Radiopharm Theranostics (NASDAQ:RADX) provided an update on its clinical-stage radiopharmaceutical pipeline during an investor conference presentation led by CEO Riccardo Canevari, highlighting interim results from its lead imaging program and progress across four therapeutic candidates in human trials.
RAD101 interim data in brain metastases trial
Canevari focused first on RAD101, the company’s lead program, which is in a Phase II-B trial for brain metastases in patients where MRI imaging “doesn’t work well” and physicians lack enough information to determine whether tumor remains after treatment. He said Radiopharm reported a second interim analysis “yesterday,” following a first interim readout of 12 patients in December. The new interim analysis included 20 patients out of a total planned 30.
He also shared an additional operational update not included in the company’s prior announcement, stating that Radiopharm had recruited 27 of 30 patients, with two more patients having appointments scheduled. He said recruitment could be completed in “two to three weeks during the month of April,” with final trial data expected around May or June. Canevari added that the company is planning an FDA meeting around June to discuss Phase III trial design and patient numbers, characterizing the interim data as supportive of advancing to a registrational study.
He described the indication as a large unmet need and cited “300,000 new patients only in U.S.” for the target population. He also said the company’s ambition is to obtain approval to start a pivotal Phase III registrational trial by the end of 2026.
Therapeutic pipeline: four clinical-stage programs
Beyond RAD101, Canevari outlined four therapeutic radiopharmaceutical programs, noting that all are in the clinic and that three are being studied in Australia.
- RAD204 (PD-L1 positive tumors): A Phase I dose-escalation trial using a nanobody labeled with Lutetium-177. Canevari said data have been generated at 30 millicurie and 60 millicurie dose levels, with dosing currently at 90 millicurie. He said the escalation is continuing because the company has not seen “negative side effect” to date, with the goal of reaching tumor efficacy. He added that final Phase I data are expected by the end of 2026.
- RAD202 (HER2-expressing breast or gastric cancer): Also a Phase I trial in Australia using a nanobody with Lutetium-177. Canevari said the 30 millicurie dose level has been completed and that recruitment at 75 millicurie is nearly complete, with plans to move to the next dose level. He reported “very positive tumor uptake” and no significant side effects so far, supporting continued dose escalation.
- BetaBart (B7-H3 target): A U.S.-based trial targeting B7-H3 across multiple solid tumors. Canevari said the first patient was dosed on February 23 and described the asset as an in-licensed monoclonal antibody from MD Anderson under an exclusive deal, targeting the “4Ig isoform” of B7-H3 and using Lutetium-177. The initial plan is 35 millicurie dosing for three patients before escalation. He listed tumor types including prostate, lung, colorectal, breast, head and neck, ovarian, and endometrial cancers.
- KLK3-targeted prostate cancer program (Terbium-161): An Australia trial screening prostate cancer patients using a monoclonal antibody paired with Terbium-161. Canevari said the company believes it is the first to target KLK3 rather than PSMA, arguing KLK3 is expressed only in prostate cancer while PSMA can also be expressed in healthy tissues. He also pointed to demand for trial participation in Australia, citing a lack of reimbursement for Pluvicto as a factor, and said the company expects to dose the first patient “very soon.”
Competitive positioning and upcoming data flow
Canevari said Radiopharm is aiming to develop assets in areas where it can be first in clinical development, describing RAD101 as “first in class,” RAD204 as the only PD-L1 radiopharmaceutical, and the HER2, B7-H3, and KLK3 programs as first in clinical development.
On B7-H3, he mentioned other radiopharmaceutical developers including Aktis and Novartis, and said Radiopharm believes it has a “6 to 9, 10 months advantage” in clinical development.
He also emphasized that the company does not currently face radioisotope supply constraints and said it is “well-organized” to ship products from production to clinical centers on time.
Q&A: sector momentum, early efficacy expectations, and prioritization
During the question-and-answer session, Canevari said investor and industry interest in radiopharmaceuticals has continued, noting a limited number of public radiopharma companies, including several in Australia and a small number on Nasdaq.
Asked about signs of efficacy in the early cohorts of RAD202 and RAD204, Canevari said the company started cautiously at low doses and has not yet seen clinical efficacy because doses remain well below those used in approved Novartis products Pluvicto and Lutathera, which he said are dosed at 200 millicurie. He said Radiopharm is approaching dose levels above 100 millicurie, where clinical responses may become more likely, and suggested the “second part of 2026” is when dosing levels could be more consistent with seeing efficacy signals.
On pipeline prioritization, he said the company currently has the team and financial capacity to run the four Phase I therapeutic trials while completing the Phase II imaging study, with a plan to decide in the second half of the year which products should be accelerated versus deprioritized based on emerging data.
Discussing execution risks, Canevari said the primary hurdle is competition for patient enrollment across oncology trials broadly, rather than competition only within radiopharmaceuticals, and he highlighted the importance of selecting centers without competing trials in the same indication.
Stated catalysts
In closing, Canevari summarized key upcoming milestones:
- RAD101 Phase II readout: expected between May and June.
- RAD204 and RAD202 Phase I readouts: anticipated before the end of the year, as stated during the Q&A.
He added that 2026 is expected to include additional Phase II and Phase I readouts across the portfolio.
About Radiopharm Theranostics (NASDAQ:RADX)
Radiopharm Theranostics, Inc is a clinical-stage biopharmaceutical company focused on the development and commercialization of radiopharmaceutical products for both diagnostic imaging and targeted radiotherapeutic applications. By harnessing the unique properties of radioisotopes, the company aims to improve the precision of disease detection and deliver therapeutic payloads directly to diseased tissues, particularly in oncology.
The company’s research and development efforts are concentrated on a pipeline of radioligand therapies and companion diagnostic agents designed to address a variety of tumor types.
