Full Press Release Details
Radiopharm Theranostics Reports Business Update
Completed enrolment in Phase 2b clinical trial
of imaging agent RAD 101 in patients with recurrent brain metastases following earlier announcement of interim data demonstrating concordance
with MRI (the primary endpoint) in 90% of evaluable subjects (18/20)
Presented initial Phase 0/1 data for RAD 202
at the American Association for Cancer Research demonstrating encouraging tumor uptake and a favorable safety profile in the lowest dose
Received positive recommendation from Data
and Safety Monitoring Committee (DSMC) to advance RAD 202 to the next dose level
Initiated two First-In-Human (FIH) clinical
trials for radiotherapeutic assets RV-01 in various tumor types and RAD 402 in advanced prostate cancer
Sydney, Australia - XX April 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 quarter ended March 31, 2026, and provided a corporate update.
"We entered 2026 with strong momentum and
continue to execute across our differentiated therapeutics and diagnostics pipeline," said Riccardo Canevari, CEO and Managing
Director of Radiopharm Theranostics. "The Phase 2b interim results for RAD 101, demonstrating 90% concordance with MRI in recurrent
brain metastases, further validate the potential of our imaging platform and strengthen our confidence as we prepare for the next stages
of development. In parallel, initial first-in-human data from RAD 202 showing meaningful tumor uptake and a favorable safety profile
underscore the breadth of our therapeutic opportunities."
"Importantly, the initiation of two additional
Phase 1 trials-RV-01 through our Radiopharm Ventures collaboration and RAD 402 in advanced prostate cancer-reflects the growing
productivity of our platform and our disciplined approach to pipeline expansion. With multiple clinical milestones ahead, we are well
positioned to build long-term value as we advance innovative radiopharmaceuticals for patients with high unmet needs," concluded
Program and Business Updates
18F-RAD101 - Small molecule targeting
fatty acid synthase radiolabelled 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
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
177Lu-RAD202 - Nanobody targeting HER2 radiolabelled with
The Company continues to evaluate RAD 202 in
the Phase 0/1 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.
177Lu-RAD204 - Nanobody targeting PD-L1 radiolabelled with
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.
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
Lu177-RV 01 - monoclonal antibody targeting 4Ig isoform of
B7H3 radiolabelled 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.
Tb161-RAD 402 - Monoclonal antibody targeting KLK3 radiolabelled
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.
Ga68-RAD301 - Peptide targeting vB-integrin radiolabeled
RAD 301 is 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.
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
Closing cash at the end of the quarter was $19.2
million, decreasing from $34.5 million at the end of the prior quarter.
Net cash outflows from operating activities during
the period was $14.9 million with direct Research and Development expenditure and staff costs accounting for 95% of the operating activities.
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
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 five 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.
For more information:
CEO & Managing Director
Precision AQ (formerly Stern IR)
Follow Radiopharm Theranostics:
Website - https://radiopharmtheranostics.com/
Investor Hub - 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 March 2026 |
| Consolidated statement of cash flows | Current quarter $A'000 | Year to date (9 months) $A'000 | |||||||||
| 1. | Cash flows from operating activities | 443 | 443 | ||||||||
| 1.1 | Receipts from customers | ||||||||||
| 1.2 | Payments for | (11,805 | ) | (31,156 | ) | ||||||
| (a) research and development | |||||||||||
| (b) product manufacturing and operating costs | - | - | |||||||||
| (c) advertising and marketing | (108 | ) | (336 | ) | |||||||
| (d) leased assets | - | - | |||||||||
| (e) staff costs | (2,370 | ) | (8,681 | ) | |||||||
| (f) administration and corporate costs | (1,633 | ) | (3,507 | ) | |||||||
| 1.3 | Dividends received (see note 3) | - | - | ||||||||
| 1.4 | Interest received | 152 | 414 | ||||||||
| 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 | 402 | 747 | ||||||||
| 1.9 | Net cash from / (used in) operating activities | (14,919 | ) | (37,591 | ) |
| ASX Listing Rules Appendix 4C (17/07/20) | Page 1 |
| + See chapter 19 of the ASX Listing Rules for defined terms. |
Quarterly cash flow report for entities subject to Listing Rule 4.7B
| Consolidated statement of cash flows | Current quarter $A'000 | Year to date (9 months) $A'000 | |||||||||
| 2. | Cash flows from investing activities | - | - | ||||||||
| 2.1 | Payments to acquire or for: | ||||||||||
| (a) entities | |||||||||||
| (b) businesses | - | - | |||||||||
| (c) property, plant and equipment | - | - | |||||||||
| (d) investments | - | - | |||||||||
| (e) intellectual property | - | - | |||||||||
| (f) other non-current assets | - | - | |||||||||
| 2.2 | Proceeds from disposal of: | - | - | ||||||||
| (a) entities | |||||||||||
| (b) businesses | - | - | |||||||||
| (c) property, plant and equipment | - | - | |||||||||
| (d) investments | - | - | |||||||||
| (e) intellectual property | - | - | |||||||||
| (f) 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 | - | (5,312 | ) | |||||||
| 2.6 | Net cash from / (used in) investing activities | - | (5,312 | ) | |||||||
| 3. | Cash flows from financing activities | - | 35,263 | ||||||||
| 3.1 | Proceeds from issues of equity securities (excluding convertible debt securities) | ||||||||||
| 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 | (284 | ) | (2,109 | ) | ||||||
| 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 | (284 | ) | 33,154 |
| ASX Listing Rules Appendix 4C (17/07/20) | Page 2 |
| + See chapter 19 of the ASX Listing Rules for defined terms. |
Quarterly cash flow report for entities subject to Listing Rule 4.7B