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Biotron Limited (ASX:BIT)

ALERT: Price-sensitive ASX Announcement for BIT
Current share price for BIT : $0.002 0 (0%)+
Announcement
Release
28 Oct 2026 10:32AM
Price at Release
$0.002
Full Release
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Summary
Biotron Limited’s quarterly activities report and Appendix 4C for the quarter ended 30 September 2026 stated that the company continued advancing SedRx, its next-generation alfaxalone anaesthetic, through work with an international regulatory advisory group on an updated European Medicines Agency submission to clarify the European regulatory pathway and pivotal clinical trial requirements, while also progressing preparations for animal studies in an additional neurological indication; in its antiviral program, new Scripps Research Institute cell-based data showed BIT-HBV001 had strong activity against HBV and HDV in co-infected cells, with greater reductions than Myrcludex B in HBsAg (98.1% vs 93.8%) and HBV-DNA (99.7% vs 93.0%), while Myrcludex B achieved a greater HDAg reduction (94.8% vs 81.0%), and combination testing demonstrated significant antiviral synergy across three replication endpoints; corporately, Dr Michelle Miller resigned as Managing Director and CEO on 14 September 2026, and after quarter end the company appointed Glenn Gilbert as CEO and Executive Director effective 18 January 2027 and Dr Michael Thurn as Non-Executive Director; financially, Biotron reported cash and cash equivalents of A$1.060 million at 30 September 2026, net operating cash outflow of A$494,000, research and development payments of A$82,000, no investing or financing cash flows, related-party payments of A$268,000 for director fees, salaries and superannuation, estimated funding of 2.15 quarters based on current burn, and noted a post-quarter additional refundable FY2024 tax offset of A$208,463 from the Australian Taxation Office, increasing total recognised tax offset refunds for the year to about A$2.022 million.
Key Points
  • Quarter covered the period ended 30 September 2026 and the announcement was released on 28 October 2026.
  • Biotron continued work on an updated EMA submission for SedRx to clarify the European regulatory pathway and pivotal clinical trial requirements.
  • SedRx development also progressed for an additional neurological indication through drug procurement, assay development and animal study design.
  • New Scripps Research Institute studies showed BIT-HBV001 had strong antiviral activity in HBV/HDV co-infected cells.
  • BIT-HBV001 reduced HBsAg by 98.1% and HBV-DNA by 99.7%, compared with Myrcludex B reductions of 93.8% and 93.0% respectively.
  • Myrcludex B produced the greater HDAg reduction at 94.8% versus 81.0% for BIT-HBV001.
  • Combination testing of BIT-HBV001 with Myrcludex B showed significant antiviral synergy across three viral replication endpoints.
  • Dr Michelle Miller stepped down as Managing Director and CEO on 14 September 2026.
  • After quarter end, Glenn Gilbert was appointed CEO and Executive Director effective 18 January 2027.
  • After quarter end, Dr Michael Thurn was appointed Non-Executive Director effective immediately.
  • Cash and cash equivalents at 30 September 2026 were A$1.060 million.
  • Net cash used in operating activities during the quarter was A$494,000.
  • Research and development cash payments for the quarter were A$82,000.
  • There were no investing or financing cash flows reported in the Appendix 4C.
  • Related-party payments totalled A$268,000 and comprised director fees, salaries and superannuation.
  • Based on the September-quarter operating cash outflow, Biotron estimated 2.15 quarters of funding available.
  • Post quarter end, the company received an additional ATO refundable amount of A$208,463 for FY2024, increasing recognised annual tax offset refunds to about A$2.022 million.
  • Near-term priorities included advancing EMA engagement for SedRx, progressing the added neurological indication work, evaluating development and partnering options for BIT-HBV001, and completing the leadership transition.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.