OncoSil Medical Raises $8M to Fund German Trial and European Expansion

OncoSil Medical has secured an $8.0 million OncoSil Medical Capital Raise to fund its European commercial expansion, with the German government-sponsored G-BA clinical trial representing the centrepiece opportunity. The raise comprises a $6.0 million placement to institutional investors and a fully underwritten $2.0 million entitlement offer priced at $0.68 per share, representing a 15.0% discount to the last closing price of $0.80. Post-transaction, the company anticipates a pro-forma cash position of approximately $12.0 million.

The capital raising received strong institutional backing, including Pengana High Conviction Equities Fund as a cornerstone investor. Directors and key management are committing $150,000 to the placement, signalling confidence in the commercial strategy ahead.

Capital raise structure and investor participation

The OncoSil Medical Capital Raise is structured across two tranches and a shareholder entitlement offer designed to provide funding certainty while minimising dilution.

Tranche 1 will raise $3.2 million through the issue of approximately 4.7 million shares using the company’s existing ASX Listing Rule 7.1 and 7.1A capacity. Settlement is scheduled for 9 February 2026, with trading to commence the following day. Tranche 2, conditional on shareholder approval at an Extraordinary General Meeting on 12 March 2026, will raise $2.8 million via approximately 4.1 million shares.

The entitlement offer grants eligible shareholders the right to subscribe for 1 new share for every 6.4 shares held as at the record date of 6 February 2026. Each share subscribed will carry 1 free-attaching option with an exercise price of $0.90 and expiry of 30 June 2027. Bell Potter Securities Limited is acting as sole lead manager and has fully underwritten the entitlement offer, providing execution certainty.

Directors and key management are investing $150,000 in the placement, subject to shareholder approval. This participation demonstrates alignment between the board and retail shareholders at a critical juncture in the company’s commercialisation strategy.

Germany represents the commercial prize

Germany’s government-sponsored G-BA clinical trial positions OncoSil Medical (ASX: OSL) to capture dual revenue streams while generating regulatory evidence applicable across Europe’s largest healthcare markets.

The G-BA study is anticipated to commence recruitment in 1H CY26, involving approximately 40 new German hospitals. The trial structure creates two distinct revenue opportunities: $5.6 million in estimated trial revenues and an additional $6.5 million from treating patients who are ineligible for trial participation but qualify for commercial reimbursement. This dual pathway provides immediate revenue visibility while the trial progresses.

Data generated through the G-BA process will support future reimbursement submissions in the United Kingdom, France, BENELUX, and Nordic markets. The evidence is also expected to bolster OncoSil’s case for inclusion in Germany’s S3 treatment guidelines and broader European Society for Medical Oncology (ESMO) protocols, potentially unlocking access to millions of additional patients across the continent.

CEO Commentary
“In CY26, the key focus for the Company will be Germany, representing a significant commercial and strategic opportunity. The planned G-BA clinical trial is expected to involve approximately 40 hospitals and is anticipated to commence in 1H CY26,” said Nigel Lange, Chief Executive Officer and Managing Director.

European commercial momentum building

Beyond Germany, OncoSil Medical is gaining traction across Spain, Italy, and Turkey, where a growing network of active implanting centres demonstrates clinical adoption.

15 hospitals are now consistently re-ordering the OncoSil™ device, providing tangible evidence of physician satisfaction and repeat usage. This metric serves as a leading indicator for sustainable demand, as repeat orders suggest clinicians are integrating the therapy into standard treatment protocols rather than conducting isolated pilot cases.

Active commercial treatments have been completed across multiple jurisdictions:

• Spain
• Italy
• Turkey
• Austria
• Germany
• Greece
• Portugal
• Israel
• United Kingdom

This geographic footprint, combined with repeat purchasing behaviour, validates the real-world clinical utility of OncoSil’s targeted brachytherapy approach in pancreatic cancer treatment.

Understanding brachytherapy and OncoSil’s targeted approach

OncoSil Medical has developed a targeted radiation therapy designed to address the challenges of treating locally advanced pancreatic cancer, a disease notorious for late-stage diagnosis and poor survival outcomes.

The OncoSil™ device delivers Phosphorous-32 (32P) microparticles directly into the tumour via intratumoural placement. This brachytherapy approach contrasts with external beam radiotherapy by concentrating a higher radiation dose within the tumour itself while minimising exposure to surrounding critical organs such as the stomach, bowel, and kidneys.

Pancreatic cancer presents a significant clinical challenge globally. The disease accounts for approximately 500,000 new cases annually worldwide, ranking as the 12th most common cancer in men and 11th most common in women. Because symptoms often manifest late, diagnosis typically occurs at an advanced stage, contributing to the poor long-term survival rates associated with the disease.

OncoSil™ has secured CE Marking approval, granting marketing authorisation across the European Union and United Kingdom. The therapy has also received breakthrough device designation in both Europe and the United States, reflecting regulatory recognition of its potential to address an unmet medical need. The device is currently approved for sale in over 30 countries, including European Union member states, the UK, Turkey, and Israel.

Breakthrough device designation accelerates regulatory pathways by acknowledging therapies that offer significant advantages over existing treatments for life-threatening or irreversibly debilitating conditions. This status positions OncoSil for expedited review processes as it pursues label expansions and additional market approvals.

CY26 clinical and regulatory milestones

OncoSil Medical has outlined a milestone-driven roadmap for 2026 that targets label expansions, regulatory approvals, and manufacturing capability, each designed to broaden the commercial opportunity and de-risk the investment thesis.

1H CY26:

1. TRIPP FFX Clinical Trial full data release (label expansion to include FOLFIRINOX chemotherapy combination)
2. OSPREY Analysis full data release (real-world evidence study)
3. PANCOSIL Clinical Trial regulatory submission (percutaneous administration label expansion)
4. Macquarie Park manufacturing facility ongoing validation

2H CY26:

5. TRIPP FFX regulatory filing and anticipated regulatory approval
6. OSPREY manuscript preparation on real-world data and journal submission
7. PANCOSIL anticipated regulatory approval
8. Manufacturing facility anticipated regulatory approval and first commercial supply

The TRIPP FFX trial evaluates OncoSil™ in combination with FOLFIRINOX, a chemotherapy regimen commonly used in pancreatic cancer. Approval would expand the device’s label to include this combination therapy, materially increasing the addressable patient population. The PANCOSIL trial focuses on percutaneous administration, a less invasive delivery method that could further broaden clinical adoption.

Label expansions represent a critical value driver, as they enable OncoSil to target previously excluded patient cohorts without requiring entirely new regulatory approvals in existing jurisdictions. This regulatory efficiency allows the company to leverage its existing CE Mark across 30+ countries while incrementally expanding treatment indications.

Manufacturing capability coming online

The Macquarie Park manufacturing facility is undergoing validation in 1H CY26, with regulatory approval and first commercial supply anticipated in 2H CY26.

In-house manufacturing capability provides three strategic advantages: supply chain control, margin expansion, and scalability to meet increasing European demand. By reducing reliance on third-party contract manufacturers, OncoSil Medical positions itself to respond more rapidly to order fluctuations while retaining a greater proportion of gross profit on each device sold.

Use of funds and financial position

Proceeds from the OncoSil Medical Capital Raise will be allocated across clinical, manufacturing, and commercial priorities designed to support near-term revenue generation and regulatory de-risking.

Funding priorities:

• Complete clinical trials
• Complete manufacturing facility
• Sales and marketing investment
• Market access investment
• General working capital
• Offer costs

Post-transaction, OncoSil Medical will hold a pro-forma cash balance of approximately $12.0 million, providing runway to advance multiple concurrent workstreams without immediate recapitalisation pressure.

The allocation reflects a dual focus: advancing revenue-generating commercial activities (sales, marketing, and market access) while completing clinical and manufacturing infrastructure required for long-term scalability. Market access investment is particularly material, as reimbursement pathways determine the speed at which new hospital networks can adopt OncoSil™ therapy on a sustainable commercial basis.

Key dates for shareholders

Shareholders considering participation in the entitlement offer should note the following dates:

• Record date: 6 February 2026
• Entitlement offer opens: 11 February 2026
• Entitlement offer closes: 10 March 2026
• Extraordinary General Meeting (EGM): 12 March 2026
• New shares and options issued: 17 March 2026
• Trading commences: 18 March 2026

Eligible shareholders will receive a personalised Entitlement and Acceptance Form accompanying the prospectus, which was lodged with ASIC and ASX on 3 February 2026. Fractional entitlements will be rounded up to the nearest whole number.

Closing investment thesis

The $8.0 million capital raise positions OncoSil Medical to capitalise on a near-term commercial inflection point in Europe’s largest healthcare market. With the German G-BA trial offering dual revenue streams totalling $12.1 million while generating evidence to unlock reimbursement across the UK, France, BENELUX, and Nordic regions, 2026 represents a pivotal year for the company.

The fully underwritten structure eliminates execution risk, while director participation of $150,000 signals board confidence in the commercial strategy. Multiple regulatory catalysts across CY26, including TRIPP FFX and PANCOSIL approvals, provide regular de-risking events and broaden the addressable patient population through label expansions.

A strengthened balance sheet of approximately $12.0 million provides runway to execute clinical, manufacturing, and commercial milestones without near-term funding pressure. As 15 hospitals consistently re-order OncoSil™ devices, the company is demonstrating real-world clinical adoption that validates physician confidence and sustainable demand dynamics.

CEO on Capital Raise Strategy
“We are pleased to announce a capital raising, including strong commitments received under the Placement from institutional and professional investors. Together with the fully underwritten Entitlement Offer, the capital raising is intended to strengthen the Company’s balance sheet and support execution of key near and medium-term clinical, regulatory and commercial milestones,” said Nigel Lange, Chief Executive Officer and Managing Director.

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