Research analysts covering Radiopharm Theranostics.
Recent press releases and 8-K filings for RADX.
Radiopharm Theranostics Reports Half-Year Financial Results and Clinical Pipeline Updates
RADX
Earnings
New Projects/Investments
- Radiopharm Theranostics reported cash and cash equivalents of approximately $34.52 million as of December 31, 2025, providing a runway into 2027, following a $35 million private placement in October 2025.
- Net cash outflows from operating activities for the six months ended December 31, 2025, totaled $22.67 million, with an estimated 2.58 quarters of funding available.
- Interim results from the Phase 2b clinical trial of RAD 101 showed 92% of evaluable participants met the primary endpoint of MRI concordance in patients with brain metastases.
- The company anticipates significant clinical milestones in 2026, including interim data for RAD 202 and RAD 204 in mid-2026, and the initiation of Phase 1 trials for RV-01 and RAD 402 in Q1 2026.
Jan 28, 2026, 12:03 PM
Radiopharm Theranostics Increases Ownership in Radiopharm Ventures to 87.5%
RADX
New Projects/Investments
M&A
- Radiopharm Theranostics (RADX) has increased its ownership stake in Radiopharm Ventures, LLC from 75% to 87.5%.
- This decision was made due to promising progress in the joint venture's cancer therapeutic pipeline.
- The lead candidate, Betabart (RV01), a monoclonal antibody targeting B7H3, received FDA IND clearance in July 2025 and is expected to dose its first patient in a Phase I therapeutic trial in Q1 2026.
- Two additional preclinical candidates from Radiopharm Ventures have shown early positive results and are progressing towards final candidate selection in 2026.
Jan 12, 2026, 1:05 PM
Radiopharm Theranostics announces positive interim Phase 2b data for RAD 101
RADX
New Projects/Investments
Product Launch
- Radiopharm Theranostics announced positive interim data from its U.S. Phase 2b clinical imaging trial of RAD 101 in brain metastases on December 15, 2025.
- The interim analysis showed that 92% (11/12) of evaluable patients treated with RAD 101 achieved concordance with MRI imaging, which was the primary endpoint.
- The company plans to initiate a pivotal study for RAD 101 by the end of 2026.
- RAD 101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation.
- Independent commercial assessments estimate RAD 101's U.S. market opportunity at over $500 million annually.
Dec 15, 2025, 1:00 PM
Radiopharm Theranostics Shareholders Approve Share and Option Issuances
RADX
Proxy Vote Outcomes
- Radiopharm Theranostics Limited announced that all resolutions considered at its General Meeting held on December 3, 2025, were carried by poll.
- Shareholders approved the ratification of a prior issue of First Tranche Placement Shares to Placement Participants with 98.19% of votes FOR.
- The issuance of Second Tranche Placement Shares was approved with 96.62% of votes FOR.
- The issuance of Placement Attaching Options and SPP Attaching Options were also approved, receiving 95.21% and 98.39% of votes FOR, respectively.
Dec 4, 2025, 2:27 AM
Radiopharm Theranostics Announces Annual General Meeting Results and Clinical Pipeline Progress
RADX
Proxy Vote Outcomes
New Projects/Investments
Board Change
- Radiopharm Theranostics Limited held its Annual General Meeting on November 20, 2025, where all resolutions considered were carried by poll, and Mr. Bruce Goodwin was re-appointed as a Non-Executive Director.
- The company reported a cash runway extending to Q1 2027.
- In its clinical pipeline, RAD101 (diagnostic) for Brain Mets has 15 out of 30 patients dosed in its Phase IIb trial as of November 17, 2025, with trial completion expected in Q1 2026 and a Phase 2b readout in the first half of 2026.
- Additionally, RAD402 (therapeutic) for advanced prostate cancer received ethics approval in November 2025, and its Phase 1 study is expected to start in Q4 2025.
Nov 20, 2025, 11:18 AM
Radiopharm Theranostics receives approval for Phase 1 therapeutic trial of RAD 402
RADX
New Projects/Investments
- Radiopharm Theranostics Limited has received Bellberry Human Research Ethics Committee (HREC) approval in Australia to initiate its First-In-Human (FIH) Phase 1 clinical trial for RAD 402.
- RAD 402 is a Kallikrein Related Peptidase 3 (KLK3)-targeting radiotherapeutic intended for the treatment of metastatic or locally advanced prostate cancer.
- The trial will utilize RAD 402, an anti-KLK3 monoclonal antibody radiolabelled with the radionuclide 161Tb, making it the first company-sponsored therapeutic trial using 161Tb.
Nov 18, 2025, 11:07 AM
Radiopharm Theranostics Announces 50% Enrollment in Phase 2b Trial of RAD101
RADX
New Projects/Investments
- Radiopharm Theranostics announced 50% patient enrollment in its Phase 2b clinical trial evaluating RAD101 imaging in brain metastases.
- Early patient data from the trial showed significant and selective tumor uptake in brain metastases, which is intended to help distinguish tumor recurrence from radiation necrosis.
- The company anticipates completing enrollment and releasing topline data in the first half of 2026.
- RAD101 has received U.S. FDA Fast Track Designation for distinguishing recurrent disease from treatment effects in brain metastases.
Nov 17, 2025, 1:00 PM
Radiopharm Theranostics Director Riccardo Canevari Increases Shareholding
RADX
Board Change
- Riccardo Canevari, a director of Radiopharm Theranostics Limited, increased his indirect interest in the company's shares through an on-market trade on October 30, 2025.
- He acquired 1,500,000 ordinary fully paid shares at a price of $0.025 per share.
- Following this transaction, Riccardo Canevari's indirect shareholding increased from 1,150,000 shares to 2,650,000 shares, bringing his total interest in shares to 22,679,986 and 110,949,299 options.
Nov 3, 2025, 1:00 PM
Radiopharm Theranostics Reports Q1 2026 Financials and Clinical Progress
RADX
Earnings
New Projects/Investments
Guidance Update
- Radiopharm Theranostics reported a quarter-end cash balance of A$19.04 million as of September 30, 2025, with net cash outflows from operating activities totaling A$9.29 million for the quarter.
- Subsequent to the quarter, the company completed an A$35 million institutional placement and launched an A$5 million Share Purchase Plan, which, combined with existing cash, is expected to extend its funding runway into 2027.
- The company received IND approval from the FDA to initiate a Phase I therapeutic clinical study for Betabart (RV-01), a radiopharmaceutical therapy targeting B7H3, with the study planned to commence in the fourth quarter of 2025.
- Positive clinical updates were provided across four programs, including encouraging results from the RAD 101 Phase 2b imaging study and higher-than-expected tumor uptake in the RAD 202 Phase 1 'HEAT' trial.
Oct 28, 2025, 12:00 PM
Radiopharm Theranostics Completes A$35M Placement and Provides Positive Clinical Updates
RADX
New Projects/Investments
- Radiopharm Theranostics Ltd (RADX) completed an A$35 million institutional private placement and launched an A$5 million Share Purchase Plan (SPP), raising approximately A$40 million. Lantheus Holdings, Inc. invested A$7.6 million (US$5.0 million) in the placement, increasing its shareholding to 14.5%.
- With an existing cash balance of A$19 million as of September 30, 2025, the company now has A$59 million in total funds, extending its funding runway into 2027. These funds are primarily allocated to clinical trials (A$34 million) and drug manufacturing (A$6 million).
- RADX reported positive clinical updates across four programs (RAD 101, RAD 202, RAD 204, RAD 301), with interim data showing promising results. Key milestones include topline results for RAD 101 by H1 2026 and data for RAD 202 by year-end 2025. The company also plans to initiate Phase 1 trials for RV01 and RAD402 by year-end 2025.
Oct 20, 2025, 10:46 AM
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