Biotron Limited · ASX:BIT
Biotron — Shareholder Meeting (November 2018)
19 slides from Biotron's shareholder meeting presentation, November 2018
Slide 1: Biotron Annual General Meeting
Biotron Annual General Meeting 20** November 2018
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
Key Achievements 2018 • Completed Phase 2 clinical trial of BIT225 and Combination Antiretroviral Therapy (cART) • Reported positive data in September 2018 • Presenting data from trial at HIV DART conference in late November 2018 • Raised $1.48 million (after costs) via rights issue in June ‘18 • Re
Slide 4: Biotron – New Approach to Anti-Viral Drug Development
Biotron – New Approach to Anti‐Viral Drug Development Biotron – New Approach to Anti‐Viral Drug Development • Focused on the design and development of a new class of antiviral drugs targeting viral‐ encoded viroporin proteins • Viroporins are present in wide range of viruses: Influenza (M2), HIV‐1 (
Slide 5: HIV-1 Eradication
HIV‐1 Eradication HIV‐1 Eradication Current antiretroviral drugs to not cure HIV‐1 infection • HIV‐1 reservoirs set up early, leading to chronic, life‐long infection • Not sensitive to current anti‐HIV‐1 drugs • New mode of actions drugs are needed to eradicate or cure HIV‐1 infection Why is HIV‐1 e
Slide 6: BIT225 Targets HIV-1 Macrophage Reservoirs
BIT225 Targets HIV‐1 Macrophage Reservoirs BIT225 targets and kills HIV‐1 in macrophage cells – these are a key reservoir of infection, even in people taking antiretroviral drugs Mario Stevenson Scientific American 299, 78 ‐ 83 (2008)
Slide 7: BIT225-009 Phase 2 HIV-1 Trial
BIT225‐009 Phase 2 HIV‐1 Trial ‐ Double‐blind, placebo‐controlled, randomised, multi‐centre study Protocol ‐ 12 weeks, once daily, oral treatment with BIT225 or placebo in combination with antiretroviral treatment (ART) 36 HIV +ve, treatment‐naïve subjects commencing standard antiretroviral treatmen
Slide 8: BIT225-009 Phase 2 HIV-1 Trial Outcomes
BIT225‐009 Phase 2 HIV‐1 Trial Outcomes Pharmacokinetics (PK): ‐ Reports by third parties in progress. Data generally not reported, as details are considered trade secrets, other than required for regulatory filings ‐ Adds to a large body of data (over 200 subjects dosed in trials to date) on PK of
Slide 9: BIT225-009 Phase 2 HIV-1 Trial Outcomes
BIT225‐009 Phase 2 HIV‐1 Trial Outcomes Virological Outcomes (Measurement of virus levels in the blood) 1. Plasma viral loads • Standard way to measure effectiveness of anti‐HIV‐1 drugs • Routine diagnostic test run by pathology laboratories worldwide • Approved anti‐HIV‐1 drugs are very efficient a
Slide 10: BIT225-009 Phase 2 HIV-1 Trial Outcomes
BIT225‐009 Phase 2 HIV‐1 Trial Outcomes Immunological Outcomes 1. Soluble CD163 • A macrophage immune activation marker found in the blood • High levels in untreated HIV+’s; levels are known to be lowered once on anti‐HIV‐1 drugs • BUT despite treatment with anti‐HIV‐1 drugs, some patients have high
Slide 11: BIT225-009 Phase 2 HIV-1 Trial Outcomes
BIT225‐009 Phase 2 HIV‐1 Trial Outcomes Immunological Outcomes 2. Other immunological markers • A range of other immunological markers have been assessed to determine impact of BIT225 • Statistically significant differences found between the BIT225 + ART cohort and the placebo + ART cohort • Details
Slide 12: Trial Data Supports BIT225 Clearing Virus from Macrophage Reservoirs
Trial Data Supports BIT225 Clearing Virus from Macrophage Reservoirs Infectious HIV‐1 Non‐infectious HIV‐1 • Cell culture studies showed that BIT225 targets A B formation of new virus in macrophage cells (Figs A and B), producing non‐infectious, dead virus • Immunological data from the Phase 2 clini
Slide 13: BIT225-009 Phase 2 HIV-1 Trial Outcomes
BIT225‐009 Phase 2 HIV‐1 Trial Outcomes What do these results mean for BIT225 and Biotron’s HIV‐1 Program? ‐ The immunological data provide clear clinical evidence that BIT225 is having a unique effect in individuals infected with HIV‐1 ‐ This effect is not seen in individuals treated with current a
Slide 14: Unlocking Value for Other Virus Targets
Unlocking Value for Other Virus Targets Biotron’s approach enables the targeting of a wide range of viral diseases; examples include: • Hepatitis B virus (HBV) • Respiratory Viruses such as Respiratory Syncytial Virus (RSV), Influenza, & Coronaviruses (leading cause of “common cold”) • Flaviviruses
Slide 15: Hepatitis B Virus Program
Hepatitis B Virus Program • Hepatitis B virus (HBV) therapeutic space has generated significant interest from pharma & biotech companies • Oct ‘18 – J&J and Arrowhead in deal worth up to US$3.7 billion • Screening of Biotron’s compound library has identified several compounds with activity against H
Slide 16: Commercialisation – Key Focus
Commercialisation – Key Focus • Three tactical priorities: • Partnering lead clinical program ‐ BIT225 for HIV‐1 eradication • Partnering one or more preclinical programs – e.g. HBV • Execute a regional licensing deal in China ‐ HCV program remains a key potential opportunity
Slide 17: Commercialisation & Outlook for 2018/2019
Commercialisation & Outlook for 2018/2019 Commercialisation & Outlook for 2019 FY • Aim is to achieve commercial outcomes for the company’s programs • Prime focus is partnering the HIV‐1 program • Data from the Phase 2 HIV‐1 trial to be presented at key conference(s), and also shared with potential
Slide 18: Summary
Summary • HIV‐1/BIT225 • BIT225‐009 Phase 2 trial provides clear clinical evidence that BIT225 is having a unique effect in individuals infected with HIV‐1 • Engaged with the right potential partners, with the right legal/commercial deal‐making skills in place • This is not a fast process; but we ar
Slide 19: Thanks
Thanks ‐ Huge thank you to Biotron’s small, focused, and highly dedicated team ‐ Thank you to Biotron’s contractors and consultants ‐ Thank you to shareholders, especially long‐term shareholders and those that participated in the recent rights issue