• Completed FDA registration and received $4.2 million license fee from Superpower Health
• Raised $15.6 million through secondary capital raise
• Tutelix received fast track ethics approval for pivotal clinical trial
• Advanced manufacturing campus nearing completion
• Strong cash position of $34.4 million

Tetratherix Limited (ASX: TTX) released its Q4 FY26 quarterly activities report, highlighting significant achievements. The company formalized its substance registration with the FDA, enabling the regulatory pathway for export to the US market for its Precision Medicine franchise. Additionally, Tetratherix received its first license fee revenue of US$3 million (~A$4.2 million) in Q4 FY26. The company raised $15.6 million (before costs) via a secondary capital raise from new and existing institutional investors, strengthening its cash position to accelerate growth. Positive data from the TUTELA trial identified the potential expansion of the Tutelix platform opportunity into gynaecological cancers, representing an exciting entry into a grossly underserved market. Tutelix attained fast track ethics approval for the Tutelix international pivotal clinical trial (n=240) targeting FDA 510(k) clearance. The company also completed the Medical Device Single Audit Program (MDSAP) Stage 1 audit, with the full stage 2 audit expected in CY2027. Tetratherix's advanced manufacturing campus in Alexandria, New South Wales, Australia, is nearing completion, expected to be certified and operational in CY26.

Tetratherix expects to accelerate commercial scale across all franchises, with FDA clearances for Tegenix and TegenEOS in CY26.

Tetratherix is optimistic about its commercial growth across the entire ecosystem, with a focus on expanding production capacity, establishing a customer success team, and building digital science organizational capability.