Announcement PDF Investor Webinar FDA Approval: A New Chapter for OncoSil CEO & Managing Director, Nigel Lange 17 August 2026 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 information contained should be read in conjunction with past and future ASX announcements made by OncoSil and should not be relied upon as an independent source of information. Please contact OncoSil and/or refer to the Company's website www.oncosil.com for further information. Not an Offer for Securities Nothing in this Presentation constitutes investment advice or should be construed as either an offer to sell or a solicitation of an offer to buy or sell shares in the Company, in any jurisdiction. This presentation is not exhaustive of all of the information a potential investor or their professional advisers would require for evaluating OSL, its assets, possible valuation, prospects or potential opportunities. Please note that the information contained herein is only of a general nature. It should NOT be relied upon for any evaluation of OSL or for making any investment decision. This presentation does NOT constitute a “Prospectus" or a "Disclosure Document” (as defined in the Corporations Act 2001 (Cth) (Corporations Act)) and has not been, and will not be, lodged with the Australian Securities and Investments Commission or any other regulatory authority. Accordingly, it is not required to contain, and may not necessarily contain, all of the information that a Prospectus or like Disclosure Document would be required to contain pursuant to the Corporations Act. The distribution of this presentation in jurisdictions outside Australia may be restricted by law. 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Forward-Looking Statements This document contains certain forward-looking statements as at the date of this presentation relating to OncoSil’s business, which can be identified by the use of forward-looking terminology such as “promising”, “plans”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”, “targeting”, “aiming”, “set to”, “potential”, “seeking to”, “goal”, “could provide”, “intends”, “is being developed”, “could be”, “on track”, or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA and other national and international authorities’ requirements regarding any one or more product candidates, nor can there be any assurance that such product candidates will be approved by any authorities for sale in any market or that they will reach any particular level of sales, nor that that any specific objective of the Company will be achieved or that any particular performance of the Company or of its shares will be achieved. A number of important factors could cause the Company’s actual results to differ materially from the plans, objectives, expectations, estimates and intentions expressed in such forward looking statements, including (without limitation) the risks and uncertainties associated with the ongoing impacts of the Australian and global economic environment and capital market conditions and the risk factors described in the slides titled "Key Risks", with many of these factors beyond the Company’s control. In particular, the Company's expectations regarding the approval and commercialisation of the product candidates could be affected by, amongst other things, unexpected trial results, including additional analysis of existing data, and new data; unexpected regulatory actions or delays, or government regulation generally; changes in legislation or regulatory requirements, our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our Company, products, product candidates, financial results and business prospects. Should one or more of these changes, risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. OncoSil is providing this information as of the date of this document and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or developments or otherwise in relation to the underwritten accelerated non-renounceable rights issue and placement to institutional investors of new fully paid ordinary shares in the Company (New Shares) and attaching options. There is NO guarantee of future performance - actual results and future outcomes will in all likelihood differ from those outlined herein. You are urged to consider all of the above and advice from your own advisers carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on the forward-looking statements. The information in this presentation is not financial product advice, is not an offer to invest in the securities of OncoSil and does not take into account your investment position or objectives, financial situation or any particular requirements. For these and other reasons, you are strongly recommended to obtain your own up to date independent legal, financial and investment advice – those acting without such advice do so at their own risk. Disclaimer This Presentation and any supplemental materials have been prepared by OncoSil based on available information. Although reasonable care has been taken to ensure the facts stated in this presentation are accurate and that the opinions expressed are fair and reasonable, no representation or warranty, express or implied, is made as to the fairness, accuracy, completeness, or correctness of such information and opinions and no reliance should be placed on such information or opinions. The Company is not obliged to advise of changes or provide updates to any such materials. To the maximum extent permitted by law, none of OncoSil or any of its members, directors, officers, employees, or agents or corporate advisors, nor any other person accepts any liability whatsoever for any loss, however arising, from the use of the presentation or its contents or otherwise arising in connection with it, including, without limitation, any liability arising from fault or negligence on the part of OncoSil or any of its directors, officers, employees or agents. Any investment in the Company is subject to a number of investment risks including the possibility of loss of capital invested and no return of income or payment of any dividends. Neither OncoSil nor any other entity or person in or associated with OncoSil guarantees any return (whether capital or income) or generally the performance of OncoSil or the price at which its securities may trade. Past performance of the Company cannot be assumed as indicative of the future performance. There is NO guarantee of future performance - actual results and future outcomes will in all likelihood differ from those outlined in this presentation. All dollar values are in Australian dollar ($A) terms unless otherwise stated. Figures in this presentation are subject to rounding. The information contained in this presentation is current as of 17 August 2026. 2 OncoSil Device Receives U.S. Humanitarian Device Exemption Approval from FDA for Distal Cholangiocarcinoma U.S. Food and Drug Administration (FDA) has granted Humanitarian Device Exemption (HDE) approval for the OncoSil device for the treatment of distal cholangiocarcinoma (dCCA) in the United States. FDA approval completes OncoSil Medical’s HDE regulatory process and provides U.S. marketing authorisation for the approved indication, enabling commercial marketing and sale subject to HDE requirements and conditions. OncoSil device the first and only U.S. FDA approved Class III device for the treatment of dCCA. OncoSil Medical will now commence a focused U.S. commercialisation strategy targeting leading academic cancer centres and specialist hepatobiliary oncology teams, with U.S. launch expected in the second half of FY27. 3 Patients with dCCA have a poor prognosis with limited treatment options and survival Distal Cholangiocarcinoma (dCCA) • 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 tumour has developed to a point that it is difficult to remove with surgery. • More than 50% of patients who develop dCCA cannot have the tumour removed surgically (the tumour is “unresectable”).1 • Unresected, non-metastatic dCCA is associated with a poor prognosis, with reported median overall survival of just 6.7 months,2 while dCCA incidence has been reported to be increasing by 1.4% annually.3 • Treatments for unresectable tumours involve the placement of a stent, chemotherapy, external radiation therapy, or a combination of the two. • Side effects due to chemotherapy and radiotherapy are considerable and have a negative impact on the quality of life for the patient. • OncoSil has shown promise for dCCA 3 and is the basis for the HDE. • The advantage of OncoSil is the ability to deliver a high radiation dose to the target dCCA tumour with minimal side-effects. 4 References: 1. Hester CA, Dogeas E, Augustine MM, et al. Incidence and comparative outcomes of periampullary cancer: A population-based analysis demonstrating improved outcomes and increased use of adjuvant therapy from 2004 to 2012. J Surg Oncol 2019; 119:303- 317. doi: 10.1002/jso.25336 2. Strijker, M. et al. (2019) ‘Treatment and survival of resected and unresected distal cholangiocarcinoma: a nationwide study’, Acta Oncologica, 58(7), pp. 1048–1055. 3. Rahman R, et al. (2022). “Age trends in biliary tract cancer incidence by anatomical subtype: A Swedish cohort study.” European Journal of Cancer, 175, 291–2982. 4. Ross PJ et al. Results of a single-arm pilot study of 32P microparticles in unresectable locally advanced pancreatic adenocarcinoma with gemcitabine/nab-paclitaxel or FOLFIRINOX chemotherapy. ESMO Open February 2022; 7 (1): 100356. The dCCA disease course has a negative impact on QoL for the patient Treatment for Unresectable dCCA and Impact on Quality of Life (QoL) 5 • Since most dCCA patients have a stent implanted, the challenge for clinicians is to maintain the patency of the common bile duct. • Invariably the stent occludes within 4–6 months due to tumour development . • This results in significant complications including extreme abdominal pain and cholangitis (inflammation and infection) which necessitates admission to hospital: o interruption of chemotherapy o possible surgery to replace the stent and reopen the bile duct o administration of antibiotics to control the infection • As the disease continues to progress, subsequent re-occlusion of the stent results in repeated admissions to hospital. • The patient inevitably succumbs to sepsis (systemic infection) and liver or multi-organ failure. OncoSil has the potential to control local tumour development and maintain bile duct patency, resulting in increased quality of life and extended survival. HDE: Accelerating US Market Access for OncoSil in dCCA * Subject to oversight conditions standard under the HDE framework What is HDE Pathway? • Designed for medical devices targeting rare diseases affecting fewer than 8,000 individuals annually • Permits approval based on demonstration of probable benefit outweighing risk, rather than requiring the extensive clinical evidence of a costly Phase III randomised clinical trial needed for a (Pre-market approval) PMA • Provides shortened market access with a cost-efficient route Why HDE is Relevant for OncoSil in dCCA • dCCA is a rare and highly aggressive cancer with limited treatment options and poor prognosis • OncoSil is being positioned as a novel, localised radiation treatment that can address a significant unmet need in this patient population • Under this approval, OncoSil Medical will be authorised to commercially market and sell the OncoSil device in the US* Strategic Benefit for OncoSil ✓ Reduced clinical development burden and cost (no randomised trial) ✓ Earlier US commercial entry opportunity ✓ Homogeneous reimbursement landscape ✓ Shorter regulatory timeline versus PMA ✓ Ability to generate real-world evidence and physician adoption post-approval ✓ Establishes US market presence in a high-value oncology indication HDE Eligibility → FDA Approval → Coding & Reimbursement → Initial Commercialisation → US Adoption 6 U.S. dCCA Patient Population Represents an A$80m Annual Addressable Market 1. American Cancer Society / Key Statistics for Bile Duct Cancer / https://www.cancer.org/cancer/types/bile-duct-cancer/about/key-statistics.html Last revised on October 11, 2024 2 Terasaki F, Sugiura T, Okamura Y, et al. Systemic immune-inflammation index as a prognostic marker for distal cholangiocarcinoma. Surg Today. 2021;51(10):1602–1609. doi:10.1007/s00595-021-02312-7 3 Includes incidence increases of 1.4% per annum. Strijker, M. et al. (2019) ‘Treatment and survival of resected and unresected distal cholangiocarcinoma: a nationwide study’, Acta Oncologica, 58(7), pp. 1048–1055 4 Rahman R, et al. (2022). “Age trends in biliary tract cancer incidence by anatomical subtype: A Swedish cohort study.” European Journal of Cancer, 175, 291–2982 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* 7 * USD/AUD = 1.43 6.7 MONTHS Median overall survival unresected, non-metastatic dCCA3 +1.4% P.A. Reported annual increase in dCCA incidence4 HDE Approval Opens a New Treatment Option for Patients in U.S. with dCCA 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 guidance. OncoSil is indicated for the treatment of patients with distal cholangiocarcinoma (dCCA) that is both unresectable (locally advanced and/or unfit for surgery) and non-metastatic, as an adjunct to systemic therapy. OncoSil is indicated for the treatment of patients over 21 years of age. Implantable components of OncoSil are supplied sterile and are intended for single-patient, single-use. 8 Post-Approval Study (PAS) Distal Cholangiocarcinoma Study Evaluate the safety and probable benefit of OncoSil in patients with distal cholangiocarcinoma (dCCA) that is both unresectable (locally advanced and/or unfit for surgery) and non-metastatic, as an adjunct to systemic therapy. STUDY DESIGN STUDY OBJECTIVE 30 PATIENTS 5 SITES 24MONTHS FOLLOW UP Multicentre │ Observational │ Prospective OUTCOMES ASSESSED • Overall survival • Safety and tolerability • Implantation performance • Biliary patency • Local disease control/progression • Target tumour response • Progression-free survival • Local progression-free survival • Surgical resection rates and outcomes 9 Initial ~US$1.7 million in commercial revenue for OncoSil Medical Pathway to a targeted U.S. launch of the OncoSil device in 2H FY27 Focused U.S. Commercialisation Strategy and Market Launch • Focus launch on leading academic cancer centres with established dCCA and hepatobiliary oncology expertise • Establish and activate priority treatment sites ahead of the planned U.S. launch in 2H FY27 • Build a concentrated initial footprint, supported by a small, focused U.S. team, designed to support high- quality execution and early adoption • Low capital requirements under initial commercial model • Engage key opinion leaders and multidisciplinary clinical teams to support clinical adoption • Enhance clinician education and training so treatment teams are prepared and supported from launch • Leverage early centre experience to build confidence, advocacy and referral momentum • Submit the application for Transitional Pass-Through Payment Status in Q1 FY26 and advance market-access pathways to facilitate patient access to treatment • Deploy targeted physician, patient and referral initiatives to build awareness and support patient identification • Drive adoption through coordinated market access, education and focused commercial execution Commercial objective: establish a high-quality early U.S. centre network, remove access barriers and create a scalable platform for broader adoption. Activate Priority Treatment Centres Build Clinical Advocacy and Launch Readiness Enable Access and Drive Adoption 10 Summary FDA HDE Approval Granted • 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 regulatory process and provides U.S. marketing authorisation for the approved indication. Commercial Authorisation & Market Opportunity • OncoSil Medical is authorised to commercially market and sell the OncoSil device in the U.S. for the approved indication, subject to applicable HDE requirements and conditions. • FDA approval provides entry into the world’s largest healthcare market, representing an estimated A$80 million annual Total Addressable Market (TAM) and significantly broadens the commercial opportunity for the OncoSil platform. U.S. Commercialisation • The Company will commence a focused U.S. commercialisation strategy targeting leading academic cancer centres and specialist hepatobiliary oncology teams. • OncoSil is expected to launch in the U.S. during the second half of FY27. 11 Outlook Upcoming Milestones in FY27 13 1H FY27 2H FY27 • OncoSil device US label filing to FDA (HDE) • Presentation of TRIPP-FFX Clinical Trial Results at ESMO GI Congress • Completion of validation of manufacturing at Cyclotek • PALACROS European consortium | PULSE trial • FDA HDE approval for distal cholangiocarcinoma (dCCA) • ISO 13485 Certification OncoSil|Cyclotek manufacturing facility • G-BA funded study commencement • Transitional Pass Through Payment Application: Centers for Medicare and Medicaid Services (CMS) - Reimbursement • EU regulatory submission – percutaneous label change (PANCOSIL) • EU regulatory submission – FOLFIRINOX label change (TRIPP- FFX) • Commercial sales from OncoSil|Cyclotek manufacturing facility in Sydney* • EU regulatory approval – percutaneous label change (PANCOSIL) • EU regulatory approval – FOLFIRINOX label change (TRIPP-FFX) • Launch of OncoSil device in Australia • Launch of OncoSil device in the United States* * Subject to approvals Q&A 14 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 Phosphorous-32 Microparticles into pancreatic tumours under endoscopic ultrasound guidance. OncoSil is indicated for the treatment of patients with locally advanced unresectable pancreatic cancer, in addition to gemcitabine-based chemotherapy. This information is intended for healthcare professionals only. All medical treatments carry benefits and risks. For safety related information, please refer to the OncoSil System Instructions for Use. OncoSil is a registered trademark of OncoSil Medical Ltd. Level 5, 7 Eden Park Drive, Macquarie Park, NSW, 2113, Australia. www.oncosil.com Learn more about OncoSil Medical: • Website • ASX announcements • LinkedIn This announcement was authorised by the Board of Directors of OncoSil Medical Limited.