Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 51

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 51
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 external beam radiation
showed higher tumor uptake of the radiotracer, while previously treated patients show a trend towards lower uptake of the radiotracer.
There were no adverse safety events, confirming the Phase I result.

18F-FPIA essentially targets
fatty acid synthetase, selectively overexpressed by tumors, but not by normal brain cells. Tumor cells have evolved unique biochemical
pathways for de novo fatty acid synthesis aimed at preventing excessive oxidative stress, an outcome of which is cell death, and maintaining
favorable cellular composition for membrane formation and proliferation. Part of this process is the uptake of short chain carboxylates
by cells, such as acetate and propionate. Non-naturally occurring pivalate is retained in this process and the ICL researchers have shown
that the analogue fluoropivalate (using 18F-FPIA) is imported into and retained by tumor cells. High tumor uptake of 18F-FPIA has been
demonstrated in murine and human tumor xenografts (tumors implanted into mice) of the breast, brain, and prostate. In July 2024, we received
the IND approval from the FDA to conduct a Phase IIb for RAD101 in the United States. RAD101 targets brain metastases.

Phase IIb is expected to enroll
30 patients in the United States and is expected to complete by the first quarter of 2026. Phase III is planned to be conducted in the
United States by enrolling 150 patients with a start date expected in in the second half of 2026 and is expected to complete by the end
of 2027. RAD102 is in an early preliminary stage and we thus do not plan to submit an IND application with the FDA until we have gathered
more preclinical data. RAD102 targets brain tumors.

Avβ6-Integrin (Trivehexin)

Avβ6 is the invention
of internationally regarded integrin expert Professor Johannes Notni, formerly at the Technical University of Munich and now senior executive
at TRIMT. Avβ6-integrin is an antigen over-expressed in tumors such as pancreatic carcinoma, head-and-neck cancer, and certain lung
cancers, as well as in fibrotic tissues. Avβ6 is a strong selective ligand for a cell surface protein called avβ6-integrin.
As such, it can accumulate in tissue areas characterized by high avβ6-integrin levels.

Avβ