Biotron Limited · ASX:BIT
Biotron — Shareholder Meeting (November 2024)
17 slides from Biotron's shareholder meeting presentation, Nov 28, 2024
Slide 1: Annual General Meeting
ANNUAL GENERAL MEETING ASX:BIT 28 November 2024
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: Industry-leading experts focused on transformative viral treatments
Industry-leading experts focused on transformative viral treatments Experienced Board & Management team with pharma, finance and VC backgrounds Clinical stage company with portfolio of small molecule drugs targeting viral diseases with major health problems and large international markets HIV-1 SARS
Slide 4: 2024 in Review
2024 in Review - Readout of the results from three Phase 2 clinical trials - This is a remarkable achievement for any organisation in a relatively short period of time - Progressed early-stage programs - Hepatitis B virus - Dengue virus - Progressed next-generation drugs for HIV-1 and SARS-CoV-2 pro
Slide 5: BIT225-010 and -011 Phase 2 HIV Clinical Trials Met Primary End Points
BIT225-010 and -011 Phase 2 HIV Clinical Trials Met Primary End Points 01 02 03 Results from these two Unique mechanism that Implications go beyond the trials further our combines Company’s HIV Program understanding of BIT225 immunomodulation combined with direct acting • The results provide evidenc
Slide 6: Why HIV-1?
Why HIV-1? The increased prevalence of HIV-1 infections, % of patients on treatment due to improved disease awareness and the need for treatments to improve quality of life are ~38.4m people expected to drive market growth to over globally living with US$50b by 2030 HIV despite ARTs An estimated one
Slide 7: BIT225-010: Phase 2 Trial in Naïve, Acutely Infected HIV Population - Overview
BIT225-010: Phase 2 Trial in Naïve, Acutely Infected HIV Population - OVERVIEW BIT225 or placebo added to cART in HIV-positive individuals commencing cART treatment (n=27, randomised 2:1) BIT225/cART or placebo/cART dosing continued for 24 weeks. At conclusion, everyone continued on cART Parameters
Slide 8: BIT225-010: Outcomes vs Objectives
BIT225-010: Phase 2 Trial in Naïve, Acutely Infected HIV Population – OUTCOMES vs OBJECTIVES PRIMARY OBJECTIVES OUTCOMES 1. Safety and tolerability - Safe and generally well tolerated - No deaths or drug-related SAEs - AEs were similar to those seen in previous trials 2. Impact on virus levels BIT22
Slide 9: BIT225-010 HIV-1 – Reduction in Viral Loads Are Faster in BIT225 Group
BIT225-010 HIV-1 Phase 2 Trial – Reduction in Viral Loads Are Faster in BIT225 Group - BIT225-treated cleared virus faster than those on ART alone - 72% of BIT225/ART group vs 33% of placebo/ART reached limited of detection by day 28 - Rate of decline of virus levels in critical second phase of deca
Slide 10: BIT225-010 HIV-1 – Conclusions
BIT225-010 HIV-1 Phase 2 Trial – Conclusions • The changes seen when BIT225 is added indicate that the drug has induced statistically significant changes in specific immune cell populations, markers, and cytokines. • The immune results are consistent with those seen in earlier trials and suggest a p
Slide 11: BIT225-011: Phase 2 Trial in Treatment-Experienced Immune Non-Responders
BIT225-011: Phase 2 Trial in Treatment-Experienced Immune Non-Responders First time BIT225 has been trialed in this at-risk HIV population. Trial was run at sites in Sydney, Australia 20 participants cART cART + BIT225 cART Screening Observation Period Treatment Period Follow-up Period -35 days -28
Slide 12: BIT225-011: Outcomes vs Objectives
BIT225-011: Phase 2 Trial in Treatment-Experienced Immune Non-Responders – OUTCOMES vs OBJECTIVES PRIMARY OBJECTIVES OUTCOMES 1. Safety and tolerability Safe and generally well tolerated No deaths or drug-related SAEs AEs were similar to those seen in previous trials 2. Viral markers All participant
Slide 13: COVID-19 Clinical Program
COVID-19 Clinical Program In 2022 BIT's lead antiviral drug was shown to: • Prevent COVID-19, • Reduce virus levels, and • Stop the cytokine storm in a relevant, robust, industry- recognised animal model of disease As BIT225 had been tested in humans for other viral diseases it could move quickly in
Slide 14: BIT225-012: Phase 2 COVID-19 Clinical Trial
BIT225-012: Phase 2 COVID-19 Clinical Trial PRIMARY OBJECTIVES OUTCOMES 1. Safety and tolerability - Safe and generally well tolerated - No deaths or drug-related SAEs - AEs were similar to those seen in previous trials 2. Efficacy assessed by nasal viral loads No statistically significant differenc
Slide 15: Early-Stage Antiviral Programs
EARLY-STAGE ANTIVIRAL PROGRAMS • Biotron remains focused on its platform of viroporin antagonists which uniquely combine direct-acting antiviral and immunomodulatory activities across numerous viruses responsible for important human disease. • The results from BIT225 have important implications for
Slide 16: Summary
SUMMARY - Preliminary analyses indicate that both HIV trials achieved their primary objectives - The data supports previous findings that BIT225 uniquely combines direct-acting antiviral and immunomodulatory activities - The challenge for HIV therapies is demonstrating clinical benefit over and abov
Slide 17: Biotron Limited (ASX:BIT)
BIOTRON LIMITED (ASX:BIT) Michelle Miller Managing Director mmiller@biotron.com.au www.biotron.com.au +61 412313329