OncoSil Medical Expands Global Reach and Boosts Cash Reserves in Q2 FY25
OncoSil Medical has secured new distribution agreements across key international markets and achieved critical regulatory milestones, while raising $8 million to fuel its growth in pancreatic cancer treatment.
- New exclusive distribution agreements signed for GCC, Egypt, and Nordic regions
- UKCA and MDR certifications renewed, easing market access in Europe and UK
- G-BA approval for German clinical trial under Coverage with Evidence Development program
- First OncoSil treatments initiated in Italy and Australia’s TRIPP-FFX trial enrolment progresses
- Raised $8 million through placement and Share Purchase Plan, cash balance increased to $8.463 million
Strategic Expansion into High-Potential Markets
OncoSil Medical Ltd (ASX: OSL) has made significant strides in the quarter ended 31 December 2024, announcing a series of exclusive distribution agreements that broaden its footprint across the Gulf Cooperation Council (GCC), Egypt, and the Nordic countries. Partnering with Al Zahrawi Medical Supplies LLC, CardiRad, and Femto Trade respectively, OncoSil is positioning its innovative brachytherapy device for locally advanced pancreatic cancer in regions with growing healthcare investments and increasing demand for advanced oncology treatments.
The GCC agreement covers the UAE, Qatar, Oman, and Bahrain, tapping into a rapidly expanding market keen on innovative cancer therapies. Meanwhile, the Nordic partnership leverages CardiRad’s oncology expertise to access Sweden, Denmark, Norway, and Finland, known for their early adoption of cutting-edge medical technologies. Femto Trade’s network in Egypt opens a gateway to the broader Middle East and North Africa (MENA) region, where rising cancer incidence rates underscore the urgent need for new treatment options.
Regulatory Milestones Enhance Market Access
OncoSil’s regulatory progress complements its commercial expansion. The company secured renewal of its UK Conformity Assessed (UKCA) certificates from the British Standards Institution, with no post-market restrictions, reinforcing the device’s safety profile and facilitating smoother UK market operations. Additionally, OncoSil received Medical Device Regulation (MDR) certification from BSI in January 2025, lifting previous post-market restrictions and streamlining commercial activities across the European Union and UK.
Notably, the German Federal Joint Committee (G-BA) granted approval for a randomised controlled trial under its Coverage with Evidence Development (CED) program. This approval, now ratified by the German Ministry of Health and published in the National Gazette, enables conditional reimbursement and supports the collection of further clinical evidence for OncoSil’s device in treating unresectable pancreatic tumors. OncoSil is the first oncology company to gain such approval under this innovative framework, underscoring its pioneering role in the field.
Clinical Progress and Commercial Traction
Clinical momentum continues with the first OncoSil treatment performed at the prestigious Instituto Nazionale dei Tumori in Milan, Italy, marking a key milestone in European adoption. In Australia, the TRIPP-FFX clinical trial advanced with the randomisation of its first patient at the Royal Adelaide Hospital, bringing global enrolment to 49 participants. These developments signal growing clinical validation and adoption of OncoSil’s targeted brachytherapy approach.
Financial Strengthening to Support Growth
OncoSil bolstered its financial position by raising $8 million through a placement to sophisticated investors and a Share Purchase Plan (SPP) for existing shareholders. The capital raise involved issuing approximately 700 million new shares at 1 cent each, accompanied by options exercisable at 1.5 cents over three years. This injection lifted the company’s cash reserves to $8.463 million as of 31 December 2024, nearly doubling from the previous quarter.
The company’s cash flow report also highlighted a 45% increase in customer receipts for the half-year period, reflecting early commercial traction. Management emphasized that ongoing commercialization efforts across multiple markets are expected to drive revenue growth over the next 12 months.
Governance and Future Outlook
Strengthening its governance, OncoSil appointed Ms. Lel Smits as a Non-Executive Director. With extensive experience advising ASX-listed companies and a background in finance journalism, Ms. Smits brings valuable expertise in strategy and risk oversight to support OncoSil’s ambitious growth plans.
Looking ahead, OncoSil’s combination of expanded market access, regulatory approvals, clinical progress, and enhanced financial resources sets a promising stage for advancing its mission to improve outcomes for patients with locally advanced pancreatic cancer worldwide.
Bottom Line?
OncoSil’s recent achievements lay a robust foundation, but the market will watch closely as clinical trials and commercial rollouts unfold.
Questions in the middle?
- How will the new distribution agreements translate into revenue growth in the coming quarters?
- What are the anticipated timelines and endpoints for the German G-BA clinical trial under the CED program?
- How might the lifting of post-market restrictions under MDR certification accelerate OncoSil’s EU and UK market penetration?