RAD Provides Positive Clinical Updates Across Four Programs
Released
Released
Announcement PDF
ASX ANNOUNCEMENT
20 October 2025
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889
Radiopharm Theranostics Provides Positive Clinical Updates Across
Four Programs
Preliminary data from first three patients in Phase 2b imaging clinical trial of RAD 101 show
uptake in brain metastases from solid tumors, confirming proof-of-concept with Phase 2
topline results expected by H1 2026
First cohort of patients in Phase 1 clinical trial of RAD 202 (HER2) shows higher than expected
tumour uptake; Anticipates second cohort of patients to be fully enrolled with data available
by year-end 2025
Data from first six patients in Phase 1 clinical trial of RAD 204 (PDL-1) show promising tumor
uptake, stable disease at the first dose level in two out of three patients
Data from Phase 1 study with RAD 301 supports decision to advance to Phase 2 imaging trial
in patients with loco-regional pancreatic cancer
Sydney, Australia – 20 October 2025 – Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX,
“Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on
developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today
announced an update on its pipeline of clinical programs and outlined expected milestones through
the end of 2025 and into 2026.
“We are highly encouraged by the consistent and positive data emerging from our four lead clinical
programs, which continue to validate the potential of our differentiated radiopharmaceutical
pipeline,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “Our
strategic execution remains strong, and we anticipate a steady stream of topline data readouts
across multiple trials in the near term. As we advance these programs toward their next stages of
development, we are proud of the meaningful progress being made. On behalf of our entire team, I
express our gratitude to the investigators, patients, and families participating in our clinical trials—
their trust and commitment are the foundation of our work.”
“Looking ahead, we are excited to initiate Phase 1 trials for RV01 and RAD402, our promising
preclinical monoclonal antibody assets, by year-end. With this expansion, our clinical portfolio will
include four therapeutic candidates and two imaging agents by December 2025, underscoring our
commitment to transforming cancer care through potentially first-in class and best-in-class
radiopharmaceuticals,” Canevari concluded.
Recent Clinical Achievements and Upcoming Milestones (additional data available in the
accompanying PowerPoint presentation)
18F-RAD101 – Small molecule targeting fatty acid synthase radiolabelled with Fluorine-18
The Company continues to evaluate RAD 101 in a single-arm U.S. Phase 2b clinical trial evaluating
the diagnostic performance of the molecule in 30 individuals with suspected recurrent brain
ASX ANNOUNCEMENT
20 October 2025
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889
metastases from solid tumors of different origin. RAD 101 has received U.S. Food and Drug
Administration (FDA) Fast Track Designation to expedite the review process and help bring the novel
imaging small molecule to the more than 300,000 patients diagnosed annually in the U.S. with
cerebral metastases. The study has currently enrolled 12 patients and the Company anticipates to
complete enrollment in the first quarter of 2026.
Data from the first three patients show significant and selective tumor uptake in brain
metastases. Images confirm metabolic activity in brain metastases compared to equivocal
MRI findings.
These promising early results are in line with the previously published Phase 2a results and,
if confirmed, will trigger the preparation of a multi-center, global Phase 3 registrational trial.
177Lu-RAD202 – Nanobody targeting HER2 radiolabelled with Lutetium 177
The Company continues to evaluate RAD 202 in the Phase 1 ‘HEAT’ clinical trial in patients with
Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors. HER2 is
overexpressed or amplified in breast cancer and several other solid tumors and represents a
validated target in oncology. RAD 202 has demonstrated clinical proof-of-concept with favourable
safety and biodistribution and was recently recommended by the Data Safety and Monitoring
Committee (DSMC) to progress to the next dose level of 75mCi in the ‘HEAT’ trial.
Dosing at the 30mCi dose level of RAD202 has been completed and the study is advancing to
the next dose level of 75mCi following recommendation from the DSMC.
Data available from the first three patients in the first cohort of the study show very
significant tumor uptake in HER2 positive tumors.
The safety profile of RAD202 has been favourable with no drug-related adverse events
reported.
The Company expects to complete enrollment in the higher dose Cohort 2 and to have data
from both the first and second cohorts available by year-end 2025.
177Lu-RAD204 – Nanobody targeting PD-L1 radiolabelled with Lutetium 177
The Company continues to evaluate RAD 204 in its Phase 1 study in PD-L1-positive cancers, including
Non-Small Cell Lung Cancer (NSCLC), Small-Cell Lung Cancer (SCLC), Triple-negative Breast Cancer
(TNBC), Cutaneous Melanoma, head and neck squamous cell carcinoma (HNSCC) and Endometrial
Cancer. Previous Phase 1 imaging data of 16 NSCLC patients treated with RAD 204 demonstrated
that the diagnostic compound is safe and is associated with acceptable dosimetry. The Company
recently completed dosing in its first cohort of patients at 30mCi.
Two out of three patients in the 30mCi cohort exhibited stable disease for 5.5 months in
last-line metastatic NSCLC, compared to historical data of 3.5 months PFS with standard of
care (SOC).
Dosing is completed at the second cohort dose level of 60mCi. Meeting with the DSMC is
scheduled to approve further dose escalation to the third dose level.
Initial data from the first six patients across the first two cohorts show tumor uptake in the
PD-L1-positive lesions, in line with published results of the previously conducted imaging
study.
ASX ANNOUNCEMENT
20 October 2025
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889
The safety profile of RAD204 has been favourable and there have been no dose limiting
toxicities reported.
Ga68-RAD301 – Peptide targeting αvβ6-integrin radiolabelled with Gallium 68
RAD 301 is being evaluated in a Phase 1 imaging trial in patients with Pancreatic Ductal
Adenocarcinoma (PDAC). The αvβ6-integrin is a cellular marker for tumor invasion and metastatic
growth, which correlates with decreased survival in several carcinomas, particularly pancreatic. RAD
301 has previously received Orphan Drug Designation (ODD) from the FDA and data from the Phase
1 trial are supportive of the Company’s decision to move to a Phase 2 imaging trial in patients with
loco-regional pancreatic cancer.
Enrollment in the Phase 1 imaging trial in metastatic pancreatic cancer is continuing with six
subjects dosed out of nine subjects in total.
Initial data from the first six subjects confirmed safety and significant uptake in αvβ6
positive lesions.
The unmet medical need in the earlier stages of disease and the large disease prevalence
have influenced the decision to plan a Phase 2 imaging trial to evaluate RAD 301 in the
preoperative setting of loco-regional pancreatic cancer.
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class
platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in
areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The
company has a pipeline of distinct and highly differentiated platform technologies spanning
peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes
one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and
brain metastases. Learn more at radiopharmtheranostics.com.
Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman
Paul Hopper.
For more information:
Investors:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com
Anne Marie Fields
Precision AQ (formerly Stern IR)
E: annemarie.fields@precisionaq.com
Media:
Matt Wright
NWR Communications
ASX ANNOUNCEMENT
20 October 2025
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889
P: +61 451 896 420
E: matt@nwrcommunications.com.au
Follow Radiopharm Theranostics:
Website – https://radiopharmtheranostics.com/
X – https://x.com/TeamRadiopharm
LinkedIn – https://www.linkedin.com/company/radiopharm-theranostics/
InvestorHub – https://investorhub.radiopharmtheranostics.com/
Share your feedback
Discover