Company: RDPTF
Filing Date: 2025-09-18
Form Type: 20-F
Source: 0001213900-25-088699
Chunk: 58

Company: Radiopharm Theranostics Ltd
Filing Date: 2025-09-18
Form: 20-F
Item: Item 3
Chunk 58
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 or in combination with checkpoint inhibitors.

In October 2023, we received
approval from the Human Research Ethics Committee to start its Phase I clinical trial in Australia. RAD204 targets non-small cell lung
cancer. RAD204 Phase I started in Australia in January 2024. In July 2024, the first patient in Phase I was dosed in Australia. The clinical
data that will be gathered outside the United States in Phase II may not be accepted by the FDA or other comparable foreign regulatory
authorities, which could result in the need to conduct additional trials in the United States or elsewhere. We expect to recruit 27 patients
for Phase I in Australia of RAD204 and to complete it by end of the second quarter of 2026. We will seek IND approval from the FDA to
start a Phase II trial with RAD204 after completion of Phase I. We also expect to start Phase II for RAD204 by the end of the fourth quarter
in 2026 in the United States, to recruit 50 patients and to complete Phase II by the end of 2027.

RAD301 and RAD302(Avβ6-Integrin Pancreatic
Diagnostic and Therapeutic)

The company has published
studies presenting evidence supporting the utility of 68Ga-Trivehexin coupled with PET/CT in localizing PDAC, parotid duct cancer metastasis
and head and neck squamous cell carcinoma along with comparative scans obtained with a healthy subject. While these studies may be described
as anecdotal, requiring validation in multi-patient cohorts, they provide a rationale for progression into a formal Phase I trial as a
diagnostic product in multiple cancers.

In September 2022, the RAD301
asset was independently endorsed by a medical team in Dresden, in a presentation at the 35th Annual Congress of the European Association
of Nuclear Medicine (EANM), titled “ PET/CT and PET/MRI imaging with RAD301 in patients with pancreatic cancer - first clinical
experience”, highlighting the significance and growing recognition of the technology.

In May 2023, we received Orphan
Drug Designation by the FDA. In October 2023, the FDA accepted an amended IND to start our Phase I in the United States. In February 2024,
the first patient in Phase I was dosed. Phase I is intended to recruit 9 patients. RAD301 targets pancreatic cancer. We expect to start
a Phase II for RAD301 in the United States by the first half