Radiopharm Theranostics (ASX:RAD) dosed the first participant in its 177Lu‑BetaBart Phase 1/2a trial on February 24 2026, marking the first human exposure of the company’s lutetium‑based therapeutic agent for solid tumours.
The trial will enroll 61 patients with advanced solid tumours—including prostate, colorectal, lung, head‑and‑neck, ovarian, cervical, endometrial, triple‑negative breast and esophageal squamous‑cell cancers—and will assess safety, biodistribution, radiation dosimetry and preliminary anti‑tumour activity of the antibody that targets the 4Ig isoform of B7‑H3.
This milestone advances the asset from pre‑clinical to early clinical development, supporting Radiopharm’s capital‑light strategy and potentially attracting non‑dilutive funding or strategic collaborations. The company has recently increased its ownership stake in the joint venture with The University of Texas MD Anderson Cancer Center to 87.5%, further aligning incentives for the program’s success.
Financially, Radiopharm remains unprofitable, with trailing‑12‑month revenue of $2.35 million and operating and net margins of –953.51 % and –1,055.38 %, respectively. The company’s current and quick ratios are 2.67, indicating adequate liquidity, but flat revenue growth over the past three years and significant losses underscore the need for future clinical success to generate revenue streams.
CEO Riccardo Canevari said the first‑in‑human dose “marks an important milestone for Radiopharm, as this is the first radiotherapeutic agent from our joint venture to enter the clinic,” adding that 177Lu‑BetaBart “has the potential to become a highly differentiated radiotherapeutic for patients with aggressive advanced solid tumours.”
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