New Risk • Apr 10
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 18% 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 (18% average weekly change). Shareholders have been substantially diluted in the past year (102% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (AU$23.1m market cap, or US$16.3m). Announcement • Dec 19
TrivarX Limited has completed a Follow-on Equity Offering in the amount of AUD 4.2 million. TrivarX Limited has completed a Follow-on Equity Offering in the amount of AUD 4.2 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 87,274,663
Price\Range: AUD 0.008
Discount Per Security: AUD 0.00048
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 437,725,337
Price\Range: AUD 0.008
Discount Per Security: AUD 0.00048
Transaction Features: Subsequent Direct Listing Announcement • Oct 27
TrivarX Limited has completed a Follow-on Equity Offering in the amount of AUD 0.698197 million. TrivarX Limited has completed a Follow-on Equity Offering in the amount of AUD 0.698197 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 87,274,663
Price\Range: AUD 0.008
Discount Per Security: AUD 0.00048
Transaction Features: Subsequent Direct Listing Announcement • Oct 16
TrivarX Limited has filed a Follow-on Equity Offering in the amount of AUD 0.698197 million. TrivarX Limited has filed a Follow-on Equity Offering in the amount of AUD 0.698197 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 87,274,663
Price\Range: AUD 0.008
Discount Per Security: AUD 0.00048
Transaction Features: Subsequent Direct Listing Announcement • Sep 26
TrivarX Limited, Annual General Meeting, Nov 21, 2025 TrivarX Limited, Annual General Meeting, Nov 21, 2025. Location: at the companys registered office, at 647 beaufort street, mount lawley, Australia New Risk • Aug 30
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$2.3m 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$2.3m free cash flow). Shareholders have been substantially diluted in the past year (36% increase in shares outstanding). Revenue is less than US$1m (AU$1.1m revenue, or US$739k). Market cap is less than US$10m (AU$5.89m market cap, or US$3.85m). Minor Risk Share price has been volatile over the past 3 months (18% average weekly change). Announcement • May 20
TrivarX Limited has completed a Follow-on Equity Offering in the amount of AUD 2.25 million. TrivarX Limited has completed a Follow-on Equity Offering in the amount of AUD 2.25 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 102,818,898
Price\Range: AUD 0.015
Discount Per Security: AUD 0.0009
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 47,181,102
Price\Range: AUD 0.015
Discount Per Security: AUD 0.0009
Transaction Features: Subsequent Direct Listing New Risk • Mar 22
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 16% 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 (16% average weekly change). Shareholders have been substantially diluted in the past year (38% increase in shares outstanding). Market cap is less than US$10m (AU$5.60m market cap, or US$3.51m). Minor Risk Revenue is less than US$5m (AU$2.0m revenue, or US$1.3m). Announcement • Mar 17
TrivarX Limited has filed a Follow-on Equity Offering in the amount of AUD 2.25 million. TrivarX Limited has filed a Follow-on Equity Offering in the amount of AUD 2.25 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 102,818,898
Price\Range: AUD 0.015
Discount Per Security: AUD 0.0009
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 47,181,102
Price\Range: AUD 0.015
Discount Per Security: AUD 0.0009
Transaction Features: Subsequent Direct Listing New Risk • Jan 29
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 16% 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 Less than 1 year of cash runway based on free cash flow trend (-AU$4.0m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Earnings have declined by 2.4% per year over the past 5 years. Shareholders have been substantially diluted in the past year (38% increase in shares outstanding). Revenue is less than US$1m (AU$889k revenue, or US$556k). Market cap is less than US$10m (AU$9.30m market cap, or US$5.81m). New Risk • Jan 16
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 38% 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 Less than 1 year of cash runway based on free cash flow trend (-AU$4.0m free cash flow). Earnings have declined by 2.4% per year over the past 5 years. Shareholders have been substantially diluted in the past year (38% increase in shares outstanding). Revenue is less than US$1m (AU$889k revenue, or US$554k). Market cap is less than US$10m (AU$7.90m market cap, or US$4.92m). Minor Risk Share price has been volatile over the past 3 months (16% average weekly change). Announcement • Oct 09
TrivarX Limited, Annual General Meeting, Nov 28, 2024 TrivarX Limited, Annual General Meeting, Nov 28, 2024. Location: 647 beaufort street, mount lawley, western australia., western australia. Australia Announcement • Sep 25
TrivarX Limited Appoints John H. Mathias II as Non-Executive Director, Effective 1 October 2024 TrivarX Limited announced that it has strengthened the composition of its Board with the appointment of Mr. John H. Mathias II as a Non-executive Director, effective 1 October 2024. Mr. Mathias is an accomplished healthcare focused operations and business development executive, with a clinical background in respiratory care. He has a demonstrated track record of success over a 30-year career in the US healthcare industry. Currently, he holds the role of Chief Development Officer at Medbridge Healthcare. MedBridge also has a number of professional partnerships that support adjacent services including hospital readmission reduction programs (HRRP), product and drug research, occupational health, professional services and therapeutic sleep offerings. As CDO, he plays a central role in building partnerships with stakeholders across the US healthcare system in the field of sleep medicine including hospitals, medical research institutions, clinical partnerships, and insurance companies. Prior to his role as CDO, Mr. Mathias also served as Chief Operating Officer and President of Sleep Services of America Inc., an entity of Johns Hopkins Health System, where he managed operations for sleep diagnostics and therapeutic coordination, oversaw strategic M&A and led a business turnaround which returned the division to profitability. Throughout his career, Mr. Mathias has been recognised for building and leading high-performing healthcare managers and sales teams and implementing strategic business plans to drive consistent growth in revenue and margin levels. With direct experience across several US healthcare industries, his core areas of expertise include contract management services for sleep and respiratory services, along with acute care hospital operations and developing improved patient solutions in the aged care industry. Mr. Mathias' appointment provides the Board with additional depth and expertise as it moves from clinical development towards regulatory approval and commercialisation for its proprietary MEB-001 algorithm with the effective screening of a current Major Depressive Episode (cMDE) in the US market. Announcement • May 02
TrivarX Limited has filed a Follow-on Equity Offering in the amount of AUD 2.5 million. TrivarX Limited has filed a Follow-on Equity Offering in the amount of AUD 2.5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 70,970,745
Price\Range: AUD 0.025
Discount Per Security: AUD 0.0015
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 29,029,255
Price\Range: AUD 0.025
Discount Per Security: AUD 0.0015
Transaction Features: Subsequent Direct Listing Announcement • Oct 06
Medibio Limited, Annual General Meeting, Nov 29, 2023 Medibio Limited, Annual General Meeting, Nov 29, 2023, at 09:00 W. Australia Standard Time. Location: COMO The Treasury, Executive Boardroom, 1 Cathedral Avenue, Perth WA 6000 Australia Reported Earnings • Oct 02
Full year 2023 earnings released: AU$0.001 loss per share (vs AU$0.006 loss in FY 2022) Full year 2023 results: AU$0.001 loss per share (improved from AU$0.006 loss in FY 2022). Net loss: AU$3.07m (loss narrowed 76% from FY 2022). Over the last 3 years on average, earnings per share has fallen by 9% per year but the company’s share price has fallen by 49% per year, which means it is performing significantly worse than earnings. Announcement • Sep 06
Medibio Limited, Annual General Meeting, Oct 06, 2023 Medibio Limited, Annual General Meeting, Oct 06, 2023, at 10:00 W. Australia Standard Time. Location: COMO The Treasury, Executive Boardroom, 1 Cathedral Avenue Perth, WA 6000 Perth WA 6000 Australia Agenda: To consider share issue to Mr. David Trimboli and to Mr. Christopher Ntoumenopoulos in lieu of payment of Director fees; to consider the approval of grant options to Mr. David Trimboli and to Mr. Christopher Ntoumenopoulos; and to consider other matters. Reported Earnings • Sep 01
Full year 2023 earnings released: AU$0.001 loss per share (vs AU$0.006 loss in FY 2022) Full year 2023 results: AU$0.001 loss per share (improved from AU$0.006 loss in FY 2022). Net loss: AU$3.12m (loss narrowed 76% from FY 2022). Over the last 3 years on average, earnings per share has fallen by 10% per year but the company’s share price has fallen by 47% per year, which means it is performing significantly worse than earnings. New Risk • Aug 27
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 Less than 1 year of cash runway based on free cash flow trend (-AU$4.0m free cash flow). Share price has been highly volatile over the past 3 months (59% average weekly change). Shareholders have been substantially diluted in the past year (84% increase in shares outstanding). Revenue is less than US$1m (AU$987k revenue, or US$633k). Market cap is less than US$10m (AU$9.15m market cap, or US$5.87m). Minor Risk Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Reported Earnings • Feb 25
First half 2023 earnings released First half 2023 results: Net loss: AU$420.7k (loss narrowed 35% from 1H 2022). Announcement • Feb 18
Medibio Limited Appoints Christopher Ntoumenopoulos as Director Medibio Limited announced the appointment of Christopher Ntoumenopoulos as Director of the company. The date of appointment is 15 February 2023. Board Change • Nov 16
Less than half of directors are independent There are 3 new directors who have joined the board in the last 3 years. Of these new board members, 1 was an independent director. The company's board is composed of: 3 new directors. 4 experienced directors. No highly experienced directors. 1 independent director (2 non-independent directors). Chairman of Growth & Advocacy Advisory Board Peter Carlisle is the most experienced director on the board, commencing their role in 2017. Independent Non-Executive Chairman David Trimboli was the last independent director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of experienced directors. Announcement • Nov 11
Medibio Limited Announces Resignation of Stephen Mitchley as a Director Medibio Limited announced the resignation of Mr. Stephen Mitchley as a Director of the Company. Mr. Mitchley has elected to resign from the Medibio board as he did not feel he had capacity to fully serve the director role given increases in scope of his role. Mr. Mitchley remains committed to assisting Medibio's growth, in his personal capacity, as he is passionate about the potential that Medibio has to assist in early detection and intervention in mental wellbeing. Announcement • Oct 26
Medibio Limited Appoints David Trimboli as the Company's New Non-Executive Chair Medibio Limited announced the appointment of Mr. David Trimboli currently Non-Executive Director (appointed on 25 August 2022) of the Company as the Company's new Non-Executive Chair. Mr. Trimboli is an experienced Chairperson and is considered independent and thus will bring an objective view to the Board in order to progress the Company's strategic objectives. Reported Earnings • Oct 02
Full year 2022 earnings released: AU$0.006 loss per share (vs AU$0.001 loss in FY 2021) Full year 2022 results: AU$0.006 loss per share (further deteriorated from AU$0.001 loss in FY 2021). Net loss: AU$12.7m (loss widened AU$11.2m from FY 2021). Over the last 3 years on average, earnings per share has increased by 89% per year but the company’s share price has fallen by 57% per year, which means it is significantly lagging earnings. Announcement • Sep 22
Medibio Limited, Annual General Meeting, Nov 11, 2022 Medibio Limited, Annual General Meeting, Nov 11, 2022. Agenda: To consider election for Directors. Announcement • Sep 19
Medibio Limited Appoints Thomas R. Young as CEO Medibio Limited announced the appointment of Dr. Thomas R. Young, M.D. as the Company's Chief Executive Officer, with effect from 19 September 2022. Dr. Thomas R. Young is a family physician with more than 40 years of medical experience. He is recognized as an innovator and thought leader in the fields of Consumer Directed Health Care and Behavioral Health. Dr. Young was the co-founder of Nview Behavioral Health and currently serves as the Chief medical Officer and board member. Nview is a leader in the provision of digital technology for the behavioral health space. Dr. Young currently serves as the medical director for Port of Hope a non-profit substance use disorder clinic. Dr. Young served for six years as the Medical Director of Idaho Medicaid and Dr. Young was also Chief Clinical /Medical Officer of Idaho Medicare QIO Qualis Health for nine years. Previously, Dr. Young served as Executive Vice President and Chief Medical Officer at Connextions Health, a Florida- based healthcare technology company that was acquired by Optum Health, a division of United Health Group. Dr. Young also served as President of Behavioral Imaging Solutions, a technology firm recognized for its application of video imaging for the treatment of children with autism. Reported Earnings • Sep 01
Full year 2022 earnings released: AU$0.006 loss per share (vs AU$0.001 loss in FY 2021) Full year 2022 results: AU$0.006 loss per share (down from AU$0.001 loss in FY 2021). Net loss: AU$12.7m (loss widened AU$11.2m from FY 2021). Over the last 3 years on average, earnings per share has increased by 89% per year but the company’s share price has fallen by 51% per year, which means it is significantly lagging earnings. Announcement • Aug 25
Medibio Appoints David Trimboli to Its Board of Directors as Non-Executive Director Medibio Limited announced Mr. David Trimboli to its Board of Directors as Non-Executive Director with immediate effect. Mr. Trimboli is an experienced global investor with experience in commodities financing and trading. He has undertaken investments activities and hold diverse interests in commodities, industrial minerals, real estate and technology and mental health in Australia and internationally. Mr. Trimboli is the founder of Seefeld Investments with offices in London, Zug and Perth. He has formerly a long serving senior coal trader at the world's large commodities trading group, Glencore International AG and was a key member of the Glencore team when the group successfully completed its IPO in London and Hong Kong. He currently holds a Managing Director position in Seefeld Investments Pty Ltd, Non-Executive Chairman in Audeara Limited and Non-Executive Director positions in the following Companies Quantum Graphite Limited, TradeMutt, Yumm Confectionar, The Reading Switch, Carecircle and Greater Outcomes, all being companies in revenue generating businesses with developed management teams and on pathways to profitability. The Board is excited to have Mr. Trimboli join the Board who brings extensive experience to the Company, not only in the mental health space but the ASX Listing space. Announcement • Jul 21
Medibio Limited Announces Sleep Analysis Depressive Burden Study Clinical Trial Commencement Medibio Limited announced the opening of the Sleep Analysis of Major Depressive Episode (SAMDE) clinical trial, the final stage prior to commencement of the FDA validation phase. This clinical trial aims to detect the likelihood of a current major depressive episode in individuals referred to sleep clinics for polysomnography assessment. There is a robust bidirectional relationship between mental illness and sleep disturbances. Depression is highly prevalent in individuals with sleep disorders. However, there is insufficient depression screening in sleep facilities. The trial aims to involve at least 17 sleep centres across the US in recruiting patients for the study. Nationwide enrolment is critical to the study to demonstrate clinical and geographical diversity, two key components of FDA standards. The Company's project aims to contribute to overcoming current unmet medical needs and foster the implementation of depression screening in sleep clinics. For future realisation of the work being undertaken, the Company has identified the major market-share holding companies in the sleep health environment, which may benefit from the integration of the Company's technology. Throughout the clinical trial, the Company will continue with the algorithm and software development according to the outcome of discussions held with the FDA. Algorithm and technology development must be completed by the time the Company enrols the first patient in clinical validation phase. Announcement • Jun 14
Medibio Limited Announces Executive Changes Medibio Limited advises that Mr. Peter Carlisle has tendered his resignation from his position as Non-Executive Director and Lead Independent Director of the Company, effective on 10 June 2022, in order to focus his time and efforts on the activities of the Growth and Advocacy Advisory Board. Peter has made a considerable contribution to the Company over many years, and that he will continue to contribute as Chairman of the Company's Growth and Advocacy Board. Given the Company is moving into a critical time in the Company's development, Peter's expertise in directing the Growth and Advocacy Advisory Board will be significant. Announcement • May 19
Medibio Limited Announces That A DSM-V1 Diagnosis Will Be Included as Primary Comparator for the Purposes of Assessing the Efficacy of Its Depression Algorithms, MEB-001 Medibio Limited announced that a DSM-V1 diagnosis will be included as a primary comparator for the purposes of assessing the efficacy of its depression algorithms, MEB-001. Medibio's clinical team proposed the International Neuropsychiatric Interview (MINI) as a diagnostic tool to satisfy the FDA's request whilst minimizing the burden of conduct for the validation trial. The FDA has confirmed that the MINI can be used to support the trial clinician diagnosis. Board Change • Apr 27
Less than half of directors are independent There are 5 new directors who have joined the board in the last 3 years. Of these new board members, none were independent directors. The company's board is composed of: 5 new directors. 3 experienced directors. No highly experienced directors. 1 independent director (4 non-independent directors). Chairman of Growth & Advocacy Advisory Board and Non-Executive & Lead Independent Director Peter Carlisle is the most experienced director on the board, commencing their role in 2017. They were also the last independent director to join the board. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Lack of experienced directors. Announcement • Mar 03
Medibio Limited Appoints Matt Mesnik as Non-Executive Director Medibio Limited appointed Dr. Matt Mesnik to its board of directors as non-executive director with immediate effect. Dr. Mesnik is a physician, business executive, health IT and medical device entrepreneur. In addition to being Medibio's first chief medical officer (CMO) (some years ago), Dr. Mesnik has served in the following roles, over the course of his 30-plus-year career: emergency physician and emergency department and urgent care medical director; CMO of CVS-MinuteClinic (which during his tenure grew from 80 clinics in 9 states to more than 650 in 27 states, with more than 12 million annual patient visits); CMO of Aprima Medical Software, an electronic health records company; Co-founder and CMO of Sanso, a medical device company to improve the care of COPD patients; and CMO of Ativa Medical, Vigilant Diagnostics and Quick Check Health. Currently, Dr. Mesnik serves as CMO of Spok, a clinical communication and collaboration company serving more than 2,200 hospitals in the US, Australia and Canada. In addition, Dr. Mesnik has served as director and a consultant to several health, IT, and medical device companies and is currently a clinical and technical advisor to iGan Partners, Canada's large health tech VC. Dr. Mesnik's unique diversity of expertise across multiple disciplines and demonstrated ability to execute strategic and tactical plans has earned him a reputation as an accomplished healthcare executive who develops quality solutions and delivers strong financial results. Reported Earnings • Feb 28
First half 2022 earnings: EPS in line with expectations, revenues disappoint First half 2022 results: EPS: AU$0 (up from AU$0.001 loss in 1H 2021). Net loss: AU$644.7k (loss narrowed 13% from 1H 2021). Revenue missed analyst estimates by 66%. Earnings per share (EPS) were in line with analyst estimates. Over the last 3 years on average, earnings per share has increased by 123% per year but the company’s share price has fallen by 44% per year, which means it is significantly lagging earnings. Announcement • Feb 17
Medibio Limited Appoints Stephen Mitchley as Non-Executive Director Medibio Limited welcomed Stephen Mitchley on Medibio's Board of Directors as Non-Executive Director with immediate effect. Stephen is based in New York and leads Vitality Group's digital and global partner disciplines. He brings 25 years of experience and expertise in overseeing operations and technology to the Vitality Group product team. Reported Earnings • Sep 01
Full year 2021 earnings released: AU$0.001 loss per share (vs AU$0.004 loss in FY 2020) Full year 2021 results: Net loss: AU$1.49m (loss narrowed 62% from FY 2020). Over the last 3 years on average, earnings per share has increased by 109% per year but the company’s share price has fallen by 59% per year, which means it is significantly lagging earnings. Announcement • Apr 29
Medibio Limited to Resubmit FDA 510(K) Application for its Sleep Staging Software, MEBbsleep Medibio Limited announced that it has secured a pre-submission meeting with the US Food and Drug Administration (FDA) on the 1st July 2021, regarding a new 510(k) application for its sleep staging software, MEBsleep. Medibio submitted a 510(k) application for MEBsleep in April 2020. In December 2020, the FDA informed Medibio that it required clinical data that better reflected the proposed intended use population and provided a detailed pathway as to how Medibio may achieve approval for MEBsleep. Following that guidance, Medibio commissioned an independent, in-depth review of its MEBsleep technology by the well-known and respected regulatory law firm, DuVal & Associates. As a result of the FDA guidance and subsequent extensive consultation with DuVal & Associates, Medibio has designed a new prospective, multicenter clinical trial to address the FDA issues raised and to inform its new 510(k) application. Access to sleep clinics pursuant to Medibio's agreement with MedBridge Healthcare, which operates 130 sleep clinics across the USA, will greatly assist in completing the trial as quickly as possible. It is anticipated that, barring any unforeseen circumstances or delays, the trial can be completed, and the new application submitted, within 6 to 8 weeks from commencement. The purpose of the pre-submission meeting with the FDA is to agree on, amongst other things, the trial design, its objectives and the number and diversification of the patient population. MEBsleep forms a substantial part of the suite of algorithms used to identify depressive burden, known as MEB-001 (i.e., MEB-001 consists of MEBsleep algorithms with overlaying overnight resting heart rate and heart rate variability analysis) It is noteworthy from a cost-efficiency standpoint that the patients participating in the MEBsleep trial will also be eligible for the depressive burden trial (MEB-001). Medibio will provide further details following the pre-submission meeting with the FDA. Reported Earnings • Feb 28
First half 2021 earnings released: AU$0.001 loss per share (vs AU$0.003 loss in 1H 2020) First half 2021 results: Net loss: AU$741.8k (loss narrowed 69% from 1H 2020). 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 65% per year, which means it is significantly lagging earnings. Announcement • Feb 23
Medibio Limited, Annual General Meeting, Mar 24, 2021 Medibio Limited, Annual General Meeting, Mar 24, 2021, at 11:00 AUS Eastern Standard Time. Agenda: To consider the ratification of prior issue of shares and options under placement tranche one; to consider the ratification of prior issue of options to CPS Capital Group Pty Ltd; to consider the approval of issue of shares and options under placement tranche two; to consider the approval of issue of options to CPS Capital Group Pty Ltd; and to consider the approval of issue of shares and options under share purchase plan. Announcement • Feb 11
Medibio Limited has completed a Follow-on Equity Offering in the amount of AUD 3 million. Medibio Limited has completed a Follow-on Equity Offering in the amount of AUD 3 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 333,333,333
Price\Range: AUD 0.009
Transaction Features: Subsequent Direct Listing Announcement • Jan 20
Medibio Limited Receives CE Mark Approval for Its Sleep Staging Software, MEBsleep Medibio Limited announce that it has received CE Mark approval for its sleep staging software, MEBsleep. MEBsleep is a software-only medical device that analyses Electroencephalogram (EEG) and
Electrocardiogram (ECG) data collected during polysomnography to verify sleep stages and heart rate variability (HRV) in patients suffering from primary or secondary sleep disturbances. MEBsleep uses
artificial intelligence, deep learning algorithms and neural network methodology to analyse large amounts of raw data, including autonomic nervous system modulation throughout sleep stages, to highlight key information to assist the physician in understanding the patient's condition. Currently, the gold standard for identifying sleep stages in a sleep laboratory setting is a 60 to 90 minute
visual assessment conducted by a clinician. MEBsleep performs the same assessment in 60 to 90 seconds, thereby providing improved efficacy for overall patient evaluation by sleep medicine technicians, under the supervision of a physician. CE Mark approval will allow Medibio to commercialise MEBsleep across the European Economic Community. The intended users of this device are sleep technicians and researchers. The path is now clear for Medibio to accelerate its commercialization activities for MEBsleep in the EEC. The company is currently exploring commercialization paths with European academic groups and pharma companies focused on behavioural sleep medicine. Announcement • Jan 11
Medibio Limited Commences the Initial Phase of Testing of its Consumer Mental Health App Medibio Limited announced it has commenced the initial phase of testing of its consumer mental health app (Consumer App). The company's pioneering work in the use of biometric data to aid in the early detection and screening of mental health conditions, together with its patented method of assessing stress by monitoring overnight heart rate 1, underpins the functionality of the Consumer App, which includes both biometric and psychometric assessments. The Consumer App's unique biometric functionality matches day and night heart rate activity and its variability throughout the night (drawn from wearable devices such as Garmin or the Apple Watch) against sleep architecture parameters and physical activity levels, producing an overall daily score to help users objectively measure, monitor, and manage stress levels and improve them over time. This unique feature will set it apart from competitors in the marketplace. Market research indicates no other viable in- store mental health app has patent protected biometric functionality. The Consumer App will also support users whom do not have a wearable device, through Its interactive psychometric assessment feature, which utilizes a clinically validated questionnaire to indicate stress levels. In 2018 (pre-COVID) the estimated market size of global mHealth apps (using smartphones to keep track of well-being) was USD 12.4 billion and projected to expand at a compound annual growth rate of 44.7% through 2026. The COVID-19 pandemic and its many social and economic consequences has exacerbated mental health conditions among the global population. In the United States, the increased stress and worry has adversely impacted the mental health of an estimated 53% of adults 3. Medibio intends to address this increased need and demand for mobile mental health services through the development and launch of its Consumer App, which the Company plans to make available on Android and IOS platforms, with an expected commercial launch in advance of Mental Health Awareness Week in the United States in October 2021. Announcement • Dec 30
Medibio Limited Announces US FDA Advises Further Data Needed for Mebsleep Approval Medibio Limited announces that the US Food and Drug Administration (FDA) has advised it will require a larger sample of clinical data, better reflecting the proposed intended use population, in order for it to be considered substantially equivalent in relation to its 510(k) application. The FDA has provided a detailed pathway as to how Medibio may achieve approval for MEBsleep and they have invited the company to discuss the additional steps required for approval. The Company intends to meet with the FDA as soon as practical to discuss the additional data required for approval in order to determine the next steps for MEBsleep. Whilst regulatory approval is not required for MEBsleep's primary purpose as an integral part of the depressive burden software device MEB-001, the Company believes MEBsleep is of value to potential partners for uses independent of MEB-001. Announcement • Nov 23
Medibio Limited Signs Global Master License & Services Agreement with Compass Group Plc Medibio Limited signed a Global Master License and Services Agreement with Compass Group Plc. for Medibio's corporate mental health product, ilumen. Under the terms of the Agreement, Medibio will make ilumen available to Compass companies electing to adopt the technology for the benefit of their employees. The agreement also grants Compass companies the right to license ilumen to their clients, which include many multinational corporations. Medibio will receive annual licence fees from each Compass company and client company that implements ilumen. Revenue generation, which Medibio expects to be material, will depend on the rate and level of adoption by Compass companies and their clients. The annual licence fee is a SaaS (Software as a Service) fee calculated per-employee, per annum based on the size of the workforce of the particular company enrolled in the program, regardless of the level of employee participation. The Agreement also establishes a sliding fee scale designed to encourage early adoption and maximize participation. Announcement • Oct 07
Medibio Limited Signs Clinical Trial Agreement with MedBridge Healthcare Medibio Limited announced that it has entered into a Clinical Trial Agreement with MedBridge Healthcare LLC ("MedBridge"), to support Medibio's Sleep Analysis of Depressive Burden ("SADB") trial. The SADB trial aims to identify clinical depressive burden in patients with sleep disturbance who undergo a sleep study in a clinical environment. Under the CTA, MedBridge, in collaboration with Ohio Sleep Solutions in Columbus, Ohio, will coordinate research guidelines and services for the purposes of the SADB trial to help fast-track patient recruitment. Announcement • Oct 04
Medibio Limited Submits Request for FDA Breakthrough Device Designation Medibio Limited (MEB or the Company) announced that it has submitted with the US Food and Drug Administration (FDA) a Designation Request for Breakthrough Device for its depressive burden software medical device MEB-001. The submission occurs concurrently to Medibio's ongoing clinical trial as devices subject to requests for De Novo designation are also eligible for Breakthrough Device Designation. The FDA's Breakthrough Devices Program supports accelerated development, assessment, and review of devices that promise a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, and meet at least one of the following criteria: (a) Represents Breakthrough Technology; (b) No Approved or Cleared Alternatives Exist; (c) Offers Significant Advantages over Existing Approved or Cleared Alternatives; or (d) Device Availability is in the Best Interest of Patients. Breakthrough Device Designation provides additional opportunities to interact with FDA experts and senior management prior to its submission for approval; and fast-tracks the FDA's review process to reduce time-to-market for qualified devices. The FDA typically communicates its decision to grant or deny Breakthrough Device Designation within 60 calendar days of receiving the request. Depression is a known and robust risk factor for self-harm behaviour and death by suicide. The global annual mortality rate from suicide has been estimated by the World Health Organization to be 10.7 per
100,000 individuals, with variations across age groups and countries. A major barrier to effective treatment for depression is inaccurate and/or inadequate diagnosis, which in turn contributes to its recurrence. Significantly, under-detection of depression increases the likelihood that it will result in a life-threatening disorder. Only fifty percent of patients with depression who are seen in the primary care setting will be accurately diagnosed, and of these, fewer than 10% will be appropriately treated. Currently, screening is often conducted through subjective self-report questionnaires, which introduce multiple difficulties and biases into the screening. MEB-001 provides an objective measure of depressive burden, overcoming multiple difficulties and biases of self-report questionnaires. Reported Earnings • Sep 26
Full year earnings released - AU$0.0044 loss per share Over the last 12 months the company has reported total losses of AU$3.87m, with losses narrowing by 41% from the prior year. Announcement • Jul 09
Medibio Limited has completed a Follow-on Equity Offering in the amount of AUD 1.517195 million. Medibio Limited has completed a Follow-on Equity Offering in the amount of AUD 1.517195 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 252,865,843
Price\Range: AUD 0.006
Transaction Features: Rights Offering Announcement • Jun 18
Medibio Limited announced that it expects to receive AUD 0.5 million in funding Medibio Limited (ASX:MEB) announced a private placement placement of 83,333,333 shares at an issue price of AUD 0.006 per share for gross proceeds of AUD 500,000 on June 10, 2020. The transaction will include participation from sophisticated, professional and other exempt
investors. 
