RadioPharm Theranostics
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.
- Company typePublic
- Founded2021
- HeadquartersCarlton South, Australia
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
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.
RadioPharm Theranostics firmographics
Firmographics- 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
RadioPharm Theranostics industry classification
Industry- 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
Where RadioPharm Theranostics is headquartered
LocationHeadquarters
- HQ city
- Carlton South
- HQ country
- Australia
- HQ region
- Oceania
Offices1 record
Markets served
RadioPharm Theranostics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Supply Chain, Operations, Marketing or Sales
Revenue model
- 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.
- 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
RadioPharm Theranostics product offering
Product offeringCore 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
Companies that use RadioPharm Theranostics
Customer profileNamed customers1 record
Segments4 records
Ideal customer profiles3 records
RadioPharm Theranostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
RadioPharm Theranostics partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered core.
- Siemens HealthineerscoreSupply 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 RadiopharmacoreGMP 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)coreJoint 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
RadioPharm Theranostics competitors and assessment
Company assessmentDirect 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
RadioPharm Theranostics social profiles
Digital presenceRadioPharm Theranostics compliance and trust
Trust signalCompliance1 record
RadioPharm Theranostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
RadioPharm Theranostics leadership team
Management profileNumber of profiles
Profiles3 records
RadioPharm Theranostics subsidiaries and ownership
Company hierarchySubsidiaries2 records
RadioPharm Theranostics funding detail
Funding detailFunding overview
Funding rounds4 records
Investors2 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
RadioPharm Theranostics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about RadioPharm Theranostics
What does RadioPharm Theranostics do?
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.
Is RadioPharm Theranostics a public or private company?
RadioPharm Theranostics is a public company. It is classified as public and is currently operating.
When was RadioPharm Theranostics founded?
RadioPharm Theranostics was founded in 2021. It employs 11 to 50 people.
Where is RadioPharm Theranostics based?
RadioPharm Theranostics is headquartered in Carlton South, Australia, in the Oceania region.
How does RadioPharm Theranostics make money?
Two revenue lines are on record. Radiopharmaceutical Drug Development is the primary driver. The others are partnership Revenue (Future).
Who are RadioPharm Theranostics's main competitors?
Direct peers on record are Telix Pharmaceuticals, ITM Isotope Technologies Munich SE, Fusion Pharmaceuticals, Point Biopharma, Curium Pharma and Actinium Pharmaceuticals. Broad incumbents are Lantheus Holdings, Novartis (Radioligand Therapy franchise), Bayer (Radiopharmaceuticals division) and GE HealthCare.
Does RadioPharm Theranostics have an API?
No public API is recorded for RadioPharm Theranostics.
What industry is RadioPharm Theranostics in?
RadioPharm Theranostics's product category is Radiopharmaceuticals. Its primary akta.pro industry code is HLAIAGAC, Theranostic Radiopharmaceutical Platforms (Paired Dx/Tx), with a secondary code of HLAIAGAB, Therapeutic Radiopharmaceuticals (Radioligand/Targeted Radionuclide Therapy). Its NAICS code is 325414 and its SIC code is 2834.