# EDGAR Filing Document

**Accession Number:** 0001949257
**File Stem:** 0001213900-25-067889
**Filing Date:** 2025-7
**Character Count:** 8992
**Document Hash:** 641d656b77e903cb4640df1d46f0053a
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-25-067889.hdr.sgml**: 20250728

**ACCESSION NUMBER**: 0001213900-25-067889

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 3

**CONFORMED PERIOD OF REPORT**: 20250728

**FILED AS OF DATE**: 20250728

**DATE AS OF CHANGE**: 20250728

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Radiopharm Theranostics Ltd
- **CENTRAL INDEX KEY:** 0001949257
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** C3
- **FISCAL YEAR END:** 0630

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-41621
- **FILM NUMBER:** 251152956

**BUSINESS ADDRESS:**
- **STREET 1:** LEVEL 3, 62 LYGON STREET
- **CITY:** CARLTON VIC
- **STATE:** C3
- **ZIP:** 3053
- **BUSINESS PHONE:** 61 3 9824 5254

**MAIL ADDRESS:**
- **STREET 1:** LEVEL 3, 62 LYGON STREET
- **CITY:** CARLTON VIC
- **STATE:** C3
- **ZIP:** 3053

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**Form 6-K**

**REPORT OF FOREIGN PRIVATE ISSUER**

**PURSUANT TO RULE 13a-16 OR 15d-16 UNDER**

**THE SECURITIES EXCHANGE ACT OF 1934**

For the Month of July 2025

Commission File Number: 001-41621

**<u>RADIOPHARM THERANOSTICS LIMITED</u>**

(Name of Registrant)

**<u>Level 3, 62 Lygon Street, Carlton South, Victoria, 3053, Australia</u>**

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes ☐ No ☒

If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-

**RADIOPHARM THERANOSTICS LIMITED**

**<u>EXPLANATORY NOTE</u>**

Radiopharm Theranostics Limited (the "Company") published one announcement (the "Public Notice") to the Australian Securities Exchange on July 28, 2025 titled:

- "RAD receives IND approval from US FDA for Betabart (RV-01)"

A copy of the Public Notice is attached as an exhibit to this report on Form 6-K.

This report on Form 6-K (including the exhibit hereto) shall not be deemed to be "filed" for purposes of the Securities Exchange Act of 1934, as amended (the "Exchange Act") and shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

**EXHIBITS**

---

| | |
|:---|:---|
| **Exhibit** <br> **Number** | **Description** |
| 99.1 | <u>[RAD receives IND approval from US FDA for Betabart (RV-01)](ea025038201ex99-1_radio.htm)</u> |

---

**SIGNATURE**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

---

| | | |
|:---|:---|:---|
|  | **RADIOPHARM THERANOSTICS LIMITED** | **RADIOPHARM THERANOSTICS LIMITED** |
| Date: July 28, 2025 | By: | /s/ Phillip Hains |
|  |  | Phillip Hains |
|  |  | Company Secretary |

---

## Exhibit 99.1

**Exhibit 99.1**

---

| | |
|:---|:---|
| **ASX ANNOUNCEMENT** | ![](ex99-1_001.jpg) |

---

**Radiopharm Theranostics Receives IND approval from US FDA to Initiate Phase I Therapeutic Clinical Study to target B7H3 with Betabart (RV-01)**

 

*Lu177-B7H3 monoclonal antibody is first in class targeted radiopharmaceutical in development against the 4lg subtype of B7-H3*

 

*On track to initiate first-in-human study of RV-01 in solid tumors in 4Q25*

Sydney, Australia – 28 July 2025 – 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 need, today announced that the U.S. Food and Drug Administration (FDA) has provided clearance of the Company's Investigational New Drug (IND) application for Betabart (RV-01), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7H3 that is highly expressed in tumors and not in healthy tissues.

"FDA clearance to initiate our first-in-human Phase 1 clinical trial of RV-01 represents a major milestone for Radiopharm Theranostics and our joint venture with MD Anderson Cancer Center," said Riccardo Canevari, CEO and Managing Director. "RV-01 is the first monoclonal antibody developed through this collaboration, and we believe it has the potential to become a highly differentiated radiopharmaceutical for patients with aggressive solid tumors. We are excited to advance this program into the clinic and anticipate dosing the first patients later this year."

"Recent reported preclinical studies demonstrated that RV-01 exhibits hepatic clearance, allowing the isotope sufficient time to effectively target tumors while potentially minimizing adverse effects such as hematological toxicities. Unlike peptides or small molecules, monoclonal antibodies are primarily cleared by the liver—an organ known for its radio-resistance. This characteristic, combined with the shortened half-life of RV-01 and the strong affinity for the target make this agent stand out and may offer a significant advantage not just over other monoclonal antibodies but also targeted radiotherapeutics with renal excretion pathway, the latter of which are often associated with higher risk of radiopharmaceutical-induced kidney toxicity," noted Dimitris Voliotis, M.D., Chief Medical Officer of Radiopharm Theranostics.

"The high affinity and selectivity of RV-01 for the 4Ig isoform of B7H3 allows the antibody to bypass the soluble 2Ig isoform in the blood, boost binding of the radiopharmaceutical to tumor targets and avoid the formation of immune complexes in circulation," noted David Piwnica-Worms, M.D., Ph.D., Professor, MD Anderson Cancer Center, and scientific co-founder of Radiopharm Ventures.

B7-H3 is an immune checkpoint molecule that is overexpressed across several tumor types and has emerged as a compelling target for antibody-based cancer immunotherapy. Deregulated B7-H3 expression is consistently correlated with enhanced tumor aggressiveness and poor clinical outcomes. Targeting the 4 Ig isoform of B7-H3 with a selective radioligand therapy may offer a novel strategy for treating refractory or high-risk tumors.

**About RV-01**

RV-01 is the first radiopharmaceutical therapeutic agent developed by Radiopharm Ventures, the Joint Venture formed between Radiopharm Theranostics and MD Anderson Cancer Center (MDACC). RV-01 is a 177Lutetium-conjugated therapeutic that targets B7-H3, an immune checkpoint molecule that is overexpressed in several tumor types. Multiple preclinical studies with RV-01 have shown tumor shrinkage and prolonged survival in animals treated with the radiotherapeutic agent. RV-01 has received IND-clearance from the U.S. FDA and plans to initiate a first-In-human Phase 1 study in the second half of 2025.

**Radiopharm Theranostics Limited<br> Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia<br> ABN: 57 647 877 889**

---

| | |
|:---|:---|
| **ASX ANNOUNCEMENT** | ![](ex99-1_001.jpg) |

---

**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 three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain. Learn more at radiopharmtheranostics.com.

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

**For more information:**

 **Investors:**

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

Anne Marie Fields

Precision AQ (formerly Stern IR)

E: annemarie.fields@precisionaq.com

 **Media:**

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

**Follow Radiopharm Theranostics:** 

Website – https://radiopharmtheranostics.com/<br> X – https://x.com/TeamRadiopharm<br> LinkedIn – https://www.linkedin.com/company/radiopharm-theranostics/<br> InvestorHub – https://investorhub.radiopharmtheranostics.com/

**Radiopharm Theranostics Limited<br> Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia<br> ABN: 57 647 877 889**