Reported positive results from the Phase 2b clinical trial of imaging agent RAD 101, showing 93% of evaluable patients treated with RAD 101 achieved the primary endpoint
Plans to initiate Phase 3 registrational trial of RAD 101 in Q4 2026
Raised approximately $12.5M through an institutional offer and launched a $6million Share Purchase Plan, post balance date
SYDNEY, July 31, 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 quarter ended June 30, 2026, and provided a corporate update.
“We continue to make meaningful progress across our portfolio as we advance a diverse pipeline of targeted radiopharmaceutical candidates designed to address some of the most challenging cancers,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “The positive Phase 2b results for RAD 101 represent an important milestone for Radiopharm and reinforce our confidence in the potential of our technologies. In addition, the early clinical signs in the third cohort of RAD 204, showing RECIST-confirmed Partial Response in the first patient treated at this dose, is creating a lot of excitement among the Clinical Investigators of our Phase I therapeutic trial. Across the organization, we are generating clinical data, advancing multiple development programs, and building the capabilities required to realize the full value of our platform. With six active clinical programs spanning both diagnostic and therapeutic applications, we believe Radiopharm is establishing a leading radiopharmaceutical company uniquely positioned to deliver innovative new medicines to patients while creating long-term value for shareholders. We remain focused on executing against our development priorities and advancing what we believe could become a new generation of precision cancer treatments.”
Program and Business Updates
18F-RAD101 – Small molecule targeting fatty acid synthase radiolabelled 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.
- In July 2026, the Company announced that RAD 101 had met its primary endpoint, with 93% of patients treated with RAD 101 achieving concordance with MRI imaging. Additionally, an interim analysis of 14 patients from six-month follow-up and biopsy shows 86% (12/14) sensitivity.
- The Company anticipates the initiation of a Phase 3, multi-center, multi-country registrational study in Q4 2026. Siemens Healthineers will manufacture and distribute doses of 18F-labeled RAD-101 through a partnership to support the Phase 3 registrational trial.
177Lu-RAD204 – Nanobody targeting PD-L1 radiolabelled with Lutetium 177
RAD 204 is being 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.
- Initial data from the first six patients across the first two cohorts of the Phase 1 study showed tumor uptake in the PD-L1 positive lesions, in line with the published results of the previously conducted imaging study
- Data from the third cohort (90mCi) in the Phase 1 study of RAD 204 showed that the first patient dosed at this dose level achieved a durable RECIST-confirmed partial response, with tumor shrinkage up to -43%, still progression free after 7+ months.
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 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.
- At the American Association for Cancer Research (AACR) Annual Meeting 2026, the company presented initial findings from the Phase 1 first-in-human ‘HEAT’ clinical trial for RAD 202. At the lowest dose level, RAD 202 showed meaningful tumor uptake and was generally well-tolerated in the first three treated patients, with no dose-limiting toxicities or treatment discontinuations due to adverse events being observed. Organ-level absorbed radiation doses were within expected and clinically acceptable ranges.
- The Company previously received a positive recommendation from the Data Safety and Monitoring Committee to advance RAD 202 to the next dose level of 130mCi in the Phase 1 ‘HEAT’ clinical trial. The Company expects to complete enrolment of Cohort #3 in Q3 and the entire Phase 1 Dose Escalation by 1H 2027.
Lu177-RV 01 – monoclonal antibody targeting 4Ig isoform of B7H3 radiolabelled 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.
- The Company continues to make progress advancing the first-in-human (FIH) Phase 1/2a clinical trial of RV 01, which is designed to establish the safety profile, biodistribution, pharmacokinetics, and radiation dosimetry of RV 01 in various tumor types. The trial will also determine the recommended dose of RV-01 for future studies.
Tb161-RAD 402 – Monoclonal antibody targeting KLK3 radiolabelled 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 mouse models, RAD 402 showed strong tumor targeting, limited bone and marrow uptake, and a hepatic excretion profile consistent with expectations for a monoclonal antibody.
- The Company continues to progress its First-In-Human (FIH) Phase 1 clinical trial of RAD 402, designed to evaluate the safety, tolerability, whole-body distribution, and preliminary clinical activity of RAD 402 in patients with advanced prostate cancer. The dose escalation Phase 1 study is designed to determine the Maximum Tolerated Dose and recommended Phase 2 dose for expansion.
Ga68-RAD301 – Peptide targeting αvB-integrin radiolabelled with Gallium 68
RAD 301 is being evaluated in a Phase 1 imaging trial in patients with Pancreatic Ductal Adenocarcinoma (PDAC). The αvB-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 to be dosed in 2H 2026.
Financial Update
Closing cash at the end of the quarter was $4.1 million, decreasing from $19.2 million at the end of the prior quarter. Net cash outflows from operating activities during the period was $14.97 million with direct Research and Development expenditure and staff costs accounting for 95% of the operating activities.
Following the close of the quarter, the Company received its FY25 Australian R&D Tax Incentive of $5.9 million and also completed a $12.5 million institutional offer and launched a $6 million Share Purchase Plan which is already subscribed for up to $3 million.
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
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 five 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
P: +61 451 896 420
E: matt@nwrcommunications.com.au
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Website – https://radiopharmtheranostics.com/
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Investor Hub – https://investorhub.radiopharmtheranostics.com/
