Interim results from Phase 2b clinical trial of RAD 101 showed 92% of evaluable participants met the primary endpoint of MRI concordance in imaging study of patients with brain metastases
Interim data from additional Cohorts of the Phase 1 clinical trial of RAD 202 and RAD 204 in advanced solid tumors are expected in mid-2026
Cash and cash equivalents of approximately $34.52 million provide runway into 2027 to advance pipeline of high value radiotherapeutic programs through key clinical and regulatory milestones
SYDNEY, Jan. 28, 2026 (GLOBE NEWSWIRE) -- 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 financial results for the first six months of fiscal 2026 ended December 31, 2025 and provided an update on its clinical pipeline with an outline of its expected milestones for 2026.
"2025 was a year of strong execution across our pipeline, as we presented unprecedented imaging data from our RAD 101 diagnostic program, received Data Safety Monitoring Committee approval to escalate dosing in both RAD 204 and RAD 202 programs and secured clearance to advance both RV 01 and RAD 402 into Phase 1 clinical trials," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "As we enter 2026, we remain laser-focused on advancing our radiopharmaceutical assets and taking a deliberate approach to pipeline prioritization. This year, we aim to deliver meaningful data from across multiple programs, expand treatment and diagnostic options for patients with solid tumors, and create long-term value for all stakeholders."
Program and Business Updates
18F-RAD101 -- Small molecule targeting fatty acid synthase radiolabeled with Fluorine-18
RAD 101 is being evaluated in a single-arm U.S. Phase 2b clinical trial for the diagnostic performance of the molecule in 30 individuals with confirmed recurrent brain metastases from solid tumors of different origins. 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 over 300,000 patients diagnosed annually in the U.S. with cerebral metastases. The study is currently enrolling patients and anticipates completing enrollment in the first quarter of 2026.
-- In December 2025, Radiopharm Theranostics announced interim data from the
first twelve patients in the Phase 2b trial of RAD 101, with 92% of
evaluable patients achieving concordance with MRI imaging, the primary
endpoint.
-- These promising interim results are in line with the Phase 2a results and,
if confirmed, will trigger the preparation of a multi-center,
multi-country Phase 3 registrational trial.
177Lu-RAD202 -- Nanobody targeting HER2 radiolabeled 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 in breast cancer and several other solid tumors and represents a validated target in oncology. RAD 202 has demonstrated clinical proof-of-concept with positive 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.
-- Recently completed dosing at the 30mCi dosing level and is moving 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 significant tumor uptake in HER2 positive tumors.
-- RAD 202's has shown a favorable safety profile 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 in the first half
of 2026.
177Lu-RAD204 -- Nanobody targeting PD-L1 radiolabeled with Lutetium 177
RAD 204 is continuing to be evaluated in a Phase 1 study in PD-L1-driven 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 completed enrollment of the second Cohort of the Phase 1
study of RAD 204 and can proceed with dosing patients in the third Cohort
with an updated dose of 90mCi of Lu177 as approved by the Data and Safety
Monitoring Committee.
-- Two out of three patients in the 30mCi cohort exhibited stable disease
for 5.5 months in metastatic NSCLC, compared to historical data of 3.5
months PFS with standard of care $(SOC)$.
-- 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.
-- RAD 204's safety profile is reassuring and there have been no
drug-related adverse events reported.
Lu177-RV 01 -- monoclonal antibody targeting 4Ig isoform of B7H3 radiolabeled with Lutetium 177
RV 01 (Betabart) is a monoclonal antibody targeting the 4Ig isoform of B7H3, an immune checkpoint protein that is highly expressed in tumors and not in healthy tissue. In multiple preclinical studies, RV-01 has shown tumor shrinkage and prolonged survival. This is the first radiopharmaceutical therapeutic developed by Radiopharm Ventures, a Joint Venture between Radiopharm Theranostics and the MD Anderson Cancer Center.
-- In January 2026, the Company increased its ownership in Radiopharm
Ventures from 75% to 87.5% as the joint venture continues to show
promising progress in its cancer therapeutic pipeline, including the
advancement of its leading B7H3 candidate and other preclinical assets.
-- In July 2025, RV 01 received Investigational New Drug clearance from the
FDA to initiate the first-in-human Phase 1 clinical trial. The Company
expects to dose the first patients in the Phase 1 trial in the first
quarter of 2026.
Tb161-RAD 402 -- Monoclonal antibody targeting KLK3 radiolabeled with Terbium 161
RAD 402 is a monoclonal antibody targeting Kallikrein Related Peptidase 3 (KLK3) radiolabelled with the radionuclide 161Tb for the treatment of prostate cancer. In preclinical studies, RAD 402 in mouse xenografts showed strong tumor targeting, limited bone and marrow uptake, and a hepatic excretion profile consistent with expectations for a monoclonal antibody.
-- In November 2025, RAD 402 was granted Bellberry Human Research Ethics
Committee approval in Australia to initiate a First-In-Human (FIH) Phase
1 clinical trial of RAD 402 for the treatment of metastatic or locally
advanced prostate cancer.
-- The Company anticipates initiating a Phase 1 trial of RAD 402 in adults
with metastatic or locally advanced prostate cancer in Q1 2026.
Ga68-RAD301 -- Peptide targeting <ALPHA>vB-integrin radiolabeled with Gallium 68
RAD 301 is being evaluated in a Phase 1 imaging trial in patients with Pancreatic Ductal Adenocarcinoma (PDAC). The <ALPHA>vB-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 is 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
continues, having dosed 8 patients out of 9, with last patient expected
in Q1 2026
-- Initial data from the first six patients demonstrated confirmed safety
and significant uptake in the AvB6 positive lesions.
The unmet medical need in the earlier stage of disease and the larger disease prevalence compared to the patient population of the current Phase 1 trial have influenced the decision to evaluate RAD 301 in loco-regional pancreatic cancer.
Financial Update
The following is a summary of the Appendix 4C Cash Flow Report:
-- The half-year closing cash balance was $34,52 million, a rise from $29.12
million at the close of the year-end balance.
-- Net cash outflows from operating activities for the 6 months ended
December 31, 2025 totaled $22.67 million.
-- In October 2025, Radiopharm Theranostics announced that it had received
firm commitments from international and Australian institutional and
industry investors to raise approximately $35 million by way of private
placement.
In compliance with Listing Rule 4.7C, payments to related parties and their associates, as detailed in item 6.1 of Appendix 4C, encompass remuneration for director fees to executive and non-executive directors, conducted in the ordinary course of business at commercial rates, excluding reimbursements for out-of-pocket expenses.
About Radiopharm Theranostics
(MORE TO FOLLOW) Dow Jones Newswires
January 28, 2026 07:00 ET (12:00 GMT)
Comments