Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 59

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 59
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 of 2026, to recruit 30 patients and to complete by first half of 2027.

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

RAD401(PSA-mAb Prostate Cancer Diagnostic)
andRAD402(PSA-mAb Prostate Cancer Therapeutic)

PSA-mAb is capable of targeting
free human prostate kallikren (PSA) in prostate cancer cells. In addition, its combination with the radioisotope Tb161 results in potentially
curative treatment by sustained tumor regression and a significant increase in median survival time.

PSA-mAb is at pre-clinical
stage. The antibody was investigated in an independent study, involving many institutions including the Memorial Sloane Kettering Cancer
Centre, using two murine models, (i) mice with xenografted prostate cancer (human androgen-sensitive prostate adenocarcinoma cells, “ LNCaP-AR”),
and (ii) PSA-expressing, cancer- susceptible transgenic mice (known as KLK3_Hi-Myc mice). The animals were imaged with 89Zr, or treated
with 90Y or 225Ac-labelled PSA-mAb and subjected to gamma counting, PET, autoradiography, and microscopy for biodistribution and subcellular
localization of the labelled mAb. The potential therapeutic efficacy of 225Ac-PSA-mAb and 90Y-PSA-mAb in LNCaP-AR tumors was assessed
by various measures including survival. An investigation of the pharmacokinetics of 89Zr-PSA-mAb PET were carried out in non-human primates
(“ NHP”), cynomolgus macaques - such studies aim to provide better guidance on the activity of the radiolabeled material
in humans. 89Zr-PSA-mAb-PET visualization in the NHP animals was conducted over a 2-week observation period.

In the mouse models, specific
tumor uptake of radiolabeled PSA-mAb increased over time and correlated with PSA expression. Uptake was highly specific for the tumor
masses as compared to healthy tissue. Administration of the three different radio-conjugates resulted in almost identical biodistributions