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6-K 1 ea0257333-6k_radio.htm REPORT OF FOREIGN PRIVATE ISSUER

 

 

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 September 2025

 

Commission File Number: 001-41621

 

RADIOPHARM THERANOSTICS LIMITED

(Name of Registrant)

 

Level 3, 62 Lygon Street, Carlton South, Victoria, 3053, Australia

(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 (the “Company”) published one announcement (the “Public Notice”) to the Australian Securities Exchange on September 15, 2025 titled:

 

 

 


 

RADIOPHARM THERANOSTICS LIMITED

 

EXPLANATORY NOTE

 

 

  -   “Pivalate (Brain Mets) key opinion leader webinar”  

 

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.

 

1


 

EXHIBITS

 

Exhibit
Number
  Description
99.1   Pivalate (Brain Mets) key opinion leader webinar

 

2


 

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
     
Date: September 15, 2025 By: /s/ Phillip Hains
    Phillip Hains
    Company Secretary

 

 

3

 

 

EX-99.1 2 ea025733301ex99-1_radio.htm PIVALATE (BRAIN METS) KEY OPINION LEADER WEBINAR

Exhibit 99.1

 

ASX ANNOUNCEMENT
15 SEPTEMBER 2025

 

RADIOPHARM TO HOST PIVALATE (BRAIN METS) KEY OPINION LEADER WEBINAR

 

Sydney, Australia – 15 September 2025 – Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a developer of a world-class platform of radiopharmaceutical products for both diagnostic and therapeutic uses, is pleased to advise that it is hosting a key opinion leader webinar to discuss Pivalate and the detection of relapsed brain metastases from solid tumors.

 

WEBINAR DETAILS

 

10:30am AEST – Thursday 25 September

 

Click here to register

 

TIME

TOPICS SPEAKERS
10:30-10:35am Webinar Introduction Dr Dimitris Voliotis (RAD)
10:35-10:50am Challenges, unmet needs for the radiographic detection of relapsed brain metastases from solid tumors and consequences for therapeutic approaches Dr Ramji Rajendran (Alexian Brothers Medical Center, Chicago, IL)
10:50-11:00am Background of Pivalate (18F-FPIA) as an imaging agent in patients with brain metastases from solid tumors Dr Dimitris Voliotis (RAD)
11:00-11:10am Pivalate’s path to approval and its clinical and commercial potential Riccardo Canevari (RAD)
11:10-11:25am Q&A and closing remarks Dr Dimitris Voliotis (RAD)

 

F18-Pivalate is a novel radiotracer being developed for the detection, characterisation, and progression monitoring of glioblastoma and relapsed brain metastases. It works by targeting fatty acid synthase, which is selectively overexpressed by tumors but not in normal brain cells. This gives Pivalate a unique mechanism of action and a potentially transformational approach in the imaging and monitoring of brain metastases. Approximately 20-40% of patients with cancer will develop metastatic cancer to the brain during the course of their illness, making more accurate detection methods essential. Currently available technologies, such as FDG PET and MRI, have significant limitations in their ability to differentiate between necrosis, inflammation and true recurrence. F18-Pivalate has been designed to overcome these limitations, offering a more precise and reliable tool for clinicians.

 

Dr Ramji Rajendran

 

Dr Ramji Rajendran is a highly skilled and compassionate radiation oncologist with a unique background in both clinical practice and research. He completed his MD and PhD in a combined program at the University of Illinois at Urbana-Champaign, where his doctoral research focused on molecular mechanisms and cell biology of hormone-dependent cancers such as breast and prostate cancer.

 

After completing his residency at the prestigious Hospital of the University of Pennsylvania in Philadelphia, Dr Rajendran has dedicated his career to advancing cancer treatment through radiation oncology. He currently serves as the Medical Director of the Department of Radiation Oncology and Illinois Gamma Knife Center at Ascension Alexian Brothers Medical Center.

 

Dr Rajendran’s expertise spans a wide range of advanced radiation therapy techniques, including IMRT, SBRT, and gamma knife radiosurgery. His research contributions in prostate organ motion, proton radiation therapy, and radiation therapy for breast and thoracic tumors have been presented nationally and internationally.

 

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

 


 

ASX ANNOUNCEMENT
15 SEPTEMBER 2025

 

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 metastases. Learn more at radiopharmtheranostics.com.

 

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

 

For more information:

 

Investors:

 

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

 

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/

 

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