# EDGAR Filing Document

**Accession Number:** 0001949257
**File Stem:** 0001213900-25-056874
**Filing Date:** 2025-6
**Character Count:** 9169
**Document Hash:** 49746383fdf1ee08a316da95d47c21df
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-25-056874.hdr.sgml**: 20250624

**ACCESSION NUMBER**: 0001213900-25-056874

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 3

**CONFORMED PERIOD OF REPORT**: 20250624

**FILED AS OF DATE**: 20250624

**DATE AS OF CHANGE**: 20250623

**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:** 251066509

**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 June 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 June 24, 2025 titled:

- "RAD and Cyclotek Sign Supply Agreement for 161Tb-KLK3-mAb"

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**

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| | |
|:---|:---|
| **Exhibit** <br> **Number** | **Description** |
| 99.1 | <u>[RAD and Cyclotek Sign Supply Agreement for 161Tb-KLK3-mAb](ea024665201ex99-1_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: June 24, 2025 | By: | /s/ Phillip Hains |
|  |  | Phillip Hains |
|  |  | Company Secretary |

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## Exhibit 99.1

**Exhibit 99.1**

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

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**Radiopharm Theranostics and Cyclotek Sign Clinical Supply Agreement for**

**<sup>161</sup>Tb-KLK3-mAb Phase I Clinical Trial in Australia**

 

*RAD 402 preclinical data package complete; demonstrates safety and promising biodistribution profile*

 

*Ethics approval and Phase 1 clinical trial start in prostate cancer anticipated in 2H 2025*

Sydney, Australia and Bundoora, Australia– 24<sup>th</sup> June 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 the signing of a supply agreement with Cyclotek to radiolabel RAD 402 with Terbium-161 (<sup>161</sup>Tb) in Australia, which supports the initiation of a Phase 1 clinical trial. RAD 402 is an anti-Kallikrein Related Peptidase 3 (KLK3) monoclonal antibody radiotherapeutic labelled with the radionuclide <sup>161</sup>Tb for treatment of prostate cancer.

"This agreement is an important milestone for the development of RAD 402 and is the last step needed to submit for ethics approval and begin our Phase 1 clinical trial in prostate cancer," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "We are very appreciative of the entire team at Cyclotek for their support as we work together to bring an innovative new treatment option to patients battling prostate cancer."

RAD 402 has been designed to target KLK3, which is highly expressed in the prostate, with very limited/no expression in other tissues and organs. Compared to <sup>177</sup>Lu, <sup>161</sup>Tb emits additional Auger and conversion electrons alongside its β-radiation, which can lead to potentially improved antitumoral therapeutic efficacy. <sup>161</sup>Tb-RAD 402 is the first company-sponsored Phase I trial in prostate cancer using <sup>161</sup>Tb.

Under the agreement, Cyclotek will produce and provide doses of <sup>161</sup>Tb-labeled RAD 402 to support Radiopharm's upcoming Phase 1 clinical trial in prostate cancer in Australia. The Phase 1 trial is anticipated to start in the second half of 2025.

"We are pleased to partner with Radiopharm to facilitate the development of their innovative radiotherapeutic, RAD 402, for the treatment of prostate cancer," stated Greg Santamaria, CEO of Cyclotek. "Our mission at Cyclotek is to improve the accessibility of radiopharmaceuticals to enhance patient outcomes. As we support the Radiopharm Theranostics team, we look forward to RAD402 advancing toward market approval while demonstrating the value radiotherapeutics can bring to patients."

**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.

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

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

---

**About Cyclotek**

Cyclotek is the leading radiopharmaceutical manufacturer in Australia and New Zealand. We manufacture diagnostic and therapeutic radiopharmaceuticals for supply into clinical trials and for clinical use.

At Cyclotek, we are committed to improving patient outcomes by making diagnostic and therapeutic radiopharmaceuticals accessible. PET tracers provide patient specific insights into their disease state, leading to earlier diagnosis, more accurate assessment of disease extent, and improved treatment planning and monitoring. Paired with radionuclide therapies, these products offer a comprehensive, non-invasive disease management option.

Our dedication to innovation drives our continuous development of new radiopharmaceuticals.

This helps provide our customers a growing range of tools that enhance the understanding of each patient's health, contributing to more cost-effective healthcare solutions.

At Cyclotek, we are not just a manufacturer, we are a hub of innovation. Our commitment to quality, safety, supply and customer service ensures that healthcare providers have the best tools available for precise diagnostics and therapies, fostering improved patient care.

Through our unwavering focus on excellence, we aim to make a lasting, positive impact on healthcare.

**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**