RAD Increases Ownership in Radiopharm Ventures to 87.5%

Radiopharm Theranostics (NASDAQ: RADX) increased its ownership in Radiopharm Ventures, LLC (a joint venture with MD Anderson) from 75% to 87.5% as the JV advances its oncology radiopharmaceutical pipeline.

Rhea-AI Summary

Radiopharm Theranostics (NASDAQ: RADX) increased its ownership in Radiopharm Ventures, LLC (a joint venture with MD Anderson) from 75% to 87.5% as the JV advances its oncology radiopharmaceutical pipeline. The lead candidate, Betabart (RV01), a 177Lu-labelled monoclonal antibody targeting B7H3, received FDA IND clearance in July 2025 and is expected to dose its first patient in a Phase I therapeutic study in Q1 2026. Two additional preclinical assets reported early positive results and are moving toward final candidate selection in 2026. The JV combines MD Anderson’s antigen discovery and imaging expertise with Radiopharm’s therapeutic development capabilities.

Positive

• Ownership increased to 87.5% in Radiopharm Ventures
• Betabart (RV01) received FDA IND clearance (July 2025)
• First patient dosing for Phase I expected in Q1 2026
• Two preclinical assets moving to final candidate selection in 2026

Market Context

This announcement highlights Radiopharm’s increased stake to 87.5% in its MD Anderson JV and the adv...

Analysis

This announcement highlights Radiopharm’s increased stake to 87.5% in its MD Anderson JV and the advancement of Betabart, which has FDA IND clearance with first dosing targeted for Q1 2026. Viewed alongside recent strong RAD101 data and an effective $50,000,000 shelf registration, the news underscores both expanding clinical optionality and ongoing financing flexibility. Investors may watch future trial readouts, use of the shelf, and additional JV developments as key markers of execution.

Key Figures

Radiopharm Ventures stake: 87.5% Prior JV ownership: 75% RAD101 endpoint rate: 92% +5 more

Radiopharm Ventures stake

87.5%

Ownership in Radiopharm Ventures increased from 75% to 87.5%

Prior JV ownership

75%

Previous Radiopharm stake in Radiopharm Ventures JV

RAD101 endpoint rate

92%

Patients achieving primary endpoint in RAD101 Phase 2b interim data (11/12 patients)

RAD101 concordant patients

11/12

RAD101 PET imaging concordance with MRI in brain metastases

Estimated RAD101 market

$500M+ annually

Independent U.S. market opportunity estimate for RAD101 imaging

Shelf registration size

$50,000,000

Maximum ADSs and warrants that may be offered under Form F-3 shelf

ATM program size

$22,400,000

ADSs that may be issued via sales agreement prospectus under shelf

Private placement proceeds

A$35 million

October 2025 private placement of 1,166,666,667 ordinary shares

Historical Context

5 past events · Latest: Dec 15

5 events

1. Dec 15

   Clinical trial data

   24h Move

   +149.5%

   RAD101 Phase 2b interim data showed 92% concordance and strong imaging uptake.

2. Nov 18

   Trial initiation ok

   24h Move

   -4.8%

   Approval to initiate Phase 1 RAD402 trial in advanced prostate cancer.

3. Nov 17

   Enrollment update

   24h Move

   +2.6%

   RAD101 Phase 2b brain metastases trial reached 50% enrollment with early uptake data.

4. Nov 12

   Dose escalation

   24h Move

   +2.0%

   DSMC cleared escalation to 90 mCi in 177Lu-RAD204 Phase 0/1 basket trial.

5. Oct 20

   Multi-program update

   24h Move

   -19.8%

   Positive early data across four radiopharmaceutical programs and 2025–2026 milestones.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

monoclonal antibody, b7h3, immune checkpoint protein, investigational new drug, +4 more

8 terms

monoclonal antibody medical

"Leading candidate Betabart, a monoclonal antibody targeting B7H3, has received FDA IND..."

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

b7h3 medical

"Betabart, a monoclonal antibody targeting B7H3, has received FDA IND clearance..."

B7-H3 (also called CD276) is a protein found on the surface of some healthy and cancerous cells that helps regulate the immune system’s response. For investors, it matters because therapies or diagnostics that target B7-H3 aim to unmask cancer cells or deliver drugs directly to them—similar to removing camouflage or attaching a homing beacon—and success can drive significant commercial value and affect clinical and regulatory risk for companies developing these products.

immune checkpoint protein medical

"B7H3 is an immune checkpoint protein that is very infrequently seen in healthy cells..."

An immune checkpoint protein is a molecule on immune or other cells that acts like a biological brake or accelerator, helping turn immune responses up or down to prevent damage to healthy tissue. For investors, these proteins are important because drugs that block or activate them can dramatically change treatment outcomes for diseases such as cancer or autoimmune disorders, so progress in targeting checkpoints often signals significant clinical and commercial value.

investigational new drug regulatory

"Betabart... successfully received Investigational New Drug clearance in July 2025..."

An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.

phase i therapeutic trial medical

"FDA IND clearance for a Phase I therapeutic trial in multiple solid tumors..."

The first stage of testing a new drug or treatment in people, carried out to check safety, find the right dose, and look for any early signs it might work. Think of it as a controlled test drive by a small group to make sure the therapy is not harmful and to guide later, larger trials; for investors it marks a major early risk milestone that can change a company’s value and timeline for potential approval.

radiopharmaceutical medical

"First clinical trial globally targeting B7H3 with a systemic radiopharmaceutical..."

A radiopharmaceutical is a special type of medicine that contains a small amount of radioactive material, used primarily for medical imaging or treatment. It can be thought of as a tiny, targeted signal that helps doctors see inside the body or deliver therapy directly to affected areas. For investors, understanding radiopharmaceuticals is important because they represent a growing field within healthcare, driven by advancements in diagnostics and personalized treatments.

american depositary shares financial

"has filed a Form F-3 to register the resale by existing investors of up to 940,000 American Depositary Shares..."

American depositary shares (ADSs) are a way for investors in the United States to buy shares of foreign companies without dealing with international markets directly. They represent ownership in a foreign company's stock and are traded on U.S. stock exchanges, making it easier for American investors to buy, sell, and own parts of companies from around the world.

foreign private issuer regulatory

"Radiopharm highlights that it is both an emerging growth company and a foreign private issuer..."

A foreign private issuer is a company organized outside the United States that meets tests showing it is primarily foreign-controlled and therefore qualifies for a different set of U.S. reporting rules. For investors, that means the company files less frequent or differently formatted disclosures with U.S. regulators and may follow home-country accounting and governance practices, so buying its stock is like dining at a well-reviewed restaurant that follows its home kitchen’s rules instead of the local menu — you get access but should check what standards apply.

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AI-generated analysis. How Rhea-AI works. Not financial advice.

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Add on Google Not now

• Radiopharm Ventures, LLC, is a joint venture created in 2022 between MD Anderson Cancer Center and Radiopharm Theranostics
• Leading candidate Betabart, a monoclonal antibody targeting B7H3, has received FDA IND clearance for a Phase I therapeutic trial in multiple solid tumors expected to dose the first patient in Q1 2026
• First clinical trial globally targeting B7H3 with a systemic radiopharmaceutical
  
• Two additional preclinical Radiopharm Ventures’ assets show early positive results with plans to move to final candidate selection in 2026

SYDNEY, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, Nasdaq: RADX, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical needs, is pleased to announce that it has increased its ownership stake in Radiopharm Ventures, LLC, a joint venture created with The University of Texas MD Anderson Cancer Center (MDACC), from 75% to 87.5%.

Radiopharm’s decision to increase the ownership percentage comes as the joint venture continues to show promising progress in its cancer therapeutic pipeline, including the advancement of its leading B7H3 candidate and other preclinical assets.

B7H3 is an immune checkpoint protein that is very infrequently seen in healthy cells but is consistently overexpressed in the majority of cancer tissues. High expression of B7H3 in cancer is associated with greater tumor size and lymphatic invasion.

Riccardo Canevari, CEO & Managing Director of Radiopharm, commented: "We are very encouraged by the progress to date within Radiopharm Ventures. Now is an exciting time to increase our ownership in the joint venture, as we will soon have first-in-human results of Betabart (RV01) from our dose escalating therapeutic Phase I study. We remain confident in the potential value of this program and its potential to benefit patients battling a multitude of solid tumor cancers.”

The lead candidate monoclonal antibody (mAb) radiolabelled with ¹⁷⁷Lu, Betabart, targets B7H3 and successfully received Investigational New Drug clearance in July 2025 by the U.S. Food and Drug Administration. The first patient in this Phase 1 therapeutic trial is expected to be dosed in Q1 2026, with a number of centers already activated.

Additionally, two other preclinical candidates have demonstrated early positive results and have progressed towards final candidate selection, with potential applications across multiple solid tumor types.

Radiopharm and MDACC launched Radiopharm Ventures, LLC in September 2022 to develop novel radiopharmaceutical products for cancer treatment. The joint venture leverages MD Anderson’s expertise in antigen discovery and molecular imaging alongside Radiopharm’s capabilities in developing targeted radiopharmaceutical therapies.

About Radiopharm Theranostics

Radiopharm Theranostics is a clinical-stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules, and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and four Phase 1 trials in a variety of solid tumor cancers, including lung, breast, and brain metastases. Learn more at radiopharmtheranostics.com.

Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper.

For more information:

Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com

Anne Marie Fields
Precision AQ (Formerly Stern IR)
E: annemarie.fields@precisionaq.com

Paul Hopper
Executive Chairman
P: +61 406 671 515
E: paulhopper@lifescienceportfolio.com

Media
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au

Follow Radiopharm Theranostics:

Website – https://radiopharmtheranostics.com/
Twitter – https://twitter.com/TeamRadiopharm  
Linked In – https://www.linkedin.com/company/radiopharm-theranostics/
InvestorHub – https://investorhub.radiopharmtheranostics.com/

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What stake does Radiopharm Theranostics now hold in Radiopharm Ventures (RADX)?

Radiopharm increased its ownership in Radiopharm Ventures to 87.5% from 75%.

When did Betabart (RV01) receive FDA IND clearance for the Phase I trial (RADX)?

Betabart received FDA IND clearance in July 2025.

When is the first patient expected to be dosed in the Betabart Phase I study (RADX)?

The first patient is expected to be dosed in Q1 2026.

What is Betabart (RV01) targeting in cancer therapy (RADX)?

Betabart is a 177Lu‑labelled monoclonal antibody that targets the immune checkpoint protein B7H3.

What progress do the other Radiopharm Ventures preclinical assets have (RADX)?

Two additional preclinical assets showed early positive results and are progressing toward final candidate selection in 2026.

How does the Radiopharm/MD Anderson joint venture combine expertise (RADX)?

The joint venture pairs MD Anderson’s antigen discovery and molecular imaging capabilities with Radiopharm’s targeted radiopharmaceutical development expertise.