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SYDNEY - Radiopharm Theranostics (ASX:RAD, Nasdaq: RADX), a clinical-stage biotech company with a current market capitalization of $35.8 million, announced Monday that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for Betabart (RV-01), a Lu177-B7H3 monoclonal antibody targeting solid tumors. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 3.37x, indicating robust short-term financial stability.
RV-01 is designed to target the 4Ig isoform of B7H3, a protein highly expressed in tumors but not in healthy tissues. The company plans to initiate its first-in-human Phase 1 clinical trial later this year, with patient dosing expected in the fourth quarter of 2025.
"FDA clearance to initiate our first-in-human Phase 1 clinical trial of RV-01 represents a major milestone for Radiopharm Theranostics and our joint venture with MD Anderson Cancer Center," said Riccardo Canevari, CEO and Managing Director of Radiopharm. The company’s stock has seen significant volatility, with InvestingPro showing a 73% decline over the past year, though it maintains several positive financial health indicators. Get access to more detailed analysis and 8 additional ProTips with an InvestingPro subscription.
According to the company, preclinical studies have shown that RV-01 exhibits hepatic clearance, which may allow the isotope sufficient time to target tumors while potentially minimizing adverse effects such as hematological toxicities.
Dimitris Voliotis, Chief Medical Officer of Radiopharm, noted that the antibody’s liver clearance pathway may offer advantages over radiotherapeutics with renal excretion, which can be associated with kidney toxicity.
RV-01 is the first radiopharmaceutical therapeutic agent developed through Radiopharm Ventures, the joint venture between Radiopharm Theranostics and MD Anderson Cancer Center.
B7-H3 is an immune checkpoint molecule overexpressed across several tumor types, with deregulated expression correlated with tumor aggressiveness and poor clinical outcomes.
The information in this article is based on a press release statement from Radiopharm Theranostics. While the company reported an EBITDA of -$20.4 million in the last twelve months, InvestingPro analysis indicates it holds more cash than debt, providing financial flexibility for its clinical development programs. Analysts have set price targets ranging from $12.26 to $30.52, suggesting potential upside from current levels.
In other recent news, Radiopharm Theranostics Ltd has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration for Betabart (RV-01), allowing the company to begin clinical trials in the United States. Additionally, Radiopharm Theranostics announced it has received a $4.5 million research and development tax incentive from the Australian government, supporting its ongoing R&D activities. Brookline Capital Markets initiated coverage on Radiopharm Theranostics with a Buy rating and a price target of $18.00, highlighting the company’s pipeline of radiopharmaceutical candidates. Similarly, ThinkEquity began coverage with a Buy rating and set a price target of $15.00, citing the company’s focus on solid tumors and its diversified pipeline. In governance updates, Radiopharm Theranostics appointed Dr. Oliver Sartor to its Scientific Advisory Board, a move disclosed to the U.S. Securities and Exchange Commission. These developments reflect the company’s ongoing efforts in advancing its clinical programs and strengthening its advisory team.
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