Radiopharm Theranostics reports Fiscal Year 2025 Financial Results and Business Update
Radiopharm Theranostics (NASDAQ: RADX), a clinical-stage biopharmaceutical company, reported significant progress across its radiopharmaceutical pipeline for FY2025. Key developments include FDA Fast Track Designation for RAD101 for brain metastases treatment differentiation, positive DSMC recommendation for RAD204 dose escalation to 60mCi, and advancement in the Phase 1 'HEAT' trial of RAD202 for HER2-positive tumors.
The company maintains a strong financial position with cash balance of $29.12 million, up from $18.58 million year-over-year, providing runway through mid-2026. Notable achievements include IND clearance for RV-01, strategic supply agreements with ITM and Cyclotek for radioisotopes, and progression across multiple clinical trials with data readouts expected in H2 2025.
Radiopharm Theranostics (NASDAQ: RADX), una società biofarmaceutica in fase clinica, ha riportato progressi significativi nel suo portafoglio di radiofarmaci per l'anno fiscale 2025. Tra gli sviluppi chiave figurano la designazione Fast Track FDA per RAD101 per il trattamento delle metastasi cerebrali, la raccomandazione positiva del DSMC per l'incremento della dose di RAD204 a 60mCi e l'avanzamento della sperimentazione di Fase 1 'HEAT' di RAD202 per tumori HER2-positivi.
La società mantiene una solida posizione finanziaria con un saldo di cassa di 29,12 milioni di dollari, in aumento rispetto ai 18,58 milioni dell'anno precedente, garantendo liquidità fino a metà 2026. Tra i risultati più rilevanti vi sono l'approvazione IND per RV-01, accordi strategici di fornitura con ITM e Cyclotek per radioisotopi e il progresso in diversi trial clinici con dati attesi nella seconda metà del 2025.
Radiopharm Theranostics (NASDAQ: RADX), una empresa biofarmacéutica en etapa clínica, informó avances significativos en su cartera de radiofármacos para el año fiscal 2025. Los desarrollos clave incluyen la designación Fast Track de la FDA para RAD101 para el tratamiento de metástasis cerebrales, la recomendación positiva del DSMC para la escalada de dosis de RAD204 a 60 mCi y el avance en el ensayo de Fase 1 'HEAT' de RAD202 para tumores HER2 positivos.
La compañía mantiene una sólida posición financiera con un saldo de efectivo de 29,12 millones de dólares, superior a los 18,58 millones del año anterior, lo que le proporciona fondos hasta mediados de 2026. Logros notables incluyen la aprobación IND para RV-01, acuerdos estratégicos de suministro con ITM y Cyclotek para radioisótopos y el progreso en múltiples ensayos clínicos con datos esperados en la segunda mitad de 2025.
Radiopharm Theranostics (NASDAQ: RADX)는 임상 단계의 바이오제약 회사로서 2025 회계연도 라디오파마슈티컬 파이프라인에서 중요한 진전을 보고했습니다. 주요 개발 사항으로는 뇌 전이 치료를 위한 RAD101의 FDA 패스트 트랙 지정, RAD204 용량을 60mCi로 증량하는 DSMC의 긍정적 권고, HER2 양성 종양에 대한 RAD202의 1상 'HEAT' 임상시험 진행이 포함됩니다.
회사는 2,912만 달러의 현금 보유고를 유지하며 전년 대비 1,858만 달러에서 증가하여 2026년 중반까지 운영 자금을 확보하고 있습니다. 주목할 만한 성과로는 RV-01에 대한 IND 승인, ITM 및 Cyclotek과의 방사성 동위원소 공급 전략적 계약, 그리고 2025년 하반기에 데이터 공개가 예정된 다수의 임상시험 진행이 있습니다.
Radiopharm Theranostics (NASDAQ : RADX), une entreprise biopharmaceutique en phase clinique, a annoncé des progrès significatifs dans son portefeuille de radiopharmaceutiques pour l'exercice 2025. Les développements clés comprennent la désignation Fast Track de la FDA pour RAD101 dans le traitement des métastases cérébrales, la recommandation positive du DSMC pour l'augmentation de dose de RAD204 à 60 mCi, ainsi que l'avancement de l'essai de phase 1 'HEAT' de RAD202 pour les tumeurs HER2-positives.
L'entreprise conserve une solide position financière avec un solde de trésorerie de 29,12 millions de dollars, en hausse par rapport à 18,58 millions l'année précédente, assurant une visibilité financière jusqu'à mi-2026. Parmi les réalisations notables figurent l'autorisation IND pour RV-01, des accords stratégiques d'approvisionnement avec ITM et Cyclotek pour les radio-isotopes, ainsi que des progrès dans plusieurs essais cliniques avec des résultats attendus au second semestre 2025.
Radiopharm Theranostics (NASDAQ: RADX), ein biopharmazeutisches Unternehmen in der klinischen Phase, meldete bedeutende Fortschritte in seiner Radiopharma-Pipeline für das Geschäftsjahr 2025. Zu den wichtigsten Entwicklungen zählen die FDA Fast Track-Zulassung für RAD101 zur Behandlung von Hirnmetastasen, die positive DSMC-Empfehlung für die Dosissteigerung von RAD204 auf 60 mCi und die Fortschritte in der Phase-1-Studie 'HEAT' von RAD202 bei HER2-positiven Tumoren.
Das Unternehmen verfügt über eine solide finanzielle Basis mit einem Barguthaben von 29,12 Millionen US-Dollar, gegenüber 18,58 Millionen US-Dollar im Vorjahr, was den Betrieb bis Mitte 2026 sichert. Zu den bemerkenswerten Erfolgen zählen die IND-Freigabe für RV-01, strategische Liefervereinbarungen mit ITM und Cyclotek für Radioisotope sowie Fortschritte in mehreren klinischen Studien mit Datenauswertungen, die für die zweite Hälfte 2025 erwartet werden.
- None.
- Net cash outflows from operating activities totaled $36.67M
- Most clinical programs still in early phases (Phase 1/2)
- Multiple concurrent clinical trials requiring significant ongoing capital investment
Insights
Radiopharm shows promising clinical progress across multiple radiopharmaceutical candidates with key regulatory advancement and sufficient funding through mid-2026.
Radiopharm Theranostics is demonstrating meaningful clinical momentum across its radiopharmaceutical pipeline, with several significant developments that strengthen its position in targeted cancer therapeutics. The Data and Safety Monitoring Committee's recommendation to escalate the 177Lu-RAD204 dose to 60mCi (from the planned 40mCi) is particularly encouraging, suggesting a favorable safety profile that could potentially improve efficacy outcomes. This PD-L1 targeting radiotherapeutic is expanding into multiple tumor types, indicating broad potential applicability.
The initiation of the Phase 1 HEAT trial for 177Lu-RAD202 targeting HER2-positive tumors represents another important advancement, especially considering HER2 is a clinically validated target across multiple cancers. Their diagnostic asset 18F-RAD101 received FDA Fast Track Designation for distinguishing between recurrent disease and treatment effects in brain metastases – a critical unmet need in neuro-oncology where current imaging modalities often struggle with this differentiation.
The company's preclinical assets also show promise, particularly the Lu177-B7H3-mAb (RV-01) which received FDA IND clearance and targets B7-H3, a marker associated with poor prognosis in multiple cancer types. The secured radioisotope supply agreements with ITM and Cyclotek are strategically important, as reliable access to medical radioisotopes is essential for clinical development in this space.
Financially, Radiopharm has strengthened its position with
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 over90% 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: 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
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Website – https://radiopharmtheranostics.com/
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LinkedIn – https://www.linkedin.com/company/radiopharm-theranostics/
InvestorHub – https://investorhub.radiopharmtheranostics.com/
FAQ
What are the key financial results for Radiopharm Theranostics (RADX) in FY2025?
What progress has RADX made with its RAD204 clinical trial?
What is the significance of the FDA Fast Track Designation for RAD101?
What are the upcoming milestones for Radiopharm Theranostics in 2025?
What strategic partnerships has RADX secured for radioisotope supply?
