Announcement • Feb 16
Adherium Limited has filed a Follow-on Equity Offering in the amount of AUD 7.521143 million. Adherium Limited has filed a Follow-on Equity Offering in the amount of AUD 7.521143 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 446,396,488
Price\Range: AUD 0.003
Discount Per Security: AUD 0.00021
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,788,525,450
Price\Range: AUD 0.003
Discount Per Security: AUD 0.00021
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 272,125,608
Price\Range: AUD 0.003
Discount Per Security: AUD 0.00021
Transaction Features: Rights Offering; Subsequent Direct Listing New Risk • Dec 17
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 Risks Share price has been highly volatile over the past 3 months (20% average weekly change). Negative equity (-AU$4.8m). Shareholders have been substantially diluted in the past year (229% increase in shares outstanding). Revenue is less than US$1m (AU$817k revenue, or US$541k). Market cap is less than US$10m (AU$9.99m market cap, or US$6.61m). Announcement • Dec 09
Adherium Limited has completed a Follow-on Equity Offering in the amount of AUD 0.35104 million. Adherium Limited has completed a Follow-on Equity Offering in the amount of AUD 0.35104 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 66,208,082
Price\Range: AUD 0.005
Discount Per Security: AUD 0.0003
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 4,000,000
Price\Range: AUD 0.005
Discount Per Security: AUD 0.0003
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing Announcement • Oct 21
Adherium Limited, Annual General Meeting, Nov 18, 2025 Adherium Limited, Annual General Meeting, Nov 18, 2025. Reported Earnings • Oct 05
Full year 2025 earnings released: AU$0.017 loss per share (vs AU$0.028 loss in FY 2024) Full year 2025 results: AU$0.017 loss per share. Revenue: AU$817.2k (down 2.8% from FY 2024). Net loss: AU$12.7m (loss widened 24% from FY 2024). Announcement • Sep 16
Adherium's Hailie Smartinhaler Chosen for Groundbreaking iCARE Study Preliminary results from a groundbreaking and transformational real-world study by Adherium Limited – together with research from Intermountain Health, a leading nonprofit health system based in Salt Lake City and CareCentra, an AI-driven prevention-as-a-service remote monitoring platform – has resulted in significant positive clinical outcomes, including record adherence rates and consistent engagement with chronic obstructive pulmonary disease (COPD) and asthma patients. Researchers say results of the iCARE study ('the Study') are promising and may redefine what is possible in COPD and asthma care. The iCARE study included the supply of 4,000 Hailie® Smartinhalers®, supporting up to 2,500 COPD and asthma patients across five Intermountain Health facilities over two years. This underscores both the scale of the program and the early commercial adoption of Adherium's suite of Hailie® devices. Analysis of the nearly 850 Intermountain Health patients enrolled in the iCARE program for the Study, of which more than 9 out of 10 remain active participants, demonstrated exciting results. Among important findings, adherence was evaluated in a subset of patients with connected controller inhalers and at least 30 days of inhalation data. Across this group, the typical patient used their inhaler as prescribed nearly two-thirds of the time, far higher than the roughly one-in-five times typically reported in these populations, making this one of the strongest independent, real-world adherence outcomes recorded in chronic respiratory care. Nearly four in ten patients reached the critical threshold of greater than 80% adherence, a level long associated with nearly 50% fewer respiratory attacks. This closes one of the largest historical gaps in respiratory management unlocking value for patients, providers, payers, and investors alike. Separately, analysis of nearly 700 patients demonstrated clinically meaningful improvements across multiple dimensions of respiratory care including reductions in inpatient admissions, 30-day readmissions, and average length of stay; lower reliance on rescue medications; resulting in decreases in overall cost of care. The iCARE program also demonstrated 54% persistence ("stickiness") among active users of the CareCentra remote monitoring platform, calculated over a 14-month period. Engagement tended to be highest in older patients, who are the least likely to adopt or sustain digital health interventions. These patients also represent the highest-cost segment of the healthcare system, resulting in most hospitalizations and readmissions. Compared to the 30–45% persistence typically reported in behavior-change programs, iCARE's stickiness results indicate that even the most vulnerable patients are consistently engaging, highlighting the unique impact of iCARE. Final long-term loyalty data will be released in due course, but these statistically significant persistence results already serve as a leading indicator of iCARE's ability to sustain engagement over time and deliver enduring value for patients, payers, and health systems. Together, these shifts demonstrate iCARE's potential to fundamentally bend the cost curve in respiratory disease management—an outcome highly aligned with payer priorities in both U.S. and Australian markets. Reported Earnings • Aug 30
Full year 2025 earnings released: AU$0.014 loss per share (vs AU$0.028 loss in FY 2024) Full year 2025 results: AU$0.014 loss per share. Revenue: AU$817.2k (down 2.8% from FY 2024). Net loss: AU$12.7m (loss widened 24% from FY 2024). Announcement • Aug 04
Adherium Limited has filed a Follow-on Equity Offering in the amount of AUD 0.35104 million. Adherium Limited has filed a Follow-on Equity Offering in the amount of AUD 0.35104 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 66,208,082
Price\Range: AUD 0.005
Discount Per Security: AUD 0.0003
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 4,000,000
Price\Range: AUD 0.005
Discount Per Security: AUD 0.0003
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing New Risk • Jul 17
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 83% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (26% average weekly change). Shareholders have been substantially diluted in the past year (83% increase in shares outstanding). Revenue is less than US$1m (AU$964k revenue, or US$626k). Market cap is less than US$10m (AU$9.71m market cap, or US$6.30m). New Risk • Jul 04
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 18% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (24% average weekly change). Revenue is less than US$1m (AU$964k revenue, or US$632k). Market cap is less than US$10m (AU$4.49m market cap, or US$2.94m). Minor Risk Shareholders have been diluted in the past year (18% increase in shares outstanding). Announcement • Jun 24
Adherium Limited has filed a Follow-on Equity Offering in the amount of AUD 4 million. Adherium Limited has filed a Follow-on Equity Offering in the amount of AUD 4 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 600,000,000
Price\Range: AUD 0.005
Discount Per Security: AUD 0.0003
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 200,000,000
Price\Range: AUD 0.005
Discount Per Security: AUD 0.0003
Security Features: Attached Options
Transaction Features: Rights Offering Reported Earnings • Mar 04
First half 2025 earnings released: AU$0.008 loss per share (vs AU$0.014 loss in 1H 2024) First half 2025 results: AU$0.008 loss per share. Revenue: AU$500.3k (up 33% from 1H 2024). Net loss: AU$5.78m (loss widened 24% from 1H 2024). Revenue is forecast to grow 105% p.a. on average during the next 3 years, compared to a 23% growth forecast for the Healthcare Services industry in Australia. New Risk • Mar 01
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$11m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$11m free cash flow). Share price has been highly volatile over the past 3 months (21% average weekly change). Shareholders have been substantially diluted in the past year (124% increase in shares outstanding). Revenue is less than US$1m (AU$964k revenue, or US$598k). Market cap is less than US$10m (AU$8.23m market cap, or US$5.11m). Board Change • Mar 01
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. 3 highly experienced directors. Executive Chairman of the Board Lou Panaccio was the last director to join the board, commencing their role in 2022. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Oct 08
Adherium Limited, Annual General Meeting, Nov 15, 2024 Adherium Limited, Annual General Meeting, Nov 15, 2024. Location: offices of k&l gates, level 25, rialto south tower, 525 collins street, melbourne, vic 3000, melbourne Australia Reported Earnings • Oct 04
Full year 2024 earnings released: AU$0.014 loss per share (vs AU$0.036 loss in FY 2023) Full year 2024 results: AU$0.014 loss per share. Revenue: AU$841.0k (down 74% from FY 2023). Net loss: AU$10.2m (loss widened 3.7% from FY 2023). Revenue is forecast to grow 87% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Healthcare Services industry in Australia. New Risk • Apr 19
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.1% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$9.8m free cash flow). Market cap is less than US$10m (AU$9.86m market cap, or US$6.33m). Minor Risks Share price has been volatile over the past 3 months (14% average weekly change). Shareholders have been diluted in the past year (2.1% increase in shares outstanding). Revenue is less than US$5m (AU$2.4m revenue, or US$1.5m). New Risk • Mar 01
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$9.8m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$9.8m free cash flow). Share price has been highly volatile over the past 3 months (25% average weekly change). Market cap is less than US$10m (AU$14.0m market cap, or US$9.10m). Minor Risk Revenue is less than US$5m (AU$2.4m revenue, or US$1.5m). New Risk • Jan 31
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: AU$15.0m (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 Share price has been highly volatile over the past 3 months (33% average weekly change). Market cap is less than US$10m (AU$15.0m market cap, or US$9.87m). Minor Risks Less than 1 year of cash runway based on current free cash flow (-AU$9.3m). Revenue is less than US$5m (AU$3.2m revenue, or US$2.1m). New Risk • Oct 30
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: AU$15.0m (US$9.55m) 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 Less than 1 year of cash runway based on free cash flow trend (-AU$9.3m free cash flow). Share price has been highly volatile over the past 3 months (26% average weekly change). Market cap is less than US$10m (AU$15.0m market cap, or US$9.55m). Minor Risks Shareholders have been diluted in the past year (4.5% increase in shares outstanding). Revenue is less than US$5m (AU$3.2m revenue, or US$2.0m). Announcement • Oct 27
Adherium Limited, Annual General Meeting, Nov 30, 2023 Adherium Limited, Annual General Meeting, Nov 30, 2023, at 11:01 AUS Eastern Standard Time. Location: Offices of K&L Gates Level 25, Rialto South Tower, 525 Collins Street Melbourne Victoria Australia Agenda: To consider Adoption of Remuneration Report; Re-Election of Jeremy Curnock Cook as a Director; Election of Mr Bruce McHarrie as a Director; Approval of additional 10% Placement Facility; Approval of the Employee Securities Incentive Plan; and to discuss other matters. Reported Earnings • Aug 31
Full year 2023 earnings released: AU$0.002 loss per share (vs AU$0.005 loss in FY 2022) Full year 2023 results: AU$0.002 loss per share (improved from AU$0.005 loss in FY 2022). Revenue: AU$3.20m (up AU$2.67m from FY 2022). Net loss: AU$9.86m (loss narrowed 1.9% from FY 2022). Over the last 3 years on average, earnings per share has increased by 86% per year but the company’s share price has fallen by 48% per year, which means it is significantly lagging earnings. New Risk • Aug 31
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$9.3m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$9.3m free cash flow). Share price has been highly volatile over the past 3 months (28% average weekly change). Shareholders have been substantially diluted in the past year (124% increase in shares outstanding). Minor Risks Revenue is less than US$5m (AU$3.2m revenue, or US$2.1m). Market cap is less than US$100m (AU$22.5m market cap, or US$14.5m). New Risk • Aug 30
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 Risks Share price has been highly volatile over the past 3 months (28% average weekly change). Earnings have declined by 0.9% per year over the past 5 years. Shareholders have been substantially diluted in the past year (124% increase in shares outstanding). Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Revenue is less than US$5m (AU$1.6m revenue, or US$1.0m). Market cap is less than US$100m (AU$20.0m market cap, or US$13.0m). New Risk • Aug 17
New major risk - Revenue size The company makes less than US$1m in revenue. Total revenue: AU$1.6m (US$997k) This is considered a major risk. Companies with a small amount of revenue 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 Share price has been highly volatile over the past 3 months (27% average weekly change). Earnings have declined by 0.9% per year over the past 5 years. Shareholders have been substantially diluted in the past year (126% increase in shares outstanding). Revenue is less than US$1m (AU$1.6m revenue, or US$997k). Minor Risk Market cap is less than US$100m (AU$20.0m market cap, or US$12.8m). Announcement • Jul 06
Adherium Limited Announces Resignation of Mark Licciardo as Joint Company Secretary Adherium Limited announced the resignation of Mark Licciardo as joint company secretary. The company thanks Mr. Licciardo for his contribution to the company in this role over the past seven years. Mr. Brett Tucker remains as the sole company secretary. Announcement • May 05
Adherium Limited Announces Executive Changes Adherium Limited announced the appointment of Brett Tucker as Company Secretary following the resignation of Rob Turnbull. Mr. Tucker holds a Bachelor of Commerce from the University of Western Australia and has completed the Chartered Accountant program. With over 10 years' experience in governance and equity capital markets, he has been a company secretary for numerous ASX listed and unlisted public & private companies across a range of industries, including technology and healthcare. Announcement • Jan 21
Adherium Limited Commences Production and Market Release of the New, Next Generation Ellipta Sensor Adherium Limited announced that it has commenced production and market release of the new, next generation Hailie® sensors with physiologicalparameters connecting GlaxoSmithKline (GSK) ELLIPTA® inhalers for monitoring Asthma and Chronic Obstructive Pulmonary Disease (COPD). This product rollout adds to Adherium's growing Hailie sensor portfolio in the market with US FDA 510(k) clearances. Adherium offers the only 510(k) cleared sensor on the market with respiratory flow rate data and adherence tracking feedback at the time of medication use. Announcement • Jan 20
Adherium Limited Receives Australian Therapeutic Goods Administration Approval for Next Generation Sensors Adherium Limited announced receiving Australian Therapeutic Goods Administration (TGA) approval to commercially distribute its new, next generation Hailie® sensors with physiological parameters. These latest additions to the Hailie sensor product family connect patients with GlaxoSmithKline (GSK) pMDIs (Ventolin®, Advair®, Flovent®), GSK Ellipta® DPI's (Breo®, Anoro®, Incruse®, Trelegy® and Arnuity®), and AstraZeneca's Symbicort® pMDI inhaler medications. Hailie sensors are intended for single-patient multiple use as an electronic data capture accessory for monitoring and recording actuation and other parameters, including inspiratory flow of prescribed inhaler usage and inhaler technique. As the sensor may be used in clinical trials, in patient self-management and by doctors and healthcare providers for patient care, these applications will be the focus of commercial opportunities in the Australian market. Announcement • Nov 30
Adherium Announces James Ward-Lilley Step Down from the Board Adherium Limited announced Mr. James Ward-Lilley is stepping down from the Adherium Board based on his full-time executive commitments as Chief Commercial Officer at the Aerogen Group. Announcement • Nov 28
Adherium Limited Receives U.S. FDA 510(k) Clearance for GSK pMDI Inhaler Users to Remotely Monitor Physiological Parameters Adherium Limited announced that is has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market application, connecting GlaxoSmithKline's (GSK) Ventolin®, Advair®, and Flovent® pressurised metered dose inhaler (pMDI) users with its new, next generation Hailie® sensor with physiological parameters. With these 510(k) market clearances and an integrated and highly scalable digital platform allowing multiple data inputs, Adherium is well positioned to offer a single- source customer solution to capitalise on remote patient monitoring opportunities. As shown in the attached competitive analysis graphic, with this Hailie for GSK pMDI 510(k) clearance together with the Ellipta 510(k) clearance received earlier this year, Adherium progressed from covering U.S. top 20 branded inhaler medications by sales volume as follows: 91% up from 71% in 2021 for adherence usage remote patient monitoring enabling access by healthcare providers for the US Centers for Medicare and Medicaid Services (CMS) Remote Therapeutic Monitoring reimbursement codes, 51% up from 11% in 2021 to be the clear market leader with physiological parameter sensors enabling the CMS Remote Physiological Monitoring reimbursement codes. Using Adherium's drug agnostic platform, doctors and healthcare partners always own the medication decision and receive the data and insights for improving patient care without changing a patient's prescriptions. These new generation devices provide superior data and insights into patient inhaler technique and usage giving healthcare providers immediate, real-time feedback enabling physicians to enhance patient care by capturing clinical data supporting patient management and treatment. Adherium's broad medication market coverage makes possible a total patient view with digital sensor technology applied in a combined monitoring of both maintenance and reliever (rescue) medications. A recently published clinical study demonstrates digital physiological sensors can predictimpending asthma exacerbation within 5 days prior to the start of the event. Announcement • Oct 05
Adherium Limited, Annual General Meeting, Nov 29, 2022 Adherium Limited, Annual General Meeting, Nov 29, 2022. Announcement • Sep 21
Adherium Limited Appoints Daniel Kaplon as Chief Financial Officer, Effective 10 October 2022 Adherium Limited announced the appointment of Mr. Daniel Kaplon as Chief Financial Officer, effective 10 October 2022. Daniel Kaplon will be based in Melbourne and report directly to Mr. Legleiter. Reported Earnings • Sep 02
Full year 2022 earnings released: AU$0.005 loss per share (vs AU$0.017 loss in FY 2021) Full year 2022 results: AU$0.005 loss per share (up from AU$0.017 loss in FY 2021). Net loss: AU$11.2m (loss narrowed 25% from FY 2021). Over the last 3 years on average, earnings per share has increased by 71% per year but the company’s share price has fallen by 35% per year, which means it is significantly lagging earnings. Announcement • Aug 25
Adherium Limited Submits FDA 510(K) Application for Next Generation Hailie Sensor for Teva MDI Inhalers Adherium Limited announced submission to the US Food and Drug Administration (FDA) of its 510(k) clearance to market application, which connects Teva ProAir® and Teva Albuterol Sulphate HFA metered dose inhalers with its new, next-generation Hailie® sensor with physiological parameters such as respiratory flow rate in litres per minute for remote monitoring of patients with Asthma and COPD. Following sensor applications for AstraZeneca's Symbicort®, GSK's Ellipta® and, most recently, GSK's pressurized metered dose inhalers (pMDI), this 510(k) submission for the next-generation Hailie sensor is the fourth in a series of new sensors. Delivering on the Company's commercial strategy and achieving product roadmap milestones, this new sensor series provides a superior perspective into inhaler usage and technique giving patients and doctors real-time feedback for improving patient care and treatment and reducing the cost burden on healthcare systems. The ongoing support from the United States Centers for Medicare & Medicaid Services (CMS) in advocating for smart medicine by providing two reimbursement code options for remote patient monitoring advances Adherium's path toward value-based care. Currently, for the top 20 US branded inhaler medications, Adherium's 510(k) clearances cover 91% of the market for inhaler usage enabling doctors access for the CMS Remote Therapeutic Monitoring reimbursement codes (up from 71% last year) and 32% of the market for enabling Remote Physiological Monitoring reimbursement codes (up from 11% last year). Adherium's drug agnostic platform is uniquely positioned allowing doctors to keep patients on existing medications while receiving valuable data and insights, tracking medication usage and thereby guiding clinical care. Announcement • Aug 02
Adherium Limited Submits US FDA Application for Hailie for GSK pMDI inhalers Adherium Limited announced submission to the US Food and Drug Administration (FDA) of its 510(k) clearance to market application, which connects GlaxoSmithKline® (GSK) Ventolin®, Advair®, and Flovent® pressurized metered-dose inhaler (pMDI) users with its new, next generation Hailie® sensor with physiological measures, for monitoring Asthma and COPD medication use. This 510(k) submission for the next-generation Hailie sensor, the third in a series of new sensors following AstraZeneca® Symbicort® pMDI inhaler and GSK's Ellipta, is designed to capture physiological parameters such as respiratory flow rate in litres per minute. Adherium has 510(k) clearances for 91% of the US top 20 branded inhalers for adherence usage enabling the Remote Therapeutic Monitoring (RTM) reimbursement codes, and 32% coverage for physiological parameters enabling the Remote Physiological Monitoring (RPM) reimbursement codes. This broad market coverage makes possible a total patient view to improve their quality of life with combinedassessment of both reliever (rescue) and maintenance treatments. The combined data and insights help doctors understand a patient's degree of adherence and symptom control which a single device approach will not provide. A recently published clinical study demonstrates digital physiological sensors measuring inhalation parameters can predict impending Asthma exacerbation within 5 days prior to the start of the event. Announcement • Jul 25
Adherium Limited Receives U.S. Food and Drug Administration Clearance for Hailie for Ellipta Adherium Limited announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market application connecting GlaxoSmithKline's (GSK) Ellipta® inhaler users with Adherium's new, next generation Hailie® sensor with physiological parameters for monitoring Asthma and COPD medication use. Following market clearance of the Hailie sensor with physiological parameters for AstraZeneca's Symbicort® pMDI inhaler, Adherium's latest Hailie sensor is designed for use with the Breo®, Anoro®, Incruse®, Trelegy® and Arnuity® Ellipta dry powder inhalers (DPIs), and captures physiological parameters, including inhalation duration, volume, and peak inhalation flow. This new series of devices provide a superior perspective into inhaler usage and technique giving patients and doctors immediate, real-time feedback thereby allowing patients to improve their quality of life and enabling physicians to enhance patient care by capturing clinical data supporting patient management and treatment. Adherium continues its global expansion strategy to extend its digital technological innovations to enable reimbursement on 18 of the top 20 US branded inhaler medications in CY23. As shown in the attached competitive analysis graphic, with this Hailie for Ellipta 510(k) clearance, Adherium progressed from covering 71% to 91% of the top 20 branded inhaler medications for adherence usage parameters enabling access by healthcare providers for the Remote Therapeutic Monitoring (RTM) reimbursement codes and progressed from 11% to 32% coverage for physiological parameters enabling the Remote Physiological Monitoring (RPM) reimbursement codes. Using Adherium's drug agnostic platform, doctors and healthcare partners always own the medication decision and receive the data and insights for improving patient care without changing prescriptions. Announcement • May 30
Adherium Limited Announces Conclusion of Robert Spurr's Assignment as Interim CFO Adherium Limited announced that Robert Spurr's interim CFO assignment has concluded and recruiting for the backfill of this Melbourne-based position is progressing. Announcement • Apr 28
Adherium Limited Releases Next Gen Platform Integration Services Adherium announced the release of the latest Hailie platform integration tools comprised of an advanced Rest application programming interface (API) and a new, updated software development kit (SDK) to improve connection with partner and customer patient management systems. Both tools represent important software milestone achievements on product development roadmap. In the latest platform release, Hailie's Rest Application programming interface (API) and software development kit (SDK) integration services enable Adherium to securely connect with partner and customer patient management and medical records systems, as well as enabling Hailie sensors to be integrated directly with third-party clinical applications via the SDK. This release of the next generation of integrated infrastructure as shown in the Appendix extends Adherium's interoperability capabilities and integration with disease management and clinical trial customers with the Hailie platform. improving the usability of Hailie sensors, Apps and platform for customers and partners. Further good progress against planned portfolio roadmap has already expanded market coverage from 56% in 2021 to 71% of the top 20 US branded medications. New physiological enabled sensors and software coupled with expanded US reimbursement with the new 2022 CMS1 Remote Therapeutic Monitoring (RTM) code set and the US respiratory medication market shares shifts are both favourable trends and positive proof points for Adherium. Announcement • Mar 07
Adherium Limited Submits US FDA 510(k) Application for Ellipta Inhaler Users to Connect to Hailie Platform with Physiological Parameters Adherium Limited announced the submission to the U.S. Food and Drug Administration (FDA) of a 510(k) clearance to market application to connect Ellipta® inhaler users with its new, next generation Hailie® sensor with physiological parameters for monitoring Asthma and COPD medication use. Adherium's latest Hailie sensor, designed for use with the GlaxoSmithKline (GSK) Ellipta® dry powder inhaler (DPI), is the second in Adherium's series of new sensors, following AstraZeneca's Symbicort® pMDI inhaler, specifically designed to capture physiological parameters such as respiratory flow rate in litres per minute. This additional information and reporting adherence provides a new, never before available window into inhaler usage and technique giving patients immediate feedback and promoting greater engagement with the Hailie phone app. Recording inhaler adherence and physiological parameters also empowers the patient-physician relationship with remote, automated and objective data to guide patient care and support patient management. Ellipta's addition to the Hailie range of products will broaden the pathway for Adherium's customers in the U.S. to access reimbursement for remote monitoring of patients prescribed Asthma and COPD medications. Announcement • Feb 25
Adherium Limited Announces Board Changes Adherium Limited announced the appointment of Mr. Lou Panaccio as a Non-executive director of Adherium with Mr. Matthew McNamara stepping down as a Non-executive Director. Announcement • Feb 11
Adherium Limited Announces That Manufacturing Started for Hailie® for Symbicort® Sensors with Physiological Parameters Adherium Limited announced it has completed the first production run of the next generation Hailie® sensors with physiological parameters for monitoring Asthma and Chronic Obstructive Pulmonary Disease (COPD) medication use. Adherium's newest FDA 510(k) cleared Hailie for Symbicort sensor, which was engineered specifically for use with AstraZeneca's market leading aerosol inhaler, has commenced manufacturing and completed the first production run at its contract manufacturing partner facility in SE Asia. United States Centers for Medicare & Medicaid Services (CMS) reimbursement under the Remote Physiologic Monitoring CPT® codes encourages and financially supports the market adoption of technological innovation in digital health. The addition of physiological parameters to the Hailie range of products enhances the opportunity for remote patient monitoring services. This is especially valuable when managing severe, uncontrolled and difficult to treat Asthma and COPD patients. This U.S. patient group is estimated to represent a total addressable market of USD 1.5 billion. The Hailie for Symbicort sensor with physiological parameters is the first in a series of devices specifically designed to enable physicians and providers to improve patient care and clinical workflow by capturing advanced data supporting patient management and treatment. In addition to Hailie sensors, Adherium's product portfolio goes beyond medical devices to include an integrated digital platform comprised of the Hailie apps, online interface portals, third-party software interface architecture, data management and analytics cloud. The Company is continuing to invest in advanced development, updates and enhancements of the digital infrastructure required of a respiratory digital health leader. Announcement • Jun 01
Adherium Submits US FDS 510(k) Application for Next Generation Hailie Sensor with Physiological Measures Adherium Limited announced submission to the US Food and Drug Administration (FDA) of a 510(k) clearance to market application for its first next generation Hailie® sensor with physiological measures for monitoring Asthma and COPD medication use. Adherium's latest Hailie® sensor, designed for use with AstraZeneca's Symbicort® aerosol inhaler, is the first in a series of devices specifically designed to enable physicians and providers to enhance patient care and clinical workflow by capturing clinical data and supporting patient management. This addition to the Hailie® range of products will allow access to reimbursement in the US for the remote monitoring of patients. Announcement • May 01
Respiri Limited (ASX:RSH) made an offer to acquire Adherium Limited (ASX:ADR) from BioScience Managers Translation Fund I and IB Asia Pacific Healthcare Fund II managed by Bioscience Managers Pty Ltd, Regal Funds Management Pty Limited, Trudell Medical Limited, HSBC Custody Nominees (Australia) Limited, Citicorp Nominees Pty Ltd and other shareholders for AUD 15.2 million. Respiri Limited (ASX:RSH) made an offer to acquire Adherium Limited (ASX:ADR) from BioScience Managers Translation Fund I and IB Asia Pacific Healthcare Fund II managed by Bioscience Managers Pty Ltd, Regal Funds Management Pty Limited, Trudell Medical Limited, HSBC Custody Nominees (Australia) Limited, Citicorp Nominees Pty Ltd and other shareholders for AUD 15.2 million on April 29, 2021. Under the terms, Adherium shareholders will receive 1 Respiri Limited share for every 7 of your Adherium Limited shares. Where all outstanding Adherium Shares are acquired as part of the Offer, Adherium Shareholders would collectively hold 29.6% shareholding of the Combined Group. The Offer is subject to a number of Conditions, including a minimum acceptance condition of 50.1%; Adherium not acquiring or disposing of significant assets or entering into any significant transaction; Adherium not declaring a distribution. If, in connection with or following the Offer, Respiri acquires between 90% and 100% of the Adherium Shares, Respiri may be entitled to compulsorily acquire the remaining shares of the Adherium Shareholders. BDO Australia acted as financial advisor and Gadens acted as legal advisor to Respiri Limited. As of April 30, 2021, Adherium shareholders are advised to TAKE NO ACTION in respect of the Respiri Offer until the Adherium Board makes a formal recommendation to shareholders. The fee for professional services paid or payable to BDO Australia as financial advisor to Respiri is up to AUD 450,000. The fee for professional services paid or payable to Gadens as Australian legal adviser is up to AUD 85,000. Computershare Investor Services Pty Limited acted as registrar to Respiri. Announcement • Mar 19
Adherium Limited announced that it expects to receive AUD 3 million in funding from Trudell Medical Limited, Bioscience Managers Pty Ltd Adherium Limited (ASX:ADR) announced a private placement of 200,000,000 common shares at a price of AUD 0.015 each for gross proceeds of AUD 3,000,000 on March 18, 2021. The transaction will include participation from BioScience Managers Translation Fund I, a fund managed by Bioscience Managers Pty Ltd. and Trudell Medical Limited for The company will receive funding in tranches. The first tranche is expected to close on March 24, 2021 and second tranche expected to close on May 21, 2021subject to the approval of the shareholders at extraordinary general meeting. Executive Departure • Jan 29
Independent Non-Executive Director has left the company On the 29th of January, Bryan Mogridge's tenure as Independent Non-Executive Director ended after 5.5 years in the role. As of September 2020, Bryan personally held 10.60m shares (AU$318k worth at the time). A total of 2 executives have left over the last 12 months. Announcement • Sep 08
Adherium Limited Auditor Raises 'Going Concern' Doubt Adherium Limited filed its Annual on Aug 28, 2020 for the period ending Jun 30, 2020. In this report its auditor, PricewaterhouseCoopers LLP, gave an unqualified opinion expressing doubt that the company can continue as a going concern.