Radiopharm Theranostics Highlights RAD101 Phase II Progress, Lu-177 Pipeline Updates at EGC Conference

Radiopharm Theranostics (ASX:RAD) provided an update on its clinical-stage radiopharmaceutical pipeline during the Emerging Growth Conference, outlining progress across five programs and highlighting near-term data and enrollment milestones. Managing Director, CEO and Director Riccardo Canevari said the company’s strategy is focused on advancing “first-in-class” radiopharmaceuticals that are “highly differentiated” and aimed at areas of significant unmet medical need.

Partnerships and pipeline positioning

Canevari said Radiopharm was created at the end of 2021 and has built two strategic partnerships in its first four years. He described Lantheus as a major partner and shareholder, saying it is the company’s largest shareholder at about 15%. He also cited a scientific partnership with MD Anderson Cancer Center, which has contributed a program in the company’s therapeutic portfolio.

Radiopharm’s pipeline includes an imaging agent and four therapeutic candidates. Canevari said all five molecules are now in clinical stage, and he focused his remarks on the four most advanced programs.

RAD101 imaging program in brain metastasis: Phase II recruitment and interim data

The company’s most advanced program is RAD101, a PET imaging agent in a Phase II trial in brain metastasis. Canevari characterized the market as large, citing approximately 300,000 new patients per year in the U.S. He said the unmet need stems from limitations of MRI following stereotactic radiosurgery, which is a standard-of-care treatment in this setting.

Canevari said the Phase II trial is more than 50% recruited and compares a single dose of RAD101 PET imaging to MRI. He reported that the company released interim data in 12 of 30 planned patients, with 11 of 12 (92%) achieving the trial’s primary endpoint of concordance with MRI.

He also described examples where RAD101 matched MRI findings and one example suggesting earlier detection than MRI. In that case, he said RAD101 detected a lesion when MRI did not, and subsequent follow-up MRIs at two and four months later showed emerging findings consistent with the earlier PET signal. Canevari said the company plans to complete Phase II enrollment around March or April and report full Phase II data before June. After completion of the Phase IIb trial, he said the company intends to discuss Phase III design with the FDA and move toward a Phase III registration trial.

Therapeutic portfolio: PD-L1 and HER2 nanobodies and an MD Anderson-derived B7-H3 program

Radiopharm outlined progress in two Lutetium-177 (Lu-177) nanobody programs, as well as a monoclonal antibody program targeting B7-H3.

• PD-L1 nanobody (Lu-177): Canevari said this Phase I program is in dose escalation and is now at the third dose level. He said patients have been dosed at 30 mCi, 60 mCi, and the company is currently dosing at 90 mCi. Early observations from the first two cohorts showed “very positive tumor uptake” and no side effects, leading the company to continue escalating dose in order to evaluate clinical activity.
• HER2 nanobody (Lu-177): This program is being evaluated in a basket trial in breast cancer and gastroesophageal cancer. Canevari said the trial is in Phase I and has moved into a second dose level after dosing a first cohort at 30 mCi. He cited early data from three patients showing significant tumor uptake and a favorable safety profile with no adverse events. He said the company is increasing dose and is dosing at 75 mCi, with plans to continue escalating.
• RV01 B7-H3 monoclonal antibody (Lu-177): Canevari said this molecule comes from Radiopharm’s partnership with MD Anderson. He described modifications to the antibody’s Fc region intended to reduce circulation time and lower the risk of bone marrow toxicity, while maintaining strong affinity for the B7-H3 target. He cited preclinical data showing 56% survival after a single injection in an animal model, which supported FDA discussions and IND approval. He said two U.S. centers are already open, with plans to expand to six centers, and that the first patient could be dosed “any day,” potentially within the next couple of weeks.

Canevari also addressed competitive dynamics for several targets. He said Radiopharm currently has no radiopharmaceutical competitors in development for imaging in brain metastasis and described its PD-L1 program as “first in class.” For HER2, he said two other companies are developing HER2 radiopharmaceuticals but remain in preclinical stage. For B7-H3, he named Aktis Oncology and Novartis as companies pursuing the target, while estimating Radiopharm is six to 12 months ahead based on its IND approval and readiness to screen patients.

Manufacturing, cash runway, and commercialization approach

Responding to questions on isotope supply, Canevari emphasized the importance of reliable sourcing given isotope decay and said the company has secured multiple Lu-177 suppliers across Australia, Europe, and the U.S. He said this redundancy is intended to support progression to Phase III and commercialization.

On spending and cash runway, Canevari said Radiopharm operates with 14 employees and typically spends about $6 million to $7 million per quarter, with the possibility of some increase as additional trials start. He said the company has enough cash to reach the beginning of Q1 2027, assuming it continues all five trials discussed.

On revenue timing, Canevari said RAD101 is the program closest to potential commercialization, noting it is “only one trial away” from a Phase III prior to launch. He estimated Phase III completion “probably end of 2028,” with 2029 as a potential first year of sales, assuming no earlier partnership. He added that the company is open to partnering for Phase III and commercialization, including structures such as upfront payments, milestones, or profit-sharing, and said Radiopharm does not view building a near-term commercial organization as its most appropriate strategy given its size.

Looking ahead, Canevari said 2026 is expected to be a critical year, with clinical milestones anticipated across the company’s trials and completion of the RAD204 and RAD102 studies targeted for 2026. He concluded that the team’s near-term focus is execution and advancing programs to generate clinical data that could support future partnering and financing decisions.

About Radiopharm Theranostics (ASX:RAD)

Radiopharm Theranostics Limited engages in the research and development of radiopharmaceutical products for diagnostic and therapeutic uses in areas of high unmet medical needs. It is developing its lead products comprising Nano-mAbs and AVB6 Integrin. The company was incorporated in 2021 and is based in Carlton, Australia.