Recent advances in RNA therapeutics have made it possible to directly target the liver with ASO drugs, enabling the administration of lower therapeutic doses, at greater efficacy and, with an improved safety profile. In view of the positive data achieved, and given the commercial potential of the technology, the Board has decided to extend the Company's anti-viral testing program to include other important viral diseases. Additionally, the Company will investigate the application of AS3 in the treatment of important non-viral related human diseases linked to the company's drug target. Accordingly, the Company is expanding its Patent Cooperation Treaty ("PCT") patent filing to include these additional disease indications. The updated PCT patent filing is expected to be finalised this month. The next step in the commercialisation timeline for this project is a liver dosing study in humanised- liver mice which will commence this quarter. The Company looks forward to providing further updates as the ASO R&D Project progresses. Announcement • Feb 24
Resonance Health Ltd HepaFat-AI Receives CE Marking Resonance Health Ltd. announced that it has received CE mark for HepaFat-AI, the company's fully automated artificial intelligence ("AI") software that assesses liver fat (the "Device"). CE marking signifies that the Device is compliant with the requirements of Medical Device Directive 93/42/EEC for CE Marking and is registered for sale within the European Economic Area ("EEA"). The company obtained United States Food & Drug Administration ("FDA") clearance for the Device in December 2020, and Australian Therapeutic Goods Administration ("TGA") approval in February 2021. Collectively, these clearances allow the company to lawfully distribute and supply the Device into Australia, the EEA, and the United States of America (and their territories). HepaFat-AI automatically analyses magnetic resonance imaging ("MRI") datasets to assess liver fat in patients, providing doctors with a comprehensive, multi-metric solution for use in the assessment of individuals with confirmed or suspected fatty liver disease. HepaFat-AI assesses these images and provides the following information on the resultant patient report (a sample report can be seen in Annex A to this announcement): . NASH-CRN Steatosis Grading - HepaFat AI is the only regulatory cleared imaging technology capable of reporting a standardised steatosis grade that is substantially equivalent to a histopathologist NASH- CRN score. Steatosis grading until now has required a histopathological assessment of a patient's liver fat levels from a liver biopsy (this has previously been considered the gold standard for clinical assessment of liver fat); Proton Density Fat Fraction (PDFF) - Provides the commonly reported liver MR fat metric from imaging and spectroscopy. PDFF has been widely shown to correlate with the degree of hepatic steatosis, with a cut-off of 5% being indicative of non-alcoholic fatty liver disease ("NAFLD"); Volumetric Liver Fat Fraction (VLFF) - Provides an MR liver fat metric that correlates with hepatocyte macro-vesicular fat volume; Includes a Liver Fat Distribution Map for illustrative purposes. The treating physician can use this information to: monitor patients undergoing weight loss management; to screen the livers of live donors for transplant suitability; monitor patients with or suspected to have NAFLD or the more serious subtype, non-alcoholic steatohepatitis ("NASH"); drug induced fatty liver; pancreatic insufficiency. The company will market HepaFat-AI to radiologists and physicians involved in the routine clinical diagnosis and management of patients with confirmed or suspected fatty liver disease. Clinicians and radiologists will soon be able to access HepaFat-AI via Resonance Health's own cloud-based portal. The company is also assessing the use of radiology-based channel partners for direct route to market. HepaFat-AI will also be marketed to pharmaceutical companies engaged in NASH drug development due to the highly standardised and reproducible nature of the AI solution. As HepaFat-AI is validated for all the major MRI scanner makes and models, it is ideally suited for these purposes, particularly in NASH multi-center trials which require standardised workflows to ensure clinically meaningful data is generated. Moreover, as HepaFat-AI can deliver data in near real-time, investigators can respond rapidly if adaptive trial protocols are implemented, which is particularly advantageous in recently designed NASH studies. Additionally, HepaFat-AI's unique capability of reporting a `pathologist's equivalent' steatosis grade could help bridge the gap caused by the reportedly high screening failure rates (up to 50%) as evidenced by liver biopsy in patients recruited to NASH trials. The company has commenced investigating reimbursement for HepaFat-AI in the United States of America. Additional work in machine learning is continuing with the Company remaining focused on developing and deploying cutting-edge assistance tools for clinicians and radiologists for various disease states. Further updates will be provided as work progresses. Announcement • Feb 18
Resonance Health Ltd Receives Australian Therapeutic Goods Administration Approval for HepaFat-AI Resonance Health Ltd. announced that it has received Australian Therapeutic Goods Administration approval for HepaFat-AI, the company's fully automated artificial intelligence software that assesses liver fat. TGA approval means that the Device conforms to Australian regulatory requirements and is approved by the TGA for inclusion in the Australian Register of Therapeutic Goods ("ARTG") and allows the Company to lawfully supply the Device in Australia. The Company obtained United States Food & Drug Administration ("FDA") clearance for the Device in December 2020. HepaFat-AI automatically analyses magnetic resonance imaging ("MRI") datasets to assess liver fat in patients, providing doctors with a comprehensive, multi-metric solution for use in the assessment of individuals with confirmed or suspected fatty liver disease. HepaFat-AI assesses these images and provides the following information on the resultant patient report. NASH-CRN Steatosis Grading - HepaFat AI is the only regulatory cleared imaging technology capable of reporting a standardised steatosis grade that is substantially equivalent to a histopathologist NASH-CRN score. (Steatosis grading until now has required a histopathological assessment of a patient's liver fat levels from a liver biopsy - this has previously been considered the gold standard for clinical assessment of liver fat.) Proton Density Fat Fraction (PDFF) - Provides the commonly reported liver MR fat metric from imaging and spectroscopy. PDFF has been widely shown to correlate with the degree of hepatic steatosis, with a cut-off of 5% being indicative of non-alcoholic fatty liver disease. Volumetric Liver Fat Fraction (VLFF) - Provides an MR liver fat metric that correlates with hepatocyte macro-vesicular fat volume; Includes a Liver Fat Distribution Map for illustrative purposes. The treating physician can use this information to: monitor patients undergoing weight loss management; to screen the livers of live donors for transplant suitability; monitor patients with or suspected to have NAFLD or the more serious subtype, non-alcoholic steatohepatitis ("NASH"); drug induced fatty liver; pancreatic insufficiency. A number of clinical applications that may suit HepaFat-AI can be seen in Annex C of this announcement. With an estimated global prevalence of between 24-30%1, NAFLD affects up to 2.3 billion people, a figure expected to grow year-on-year. Of these, about 470 million people (or 20%) will develop NASH2, an inflammatory condition of the liver, of which an estimated 27% will develop serious fibrotic, disease increasing their risk of cirrhosis, cancer and liver failure3. Having surpassed viral hepatitis, NAFLD is now the leading cause of liver morbidity and mortality and the leading indicator for liver transplants in the US. It is predicted that over the next 10 years the healthcare costs associated with the management of NAFLD will exceed USD $1 trillion in the US and 334 billion in Europe (Germany, France, Italy, and the United Kingdom). The Company intends to market HepaFat-AI to radiologists and physicians involved in the routine clinical diagnosis and management of patients with confirmed or suspected fatty liver disease. Clinicians and radiologists will soon be able to access HepaFat-AI via Resonance Health's own cloud-based portal. The Company is also assessing the use of radiology-based channel partners for direct route to market. To this end, the Company has amended its existing agreement with channel partner Blackford Analysis Inc. (the "Agreement") entered into between Resonance Health and Blackford Analysis Inc. The Agreement allows Blackford's current and future customers' including their channel partners such as Intelerad and eRAD, access to HepaFat-AI and FerriSmart via the Blackford platform. HepaFat-AI is also intended to be marketed towards pharmaceutical companies engaged in NASH drug development due to the highly standardised and reproducible nature of the AI solution. As HepaFat-AI is validated for all the major MRI scanner makes and models, it is ideally suited for these purposes, particularly in NASH multi-center trials which require standardised workflows to ensure clinically meaningful data is generated. Moreover, as HepaFat-AI can deliver data in near real-time, investigators can respond rapidly particular if adaptive trial protocols implemented, a particular advantage when compared to current NASH studies. Additionally, HepaFat-AI's unique capability of reporting a `pathologists equivalent' steatosis grade could help bridge the gap caused by the reportedly high screening failure rates (up to 50%) as evidenced by liver biopsy in patients recruited to NASH trials5. The Company has commenced investigating reimbursement for HepaFat-AI in the United States of America. The Competent Authority (the medical device regulator in EU) decision on CE marking for the product is also pending. CE marking signifies that the Device is compliant with the requirements of Medical Device Directive 93/42/EEC for CE Marking and is registered for sale within the European Economic Area. Additional work in machine learning is continuing with the Company remaining focused on developing and deploying cutting-edge assistance tools for clinicians and radiologists for various disease states. Further updates will be provided as work progresses. Announcement • Dec 26
Resonance's HepaFat-AI Incorporated into Blackford Analysis Resonance Health Ltd. announced that its artificial intelligence medical device software, HepaFat-AI, has been added as a Resonance Health product available for distribution and promotion by Blackford Analysis Inc. under the Alliance Partner Agreement entered into between the Company and Blackford in 2018. HepaFat-AI recently received 510(k) regulatory clearance from the US Food and Drug Administration ("FDA") allowing for its commercial sale in the United States of America. HepaFat-AI is a fully automated artificial intelligence ("AI") fatty-liver assessment device that measures the volumetric liver fat fraction ("VLFF"), proton density fat fraction ("PDFF") and steatosis grade in individuals with confirmed or suspected fatty liver disease. When interpreted by a trained physician, the HepaFat-AI results can be used to monitor liver fat content in patients undergoing weight loss management, and to aid in the assessment and screening of living donors for liver transplant. Blackford delivers a dedicated platform and service for the effective selection, deployment, orchestration, and use of medical imaging applications and AI. This enables healthcare providers to quickly access and manage medical image analysis applications and AI algorithms that add clinical value. The Agreement allows Blackford's current and future customers access to HepaFat-AI and other Resonance Health products via the Blackford platform and their channel partners such as Intelerad and eRAD. The Company looks forward to continuing to work with the Blackford team to deliver service to radiologists. Is New 90 Day High Low • Dec 09
New 90-day high: AU$0.28 The company is up 93% from its price of AU$0.14 on 10 September 2020. The Australian market is up 14% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is up 12% over the same period. Announcement • Oct 06
Resonance Health Ltd Develops New Artificial Intelligence Tool for the Automated Review of Chest Computed Tomography Scans of Patients with Suspected Pulmonary Embolism Resonance Health Ltd. announced that it has developed a new artificial intelligence tool for the automated review of chest computed tomography scans of patients with suspected pulmonary embolism. This new product, named `ALERT-PE', has been produced by the Company's AI R&D workstream. Neural network training has been performed using datasets of the lungs provided via the collaboration with Perth Radiological Clinic. The Company advises that it has filed a Pre-Submission to the United States Food & Drug Administration to discuss the requirements for a potential future submission for FDA clearance of ALERT-PE. The Pre- Submission meeting is scheduled to take place in November 2020. A Pre-Submission is a process that includes a formal written request from a submitter for feedback from the FDA to guide product development and/or submission preparation prior to an intended premarket submission1. The Company considers that ALERT-PE is able to perform as an AI-based radiological computer-assisted triage and notification software for PE. It is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected PE pathologies, with the user presented with alert notifications for cases that have suspected PE findings. PE is part of the venous thromboembolism (VTE) spectrum, which ranges from asymptomatic deep vein thrombosis (DVT) to fatal PE, and is a blockage of the pulmonary arteries in the lungs caused by blood clots2. With at least 650,000 cases occurring annually, PE is the third most common cause of death in hospitalized patients. Autopsy studies have shown that approximately 60% of patients who have died in hospital had PE, with the diagnosis having been missed in up to 70% of the cases3. It is estimated that there are 1 million cases of VTE and over 500,000 hospital admissions in the United States, with annual costs exceeding an estimated 10 billion dollars2. With prompt treatment, medical intervention can be highly effective and it has been shown to greatly reduce the likelihood of death4. Symptoms and signs of PE are typically non-specific, when the pre-test probability is high (PE likely), imaging becomes the first-line test to confirm the existence of PE. CT Pulmonary Angiogram imaging is widely used for this purpose. It is sufficiently sensitive and specific to exclude the diagnosis of PE when it is negative and to confirm it when positive. As positive patient outcomes are extremely time sensitive, triage PE tools (such as ALERT-PE) may be very beneficial in drawing immediate attention to cases of suspected PE for medical specialists. Reported Earnings • Oct 03
Full year earnings released - AU$0.0017 loss per share Over the last 12 months the company has reported total losses of AU$715.1k, with earnings decreasing by AU$1.97m from the prior year. Total revenue was AU$3.67m over the last 12 months, up 1.2% from the prior year.