Oncosil Medical Ltd · ASX:OSL

Oncosil Medical — Investor Presentation (August 2026)

15 slides from Oncosil Medical's investor presentation, Aug 17, 2026

  1. Slide 1: Investor Webinar: FDA Approval: A New Chapter for OncoSil

    For personal use only Investor Webinar FDA Approval: A New Chapter for OncoSil CEO & Managing Director, Nigel Lange 17 August 2026

  2. Slide 2: Disclaimer

    Disclaimer This Presentation has been prepared by OncoSil Medical Ltd (ASX:OSL) (OncoSil, OSL or the Company) to provide a general overview of the Company. This Presentation and the information contained may require further explanation and/or clarification. Accordingly, this Presentation and the inf

  3. Slide 3: OncoSil Device Receives U.S. Humanitarian Device Exemption Approval from FDA for Distal Cholangiocarcinoma

    OncoSil Device Receives U.S. Humanitarian Device Exemption Approval from FDA for Distal Cholangiocarcinoma For personal use only U.S. Food and Drug Administration (FDA) has granted Humanitarian Device Exemption (HDE) approval for the OncoSil device for the treatment of distal cholangiocarcinoma (dCC

  4. Slide 4: Distal Cholangiocarcinoma (dCCA)

    Distal Cholangiocarcinoma (dCCA) Patients with dCCA have a poor prognosis with limited treatment options and survival For personal use only • dCCA develops as a cancerous tumour in the common bile duct within the head of the pancreas. • Clinical symptoms of the disease are not evident until the tumo

  5. Slide 5: Treatment for Unresectable dCCA and Impact on Quality of Life (QoL)

    Treatment for Unresectable dCCA and Impact on Quality of Life (QoL) The dCCA disease course has a negative impact on QoL for the patient • Since most dCCA patients have a stent implanted, the challenge for clinicians is to maintain the patency of the For personal use only common bile duct. • Invaria

  6. Slide 6: HDE: Accelerating US Market Access for OncoSil in dCCA

    HDE: Accelerating US Market Access for OncoSil in dCCA What is HDE Pathway? Why HDE is Relevant for Strategic Benefit for OncoSil OncoSil in dCCA For personal use only • Designed for medical devices ✓ Reduced clinical development targeting rare diseases burden and cost (no randomised affecting fewer

  7. Slide 7: U.S. dCCA Patient Population Represents an A$80m Annual Addressable Market

    U.S. dCCA Patient Population Represents an A$80m Annual Addressable Market For personal use only Annual U.S. cholangiocarcinoma cases ~ 8,000 1 dCCA (~30 - 40%) ~ 2,800 2 Unresected, non-metastatic dCCA (~33%) ~ 1,000 3 Assumed ASP per patient US$55,000 Total Addressable Market (TAM) ~ A$80 million*

  8. Slide 8: HDE Approval Opens a New Treatment Option for Patients in U.S. with dCCA

    HDE Approval Opens a New Treatment Option for Patients in U.S. with dCCA For personal use only The FDA has approved the OncoSil device under the HDE pathway for the following indication: OncoSil is intended for intratumoral implantation into a solid tumour via injection under endoscopic ultrasound g

  9. Slide 9: Distal Cholangiocarcinoma Study: Post-Approval Study (PAS)

    Distal Cholangiocarcinoma Study Post-Approval Study (PAS) For personal use only STUDY DESIGN STUDY OBJECTIVE Evaluate the safety and probable benefit of Multicentre │ Observational │ Prospective OncoSil in patients with distal cholangiocarcinoma (dCCA) that is both unresectable (locally advanced 5 3

  10. Slide 10: Focused U.S. Commercialisation Strategy and Market Launch

    Focused U.S. Commercialisation Strategy and Market Launch Pathway to a targeted U.S. launch of the OncoSil device in 2H FY27 For personal use only Activate Priority Build Clinical Advocacy Enable Access and Treatment Centres and Launch Readiness Drive Adoption • Focus launch on leading academic • En

  11. Slide 11: Summary

    Summary FDA HDE Approval Granted For personal use only • On 14 August 2026 (U.S. Eastern Time), the FDA has granted Humanitarian Device Exemption (HDE) approval for the OncoSil device for the treatment of distal cholangiocarcinoma (dCCA) in the United States. • Approval completes the Company’s HDE r

  12. Slide 12: Outlook

    For personal use only Outlook

  13. Slide 13: Upcoming Milestones in FY27

    Upcoming Milestones in FY27 1H FY27 2H FY27 For personal use only • OncoSil device US label filing to FDA (HDE) • EU regulatory approval – percutaneous label change (PANCOSIL) • Presentation of TRIPP-FFX Clinical Trial Results at ESMO GI • EU regulatory approval – FOLFIRINOX label change (TRIPP-FFX)

  14. Slide 14: Q&A

    For personal use only Q&A 14

  15. Slide 15: Learn more about OncoSil Medical

    For personal use only Learn more about OncoSil Medical: • Website • ASX announcements • LinkedIn This announcement was authorised by the Board of Directors of OncoSil Medical Limited. INTENDED USE / INDICATIONS FOR USE: The OncoSil System is intended to induce prolonged local tumour control and tumo

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