Full Press Release Details
| ASX ANNOUNCEMENT |
| 29 April 2025 |
QUARTERLY ACTIVITIES AND CASH
QUARTER ENDED 31 MARCH 2025
Sydney, Australia - 29 April
2025 - Radiopharm Theranostics (ASX:RAD, "Radiopharm" or the "Company"), a developer of a world-class
platform of radiopharmaceutical products for both diagnostic and therapeutic uses, is pleased to provide a summary of its activities for
the quarter ended 31 March 2025
Lantheus increases to 12.16% shareholding
in Radiopharm with US$5m (A$8m) placement
In January, the Company raised US$5
million (A$8 million) through a private placement of 133 million shares to Lantheus Holdings Inc. at A$0.060 per share - representing
a 150% premium to the last traded price of A$0.024. As a result, Lantheus increased its stake in Radiopharm to 12.16%, becoming its largest
The funds will be used to advance Radiopharm's
clinical pipeline, which includes one Phase II and three Phase I trials across solid tumour cancers such as brain, lung, breast, and pancreas.
The placement replaces six-month options issued in August 2024 and was completed under Radiopharm's existing ASX placement capacity.
New clinical trial data highlights
RAD 101 (18F-Pivalate) successfully detects Brain Metastases
During the quarter, Radiopharm reported
encouraging new clinical trial data demonstrating that its novel imaging agent, RAD 101 (18F-Pivalate), effectively detects brain metastases
across a diverse patient population.
The study, published in the European
Journal of Nuclear Medicine and Molecular Imaging, involved 22 patients - 12 of whom had never received brain radiotherapy and 10
who had. All brain metastases were successfully identified, regardless of treatment history or the original cancer type, using a novel
imaging approach that combines Positron Emission Tomography (PET) and Multiparametric Magnetic Resonance Imaging (mpMRI).
The high tumor-to-background
signal ratio achieved in these scans demonstrates the potential of RAD 101 to provide highly sensitive and specific imaging of brain
metastases. This represents a significant advancement over current standard-of-care imaging methods, such as contrast-enhanced MRI,
which often struggle to differentiate between active disease and treatment-related changes.
Radiopharm Theranostics
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
| ASX ANNOUNCEMENT |
| 29 April 2025 |
RAD 101 is a small-molecule radiotracer
that targets fatty acid metabolism, a pathway that is upregulated in many solid tumors, including those that spread to the brain. By focusing
on metabolic activity rather than structural changes, RAD 101 may offer a more reliable means of detecting brain metastases early and
These findings build upon earlier data
from a Phase 2a study at Imperial College London, where RAD 101 demonstrated substantial tumor uptake independent of the tumor's
origin. The new data further confirm the agent's broad applicability across various cancer types.
Radiopharm is currently advancing a
Phase 2b clinical trial in the United States (NCT06777433) to evaluate the diagnostic performance of RAD 101 in patients with suspected
recurrent brain metastases from solid tumors. The trial is open and actively recruiting across three sites in Michigan.
New RAD202 data confirms positive
tumor uptake and favorable biodistribution
In March, the Company announced new
preclinical data supporting the utility of its HER2-targeting radiopharmaceutical candidate, RAD202, presented at the European Molecular
Imaging Meeting (EMIM 2025).
The study demonstrated that Ga-RAD202
achieved strong and specific tumor accumulation with favorable biodistribution and low off-target uptake - except in the bladder
and kidney, as expected for renal clearance. Imaging results also showed a high tumor-to-background ratio in HER2-positive xenograft models,
supporting its diagnostic potential. The removal of a His-tag on the nanobody further improved imaging performance by enhancing the tumor-to-organ
Therapeutically, ¹ Lu-RAD202
significantly reduced tumor volume and extended survival in preclinical models, with fractionated dosing outperforming single-dose administration.
These results reinforce the rationale for fractionated therapeutic regimens and highlight the agent's potential in treating HER2-positive
RAD202 targets HER2, a well-validated
receptor overexpressed in several solid tumors, including breast cancer. A First-In-Human Phase 1 dose-escalation study of ¹ Lu-RAD202
is currently recruiting in Australia. The trial is designed to assess safety and preliminary activity in patients with advanced HER2-positive
solid tumors, particularly those who have progressed on, or cannot tolerate, current standard-of-care treatments.
Radiopharm Theranostics
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
| ASX ANNOUNCEMENT |
| 29 April 2025 |
Conference Participation
During the quarter, Radiopharm's
executive team participated in a series of prominent healthcare and investor conferences in the United States:
JP Morgan 43rd Annual Healthcare Conference (San Francisco,
Radiopharm's Managing Director and CEO Ricardo Canevari
and Chief Medical Officer, Dr Dimitris Voliotis attended the renowned conference on 14 to 17 January 2025 (ET) that feature global industry
leaders, emerging companies, and members of the investment community.
B. Riley Securities Precision Oncology
& Radiopharma Investor Conference (New York, NY)
Held on 28 February 2025, this specialist
event featured more than 35 biopharma and med-tech companies. Radiopharm participated in presentations and investor meetings with a focus
on its pipeline of targeted radiopharmaceutical therapies.
TD Cowen 45th Annual Healthcare
Conference (Boston, MA)
Radiopharm's Managing Director
and CEO, Riccardo Canevari, presented on 4 March 2025 (ET), detailing the Company's platform, clinical strategy, and market opportunities.
The event brought together leading global healthcare companies and investors for presentations, fireside chats, and panel discussions
moderated by TD Cowen's research team.
Leerink Partners Global Healthcare
Conference (Miami, FL)
Chief Medical Officer Dr Dimitris Voliotis engaged with
a range of professional and institutional investors to discuss Radiopharm's clinical progress and innovation strategy.
The Appendix 4C Quarterly Cash Flow
report is set out below.
Closing cash at the end of the quarter
was $36.86 million, increasing from $36.44 million at the end of the prior quarter.
Net cash outflows from operating activities
during the period was $7.43 million. Excluding receipts from customers, direct Research and Development expenditure and staff costs accounting
for 93% of the operating expenditure.
The net cash inflows from financing
activities for the quarter was $8.07 million from the placement with Lantheus as announced on 10 January 2025. The funds raised will extend
the Company's cash runway and will be applied to develop Radiopharm's clinical pipeline.
In accordance with Listing Rule 4.7C,
payments made to related parties and their associated included in items 6.1 of the Appendix 4C include payments for remuneration of director
fees to executive and non-executive directors in the normal course of business at commercial rates, excluding reimbursements of out-of-pocket
Radiopharm Theranostics
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
| ASX ANNOUNCEMENT |
| 29 April 2025 |
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical
stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic