Full Press Release Details
Theranostics Reports Half-Year Financial Results and Business Updates
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
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
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
- 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.
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."
and Business Updates
- Small molecule targeting fatty acid synthase radiolabeled with Fluorine-18
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.
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
- Nanobody targeting HER2 radiolabeled with Lutetium 177
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.
- Nanobody targeting PD-L1 radiolabeled with Lutetium 177
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.
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
01 - monoclonal antibody targeting 4Ig isoform of B7H3 radiolabeled with Lutetium 177
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.
Tb161-RAD 402 - Monoclonal antibody targeting KLK3 radiolabeled with Terbium 161
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.
- Peptide targeting vB-integrin radiolabeled with Gallium 68
being evaluated in a Phase 1 imaging trial in patients with Pancreatic Ductal Adenocarcinoma (PDAC). The vB-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.
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
is a summary of the Appendix 4C Cash Flow Report:
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.
Radiopharm Theranostics
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.
on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper.
CEO & Managing Director
AQ (formerly Stern IR)
Radiopharm Theranostics:
InvestorHub - https://investorhub.radiopharmtheranostics.com/
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
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
| 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
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
| 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
| Authorised by: | The Board | |
| (Name of body or officer authorising release - see note 4) |
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia