OncoSil Medical Ltd (ASX: OSL), a medical device company focused on localised treatments for patients with unresectable locally advanced pancreatic cancer (LAPC), is pleased to announce its Appendix 4C cash flow report for the quarter ended 31 December 2024 (Q2 FY25), along with the following financial and operational update.
Key Highlights
• OncoSil signs distribution agreements for GCC, Egypt and Nordics
• OncoSil Medical Receives UKCA Renewal Certificates
• G-BA clinical trial approval received for OncoSil Device
• First OncoSil Treatment at Instituto Nazionale dei Tumori, Milan, Italy
• First Patient in Australia Randomised in TRIPP-FFX Trial
OncoSil signs distribution agreements for GCC, Egypt and Nordics
OncoSil Medical expanded its global presence through several exclusive distribution agreements:
• Al Zahrawi Medical Supplies LLC: The agreement grants exclusive rights to distribute OncoSil™ in the United Arab Emirates (UAE), Qatar, Oman, and Bahrain. The GCC region represents a rapidly growing market for advanced medical technologies, with significant investments in healthcare infrastructure and a focus on improving access to innovative cancer treatments. Al Zahrawi’s extensive network and expertise position OncoSil to make a meaningful impact on pancreatic cancer care in this high-potential region.
• CardiRad: This partnership enables the distribution of OncoSil™ in Sweden, Denmark, Norway, and Finland. The Nordics are renowned for their advanced healthcare systems, strong emphasis on research, and early adoption of cutting-edge medical technologies. CardiRad’s expertise in the field of oncology and nuclear medicine, coupled with its well-established sales force and connections in the region, will drive the adoption of OncoSil™ technology, providing a transformative option for patients in these countries.
• Femto Trade: As a leader in medical solutions within Egypt, Femto Trade brings deep market insights, clinical expertise, and a strong network of relationships with key healthcare providers. Egypt is a critical entry point into the broader Middle East and North Africa (MENA) region, where the demand for advanced cancer treatments is growing due to rising cancer incidence rates and increasing investments in healthcare. This agreement enables OncoSil to address the urgent need for innovative therapies in this region.
OncoSil Medical Receives UKCA Renewal Certificates
In October 2024; The British Standards Institution (BSI) renewed the UK Conformity Assessed (UKCA) certificates for OncoSil™ with no post-market restrictions. This milestone highlights the device's robust safety profile, reduces regulatory burdens, and streamlines market access in the UK.
G-BA Approval received for OncoSil Device
In October 2024; The German Federal Joint Committee (G-BA) approved a randomised controlled trial for the OncoSil™ device under a Coverage with Evidence Development (CED) program. This initiative will enable conditional reimbursement and support the collection of additional clinical evidence to demonstrate its effectiveness in treating unresectable, locally advanced pancreatic tumours. OncoSil Medical is the first company to receive approval for a clinical trial in oncology under this program.
First OncoSil Treatment at Instituto Nazionale dei Tumori
The first OncoSil™ device implantation was successfully completed on November 8, 2024, at the Instituto Nazionale dei Tumori, Milan, Italy. This marks a significant advancement in the treatment of locally advanced pancreatic cancer and strengthens OncoSil’s footprint in leading European oncology centres.
First Patient in Australia Randomised in TRIPP-FFX Trial
In December 2024; the first patient at the Royal Adelaide Hospital, Australia, was successfully randomized for the TRIPP-FFX clinical trial. This milestone initiates patient recruitment at this esteemed Australian institution, bringing the total number of global enrolees to 49.
OncoSil Medical CEO & Managing Director Nigel Lange, said:
“This has been an exceptional quarter for OncoSil Medical, marked by significant progress across multiple fronts. From expanding our distribution network in strategic global markets to achieving critical regulatory milestones and advancing our clinical trial initiatives, we have also seen a substantial increase in sales, reflecting the growing demand for our innovative pancreatic cancer treatment. Each of these achievements strengthens our position as a leader in this field and demonstrates our commitment to improving outcomes for patients worldwide.”
$8m in new equity raised;
Through a placement to sophisticated and professional investors OncoSil successfully raised $7 million before costs. Issuing approximately 700 million New Shares at an issue price of $0.01 (1 cent) per New Share (Placement). The Placement shares were issued under the Company's existing capacity with the Placement including the issue of 1 Option for every 1 New Share issued under the Placement (Placement Options). The 700 million Placement Options have an exercise price of $0.015 each and expiry date of 3 years from their issue date. These Options were listed with security code OSLOC. These Options were approved at the Extraordinary General Meeting held on 11 December 2024.
The Share Purchase Plan (SPP) announced on 28 October 2024 raised a total of $1 million from eligible shareholders at the same price as payable by the Placement subscribers (SPP Offer). The total amount raised comprised 69 million New Shares and 69 million New Options issued to existing Eligible Shareholders under the SPP Offer and 31 million New Shares and 31 million New Options were issued under the SPP Shortfall Commitment. These Shares and Options were approved at the Extraordinary General Meeting held on 11 December 2024.
The funds raised from the Placement and the SPP Offer will be applied to further investment in OSL's Macquarie Park manufacturing facility, funding of clinical trials, together with payment for other working capital costs and costs of the offer.
Finance Update
The Appendix 4C Quarterly Cash Flow report for the December 2024 quarter is attached to this announcement.
As detailed in the report, the Company had $8.463 million in cash and equivalents as at 31 December 2024, increasing by $4.462 million from $4.001 million at 30 September 2024.
The Company received $0.339 million in customer receipts for the quarter, bring the receipts to $0.402 million for the half year. This result is a 45% increase on the $0.277 million FY2024 full year results.
The management are focused on commercialization of the device in several markets, and this is expected to contribute to the revenue growth trajectory over the coming 12 months.
The Company raised $8 million in capital during the quarter, with $7 million through a placement and $1 million through a Share Purchase Plan.
Related Party Payments
Pursuant to Listing Rule 4.7C.3 and as disclosed in Item 6.1 of the attached Appendix 4C, A$329,170 was paid in respect of remuneration of director fees in the normal course of business at commercial rates, excluding reimbursements of out-of-pocket expenses.
Subsequent Events:
National Ministry of Health in Germany approves Coverage with Evidence Development Study Directive by the GBA for OncoSil
In January 2025; Ministry of Health approval has been received and the Coverage with Evidence Development Study Directive has been published in the National German Gazette. This is an important step forward for the initiation of the randomised controlled trial conducted under the framework for a Coverage with Evidence Development (CED) program in Germany.
OncoSil receives $1.05m R&D tax incentive
In January 2025; Further, the company has received a research and development (R&D) tax refund of $1.050 million under the Australian Government’s R&D tax incentive. The refund is in recognition of OncoSil’s R&D activities during the 2024 financial year and will provide important funding for continued development of its commercial-stage device.
Appointment of Ms. Lel Smits to the Board
In January 2025; Ms. Lel Smits joins OncoSil Medical Board as Non-Executive Director. With extensive experience in governance, strategy, risk oversight, and corporate communications, Ms. Smits has advised over 500 ASX-listed companies. An award-winning entrepreneur and twice-named Director of the Year by Women in Finance (2024, 2022), she currently serves on the Board of the Australian Shareholders' Association. Her distinguished career includes roles as a finance journalist and foreign correspondent at the New York Stock Exchange. Ms. Smits’ expertise strengthens OncoSil’s Board, supporting the company’s mission to advance pancreatic cancer treatment.
Oncosil Medical Receives MDR Approval
In January 2025; MDR (Medical Device Regulation) certification received from BSI. The certification includes the lifting of post-market restrictions, which will streamline commercial operations across the EU and UK, accelerates market access, and reduces costs to be reinvested in growth initiatives. This approval also enables OncoSil to re-submit its TGA application, supporting its mission to enhance global patient outcomes.
Read the full announcement here
About us:
About OncoSil Medical
OncoSil Medical Limited (ASX:OSL) has developed a cancer treatment device, the OncoSil™ brachytherapy device, which is a critical component of a revolutionary brachytherapy treatment for locally advanced unresectable pancreatic cancer. This type of cancer is the 12th most common cancer in men and the 11th most common cancer in women across the globe, with some 500,000 new cases of pancreatic cancer detected every year. With pancreatic cancer typically diagnosed at a later stage, it has a poor prognosis for longterm survival.
The OncoSil™ device delivers a targeted intratumoural placement of Phosphorous-32 (32P) in the treatment of locally advanced unresectable pancreatic cancer. This occurs via injection directly into a patient’s pancreatic tumours under endoscopic ultrasound guidance and takes place in combination with gemcitabine-based chemotherapy.
The OncoSil™ device that has already received breakthrough device designation in the European Union, United Kingdom and United States for the treatment of locally advanced unresectable pancreatic cancer in combination with chemotherapy. CE Marking has additionally been granted for the OncoSil™ device, which can be marketed in the European Union, United Kingdom.
While clinical trials involving the OncoSil™ device continue to occur, the Company is simultaneously moving to commercialise this unique medical technology. It is currently approved for sale in 30+ countries including European Union, United Kingdom, Türkiye and Israel, with initial commercial pancreatic cancer treatments using the device already undertaken in Spain, Italy and Israel.
To learn more, please visit: www.oncosil.com
Contact details:
For more information, please contact:
Mr. Nigel Lange
CEO & Managing Director
E: nigel.lange@oncosil.com
T: +49 30 300 149 3043
Mr. Christian Dal Cin
CFO & Company Secretary
E: c.dalcin@acclime.com
T: +61 3 9824 5254
Media & Investor Enquiries
Ms. Julia Maguire
The Capital Network
Media and Investor Enquiries
E: julia@thecapitalnetwork.com.au
T: +61 2 8999 3699