Going Concern Clouds Invion’s Path Despite Clinical Progress and Funding
Invion Limited posted a $8.8 million loss for FY25, marking a 56.5% increase, while advancing clinical trials and securing fresh capital. The biotech faces a going concern warning amid ongoing development and funding challenges.
- Net loss increased 56.5% to $8.8 million for FY25
- No revenue recorded, down 100% from prior year
- Progress in Phase I/II trials for non-melanoma skin cancer and prostate cancer
- Raised approximately $2 million via share placement and $980,000 through loyalty option entitlement
- Auditor flagged material uncertainty on going concern due to operating losses and net current liabilities
Financial Results Highlight Increased Losses
Invion Limited, a clinical-stage life sciences company focused on Photosoft™ technology for cancer and other diseases, reported a net loss of $8.8 million for the year ended 30 June 2025. This represents a 56.5% increase from the $5.6 million loss recorded in the prior year. Revenues from ordinary activities fell to zero, down 100% from the previous period, reflecting the company’s continued focus on research and development rather than commercial sales.
Clinical Development Advances
Despite the financial pressures, Invion made notable progress in its clinical programs. The company advanced its Phase I/II adaptive platform trial for non-melanoma skin cancer (NMSC) in Queensland, Australia, with early safety data showing encouraging tolerability and signs of efficacy. Additionally, promising Phase II results from a prostate cancer trial using a sublingual formulation of the lead compound INV043 were reported, with 40% of patients showing positive tumour regression signals.
Invion also secured a $20,000 grant from the Colorectal Surgical Society of Australia and New Zealand to support an upcoming anogenital cancer trial in partnership with the Peter MacCallum Cancer Centre. Collaborations with Hanlim Pharm Co., Ltd in South Korea were expanded to include studies on glioblastoma multiforme and oesophageal cancer, further diversifying the company’s pipeline.
Funding and Capital Raising
To support ongoing development, Invion raised approximately $2 million through a placement of 14.23 million shares at $0.14 per share to institutional and sophisticated investors. Post-year-end, the company completed a fully underwritten loyalty option entitlement offer, raising an additional $980,000. These capital injections are critical as the company’s cash balance stood at $850,373 at 30 June 2025, down from $783,526 the previous year.
Going Concern and Risk Factors
The company’s auditor, William Buck Audit (Vic) Pty Ltd, issued an unmodified opinion but highlighted a material uncertainty related to Invion’s ability to continue as a going concern. This stems from the recurring operating losses and the fact that current liabilities exceed current assets by approximately $305,000. The directors acknowledge these risks and emphasize ongoing efforts to secure funding and manage operational costs.
Invion also disclosed key business risks including the efficacy of its lead compound, funding availability, reliance on key partnerships such as with RMW Group and Cho Limited, intellectual property protection, and market competition from emerging therapies. The company continues to monitor and mitigate these risks as it advances its strategic priorities.
Experienced Leadership and Governance
The board comprises seasoned executives with deep expertise in biotechnology, finance, and corporate governance. Executive Chairman and CEO Thian Chew brings over 25 years of healthcare and biotech experience, supported by non-executive directors with strong backgrounds in investment management and corporate finance. The company maintains rigorous governance practices, including a remuneration framework aligned with shareholder interests.
Bottom Line?
Invion’s next milestones hinge on clinical trial outcomes and securing further funding to sustain its development trajectory amid financial headwinds.
Questions in the middle?
- Will upcoming clinical trial data validate the efficacy and safety of INV043 across indications?
- How will Invion manage funding needs given the going concern uncertainty and cash burn?
- What progress will be made in expanding Photosoft™ technology licensing and commercialization partnerships?
