Annual Report (Typeset)
Released
Released
Announcement PDF
Annual
Report
2026
Transforming Clinical Evidence into
Commercial Growth
I
2026
Annual
Report
II
Transforming Clinical
Evidence into
Commercial Growth
Meeting one of oncology’s greatest unmet needs requires more than
innovation—it demands clinical evidence, regulatory progress and
commercial execution. Throughout FY26, OncoSil Medical Limited
(“OncoSil Medical” or “the Company”) delivered meaningful milestones
that strengthened its clinical foundation, expanded market access and
positioned the Company for its next phase of growth.
THE
UNMET
NEED Fighting One of the World’s
Deadliest Cancers
Pancreatic cancer remains one of the most challenging cancers to
diagnose and treat. Often detected at an advanced stage, the disease
is associated with poor survival outcomes and limited treatment options.
Despite advances in systemic therapies over recent years, long-term
outcomes for many patients remain largely unchanged.
For patients diagnosed with unresectable locally advanced pancreatic
cancer (LAPC), treatment is typically focused on controlling disease
progression and extending survival. While chemotherapy regimens
such as FOLFIRINOX and gemcitabine-based therapies have improved
outcomes, many patients ultimately experience local tumour progression,
significant symptoms, and limited opportunities for curative surgery.
III
IV
• More than 80% of patients are not eligible for surgery at
diagnosis.
• Locally advanced disease frequently involves invasion of
major blood vessels, adding significant risk thereby limiting
opportunities for surgical resection.
• Increasing resection rates remains one of the key
objectives of modern pancreatic cancer management.
• Many patients ultimately experience local disease
progression despite systemic therapy.
OncoSil™ addresses one of the most important objectives
in pancreatic cancer treatment: increasing the number of
patients who can progress to surgical resection.
By delivering highly targeted intratumoural radiation in
addition to standard chemotherapy, OncoSil™ enhances
local tumour control at the site of disease. This approach
supports tumour downstaging, expands opportunities for
surgical intervention and addresses a critical unmet need in
the management of unresectable LAPC.
Growing clinical and real-world evidence continues to
reinforce the value of OncoSil™ as a treatment designed not
only to control disease, but to create a pathway to surgery for
patients who would otherwise have limited options.
The Challenge
The Opportunity
FY26
AT
A
GLANCE
• Recruitment completed in PANCOSIL Trial
• Recruitment completed in TRIPP-FFX Trial
• Preliminary results of PANCOSIL Trial
presented at CIRSE 2025
V
July
September
• Dr Thomas Duthy
appointed as Non-
Executive Chairman
• First commercial OncoSil™
treatments in Germany and
Portugal
October
2025
• First commercial OncoSil™ treatment in the United Kingdom
• First successful hot (radio-activated) production test run at
Sydney facility
• TRIPP-FFX Trial completes Last Patient Last Visit
• OSPREY Interim Results presented at ESGE Days 2026
• TGA Approval received
VI
December
January
May
• TRIPP-FFX Trial meets co-primary endpoints
• Final step reached for HDE with US FDA
• TRIPP-FFX abstract accepted for oral presentation at
ESMO GI 2026
June
2026
STRENGTHENING
THE
CLINICAL
EVIDENCE
OSPREY Registry
What is OSPREY?
OSPREY (OncoSil Pancreatic Cancer Post-Marketing Clinical
Registry) is the largest prospective real-world registry
evaluating the use of OncoSil™ device in patients with
unresectable LAPC.
Unlike controlled clinical trials, OSPREY reflects routine clinical
practice across multiple countries and treatment centres,
providing valuable insight into how patients perform outside
of highly selected study populations.
VII
Key Findings
VIII
Why Real-World Data Matters
Real-world evidence is increasingly recognised by clinicians, regulators
and payers as a critical component of healthcare decision making.
OSPREY helps answer important questions:
• How does OncoSil™ perform in routine practice?
• Can outcomes observed in clinical studies be replicated in broader
patient populations?
• What treatment patterns emerge as clinician experience grows?
No Serious Adverse
Device Effects (SADEs)
or Grade ≥3 Adverse
Device Effects (ADEs)
reported
Median Overall Survival
from diagnosis of 20.6
and 22.0 months,
respectively, in the ≤4 and
4–12 months 1st-line
cohorts, and 10.5 months
in patients implanted ≤4
months from starting
2nd-line chemo
Surgical resection in 16.7%
of patients implanted ≤4
months of 1st-line chemo,
15.8% of patients implanted
at 4–12 months of 1st-line
chemo and 10.0% of the
2nd-line cohort implanted
at ≤4 months
Enrolment in the registry is
ongoing (≥80 patients enrolled
to date) and follow-up
continues
1
1
0(0)
0(0)
7/9(77.8)
1/10(10.0)
1/1(100)
0(0)
17.0(1
1.3-20.0)
10.5(8.4-12.9)
3
0 (0)
0 (0)
nc
-
-
-
-
-
1
0 (0)
0 (0)
1/1 (100)
-
-
-
-
-
22
0(0)
0(0)
18/18(100)
3/19(15.8)
3/3(100)
0(0)
22.0(17.2-22.7)
20.0(16.0-22.2)
1
0 (0)
0 (0)
0/1 (0)
-
-
-
21.7
3.0
3rd
- Line
≤4 months
2nd
- Line
≤4 months
25
0(0)
0(0)
14/17(82.4)
3/18(16.7)
1/3(33.3)
2/3(66.7)
20.6(16.9-20.1)
17.3(15.7-23.7)
Number of patients
Grade ≥3 ADES Grade ≥3, n(%)
Serious ADES (SADES)
Surgically Resected with Curative Intent
n/n (%)
Overall Survival,
months; median
(95% CI)
R0 resection margin
R1 resection margin
From Diagnosis
From Commencing
Current Chemo Line
LDCR12 weeks
a
, n/n (%)
Any Grade, n(%)
≤4 months
Implant Timing vs. Start of Chemo Line 4-12 months
1st
- Line
Concurrent Chemotherapy Line
4-12 months >12 months
STRENGTHENING
THE
CLINICAL
EVIDENCE
TRIPP-FFX│Expanding the
Clinical Potential of OncoSil™
TRIPP-FFX at a Glance
• Randomised, non-comparative Phase II study
• Evaluated OncoSil™ in addition to FOLFIRINOX chemotherapy
vs. FOLFIRINOX alone
• Experimental arm benchmarked against historical control data
• Control arm included to validate historical outcomes
• Not powered for formal statistical comparison between study
arms
• Designed to support EU-MDR (European Union Medical
Device Regulation) clinical evidence requirements
• Generates clinical evidence to support expansion of the
OncoSil™ label to include use in addition to FOLFIRINOX
IX
Key Findings
X
TRIPP-FFX met both co-primary endpoints, supporting the use of
OncoSil™ alongside standard-of-care FOLFIRINOX chemotherapy in
patients with unresectable LAPC.
Investigators concluded that toxicities associated with the addition
of OncoSil™ to FOLFIRINOX chemotherapy were limited and
manageable.
Encouraging efficacy outcomes observed, including 82.2% (95%
Confidence Interval (CI) 65-90%) Local Disease Control Rate
(LDCR) at 16 weeks and 18.3 months of median overall survival
in patients treated with OncoSil™ plus FOLFIRINOX chemotherapy.
Historically, OncoSil™ has been used alongside gemcitabine-based
chemotherapy. Positive TRIPP-FFX results demonstrate that the therapy
can potentially be integrated with FOLFIRINOX treatment pathways,
significantly expanding the addressable patient population.
The Company expects to submit a Change Notification to the
Company’s EU & UK Notified Body in late 1H FY27 to add
FOLFIRINOX to the approved OncoSil™ product label.
The TRIPP-FFX dataset supports regulatory submissions seeking
approval to expand the approved indication for OncoSil™ to include
use with FOLFIRINOX.
A successful label expansion would:
• Increase eligible patient populations
• Support broader physician adoption
• Strengthen reimbursement discussions
• Accelerate commercial growth
What These Results Mean
Path to Label Expansion
STRENGTHENING
THE
CLINICAL
EVIDENCE
TRIPP-FFX│Expanding the
Clinical Potential of OncoSil™
Expert Perspectives
The encouraging findings of the TRIPP-FFX study were
further reinforced by the perspectives of the study’s Principal
Investigators, who highlighted the clinical relevance of achieving
both primary endpoints, the consistency of the data with
previous evidence, and the study’s contribution to advancing
multidisciplinary care for patients with unresectable LAPC.
XI
XII
Michele Milella
Professor of Medical Oncology, University of
Verona, Italy
& Principal Investigator of TRIPP-FFX Study:
Giuseppe Malleo
Associate Professor of Surgery at the University
of Verona, Italy
& Principal Investigator of TRIPP-FFX Study:
“As TRIPP-FFX was designed as a randomized but non-comparative study,
the significance of these findings lies in the successful achievement of the
predefined clinical endpoints and the consistency of the overall data, with
the control arm serving primarily as a benchmark against historical outcomes
rather than for direct statistical comparison.
In this context, the results are consistent with previously reported findings
from historical datasets, including the PANCO trial and the OSPREY Registry
and favourably compare with chemotherapy alone or the combination of
chemotherapy and other forms of local treatment commonly used in this
difficult-to-treat disease setting.”
“The TRIPP-FFX study marks an important step forward in the treatment
of unresectable locally advanced pancreatic cancer, particularly from a
multidisciplinary care perspective. The achievement of both primary endpoints
supports the continued clinical development of the OncoSil™ device and adds
to the growing body of evidence generated through previous studies and real-
world experience.
From a surgical standpoint, the study confirms the possibility to downstage
selected patients towards surgical resection. Further detailed analysis will help
us better understand which patients may benefit the most, and I would like
to acknowledge the strong commitment of everyone involved in the study,
especially the patients and clinical teams whose contribution made these
results possible.”
EXPANDING
THE
CLINICAL
POTENTIAL
OF
ONCOSIL
XIII
PANCOSIL (Investigator-Initiated Study)
Opening the Door to a New Clinical
Specialty
Expanding Access Through
Interventional Radiology
PANCOSIL was designed to evaluate a novel CT (Computed
Tomography)-guided percutaneous delivery approach for the
OncoSil™ device, with the potential to expand the approved
delivery method beyond endoscopic ultrasound (EUS)-guided
implantation.
Successful validation of this approach would support broader
access to OncoSil™ by enabling treatment through a well-
established, globally available minimally invasive procedure
performed under CT guidance.
│
XIV
Why This Matters
Interventional Radiologists are highly experienced in image-guided,
minimally invasive procedures and routinely perform percutaneous
tumour interventions across a wide range of cancers.
This specialty is also familiar with handling radioactive materials and
delivering image-guided therapies, making it well positioned to adopt
OncoSil™ if the delivery approach is approved.
The significance of PANCOSIL extends beyond clinical feasibility. A
successful outcome could:
• Significantly increase the number of physicians able to deliver
OncoSil™ treatment
• Reduce adoption barriers at treatment centres by leveraging existing
CT-guided procedural capabilities
• Provide greater procedural flexibility where EUS expertise or
infrastructure is limited
• Improve patient access by enabling treatment at a broader range of
hospitals and cancer centres
• Support international commercial expansion by broadening the
addressable clinical user base
• No procedure-related mortality
• Two (10%) of the 20 patients experienced CTCAE (Common
Terminology Criteria for Adverse Events) grade 3 serious adverse
events within 90 days; no clinical sequalae; both patients
recovered.
• 90% technical success rate
• 20.6 months median overall survival (OS) from diagnosis
OncoSil Medical is targeting submission for a label extension in 1H
FY27, seeking approval for CT-guided percutaneous implantation of
the OncoSil™ device.
Key Findings
FROM
EVIDENCE
TO
IMPACT EUROPEAN COMMERCIAL
TRACTION│Expanding Adoption
Across Europe
Commercially Active Implanting
Centres
The number of commercially active implanting centres has
continued to grow across Europe, reflecting increasing physician
confidence, growing clinical experience and expanding utilisation
of OncoSil™. With additional centres expected to become
active throughout FY27, the Company remains well positioned to
accelerate commercial adoption across existing and new markets.
XV
XVI
Commercially Active Implanting Centres
60
50
40
30
20
10
0
FY24 FY25 FY26 1H FY27
Actual Forecast
GERMANY│Unlocking Europe’s
Largest Reimbursement Opportunity
Why Germany Matters
Germany represents Europe’s largest and most strategically
important pancreatic cancer market. The country’s
reimbursement framework creates a pathway for innovative
technologies to gain access while generating real-world
evidence and supporting long-term adoption.
XVII
FROM
EVIDENCE
TO
IMPACT
XVIII
Understanding the G-BA
Opportunity
The Federal Joint Committee (G-BA) is Germany’s highest decision-
making body for healthcare reimbursement within the country’s
statutory health insurance system, which covers the vast majority of the
population. The G-BA determines which medical treatments, procedures
and technologies are eligible for reimbursement based on clinical
evidence, patient benefit and health economic considerations. For
innovative medical technologies, the G-BA may approve the conduct
of a clinical reimbursement study to generate the evidence needed to
support future funding decisions. As Germany represents the largest
healthcare market in Europe, successful progression through the G-BA
process is widely regarded as an important milestone for companies
seeking long-term reimbursement, clinical adoption and broader
market access across Europe.
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 trial.3
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
Population
~84 million
Pancreatic Cancer
Incidence p.a.1
22,587
Pancreatic Cancer
Incidence p.a.1
$264 million
Locally Advanced
Pancreatic Cancer
6,776
GERMANY
Progress to Date
• G-BA approval achieved, trial expected to commence in 1H
FY27
• Growing physician engagement
• First patient treated at Germany in October 2025 (outside of
trial)
• Increasing number of trained centres
• Positive clinical experience across hospitals
XIX
FROM
EVIDENCE
TO
IMPACT
XX
Germany Reimbursement
Opportunity
The proposed German reimbursement study represents a significant
strategic opportunity that extends beyond direct revenue generation.
Key benefits include:
• Generation of Level 1 clinical evidence, the highest standard of
evidence for clinicians, regulators and reimbursement bodies
• Potential pathway to national reimbursement in Germany following
positive study outcomes
• Opportunity for inclusion in German consensus treatment guidelines
• Potential incorporation into broader European treatment guidelines
• Valuable evidence for Health Technology Assessments (HTAs)
supporting reimbursement discussions in additional markets,
including NICE (UK) and HAS (France)
• Significant expansion of the trained physician base in Germany,
supporting long-term adoption and utilisation of OncoSil™
• Increased awareness and engagement among leading pancreatic
cancer treatment centres across Europe
Strategic Benefits Beyond Revenue
Phase III Randomised Controlled Trial
~40
280
24 Months
~$5.6M
~$6.5M
65–70%
Study Design
Centres
Patients
Recruitment
Trial Revenue
Additional Commercial
Revenue
Gross Margin
Opportunity
Metric
Together, these outcomes have the potential to strengthen OncoSil
Medical’s clinical, regulatory and commercial position across
Europe while supporting broader patient access to treatment.
EXPANDING
THE
PIPELINE
XXI
Advancing Towards FDA
Approval For dCCA
OncoSil Medical reached a significant regulatory
milestone during FY26, with the U.S. Food and Drug
Administration (FDA) confirming that all outstanding
questions relating to the Company’s Humanitarian
Device Exemption (HDE) application for distal
cholangiocarcinoma (dCCA) have been satisfactorily
addressed. The application has now advanced to the
final stage of FDA review prior to a potential favourable
decision.
XXII
Understanding the HDE
The HDE is a FDA regulatory pathway for medical devices intended to
treat or diagnose rare diseases or conditions affecting a small patient
population. It enables eligible devices to be approved based on
evidence of safety and probable clinical benefit, providing a pathway
to make innovative treatments available where large clinical studies
may not be feasible.
• HDE application submitted for the treatment of dCCA
• FDA confirmed all outstanding review questions have been resolved
• Application advanced to final FDA review stage
• Final device labelling and post-market study updates requested
• FDA intends to complete its review within 45 days of final submission
• Potential first FDA approval for the OncoSil™ device
• Establishes a commercial pathway into the U.S. market
• Rare and aggressive cancer with limited treatment options
• Eligible for the FDA HDE pathway
• Significant unmet clinical need
Key Highlights
Why dCCA?
“The FDA’s confirmation that all outstanding questions have been
resolved represents a major achievement for the Company and
places OncoSil™ at the final stage of the HDE review process.”
Nigel Lange, CEO & Managing Director
SCALING
FOR
GROWTH
XXIII
Manufacturing Update
Building Scale. Improving
Margins.
During FY26, OncoSil Medical established a new manufacturing
capability in Australia using its proprietary manufacturing process
and product, representing a key strategic initiative to support
future commercial growth and improve production economics.
Manufacturing validation runs have now been successfully
completed, and the Company is awaiting inspection and
regulatory approval. Following approval, the Company expects
to commence production of its first commercial doses, representing
a significant operational milestone.
This new manufacturing capability is expected to be accretive to
gross margins while providing greater control over manufacturing
processes, quality systems and supply chain management as
commercial demand continues to increase.
XXIV
Q: Why is this manufacturing
capability such an important
milestone for OncoSil Medical?
Q: What are you most looking
forward to in the next six months?
Renzo DiCarlo: Establishing this manufacturing capability using our
proprietary process gives us greater control over our manufacturing
processes, quality systems and future scalability. By leveraging
our proprietary process and product, we have strengthened our
manufacturing capability while maintaining greater oversight of
quality, supply and future capacity. This model is expected to reduce
our cost of goods sold over time, supporting improved gross margins
as commercial volumes increase. As demand for OncoSil™ grows, this
capability will become increasingly important in supporting both our
operational efficiency and expansion plans.
Renzo DiCarlo: Our manufacturing validation runs have now been
completed, and we are focused on obtaining the required inspection
outcomes and regulatory approval before commencing production
of our first commercial doses. Achieving these milestones will mark an
important step in OncoSil Medical’s evolution, providing the foundation
for improved margins, greater operational control and future growth.
1
Corporate directory
Chairman’s letter
CEO’s report
Directors’ report
Auditor’s independence declaration
Statement of profit or loss and other comprehensive income
Statement of financial position
Statement of changes in equity
Statement of cash flows
Notes to the financial statements
Consolidated entity disclosure statement
Directors’ declaration
Independent auditor’s report to the members of OncoSil Medical Ltd
Shareholder information
2
3
6
9
29
30
31
32
33
34
63
64
65
70
CONTENTS
2
Directors Dr Thomas Duthy - Chairman
Mr Nigel Lange
Ms Lel Smits
Joint company secretary Tim Luscombe
Nova Taylor
Notice of annual general meeting The details of the annual general meeting of OncoSil Medical Ltd are:
1
1:00 (AEDT)
Wednesday 18 November 2026
The meeting will be held virtually.
Registered office and principal Level 5
place of business 7 Eden Park Drive
Macquarie Park, NSW 21
13
Phone: +61 2 8935 9629
Share register Automic Pty Ltd
Level 5
126 Phillip Street
Sydney NSW 2000
Phone: +61 2 9698 5414
Auditor Crowe Sydney
Level 24
1 O’Connell Street
Sydney NSW 2000
Solicitors K&L Gates
Level 25, South Tower
525 Collins Street
Melbourne VIC 3000
Bankers National Australia Bank
330 Collins Street
Melbourne VIC 3000
Stock exchange listing OncoSil Medical Ltd shares are listed on the Australian Securities
Exchange (ASX code: OSL)
Website www.oncosil.com
Corporate Governance Statement OncoSil Medical Ltd and the Board of Directors are committed to achieving and
demonstrating the highest standards of corporate governance. OncoSil Medical
Ltd has reviewed its corporate governance practices against the
Corporate Governance Principles and Recommendations (4th Edition) published
by the ASX Corporate Governance Council.
Details of the corporate governance report is available on the Group website at:
https://investors.oncosil.com/corporate-governance
CORPORATE
DIRECTORY
ONCOSIL MEDICAL LTD 30 JUNE 2026
3
DIRECTORS’
REPORT
ONCOSIL MEDICAL LTD 30 JUNE 2026
CHAIRMAN’S
LETTER
Dr Thomas Duthy
Non-Executive Chairman
OncoSil Medical
Dear Shareholders,
On behalf of the Board of Directors, I am pleased to present
OncoSil Medical Limited’s Annual Report for the financial
year ended 30 June 2026.
This has been a transformative year for OncoSil Medical.
During the year, we achieved several significant regulatory,
clinical and commercial milestones that further advanced
our mission of improving outcomes for patients suffering
from one of the most challenging forms of cancer. These
achievements reflect the dedication of our employees,
clinicalinvestigators,commercialpartnersandshareholders,
all of whom have contributed to the Company’s continued
progress.
A landmark regulatory year
The single most significant event of FY26 was the approval
by Australia’s Therapeutic Goods Administration (TGA) of
the OncoSil™ device in May 2026. This approval enables inclusion on the
Australian Register of Therapeutic Goods for the treatment of unresectable
locally advanced pancreatic cancer in combination with gemcitabine-based
chemotherapy. This approval opens our home market for the first time, and with
approximately 4,350 new cases of pancreatic cancer diagnosed in Australia
each year, the clinical need is both clear and immediate. We anticipate
launching in Australia in the first half of the 2027 calendar year.
Approval from the Therapeutic Goods Administration (TGA) also validates the
quality of our manufacturing operations at our Macquarie Park, New South
Wales facility. As we scale production to meet anticipated domestic and export
demand, this facility will serve as the backbone of our global supply chain.
In Europe, our regulatory position continues to strengthen. The Medical
Device Regulation (MDR) certification achieved in January 2025 has already
materially simplified commercial treatment initiation across the European Union
and United Kingdom, a benefit that flowed directly into our strongest ever
sales performance in FY26. We are also progressing regulatory submissions
to extend our CE Mark to include use with FOLFIRINOX chemotherapy
and percutaneous delivery via Interventional Radiology, both of which are
anticipated in the second half of calendar year 2026.
In the United States, we were very pleased to announce in June 2026 the US
Food and Drug Administration (FDA) confirming that all outstanding questions
relating to the Company’s Humanitarian Device Exemption (HDE) application
for the treatment of distal cholangiocarcinoma (dCCA) had been satisfactorily
addressed. We submitted our HDE package in early July and on 17 August
2026 were very pleased to receive FDA HDE approval for the OncoSil™
device in dCCA. This is a major milestone in the Company’s history with very
few ASX listed medical device companies having achieved an FDA approval
for a Class III medical device like ours.
4
Clinical momentum converting to commercial outcomes
The clinical de-risking of OncoSil™ device has been a multi-year
endeavour, and FY26 has seen that investment bear significant
fruit.
Firstly, the PANCOSIL study, which was an investigator-initiated
Phase 1/2 feasibility trial led by Amsterdam UMC. On 18
September 2025 we announced PANCOSIL delivered strong
technical feasibility and encouraging preliminary efficacy results.
Data was presented at the CIRSE 2025 Congress in Barcelona.
As the first study in the world to administer the OncoSil™ device
by CT-guided percutaneous injection, PANCOSIL demonstrated
that this less invasive delivery approach is both safe and feasible.
We are targeting a regulatory submission in the second half of
the 2026 calendar year to support percutaneous administration
as an approved delivery method, which opens up an entire new
clinical speciality group highly familiar with technologies like the
OncoSil™ device, namely the interventional radiologists.
In June, we announced the results of the TRIPP-FFX study. The
study met both of its co-primary endpoints. While the study was
designed as a non-comparative trial and was not powered for
direct statistical comparison between treatment arms, these
outcomes represent an important addition to the growing body
of clinical evidence supporting the OncoSil™ device in a disease
of profound unmet need. Together with the completion of the
investigator-initiated PANCOSIL study, this milestone allows
the Board to turn its focus firmly toward regulatory engagement
and commercial execution, and the Company is preparing a
regulatory submission intended to extend the device’s CE Mark to
include use in combination with FOLFIRINOX.
Separately, a comparative study presented at Digestive Disease
Week 2025 by investigators from the Royal Adelaide Hospital
demonstrated superior outcomes for patients treated with
OncoSil™ over stereotactic body radiation therapy, with median
overall survival of 22 months versus 14 months. This data, which
is generated independently by leading clinicians is invaluable in
building physician confidence and institutional adoption.
On behalf of the Board, I extend my sincere thanks to the patients,
clinicians and investigators whose participation made this
progress possible.
Germany: The pivotal market
Germany remains our most strategically significant near-
term commercial opportunity. The G-BA (Gemeinsamer
Bundesausschuss) sponsored study, commencing in the second
half of calendar year 2026, has the potential to unlock access to
Germany’s entire public hospital reimbursement system consisting
of a market with approximately 20,000 new pancreatic cancer
cases per year and one of Europe’s most structured and well-
funded healthcare environments. The addressable market
opportunity in Germany is conservatively in the order 2.000 to
3.000 patients annually.
Commercial momentum in Germany has continued to build. The
number of hospitals eligible to seek NUB (Neue Untersuchungs-
und Behandlungsmethoden) reimbursement for the OncoSil™
device has grown substantially, and the first successful treatment
at Vivantes Neukölln Hospital in Berlin represents one of the
largest hospitals in Germany’s largest municipal hospital network.
This is an important first step in embedding the OncoSil™ device
within leading German oncology centres. We regard the G-BA
trial as a potential inflection point not only for Germany but for
reimbursement negotiations across other European member states
that frequently reference G-BA decisions.
Capital management and financial discipline
In February 2026, we completed an $8 million capital raise
comprising a $6 million placement and a $2.0 million fully
underwritten non-renounceable entitlement offer, supported by
new and existing substantial shareholders including Pengana
Capital Group and Regal Funds Management as cornerstone
investors. Your Directors also participated in this raise with a
commitment of $0.1
1 million. A further $1.84 million R&D tax
incentive refund was received in the second half of the year.
CEO Nigel Lange’s decision to convert a 10% salary reduction
into ordinary shares reflects a commitment shared across our
leadership team: to align management incentives directly with
shareholder value creation at this critical stage of the Company’s
commercialisation journey.
We continue to manage the cost base with discipline. Annualised
cost savings of $3.4 million to $3.9 million have been identified
for realisation from FY27, ensuring that as revenues grow,
the operating leverage in our business model translates into
meaningful shareholder returns.
Board and governance
During FY26 the Board was refreshed to align its composition with
the Company’s next phase of clinical and commercial execution.
I joined the Board as a Non-Executive Director on 1
1 July 2025
and was subsequently appointed Non-Executive Chairman
following Mr Douglas Cubbin’s retirement. As a demonstration
of my confidence in OncoSil Medical and my alignment with
the interests of shareholders, I elected to sacrifice 100% of my
Non-Executive Director fees in favour of equity, taken as OncoSil
Medical shares at $1.50 per shar
Share your feedback
Discover