Slide 1: Presentation to Investors
Level 2, 66 Hunter Street Sydney NSW 2000 Tel: (61-2) 9300 3344 Fax: (61-2) 9221 6333 E-mail: mmora@miscorp.com.au Website: www.biotron.com.au 11 November 2025 The Manager Companies ASX Limited 20 Bridge Street SYDNEY NSW 2000 Dear Madam PRESENTATION TO INVESTORS I attach a PowerPoint presentation w
Slide 2: Investor Webinar
INVESTOR WEBINAR ASX:BIT 11 November 2025
Slide 3: 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 4: Expansion of Clinical Portfolio with Acquisition of Sedarex Limited
Expansion of Clinical Portfolio with Acquisition of Sedarex Limited Strategic development for Biotron that positions the company for significant growth and diversification. Expanding beyond antivirals with the acquisition of Sedarex Limited, the owner of SedRx — a patented, next- generation general
Slide 5: Biotron to continue development of its antiviral portfolio
Biotron to continue development of its antiviral portfolio The Sedarex acquisition will not impact on ongoing development of Biotron’s antiviral programs. Biotron remains focused developing effective therapies for unmet medical needs and on achieving commercial outcomes for all programs. The Hepatit
Slide 6: SedRx – Graeme Wald, Director, Sedarex
SedRx Graeme Wald Director, Sedarex
Slide 7: SedRx
Overview | November 2025 SedRx Sedarex Ltd A proprietary safer validated PLUS Additional neuroscientific anaesthetic designed to deliver applications addressing area of key better surgical outcomes: unmet medical need with large, ▪ Cognition expanding international markets. ▪ Neuroprotection ▪ Cardi
Slide 8: SedRx: A Proprietary Safer Validated Anaesthetic
Overview | November 2025 SedRxTM: A Proprietary Safer Validated Anesthetic ▪ Patented, improved reformulation of a proven general anesthesic marketed in Europe for 14 years ▪ Previous version had 50% market share in the UK ▪ Fixed issue of side effects from previous version’s solubilising agent ▪ Op
Slide 9: Opportunity - Commercialising a proven, safer anaesthetic
Overview | November 2025 Opportunity - Commercialising a proven, safer anaesthetic Sedarex aims to re-launch a reformulated safer general anaesthetic into a global US$5 billion market with a 3.3% CAGR. The previous formulation had 50% market share of day care procedures in UK. Replacing the original
Slide 10: Path to Market: Novel Patented Formulation
Overview | November 2025 Path to Market: Novel Patented Formulation Alfaxalone SBECD API Solubilising agent Formulation and use Using the same proven SBECD approved by FDA patents granted API, used as anaesthetic in millions of humans and EMA Widely used in worldwide Alfaxalone widely used numerous
Slide 11: Path to Market: Animal Testing: Successful
Overview | November 2025 Path to Market: Animal Testing: Successful Alphaxalone Reformulated: A Water-Soluble Intravenous Anesthetic Preparation in Sulfobutyl-Ether-β- Cyclodextrin Colin S. Goodchild, MA, MB, BChir, PhD, FRCA, FANZCA, FFPMANZCA,* Juliet M. Serrao, MB, BS, PhD, FRCA,† Anton Kolosov,
Slide 12: Path to Market: Phase 1: Successful cardiovascular results
Overview | November 2025 Path to Market: Phase 1: Successful cardiovascular results: Effective and safer than propofol Less CVS depression at No compensatory heart equivalent depth of rate change to explain the anaesthesia difference SedRx SedRx v Propofol SedRx GA SedRx GA SedRx GA Monagle et al. A
Slide 13: Successful Phase IIA (Pilot Phase III) Clinical Trial
Overview | November 2025 Successful Phase IIA (Pilot Phase III) Clinical Trial Alfaxalone anaesthesia delivers better recovery of cognition and preservation of brain derived neurotrophic factor compared with propofol and sevofluran Propofol: filling in Digit Symbol Substitution test 40 mins after an
Slide 14: Summary of Completed Work and Major Publications
Overview | November 2025 Summary of Completed Work and Major Publications Sedarex Ltd –Trusted anaesthesia designed for a safer, better patient experience 13
Slide 15: Problem: Current anaesthetics may cause harm
Overview | November 2025 Problem: Current anaesthetics may cause harm such as: Reduce blood pressure • 43% of heart attacks during surgery are associated with low blood pressure • 6.8 day increase in hospital stay • Increases risk of stroke and kidney failure Reduce respiration & airway control • Le
Slide 16: SedRx designed to be the ideal anaesthetic
Overview | November 2025 SedRx designed to be the ideal anaesthetic SedRx Propofol Fluranes • SedRx has improved clinical outcomes Rapid sleep onset compared to propofol & fluranes Fast wakeup • It is easier and Improved CVS safety cheaper to manufacture Breathing safety • Less chance of Less damage
Slide 17: Anonymous survey of anaesthesiologists backs Target Product Profile
Overview | November 2025 Anonymous survey of 155 anaesthesiologists backs Target Product Profile (TPP) Expect strong acceptance by clinicians due to 91 superior results over propofol 77 74 69 71 61 63 56 55 An elderly patients with heart A patient with severe respiratory A healthy patient A case of
Slide 18: Growing market for general anaesthetic drugs
Overview | November 2025 Growing market for general anaesthetic drugs Other Propofol, Sevoflurane and Desflurane are 64% of the Midazolam 3% market and growing at ~4% per annum. 6% Dexmedetomidine Propofol Demand is driven by: 17% 27% $3.2B Aging population Revenue opportunity from Remifentanil a $4
Slide 19: Competitive Advantages
Overview | November 2025 Competitive Advantages ICU Market (Patients on Ventilators) Cognitive Ability Retained by SedRx • Sedation in ICU estimated to reach US$3.69B Remifentanil by 2026 (Fortune Business Insights). 13% • Major drivers are: Dexmedetomidine • Aging population, co-morbidities. 14% •
Slide 20: Problem to be Solved
Overview | November 2025 Problem to be Solved JAMA August 2, 2021: ”Among patients aged 65 years and older, up to an estimated 65% experience delirium and 10% develop long-term cognitive decline after noncardiac surgery. Complications associated with delirium include longer hospitalization, more day
Slide 21: Phase-Three Pathway: Low hurdles to commercialisation
Overview | November 2025 Phase-Three Pathway Low hurdles to commercialisation We will seek Successfully approval without Manufacturing completed pre- FDA should allow a clinical trial alfaxalone clinical trial, Phase for short path to from the scheduled to I trial, and a pilot approval European star
Slide 22: Historic formulation: Althesin
Overview | November 2025 Historic formulation: Althesin Althesin: 3 million doses administered (at March 1977) Althesin with flawed solubilizing agent CremophorE Alfaxalone API L Solubilising agent Althesin held ~50% CremophorEL caused market share of human some patients to develop day care procedur
Slide 23: Solution: SedRx
Overview | November 2025 Solution: SedRxTM Historic formulation: Althesin Novel, patented formulation: SedRx CremophorE Alfaxalone Alfaxalone SBECD API L API Solubilising agent Solubilising agent Althesin held ~50% CremophorEL caused Using the same proven SBECD approved by FDA market share of human
Slide 24: Target Product Profile
Overview | November 2025 Target Product Profile Indications Clinical Profile General anaesthesia (induction and Efficacy: comparable to propofol maintenance) A neuroactive anaesthetic Sedation for short Safety: superior to propofol (Improved formulation term procedures - cardiovascular stability, an
Slide 25: Accelerated regulatory pathway – EMA
Overview | November 2025 Accelerated regulatory pathway – EMA: possibly no additional clinical trial EMA - Pathway to near term revenue $863 million EU market opportunity • Althesin was approved in UK with up to 50% market share in day Peak market care market (also approved in France, Germany and Ne
Slide 26: Regulatory status – FDA: completed phase 2A trial
Overview | November 2025 Regulatory status – FDA: completed phase 2A trial FDA US$3.2B: US revenue opportunity • Successfully completed pre-clinical trial, Phase I trial, and a Peak market pilot Phase III (IIa) trial comparing SedRx GA to propofol and Valuation (USD) penetration sevoflurane, the cur
Slide 27: Contact: Dr Graeme Wald
Overview | November 2025 Contact: Dr Graeme Wald Director Email: Graeme@sedarex.com Tel: +61 421 053 169 Sedarex Ltd –Trusted anaesthesia designed for a safer, better patient experience 26
Slide 28: Financing lead by Peak Asset Management
Financing lead by Peak Asset Management - Commitments received for a $1M Placement (2 tranche) - Issue price of $0.003 per share, with one attaching option ($0.02 expiring 2 years from date of issue) for every 2 shares issued - Tranche 1 (under Listing Rule 7.1) – 199,086,876 shares ($597,260) - COM
Slide 29: Acquisition of Sedarex Limited
Acquisition of Sedarex Limited - Summary of acquisition terms: - Biotron to purchase 100% of Sedarex issued shares for: - 500 million BIT fully paid ordinary shares ($1.5M @ $0.003 per share) - $250,000 BIT shares subject to receipt of regulatory guidance pathway from EMA - $250,000 BIT shares subje
Slide 30: Outlook for 2026
Outlook for 2026 - Two key milestones for Sedarex technology: - Sedarex receiving guidance regarding the European regulatory pathway for the Sedarex general anaesthetic product by no later than 31 July 2026.* - Sedarex demonstrating efficacy of a new formulation of the SedRx product in a suitable an
Slide 31: Summary
Summary - SedRx opens up significant development and commercial opportunities for Biotron - Positions Biotron with a clear commercialisation pathway in multi-billion dollar markets - SedRx is a well differentiated product with significant advantages over current standard general anaesthetics, especi
Slide 32: Biotron Limited (ASX:BIT)
BIOTRON LIMITED (ASX:BIT) Michelle Miller Managing Director mmiller@biotron.com.au www.biotron.com.au +61 412313329