Radiopharm Theranostics (RAD) NWR Virtual Healthcare Conference summary

Pipeline overview and clinical progress

• Six differentiated radiopharmaceutical technologies in development, with four ongoing clinical trials (two therapeutic, two imaging) and three promising preclinical assets advancing toward clinical studies.

• Lead therapeutic compounds target PD-L1 and HER2, both in phase I trials in Australia, using nanobody formats for improved specificity and rapid clearance.

• Imaging assets include RAD-101 for early brain metastases (phase II in the U.S.) and RAD-301 for pancreatic and other solid tumors, with strong proof-of-concept data.

• Preclinical pipeline features RV01 (B7-H3 checkpoint inhibitor), RAD-402 (KLK3 in prostate cancer), and RAD-302 (integrin-targeted therapy), with first-in-human studies planned for 2024–2026.

• Multiple formats (antibodies, nanobodies, peptides) and isotopes (lutetium-177, terbium-161) are used to maximize therapeutic and diagnostic potential.

Financials, partnerships, and operations

• Financial position is solid, with institutional shareholders and a cash runway through mid-2026.

• Strategic partnerships include Lantheus (12% ownership), collaborations with MD Anderson Cancer Center, and isotope suppliers such as ANSTO, Isotopia, SHINE, and TerThera.

• Listed on the Australian Stock Exchange (RAD) and NASDAQ (RADX) since December last year, with board and management holding 9%.

• Operations span the U.S., U.K., and Australia, with a growing team supporting clinical and preclinical activities.

Clinical and preclinical highlights

• PD-L1 nanobody radiotherapy is first-in-class, showing rapid renal clearance and strong tumor targeting in imaging studies.

• HER2-targeted nanobody addresses relapsed patients post-antibody therapy, with broad applicability across multiple tumor types.

• RAD-101 imaging agent detects brain metastases from various primaries, outperforming standard MRI and moving toward a registrational phase III study in 2025.

• Preclinical RV01 (B7-H3) shows potential for tumor vaccination effect in animal models, with clinical trials starting in 2024.

• KLK3-targeted therapy for prostate cancer uses terbium-161, offering specificity post-Pluvicto and aiming for clinical entry by 2026.