RAD204 / Radiopharm Theranostics - LARVOL DELTA

Radiopharm Theranostics starts enrollment of the Third Cohort of Phase 1 Dose Escalation Clinical Trial of 177Lu-RAD204 (GlobeNewswire) - "Radiopharm Theranostics...announced the completion of enrollment for the second cohort of patients in the Phase 1 dose escalation trial of 177Lu-RAD204 in PD-L1 positive advanced 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....Data Safety Monitoring Committee approves advancing to a higher dose of 90mCi. The first two Cohorts’ patients show tumor uptake and a favourable safety profile."

DSMB • Trial status • Cutaneous Melanoma • Endometrial Cancer • Non Small Cell Lung Cancer • Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

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

Radiopharm (ASX: RAD) Advances 177Lu-RAD204 to Higher Dose in Phase 1 Trial (Kalkine Media) - "Radiopharm has received approval from the Data and Safety Monitoring Committee (DSMC) to progress to the next dosing level in its ongoing Phase 1 clinical trial targeting patients with PD-L1-positive advanced cancers. This approval enables Radiopharm to advance to a higher dose cohort across a range of PD-L1-driven tumor types. The DSMC has reviewed the first patient cohort, which received 30mCi of 177Lu-RAD204. The next patient cohort will proceed with a higher dose of 60mCi of 177Lu-RAD204, an increase from the initially planned 40mCi."

DSMB • Trial status • Cutaneous Melanoma • Endometrial Cancer • Hepatocellular Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Radiopharm Theranostics Accelerates 177Lu-RAD204 Phase 1 Dose Escalation Clinical Trial Based on Positive Recommendation from Data Safety and Monitoring Committee (DSMC) (GlobeNewswire) - "Radiopharm Theranostics...announced today that it has achieved a key milestone in its ongoing clinical development program for its clinical-stage radiotherapeutic asset, 177Lu-RAD204, as the Data and Safety Monitoring Committee (DSMC) has approved to proceed to the next dose in its Phase 1 clinical trial in patients with PD-L1 positive advanced cancers....With this clearance from the DSMC, the increased number of active centers and expansion to multiple tumor types beyond Non-Small Cell Lung Cancer (NSCLC), we expect to accelerate our timelines for complete enrolment of the next cohort by mid-2025....we look forward to seeing data from the first two cohorts of patients later this year."

DSMB • P1 data • Trial status • Non Small Cell Lung Cancer

Lantheus Increases to 12.16% shareholding in Radiopharm with US$5m (A$8m) Placement (GlobeNewswire) - "The funds raised will be applied to the development of Radiopharm’s clinical pipeline...Radiopharm Theranostics...is pleased to announce that it has executed a subscription agreement for a private placement of ordinary shares to Lantheus Holdings Inc. ('Lantheus'), raising US$5.0 million (A$8.0 million)....The placement of 133 million shares was completed at an issue price of A$0.060 per share, representing a 150% premium to the last traded price of RAD shares (A$0.024). Settlement is expected to occur within 7 days."

Financing • Solid Tumor

Radiopharm Theranostics (ASX: RAD) Receives HREC Approval to Expand RAD204 Study Across Multiple Cancer Indications (Kalkine Media) - "This positive movement follows the announcement that the company has received approval from the Australian Ethics Committee to expand its PD-L1 nanobody (RAD204) Phase 1 Trial in multiple tumor types....The ongoing Phase 1 first-in-human study aims to evaluate the tolerability and safety profile of 177Lu-RAD204 in patients with PD-L1-positive advanced solid tumors....The trial is currently underway and recruiting participants at four sites across New South Wales, South Australia, and Western Australia. It is being supported by GenesisCare CRO, a prominent provider of oncology care."

New P1 trial • Endometrial Cancer • Head and Neck Cancer • Melanoma • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer

First Patient Dosed with PD-L1 Nanobody in Phase 1 Therapeutic Non-Small Cell Lung Cancer Trial (Investing.com) - "Radiopharm Theranostics...is pleased to announce the therapeutic dosing of the first patient in its Phase 1 clinical trial of RAD 204, a proprietary nanobody which targets Programmed death-ligand 1 (PD-L1)-positive expression in Non-Small Cell Lung Cancer (NSCLC), the most common type of lung cancer."

Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

177Lu-anti-PD-L1 sdAb in Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=23 | Recruiting | Sponsor: Radiopharm Theranostics, Ltd | Initiation date: Mar 2024 ➔ Jun 2024

Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Lutetium-177-anti-Programmed Cell Death-Ligand 1 single domain antibodies (177Lu-anti-PD-L1 sdAb) in metastatic non-small cell lung cancer (ANZCTR) - P1 | N=23 | Recruiting | Sponsor: Radiopharm Theranostics Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

177Lu-anti-PD-L1 sdAb in Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=23 | Recruiting | Sponsor: Radiopharm Theranostics, Ltd

Metastases • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Radiopharm Theranostics launching Phase 1 lung cancer trials in January (Proactiveinvestors) - "Radiopharm Theranostics Ltd...has completed a site initiation visit (SIV) for its RAD 204 Phase 1 study, designed to evaluate the safety and efficacy of this novel radiotherapeutic in eligible individuals with advanced non-small cell lung cancer (NSCLC), the most common type of lung cancer....The study will be conducted at Princess Alexandra Hospital in Brisbane, Australia, with the support of leading oncology care provider GenesisCare. Lu-RAD 204 will be formally activated on January 4, 2024 with the first patient expected to be dosed in January 2024."

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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

RAD receives approval for Phase 1 therapeutic study of PDL1-nanobody in Non-Small Cell Lung Cancer (GlobeNewswire) - "Radiopharm Theranostics...is pleased to announce it has been granted Human Research Ethics Committee (HREC) approval to commence its First-In-Human Phase I study in Australia for the Company’s therapy for patients with PDL1-positive non-small cell lung cancer (NSCLC)....The trial is expected to start shortly."

Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Lutetium-177-anti-Programmed Cell Death-Ligand 1 single domain antibodies (177Lu-anti-PD-L1 sdAb) in metastatic non-small cell lung cancer (ANZCTR) - P1 | N=23 | Not yet recruiting | Sponsor: Radiopharm Theranostics Ltd

Metastases • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor