Full Press Release Details
ACTIVITIES AND CASH FLOW REPORT
ENDED 31 DECEMBER 2024
Australia - 30 January 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 provide
a summary of its activities for the quarter ended 31 December 2024.
202 RECEIVES APPROVAL TO START PHASE 1 HER-2THERAPEUTIC TRIAL in Australia
December, Radiopharm received ethics approval in Australia to initiate a Phase 1 trial of 177Lu- RAD202 for HER2-positive
metastatic solid tumors, including breast and gastric cancers.
open-label HEAT' trial will assess the safety, tolerability, and preliminary clinical activity of this radiotherapeutic
across multiple Australian sites, supported by GenesisCare CRO. The trial builds on prior data demonstrating the safety, biodistribution,
and potential therapeutic effects of RAD202 in preclinical and diagnostic studies. RAD202 targets HER2, a key oncology marker, aiming
to provide an alternative treatment for patients resistant to standard therapies.
data on RAD202 was presented at the 2024 European Association of Nuclear Medicine (EANM) Annual Meeting during October. The findings
confirmed that 68Ga-RAD 202 demonstrates rapid tumor uptake, a high tumor-to-background ratio, and low uptake in non-specific organs,
supporting its potential for imaging and therapy in HER2-positive cancers.
studies further validated RAD 202's efficacy, showing tumor growth inhibition and significantly prolonged survival in HER2-positive xenograft
models when labeled with 177Lu.
ETHICS COMMITTEE APPROVAL TO EXPAND PD-L1 NANOBODY (RAD204) THERAPEUTIC PHASE 1 TRIAL IN MULTIPLE TUMOR TYPES
announced in November that it has received ethics approval from the Australian Human Research Ethics Committee (HREC) to expand the scope
of its ongoing Phase 1 trial of the radiotherapeutic 177Lu-RAD204. Initially focused on Non-Small Cell Lung Cancer (NSCLC), the trial
will now include participants with five additional PD-L1-positive solid tumors: Small Cell Lung Cancer (SCLC), Triple Negative Breast
Cancer (TNBC), Melanoma, Head and Neck Cancer (HNSCC), and Endometrial Cancer.
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South
The open-label, First-In-Human dose escalation
trial, titled "Phase 0/1 Study of the Safety and Tolerability of 177Lu-RAD204," is designed to evaluate the safety and preliminary
clinical activity of the radiotherapeutic in individuals with PD-L1-expressing advanced cancers. RAD204 is a single- domain monoclonal
antibody targeting PD-L1, a protein that regulates immune system activity and is overexpressed in many cancers. By targeting PD-L1, RAD204
aims to overcome resistance mechanisms associated with standard treatments for these tumor types.
Phase 1 imaging data from 16 NSCLC patients demonstrated the safety and biodistribution of RAD204, confirming its tumor-targeting capability
and potential for therapeutic application. With recruitment underway at numerous sites across New South Wales, South Australia, and Western
Australia, the trial is supported by leading oncology care provider GenesisCare CRO.
trial's expansion aligns with Radiopharm's strategy to develop RAD204 as a tumor-agnostic radioimmunotherapy. By broadening
eligibility to include additional tumor types, the company aims to validate the compound's potential for a pan-tumor predictive
biomarker approach, offering a new treatment avenue for patients with advanced PD-L1-positive cancers.
OF PRECLINICAL DATA PACKAGE FOR KLK3-TARGETING RADIOTHERAPEUTIC (RAD 402)
the quarter, the Company completed preclinical studies for its KLK3-targeting radiotherapeutic, RAD 402, which uses the radionuclide
Terbium-161 (Tb-161). The studies demonstrated promising safety and biodistribution profiles, with high tumor targeting and minimal kidney
and bone marrow uptake.
findings support progression to First-In-Human trials, planned for H2 2025. GMP manufacturing is underway and expected to be completed
by Q1 2025. RAD 402, designed for advanced prostate cancer, leverages Tb-161's enhanced therapeutic activity compared to Lutetium-177,
reinforcing its potential as a first-in-class treatment option.
THERANOSTICS AND ATOMVIE GLOBAL RADIOPHARMA PARTNER TO DEVELOP AND MANUFACTURE 177LU-BETABART
has partnered with AtomVie Global Radiopharma to develop and manufacture 177Lu- BetaBart, a radiopharmaceutical targeting
B7-H3, an immune checkpoint molecule overexpressed in several solid tumors.
compound is designed to reduce off-target toxicity while enhancing tumor specificity. It targets the 4Ig subtype of B7-H3, the most common
subtype in human tumors, and represents a promising approach for antibody-based cancer immunotherapy.
collaboration, which includes Radiopharm Ventures (a joint venture between Radiopharm and MD Anderson Cancer Center), aims to advance
177Lu-BetaBart to a Phase I/II First-In-Human trial in the US by mid-2025. AtomVie will leverage its extensive expertise and
new state-of-the-art manufacturing facility, scheduled to open in early 2025, to support clinical development and eventual commercialization.
in the quarter Radiopharm also announced significant progress in developing BetaBart. A pre- IND meeting request has been submitted to
the FDA, and the first GMP batch of the antibody with chelator has been successfully produced. BetaBart has previously demonstrated tumor
shrinkage and prolonged survival in preclinical studies.
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South
FDA IND APPROVAL & STRATEGIC COLLABORATION WITH BAMF HEALTH
TO MANUFACTURE AND DOSE 18F-RAD 101 FOR PHASE 2B IMAGING STUDY OF BRAIN METASTASIS
October, the Company announced a partnership with BAMF Health to manufacture and dose its proprietary radiotracer, 18F-RAD 101, for a
Phase 2b imaging trial targeting brain metastases. BAMF Health is also expected to serve as the first clinical trial site as part of
101 is a small molecule targeting fatty acid synthase (FASN), an enzyme overexpressed in many solid tumors, including brain metastases.
Previous Phase 2a trials demonstrated significant tumor uptake and imaging consistency across tumor origins. The Phase 2b study, an open-label,
single- dose trial, will evaluate the imaging performance of 18F-RAD 101 in patients with suspected recurrent brain metastases.
Health, a leader in molecular imaging and radiopharmaceutical manufacturing, will leverage its advanced facilities and clinical trial
platform to support the trial.
IND approval to start phase 2b has been received during Q4 2024.
CO-DEVELOPMENT PARTNERSHIP WITH LANTHEUS FOR AUSTRALIA
finish the calendar year 2024, Radiopharm announced a strategic co-development partnership with Lantheus to advance clinical development
of innovative radiopharmaceuticals in Australia.
will lead clinical development efforts in Australia, with an initial focus on a Phase 1 imaging trial targeting multiple solid tumors,
with Lantheus funding all associated clinical costs associated with the program. Milestone payments of up to USD 2 million will be made
to Radiopharm upon achieving key objectives, including ethics approval, first patient dosing, and enrollment completion for the first
imaging trial under the agreement.
INCREASES TO 12.16% SHAREHOLDING IN RADIOPHARM WITH $US5 MILLION (AUD$8.0 MILLION) PLACEMENT
after the conclusion of the reporting period, Radiopharm was pleased to announce it had executed a subscription agreement for a private
placement of shares to its strategic US partner and substantial shareholder, Nasdaq-listed Lantheus Holdings, raising US$5 million (approx.
placement was completed at A$0.06 per share, a 150% premium to the last traded price of Radiopharm shares prior to the execution of the
agreement. The placement replaces 6-month options that Radiopharm issued to Lantheus in August 2024.
Lantheus is the leading radiopharmaceutical-focused company, delivering lifechanging science to enable clinicians to Find, Fight and
Follow disease to deliver better patient outcomes. It also has offices in Canada and Sweden and has provided radiopharmaceutical solutions
for more than 65 years.
LISTING OF AMERICAN DEPOSITARY SHARES
Company achieved a Nasdaq listing for its American Depositary Shares (ADSs), trading under the ticker "RADX" as of 27 November
2024. Each ADS represents 300 ordinary shares, complementing its primary ASX listing and significant US shareholder base. The listing
was completed without an associated capital raise and aims to enhance the Radiopharm's visibility among US and international investors.
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South
RADIOPHARM PRESENTS AT JONES RESEARCH RADIOPHARMA DAY
October the Company was invited to present at the JonesResearch Virtual Radiopharma Day. It featured fireside chats and panel discussions
with public and private companies in the radiopharmaceutical sector, as well as accommodating 1-on-1 meetings with investors. The panel
discussion covered topics including potential advantages of novel targeting modalities, isotope supply and logistics, and novel molecular
OF NOEL DONNELLY AS NON-EXECUTIVE DIRECTOR
October the Company announced the appointment of Noel Donnelly as a Non-Executive Director. Mr Donnelly brings over 25 years of experience
in finance, strategy, and operations within the biopharmaceutical industry, with significant achievements in corporate governance and
financial strategy. He is currently CFO at PepGen Inc., where he oversaw a successful IPO and subsequent financing rounds, raising a
he held senior roles at Takeda/Shire PLC, managing R&D integrations worth over US$160 billion and contributing to strategic portfolio
management. His expertise spans valuation, investor relations, and decision support analysis.
Appendix 4C Quarterly Cash Flow report is set out below.
cash at the end of the quarter was $36.47 million, decreasing from $46.46 million at the end of the prior quarter.
cash outflows during the period in operating activities was $8.74 million with direct Research and Development expenditure and staff
costs accounting for 93% of the operating expenditure.