Level 2, 66 Hunter Street | |
Sydney NSW 2000 | |
Tel: (61-2) 9300 3344 | |
Fax: (61-2) 9221 6333 | |
E-mail: pnightingale@biotron.com.au | |
Website: www.biotron.com.au | |
29 August 2019 | |
The Manager - Companies | |
ASX Limited | |
20 Bridge Street | |
SYDNEY NSW 2000 | (52 pages by email) |
Dear Madam,
YEAR END ACCOUNTS AND PRELIMINARY FINAL REPORT
I attach the Company's Year End Accounts and Appendix 4E Preliminary Final Report for the year ended 30 June 2019.
Full details of the Company's Operating and Financial Review are contained in the attached Annual Report which forms part of this Preliminary Final Report.
Yours sincerely
Peter J. Nightingale
Company Secretary
pjn10041
Appendix 4E | |||
Preliminary final report | |||
Name of entity | |||
BIOTRON LIMITED | |||
ABN or equivalent company | Financial year ended ('current period') | ||
reference | |||
60 086 399 144 | 30 JUNE 2019 | ||
Results for announcement to the market
Revenues from ordinary activities
Loss from ordinary activities after tax attributable to members
Net loss for the period attributable to members
Dividends (distributions)
Final dividend
Interim dividend
Previous corresponding period
Final dividend
Interim dividend
N/A | Nil | to | Nil |
Up | 1.14% | to | $1,611,799 |
Up | 1.14% | to | $1,611,799 |
Amount per security | Franked amount per | |||
security | ||||
Nil | Nil | |||
Nil | Nil | |||
Nil | Nil | |||
Nil | Nil | |||
Record date for determining entitlements to the | N/A |
dividend. | |
Brief explanation of any of the figures reported above and short details of any bonus or cash issue or other item(s) of importance not previously released to the market:
Refer attached Annual Report for the year ended 30 June 2019.
NTA backing | Current period | Previous |
corresponding | ||
period | ||
Net tangible asset backing per ordinary security | 0.91 cents | 0.25 cents |
The attached Annual Report which forms part of this Appendix 4E has been audited.
BIOTRON LIMITED
A.B.N. 60 086 399 144
ANNUAL REPORT
FOR THE YEAR ENDED
30 JUNE 2019
BIOTRON LIMITED
CONTENTS
Operating and Financial Review | 1 |
Corporate Governance Statement | 5 |
Directors' Report | 6 |
Lead Auditor's Independence Declaration | 16 |
Statement of Profit or Loss and Other | |
Comprehensive Income | 17 |
Statement of Financial Position | 18 |
Statement of Changes in Equity | 19 |
Statement of Cash Flows | 20 |
Notes to the Financial Statements | 21 |
Directors' Declaration | 40 |
Independent Auditor's Report | 41 |
Additional Stock Exchange Information | 45 |
Corporate Directory | 48 |
BIOTRON LIMITED
OPERATING AND FINANCIAL REVIEW
REVIEW OF OPERATIONS
Biotron Limited ('Biotron' or 'the Company') has completed several significant milestones during the 2018-
2019 financial year. These include:
Reporting of positive results from the Company's pivotal Phase 2 BIT225 HIV-1 clinical trial.
Presentation of data from the BIT225 HIV-1 trial at the HIV DART and Emerging Viruses 2018 conference in Miami, Florida USA, which received the Conference's 2018 Poster Award.
Appointment of Professor Stephen Locarnini as a Non-Executive Director.
Raising $6.0 million in capital from the exercise of Company options.
HIV-1 Program
The major highlight during the year was the release of positive human clinical data from the BIT225-009 Phase 2 trial of its lead drug BIT225 in HIV-infected patients in combination with current antiretroviral drugs.
The data from this Phase 2 clinical trial indicates that BIT225 has induced key immune responses not seen in patients dosed with approved anti-HIV drugs.
During HIV-1 infection, the virus hides in long-lived cells known as macrophages. This cellular source of virus persists even in people taking antiretroviral drugs, although there is no detectable virus in their blood. The continued presence of virus causes serious problems including accelerated aging of the immune system and HIV-associated neurocognitive disorder (also known as AIDS-related dementia). Eradication of virus from hidden reservoirs is key to further improving health outcomes in this population and also key to any strategy to cure patients infected with HIV-1.
In previously reported laboratory-based studies, Biotron has shown that BIT225 attacks HIV-1 growing in macrophages. An earlier Phase 1b/2a human clinical trial (BIT225-004) demonstrated that BIT225 targets replication of HIV-1 in macrophage lineage cells in infected individuals.
The data from the BIT225-009 clinical trial indicate that treatment with BIT225 triggers a range of positive changes to the immune cells which help to fight HIV-1 in these patients.
In addition to statistically significant changes in immune cells, there was a statistically significant reduction in the level of the macrophage activation marker sCD163 in the blood of the BIT225-treated cohort by the end of the treatment period compared to the placebo group in the trial.
Higher levels of sCD163 are linked with worse clinical outcomes in patients and so this reduction of sCD163 by BIT225 provides additional evidence of potential clinical benefit in these patients.
Since releasing data from the BIT225-009 trial, the Company's main efforts have been directed towards further understanding of these unique responses to BIT225. This has involved testing samples of blood collected during the trial for various markers, the levels of which allow the determination of precisely how BIT225 treatment has impacted on specific immune pathways.
These analyses are supplementary in nature and will not change the reported key positive findings from the clinical trial. These analyses are proceeding well and are important as they are providing key information on characterising the mechanism of action of BIT225 on HIV-1 behind the positive results observed in the BIT225-009 clinical trial.
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