Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or 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.
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 January 28, 2026 titled:
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.
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.
Exhibit
99.1
ASX ANNOUNCEMENT 28 January 2026 |  |
Radiopharm
Theranostics Reports Half-Year Financial Results and Business Updates
Interim
results from Phase 2b clinical trial of RAD 101 showed 92% of evaluable participants met the primary endpoint of MRI concordance in imaging
study of patients with brain metastases
Interim
data from additional cohorts of the Phase 1 clinical trial of RAD 202 and RAD 204 in advanced solid tumors are expected in mid-2026
Cash
and cash equivalents of approximately $34.52 million provide runway into 2027 to advance pipeline of high value radiotherapeutic programs
through key clinical and regulatory milestones
Sydney, Australia
– 28 January 2026 – 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 financial results for the first six months of fiscal 2026 ended 31 December 2025 and provided an update on its
clinical pipeline with an outline of its expected milestones for 2026.
“2025
was a year of strong execution across our pipeline, as we presented unprecedented imaging data from our RAD 101 diagnostic program, received
Data Safety Monitoring Committee approval to escalate dosing in both RAD 204 and RAD 202 programs and secured clearance to advance both
RV-01 and RAD 402 into Phase 1 clinical trials,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics.
“As we enter 2026, we remain laser-focused on advancing our radiopharmaceutical assets and taking a deliberate approach to pipeline
prioritization. This year, we aim to deliver meaningful data from across multiple programs, expand treatment and diagnostic options for
patients with solid tumors, and create long-term value for all stakeholders.”
Program
and Business Updates
18F-RAD101
– Small molecule targeting fatty acid synthase radiolabeled with Fluorine-18
RAD 101 is
being evaluated in a single-arm U.S. Phase 2b clinical trial for the diagnostic performance of the molecule in 30 individuals with confirmed
recurrent brain metastases from solid tumors of different origins. RAD 101 has received U.S. Food and Drug Administration (FDA) Fast
Track Designation to expedite the review process and help bring the novel imaging small molecule to the over 300,000 patients diagnosed
annually in the U.S. with cerebral metastases. The study is currently enrolling patients and anticipates completing enrollment in the
first quarter of 2026.
| ● | In
December 2025, Radiopharm Theranostics announced interim data from the first twelve patients
in the Phase 2b trial of RAD 101, with 92% of evaluable patients achieving concordance with
MRI imaging, the primary endpoint. |
| ● | These
promising interim results are in line with the Phase 2a results and, if confirmed, will trigger
the preparation of a multi-center, multi-country Phase 3 registrational trial. |
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889
ASX ANNOUNCEMENT 28 January 2026 |  |
177Lu-RAD202
– Nanobody targeting HER2 radiolabeled with Lutetium 177
The Company
continues to evaluate RAD 202 in the Phase 1 ‘HEAT’ clinical trial in patients with Human Epidermal Growth Factor Receptor
2 (HER2)-positive advanced solid tumors. HER2 is overexpressed in breast cancer and several other solid tumors and represents a validated
target in oncology. RAD 202 has demonstrated clinical proof-of-concept with positive safety and biodistribution and was recently recommended
by the Data Safety and Monitoring Committee (DSMC) to progress to the next dose level of 75mCi in the ‘HEAT’ trial.
| ● | Recently
completed dosing at the 30mCi dosing level and is moving to the next dose level of 75mCi
following recommendation from the DSMC. |
| ● | Data
available from the first three patients in the first cohort of the study show significant
tumor uptake in HER2 positive tumors. |
| ● | RAD
202 has shown a favorable safety profile with no drug-related adverse events reported. |
| ● | The
Company expects to complete enrollment in the higher dose Cohort 2 and to have data from
both the first and second cohorts in the first half of 2026. |
177Lu-RAD204
– Nanobody targeting PD-L1 radiolabeled with Lutetium 177
RAD 204 is
continuing to be evaluated in a Phase 1 study in PD-L1-driven cancers, including Non-Small Cell Lung Cancer (NSCLC), Small-Cell Lung
Cancer (SCLC), Triple-negative Breast Cancer (TNBC), Cutaneous Melanoma, head and neck squamous cell carcinoma (HNSCC) and Endometrial
Cancer. Previous Phase 1 imaging data of 16 NSCLC patients treated with RAD 204 demonstrated that the diagnostic compound is safe and
is associated with acceptable dosimetry.
| ● | The
Company completed enrollment of the second cohort of the Phase 1 study of RAD 204 and can
proceed with dosing patients in the third cohort with an updated dose of 90mCi of Lu177 as
approved by the Data and Safety Monitoring Committee. |
| ● | Two
out of three patients in the 30mCi cohort exhibited stable disease for 5.5 months in metastatic
NSCLC, compared to historical data of 3.5 months PFS with standard of care (SOC). |
| ● | Initial
data from the first six patients across the first two cohorts show tumor uptake in the PD-L1-positive
lesions, in line with published results of the previously conducted imaging study. |
| ● | RAD
204’s safety profile is reassuring and there have been no drug-related adverse events
reported. |
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889
ASX ANNOUNCEMENT 28 January 2026 |  |
Lu177-RV
01 – monoclonal antibody targeting 4Ig isoform of B7H3 radiolabeled with Lutetium 177
RV-01 (Betabart)
is a monoclonal antibody targeting the 4Ig isoform of B7H3, an immune checkpoint protein that is highly expressed in tumors and not in
healthy tissue. In multiple preclinical studies, RV-01 has shown tumor shrinkage and prolonged survival. This is the first radiopharmaceutical
therapeutic developed by Radiopharm Ventures, a Joint Venture between Radiopharm Theranostics and the MD Anderson Cancer Center.
| ● | In
January 2026, the Company increased its ownership in Radiopharm Ventures from 75% to 87.5%
as the joint venture continues to show promising progress in its cancer therapeutic pipeline,
including the advancement of its leading B7H3 candidate and other preclinical assets. |
| ● | In
July 2025, RV-01 received Investigational New Drug clearance from the FDA to initiate the
first-in-human Phase 1 clinical trial. The Company expects to dose the first patients in
the Phase 1 trial in the first quarter of 2026. |
Tb161-RAD 402 – Monoclonal antibody targeting KLK3 radiolabeled with Terbium 161
RAD 402 is
a monoclonal antibody targeting Kallikrein Related Peptidase 3 (KLK3) radiolabelled with the radionuclide 161Tb for the treatment of
prostate cancer. In preclinical studies, RAD 402 in mouse xenografts showed strong tumor targeting, limited bone and marrow uptake, and
a hepatic excretion profile consistent with expectations for a monoclonal antibody.
| ● | In
November 2025, RAD 402 was granted Bellberry Human Research Ethics Committee approval in
Australia to initiate a First-In-Human (FIH) Phase 1 clinical trial of RAD 402 for the treatment
of metastatic or locally advanced prostate cancer. |
| ● | The
Company anticipates initiating a Phase 1 trial of RAD 402 in adults with metastatic or locally
advanced prostate cancer in Q1 2026. |
Ga68-RAD301
– Peptide targeting αvB-integrin radiolabeled with Gallium 68
RAD 301 is
being evaluated in a Phase 1 imaging trial in patients with Pancreatic Ductal Adenocarcinoma (PDAC). The αvB-integrin is a cellular
marker for tumor invasion and metastatic growth, which correlates with decreased survival in several carcinomas, particularly pancreatic.
RAD 301 has previously received Orphan Drug Designation (ODD) from the FDA and data from the Phase 1 trial is supportive of the Company’s
decision to move to a Phase 2 imaging trial in patients with loco-regional pancreatic cancer.
| ● | Enrollment
in the Phase 1 imaging trial in metastatic pancreatic cancer continues, having dosed 8 patients
out of 9, with the last patient expected in Q1 2026. |
| ● | Initial
data from the first six patients demonstrated confirmed safety and significant uptake in
the AvB6 positive lesions. |
The unmet
medical need in the earlier stage of disease and the larger disease prevalence compared to the patient population of the current Phase
1 trial have influenced the decision to evaluate RAD 301 in loco-regional pancreatic cancer.
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889
ASX ANNOUNCEMENT 28 January 2026 |  |
Financial
Update
The following
is a summary of the Appendix 4C Cash Flow Report:
| ● | The
half-year closing cash balance was $34.52 million, a rise from $29.12 million at the close
of the year-end balance. |
| ● | Net
cash outflows from operating activities for the 6 months ended 31 December 2025 totaled $22.67
million. |
| ● | In
October 2025, Radiopharm Theranostics announced that it had received firm commitments from
international and Australian institutional and industry investors to raise approximately
$35 million by way of private placement. |
In compliance
with Listing Rule 4.7C, payments to related parties and their associates, as detailed in item 6.1 of Appendix 4C, encompass remuneration
for director fees to executive and non-executive directors, conducted in the ordinary course of business at commercial rates, excluding
reimbursements for out-of-pocket expenses.
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 four Phase 1 trials in a variety of solid tumor cancers including
lung, breast, and brain metastases. 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
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/
X – https://x.com/TeamRadiopharm
LinkedIn – 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
ASX ANNOUNCEMENT 28 January 2026 |  |
Appendix
4C
Quarterly
cash flow report for entities subject to Listing Rule 4.7B
| Name of entity |
|
| Radiopharm Theranostics Limited |
|
| ABN |
Quarter ended (“current quarter”) |
| 57 647 877 889 |
31 December 2025 |
| Consolidated statement of cash flows | |
Current
quarter
$A’000 | | |
Year to date
(6 months)
$A’000 | |
| 1. | | |
Cash flows from operating activities | |
| | |
| |
| 1.1 | | |
Receipts from customers | |
| | | |
| | |
| 1.2 | | |
Payments for | |
| |
| | | |
research and development | |
| (10,448 | ) | |
| (19,351 | ) |
| | | |
product manufacturing and operating costs | |
| - | | |
| - | |
| | | |
advertising and marketing | |
| (98 | ) | |
| (228 | ) |
| | | |
leased assets | |
| - | | |
| - | |
| | | |
staff costs | |
| (2,336 | ) | |
| (6,311 | ) |
| | | |
administration and corporate costs | |
| (816 | ) | |
| (1,874 | ) |
| 1.3 | | |
Dividends received (see note 3) | |
| - | | |
| - | |
| 1.4 | | |
Interest received | |
| 107 | | |
| 262 | |
| 1.5 | | |
Interest and other costs of finance paid | |
| - | | |
| - | |
| 1.6 | | |
Income taxes paid | |
| - | | |
| - | |
| 1.7 | | |
Government grants and tax incentives | |
| - | | |
| 4,485 | |
| 1.8 | | |
Other – GST refunded | |
| 211 | | |
| 345 | |
| 1.9 | | |
Net cash from/(used in) operating activities | |
| (13,380 | ) | |
| (22,672 | ) |
| 2. | | |
Cash flows from investing activities | |
| | | |
| | |
| 2.1 | | |
Payments to acquire or for: | |
| | | |
| | |
| | | |
(a) entities | |
| - | | |
| - | |
| | | |
businesses | |
| - | | |
| - | |
| | | |
property, plant and equipment | |
| - | | |
| - | |
| | | |
investments | |
| - | | |
| - | |
| | | |
intellectual property | |
| - | | |
| - | |
| | | |
other non-current assets | |
| - | | |
| - | |
| 2.2 | | |
Proceeds from disposal of: | |
| | | |
| | |
| | | |
(a) entities | |
| - | | |
| - | |
| | | |
businesses | |
| - | | |
| - | |
| | | |
property, plant and equipment | |
| - | | |
| - | |
| | | |
investments | |
| - | | |
| - | |
| | | |
intellectual property | |
| - | | |
| - | |
| | | |
other non-current assets | |
| - | | |
| - | |
| 2.3 | | |
Cash flows from loans to other entities | |
| - | | |
| - | |
| 2.4 | | |
Dividends received (see note 3) | |
| - | | |
| - | |
| 2.5 | | |
Other - payments of license fee liabilities | |
| (4,548 | ) | |
| (5,312 | ) |
| 2.6 | | |
Net cash from/(used in) investing activities | |
| (4,548 | ) | |
| (5,312 | ) |
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889
ASX ANNOUNCEMENT 28 January 2026 |  |
| Consolidated statement of cash flows | |
Current
quarter
$A’000 | | |
Year to date
(6 months)
$A’000 | |
| 3. | | |
Cash flows from financing activities | |
| | | |
| | |
| 3.1 | | |
Proceeds from issues of equity securities (excluding convertible debt securities) | |
| 35,263 | | |
| 35,263 | |
| 3.2 | | |
Proceeds from issue of convertible debt securities | |
| - | | |
| - | |
| 3.3 | | |
Proceeds from exercise of options | |
| - | | |
| - | |
| 3.4 | | |
Transaction costs related to issues of equity securities or convertible debt securities | |
| (1,815 | ) | |
| (1,825 | ) |
| 3.5 | | |
Proceeds from borrowings | |
| - | | |
| - | |
| 3.6 | | |
Repayment of borrowings | |
| - | | |
| - | |
| 3.7 | | |
Transaction costs related to loans and borrowings | |
| - | | |
| - | |
| 3.8 | | |
Dividends paid | |
| - | | |
| - | |
| 3.9 | | |
Other – (provide details if material) | |
| - | | |
| - | |
| 3.10 | | |
Net cash from/(used in) financing activities | |
| 33,448 | | |
| 33,438 | |
| 4. | | |
Net increase/(decrease) in cash and cash equivalents for the period | |
| | | |
| | |
| 4.1 | | |
Cash and cash equivalents at beginning of period | |
| 19,041 | | |
| 29,117 | |
| 4.2 | | |
Net cash from/(used in) operating activities (item 1.9 above) | |
| (13,380 | ) | |
| (22,672 | ) |
| 4.3 | | |
Net cash from/(used in) investing activities (item 2.6 above) | |
| (4,548 | ) | |
| (5,312 | ) |
| 4.4 | | |
Net cash from/(used in) financing activities (item 3.10 above) | |
| 33,448 | | |
| 33,438 | |
| 4.5 | | |
Effect of movement in exchange rates on cash held | |
| (46 | ) | |
| (56 | ) |
| 4.6 | | |
Cash and cash equivalents at end of period | |
| 34,515 | | |
| 34,515 | |
| 5. | | |
Reconciliation of cash and cash equivalents
at the end of the quarter (as shown in the consolidated statement of cash flows) to the related items in the accounts | |
Current
quarter
$A’000 | | |
Previous
quarter
$A’000 | |
| 5.1 | | |
Bank balances | |
| 34,515 | | |
| 19,041 | |
| 5.2 | | |
Call deposits | |
| - | | |
| - | |
| 5.3 | | |
Bank overdrafts | |
| - | | |
| - | |
| 5.4 | | |
Other (provide details) | |
| - | | |
| - | |
| 5.5 | | |
Cash and cash equivalents at end of quarter (should equal item 4.6 above) | |
| 34,515 | | |
| 19,041 | |
| 6. | | |
Payments
to related parties of the entity and their associates | |
Current
quarter
$A'000 | |
| 6.1 | | |
Aggregate amount of payments to related parties and their associates included in item 1 | |
| 514 | |
| 6.2 | | |
Aggregate amount of payments to related parties and their associates included in item 2 | |
| | |
Note: if any amounts are shown in items 6.1 or 6.2, your quarterly activity report must include a description
of, and an explanation for, such payments.
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889
ASX ANNOUNCEMENT 28 January 2026 |  |
In
accordance with Listing Rule 4.7C, payments made to related parties and their associates included in items 6.1 of the Appendix 4C includes
compensation and director fee related payments in the normal course of business at commercial rates, excluding reimbursements of out-of-pocket
expenses.
| 7. | | |
Financing facilities
Note: the term “facility’ includes all forms of financing arrangements available to the entity. Add notes as necessary for an understanding of the sources of finance available to the entity. | |
Total facility
amount at
quarter end
$A’000 | | |
Amount
drawn at
quarter end
$A’000 | |
| 7.1 | | |
Loan facilities | |
| - | | |
| - | |
| 7.2 | | |
Credit standby arrangements | |
| - | | |
| - | |
| 7.3 | | |
Other (please specify) | |
| - | | |
| - | |
| 7.4 | | |
Total financing facilities | |
| - | | |
| - | |
| | | |
| |
| | | |
| | |
| 7.5 | | |
Unused financing facilities available at quarter end | |
| | | |
| - | |
| 7.6 | | |
Include in the box below a description of each facility above, including the lender, interest rate, maturity date and whether it is secured or unsecured. If any additional financing facilities have been entered into or are proposed to be entered into after quarter end, include a note providing details of those facilities as well. |
| | | |
N/A |
| 8. | | |
Estimated cash available for future operating activities | |
$A’000 | |
| 8.1 | | |
Net cash from/(used in) operating activities (item 1.9) | |
| (13,380 | ) |
| 8.2 | | |
Cash and cash equivalents at quarter end (item 4.6) | |
| 34,515 | |
| 8.3 | | |
Unused finance facilities available at quarter end (item 7.5) | |
| - | |
| 8.4 | | |
Total available funding (item 8.2 + item 8.3) | |
| 34,515 | |
| | | |
| |
| | |
| 8.5 | | |
Estimated quarters of funding available (item 8.4 divided by item 8.1) | |
| 2.58 | |
| |
Note: if the entity has reported positive net operating cash flows in item 1.9, answer item 8.5 as “N/A”. Otherwise, a figure for the estimated quarters of funding available must be included in item 8.5. |
| |
|
| 8.6 |
If item 8.5 is less than 2 quarters, please provide answers to the following questions: |
| |
|
| |
8.6.1 |
Does the entity expect that it will continue to have the current level of net operating cash flows for the time being and, if not, why not? |
| |
|
|
| |
Answer: N/A |
| |
|
| |
8.6.2 |
Has the entity taken any steps, or does it propose to take any steps, to raise further cash to fund its operations and, if so, what are those steps and how likely does it believe that they will be successful? |
| |
|
|
| |
Answer: N/A |
| |
|
| |
8.6.3 |
Does the entity expect to be able to continue its operations and to meet its business objectives and, if so, on what basis? |
| |
|
|
| |
Answer: N/A |
| |
|
| |
Note: where item 8.5 is less than 2 quarters, all of questions 8.6.1, 8.6.2 and 8.6.3 above must be answered. |
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889
ASX ANNOUNCEMENT 28 January 2026 |  |
Compliance
statement
| 1 | This
statement has been prepared in accordance with accounting standards and policies which comply
with Listing Rule 19.11A. |
| 2 | This
statement gives a true and fair view of the matters disclosed. |
Date:
28 January 2026
| Authorised by: | |
The Board |
| | |
|
| | |
(Name
of body or officer authorising release – see note 4) |
Notes
| 1. | This
quarterly cash flow report and the accompanying activity report provide a basis for informing
the market about the entity’s activities for the past quarter, how they have been financed
and the effect this has had on its cash position. An entity that wishes to disclose additional
information over and above the minimum required under the Listing Rules is encouraged to
do so. |
| 2. | If
this quarterly cash flow report has been prepared in accordance with Australian Accounting
Standards, the definitions in, and provisions of, AASB 107: Statement of Cash Flows apply
to this report. If this quarterly cash flow report has been prepared in accordance with other
accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the corresponding
equivalent standard applies to this report. |
| 3. | Dividends
received may be classified either as cash flows from operating activities or cash flows from
investing activities, depending on the accounting policy of the entity. |
| 4. | If
this report has been authorised for release to the market by your board of directors, you
can insert here: “By the board”. If it has been authorised for release to the
market by a committee of your board of directors, you can insert here: “By the [name
of board committee – eg Audit and Risk Committee]”. If it has been
authorised for release to the market by a disclosure committee, you can insert here: “By
the Disclosure Committee”. |
| 5. | If
this report has been authorised for release to the market by your board of directors and
you wish to hold yourself out as complying with recommendation 4.2 of the ASX Corporate
Governance Council’s Corporate Governance Principles and Recommendations, the
board should have received a declaration from its CEO and CFO that, in their opinion, the
financial records of the entity have been properly maintained, that this report complies
with the appropriate accounting standards and gives a true and fair view of the cash flows
of the entity, and that their opinion has been formed on the basis of a sound system of risk
management and internal control which is operating effectively. |
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889