Invion Narrows FY26 Loss to $5.63M, Boosts Clinical Trial Pipeline

Financial Results and Funding Position

Invion Limited (ASX:IVX) reported a net loss of $5.63 million for the year ended 30 June 2026, marking a 36% improvement from the prior year’s $8.81 million loss. Revenue was modest at $384,707, derived primarily from non-clinical research funding provided by Hanlim Pharm Co., Ltd. Despite the loss, the company’s net assets stood at $5.32 million, down from $8.25 million the previous year. Invion’s balance sheet reflects a net current liabilities position of $2.15 million, influenced by non-cash liabilities including convertible notes and accrued director fees.

Management highlighted a material uncertainty relating to going concern, citing funding risks typical of clinical-stage biotechs. The company secured a $400,000 R&D financing facility repayable upon receipt of tax incentives and raised approximately $1.25 million through convertible notes, including significant commitments from CEO Thian Chew and a major shareholder. These funds are earmarked to support ongoing clinical trials and research programs.

Expanded Global Licensing and Strategic Collaborations

A major milestone was reached in December 2025 when Invion secured an expanded perpetual and exclusive global license to its PhotosoftTM technology. This license grants Invion worldwide rights to develop, manufacture, and commercialise PhotosoftTM across a portfolio of agreed indications in both human and animal health sectors. The arrangement, approved by shareholders in May 2026, replaces prior agreements and includes milestone-based share issuances and royalties on future sales.

The PhotosoftTM platform, a next-generation photodynamic therapy, is being developed for various cancers and infectious diseases. Invion’s lead compound, INV043, has demonstrated promising preclinical results, including an 80% tumour-free rate in combination with immune checkpoint inhibitors in studies conducted by the Peter MacCallum Cancer Centre.

Clinical and Regulatory Progress

Invion expanded its clinical trial program during FY26, notably progressing its Phase I/II non-melanoma skin cancer (NMSC) trial. Following positive safety and efficacy signals in squamous cell carcinoma cohorts, the trial was extended to include basal cell carcinoma (BCC), which accounts for approximately 80% of skin cancer cases. This expansion was approved by the Safety Review Committee and supported by investigator feedback.

Further clinical advancement includes the U.S. FDA granting Orphan Drug Designation to INV043 for anal cancer treatment, offering seven years of market exclusivity post-approval and potential financial incentives. Invion is collaborating with Peter MacCallum Cancer Centre to design an anogenital cancer trial encompassing anal, vulvar, and penile cancers using the same topical INV043 formulation.

Non-Dilutive Funding and New Partnerships

In a boost to its oesophageal cancer program, Invion secured up to $2 million in non-dilutive funding via a collaboration with Hanlim Pharm Co., Ltd, supported by the South Korean government’s Korea Drug Development Fund. This funding will support preclinical studies and regulatory preparations for a first-in-human clinical trial in Australia using intravenously administered INV043.

Invion also entered the animal health space through a collaboration with Taiwan-listed Protect Animal Health Inc., which will fund and conduct studies evaluating PhotosoftTM compounds for cancer treatment in companion animals. Invion retains all rights to the technology and any new intellectual property arising from these studies.

Additionally, Invion expanded into ophthalmology with a partnership with South Korea’s Sangmyung Innovation Co., Ltd to conduct proof-of-concept preclinical studies in wet age-related macular degeneration, a market projected to reach US$16.7 billion by 2032.

Governance and Leadership Updates

Invion strengthened its clinical leadership by appointing Dr Colin Hopper, President of the International Photodynamic Association and a global expert in photodynamic therapy, as Clinical Advisor. His expertise is expected to enhance trial design and clinical governance as Invion advances PhotosoftTM toward later-stage development.

Post-year-end, Invion appointed Paul Field, a biopharmaceutical industry veteran with extensive global commercialisation experience, as an Independent Non-Executive Director, while Alistair Bennallack resigned from the board.

Capital Structure and Shareholder Considerations

During FY26, Invion issued shares and options to fund operations and compensate directors and consultants. Notably, 12.2 million shares were issued to RMW Cho Group Limited as partial consideration for the global licensing rights acquisition. The company’s capital raising activities included the issuance of convertible notes totaling $2.03 million and a listed loyalty option entitlement offer raising nearly $1 million.

Despite ongoing losses, Invion did not declare any dividends. The company continues to manage risks inherent to drug development, including clinical efficacy, funding availability, and market competition.