Dear Shareholder,This last quarter of 2018 has been profound for Biotron. Theannouncement in late September of positive headline datafrom its pivotal Phase 2 clinical trial for the treatment of HIV‐1 provided a major inflection point for your Company. The clinical trial was built on a scientifically sound, solidfoundation of laboratory studies. Based on researchoriginating at the John Curtin School of Medical Research atthe Australian National University, the Company’s scientistsdesigned and developed BIT225. Many years have beenspent characterising how the drug works on HIV‐1, makingstep‐wise progress along a well‐considered developmentpathway, culminating in human clinical trials. All of thesesteps have led to the recently successful Phase 2 trial,BIT225‐009.Scientific evidence from laboratory and clinical studies hasdemonstrated that BIT225 attacks HIV‐1 in macrophage cells.Current drugs do an excellent job of taking HIV‐1 in theblood to undetectable levels but do not clear virus inmacrophages. These cells, which reside in the body’s tissues,produce low levels of HIV‐1, even in patients takingantiretroviral drugs. This means that the infection persists.Patients cannot stop taking antiretroviral drugs. If they do,the virus quickly rebounds to high, potentially life‐threatening, levels. Drug development is inherently risky, and many drugs failbefore or during Phase 2 trials. The positive data from theBIT225‐009 Phase 2 HIV‐1 clinical trial are important as theyprovide evidence of your Company’s drug having an effect inpatients that is quite distinct from the antiviral effect ofcurrent antiretroviral drugs. In late November, the Company presented data from theBIT225‐009 trial at the HIV DART and Emerging Viruses 2018conference in Miami, Florida USA. The conference, whichfocused on the latest developments in HIV therapeutics,management and cure, provided the first opportunity for usto share the scientific data from the trial. The data was well received, and as validation of therobustness and integrity of the data from the trial, thepresenting author, Biotron’s Head of Research andDevelopment, Dr Carolyn Luscombe, received theconference’s 2018 HIV DART Poster Award.Ongoing analyses of BIT225‐009 samples and data are inprogress to further characterise the observed unique effectsof BIT225 in patients. Work is also underway to refine theregulatory and developmental pathway to Phase 3 andbeyond. The sharing of data with the scientific community is animportant step towards commercialising your Company’santiviral platform. Briefing potential partners in thepharmaceutical industry on the trial outcomes is another keystep. These meetings with potential partners are not singleevents, but involve multiple meetings, spread severalmonths. We believe that the successful results from thisstudy will facilitate commercialisation negotiations withthese parties. In parallel with progressing the HIV‐1 program towards acommercial outcome, we continue to evaluate the activity ofBiotron compounds for activity against Hepatitis B virus(HBV). The HBV therapeutic space is currently very activewithin the pharmaceutical industry, with significant investorinterest in the search for and development of effective HBVtreatments. While the HBV program is preclinical, it mayprovide the Company with an early stage developmentopportunity with an appropriate partner. As advised to the market in early December, exercise of the30 November 2018 options has raised a total of $4.7 million,to bring our current cash balance to $7.1 million. With thepositive data from the Phase 2 HIV‐1 clinical trial in hand anda sound financial position resulting from this significantinjection of funds, the Company ends 2018 in an robustposition. We’d like to wish shareholders and their families best wishesfor the holiday season. We look forward to 2019 withconfidence.
BIT Price at posting:
13.5¢ Sentiment: None Disclosure: Held
