Medibio : Quarterly Update and Cashflow Report –

February 1, 2022

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ASX Announcement
Medibio Limited – 31 January 2022
December 2021 Quarterly Activities Report and Appendix 4C
Key highlights from the quarter:
Melbourne, Australia and Minneapolis, MN – 31 January 2022: Medibio Limited (MEB or the Company) (ASX: MEB)
(OTCPINK: MDBIF), is pleased to announce its quarterly activity report and Appendix 4C for the three months ended
31 December 2021:
Clinical trial update
Sleep Analysis of Depressive Burden study (SADB) (MEB-001)
The MEB-001 continues to demonstrate accuracy of 80% for predicting the likelihood of a current Major Depressive Episode (cMDE). The algorithm was built using the main components of the MEBSleep technology. A mental health module was added based on data collected during the SADB study. This mental health module was developed using complex statistical analyses to identify statistically significant variables that became part of the algorithm predictors.
Following FDA recommendations about geographical and clinical diversity, the current SADB study population has expanded to include sleep centres in Minnesota, Ohio, North Carolina, South Carolina, Florida, Missouri, New York, Colorado, and the West Coast. This will help to expedite the clinical study timelines. It must be noted however that due to the spread of the Covid Omicron variant and the burden of the current pandemic in the United States Health Care System, we have seen enrolments decrease across all the sleep centres. Medibio is developing several strategies, including opening more centres and incentive enrolment, to mitigate this situation as much as possible.
The MEB-001 algorithm has been developed to utilize inputs from FDA-cleared polysomnography (PSG) systems and sensors (EEG and ECG), used for sleep studies to diagnose sleep primary and secondary sleep disorders. The algorithm extracts and parses physiological biomarkers to identify the likelihood of cMDE in patients referring to sleep clinics for sleep disturbances. Using Artificial Intelligence, the Company’s technology produces a probabilistic analysis to show significant patterns of discrimination for moderate to severe cases of depressive burden. This prediction is designed to be comparable to a PHQ-9 score >= 10, the current best practice for screening for a current major depressive event.
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ASX Announcement
Medibio Limited – 31 January 2022
The proposed FDA validation trial is designed to compare the results from MEB-001 with moderate to severe depression as determined by the PHQ-9 (best practice standard for measurement of depression in the US). According to the prevalence and screening of depression in sleep centres, Medibio will propose a minimum performance of 65% to satisfy the criteria for study success. Medibio estimates, and has proposed to the FDA, a total of 370 patients will provide adequate power to satisfy the two primary endpoints.
The software to house the MEB-001 algorithm is now well under way. The result will be Software as a Medical Device (MEB-001SaMD).MEB-001SaMD in its final form will report the mental health result to the clinician as part of the PSG report on sleep disturbance. The MEB-001SaMD report is intended to assist physicians in determining whether a patient should be referred for a more in-depth mental health evaluation. MEB-001SaMD can ultimately be utilized within the USA by a primary care physician, sleep physician, neurologist, cardiologist, or ENT surgeon who are responsible for completing a referral to a mental health professional for evaluation.
Development of Software Medical Device for the Home Environment (MEB-002SaMD)
In the USA, the prevalence of obstructive sleep apnea is on the rise. With rising prevalence comes increased cost burdens to the health care system. Overnight evaluations to diagnose and treat sleep apnea early can bring down these costs. Traditionally, this sleep study has been performed in a fully outfitted sleep clinic. However, there are drawbacks to the in-clinic study. The first and most significant is cost; in-clinic sleep tests cost $3,000 or more. Inconvenience is also a factor for patients. The facility may be far away, creating expense and inconvenience. Further, in the USA, it typically takes weeks or months to get scheduled in a clinic.
New technology however, allows polysomnography to be performed at home with portable monitoring devices. The in-home study usually costs less than $600. This affordability is why payers are increasingly moving toward covering in-home sleep tests before covering in-clinic tests. Further, the requirements for an in-home sleep study are less cumbersome than for an in-clinic study, and patients can schedule them for any night that is convenient. Because no travel is involved, in-home tests are especially advantageous for the home-bound, elderly, or people with many chronic illnesses. The in-home test is administered in the comfort and privacy of the patient’s bedroom, and it involves far fewer wires than with a traditional in-lab sleep study, so the patient can get a better night’s sleep.
Due to the success of the MEB-001 algorithms and in recognition of the growing patient cohort moving from in-clinic sleep studies to the home environment, planning has now begun for the development of MEB-002, which will screen for Major Depressive Episode (cMDE) in patients undertaking a sleep study in the home environment. This study is being undertaken with Medibio’s trial partner Medbridge Healthcare and is due to commence in April 2022. Medbridge has also expressed an interest in Medibio’s sleep staging algorithms (MEBsleep) in addition to the Company’s depression software (MEB-001).
Non-regulatory Products Update – LUCA Stress App
In October 2021, Medibio launched LUCA, its consumer stress app, in the USA. US based PR company R&CPMK was engaged to facilitate the commercial launch of LUCA through a strategic, multi-pronged PR approach including earned media relations, consumer community engagement, satellite media tours (SMTs) and influencer activations. Each of these components assisted in educating and introducing LUCA to a wide variety of audiences.
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ASX Announcement
Medibio Limited – 31 January 2022
To-date, our PR efforts achieved story placements in top-tier tech outlets including VentureBeat, receiving more than 2.98 million media impressions in total, highlighted below:
Additionally, Medibio leveraged the online forum Reddit, where we successfully engaged consumers in a Reddit AMA campaign featuring Medibio’s CMO, Archie Defillo MD, garnering more than 100K views.
The Satellite Media Tour that included LUCA in a Winter Wellness highlight on US news broadcasts helped reach 12 markets, garnering 156 million impressions.
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ASX Announcement
Medibio Limited – 31 January 2022
To focus on lifestyle audiences, Medibio partnered with social media personality Whitney Port to promote the benefits of LUCA. As a result, Medibio reached 250K accounts and received 7K “likes” on Instagram.
Post-launch Medibio employed direct email, organic social, and paid/sponsored social as marketing efforts. Additionally, Medibio is using an App Store Optimization platform, to help test and refine our app store content and improve placement, impression, and boost sales.
Medibio’s organic content is aimed at providing information and education about the elements and subject matter within LUCA and its paid content has a more direct Call to Action (CTA).
The conversion rate from downloads during the 14 day trial was 22.5%, which is considered an industry high. We expect this to continue as LUCA’s point of difference and additional in-app offerings resonate throughout a competitive marketplace. To date, revenue from paid installations (post the 14 day trial) continues to grow as our marketing efforts gain traction.
Additional marketing efforts that will continue to roll out in 2022 are:
Non-regulatory Products Update – ilumen
Medibio continues to focus its sales and marketing activities on large organisations, in particular Employment Assistance Providers (EAP) that have the network of client companies to implement ilumen at scale. In this regard, Medibio is in discussions with one of Australia’s leading EAP’s, which has the potential to take ilumen to its extensive corporate client base. The provider operates in 10 countries around the world (including the USA), in the human services industry and provides essential services on behalf of governments and the private sector across employment, health and wellbeing, communities and disability and aged care support.
During the December 2021 quarter, from a public relations perspective, Medibio sought opportunities for thought leadership and commentary on key issues surrounding mental health, sharing company announcements with stakeholders and gaining coverage for client case studies that demonstrates the value of the company’s corporate wellbeing product offering, ilumen.
Medibio also developed communication strategies around Mental Health Awareness Month to amplify coverage on specific milestones in Medibio’s journey, such as the launch of LUCA in October 2021.
Company milestones and announcements on the ASX also generated interest from the country’s most important trade media publications , with articles featured on Stockhead, The Market Herald, Simply Wall St and The Motley Fool.
Our ilumen case study with client Stantec garnered stories on the cover of The Courier’s Careers section and on business website Busy Continent. We also obtained industry commentary in a featured article in the Wellbeing issue of People Matters Magazine, an HR publication distributed within the APAC region.
ilumen was also featured in a Westpac Wire article on the positive effects of mood tracking apps in corporate environments.
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ASX Announcement
Medibio Limited – 31 January 2022
Corporate and Financial Update
On 15 December 2021, the Company announced a Capital Raising which would raise up to $5.7m (before costs) (known as the (“Capital Raising“) by way of a Placement and Non-Renounceable Entitlement Offer (“Entitlement Offer“). The Placement amounting to $2.25 million is to be completed in two stages of which stage 2 will be subject to shareholder approval at an Extraordinary General Meeting on 11 February 2022 (“Placement“). The Entitlement Offer will be to eligible shareholders who will be given the opportunity to subscribe for one (1) new fully paid ordinary share for every three (3) existing fully paid ordinary shares held to raise up to $3.4 million and is partially underwritten up to $1 million.
The Placement and Entitlement Offer will be undertaken at an issue price $0.005 (0.5 cents) per share (“Issue Price“). The Capital Raising will also include the issue of one (1) free attaching Option for every two (2) Shares issued under the Capital Raising with the Placement Shares subject to shareholder approval. The Company will apply for quotation for both the New Shares and Options (subject to the conditions of the ASX Listing Rules) noting that the class of Options to be issued are already an existing class of quoted Options, being MEBOC.
Cash on hand at the end of the December quarter was approximately $1.44m. Total research and development and other intellectual property expenditure of $0.09m was incurred during the December quarter. An additional $0.67m was paid in relation to administration, corporate, staff, advertising and marketing costs. The Company received $0.97m in relation to the R&D Tax Invective initiative.
Payments to related parties and their associates during the quarter was approximately A$0.14m. These payments related to Director fees and remuneration of their associates. Included in related party payments are payments made to Vistra Australia (Melbourne) Pty Ltd, a company associated with Me Melanie Leydin, for company secretarial and accounting services
This announcement is authorised for release to the market by the Board of Directors of Medibio Limited.
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Medibio Limited published this content on 31 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 31 January 2022 08:18:01 UTC.


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