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RADX

Radiopharm TheranosticsF
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-07-22
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Investor releaseQuarter not tagged2026-07-22

Radiopharm Theranostics Announces Positive Phase 2b Trial Results of RAD 101 for Diagnosis of Brain Metastases

GlobeNewswire
RAD101 PET demonstrated 93% concordance with MRI across all evaluable lesions, meeting the trial's primary endpoint. 14 patients with available data from six-month follow-up and biopsy show preliminary 86% (12/14) Sensitivity (secondary objective). Specificity data will be available in Q4 2026. The Company plans to advance RAD101 into a U.S. Phase 3 pivotal trial in Q4 2026 The imaging Brain Metastases total addressable market is ~$600+m for which there is no currently approved PET product SYDNEY, July 22, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced positive data from all thirty evaluable patients in the Phase 2b trial of RAD101 in participants with suspected recurrence of brain metastases after radiotherapy. RAD101 is Radiopharm’s novel imaging small molecule targeting fatty acid synthase (FASN) radiolabelled with Fluorine-18 for the diagnosis of suspected recurrent brain metastases from solid tumors of different origins. The data from these findings will be used to support the initiation of a pivotal multi-center, global Phase 3 imaging trial. The analysis of the imaging data for all assessed lesions showed 93% concordance between MRI and PET imaging of brain metastases in this patient population with suspected recurrence. The results showed substantial and selective tumor uptake of RAD101. Images confirm metabolic activity in PET compared to equivocal MRI findings. Additionally, 14 patients with evaluable six-month follow-up and/or biopsy data show preliminary 86% sensitivity, representing a strong positive trend (a secondary objective). Sensitivity measures an imaging test's ability to correctly identify patients with disease. “The entirety of this dataset captures the strength and potential of RAD101 to address a difficult diagnostic challenge in neuro-oncology,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “Achieving the primary endpoint provides strong validation of our approach and supports the advancement of RAD101 into an intended registrational Phase 3 program. We look forward to continuing our discussions with the U.S. FDA as we finalize the study design and work toward bringing a more precise diagnostic tool t…Read full document

RAD101 PET demonstrated 93% concordance with MRI across all evaluable lesions, meeting the trial's primary endpoint. 14 patients with available data from six-month follow-up and biopsy show preliminary 86% (12/14) Sensitivity (secondary objective). Specificity data will be available in Q4 2026. The Company plans to advance RAD101 into a U.S. Phase 3 pivotal trial in Q4 2026 The imaging Brain Metastases total addressable market is ~$600+m for which there is no currently approved PET product SYDNEY, July 22, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced positive data from all thirty evaluable patients in the Phase 2b trial of RAD101 in participants with suspected recurrence of brain metastases after radiotherapy. RAD101 is Radiopharm’s novel imaging small molecule targeting fatty acid synthase (FASN) radiolabelled with Fluorine-18 for the diagnosis of suspected recurrent brain metastases from solid tumors of different origins. The data from these findings will be used to support the initiation of a pivotal multi-center, global Phase 3 imaging trial. The analysis of the imaging data for all assessed lesions showed 93% concordance between MRI and PET imaging of brain metastases in this patient population with suspected recurrence. The results showed substantial and selective tumor uptake of RAD101. Images confirm metabolic activity in PET compared to equivocal MRI findings. Additionally, 14 patients with evaluable six-month follow-up and/or biopsy data show preliminary 86% sensitivity, representing a strong positive trend (a secondary objective). Sensitivity measures an imaging test's ability to correctly identify patients with disease. “The entirety of this dataset captures the strength and potential of RAD101 to address a difficult diagnostic challenge in neuro-oncology,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “Achieving the primary endpoint provides strong validation of our approach and supports the advancement of RAD101 into an intended registrational Phase 3 program. We look forward to continuing our discussions with the U.S. FDA as we finalize the study design and work toward bringing a more precise diagnostic tool to patients and clinicians. With this positive data in hand, we have a strong foundation from which to launch our pivotal trial.” In the U.S. alone, there are more than 300,000 patients diagnosed annually with cerebral metastases. The incidence of Intracranial Metastatic Disease (IMD) continues to increase, in part, due to improvements in systemic therapy resulting in a more durable control of the tumors outside of the central nervous system. Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimise patient care.1 RAD101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease. The company also recently announced a partnership with Siemens Healthineers, who will manufacture and distribute doses of 18F-labeled RAD101 to support Radiopharm’s upcoming Phase 3 pivotal trial in the U.S. About the Phase 2b Clinical Trial of RAD101 The U.S. multicenter, open-label, single arm Phase 2b clinical trial is assessing the diagnosticperformance of 18F-RAD101 in 30 evaluable individuals with suspected recurrent brain metastases from solid tumors of different origins. The primary objective of the study is concordance between 18F-RAD101 PET-positive lesions and those equivocal lesions seen in conventional imaging (MRI with gadolinium) in participants with known brain metastases and suspected relapse after stereotactic radiosurgery (SRS). Secondary endpoints are sensitivity and specificity of RAD101 in identifying tumor recurrence versus radiation-associated changes in previously SRS-treated brain metastases. About RAD101 RAD101 is the Company’s novel imaging small molecule that selectively binds to fatty acid synthase (FASN), a multi-enzyme protein that catalyses de-novo fatty acid synthesis and is overexpressed in cerebral metastasis from solid tumors. Targeting FASN activity may allow for the more accurate detection of cancer cells in the CNS, representing a clinically relevant method for the imaging of brain metastases. Positive data from the Imperial College of London’s Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases (both SRS pre-treated and treatment naïve patients) showed significant tumor uptake that was independent from the tumor of origin. The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall-survival, warranting larger studies. 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 2b and five Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain metastases. Learn more at radiopharmtheranostics.com Authorised on behalf of the Radiopharm Theranostics board of directors by Chairman Paul Hopper. For more information:Riccardo CanevariCEO & Managing DirectorP: +1 862 309 0293E: [email protected] Anne Marie FieldsPrecision AQ (Formerly Stern IR)E: [email protected] MediaMatt WrightNWR CommunicationsP: +61 451 896 420E: [email protected] ____________________________________1 A hybrid [18F]fluoropivalate PET-multiparametric MRI to detect and characterise brain tumour metastases based on a permissive environment for monocarboxylate transport | European Journal of Nuclear Medicine and Molecular Imaging

Investor releaseQuarter not tagged2026-05-12

RADX: Fiscal 3Q:26 Cash Flow Report

Zacks Small Cap Research
By John Vandermosten, CFA NASDAQ: RADX READ THE FULL RADX RESEARCH REPORT Fiscal 3Q:26 Activity and Cash Flows Radiopharm Theranostics (NASDAQ: RADX) released its Quarterly Activities and Cash Report for its third quarter ending March 31st, 2026. Beyond the review of cash sources and uses for the first nine months of fiscal year 2026, the report summarizes the status of each of the company’s pipeline assets. Since the previous quarterly financial update, Radiopharm presented a second set of interim data for its RAD101 imaging agent and advanced RAD202 to the next dose level. Two Phase I trials were started: RV01 as part of the Radiopharm Ventures collaboration and RAD402 in advanced prostate cancer. We include our previously published summary of the RAD101 second interim data analysis, followed by an update on Radiopharm’s other programs. Financial Performance During its third quarter, Radiopharm’s operating activities consumed $14.9 million for the three-month period ending March 31st, 2026. Cash used in financing activities was $284,000 for the same three-month period.[1] For the fiscal third quarter: There were $443,000 in cash receipts from customers; Research and development consumed $11.8 million related to the management of multiple clinical trials; Advertising and marketing costs consumed $108,000; Staff costs consumed $2.4 million; Administration and corporate costs were $1.6 million; Interest received totaled $152,000; Other miscellaneous cash operating contributions, consisting of interest and Goods and Services Tax (GST) refunds, total $554,000; No cash flows categorized as investing activities were recognized; Cash used in financing activities was $284,000 related to transaction costs from securities issuance. As of March 31st, 2026, Radiopharm held $19.2 million in cash compared to $19.0 million at the end of FY:25 last June. Cash burn for 3Q:26 was $14.9 million, while cash burn for the first nine months of the fiscal year was $37.6 million. Radiopharm is expecting over $8 million over the next four months from tax rebates and also has an at-the-money (ATM) facility in place with Leerink Partners with capacity of up to US$50 million to support capital needs until 2028. Corporate Milestones[2] Ownership increase in Radiopharm Ventures (RV01) to 87.5% - January 2026 RAD101 Phase II trial fully enrolled – February 2026 RV01 first patient dosed in…Read full document

By John Vandermosten, CFA NASDAQ: RADX READ THE FULL RADX RESEARCH REPORT Fiscal 3Q:26 Activity and Cash Flows Radiopharm Theranostics (NASDAQ: RADX) released its Quarterly Activities and Cash Report for its third quarter ending March 31st, 2026. Beyond the review of cash sources and uses for the first nine months of fiscal year 2026, the report summarizes the status of each of the company’s pipeline assets. Since the previous quarterly financial update, Radiopharm presented a second set of interim data for its RAD101 imaging agent and advanced RAD202 to the next dose level. Two Phase I trials were started: RV01 as part of the Radiopharm Ventures collaboration and RAD402 in advanced prostate cancer. We include our previously published summary of the RAD101 second interim data analysis, followed by an update on Radiopharm’s other programs. Financial Performance During its third quarter, Radiopharm’s operating activities consumed $14.9 million for the three-month period ending March 31st, 2026. Cash used in financing activities was $284,000 for the same three-month period.[1] For the fiscal third quarter: There were $443,000 in cash receipts from customers; Research and development consumed $11.8 million related to the management of multiple clinical trials; Advertising and marketing costs consumed $108,000; Staff costs consumed $2.4 million; Administration and corporate costs were $1.6 million; Interest received totaled $152,000; Other miscellaneous cash operating contributions, consisting of interest and Goods and Services Tax (GST) refunds, total $554,000; No cash flows categorized as investing activities were recognized; Cash used in financing activities was $284,000 related to transaction costs from securities issuance. As of March 31st, 2026, Radiopharm held $19.2 million in cash compared to $19.0 million at the end of FY:25 last June. Cash burn for 3Q:26 was $14.9 million, while cash burn for the first nine months of the fiscal year was $37.6 million. Radiopharm is expecting over $8 million over the next four months from tax rebates and also has an at-the-money (ATM) facility in place with Leerink Partners with capacity of up to US$50 million to support capital needs until 2028. Corporate Milestones[2] Ownership increase in Radiopharm Ventures (RV01) to 87.5% - January 2026 RAD101 Phase II trial fully enrolled – February 2026 RV01 first patient dosed in Phase I/IIa study – February 2026 RAD402 Phase I trial initiation in metastatic or locally advanced prostate cancer – 1Q:26 RAD101 interim data readout – March 2026 First patient dosed for RAD402 Phase I trial – March 2026 Last patient dosed in RAD101 Phase IIb trial – April 2026 RAD202 presentation at AACR April 2026 RAD101 Phase II readout – 1H:26 RAD202 Phase I data release (2 cohorts) – 1H:26 RAD202 Phase I interim readout and Cohort 3 enrollment complete – mid-2026 RAD204 Phase I Cohort 3 readout – mid-2026 Dosing of last patient in Phase I RAD301 trial – mid-2026 RAD202 Phase I last patient dosed – 2H:26 RAD301 Phase II trial start – 2H:26 RAD101 Phase III launch – 2H:26 RAD202 interim readout – mid-2026 RAD204 start Phase II study - 2027 RAD301 Phase II trial complete – 2H:27 RAD204 complete Phase II study – 4Q:27 RAD101 NDA submission – 2028 Board Changes At the end of the 2025 calendar year, Radiopharm appointed Bruce Goodwin as Non-Executive Director of the company’s board. Along with his appointment, Phillip Hains and Dr. Leila Alland retired from the board at the end of 2025. Mr. Hains will continue with his roles as Chief Financial Officer and Company Secretary. Summary Radiopharm issues its 3Q:26 cash flow report and updates investors on the status of its pipeline programs. Radiopharm provided another interim look at its RAD101 trial in late March, capturing data for the first 20 patients. Results showed 90% concordance between RAD101 PET imaging and MRI findings. The trial has since been fully enrolled, evaluating a total of 32 patients. Management is preparing for the upcoming Phase III and should meet with the FDA in the next few months. Other programs are also advancing, including RAD202 and RAD204, which both moved to the next highest dose. The ASX filing provided many of the anticipated milestones over the next year and highlighted safety and uptake conclusions for other programs, including RAD402 and RAD301. In the financial sphere, Radiopharm burned about $15 million in the quarter and almost $38 million for the first nine months of the fiscal year. With cash of just over $19 million, the company will rely on just over $8 million in anticipated research and development tax credits to get it through the remainder of FY:26. The company has also executed an ATM agreement last December with Leerink Partners that will support fundraising at the margins. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives payments totaling a maximum fee of up to $50,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE. ________________________ [1] Note that results are reported in Australian Dollars. The most recent exchange rate between Australian Dollars and U.S. Dollars is $1.39 AUD to $1.00 USD. [2] Quarters and halves listed in the milestones section are calendar quarters and halves in contrast to Radiopharm’s June 30 fiscal year end.

Investor releaseQuarter not tagged2026-02-02

RADX Fiscal 1H:26 Activity and Cash Flows

Zacks Small Cap Research
By John Vandermosten, CFA NASDAQ:RADX READ THE FULL RADX RESEARCH REPORT Radiopharm Theranostics (NASDAQ:RADX) released its first half 2026 cash flow statement on January 28th, 2026. The company has a June 30 fiscal year end and reports audited financial statements semiannually. We expect the half year report, prepared under International Financial Reporting Standards (IFRS), to be issued next month. The period captured in this report is from July 1st to December 31st 2025. Beyond the review of cash sources and uses for the first half of fiscal year 2026, the report summarizes the status of each of the company’s pipeline assets. Since the previous financial update, Radiopharm has presented interim data for its RAD101 imaging agent and reiterated upcoming milestones for RAD202 and RAD204, and anticipated delivery of data. Radiopharm’s operating activities consumed ($22.7) million for the six-month period ending December 31st, 2025. Cash from financing activities was $33.4 million for the same six-month period.[1] For the first six months of the reporting period ending December 31st, 2025: There were no cash receipts from customers; Research and development consumed ($19.4) million related to the management of multiple clinical trials; Advertising and marketing costs consumed ($228,000); Staff costs consumed ($6.3) million; Administration and corporate costs were ($1.9) million; Other miscellaneous cash operating contributions total $5.1 million, mostly impacted by $4.5 million in government grants and tax incentives; Other payments categorized as investing activities consumed ($5.3) million for payments of license fees; Financing cash was $33.4 million from the issuance of equity securities, partially offset by transaction costs. As of December 31st, 2025, Radiopharm held $34.5 million in cash compared to $19.0 million at the end of FY:25. Cash burn for 1H:26 was ($28.0) million. RAD101 Phase IIb Interim Analysis Radiopharm Theranostics reported the primary endpoint for its RAD101 trial in an interim analysis on December 15th. Following the release, management held a webcast which featured the company’s CEO, Riccardo Canevari, Chief Medical Officer Dr. Dimitris Voliotis, and the principal investigator on the RAD101 trial, Dr. Harshad Kulkarni. Topline from the release indicated that 92% (11/12) of evaluated patients treated with RAD101 achieved concordance wi…Read full document

By John Vandermosten, CFA NASDAQ:RADX READ THE FULL RADX RESEARCH REPORT Radiopharm Theranostics (NASDAQ:RADX) released its first half 2026 cash flow statement on January 28th, 2026. The company has a June 30 fiscal year end and reports audited financial statements semiannually. We expect the half year report, prepared under International Financial Reporting Standards (IFRS), to be issued next month. The period captured in this report is from July 1st to December 31st 2025. Beyond the review of cash sources and uses for the first half of fiscal year 2026, the report summarizes the status of each of the company’s pipeline assets. Since the previous financial update, Radiopharm has presented interim data for its RAD101 imaging agent and reiterated upcoming milestones for RAD202 and RAD204, and anticipated delivery of data. Radiopharm’s operating activities consumed ($22.7) million for the six-month period ending December 31st, 2025. Cash from financing activities was $33.4 million for the same six-month period.[1] For the first six months of the reporting period ending December 31st, 2025: There were no cash receipts from customers; Research and development consumed ($19.4) million related to the management of multiple clinical trials; Advertising and marketing costs consumed ($228,000); Staff costs consumed ($6.3) million; Administration and corporate costs were ($1.9) million; Other miscellaneous cash operating contributions total $5.1 million, mostly impacted by $4.5 million in government grants and tax incentives; Other payments categorized as investing activities consumed ($5.3) million for payments of license fees; Financing cash was $33.4 million from the issuance of equity securities, partially offset by transaction costs. As of December 31st, 2025, Radiopharm held $34.5 million in cash compared to $19.0 million at the end of FY:25. Cash burn for 1H:26 was ($28.0) million. RAD101 Phase IIb Interim Analysis Radiopharm Theranostics reported the primary endpoint for its RAD101 trial in an interim analysis on December 15th. Following the release, management held a webcast which featured the company’s CEO, Riccardo Canevari, Chief Medical Officer Dr. Dimitris Voliotis, and the principal investigator on the RAD101 trial, Dr. Harshad Kulkarni. Topline from the release indicated that 92% (11/12) of evaluated patients treated with RAD101 achieved concordance with Magnetic Resonance Imaging (MRI) imaging, which was the primary endpoint. RAD101 uptake was selective and significant in suspected or recurrent brain metastases. RAD202 RAD202, a Lu-177 bound nanobody targeting HER2, is being evaluated in the active HEAT trial for treatment of patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors. RAD202 was cleared to move to the next dose level of 75 mCi by the Data Safety and Monitoring Committee (DSMC). The study has completed dosing of the 30 mCi cohort and data from the first three patients in this cohort show significant tumor uptake in HER2 positive tumors. The principal investigators observed a favorable safety profile with no drug-related adverse events reported. RAD204 RAD204 is a Lu-177 bound nanobody targeting PD-L1 being evaluated for treatment of 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. The first and second cohorts of the Phase I study are complete, and the third cohort is cleared to start at a 90 mCi dose of Lu-177. In the 30 mCi cohort, two of three patients achieved stable disease for 5.5 months compared to standard of care at 3.5 months. Tumor uptake for RAD204 in the first six patients in cohorts one and two shows results in line with previous imaging studies with the antibody. Investigators observe a reassuring safety profile, reporting no drug-related adverse events. RV01 RV01, also known as Betabart, is a monoclonal antibody targeting the 4Ig isoform of B7-H3. B7-H3 is highly expressed in a variety of tumors. RV01 is the subject of a joint venture between Radiopharm and MD Anderson Cancer Center. In January 2026, Radiopharm increased its ownership in the JV to 87.5% to reflect increasing interest in the asset. Last July, the FDA cleared RV01’s investigational new drug (IND) application, readying the candidate to begin a Phase I trial. Radiopharm expects to dose the first patients in 1Q:26. RV01 has a competitor in the B7-H3 targeting arena. Aktis Oncology (AKTS) recently held an initial public offering last month raising more than $365 million. A portion of these funds will be allocated to a Phase Ib trial for AKY-2519, which is an Ac-225 miniprotein radioconjugate targeting B7-H3. The marker is expressed in a wide variety of cancers, including colorectal, prostate, breast, and others.[2] A notable difference between the two candidates is the radioisotope used. While RV01 uses a Lutetium-177 radionuclide, which emits beta and gamma particles, AKY-2519 employs the alpha emitter Ac-225. Beta radiation has a low linear energy transfer with a medium sphere of impact, with the benefit of killing nearby tumor cells that do not express B7-H3. Alpha emitters are high-energy, short-range particles that cause double-strand DNA breaks and are more appropriate for precision treatment. AKY-2519 is now conducting investigational new drug (IND) enabling studies, while RV01 is the subject of a Phase I study. We anticipate that RV01 will dose its first patients in the next few weeks, giving a slight edge to Radiopharm on timing. RAD402 RAD402 binds a kallikrein-related peptidase 3 (KLK3) targeting antibody to a Terbium 161 isotope for treating prostate cancer. It will soon advance from the preclinical stage, where it demonstrated strong tumor targeting, limited bone marrow uptake, and a hepatic excretion profile consistent with other monoclonal antibodies in murine xenografts. Last November, RAD402 was granted clearance in Australia to begin a Phase I study for treatment of metastatic or locally advanced prostate cancer. The trial is expected to begin in 1Q:26. RAD301 RAD301 is the subject of a Phase I imaging trial in pancreatic ductal adenocarcinoma (PDAC). It is a Ga-68 radionuclide bound to an antibody targeting αvB-integrin. αvB-integrin is a cellular marker for tumor invasion and metastatic growth, which correlates with decreased survival in several carcinomas, particularly pancreatic. The candidate has been awarded an orphan drug designation by the FDA. Corporate Milestones[3] Oliver Sartor appointed to Scientific Advisory Board – July 2025 FDA clears IND for Phase I RV01 study – July 2025 Request for ethics approval for Phase I RAD402 trial - 3Q:25 Filing of FY:25 Annual Report – September 2025 RAD204 data from first two cohorts – 2H:25 RAD101 patient recruitment – 2H:25 Launch of Phase I RV01 (Betabart) trial – 4Q:25 Begin dosing patients in Phase I RAD 402 trial – 4Q:25 RAD301 Phase I last patient dosed – 4Q:25 RAD202 report data from first two cohorts - end of 2025 Dosing of first patients in RV01 trial – 1Q:26 RAD101 Phase III trial launch – 2H:26 RAD101 Phase II trial fully enrolled – February 2026 RAD402 Phase I trial initiation in metastatic or locally advanced prostate cancer – 1Q:26 RAD101 Phase II readout – 1H:26 RAD202 Phase I data release (2 cohorts) – 1H:26 RAD204 Phase I dose escalation complete – mid-2026 RAD202 Phase I last patient dosed – 2H:26 RAD301 Phase II trial start – 2H:26 RAD101 Phase III launch – 2H:26 RAD204 start Phase II study - 2027 RAD301 Phase II trial complete – 2H:27 RAD204 complete Phase II study – 4Q:27 RAD101 NDA submission - 2028 Summary Radiopharm issues its 1H:26 cash flow report and updates investors on the status of its pipeline programs. Just seven weeks ago, Radiopharm provided an interim look at its Phase IIb RAD101 trial, generating impressive results for its primary endpoint. Results demonstrated a 92% concordance between F-18 pivalate measured by PET and MRI for the first twelve patients in its trial. While not final data, these results in 11 of 12 patients show that RAD101 in PET scans provides valuable information to oncologists that can be used to determine optimal treatment. In many cases, results from MRI are inconclusive and may delay necessary treatment or lead to further and unnecessary SRS treatment. As for next milestones, we expect to see a further readout for RAD101 in 1H:26 and the launch of a Phase III study in 2H:26. We also expect to see interim data from the Phase I RAD202 and RAD204 studies in the middle of 2026. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives payments totaling a maximum fee of up to $50,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE. ________________________ [1] Note that results are reported in Australian Dollars. The most recent exchange rate between Australian Dollars and U.S. Dollars is $1.44 AUD to $1.00 USD. [2] The Human Protein Atlas. CD276 (B7-H3). Expression in cancer. [3] Quarters and halves listed in the milestones section are calendar quarters and halves in contrast to Radiopharm’s June 30 fiscal year end.

Investor releaseQuarter not tagged2026-01-28

Radiopharm Theranostics Reports Half-Year Financial Results and Business Updates

GlobeNewswire
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, Jan. 28, 2026 (GLOBE NEWSWIRE) -- 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 December 31, 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 enroll…Read full document

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, Jan. 28, 2026 (GLOBE NEWSWIRE) -- 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 December 31, 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. 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’s 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. 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 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. 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 December 31, 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: [email protected] Anne Marie Fields Precision AQ (formerly Stern IR) E: [email protected] Media: Matt Wright NWR Communications P: +61 451 896 420 E: [email protected] 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/

Investor releaseQuarter not tagged2025-09-21

Radiopharm Theranostics Full Year 2025 Earnings: Beats Expectations

Simply Wall St.

Net loss: AU$38.3m (loss narrowed by 20% from FY 2024). AU$0.018 loss per share (improved from AU$0.12 loss in FY 2024). AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. Phase III: 3. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates by 75%. Earnings per share (EPS) also surpassed analyst estimates by 17%. Looking ahead, revenue is forecast to grow 50% p.a. on average during the next 3 years, compared to a 8.0% growth forecast for the Biotechs industry in Australia. Performance of the Australian Biotechs industry. The company's share price is broadly unchanged from a week ago. We should say that we've discovered 3 warning signs for Radiopharm Theranostics (1 is a bit concerning!) that you should be aware of before investing here. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Investor releaseQuarter not tagged2025-07-29

Radiopharm Theranostics reports Fiscal Year 2025 Financial Results and Business Update

GlobeNewswire
On track to complete enrollment of first two cohorts of RAD204 following positive recommendation from DSMC to escalate dose to 60mCi of Lu177 On track to complete enrollment of the first cohort of Phase 1 ‘HEAT’ trial of RAD202 for treatment of advanced HER2-positive solid tumors U.S. FDA granted Fast Track Designation for RAD101 to distinguish between recurrent disease and the treatment effect of brain metastases Confirmed guidance of Cash Runway through to mid-2026 SYDNEY, Australia, July 29, 2025 (GLOBE NEWSWIRE) -- 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 fiscal year ended June 30, 2025, and provided a corporate update. “During the last quarter, we continued to execute with discipline and momentum across our pipeline, advancing key milestones within both our therapeutic and diagnostic radiopharmaceutical programs,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “We are encouraged by the pace and efficiency of our development efforts. Notable achievements this quarter include the FDA’s Fast Track Designation for RAD101, DSMC clearance to proceed with higher dosing of RAD204, procurement of multiple supply agreements for key radioisotopes and meaningful clinical progress across our clinical pipeline. These milestones reflect our unwavering commitment to delivering precise, targeted radiopharmaceutical solutions that have the potential to transform cancer care. Looking ahead, we anticipate a number of important clinical and corporate milestones throughout the remainder of 2025.” Program and Business Updates 177Lu-RAD204 – Nanobody targeting PD-L1 radiolabeled with Lutetium 177 In May 2025, Radiopharm shared updates from an independent Data and Safety Monitoring Committee (DSMC), which concluded that Cohort 2 of the Phase 1 study of 177Lu-RAD204 could proceed at a higher dose level. The higher dose level was determined to be 60mCi of Lu177 rather than the 40mCi previously assumed in the protocol. The second cohort of patients is expected to be fully enrolled in the coming weeks and will include expansion to multiple tumor types including Non-Small Cell Lung Cancer, Small-Cell Lung Cancer, Triple-Negative B…Read full document

On track to complete enrollment of first two cohorts of RAD204 following positive recommendation from DSMC to escalate dose to 60mCi of Lu177 On track to complete enrollment of the first cohort of Phase 1 ‘HEAT’ trial of RAD202 for treatment of advanced HER2-positive solid tumors U.S. FDA granted Fast Track Designation for RAD101 to distinguish between recurrent disease and the treatment effect of brain metastases Confirmed guidance of Cash Runway through to mid-2026 SYDNEY, Australia, July 29, 2025 (GLOBE NEWSWIRE) -- 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 fiscal year ended June 30, 2025, and provided a corporate update. “During the last quarter, we continued to execute with discipline and momentum across our pipeline, advancing key milestones within both our therapeutic and diagnostic radiopharmaceutical programs,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “We are encouraged by the pace and efficiency of our development efforts. Notable achievements this quarter include the FDA’s Fast Track Designation for RAD101, DSMC clearance to proceed with higher dosing of RAD204, procurement of multiple supply agreements for key radioisotopes and meaningful clinical progress across our clinical pipeline. These milestones reflect our unwavering commitment to delivering precise, targeted radiopharmaceutical solutions that have the potential to transform cancer care. Looking ahead, we anticipate a number of important clinical and corporate milestones throughout the remainder of 2025.” Program and Business Updates 177Lu-RAD204 – Nanobody targeting PD-L1 radiolabeled with Lutetium 177 In May 2025, Radiopharm shared updates from an independent Data and Safety Monitoring Committee (DSMC), which concluded that Cohort 2 of the Phase 1 study of 177Lu-RAD204 could proceed at a higher dose level. The higher dose level was determined to be 60mCi of Lu177 rather than the 40mCi previously assumed in the protocol. The second cohort of patients is expected to be fully enrolled in the coming weeks and will include expansion to multiple tumor types including Non-Small Cell Lung Cancer, Small-Cell Lung Cancer, Triple-Negative Breast Cancer, Cutaneous Melanoma, Head and Neck Squamous Cell Carcinoma and Endometrial Cancer. Data from the first two cohorts of patients in the Phase 1 study of 177Lu-RAD204 are expected in the second half of 2025. 177Lu-RAD202 – Nanobody targeting HER2 radiolabeled with Lutetium 177 In June 2025, Radiopharm dosed the first patient in its Phase 1 HEAT clinical trial of 177Lu-RAD202. The open-label Phase 1 HEAT clinical trial is a dose escalation trial of 177Lu-RAD202, designed to determine the recommended Phase 2 dose and to evaluate the safety and preliminary clinical activity in individuals with Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in a wide variety of advanced solid tumors. Preliminary data from the first two cohorts of patients in the Phase 1 study of 177Lu-RAD202 are expected by the end of 2025. Ten HER2-positive breast cancer patients were previously dosed in a Phase 1 diagnostic study of RAD202, which demonstrated clinical proof-of-concept as well as the safety and distribution of RAD202. 18F-RAD101 – Small molecule targeting fatty acid synthase radiolabeled with Fluorine-18 In June 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for 18F-RAD101 to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origins. In April 2025, Radiopharm dosed the first patient in the U.S. Phase 2b imaging study of 18F-RAD101. The multicenter, open-label, single arm Phase 2b clinical trial is evaluating the diagnostic performance of 18F-RAD101 in 30 participants with confirmed recurrent brain metastases. Interim Data from the Phase 2b study are expected in the second half of 2025. Ga68-RAD301 – Peptide targeting αvΒ-integrin radiolabeled with Gallium 68 Enrollment is ongoing in the Phase 1a open label clinical study of the safety and biokinetics of Ga68-RAD301 in healthy human volunteers and participants with pancreatic ductal adenocarcinoma (PDAC). Preclinical Assets In June 2025, Radiopharm reported preclinical data for the Lu177-B7H3-mAb (a joint venture with MD Anderson Cancer Centre), RV-01, demonstrating favorable biodistribution and high tumor uptake. RV-01 is a B7-H3-targeted radiopharmaceutical therapy designed with strong affinity for the 4Ig isoform of B7H3 that is highly expressed in tumors and not in healthy tissues and which when highly expressed is associated with poor prognosis in many cancer types. RV-01 is being developed in partnership with MD Anderson Cancer Center. In July 2025, Radiopharm announced FDA clearance of its Investigational New Drug (IND) application for RV-01 enabling a pathway to Phase 1 First-In-Human study initiation in the fourth quarter of 2025. Radiopharm plans to submit a package for ethics approval to begin a Phase 1 clinical trial in prostate cancer for 161Tb-RAD 402, its anti-kallikrein related peptidase 3 monoclonal antibody radiotherapeutic labelled with Terbium 161. The Company expects to begin dosing subjects in this clinical trial in the fourth quarter of 2025 in Australia. Business Updates Radiopharm and ITM Isotope Technologies Munich SE (ITM) entered a supply agreement that will provide Radiopharm with ITM’s medical radioisotope, non-carrier-added Lutetium-177. The supply agreement enables usage in the clinical trials of the Lutetium-177-based molecules in the Company’s development pipeline, including RAD204, RAD202 and RV-01, for the treatment of solid tumors. Radiopharm and Cyclotek entered a supply agreement in which Cyclotek will produce and provide doses of 161Tb-RAD 402 to support Radiopharm’s upcoming Phase 1 clinical trial in prostate cancer in Australia. Financial update The following is a summary of the Appendix 4C Cash Flow Report: The year-end closing cash balance was $29.12 million, a rise from $18.58 million at the close of the previous year. Net cash outflows from operating activities for the year totaled $36.67 million. Direct Research and Development expenditure and Staff Costs comprised over 90% of the total operating expenditure for the year and quarter. On July 16, 2025, the Company reported the receipt of $4.58 million for the research and development tax incentive and associated interest for the 2024 financial year. 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 three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain. 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: [email protected] Anne Marie Fields Precision AQ (formerly Stern IR) E: [email protected] Media: Matt Wright NWR Communications P: +61 451 896 420 E: [email protected] 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/

As of 2026-07-25 • Updated weeklySource: Earnings sourceIngestion runbook