Disclosure Delay Raises Questions on Invion’s ASX Compliance Amid Trial Update

• No adverse events reported in initial six patients of Phase I/II trial
• Treatment well tolerated with no pain, a key advantage over existing therapies
• Observable lesion size reduction after a single treatment cycle
• Disclosure delay due to data verification and compliance with ASX rules
• Company confirms full compliance with continuous disclosure obligations

Background on the Trial and Technology

Invion Limited, a biotechnology company listed on the ASX, is developing Photosoft™, a next-generation photodynamic therapy (PDT) technology aimed at treating cancers including non-melanoma skin cancer (NMSC). PDT leverages light-activated compounds to selectively destroy cancer cells while minimizing side effects, offering a less invasive alternative to surgery.

The company recently reported early findings from its Phase I/II clinical trial involving six patients, highlighting promising safety and efficacy signals.

Details of the ASX Compliance Inquiry

Following Invion's release of a cleansing notice on 27 May 2025 and a subsequent announcement on 29 May 2025 detailing positive trial outcomes, the ASX Compliance team sought clarification on the timing and content of these disclosures. The ASX's focus was on whether the information about no adverse events, treatment tolerability, and lesion size reduction constituted material information that should have been disclosed earlier.

Invion responded comprehensively, confirming that the data was first received on 25 May from a third-party consultant but required further validation by medical experts before public release. This verification process delayed the announcement until after market close on 28 May, with the final disclosure made promptly before market open on 29 May.

Key Findings from the Trial

The Safety Review Committee (SRC) found no adverse events among the first six patients treated, a critical milestone in early-stage trials. Clinician feedback indicated the treatment was well tolerated with no pain reported, which is notable given that pain is a common side effect of existing PDT treatments for NMSC.

Most significantly, there was an observable reduction in lesion size at 15 and 30 days post-treatment, whereas untreated lesions increased slightly in size over the same period. This early efficacy signal, while preliminary, suggests Photosoft™ may offer a meaningful therapeutic benefit.

Compliance and Disclosure Considerations

Invion acknowledged that at the time of lodging the cleansing notice, it did not consider the efficacy data sufficiently verified to warrant immediate disclosure. However, the company has since recognized that the information likely fell within the scope of 'excluded information' under ASX Listing Rule 3.1A, which permits delayed disclosure under certain conditions.

Invion confirmed full compliance with ASX Listing Rules, including continuous disclosure obligations, and emphasized that its responses to the ASX were authorized by its Board. The company also issued a further announcement to correct any perceived deficiencies in the cleansing notice, demonstrating a commitment to transparency.

Looking Ahead

While these early results are encouraging, the trial is ongoing, and Invion has yet to report final outcomes. Investors will be watching closely for further data releases and updates on the company’s discussions with its technology licensor, RMW Cho Group Limited, regarding potential expansion of Photosoft™ rights to additional territories and indications.

Bottom Line?

Invion’s careful navigation of disclosure timing underscores the delicate balance biotech firms face between regulatory compliance and timely market communication.

Questions in the middle?

• When will Invion release comprehensive data from the full Phase I/II trial?
• How might the early efficacy signals influence Invion’s licensing negotiations with RMW Cho Group?
• Could the delay in disclosure affect investor confidence or share price momentum?