Investor Presentation
Released
Released
Announcement PDF
Investor
Presentation
15 July 2026
ASX Code: OSL
Corporate Summary
Share price (ASX:OSL) $1.40
Shares on Issue 30.9 million
Market Capitalisation $43.3 million
Cash (31 March 2026) $9.3 million
Enterprise Value $34.0 million
Options ASX:OSLOE ($0.90 | 30 Jun-27) 12.1 million
Options ASX:OSLOD ($1.20 | 31 Jul-27) 7.7 million
Top 20 Shareholders 58.4%
Substantial Shareholders
Pengana Capital (20.2%)
Regal Partners Funds (10.4%)
Australian Ethical (8.4%)
Analyst Coverage Nick Lau | Dr Dennis Hulme: Taylor Collison
Corporate Summary1,2
2
1. Share price, investor data as at 13 July 2026
2. Financial data per OncoSil Medical financial reports
Directors / Management
Share Price Graph
Dr Thomas Duthy Non-Executive Chairman
Nigel Lange CEO & Managing Director
Lelde Smits Non-Executive Director
Shelley Steyn Chief Financial Officer
Renzo DiCarlo Head of Operations & Development
Focus
A Class III medical device company focused on localised
treatments for patients with unresectable locally advanced
pancreatic cancer (LAPC) and more recently distal
cholangiocarcinoma (dCCA) under a pending HDE in the US
Key Product: OncoSil device (approved in 34+ countries)
Breakthrough Device Designation: US, Europe + UK
Commercialising
targeted
radiotherapy for
pancreatic cancer
• OncoSil Medical is commercialising the OncoSil device, an implanted device (brachytherapy) delivering targeted radiation (32P) to
pancreatic tumours
• OncoSil device is now approved for sale in over 34 countries via CE Mark
• Commercial ramp-up has commenced in FY26, driven by significant growth in existing European markets
• TGA approval received in Australia
• Reached final FDA review stage for Humanitarian Device Exemption (HDE) application in the United States (US) for distal
cholangiocarcinoma (dCCA)
• Increasing market access via label expansion combining new delivery methods and new chemotherapy combinations1
• $2.1 million investment in new Sydney facility supports a potential $98 million revenue opportunity at ~70% Gross Margin at scale
• Platform technology can be leveraged into other cancer indications (Bile duct cancer, liver, glioblastoma)
• Experienced Board & Management team in the commercialisation of interventional oncology devices
>US$4.2bn global
addressable
market3
• Granted Breakthrough designation in the EU, UK and US with extensive patent coverage across all key geographies
• Large global pancreatic cancer patient population of ~510k p.a and targeting locally unresectable population of ~153k (~30%) with the
market expected to increase by 37% by 20352
• Negligible survival improvement in over 20 years with <12% survival rates at 5-years and 8.5 months median overall
• Existing commercial markets have an addressable total market of approximately $900 million annually
• Patient recruitment completed for PANCOSIL & TRIPP-FFX trials, targeting:
✓ Percutaneous delivery to drive market access and clinical adoption globally
✓ Label expansion in addition to standard-of-care chemotherapy (FOLFIRINOX)
Executive Summary
References: 1. Subject to Regulatory Approval. 2. Globocan 2022 data . 3 179,000 global locally advanced pancreatic cancer population multiplied by US$24k average price
3
Significant
achievements
over FY26
• Patient recruitment completed for PANCOSIL study and preliminary data presented at CIRSE 2025 Congress (a groundbreaking delivery
method for OncoSil device)
• TRIPP-FFX trial (to expand OncoSil device label with additional chemotherapy combination) meets co-primary endpoints and initial data
presented at ESMO GI 2026 Congress
• OSPREY Interim results presented at ESGE Days 2026 Congress
• TGA Approval received in Australia
• Second manufacturing facility in Sydney, Australia activated, validation has been successfully completed, awaiting regulatory approval
• US FDA confirmed all outstanding questions relating to HDE application for the treatment of dCCA have been satisfactorily addressed.
Remaining documentation submitted and awaiting the approval
• German Federal Joint Committee (G-BA) tender process underway to appoint a CRO
• First patient treatments completed at Germany, Portugal and the UK
Executive Summary (cont.)
4
Momentum achieved in late FY26 is expected to continue in FY27, which is anticipated to deliver significant regulatory,
manufacturing and commercial milestones for OncoSil Medical:
• Expanding market access for LAPC and dCCA patients
• Facilitating new combinations of the OncoSil Device with standard chemotherapy in first-line LAPC
• Facilitating new treatment delivery method for the OncoSil device
• New manufacturing to simplify supply and expand margins
OncoSil Device
OncoSil is intended for the treatment of
locally advanced unresectable pancreatic
cancer, in combination with
gemcitabine-based chemotherapy
OncoSil is a single-use
brachytherapy device
comprised of microparticles
and a diluent
OncoSil is currently implanted
directly into a pancreatic
tumour via injection
under endoscopic
ultrasound guidance
98% of all radiation is
delivered within
81 days of injection
causing damage to
cancer cell DNA and
killing malignant cancer
cells with no damage to
surrounding tissue
Percutaneous delivery is transformational
and anticipated to significantly accelerate
market penetration*:
✓ Expanding the number of treating
clinicians to include Interventional
Radiologists
✓ Broader patient access and points of care
✓ Outpatient day procedure
✓ Conscious sedation (patient awake)
Requires only one supervised procedure
given simplicity and familiarity with
standard, everyday, biopsy procedures
Driving increased resection rates, downstaging, survival benefits and quality of life
5
Label extension with FOLFIRINOX
chemotherapy*:
✓ Accelerates market penetration with label
expansion to include coverage of
OncoSil device in addition to standard-
of-care chemotherapy (FOLFIRINOX)
* Subject to regulatory approvals
Reinforcing the significant unmet need for new therapeutic approaches
Pancreatic Cancer Treatment Has Seen Limited Guideline Evolution
6
First-Line (Initial Therapy) LAPC Second-Line LAPC
Disease Progression Disease Progression
Best Supportive Care
Experimental Therapies
FOLFIRINOX chemotherapy (2011)
Gemcitabine + nab-paclitaxel
chemotherapy (2013)
OncoSil device is chemotherapy agnostic; immunotherapies (mono therapy / combination therapies) have shown no survival benefit –
hence, no incorporation into treatment guidelines (NCCN, ESMO) – significantly lower risk of product obsolescence
Guideline recommendations have remained largely consistent across multiple annual updates, only change has been NALIRIFOX in 2024
– 10+ years after initial clinical data for other regimens
NCCN – National Comprehensive Cancer Network; ESMO – European Society for Medical Oncology
FOLFIRINOX chemotherapy (2011)
Gemcitabine + nab-paclitaxel
chemotherapy (2013)
OncoSil 1st line in LAPC
Growing number of active implanting centres to drive revenue momentum
Expanding Commercial Footprint Across Key European Markets
Germany
• 2 hospitals already opened before G-BA trial
• 40 new hospitals expected to start by 1H CY27
• Expecting to commence G-BA trial in 2H CY26
• Patients’ ineligible for trial may still be treated
commercially provided they are candidates for OncoSilTM
treatment
Spain
• Largest revenue-contributing market
• 9 hospitals routinely ordering and treating with OncoSil
• 4 new hospitals are expected to start in CY26
• Strong referral acceptance from oncologists and
surgeons
Italy
• 5 hospitals routinely ordering and treating with OncoSil
• 4 new hospitals are expected to start in CY26
• OncoSil adopted by two leading hospitals — University
of Verona and San Camillo Forlanini Hospital
• Revenue contribution expected to increase significantly
in 2H CY26 following finalisation of individual tender
agreements
Turkiye
• 5 hospitals routinely ordering and treating with OncoSil
• 4 new hospitals are expected to start in CY26
• Cumulatively 45% resection rate in real-world setting
• One of the largest potential markets in oncology and
nuclear medicine treatments
• Ongoing referral education initiatives to increase patient
flow
7
8
12
17
20
26
31
4
5
3
6
5
27
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
0
10
20
30
40
50
60
70
1H CY24(A) 2H CY24(A) 1H CY25(A) 2H CY25(A) 1H CY26(A) 2H CY26(E)
Commercially Active Implanting Centres
Existing New
G-BA Funded Study
German Federal Government Funded
Expected to be announced 1H FY27
~$47 million in est. value accretion
Population ~ 84 million
Pancreatic Cancer
Incidence p.a.1
22,587
Locally Advanced
Pancreatic Cancer p.a.
6,776
Market Opportunity p.a. $264 million
System-funded clinical evidence generation alongside ongoing commercial use
Germany: Capital-Efficient Phase III with Commercial Momentum
References: 1. Globocan 2025 data 2.https://www.aok.de/pp/hintergrund/mindestmengen/mindestmengen-transparenzkarte-
2026/ 3. The centres with appropriate nuclear medicine facilities capable of delivering OncoSilTM device
The top 40 German pancreatic cancer centres
performed approximately 4,400 complex pancreatic
surgeries in 20242, accounting for ~40% of all such
procedures nationwide.
These high-volume centres represent our primary
targets for commercial adoption, alongside their
anticipated participation in the G-BA trial3.
Abbreviation: G-BA: Gemeinsamer Bundesausschuss (Federal Joint Committee).
9
G-BA Market Opportunity
10
Est. LAPC patients within G-BA Centres (n=40)
4,400
Est. LAPC patients to be recruited into G-BA Trial1
280
1. Randomised 1:1 to the OncoSil + chemotherapy arm versus chemotherapy alone arm
2. G-BA sites are already NUB approved. No additional reimbursement approval needed to treat commercially.
4,120
Est. pool of patients potentially able to receive OncoSil outside of
trial within G-BA sites (eligible for reimbursement2)
$168 million (annually)
Serviceable market opportunity with high sales synergies
How the G-BA Initiative Accretes Significant Value in OncoSil
Direct Sales Revenue Over Trial Period1
$5.6 million
$6.5 million
Potential ancillary commercial sales at G-BA sites
over Trial Period2
$35.0 million
Est. cost if OncoSil Sponsored Identical G-BA Trial
Total est. value accretion
$47.1 million
11
Additional Actual + Potential Intangible Benefits
• Level 1 evidence trial (gold standard for regulators/clinicians)
• Positive data provides National Reimbursement in Germany
• Incorporation into German consensus treatment guidelines
• Potential for other European consensus treatment guidelines
• Important for Health Technology Assessments (HTAs) re: further
reimbursement in additional markets (e.g. NICE UK, HAS France)
• Significantly increases trained clinicians in Germany, driving
future adoption patterns
1. At the commercial selling price per OncoSil treatment
2. Trial recruitment expected to be over a two-year period, commencing 1H CY26
Clinical Trials
Two substantive studies reported both meeting primary endpoints
Total investment (ex COGS) - $8.1 million
Two major regulatory changes to approved label in FY27
Expanding Physician Access and Improving Procedural Economics
Expanded Label to Facilitate Percutaneous Administration
Preliminary results from the PANCOSIL Investigator Initiated Study, presented at the CIRSE 2025,
demonstrate that CT-guided percutaneous administration of OncoSilTM is safe and feasible.
Why Percutaneous Administration Matters
• Expanded physician access: Broadens treating base to include
Interventional Radiologists (IRs)
• Compelling healthcare economics:
• 10–20-minute procedure time
• Outpatient setting*
• Conscious sedation (no general anaesthesia)
• High procedural familiarity: IRs experienced in minimally invasive,
tumour-directed radiation therapies (e.g. SIR-Spheres®,
TheraSphereTM, QuiremSpheres®)
• Portfolio strategy: Attractive tuck-in product for surgical and
interventional offerings
* where permitted
1. BSI is a Notified Body under the EU Medical Device Regulation (EU MDR).That means BSI is one of the authorised independent organisations that assesses medical devices and can issue/maintain MDR certificates after a conformity assessment. The certification supports the manufacturer’s ability to
apply/maintain CE marking for the device in its approved indication/scope.
13
European IR Market Dynamics
> 5,000 Interventional Radiologists
CAGR 7-8% into 2030
~ 2,000 Interventional Radiologists in Germany
Active Tumour Board Participation
• OncoSil will file a change notification with the British Standards Institute (BSI) for its existing regulatory approval (CE Mark)
in 1H FY271
• Anticipate regulatory acceptance in 2H FY27 & commence on-label marketing of OncoSil device for percutaneous patient
treatment
M&A Activity in the Interventional Radiology Space
14
Significant M&A Activity in IR/Interventional Oncology since 2018
Acquirer
Target
[Embolic Bead Business]
Alicon (China)
TRIPP-FFX: Positive Phase II Results Support FOLFIRINOX Label
Expansion
Preliminary results from the TRIPP-FFX Trial, presented at the ESMO GI 2026, demonstrated that the study met both co-primary endpoints,
supporting the use of OncoSil alongside standard-of-care FOLFIRINOX chemotherapy in patients with unresectable LAPC.
• OncoSil will file a change notification with the British Standards Institute (BSI) for its existing regulatory approval (CE Mark) in 1H FY271
• Anticipate regulatory acceptance in 2H FY27 & commence on-label marketing of OncoSil device in addition to standard-of-care FOLFIRINOX chemotherapy
15
Study Results
• Study met both co-primary endpoints (Safety and
LDCR at 16 weeks)
• Median OS: 21.3 months for OncoSil + FOLFIRINOX
arm; 15.6 months for FOLFIRINOX only arm1
• LDCR at 16 weeks: 85.0% for OncoSil + FOLFIRINOX
arm1
• 12.5% resection rate, with 60% R0 margins1
• Manageable safety profile
1. Per protocol (PP) Analysis
Commercial Implications
Regulatory
• Supports label expansion to include FOLFIRINOX
Clinical
• Validates OncoSil device alongside standard-of-care chemotherapy
Market Access
• Accelerates market penetration by aligning with established
treatment pathways
Commercial
• Strengthens physician adoption and supports broader uptake of
OncoSil device
TRIPP-FFX: Positive Phase II Results Support FOLFIRINOX Label
Expansion
16
FOLFIRINOX OncoSil device + FOLFIRINOX
ITT (n=43) PP (n=41) ITT (n=45) PP (n=40)
LDCR at 16 weeks *
(95% CI)
86.0%
(72.1–94.7)
85.4%
(70.8–94.4)
82.2%
(67.9–92.0)
85.0%
(70.2–94.3)
Best Overall Response *
Partial Response
Stable Disease
Progressive Disease
Missing
37.2%
51.2%
9.3%
2.3%
36.6%
53.7%
9.8%
0
55.6%
31.1%
8.9%
4.4%
60.0%
30.0%
10.0%
0
Surgical Resection
R0 margins
11.6%
16.7%
7.3%
33%
11.1%
60%
12.5%
60%
Tumour Volume, median maximal
change
–57.0% –55.9% –72.1% –72.2%
Local PFS,* median months (95%
CI)
11.8
(7.8–nc)
9.9
(7.8–nc)
12.8
(7.8–nc)
12.8
(11.2–nc)
PFS,* median months (95% CI)
9.9
(7.8–nc)
9.9
(7.5–nc)
12.1
(7.8–15.1)
12.1
(7.8–15.1)
Overall Survival, median months
(95% CI)
15.8
(10.2–nc)
15.6
(10.2–21.0)
18.2
(13.8–nc)
21.3
(13.8–nc)
Follow-Up, median months (95%
CI)
12.2
(9.9–17.0)
Not reached
12.4
(11.0–17.0)
Not reached
Initial results. * By blinded independent central review (RECIST 1.1); CI, confidence intervals; nc, non-calculable.
Clinical trial insights supporting strategic investment decisions
PALACROS Participation and PULSE Trial Investment Rationale
What the PULSE Study Is
• Study Purpose and Consortium: PULSE is a Phase II trial evaluating the OncoSil device within the
PALACROS European academic consortium focused on LAPC treatment.
• Study Design and Patient Population: The trial enrolls 120 patients with unresectable LAPC post-
chemotherapy, comparing single versus repeat OncoSil device implantations.
• Primary and Secondary Endpoints: Primary endpoint is 9 month local progression-free survival (LDCR);
secondary endpoints include survival, quality of life, and safety measures.
• Integration and Significance: PULSE integrates OncoSil Medical into Europe's largest pancreatic
cancer research, building on earlier studies for credible multimodal therapy evidence.
17
PULSE Phase II Trial as a Value Driver
• Capital-Efficient Clinical Development: OncoSil device treatments provided in-kind as part of the trial, with no other study related-costs
applicable, resulting in estimated cost savings of $9 million versus an OncoSil Medical sponsored study.
• Regulatory and Payer Engagement: Academic trial participation enhances evidence credibility, supporting regulatory approval and
reimbursement discussions.
• Commercial Upside Potential: Positive trial outcomes could increase patient treatments and revenue through broader adoption and repeat
use.
US FDA Approval
Humanitarian Device Approval (HDE) expected in August 2026
dCCA a rare, largely untreatable cancer with poor survival
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.
• 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 radiation therapy are
considerable and have a negative impact on the quality of life for the
patient.
• OncoSilTM has shown considerable promise for dCCA2 and is the basis
for the HDE.
• The advantage of OncoSilTM is the ability to deliver a high radiation dose
to the target dCCA tumour with minimal side-effects.
19
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. 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.
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 device is being
positioned as a novel, localized
radiation treatment that may
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 Medical
• 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
20
OncoSil Advances to Final Administrative Stage Before
Potential FDA HDE Approval
Major Regulatory Milestone Achieved
• On 3 June 2026, the FDA confirmed that all previously raised questions have been satisfactorily addressed.
• Completion of the substantive review process represents the most advanced stage reached in the
Company's U.S. regulatory program.
Final FDA Requirements
• The FDA has requested submission of:
• Final device labelling for the OncoSil device – submitted 2 July
• Any required updates to the proposed post-market study – submitted 2 July
Clear Path to Approval
• Following receipt of the requested information, the FDA indicated its intention to complete the review within
45 days and grant the HDE.
• Potential HDE approval would establish OncoSil's first U.S. regulatory approval pathway.
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Manufacturing
Investment largely complete
Strong economics <5% capital intensity
Supports potential sales of ~$100 million at full capacity
Macquarie Cyclotek site
Technology & Innovation
Key Milestones
• Established a dedicated Australian manufacturing capability at Macquarie Park through a strategic partnership with Cyclotek.
• Successfully completed three manufacturing validation cycles with Cyclotek, producing more than 50 validation doses of the
OncoSil device.
• Commercial production expected to commence in 2H CY2026, subject to final regulatory approval.
Strategic Benefits
• Scalable production platform capable of supporting
increasing global commercial demand.
• Capital-efficient manufacturing model combining Cyclotek's
infrastructure with OncoSil-owned manufacturing equipment
and proprietary process.
• Greater control over product quality, manufacturing capability
and supply chain resilience.
• Expected to improve gross margins over time through
enhanced manufacturing efficiencies.
23
Outlook
Upcoming Milestones in FY27
25
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
• G-BA funded study commencement
• FDA HDE approval for distal cholangiocarcinoma (dCCA)
• 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
Learn more about OncoSil Medical:
• Website
• ASX announcements
• LinkedIn
This announcement was authorised by the Board of Directors of OncoSil Medical Limited.
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