• Expansion into Basal Cell Carcinoma (BCC) patients approved
• Further encouraging results in Squamous Cell Carcinoma (SCC) patients
• Continued strong safety data and reductions in lesion size

Invion Limited (ASX: IVX) has announced the next phase in the development of INV043 for non-melanoma skin cancer (NMSC), progressing its clinical trial to the final Part 3 and expanding to patients with Basal Cell Carcinoma (BCC) - the largest and most prevalent form representing approximately 80% of all skin cancers. The approval from the Safety Review Committee (SRC) to expand to this patient population follows the second set of preliminary unaudited data demonstrating a consistently favorable safety profile and encouraging early efficacy signals in a new cohort of six squamous cell carcinoma (SCC) patient readouts. The treatment continues to be well tolerated, with clinician feedback indicating no pain during or after treatment, comparing favorably to currently approved photodynamic therapy (PDT) treatments. The latest data shows continued strong safety, reductions in lesion size relative to baseline, complete resolution observed in select cases, and consistent fluorescence signals that further validate the theragnostic potential of the technology. Expansion to the BCC patient group was not possible until satisfactory safety results were obtained in the SCC patients. Invion's Executive Chair and CEO, Prof Thian Chew, commented that the expansion into BCC is a value-enhancing milestone, and the positive observations will further support the upcoming anogenital trial using the same topical formulation of INV043.

Invion will now initiate recruitment for the BCC cohort, building on the results observed in SCC patients. The company will continue treating and monitoring participants in the current cohort to further monitor safety and characterize lesion-level responses, and will provide further updates as the trial progresses.