Full Press Release Details
Radiopharm Theranostics Limited
| Name of entity: | Radiopharm Theranostics Limited |
| ABN: | 57 647 877 889 |
| Reporting period: | For the half-year ended 31 December 2024 |
| Previous period: | For the half-year ended 31 December 2023 |
| $ | ||||||||
| Loss from ordinary activities after tax attributable to the owners of Radiopharm Theranostics Limited | down | 20.90% to | (18,725,453 | ) | ||||
| Loss for the half-year attributable to the owners of Radiopharm Theranostics Limited | down | 20.90% to | (18,725,453 | ) |
| 31 December | 31 December | |||||||
| 2024 | 2023 | |||||||
| Cents | Cents | |||||||
| Net tangible assets per ordinary security | 0.18 | (8.71 | ) |
An explanation of the key financial elements contributing
to the revenue and result above can be found in the review of operations included within the directors' report.
No dividends have been paid or declared by the group for
the current financial period. No dividends were paid for the previous financial period.
There have been no changes in controlled entities during
the half-year ended 31 December 2024.
| a. | Details of individual and total dividends or distributions and dividend or distribution payments: | N/A |
| b. | Details of any dividend or distribution reinvestment plans: | N/A |
| c. | Details of associates and joint venture entities: | N/A |
| d. | Other information | N/A |
The financial statement have been reviewed by the group's
independent auditor who has issued an unmodified opinion.
Review of Operations & Activities
Half-year ended: 31 December
Radiopharm Theranostics Limited is
developing a world-class platform of radiopharmaceutical and nuclear medicine products for both diagnostic and therapeutic uses.
The group reported a loss for the half-year
ended 31 December 2024 of $19,643,011 (31 December 2023: $24,758,296). The decreased loss relates to the groups efforts in reducing their
expenditure in the current period. Additionally, there was a minor gain from the movement in fair value movements in contingent consideration
of $28,060 whereas at 31 December 2023 there was a significant loss of $5,757,296.
The group's net assets increased
to $52,003,713 (30 June 2024: $27,353,286). The substantial increase in the group's net assets is, primarily due to the completion of
the second tranche of the June 2024 placement which was approved at the EGM in August 2024. As at 31 December 2024, the group had cash
reserves of $36,436,938 (30 June 2024: $18,575,040).
Clinical and Research Developments
RAD204 - PD-L1 Nanobody
During the period, Radiopharm achieved
key milestones in its ongoing Phase 1 clinical trial of RAD204, a PD-L1-targeting radiotherapeutic. Initially designed for non-small cell
lung cancer (NSCLC), the trial received approval to expand into five additional cancer indications, including small cell lung cancer (SCLC),
triple-negative breast cancer (TNBC), melanoma, head and neck squamous cell carcinoma (HNSCC), and endometrial cancer. The expansion allows
Radiopharm to explore RAD204's potential efficacy across a broader spectrum of tumors expressing PD-L1, reinforcing its strategy of developing
tumor-agnostic radiotherapeutics.
The Phase 1 study is progressing across
multiple Australian sites, supported by GenesisCare CRO, with patient recruitment accelerating to meet study targets. Early data has indicated
strong tumor- targeting capability, favorable biodistribution, and encouraging safety profiles, which are essential for advancing the
clinical development pathway. Additionally, Radiopharm has been leveraging insights from the initial NSCLC cohort to refine dosing strategies
and optimize therapeutic outcomes across the expanded indications.
First Interim data expected in mid
2025 and full results in Q4 2025/Q1 2026.
RAD101 - Phase 2b Imaging
Trial for Brain Metastases
The Company secured U.S. Food and Drug
Administration (FDA) Investigational New Drug (IND) approval for a Phase 2b trial of RAD101 (F18-Pivalate) targeting brain metastases.
This follows positive Phase 2a data from a 22-patient study at Imperial College London, demonstrating significant tumor uptake and strong
study is enrolling 30 patients across multiple sites in the United States and will evaluate RAD101's imaging performance in
detecting brain metastases with high sensitivity and specificity. The trial will assess both lesion detectability and uptake
consistency, supporting its potential as a new standard for brain metastases imaging. Radiopharm has partnered with BAMF Health for
manufacturing and initial trial execution, leveraging their molecular imaging expertise to optimize patient recruitment and data
The trial is designed to provide the
necessary data to progress into a registrational Phase 3 study, which would be a critical step toward regulatory approval and commercialization
of RAD101 for clinical use.
RAD202 - HER2-Positive
Cancer Therapeutic Trial
In December 2024, Radiopharm obtained
ethics approval to initiate a Phase 1 trial of 177Lu-RAD202 for HER2-positive cancers, including breast and gastric cancers. This open-label
study, conducted across multiple Australian sites, aims to assess the safety, tolerability, and initial efficacy of RAD202 in patients
with advanced HER2-positive tumors.
Preclinical and diagnostic studies
have confirmed RAD202's tumor uptake and therapeutic potential, with preclinical models demonstrating significant tumor growth inhibition
and prolonged survival when labeled with 177Lu. The compound is designed to target HER2-overexpressing tumors with high specificity, minimizing
off-target toxicity and enhancing therapeutic efficacy.
The Company presented positive findings
at the 2024 European Association of Nuclear Medicine (EANM) Annual Meeting, highlighting RAD202's strong tumor-to-background contrast
and promising survival benefits in preclinical models. Radiopharm plans to leverage these results to accelerate clinical development and
explore potential combination strategies with existing HER2- targeting therapies.
First Interim data expected in H2 2025.
RAD 301 - Strong Potential
for Imaging in Pancreatic Cancer
During November it was announced that
a clinical study featuring 68Ga-Trivehexin (68Ga-RAD 301) had been published in Frontiers in Nuclear Medicine. The paper, entitled " v 6-integrin
targeted PET/CT imaging in pancreatic cancer patients using 68Ga-Trivehexin"1, described the clinical results of a retrospective
study of the biokinetics of 68Ga-RAD 301 in pancreatic cancer patients.
The 44-patient study is reported as
the largest cohort of individuals imaged with RAD 301 with any tracer. The primary tumor, as well as metastases in the liver, lymph nodes,
peritoneum, lung, bone, spleen, pleural cavity, and soft tissues, were visualized with a high tumor-to-background ratio. With no adverse
events recorded, the findings showed that RAD 301 is a suitable and safe diagnostic agent for imaging v 6-integrin expression
in pancreatic cancer.
The Phase I IND-approved imaging study
in patient with Pancreatic cancer is ongoing in New York, with full results expected by June 2025.
RAD 301 is a peptide that targets v 6-integrin,
a cellular marker for tumor invasion and metastatic growth, the expression of which correlates with decreased survival in several carcinomas,
particularly pancreatic.
RAD402 - KLK3-Targeting
Preclinical studies for RAD402, a KLK3-targeting
radiotherapeutic utilizing Terbium-161 (Tb-161), were successfully completed during the period. The data demonstrated favorable safety
and biodistribution profiles, with preclinical models indicating significant tumor regression and minimal off-target toxicity. These results
highlight the potential of RAD402 as a promising therapeutic candidate for advanced prostate cancer.
Further, Radiopharm is actively engaging
with regulatory agencies to finalize the clinical development pathway, ensuring a streamlined transition into First-In-Human trials in
the second half of 2025. GMP manufacturing is scheduled for completion in H1 2025, incorporating rigorous quality control measures to
support regulatory submissions. The compound's unique mechanism, leveraging the therapeutic advantages of Tb-161 over traditional isotopes,
positions RAD402 as a differentiated and potentially superior treatment for KLK3-expressing prostate tumors.
Phase I is expected to start in H2
Strategic Partnerships and Corporate
Lantheus Strategic Investment
and Co-Development Agreement
Radiopharm strengthened its collaboration
with Lantheus Holdings through an expanded co- development agreement for Australia. Under the agreement, Lantheus will fund a Phase 1
imaging trial targeting multiple solid tumors, with milestone payments of up to USD $2 million to Radiopharm. Additionally, shortly after