Core Insights - The FDA has granted clearance for Radiopharm Theranostics to initiate a first-in-human Phase 1 clinical trial of RV-01, a Lu177-B7H3 monoclonal antibody targeting the 4Ig isoform of B7-H3, which is overexpressed in tumors [1][2] - RV-01 is expected to provide a novel treatment option for patients with aggressive solid tumors, with the first patient dosing anticipated later in 2025 [2][5] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs, listed on ASX (RAD) and NASDAQ (RADX) [6] - The company has a diverse pipeline that includes distinct technologies such as peptides, small molecules, and monoclonal antibodies, with ongoing clinical trials for various solid tumors [6] Product Details - RV-01 is the first radiopharmaceutical therapeutic agent developed through a joint venture with MD Anderson Cancer Center, demonstrating tumor shrinkage and prolonged survival in preclinical studies [5] - The unique hepatic clearance of RV-01 may minimize adverse effects compared to other radiotherapeutics, which often have renal excretion pathways associated with higher toxicity risks [2][3] Scientific Significance - B7-H3 is an immune checkpoint molecule linked to tumor aggressiveness and poor clinical outcomes, making it a compelling target for antibody-based cancer immunotherapy [4] - The high affinity of RV-01 for the 4Ig isoform allows for enhanced targeting of tumors while avoiding immune complex formation in circulation [3][4]

Core Viewpoint - Monopar Therapeutics has received FDA authorization for the Expanded Access Program (EAP) for investigational imaging agent MNPR-101-Zr and therapeutic agent MNPR-101-Lu, aimed at patients with advanced solid tumors [1][2][3] Group 1: Expanded Access Program (EAP) - The MNPR-101 EAP is now open for enrollment at Excel Diagnostics and Nuclear Oncology Center (EDNOC) in Houston, Texas, targeting patients with advanced solid tumors [2][5] - EAPs provide a pathway for patients with serious or life-threatening conditions to access investigational products outside of clinical trials when no satisfactory alternative treatments are available [5] Group 2: Product Details - MNPR-101 is a proprietary antibody targeting the urokinase plasminogen activator receptor (uPAR), expressed in various tumor types including pancreatic, breast, and colorectal cancers [6] - MNPR-101-Zr is designed for imaging advanced cancers, while MNPR-101-Lu is an investigational treatment for advanced solid cancers [6] Group 3: Company Background - Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for unmet medical needs, including late-stage programs for Wilson disease and radiopharmaceuticals [7] - The company is advancing its radiopharmaceutical pipeline, which includes Phase 1 clinical trials for MNPR-101-Zr and MNPR-101-Lu [3][7] Group 4: Collaboration and Expertise - The EAP will be conducted under the supervision of Dr. Ebrahim S. Delpassand, a renowned investigator and medical director at EDNOC, which is recognized as a Radiopharmaceutical Therapy Center of Excellence [2][4][9] - The collaboration aims to provide access to therapies targeting difficult-to-treat cancers, marking a promising advancement in radioligand therapy [4]

Financial Data and Key Metrics Changes - Total operating loss from continuing operations increased from $6.6 million in 2023 to $6.9 million in 2024 [21] - Research and development expenses rose to $3.7 million in 2024 from $3.4 million in 2023 [21] - General and administrative expenses decreased from $3.5 million in 2023 to $3.2 million in 2024 [21] - Net finance expense decreased from $1.5 million in 2023 to $0.8 million in 2024 [21] - The company's net loss for 2024 was $8.5 million compared to $4.3 million in the previous year [22] - Cash and cash equivalents at year-end 2024 rose to $1 million from $0.7 million at the end of 2023 [24] Business Line Data and Key Metrics Changes - The RNA delivery business continued to gain momentum with two new partners for the X4 platform and improvements in the manufacturing process [6] - The company filed a provisional patent application for circular RNA technology, which could open new collaboration opportunities [12] - Significant progress was made in the development and refinement of nanoparticles for RNA payload delivery [11] Market Data and Key Metrics Changes - The global radiopharmaceutical market reached $8.4 billion in size in 2024 and is expected to grow to $17.1 billion by 2033 [13] Company Strategy and Development Direction - The company plans to spin off a majority of its Swiss subsidiary, Altamira Therapeutics AG, to focus on RNA delivery business [9] - The parent company will become more of a holding company, managing minority stakes in subsidiaries and legacy assets [9] - The company aims to advance at least one flagship program to an investigational new drug IND filing with the FDA in 2026 [14] Management's Comments on Operating Environment and Future Outlook - The delisting from NASDAQ was a significant setback, impacting the ability to raise capital in public markets [27] - The planned partial spin-off and involvement of private equity investors are seen as beneficial alternatives for funding and growth [27] - The company expects operating expenses to decrease significantly following the spin-off [24] Other Important Information - The financial results for 2024 were presented in U.S. dollars for the first time [20] - The company is in discussions with potential partners for its legacy assets, including nasal sprays for allergy and vertigo treatment [19] Q&A Session Summary - No specific questions or answers were documented in the provided content.