Oncosil Medical Ltd · ASX:OSL
Oncosil Medical — Corporate Update (June 2026)
20 slides from Oncosil Medical's corporate update, Jun 9, 2026
Slide 1: ASX Announcement: Investor Presentation FDA Update & TRIPP-FFX Initial Results
ASX Announcement 9 June 2026 Investor Presentation FDA Update & TRIPP-FFX Initial Results Sydney, Australia – 9 June 2026: OncoSil Medical Limited (ASX: OSL) is pleased to the release the following investor presentation to the market. OncoSil Medical will be hosting an investor webinar at 10.30 am A
Slide 2: Investor Webinar: FDA Update & TRIPP-FFX Initial Results
For personal use only Investor Webinar FDA Update & TRIPP-FFX Initial Results CEO & Managing Director, Nigel Lange 9 June 2026
Slide 3: FDA Update
For personal use only FDA Update 2
Slide 4: OncoSil Reaches Final FDA Review Stage for Humanitarian Device Exemption Application
OncoSil Reaches Final FDA Review Stage for Humanitarian Device Exemption Application For personal use only U.S. Food and Drug Administration (FDA) confirm all outstanding questions relating to OncoSil's Humanitarian Device Exemption (HDE) application for the treatment of distal cholangiocarcinoma (d
Slide 5: 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 • Designed for medical devices ✓ Reduced clinical development For personal use only targeting rare diseases burden and cost (no randomised • dCCA is a rar
Slide 6: OncoSil Advances to Final Administrative Stage Before Potential FDA HDE Approval
OncoSil Advances to Final Administrative Stage Before Potential FDA HDE Approval For personal use only Major Regulatory Milestone Achieved • On 3 June 2026 (U.S. time), the FDA confirmed that all previously raised questions have been satisfactorily addressed. • Completion of the substantive review p
Slide 7: Next Steps & Value Creation Pathway
Next Steps & Value Creation Pathway For personal use only OncoSil intends to submit the requested information within the FDA's prescribed timeframe of 30 days. Potential FDA HDE approval will provide a pathway to commercialise OncoSil in the US, the world's largest medical device market. Successful
Slide 8: 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
Slide 9: 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 For personal use only • Since most dCCA patients have a stent implanted, the challenge for clinicians is to maintain the patency of the common bile duct. • Invaria
Slide 10: TRIPP-FFX Initial Results
For personal use only TRIPP-FFX Initial Results 9
Slide 11: TRIPP-FFX Met Both Co-Primary Endpoints
TRIPP-FFX Met Both Co-Primary Endpoints TRIPP-FFX met both co-primary endpoints, supporting the use of OncoSil alongside standard-of- For personal use only care FOLFIRINOX chemotherapy in patients with unresectable LAPC. Investigators concluded that toxicities associated with the addition of OncoSil
Slide 12: TRIPP-FFX: Evaluating OncoSil with Standard-of-Care FOLFIRINOX
TRIPP-FFX: Evaluating OncoSil with Standard-of-Care FOLFIRINOX An open-label, multi-centre, randomized study of TaRgeted Intratumoural Placement of Phosphorous-32 (OncoSil ) in addition to FOLFIRINOX chemotherapy versus FOLFIRINOX For personal use only chemotherapy alone in patients with unresectabl
Slide 13: Study Design, Main Eligibility Criteria and Participant Flow
Study Design, Main Eligibility Criteria and Participant Flow Randomised non-comparative Phase II study design: • Experimental arm is compared against historical control. • The study was not prospectively powered to demonstrate statistically significant differences between study arms – no formal For
Slide 14: Growing Body of Evidence - Efficacy
Growing Body of Evidence - Efficacy* Meta-Analysis of Phase PanCO 1 TRIPP-FFX For personal use only 2/3 Trials 2 gemcitabine + nab-paclitaxel Chemotherapy or Chemo- FOLFIRINOX FOLFIRINOX + OncoSil or FOLFIRINOX + OncoSil radiotherapy (ITT; n=43) (ITT; n=45) (ITT; n=50) (n~6,000 across 74 study arms)
Slide 15: Interpretation of Efficacy Results
Interpretation of Efficacy Results • The TRIPP-FFX study achieved its primary efficacy endpoint, demonstrating a meaningful improvement in For personal use only LDCR at 16 weeks compared with the historical benchmark of 55%. • For LDCR, the pre-specified success criterion for the trial required the
Slide 16: Growing Body of Evidence - Safety
Growing Body of Evidence - Safety* PanCO 1 TRIPP-FFX For personal use only gemcitabine + nab-paclitaxel or FOLFIRINOX FOLFIRINOX + OncoSil FOLFIRINOX + OncoSil (Safety Cohort) (Safety Cohort) (PP – Safety Cohort) Grade ≥3 AEs 81.0% 60.9% 70.7% • 40 patients treated with OncoSil + FOLFIRINOX are suff
Slide 17: Principal Investigators Endorse Clinical Significance of TRIPP-FFX Results
Principal Investigators Endorse Clinical Significance of TRIPP-FFX Results Michele Milella, Professor of Medical Oncology, University of Verona, Italy For personal use only and Principal Investigator of TRIPP-FFX Study: “As TRIPP-FFX was designed as a randomized but non-comparative study, the signif
Slide 18: Next Steps & Commercial Implications
Next Steps & Commercial Implications For personal use only TRIPP-FFX study met both primary endpoints, with limited and manageable toxicities and encouraging LDCR and survival endpoints following the addition of OncoSil device to FOLFIRINOX chemotherapy. Preliminary results will be submitted to a ma
Slide 19: Upcoming Milestones in CY2026
Upcoming Milestones in CY2026 1H CY2026 2H CY2026 For personal use only • TRIPP-FFX Last Patient Last Visit • FDA HDE approval for distal cholangiocarcinoma (dCCA) • OSPREY interim data accepted at ESGE Days • Completion of Cyclotek manufacturing validation • OSPREY interim data presented at ESGE Da
Slide 20: Intended Use / Indications for Use
For personal use only INTENDED USE / INDICATIONS FOR USE: The OncoSil System is intended to induce prolonged local tumour control and tumour size reduction in patients with locally advanced unresectable pancreatic cancer, in addition to gemcitabine-based chemotherapy, by implantation of radioactive