Radiopharm Theranostics Highlights Phase 1 Pipeline, Eyes June RAD 101 Data at DB Conference

Key Points

• Radiopharm is advancing four phase 1 radiotherapeutics — led by what the company calls the "first and only PD‑L1 radiopharmaceutical in clinical development," with HER2, KLK3 (prostate) and B7‑H3 programs showing early tumor uptake and favorable safety in dose‑escalation studies.
• RAD 101 imaging agent has a June phase‑2 data readout — the phase‑2 trial is fully recruited at 30 patients (interim 18/20 concordance with MRI), and a positive primary endpoint would prompt FDA phase‑3 discussions and position RAD 101 as a near‑term commercialization candidate with a preferred external partner.
• Company operates a capital‑efficient, partnership‑focused model — Radiopharm outsources development rather than being vertically integrated, runs five trials with 17 employees plus consultants, prefers partners for phase‑3/commercialization, and leverages Australian trials that qualify for a ~42% cash‑back incentive.

Radiopharm Theranostics NASDAQ: RADX outlined progress across its radiopharmaceutical pipeline and highlighted near-term clinical catalysts during a presentation at the 30th Deutsche Bank Depositary Receipts Virtual Investor Conference.

Chief Executive Officer Riccardo Canevari described the company as a “multi-asset, first-in-class radiopharmaceutical platform” focused on attaching therapeutic isotopes to targeted molecules. He said Radiopharm is advancing four clinical-stage radiotherapeutics aimed at PD-L1, HER2, B7-H3 and KLK3 (in prostate cancer), using protein-engineered vectors and clinically established beta-emitting isotopes including Lutetium-177 and Terbium-161.

Pipeline focus and strategy

Canevari said the company is building a differentiated pipeline with “multiple shots on goal,” and emphasized a capital-efficient operating model. Radiopharm is “not vertically integrated,” instead using a distributed development approach with partners. He also framed the broader sector as entering a “second wave” of radiopharmaceutical development, with interest shifting beyond Novartis’ approved targets SSTR2 and PSMA.

He also pointed to an M&A environment that has evolved from acquisitions aimed at infrastructure to deals centered on pipeline expansion, saying larger pharmaceutical companies are now seeking “differentiated molecules.”

Four phase 1 radiotherapeutics

Radiopharm’s four core therapeutic programs are all in phase 1, with two nanobody-based assets and two monoclonal antibody programs.

• PD-L1 radiotherapeutic (lead program): Canevari said Radiopharm has the “first and only PD-L1 radiopharmaceutical in clinical development.” In the ongoing dose-escalation trial, the company completed the first two cohorts and observed “important tumor uptake” and “favorable safety.” The study is now dosing the third level at 90 millicurie of lutetium, which he described as a dose range where a biological effect could begin to emerge in a phase 1 escalation.
• HER2-targeting nanobody: The company’s HER2 program is also mid–phase 1, with the first two cohorts completed and favorable safety and tumor uptake observed, Canevari said. The trial is dosing level three at 130 millicurie. He noted the product targets a different epitope versus trastuzumab and is positioned for unmet need “post-ADC.” He also said the company introduced a next-generation formulation at dose level three intended to improve the tumor-to-kidney ratio by removing a His-tag tail, which in preclinical models reduced kidney uptake by around 50%.
• KLK3 prostate cancer program: Radiopharm is pursuing KLK3 as an alternative to PSMA-based approaches, using a humanized IgG1 monoclonal antibody and Terbium-161, which Canevari said is attractive for its dual emission (beta and Auger). The phase 1 trial has dosed “a couple of patients” so far. Canevari said KLK3’s expression profile could mean “less off-target toxicity,” describing the target as “really expressed only in the tumor.”
• B7-H3 monoclonal antibody program: Canevari called B7-H3 “one of the most interesting target at this moment,” noting increased attention at recent oncology meetings. Radiopharm’s antibody has been modified in the Fc region (FcRn and Fc-gamma receptor) to improve biodistribution. The phase 1 study is at dose level one, with “a couple of patients” dosed, and is recruiting in the U.S. with what he described as a strong recruitment rate.

Looking ahead, Canevari said the next “three, six, and nine months” include multiple catalysts across the parallel-running trials, with open-label studies expected to generate ongoing updates.

RAD 101 imaging program and June data readout

In addition to therapeutics, Canevari highlighted an imaging portfolio that he characterized as a “standalone opportunity” for commercialization or partnering. He said the company is actively discussing “strategic opportunities,” pointing in particular to RAD 101, an imaging agent intended for patients with brain metastases after stereotactic radiosurgery (SRS), where MRI can struggle to distinguish tumor progression from radiation necrosis.

Canevari said Radiopharm has completed both phase 1 and phase 2 for RAD 101, with phase 2 fully recruited at 30 patients. The company previously disclosed interim data from 20 patients, showing 18 out of 20 concordance with MRI, despite patients entering the trial due to questionable MRI results. He said the full data readout is planned for June.

Based on current progress, Canevari said the company believes it can move to discussions with the FDA regarding phase 3 design, calling RAD 101 “likely to be one trial away from commercialization.” In Q&A, he added that Radiopharm would prefer a partner to conduct phase 3 and would “definitely” seek a commercial partner, stating it is not the company’s role to build a commercial field force.

He also said that if June’s primary endpoint is positive, RAD 101 could potentially become the company’s first commercial product, though a phase 3 trial would still be required. He said phase 3 size is not yet determined and would depend on FDA alignment, with endpoints likely to include sensitivity and specificity.

Operational footprint and capital allocation

Addressing capital allocation, Canevari said the phase 2 imaging study is finished and resources are focused on the four therapeutic trials. He noted that three of the therapeutic trials are being conducted in Australia and one in the U.S., and said Australia-based trials benefit from a 42% cash-back incentive from Australian authorities. He also emphasized the company’s lean structure, saying Radiopharm has 17 employees while running five clinical trials, supplemented by consultants and third parties on a project basis.

What the company is watching for next

During Q&A, Canevari said that while safety and tumor uptake are important, what will meaningfully change market perception is early evidence of clinical efficacy in phase 1—such as partial responses. He identified the two nanobody programs (the PD-L1 and HER2 assets) as the programs furthest along in dosing and therefore among the most likely to show early activity sooner.

For the KLK3 prostate program, Canevari said one early measure of activity the company will watch is PSA reduction, which he described as a faster-readout surrogate than progression-free survival in prostate cancer, particularly in patients with bone metastases. He added that conducting the study in Australia may allow enrollment of patients who are Pluvicto-naive due to reimbursement dynamics, enabling comparison to historical benchmarks from earlier-stage Pluvicto development.

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.

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