RAD202 / Radiopharm Theranostics - LARVOL DELTA

A first-in-class HER2-targeted radiopharmaceutical therapy: Initial findings from the Phase 0/1 HEAT trial of 177Lu-RAD202 in HER2+ advanced solid tumors (AACR 2026) - P1 | "These early first-in-human data demonstrate high tumor uptake and favorable safety of 177Lu-RAD202, supporting continued dose escalation. This HER2-targeted radiotherapeutic potentially offers a novel treatment approach for HER2+ solid tumors, including breast, non-small cell lung and gastric cancer. Updated results from DL2 (75 mCi) and higher will be presented at the congress."

First-in-human • Metastases • Bladder Cancer • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

Radiopharm Theranostics Presents Initial Findings from Phase 1 First-in-Human HEAT Clinical Trial for 177Lu-RAD202 in HER2+ Solid Tumors at American Association for Cancer Research 2026 (GlobeNewswire) - "The AACR poster highlights first-in-human safety, biodistribution, dosimetry and tumor uptake clinical findings from the initial lowest dose cohort of three patients with advanced HER2-positive breast and urothelial cancers who had received multiple prior metastatic therapies and were dosed at 30 mCi. Key Findings from the AACR Abstract and Poster: (i) Meaningful tumor uptake of 177Lu-RAD202 was observed at the initial and lowest dose level of 30 mCi, particularly in breast cancer lesions; (ii) 177Lu-RAD202 was generally well tolerated in the first three treated patients, with predominantly Grade 1–2 treatment-emergent adverse events."

First-in-human • P1 data • HER2 Positive Breast Cancer • Urothelial Cancer

Radiopharm Theranostics…announced that it has received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance its clinical-stage radiotherapeutic asset, 177Lu-RAD202 (RAD202), to the next dose level of 130mCi in the Phase 1 ‘HEAT’ clinical trial in patients with…HER2-positive advanced solid tumors (GlobeNewswire) - "...'We remain on track to complete the Phase 1 dose escalation by the end of 2026'. The Phase 1 ‘HEAT’ study is currently being conducted at clinical centers across Australia."

DSMB • Trial status • Solid Tumor

RAD202: HEAT Trial (HER2 Antibody Therapy With Lutetium-177) (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Radiopharm Theranostics, Ltd | Trial completion date: Sep 2027 ➔ Dec 2027 | Trial primary completion date: Sep 2027 ➔ Dec 2027

First-in-human • Trial completion date • Trial primary completion date • Solid Tumor • HER-2

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. (The Manila Times) - "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."

Enrollment status • P1 data • Solid Tumor

Theranostic application of radiolabeled HER2-targeting single-domain antibodies (RAD202) in preclinical setting. (PubMed, Sci Rep) - "The fractionated therapy group exhibited significantly lower tumor volumes and did not exceed 200% of the initial tumor volume. 68Ga-labeled sdAbs enabled high-contrast PET imaging and 177Lu-labeled sdAbs, particularly in fractionated regimens, effectively delayed tumor progression and were well tolerated, supporting further clinical translation."

Journal • Preclinical • Oncology • HER-2

Theranostic Application of Radiolabeled HER2-Targeting Single-Domain Antibodies (RAD202) in Preclinical Setting (EANM 2025) - No abstract available

Preclinical • HER-2

Human Epidermal Growth Factor Receptor 2 (HER2) Antibody Therapy with Lutetium-177 in Patients with Advanced Solid Tumours. (ANZCTR) - P1 | N=24 | Recruiting | Sponsor: Radiopharm Theranostics Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Trial initiation date • Solid Tumor • HER-2

Radiopharm Theranostics Doses First Patient in Phase 1 ‘HEAT’ Trial of 177Lu-RAD202 for Treatment of Advanced HER2-Positive Solid Tumors (GlobeNewswire) - "Radiopharm Theranostics...announced the dosing of the first patient in its Phase 1 ‘HEAT’ clinical trial of RAD202, a proprietary nanobody that targets Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in a wide array of advanced solid tumors. The open-label Phase 1 'HEAT’ clinical trial is a dose escalation trial of 177Lu-RAD202 that is designed to determine the recommended Phase 2 dose and to evaluate the safety and preliminary clinical activity of this novel radiotherapeutic in individuals with HER2-expressing advanced cancers. The study is currently being conducted at clinical centers across Australia."

Trial status • Solid Tumor

ITM, Radiopharm ink Lu-177 supply agreement (AuntMinnie.com) - "ITM Isotope Technologies Munich SE (ITM) and Radiopharm Theranostics have entered into an agreement under which ITM will supply that company with non-carrier-added lutetium-177 (n.c.a. Lu-177) for Radiopharm Theranostics' radiopharmaceutical therapies pipeline. Radiopharm Theranostics will use ITM's n.c.a. Lu-177 in its development of RAD 204 (PD-L1-targeting nanobody, phase I), RAD 202 (HER2-targeting nanobody, phase I), and RV01 (B7-H3-targeting monoclonal antibody, preclinical), for the treatment of solid tumors, according to the two firms."

Licensing / partnership • Solid Tumor

New RAD202 Data Confirms Positive Tumor Uptake and Favorable Biodistribution (GlobeNewswire) - "Radiopharm Theranostics...is pleased to announce a poster presentation at EMIM 2025, with findings that support the clinical utility of imaging and therapy with 68Ga-RAD202 and 177Lu-RAD202 respectively, and validate an optimized therapeutic dosing regimen in murine models...The imaging data reported that 68Ga-RAD202 binds specifically to the Human Epidermal growth factor Receptor 2 (HER2) in HER2-positive xenografts, with a high tumor-to-background ratio. The removal of a His-tag from the RAD202 nanobody, a modification which impacts biodistribution and tumor targeting, was shown to be superior for PET imaging due to the higher tumor-to-organ ratio....'The current comprehensive data with RAD202 further support our rationale for the Phase 1 FIH therapeutic dose escalating trial with 177Lu-RAD202, currently recruiting in HER2-positive advanced solid tumors.'"

Preclinical • Trial status • Solid Tumor • HER-2

RAD202: HEAT Trial (HER2 Antibody Therapy with Lutetium-177) (clinicaltrials.gov) - P1 | N=35 | Recruiting | Sponsor: Radiopharm Theranostics, Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

RAD202: HEAT Trial (HER2 Antibody Therapy with Lutetium-177) (clinicaltrials.gov) - P1 | N=35 | Not yet recruiting | Sponsor: Radiopharm Theranostics, Ltd

New P1 trial • Oncology • Solid Tumor

Human Epidermal Growth Factor Receptor 2 (HER2) Antibody Therapy with Lutetium-177 in Patients with Advanced Solid Tumours. (ANZCTR) - P1 | N=24 | Not yet recruiting | Sponsor: Radiopharm Theranostics Ltd

New P1 trial • Oncology • Solid Tumor • HER-2

RAD 202 Receives Approval to Start Phase 1 Therapeutic Trial (GlobeNewswire) - "Radiopharm Theranostics...is pleased to announce it has been granted Belberry Human Research Ethics Committee (HREC) approval in Australia to initiate its First-In-Human (FIH) Phase 1 therapeutic clinical study of 177Lu-labelled RAD 202 for the treatment of HER2-expressing solid tumors...The open-label Phase 1 trial, entitled ‘HEAT’ (HER2 Antibody Therapy with Lutetium-¹⁷⁷), is a dose escalation trial of ¹⁷⁷Lu-RAD202, and is designed to evaluate the safety and preliminary clinical activity of this novel radiotherapeutic in individuals with HER2-expressing advanced cancers. RAD 202 is a single-domain monoclonal antibody (sdAb) that targets the Human Epidermal growth factor Receptor 2 (HER2), which is overexpressed in breast cancer as well as several other solid tumors, and represents a validated target in oncology. The multicenter study is planned to recruit across Australia, with the support of leading oncology care provider GenesisCare CRO."

New P1 trial • Breast Cancer • Gastric Cancer • HER-2

RAD 202 data presented at 2024 EANM Annual Meeting (Radiopharm Theranostics Press Release) - "Collectively, the recently reported findings demonstrate the clinical feasibility of imaging and therapy with RAD 202, independent of the polyhistidine tag (His-tag), a modification which impacts biodistribution and tumor targeting...The PET/CT data reported here demonstrate that in HER2-positive murine models, there is low uptake of 68Ga-RAD 202 in nonspecific organs, except for the bladder and kidney as expected. The findings indicated a rapid tumor uptake and high tumor-to-background ratio with or without the His-tag modification....A FIH open-label dose escalation Phase 1 study of 177Lu-RAD 202 will commence in Q4 2024 and is designed to evaluate the safety and preliminary activity of this novel radiotherapeutic in eligible individuals with advanced HER2-positive solid tumors. The study will be conducted in Australia."

New P1 trial • Preclinical • Oncology • Solid Tumor • HER-2

Radiopharm Theranostics launches $10 million entitlement offer to fund clinical trials (Proactiveinvestors) - "Radiopharm Theranostics Ltd...will use the $10 million to be raised in an entitlement offer of 1-for-2.35 new shares at $0.07 to progress its four clinical trials....The company intends to use proceeds of the offer to advance its clinical trials towards the achievement of multiple inflection points, including RAD 301 Imaging Phase I read out, RAD 101 Imaging Phase IIb recruitment, RAD 204 Phase 1 therapeutic recruitment and RAD 202 Phase 1 therapeutic recruitment. Funds will also be applied towards ongoing working capital as well as the cost of the new share offer."

Financing • Oncology