RADX Radiopharm Theranostics Ltd

 

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 December 2024

 

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

 

EXPLANATORY NOTE

 

Radiopharm Theranostics Limited (the “Company”) published two announcements (the “Public Notice”) to the Australian Securities Exchange on December 10, 2024 titled:

 

	-	“Completion of preclinical data package for RAD 402”
	-	“Change of Director’s Interest Notice PH”

 

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 Number		Description
99.1		Completion of preclinical data package for RAD 402
99.2		Change of Director’s Interest Notice PH

 

 

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: December 10, 2024	By:	/s/ Phillip Hains
		Phillip Hains
		Company Secretary

 

 

3

Exhibit 99.1

 

ASX ANNOUNCEMENT 10 DECEMBER 2024

 

Completion of Preclinical Data Package for KLK3-Targeting Radiotherapeutic (RAD 402)

 

●

Successful completion of preclinical studies with 161Tb-labelled RAD 402 demonstrating safety and a promising biodistribution profile.

 

●

Comprehensive preclinical dataset validates the potential of 161Tb-RAD 402 for advancing into First-In-Human therapeutic studies.

 

●

Potential first-in-class, company sponsored trial using Tb161, a next generation isotope with strong therapeutic activity.

 

Sydney, Australia – 10 December 2024 – Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce the completion of a comprehensive preclinical proof-of-concept dataset for its proprietary Kallikrein Related Peptidase 3 (KLK3)-targeting radiotherapeutic, RAD 402.

 

The preclinical toxicology reported positive data, with no observed adverse effects. Biodistribution studies of ¹⁶¹Tb-RAD 402 in mouse xenografts showed high tumor targeting, limited kidney and bone marrow uptake, and a hepatic excretion profile as expected for a monoclonal antibody. The safety findings from the toxicology and biodistribution studies provide a strong rationale for First-In-Human (FiH) clinical studies.

 

GMP manufacturing of RAD 402 and the conjugate are currently ongoing and are expected to be completed in Q1 2025. Radiopharm’s clinical development plans for RAD 402 continue to advance, and the Company is on track to commence the Phase I FiH study in H2 2025.

 

KLK3 is expressed in the prostate, and most adenocarcinomas of the prostate, including their metastases. Prostate Specific Antigen (PSA), a widely used biomarker to detect prostate cancer, is encoded by the KLK3 gene. RAD 402 is an anti-KLK3 monoclonal antibody, labelled with the radionuclide Terbium-161 (Tb-161). Compared to Lutetium-177, Tb-161 emits additional Auger and conversion electrons alongside its β-radiation, with potentially improved antitumoral therapeutic efficacy.

 

“There is an ongoing unmet need for next-generation radiotherapeutisc in advanced prostate cancer,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “RAD 402 has been specifically designed as a next-generation radiotherapeutic with a novel target and isotope, reinforcing its first-in-class potential as a novel treatment option in advanced prostate cancer. We believe that our preclinical data reaffirms our clinical development strategy for RAD 402 and provide translational support for advancing this program into FiH studies.”

 

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

 

 

ASX ANNOUNCEMENT 10 DECEMBER 2024

 

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 has been listed on ASX (RAD) since November 2021. The company has a deep pipeline of highly differentiated molecules spanning peptides, small molecules and monoclonal antibodies for use in cancer, in pre-clinical and clinical stages of development. The pipeline has been built based on the potential to be first-to-market or best-in-class. The clinical program includes one Phase II and two Phase I trials in a variety of solid tumour cancers including brain, lung, breast and pancreas. Learn more at radiopharmtheranostics.com.

 

Authorised 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

 

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

 

 

 

Exhibit 99.2

 

ASX ANNOUNCEMENT 10 DECEMBER 2024

 

Change of Director’s Interest Notice

 

Sydney, Australia – 10 December 2024 – Radiopharm Theranostics Limited (ASX:RAD, NASDAQ:RADX, “Radiopharm” or the “Company”), today announced that Executive Chairman, Mr Paul Hopper announced he has sold 5,000 American Depositary Shares (ADSs) (1,500,000 shares) on market as part of the NASDAQ listing.

 

RAD has approved the sale of a small quantity of Mr Hopper’s shareholding to satisfy the recommendations of the US bankers and lawyers. The transaction was to provide liquidity on the first day of trading of the Company’s equity on Nasdaq.

 

Mr Hopper said, “As the Founder, Executive Chairman and substantial holder in the Company, I remain committed to Radiopharm, and I am very excited about its prospects. I look forward to continuing to drive success for the Company and for its shareholders.”

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

Appendix 3Y

Change of Director’s Interest Notice

 

 

Rule 3.19A.2

 

Appendix 3Y

 

Change of Director’s Interest Notice

 

Information or documents not available now must be given to ASX as soon as available. Information and documents given to ASX become ASX’s property and may be made public.

 

Introduced 30/9/2001.      Amended 01/01/11

 

Name of Entity:	Radiopharm Theranostics Limited (ASX: RAD)
ABN:	57 647 877 889

 

We (the entity) give ASX the following information under listing rule 3.19A.2 and as agent for the director for the purposes of section 205G of the Corporations Act.

 

Name of Director:	Paul Hopper
Date of Last Notice:	18 September 2024

 

Part 1 - Change of director’s relevant interests in securities

 

In the case of a trust, this includes interests in the trust made available by the responsible entity of the trust

 

Note: In the case of a company, interests which come within paragraph (i) of the definition of “notifiable interest of a director” should be disclosed in this part.

 

Direct or Indirect Interest		Direct
Nature of indirect interest (including registered holder) Note: Provide details of the circumstances giving rise to the relevant interest.
Date of change		5 December 2024

No. of securities held prior to change			Shares	Options
		Direct	55,400,000	27,500,000
		Indirect	93,821,428	9,017,518
		Total	149,221,428	36,517,518

Class

American Depositary Shares (ADSs) / (RAD ordinary shares)

Number acquired			Shares	Options
		Direct	-	-
		Indirect	-	-
		Total	-	-

 

 

Appendix 3Y

Change of Director’s Interest Notice

 

 

Number disposed			Shares	Options
		Direct	1,500,000*	-
		Indirect	-	-
		Total	1,500,000*	-
		*5,000 American Depositary Shares (ADSs)

Value/Consideration Note: If consideration is non-cash, provide details and estimated valuation

US$28,000 (equivalent to AU$43,037.20)

No. of securities held after change			Shares	Options
		Direct	53,900,000	27,500,000
		Indirect	93,821,428	9,017,518
		Total	147,721,428	36,517,518

Nature of change Example: on-market trade, off-market trade, exercise of options, issue of securities under dividend reinvestment plan, participation in buy-back

On-market trade

 

Part 2 – Change of director’s interests in contracts

 

Note: In the case of a company, interests which come within paragraph (ii) of the definition of “notifiable interest of a director” should be disclosed in this part.

 

Detail of contract	N/A
Nature of interest	N/A
Name of registered holder (if issued securities)	N/A
Date of change	N/A
No. and class of securities to which interest related prior to change Note: Details are only required for a contract in relation to which the interest has changed	N/A
Interest acquired	N/A
Interest disposed	N/A
Value/Consideration Note: If consideration is non-cash, provide details and an estimated valuation	N/A
Interest after change	N/A

 

 

Appendix 3Y

Change of Director’s Interest Notice

 

 

Part 3 – Closed period

 

Were the interests in the securities or contracts detailed above traded during a +closed period where prior written clearance was required?	No
If so, was prior written clearance provided to allow the trade to proceed during this period?	N/A
If prior written clearance was provided, on what date was this provided?	N/A

 

 

 

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