Biotron Limited · ASX:BIT
Biotron — Shareholder Meeting (November 2019)
19 slides from Biotron's shareholder meeting presentation, Nov 26, 2019
Slide 1: AGM
BIOTRON LIMITED (ASX:BIT) AGM 26 November 2019
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation may contain forward-looking statements with respect to the financial condition, results and business achievements/performance of Biotron Limited (ACN 086 399 144) and certain of the plans and objectives of its management. These statements are statements t
Slide 3: Key Achievements 2018/2019 FY
Key Achievements 2018/2019 FY • Completed Phase 2 HIV-1 clinical trial of BIT225 & reported positive results • Raised $5.7 million after costs in late 2018, including $4.7 million for 30 Nov ‘18 $0.06 options • Set up a world-class advisory group of international HIV-1 experts in 2H2019 • Focus on t
Slide 4: Phase 2 HIV-1 Clinical Trial - Recap
Phase 2 HIV-1 Clinical Trial - Recap • BIT225-009 Phase 2 HIV-1 clinical trial: • 3 months once a day dosing of BIT225 • HIV-1-positive, treatment naïve people starting standard antiretroviral drugs • Placebo-controlled, double-blind study • Data from the clinical trial indicated that: • BIT225-trea
Slide 5: Outcomes & Implication from Trial Data
Outcomes & Implication from 009 Trial Data Trial data showed us that something quite extraordinary had happened to the immune system in these patients. BUT - How exactly had BIT225 induced these immunological changes? - What do these changes mean clinically? - What are the implications of this data
Slide 6: HIV-1 Challenge
HIV-1 Challenge • Biotron is working with a very complex, difficult virus • Globally, 75 million people have been infected with HIV; 32 million have died of HIV • ~38 million are currently infected worldwide • Between 2000 and 2015 over US$560 BILLION was spent globally on HIV/AIDS • In the history
Slide 7: WHY is HIV-1 ERADICATION so HARD
WHY is HIV-1 ERADICATION so HARD • Current antiretroviral drugs stop the replication of HIV-1 in T cells • BUT there are reservoirs of HIV-1 infection that are not cleared with current drugs • Located in sanctuary sites • Hidden in non-replicating cells (latently infected T cells) • Hidden in macrop
Slide 8: WHY is HIV-1 ERADICATION NECESSARY
WHY is HIV-1 ERADICATION NECESSARY • Long-term health implications e.g. HAND, immune activation, drug-drug interactions in an aging population • Compliance issues/drug holidays can lead to viral rebound • Cost of treatment • ~ $20 billion p.a. world wide • Major burden on healthcare systems • Those
Slide 9: HIV-1 & BIT225
HIV-1 & BIT225 • BIT225 is a new mode of action anti-HIV-1 drug • Targets HIV-1 replication/assembly in macrophage reservoir cells Infectious HIV-1 Non-infectious HIV-1 A B (A) Untreated Controls (B) BIT225 treated cells • Robust, stepwise translational R&D focused on the direct action of BIT225 on
Slide 10: BIT225-009 Phase 2
BIT225-009 Phase 2 BIT225 ANTIVIRAL DATA BIT225-INDUCED IMMUNE (PRECLINICAL & BIT225-009 CHANGES IN BIT225-009 PHASE BIT225-004 PHASE 1B/2A TRIAL) Designed Phase 2 trial 2 TRIAL to see impact of BIT225 - Inhibition of HIV-1 in monocyte- over and above current - Modification of various T cell derived
Slide 11: Understanding BIT225-009
Understanding BIT225-009 - The last 12 months has seen an extraordinary scientific detective investigation to piece together how a small molecule antiviral drug has caused a vaccine-like effect - Required in-depth understanding of very complex immunology - Reviewing relevant HIV-1/immunology literat
Slide 12: BIT225-009 Data Today
BIT225-009 Data Today - As a result of this detailed, post-trial analyses, we are forming a clear picture of how BIT225 induced the immune changes and what this means for potential eradication of HIV-1 - The time and effort to do this is of real benefit to the company and its shareholders: - This wi
Slide 13: Advisory
Advisory - We recently established a formal advisory board of the best international HIV-1 experts (all key opinion leaders) to guide and advise the company at this important stage of development - Extensive experience in clinical development within HIV-1 treatment and eradication field - Recognised
Slide 14: Next Steps for HIV-1 Program
Next Steps for HIV-1 Program - Filing new patent(s) based on new information on molecular mechanism of BIT225 in the Phase 2 trial - Publication of trial data in peer-reviewed scientific journal(s) - Presentation of additional data from post-trial analyses at key international conference(s) in 2020
Slide 15: HIV-1 Program Summary
HIV-1 Program Summary - The initial data from the 009 Phase 2 trial showed that BIT225 induced profound, unique changes to the immune system - After extensive, detailed post-trial laboratory analyses of trial samples we now have an understanding of how BIT225 has generated these positive, vaccine-li
Slide 16: Hepatitis B Virus
Hepatitis B Virus • ~300 million worldwide chronically infected with HBV • Increased risk of significant liver disease, including liver failure and cancer • HBV causes up to 80% of liver cancers • 5 year survival of 15% • >780,000 die every year as a consequence of HBV infection • Current treatments
Slide 17: Hepatitis B Virus
Hepatitis B Virus • Hepatitis B virus (HBV) therapeutic space has generated significant interest from pharma & biotech companies • Oct ‘18 – J&J/ Arrowhead in deal worth up to US$3.7 billion • Aug 19 – GSK/Ionis Pharmaceuticals HBV antisense deal worth up to US$200 million in milestones • Nov 19 – R
Slide 18: Commercialisation & Outlook for 2019/2020 FY
Commercialisation & Outlook for 2019/2020 FY • Aim is to achieve commercial outcomes for the company’s programs • Prime focus is partnering the HIV-1 program • Progressing discussions with potential partners • Ongoing analyses of clinical trial samples is adding to the data package/IP position • Con
Slide 19: BIOTRON LIMITED (ASX:BIT)
BIOTRON LIMITED (ASX:BIT) Michelle Miller Managing Director mmiller@biotron.com.au www.biotron.com.au