RadioPharm Theranostics

What RadioPharm Theranostics does

RadioPharm Theranostics is a clinical-stage Australian biotechnology company developing a portfolio of targeted radiopharmaceuticals for both diagnostic imaging and therapeutic applications in oncology. The company is headquartered in Sydney with operations in Australia and the United States, listed on the ASX (RAD) and NASDAQ (RADX), and was founded in 2021 with an 11-50 employee footprint and a market capitalization of approximately $49 million as of June 2026. Its pipeline comprises four clinical-stage programs and one first-in-class candidate: RAD 101, a Fluorine-18 radiolabeled PET imaging agent targeting fatty acid synthase (FASN) for distinguishing recurrent disease from treatment effect in brain metastases (Phase 2b, FDA Fast Track Designation, 90-92% MRI concordance); RAD 202, a Lutetium-177-conjugated HER2-targeting nanobody for HER2-positive solid tumors (Phase 1); RAD 204, a PD-L1-targeted therapeutic for solid tumors (Phase 1); RAD 402, a Terbium-161-labeled KLK3 monoclonal antibody for advanced prostate cancer beyond PSMA-based therapies (Phase 1); and BetaBart/RV-01, a Lutetium-177-conjugated antibody targeting the B7-H3 4Ig isoform developed with MD Anderson Cancer Center via the Radiopharm Ventures joint venture (Phase 1/2a, first systemic radio-theranostic against B7-H3).

The company's business model is pre-commercial and centered on advancing a multi-isotope theranostic platform (Lutetium-177, Terbium-161, Fluorine-18) through clinical development toward eventual licensing, royalty, or direct commercialization revenue. Capital sources to date include a A$1.9 million R&D tax advance from Radium Capital, an A$18 million strategic investment from Lantheus Holdings (which built a 12.16% stake by January 2025 and contributed two preclinical assets), and an A$35 million placement plus A$5 million Share Purchase Plan completed in October 2025, leaving a cash position of approximately A$59 million and runway into 2027. The go-to-market model relies on tier-1 manufacturing and distribution partnerships, including Siemens Healthineers for RAD 101 supply to U.S. Phase 3 and AtomVie Global Radiopharma for GMP manufacturing of BetaBart, with clinical operations across Australian and U.S. trial sites. Customer-facing segments are oncologists, cancer treatment centers, and neuro-oncology specialists treating solid tumors including brain metastases, breast, lung, prostate, colorectal, and pancreatic cancers.

Name

RadioPharm Theranostics

Legal name

Radiopharm Theranostics Limited

Website

https://radiopharmtheranostics.com

Company type

Public

Founded year

2021

Operating status

Operating

Headcount range

11–50 employees

Short description

RadioPharm Theranostics is a clinical-stage Australian radiopharmaceutical company developing targeted diagnostic and therapeutic radiopharmaceuticals (Lu-177, Tb-161, F-18) for solid tumors including brain metastases, breast, and prostate cancers.

Ownership category

akta.pro rank

Product category

Radiopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), In-Vitro Diagnostic Substance Manufacturing (325413), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Theranostic Radiopharmaceutical Platforms (Paired Dx/Tx) (HLAIAGAC)

akta.pro secondary industries

Therapeutic Radiopharmaceuticals (Radioligand/Targeted Radionuclide Therapy) (HLAIAGAB), Diagnostic Radiopharmaceuticals (SPECT/PET Tracers) (HLAIAGAA)

Keywords

• Radiopharmaceutical theranostics
• Cancer diagnostic imaging
• Targeted radioisotope therapy
• Clinical-stage oncology drugs
• PET imaging agents

Headquarters

HQ city

Carlton South

HQ country

Australia

HQ region

Oceania

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Supply Chain, Operations, Marketing or Sales

Revenue model

1. Radiopharmaceutical Drug Development: Clinical-stage company developing proprietary radiopharmaceutical pipeline for cancer imaging and therapy. No current commercial revenue. Revenue expected upon FDA approval and commercialization of pipeline products.
2. Partnership Revenue (Future): Siemens Healthineers partnership for manufacturing and distribution of RAD101 may generate revenue through supply agreements and milestone payments upon successful commercialization.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels4 records

Core offering

RadioPharm Theranostics is a clinical-stage biotechnology company developing a portfolio of targeted radiopharmaceutical products for both diagnostic imaging (PET imaging agents using Fluorine-18) and therapeutic applications (using Lutetium-177 and Terbium-161 radioisotopes conjugated to antibodies and nanobodies). The pipeline targets multiple solid tumor types including brain metastases, HER2-positive cancers, prostate cancer, and PD-L1-positive tumors through novel antigen targeting approaches (B7-H3, FASN, KLK3). Products are distributed via manufacturing partnerships with Siemens Healthineers and AtomVie Global Radiopharma for clinical trial supply.

Product overview

RadioPharm Theranostics is a clinical-stage biotechnology company developing a portfolio of targeted radiopharmaceutical products for both diagnostic imaging and therapeutic applications in oncology. The company's pipeline includes RAD 101 (F-18 PET imaging agent for brain metastases diagnosis), RAD 202 (177Lu HER2-targeted nanobody for solid tumors), RAD 204 (PD-L1-targeted therapeutic), RAD 402 (Tb-161 KLK3 monoclonal antibody for prostate cancer), and BetaBart/RV-01 (177Lu B7-H3 antibody for solid tumors). These radiopharmaceutical candidates utilize various radioisotopes including Lutetium-177, Terbium-161, and Fluorine-18 to enable both diagnostic imaging and targeted radiotherapy across multiple cancer types.

Differentiator

Problem solved

Functional benefit

Products and services

• RAD 101 Fluorine-18 radiolabeled PET imaging agent targeting fatty acid synthase (FASN) for diagnosis of brain metastases. Designed for cancer treatment centers, oncology practices, and neuro-oncology specialists who need to distinguish recurrent brain metastases from treatment effect. Currently in Phase 2b imaging trial with 90% MRI concordance and FDA Fast Track Designation.
• RAD 202 HER2-targeted nanobody radiopharmaceutical conjugated with Lutetium-177 (177Lu-HER2 Nanobody) for treatment of HER2-positive solid tumors including breast and urothelial cancers. Currently in Phase 1 clinical trials with positive safety profile at 30 mCi dosing.
• RAD 204 PD-L1-targeted radiopharmaceutical for PD-L1-positive solid tumors. Currently in Phase 1 clinical trials.
• RAD 402 Monoclonal antibody targeting KLK3 (prostate-specific antigen) radiolabeled with Terbium-161 for advanced prostate cancer treatment. Uses Terbium-161 for enhanced therapeutic effect with minimal bone and marrow uptake. Currently in Phase 1 clinical trials in Australia.
• BetaBart (RV-01 / 177Lu-BetaBart) First-in-class Lutetium-177 conjugated monoclonal antibody (177Lu-BetaBart) targeting the 4Ig isoform of B7-H3 protein for multiple solid tumor types. Developed through Radiopharm Ventures joint venture with MD Anderson Cancer Center. Currently in Phase 1/2a clinical trial.

Quantifiable outcome

• 90% MRI concordance in Phase 2b brain metastases imaging trial
• +3 more outcomes

Named customers1 record

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Three partnerships are on record, tiered core.

• Siemens HealthineerscoreTechnology or Integration · 8 April 2026Supply agreement for manufacturing and distribution of RAD101, a novel Fluorine-18 radiolabeled PET imaging agent for diagnosing recurrent brain metastases. Siemens will manufacture and distribute radiolabeled RAD101 doses for Phase 3 trial in the U.S., supporting an addressable market of over 300,000 individuals annually in the U.S.
• AtomVie Global RadiopharmacoreTechnology or Integration · 24 February 2026GMP manufacturing and distribution partner for 177Lu-BetaBart (RV-01) Phase 1/2a clinical study. Developed and qualified radiolabeling process and analytical methods that expedited IND filing. Supplied first patient dose for the trial.
• MD Anderson Cancer Center (Radiopharm Ventures)coreStrategic or Co-development Partner · 12 January 2025Joint venture (Radiopharm Ventures, LLC) for developing radiopharmaceutical cancer treatments. Radiopharm increased stake from 75% to 87.5%. Lead candidate BetaBart received FDA IND clearance in July 2025. First clinical study globally targeting B7-H3 with a systemic radiopharmaceutical. BetaBart uses novel antibody developed at MD Anderson targeting 4Ig isoform of B7-H3 protein.

Scale indicators9 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Telix Pharmaceuticals: Australian-headquartered clinical and commercial radiopharmaceutical company with a portfolio of diagnostic and therapeutic agents in oncology (Illuccix for prostate cancer imaging). Most direct geographic and strategic peer to Radiopharm Theranostics, both targeting the same theranostic oncology opportunity.
• ITM Isotope Technologies Munich SE: Germany-based radiopharmaceutical company developing targeted radionuclide therapies and diagnostics across oncology indications. Comparable in being a clinical-to-commercial radiopharma player with a platform spanning therapeutic and diagnostic isotopes.
• Fusion Pharmaceuticals: Clinical-stage radioconjugate developer using alpha-emitting isotopes (actinium-225) for cancer treatment, acquired by AstraZeneca in 2024. Closely comparable clinical-stage platform play with similar mechanism focus and target indications to Radiopharm's BetaBart and RAD programs.
• Point Biopharma: Clinical-stage radiopharmaceutical company developing PSMA-targeted therapies for prostate cancer (PNT2002), acquired by Eli Lilly in 2023. Direct comparable in clinical-stage radioligand therapy development and exit via strategic acquisition.
• Curium Pharma: Global nuclear medicine company manufacturing and distributing diagnostic radiopharmaceuticals (PET/SPECT tracers) and selected therapeutic radiopharmaceuticals. Closely comparable to Radiopharm's diagnostic imaging business via RAD 101 and partnership model.
• Actinium Pharmaceuticals: Clinical-stage radiopharmaceutical company developing antibody-radionuclide conjugates using actinium-225 (alpha emitter) for hematologic cancers and solid tumors. Comparable clinical-stage platform with similar theranostic and targeted radiotherapy approach.

Broad incumbents

• Lantheus Holdings: U.S. radiopharmaceutical leader and Radiopharm's largest strategic investor (12.16% stake). Operates a commercial portfolio including PNT2002 (PSMA diagnostics) and is a major acquirer in the space, making it both a collaborator and a direct strategic comparator.
• Novartis (Radioligand Therapy franchise): Owns Lutathera and Pluvicto — the first commercial radioligand therapies for neuroendocrine tumors and PSMA-positive prostate cancer. Represents the dominant incumbent in therapeutic radiopharmaceuticals against which all clinical-stage peers benchmark.
• Bayer (Radiopharmaceuticals division): Owns Xofigo (radium-223), the first commercial alpha-emitting radiopharmaceutical for prostate cancer bone metastases. Major incumbent with established radiopharma infrastructure that competes for the same oncology indications Radiopharm targets.
• GE HealthCare: Operates a substantial radiopharmaceutical and molecular imaging business (PET tracers, SPECT agents) and supplies related imaging equipment. Comparable as a broad incumbent with both diagnostic radiopharma products and the manufacturing/distribution infrastructure Radiopharm depends on.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/TeamRadioPharm

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries2 records

Funding overview

Funding rounds4 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about RadioPharm Theranostics