Appendix 4E and Annual Report
Released
Released
Announcement PDF
OncoSil Medical Ltd
Appendix 4E
Preliminary final report
1. Company details
Name of entity:
ABN:
Reporting period:
Previous period:
OncoSil Medical Ltd
89 113 824 141
For the year ended 30 June 2025
For the year ended 30 June 2024
2. Results for announcement to the market
$
Revenues from ordinary activities
up
126.6%
to
1,170,793
Other income and interest revenue
down (59.2%)
to
455,366
Loss from ordinary activities after tax attributable to the owners of OncoSil Medical Ltd
up
26.7%
to (15,099,844)
Loss for the year attributable to the owners of OncoSil Medical Ltd
up
26.7%
to (15,099,844)
Dividends
There were no dividends paid, recommended or declared during the current financial period.
Comments
Oncosil Medical Ltd advises that its Annual General Meeting will be held on 19 November 2025. The time and other details
relating to the meeting will be advised in the Notice of Meeting to be sent to shareholders.
In accordance with the ASX Listing Rules, valid nominations for the position of director are required to be lodged at the
registered office of the Company by 5.00 pm (AEDT) 19 October 2025.
The loss for the Group after providing for income tax amounted to $15,099,844 (30 June 2024: $11,913,632).
Refer to Market announcement, which precedes the Appendix 4E, and the 'Review of operations' section of the Directors'
report for further commentary on the results for the year ended 30 June 2025.
3. Net tangible assets
Reporting
period
Cents
Net tangible assets per ordinary security
21.86
Previous
period
Cents
57.32
Calculated as follows:
Consolidated
2025
2024
$
$
Net assets
Less: Right-of-use assets
Add: Lease liabilities
Net tangible assets
3,103,521
(65,331)
69,915
3,108,105
4,736,409
(32,437)
70,672
4,774,644
Number of shares on issue at 30 June
14,220,777
8,330,274
Number of shares on issue for the prior year has been restated for the share consolidation of every 400 pre-consolidation
shares into 1. Approved by shareholders at EGM on 29 May 2025.
OncoSil Medical Ltd
Appendix 4E
Preliminary final report
4. Control gained over entities
Not applicable.
5. Loss of control over entities
Not applicable.
6. Dividend reinvestment plans
Not applicable.
7. Details of associates and joint venture entities
Not applicable.
8. Foreign entities
Details of origin of accounting standards used in compiling the report:
Not applicable.
9. Audit qualification or review
Details of audit/review dispute or qualification (if any):
The financial statements have been audited and an unmodified opinion has been issued, which includes a paragraph
addressing a material uncertainty related to going concern.
10. Attachments
Details of attachments (if any):
The Annual Report of OncoSil Medical Ltd for the year ended 30 June 2025 is attached.
11. Signed
Authorised for release by the Board of Directors.
Signed ___________________________
Mr Douglas Cubbin
Non-Executive Chairman
Sydney
Date: 29 August 2025
OncoSil Medical Ltd
ABN 89 113 824 141
Annual Report - 30 June 2025
OncoSil Medical Ltd
Contents
30 June 2025
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
1
2
3
5
7
24
25
26
27
28
29
55
56
57
61
OncoSil Medical Ltd
Corporate directory
30 June 2025
Directors
Mr Douglas Cubbin - Chairman
Mr Nigel Lange
Ms Lel Smits
Dr Thomas Duthy
Company secretary
Ms Olga Smejkalova
Notice of annual general meeting
The details of the annual general meeting of OncoSil Medical Ltd are:
11:00 am (AEDT)
Wednesday 19 November 2025
The offices of K & L Gates, Level 25, 525 Collins Street, Melbourne, Victoria
Registered office
Level 3
62 Lygon Street
Carlton South, Victoria 3053
Phone: +61 2 8935 9629
Principal place of business
Level 5
7 Eden Park Drive
Macquarie Park, NSW 2113
Phone: +61 2 8935 9629
Share register
Boardroom Pty Limited
Level 8
210 George Street
Sydney NSW 2000
Phone: +61 2 9290 9600
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://www.oncosil.com/investors
2
OncoSil Medical Ltd
Chairman's letter
30 June 2025
Dear Shareholders,
I am pleased to present OncoSil Medical’s Annual Report for the fiscal year ended 30 June 2025.
This period has been transformational for our company, marked by strong operational progress and significant corporate
developments.
Regulatory and Market Access Achievements
In late January 2025, we secured Medical Device Regulation (MDR) certification for the OncoSil™ device from BSI, the EU
Notified Body. This pivotal approval removes prior post-market restrictions, significantly simplifying commercial treatment
initiation in the EU and UK, accelerating our market access capabilities and shortening sales cycles.
Clinical and Commercial Expansion
Our global footprint continues to strengthen. Notably:
x
The PANCOSIL and TRIPP-FFX clinical trials achieved 95% and 99% recruitment respectively by the end of June
2025. Both trials went on to complete recruitment in July.
x Our OncoSil™ device has been deployed in more than 30 treatments in Spain.
x We signed distribution agreements serving Egypt, the Gulf Cooperation Council (GCC) countries (which includes the
United Arab Emirates (UAE), Qatar, Oman, and Bahrain), and the Nordic countries (Sweden, Denmark, Norway, and
Finland), expanding our market reach.
x During the third quarter of FY2025, OncoSil Medical received a $1,050,896 R&D tax incentive, bolstering our capital
for continued innovation in targeted radiotherapy.
x Furthermore, at Digestive Disease Week 2025 (3 – 6 May 2025, San Diego), investigators from the Royal Adelaide
Hospital presented a comparative study demonstrating superior outcomes of OncoSil™ over SBRT (stereotactic body
radiation therapy) in patients with locally advanced pancreatic cancer – improved median overall survival (22 months
vs. 14 months), extended progression-free survival, and a favourable safety profile.
Capital Consolidation
In June 2025, shareholders approved – and we completed – a 1-for-400 consolidation of the Company’s issued capital. This
has streamlined our capital structure and positioned us for stronger market engagement and investor clarity.
Australian institution invested $2.7 million through placement
As announced on 25 July 2024, OncoSil completed a placement with Pengana Capital Group for $2.7 million before costs via
the issue of approximately (on a pre-capital consolidation basis) 386 million new fully paid ordinary shares in the Company
(New Shares) at $0.007 per New Share (Offer Price) together with one OSLOB Short Dated Listed Option (expiry date 30
June 2025, exercise price $0.009 each) (New Options) for each New Share issued under the Placement.
Robust Capital Raises
We completed a $8.0 million capital raise through a placement of $7.0 million in November 2024 and a $1 million Share
Purchase Plan (SPP) in December 2024. The funds were applied to further investment in OncoSil’s Macquarie Park
manufacturing facility, funding of clinical trials, and other working capital costs and costs of the offer.
We successfully executed an $8.7 million capital raise, comprising a $6.7 million placement and a $2 million SPP. Tranche 1
of the placement ($3.2 million) completed in June 2025 and Tranche 2 of the placement ($3.5 million) and the $2 million SPP
completed in July 2025. The raise was backed by both new and existing institutional investors, with Pengana Capital Group
playing a cornerstone role. These funds raised will primarily support the commercialisation of our OncoSil™ device across
Europe and our existing territories.
3
OncoSil Medical Ltd
Chairman's letter
30 June 2025
Governance and Board Strengthening
In January 2025, we welcomed Ms. Lel Smits to the Board as a Non-Executive Director. With deep expertise in n corporate
communications, governance, and strategic engagement from advising over 500 ASX listed entities, Ms Smits strengthens
our leadership team as we scale our operations.
Shortly after the end of the financial year, on 11 July 2025 we announced the appointment of Dr Thomas Duthy as a NonExecutive Director. He brings more than 21 years of experience across financial markets, corporate development, and boardlevel roles in the healthcare and life sciences sectors. Dr Duthy is the Founder and Director of Nemean Group, a corporate
advisory firm serving healthcare and technology companies, has been involved in numerous successful M&A transactions and
holds relevant experience in the oncology device setting, given his previous role as Head of Corporate Development and
Investor Relations at Sirtex Medical (ASX:SRX), where he played a key role in its $1.9 billion acquisition.
In conjunction with Dr Duthy’s appointment, Dr Gabriel Liberatore resigned from the OncoSil Board of Directors for personal
reasons, effective 11 July 2025. The Board extends its sincere thanks to Dr Liberatore for his valuable contribution and
dedicated service to OncoSil Medical.
Looking Ahead
As we move into FY26, OncoSil is well-positioned to deliver on its mission. We remain focussed on expanding commercial
adoption of our device, completing our key clinical trials, and pursuing new market opportunities. With a strengthened capital
position and a dedicated team, we are confident in our ability to build on the foundation laid this year.
To our shareholders, thank you for your continued support and belief in our vision. Together, we are progressing toward a
future where OncoSil™ becomes a meaningful part of the global fight against pancreatic cancer.
___________________
Douglas Cubbin
Non-executive Chairman
OncoSil Medical
4
OncoSil Medical Ltd
CEO's report
30 June 2025
Dear Shareholders,
I am pleased to present OncoSil Medical Ltd’s CEO Report for the financial year ended 30 June 2025—a year in which we
delivered meaningful progress toward our mission of improving outcomes for patients with pancreatic cancer. This year was
defined by strong clinical momentum, an exceptional regulatory breakthrough in Germany, and the continued
commercialisation of our innovative brachytherapy device across key global markets.
A key highlight of the year was the approval from German Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA)
for the clinical trial in Germany. This is one of the most significant achievements in OncoSil’s history. The G-BA (Federal Joint
Committee) is Germany’s highest decision-making body for healthcare reimbursement, and this approval and successful
completion of the clinical trial will broaden access to the OncoSil™ device across the German public hospital system. A
successful completion of the clinical trial paves the way for further reimbursement negotiations in other EU member states
and beyond, as the G-BA decision is often referenced by peer health systems. It also validates the clinical strength of our data
and positions the OncoSil™ device as a credible and scalable cancer therapy option in one of the world’s most advanced
healthcare environments.
In parallel, we have seen a sharp increase in German hospital applications for NUB (Neue Untersuchungs- und
Behandlungsmethoden) approvals, which rose by over 40% year-on-year. NUB is a hospital-led process to secure temporary,
hospital-specific extra reimbursement for new inpatient treatments. This approval serves to unlock access to funding in
Europe’s largest market.
Another major regulatory milestone was achieving certification under the EU MDR framework. The MDR represents one of
the most stringent and comprehensive medical device regulatory regimes globally. Achieving certification under this standard
is a rigorous process that speaks to the safety, quality, and clinical robustness of our product. Importantly, MDR approval
ensures our continued access to EU markets beyond the legacy MDD (Medical Device Directive) certification and removes
previous restrictions on post-market commercialisation. This certification reinforces OncoSil’s position as a trusted device
manufacturer and provides a strong foundation for long-term growth across Europe and the UK.
In parallel, we have made substantial progress in our clinical development program. Recruitment in both our TRIPP FFX and
PANCOSIL studies surpassed the >90% recruitment at the end of FY25 (both studies were completed in July 2025), a
significant achievement that reflects strong clinical interest and institutional confidence in our therapy. These trials are essential
to our long-term strategy. TRIPP-FFX study is designed to generate high-quality evidence on the efficacy and safety of
OncoSil™ when used in combination with standard-of-care chemotherapy (FOLFIRINOX). PANCOSIL study evaluates the
safety and feasibility of CT-guided percutaneous implantation of OncoSilTM device. The data from these studies will not only
support further regulatory engagement with additions to our existing labelling but also strengthen our case for reimbursement
and clinical expansion in new and existing markets.
From a commercial perspective, FY25 marked our strongest sales performance to date. Dose sales increased by 100% yearon-year, contributing to an 83% increase in full-year sales and a 127% uplift in revenue compared to the prior year. Pricing
has remained consistent throughout the year. Approximately 60% of revenue was generated by direct sales while the
remaining 40% was distributor generated. These results were driven by growing demand across the Europe, particularly in
Spain, Greece and Israel, reflecting both the maturing of our commercial model and the accelerating recognition of our
technology in clinical practice. We also broadened our geographic reach, securing distribution agreements across the Nordic
region, Egypt, and the Gulf countries ensuring that more patients worldwide will have access to our device.
To support these growth initiatives, we took proactive steps to strengthen our balance sheet. Over the course of the year, we
completed capital raises totalling more than $14 million, including a successful institutional placement and share purchase
plans. These funds have extended our operational runway into FY26 and will enable us to continue investing in clinical trials,
market development, and regulatory engagement. We also received a $1.05 million R&D tax refund, which reflects our
continued commitment to innovation and evidence-based medicine.
In support of our longer-term manufacturing and operational strategy, we also made important progress on the development
of our Macquarie Park manufacturing facility in Sydney. The facility is being prepared as a dedicated site to produce the
OncoSil™ device and is designed to meet the rigorous quality standards required for global regulatory approvals. Once
operational, the Macquarie Park facility will enhance our control over production, improve scalability, and support the transition
toward in-house manufacturing, thereby strengthening supply chain security and cost efficiency over time.
5
OncoSil Medical Ltd
CEO's report
30 June 2025
As we look ahead to FY26, our priorities are clear. We will continue driving adoption in key existing markets, launch in new
countries, and place a strong emphasis on accelerating sales growth and maximising revenue. With the major regulatory
barriers now behind us and growing clinical endorsement ahead of us, we believe we are at a genuine inflection point in our
journey.
In closing, I would like to thank our shareholders for your ongoing support and trust. The progress we have made over the
past year reflects the resilience and dedication of our team, the strength of our technology, and the clarity of our mission. We
remain committed to improving the lives of patients living with pancreatic cancer and to delivering long-term, sustainable value
to you—our shareholders.
.
___________________
Mr Nigel Lange
Chief Executive Officer & Managing Director
OncoSil Medical
6
OncoSil Medical Ltd
Directors' report
30 June 2025
The directors present their report, together with the financial statements, on the consolidated entity (referred to hereafter as
the 'Group') consisting of OncoSil Medical Ltd (referred to hereafter as the 'Company' or 'parent entity') and the entities it
controlled at the end of, or during, the year ended 30 June 2025.
Directors
The following persons were directors of OncoSil Medical Ltd during the whole of the financial year and up to the date of this
report, unless otherwise stated:
Mr Douglas Cubbin
Mr Nigel Lange
Ms Lel Smits
Dr Thomas Duthy
Dr Gabriel Liberatore
Independent Non-Executive Chairman
Chief Executive Officer and Managing Director
Independent Non-Executive Director (appointed 15 January 2025)
Independent Non-Executive Director (appointed on 11 July 2025)
Independent Non-Executive Director (resigned on 11 July 2025)
Information on directors
Name:
Title:
Qualifications:
Experience and expertise:
Other current directorships:
Former directorships (last 3 years):
Special responsibilities:
Interests in shares:
Interests in options:
Name:
Title:
Qualifications:
Experience and expertise:
Other current directorships:
Former directorships (last 3 years):
Special responsibilities:
Interests in shares:
Interests in options:
Interests in rights:
Mr Douglas Cubbin
Non-Executive Director and Chairman
BBus., FCPA, GAICD
Mr Cubbin is an experienced biopharmaceutical executive with over 31 years’
experience in senior executive, CFO, Director and Chair roles, across varied industries.
During his tenure as Group Chief Financial Officer at Telix Pharmaceuticals Limited
(ASX:TLX), a global biopharmaceutical company focused on the development and
commercialisation of diagnostic and therapeutic radiopharmaceuticals, he was a key
member of the team which successfully completed the IPO, raised $270 million in capital
and grew the business to a multi-billion dollar market capitalisation. Mr Cubbin has also
served as Chairman of various boards, including Australian Nuclear Science and
Technology Organisation (ANSTO) Nuclear Medicine.
None
None
Member of the Nomination and Remuneration Committee and member of Audit and Risk
Committee
62,000 ordinary shares (Owned by related party)
12,500 options
18,750 listed options (Owned by related party)
25,000 unlisted options (Owned by related party)
Mr Nigel Lange
Chief Executive Officer and Managing Director
BA, B.Comm
Nigel joined the Company in May 2020 as Europe, Middle East and Africa ('EMEA')
President and brings with him over 31 years of experience in the medical devices
industry. Since 2003, Nigel has held various leadership roles with Sirtex Medical, a
global leader in brachytherapy treatment for liver cancer. From 2003, Nigel served as
Chief Executive Officer of Sirtex's European business, responsible for establishing their
brachytherapy device in over 300 centres across Europe and the Middle East. Since
2017, Nigel served as Group Chief Commercial Officer where he was responsible for all
commercial aspects of the global business. During this time, Nigel has also held interim
roles including Interim Group CEO and Interim CEO of Asia Pacific.
None
None
Member of the Nomination and Remuneration Committee and member of Audit and Risk
Committee
3,750 ordinary shares
14,296 performance dependent loan shares
2,500 listed options
242,030 performance rights
7
OncoSil Medical Ltd
Directors' report
30 June 2025
Name:
Title:
Qualifications:
Experience and expertise:
Other current directorships:
Former directorships (last 3 years):
Special responsibilities:
Interests in shares:
Interests in options:
Name:
Title:
Qualifications:
Experience and expertise:
Other current directorships:
Former directorships (last 3 years):
Special responsibilities:
Interests in shares:
Interests in options:
Ms Lel Smits
Non-Executive Director (appointed on 15 January 2025)
Graduate of Australian Institute of Company Directors’ (AICD) Company Directors
Course, has secured a Diploma of Investor Relations from Australasian Investor
Relations Association (AIRA) and a Master of Arts in Journalism from University of
Technology, Sydney (UTS).
Lel Smits is an award-winning entrepreneur, director and leader with a significant track
record advising more than 500 ASX-listed management teams and Boards and serving
as a Director on Australian Shareholders’ Association since 2021. Lel was awarded
Director of the Year by Women in Finance in 2024 and 2022 and Communications and
Marketing Professional of the Year by Women in Wealth in 2025. Commencing her
career as a journalist, Lel gained extensive global financial markets experience through
producing and presenting thousands of finance reports and CEO interviews as a
broadcast finance journalist in Australia and as a New York foreign correspondent for
the Australian Financial Review, reporting from Wall Street, U.S.A. Extensive ASX listed
company experience and formal education foundations propelled Lel to advise and
contribute to more entrepreneurial ventures and boards through governance, strategy
and risk oversight and marketing, brand, communications and corporate affairs. Lel is
currently a Director of Australian Shareholders' Association.
None
None
Member of Audit and Risk Committee.
None
7,500 options
Dr Thomas Duthy
Non-Executive Director (appointed on 11 July 2025)
Dr Duthy holds a PhD from the University of Adelaide and an MBA from Deakin
University.
Dr Duthy brings more than 21 years of experience across financial markets, corporate
development, and board-level roles in the healthcare and life sciences sectors. He was
previously Head of Corporate Development and Investor Relations at Sirtex Medical
(ASX:SRX), where he played a key role in its $1.9 billion acquisition by China Grand
Pharma/CDH and is the largest medical device transaction in Australian history.
Dr Duthy is the Founder and Director of Nemean Group, a corporate advisory firm
serving healthcare and technology companies, and has been involved in numerous
successful M&A transactions including the $100 million sale of Ellex Medical Lasers
(ASX:ELX) equipment business to Lumibird in 2020, the $111 million takeover of
Limeade (ASX:LME) by WebMD in 2023 and the takeover of Pivotal Systems
(ASX:PVS) also in 2023. He currently advises Mayne Pharma (ASX:MYX) which is
progressing a $672 million takeover from Cosette Pharmaceuticals.
Director of Invex Therapeutics (ASX:IXC).
Arovella Therapeutics (ASX:ALA), Neurotech International (ASX:NTI), Neurizon
Therapeutics (ASX:NUZ)
None
None
None
'Other current directorships' quoted above are current directorships for listed entities only and excludes directorships of all
other types of entities, unless otherwise stated.
'Former directorships (last 3 years)' quoted above are directorships held in the last 3 years for listed entities only and excludes
directorships of all other types of entities, unless otherwise stated.
8
OncoSil Medical Ltd
Directors' report
30 June 2025
Meetings of directors
The number of meetings of the Company's Board of Directors ('the Board') and of each Board committee held during the year
ended 30 June 2025, and the number of meetings attended by each director were:
Nomination and
Remuneration Committee
Attended
Held
Full Board
Held
Attended
Mr Nigel Lange
Dr Gabriel Liberatore
Mr Douglas Cubbin
Ms Lel Smits
8
8
8
5
8
8
8
5
1
1
1
-
Audit and Risk Committee
Attended
Held
1
1
1
-
2
1
2
1
2
2
2
1
Held: represents the number of meetings held during the time the director held office or was a member of the relevant
committee.
Company secretary
Mr. Christian Dal Cin was the Company’s Chief Financial Officer and Company Secretary who resigned on 31 March 2025.
Mr. Dal Cin was an Operations Manager within Acclime's Listed CFO Services team in Melbourne. In this capacity, Mr. Dal
Cin managed operational efficiency while serving as a Chief Financial Officer for Nasdaq and Australian Securities Exchange
(“ASX”) clients and Company Secretary for the Company. Formerly a Partner at Scott Partners Chartered Accounting Firm,
Mr. Dal Cin’s diverse experience spans accounting, finance, and management. Mr. Dal Cin, a Certified Practicing Accountant
(CPA) with Practicing Certificate and Tax Agent registration, holds a bachelor's degree in business (Accounting) from
Swinburne University. Mr Dal Cin has extensive experience in financial leadership roles across listed companies, deep
understanding of accounting and governance requirements, and track record of managing operational efficiency.
Mr Nathan Jong was appointed Company Secretary on 1 April 2025 and resigned on 23 July 2025 when Ms Olga Smejkalova
was appointed.
Mr Jong is a qualified Chartered Secretary, Chartered Accountant and Fellow of the Governance Institute of Australia with
over 10 years of experience in providing finance and corporate compliance advisory services to a range of businesses
including multinational ASX/NASDAQ listed companies. Mr Jong is a corporate governance manager with Acclime.
Ms Smejkalova is an experienced Company Secretary with a background in financial services, specifically in the areas of
company secretarial and corporate governance services. With over ten years of experience, she has honed her skills in these
fields. Olga is a graduate of the Institute of Chartered Secretaries and Administrators, MBA (Economics and Accounting). Prior
to joining Acclime, she held positions at BoardRoom, the Australian Institute of Company Directors and the Australasian
Investor Relations Association, where she managed various corporate secretarial and financial matters. Currently, Olga serves
as the Company Secretary and Governance Advisor for several listed and unlisted Australian and International companies.
With her extensive experience and expertise, Olga brings valuable insights and guidance to the organizations she works with,
ensuring the implementation of sound governance practices and providing effective company secretarial support. Her deep
understanding of corporate governance principles and her proficiency in managing company secretarial matters make her a
trusted advisor in navigating complex regulatory requirements. Olga's attention to detail and strong organizational skills
contribute to the smooth functioning of boards and committees, promoting transparency and compliance. Her dedication to
upholding best practices in corporate governance further strengthens the overall effectiveness and integrity of the
organizations she serves.
Principal activities
The principal activities of the Group during the financial year focused on the development and commercialisation of its lead
product candidate, the OncoSil™ localised radiation therapy for the treatment of pancreatic and distal cholangiocarcinoma.
Dividends
There were no dividends paid, recommended or declared during the current or previous financial year.
Review of operations
The loss for the Group after providing for income tax amounted to $15,099,844 (30 June 2024: $11,913,632).
OncoSil Medical Limited is an ASX-listed medical device company which has developed a breakthrough implantable radiation
(brachytherapy) device for patients with pancreatic cancer. The OncoSilTM device has CE Marking approval for the treatment
of locally advanced pancreatic cancer in combination with gemcitabine-based chemotherapy.
9
OncoSil Medical Ltd
Directors' report
30 June 2025
Commercialisation
Throughout FY25, OncoSil expanded its global reach and successfully initiated several new commercial and clinical programs
as summarised below:
●
August 2024: The first surgical resection of a pancreatic tumour in a patient commercially treated with the OncoSil™
device occurring in Türkiye, just months after we signed a distribution agreement in that country.
●
September 2024: Continued penetration in the Spanish market with the successful completion of the 30th treatment
involving the OncoSil™ device.
●
September 2024: First comparative analysis indicates significant benefits from adding OncoSil™ to chemotherapy for
pancreatic cancer.
●
October/November 2024: The signing of three exclusive distribution agreements to market and distribute the OncoSil™
device, one each for the Nordics region, the Gulf Cooperation Council countries and Egypt.
●
November 2024: First OncoSil™ device treatment at Instituto Nazionale dei Tumori, Italy marking a significant
advancement in the treatment of locally advanced pancreatic cancer and strengthens OnsoSil’s footprint in leading
European oncology centres.
●
May 2025: Comparative analysis of outcomes in patients with unresectable or borderline-resectable locally advanced
pancreatic cancer (LAPC) receiving either OncoSil™ or Stereotactic Body Radiation Therapy (SBRT) reports superiority
of OncoSil™ device.
Clinical and regulatory affairs
OncoSil continued to make significant progress in advancing its clinical and regulatory programs as summarised below:
●
TRIPP-FFX Clinical Study: Enrollment reached 99% in June 2025 in the TRIPP-FF
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