How OncoSil Medical’s $15.1M Loss Masks Breakthrough Regulatory Wins and Market Expansion
OncoSil Medical reported a $15.1 million loss for FY25 amid strong revenue growth and significant regulatory milestones, supported by over $14 million in capital raises to fuel its global expansion.
- Net loss widened to $15.1 million despite 127% revenue growth
- Secured EU MDR certification and German G-BA approval
- Completed recruitment in pivotal PANCOSIL and TRIPP-FFX clinical trials
- Raised over $14 million through placements and share purchase plans
- Completed 1-for-400 share consolidation and strengthened board
Financial Performance and Capital Strengthening
OncoSil Medical Ltd has reported a net loss of $15.1 million for the year ended 30 June 2025, an increase from $11.9 million the previous year. Despite this, the company achieved a notable 127% increase in revenue to $1.17 million, driven primarily by commercial sales growth in Europe and new distribution agreements across multiple regions.
To support its ongoing operations and growth ambitions, OncoSil successfully raised over $14 million through a series of placements and share purchase plans during the year. This capital injection has bolstered the company's cash reserves to $5.1 million as of June 30, 2025, providing a stronger financial footing amid continued investment in clinical development and commercialisation.
Regulatory Milestones and Clinical Progress
A key highlight for OncoSil was securing Medical Device Regulation (MDR) certification from BSI, the EU Notified Body, which removes previous post-market restrictions and streamlines access to EU and UK markets. Additionally, the company received approval from the German Federal Joint Committee (G-BA) for a fully reimbursed clinical trial, a significant endorsement that could facilitate broader adoption within Germany’s public healthcare system.
On the clinical front, OncoSil completed recruitment in two pivotal trials, PANCOSIL, evaluating a percutaneous delivery method for the OncoSil™ device, and TRIPP-FFX, assessing its use alongside FOLFIRINOX chemotherapy. Both trials reached over 95% recruitment by June 2025 and concluded in July, with data expected to inform future regulatory and reimbursement strategies.
Commercial Expansion and Market Reach
The company expanded its geographic footprint with new distribution agreements in Egypt, the Gulf Cooperation Council countries, and the Nordic region. Commercial sales momentum was particularly strong in Spain, where over 30 treatments have been conducted, and in other European markets including Greece and Israel.
OncoSil also progressed its manufacturing capabilities with developments at its Macquarie Park facility in Sydney, aiming to enhance production control and scalability to meet growing demand.
Governance and Corporate Developments
OncoSil undertook a 1-for-400 share consolidation approved by shareholders, simplifying its capital structure and improving market clarity. The board was strengthened with the appointment of two new non-executive directors, Ms Lel Smits and Dr Thomas Duthy, bringing extensive expertise in corporate governance, healthcare, and financial markets. These changes reflect the company’s commitment to robust leadership as it scales operations.
Despite the progress, the company disclosed a material uncertainty regarding its ability to continue as a going concern, citing ongoing losses and cash burn. However, management remains confident that recent capital raises and forecasted cash inflows will sustain operations into FY26.
Bottom Line?
OncoSil Medical stands at a pivotal juncture, balancing promising clinical and regulatory advances with financial challenges that will test its path to commercial success.
Questions in the middle?
- When will the clinical trial data from PANCOSIL and TRIPP-FFX be released, and how might it impact regulatory approvals?
- How will OncoSil navigate reimbursement negotiations in key markets beyond Germany and the EU?
- What are the company’s plans to achieve sustainable profitability amid ongoing losses and cash burn?
