Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 52

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 52
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6 aims to allow early
detection of the above-mentioned conditions by PET imaging. A diagnostic compassionate use study in ongoing in Germany in pancreatic and
head & neck cancer with 66 patients to date. Trivehexin received IND approval from the FDA in October 2023. A Phase I diagnostic trial
started in February 2024 in the United States for RAD301 and is intended to recruit 9 patients. RAD301 targets pancreatic cancer. We expect
to start a Phase II for RAD301 in the United States by first half of 2026, to recruit 30 patients and to complete by first half of 2027.

Trivehexin is a novel molecule
developed specifically for the proposed applications of imaging and diagnosis. The inventors designed the molecule on the belief that
trimerization should result in elevated target-specific uptake and prolonged retention. 13 PET kinetics in limited human studies show
rapid target specific (tumor) uptake, where it remains stable for 80 minutes or more, and fast clearance from non-target tissue (blood
and muscle).

Avβ6-integrin is exclusively
expressed on epithelial cells and overexpressed by carcinomas including Pancreatic ductal adenocarcinoma (“ PDAC”), squamous
cell carcinoma, gastric, colon, ovarian and lung (specifically NSCLC). It is commonly associated with invasive tumors. Avβ6-integrin
is also involved in the development of fibrosis, for example interstitial pulmonary fibrosis and this may be an area of interest for RAD
at some future point. Avβ6-integrin is completely absent in the normal pancreatic tissue according to immunohistochemistry but overexpressed
in almost 90% of all PDAC.

In addition to the Imaging
use of Trivehexin (RAD 301), RAD is developing the therapeutic version with Lu177 (RAD 302). RAD 302 is in preclinical stage. Tox study
has been completed the Phase I clinical trial is expected to start in the United States in 2026. RAD302 targets pancreatic cancer and
head-neck and lung cancer.

PSA-mAb

PSA-mAb is the invention of
Professor David Ulmert of UCLA. PSA-mAb is a humanized monoclonal antibody, capable of targeting free human prostate kallikrien (or prostate
specific antigen (PSA)) in prostate cancer cells. The antibody platform aims to provide a theranostic approach for prostate cancer