BetaBart (RV01) / Radiopharm Theranostics - LARVOL DELTA

Radiopharm Theranostics…announced that it has dosed the first patient in the second cohort of its First-In-Human (FIH) Phase 1/2a clinical trial of RV-01 (177Lu-Betabart) in patients with B7-H3 expressing tumors (GlobeNewswire) - "This follows a positive recommendation from the Safety and Monitoring Committee (SMC), an independent multidisciplinary committee, to advance to the 70 mCi dose of RV-01....The Phase 1/2a clinical trial is a dose escalation and expansion trial designed to evaluate the safety, biodistribution, radiation dosimetry and preliminary anti-tumor activity of RV-01 in B7-H3 expressing tumors."

DSMB • First-in-human • Trial status • Solid Tumor

Radiopharm Theranostics…announced the dosing of the first patient in its First-In-Human (FIH) Phase 1/2a clinical trial of 177Lu-Betabart (RV-01) (GlobeNewswire) - "The Phase 1/2a clinical trial is a dose escalation and expansion trial of 177Lu-BetaBart, designed to evaluate its safety, biodistribution and radiation dosimetry of 177Lu-BetaBart, along with its preliminary anti-tumor activity."

First-in-human • Trial status • Solid Tumor

177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=61 | Recruiting | Sponsor: Radiopharm Theranostics, Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Nov 2025 ➔ Feb 2026

Enrollment open • Trial initiation date • Breast Cancer • Castration-Resistant Prostate Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Genito-urinary Cancer • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

RAD Increases Ownership in Radiopharm Ventures to 87.5% (The Manila Times) - "Leading candidate Betabart, a monoclonal antibody targeting B7H3, has received FDA IND clearance for a Phase I therapeutic trial in multiple solid tumors expected to dose the first patient in Q1 2026...Two additional preclinical Radiopharm Ventures’ assets show early positive results with plans to move to final candidate selection in 2026."

Pipeline update • Trial status • Solid Tumor

177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=61 | Not yet recruiting | Sponsor: Radiopharm Theranostics, Ltd

New P1/2 trial • Breast Cancer • Castration-Resistant Prostate Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Genito-urinary Cancer • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Radiopharm Theranostics Receives FDA Investigational New Drug Clearance for RV-01 Cancer Therapy (Small Caps) - "Radiopharm Theranostics...has received investigational new drug clearance from the US Food and Drug Administration (FDA) for therapeutic candidate Betabart (RV-01). RV-01 targets the B7H3 immune checkpoint molecule that plays a role in cancer development and progression. The FDA clearance will now allow the company to initiate a first-in-human Phase 1 clinical trial of RV-01, which it has developed in conjunction with the prestigious MD Anderson Cancer Centre at the University of Texas."

IND • New P1 trial • Oncology

Radiopharm Theranostics Reports Preclinical Lu177-B7H3-mAb Data Demonstrating Favourable Biodistribution and High Tumour Uptake (GlobeNewswire) - "Radiopharm Theranostics...announced that preclinical data from studies with the Lu177-B7H3-monoclonal antibody RV01 demonstrated favourable biodistribution and showed that RV01 maintained high tumour uptake. In addition, the Fc region modifications of the monoclonal antibody (mAb) confirm a shorter half-life, compared to traditional mAbs. The shorter half-life and other Fc modifications have the potential to limit off-target exposure to the isotope and mitigate toxicities associated with traditional monoclonal antibody therapies...These data allow us to confirm our guidance to file the IND-submission in mid-2025 and to initiate our first-in-human Phase 1 basket study by the end of this year"

IND • New P1 trial • Preclinical • 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

Significant progress with B7-H3 targeting radio-antibody (BetaBart) (Radiopharm Theranostics Press Release) - "Radiopharm Theranostics...is pleased to announce regulatory and manufacturing progress for its B7-H3 targeting radio-antibody, BetaBart...The strong preclinical data package combined with GMP quality production, supported the pre-IND submission to the US Food and Drug Administration (FDA). Preparations are on track to prepare the IND submission with the FDA and subsequently start the Phase I/II First-In-Human (FIH) therapeutic trial with BetaBart in multiple tumour types in the US, expected for mid-2025."

IND • New P1/2 trial • Oncology • Solid Tumor

Radiopharm Theranostics (ASX:RAD) Boosts Stake to 75% in Joint Venture with MD Anderson (Kalkine Media) - "Radiopharm Theranostics Limited...has increased its stake in Radiopharm Ventures, LLC, a joint venture (JV) formed in 2022 with The University of Texas MD Anderson Cancer Center. Originally holding a 51% stake, RAD now owns 75%...The lead candidate, a B7H3 monoclonal antibody (mAb), is nearing the end of preclinical studies, with a Phase 1 therapeutic trial planned for the first half of 2025...In addition to the B7H3 candidate, RAD is advancing two other preclinical candidates with early positive results. These are approaching final candidate selection for potential use across various solid tumour types...To support these developments, RAD has committed an additional US$4.0 million to the JV. This funding will be used to cover clinical and preclinical expenses."

Financing • New P1 trial • Pipeline update • Oncology • Solid Tumor