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BIOTRON LIMITED Capital/Financing Update 2025

Nov 10, 2025

64528_rns_2025-11-10_f52404e6-afbe-47e5-b42b-98b7a6f39ceb.pdf

Capital/Financing Update

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Level 2, 66 Hunter Street Sydney NSW 2000 Tel: (61-2) 9300 3344 Fax: (61-2) 9221 6333 E-mail: [email protected] Website: www.biotron.com.au

11 November 2025

The Manager Companies ASX Limited 20 Bridge Street Sydney NSW 2000

(3 pages by email)

Dear Madam

SHAREHOLDER UPDATE

In accordance with Listing Rule 3.17, I attach a copy of a document as sent to the Company's shareholders.

Yours sincerely

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Marcelo Mora

Company Secretary

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November 2025

Dear Shareholders

Biotron was pleased to recently announce a major strategic development for the Company that positions it for significant growth and diversification.

The acquisition of Sedarex Limited (Sedarex), the owner of SedRx[TM] , a patented, next-generation general anaesthetic formulation with superior safety and cognitive outcomes compared with the current global market standard of care, is a positive step for Biotron.

It is expected to bring significant benefit to Biotron shareholders via a number of major valueadding, short term milestones.

A brief background:

  • SedRx contains alfaxalone which is the active ingredient (API) of a proven general anesthesia Althesin that was marketed in Europe by Glaxo for 14 years and had 50% share of the day care market in the UK.

  • SedRx is a new formulation of alfaxalone mixed with a safe, FDA and EMA approved solubilising agent; Sedarex patents relate to this new formulation and associated manufacturing progresses for alfaxalone and the new solubilising agent.

  • Clinical trials of SedRx have demonstrated its safety and advantages over the current market leader (propofol).

  • FDA backing for a 505(b)(2) pathway and potential EMA abridged approval.

  • In addition to the late-stage general anaesthetic opportunity offered by SedRx, there is blue sky potential with additional new indications in the high growth neuroscientific field under development.

Sedarex provides Biotron with an advanced, largely de-risked asset with good existing clinical data and a large addressable market. Importantly, there is also the potential for a fast path to market, with the FDA agreeing to a 505(b)(2) pathway and the potential for an abridged approval pathway in Europe and the UK via the EMA.

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Two clinical trials, including a pilot Phase 3 trial, have demonstrated positive outcomes in three key areas:

  • Efficacy: comparable to propofol,

  • Safety: superior to propofol (improved cardiovascular stability and less respiratory depression),

  • Differentiated profile compared to propofol: potential to reduce post-operative cognitive decline.

The Phase 2a (pilot Phase 3) clinical trial demonstrated that SedRx delivered better recovery of cognition post-surgery compared with propofol. Complications associated with post-anaesthetic delirium include longer hospitalisation, as well as longer term health issues including progressive cognitive decline, dementia and death.

Sedarex is also developing additional new formulations and disease indications in the neuroscientific space, which are expected to provide further blue sky investor benefits.

The acquisition of Sedarex in no way impacts on the ongoing development of Biotron’s antiviral portfolio, which will continue. Through strategic partnerships and innovative viroporin-targeting compounds, Biotron remains focused on developing effective therapies for unmet medical needs. Biotron’s preclinical Hepatitis B virus (HBV) program has the potential to address chronic HBV, a global health issue affecting over 250 million people.

To support this transformative acquisition and ongoing programs, Biotron has secured:

  • $1 million via a 2-tranche Placement at $0.003 per share, with 1 attaching option (exercisable at $0.02) for every 2 shares.

  • $1.5 million Rights Issue to shareholders on the same terms.

Peak Asset Management is lead manager for both the Placement and Rights Issue and has committed to subscribe for any shortfall.

The acquisition of Sedarex as well as the second tranche of the Placement are subject to shareholder approval at the upcoming AGM on 17 November.

This acquisition marks a pivotal moment for Biotron, expanding our pipeline with a late-stage clinical asset while continuing our antiviral mission.

Biotron is conducting an Investor Webinar on Tuesday 11 November at 11am. A link for registration is available on the Biotron website homepage, and the Webinar will be available on the website afterwards for those unable to attend.

Thank you for your continued support.

Michelle Miller

Managing Director Biotron Limited

Level 2, 66 Hunter St, Sydney NSW 2000, Australia + 61 (0) 2 9300 3344 |[email protected]