RAD 402 is a humanized IgG1 internalized by prostate cells, binding KLK3 with high affinity Tb-161 antitumor activity driven by the dual emission of beta particles and Auger electrons SYDNEY, Nov. 18, 2025 (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 that it has been granted Bellberry Human Research Ethics Co ...

Financial Data and Key Metrics Changes - The company ended Q3 2025 with cash and cash equivalents of $12.6 million, down from $23.3 million as of December 31, 2024 [12] - Net loss for Q3 2025 was $4.4 million or $1.41 per share, compared to a net loss of $14.7 million or $11.18 per basic share in Q3 2024 [14] Business Line Data and Key Metrics Changes - Research and development expenses decreased to approximately $2.5 million in Q3 2025 from approximately $5.5 million in Q3 2024, attributed to lower costs related to the Clover-WM study [13] - General and administrative expenses also decreased to $2.3 million in Q3 2025 from $7.8 million in Q3 2024, primarily due to reduced pre-commercialization efforts and lower personnel costs [13] Market Data and Key Metrics Changes - The company received confirmation from the EMA that it is eligible to file for conditional marketing approval in the EU based on the Clover-WM study, which could bring iopofosine to patients as early as 2027 [5][6] - The FDA has requested 12-month follow-up data on all patients from the Clover-WM study, which is now available, allowing the company to plan for an NDA submission under the accelerated approval pathway [6] Company Strategy and Development Direction - The company is focused on advancing its lead asset, iopofosine I 131, as a first-in-class radioconjugate therapy for Waldenstrom's macroglobulinemia, with a clear regulatory strategy in both the EU and the U.S. [4][5] - Active discussions are ongoing with potential partners to secure non-dilutive capital and commercial expertise while preserving long-term shareholder value [8] - The company is also advancing its next-generation radiopharmaceutical pipeline, including CLR 125 and CLR 225, targeting solid tumors with significant unmet needs [9][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory strategy and the potential for iopofosine I 131, highlighting a high probability of success for conditional marketing authorization [5][6] - The company anticipates multiple near-term milestones that position it for rapid growth, including the initiation of the CLR 125 phase 1b clinical trial and filing for iopofosine's conditional marketing approval [10][23] Other Important Information - The company raised approximately $12.7 million in recent financings to strengthen its balance sheet and support clinical trials [10] - The CLR 125 phase 1b study will evaluate safety and tolerability, with initial response assessments expected throughout 2026 [19] Q&A Session Summary Question: Can you help us understand the specific data considered by the EMA for the recommendation? - Management provided insights into the comprehensive data package submitted to the EMA, emphasizing the focus on post-BTKi patient populations and the high response rates observed in the Clover-WM study [27][30] Question: How much resources are needed to initiate the trial in the U.S.? - Management estimated the total cost of the study at approximately $40 million, with $10 million needed to initiate the trial and $15 million for full patient enrollment [35][39] Question: Can you comment on the evolution of partnering discussions since the EU regulatory update? - Management indicated that interest and activity in partnering discussions have increased as the company approaches regulatory approval, with ongoing discussions with various parties [57][63] Question: Where are you in the Clover-WM follow-up and what is the PFS? - Management confirmed that the most recent data from January indicated a PFS of 11.4 months, with 12 months of follow-up data now available [78][85]

Financial Data and Key Metrics Changes - Consolidated net revenue for Q3 2025 was $384 million, an increase of 1.4% year-over-year [15] - Gross profit margin decreased to 63.5%, down 471 basis points due to unfavorable pricing impacts and integration costs from acquisitions [16] - Net income for Q3 was $27.8 million, with adjusted net income at $85.7 million, a decrease of 30.9% [17] - Operating cash flow totaled $105.3 million, down $69.8 million from the prior year [18] Business Line Data and Key Metrics Changes - PYLARIFY sales were $240.6 million, down 7.4% year-over-year, with U.S. volumes up 3.3% [15][7] - Precision diagnostic revenue increased by 25% to $129.7 million, with DEFINITY sales at $81.8 million, up 6.3% [15] - Neuraceq contributed $20.4 million in sales, consistent with expectations [10] Market Data and Key Metrics Changes - The U.S. Alzheimer's disease radiodiagnostic market is expected to grow significantly, driven by rising prevalence and expanded PET imaging guidelines [10] - The market for PSMA agents is stabilizing, with PYLARIFY maintaining its market leadership despite competition [9][48] Company Strategy and Development Direction - The company is preparing for the launch of a new F18 PSMA PET formulation expected in 2026, which aims to enhance production efficiency and patient access [8][9] - A leadership transition plan has been announced, with Mary Anne Heino stepping in as interim CEO [3][4] - The company is focused on executing its commercial strategy for prostate cancer and expanding its product pipeline in oncology, neurology, and cardiology [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of the company, particularly in the radiopharmaceutical sector [22][23] - The company anticipates low single-digit volume growth for PYLARIFY in the remainder of 2025, offset by price compression [9] - Management noted that the competitive landscape remains challenging but is optimistic about maintaining market share through service excellence and clinical differentiation [48] Other Important Information - The company completed the acquisition of Life Molecular Imaging for approximately $309 million, enhancing its capabilities in the neuroscience space [18][61] - The effective tax rate for the quarter was 26.9% [17] Q&A Session Summary Question: Strategies for PYLARIFY and Neuraceq - Management noted stabilization in the PSMA market and increasing customer return to PYLARIFY, with a focus on availability and expansion for Neuraceq [25][26] Question: 2026 Guidance and Market Resets - Management refrained from providing specific 2026 guidance but indicated positive trends for PYLARIFY and Neuraceq [29][31] Question: Management Changes - The CEO's retirement was described as a personal decision, with a seamless transition to the interim CEO, who has extensive experience with the company [33][35] Question: Competitive Landscape in Alzheimer's Imaging - MK-6240 is positioned as a second-generation tau agent with significant competitive advantages, although the market remains immature [40][42] Question: Pricing Stabilization Factors - Management highlighted disciplined pricing strategies and superior service as key factors in achieving market stabilization [45][48] Question: Medicare Hospital Outpatient Rule - Management expressed uncertainty about immediate changes but anticipated potential meaningful changes to ASP by 2027 [54][56]

Financial Data and Key Metrics Changes - Consolidated net revenue for Q3 2025 was $384 million, an increase of 1.4% year-over-year [14] - Gross profit margin decreased to 63.5%, down 471 basis points due to unfavorable pricing impacts and inclusion of new acquisitions [15] - Net income for the quarter was $27.8 million, with adjusted net income at $85.7 million, a decrease of 30.9% [16] - Operating cash flow totaled $105.3 million, down $69.8 million from the prior year [16] - Free cash flow was $94.7 million, $64.6 million lower than the prior year [17] Business Line Data and Key Metrics Changes - Sales from Polarify were $240.6 million, down approximately 7% year-over-year, with U.S. volumes up 3.3% [6][14] - Precision diagnostic revenue increased by 25% to $129.7 million, with Definity sales at $81.8 million, up 6.3% [14] - NeuroSeq contributed $20.4 million in sales during the quarter [14] - Strategic partnerships and other revenue decreased by 10.1% to $13.7 million, primarily due to a decline in revenue from MK-6240 [14] Market Data and Key Metrics Changes - The U.S. Alzheimer's disease radiodiagnostic market is expected to grow significantly, driven by rising prevalence and expanded PET imaging guidelines [9] - The market for PSMA PET imaging is projected to approach $3.5 billion by the end of the decade [36] Company Strategy and Development Direction - The company is focused on executing its commercial strategy to maximize the long-term value of its prostate cancer franchise [6] - A leadership transition plan has been announced, with Mary Anne Heino assuming the role of Executive Chairperson and interim CEO [3][4] - The company is preparing for the expected launch of its new F18 PSMA PET formulation in 2026, which is anticipated to enhance production efficiency and patient access [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the stabilization of the PSMA market and the ongoing growth of Polarify and NeuroSeq [22][25] - The company is actively monitoring competitive dynamics and is optimistic about maintaining its market leadership [34] - Management does not anticipate significant changes in the reimbursement landscape for 2026 but expects potential changes in 2027 [37] Other Important Information - The company completed the acquisition of Life Molecular Imaging for approximately $309 million [17] - The effective tax rate for the quarter was 26.9% [16] Q&A Session Summary Question: Strategies for Polarify and NeuroSeq - Management noted stabilization in the PSMA market and increasing customer return to Polarify, with a focus on availability and expansion for NeuroSeq [22][23] Question: 2026 Guidance and Market Resets - Management refrained from providing specific 2026 guidance but indicated positive trends for Polarify and NeuroSeq [25] Question: Management Changes - The CEO's retirement was described as a personal decision, with a seamless transition to Mary Anne Heino, who has extensive experience with the company [26][28] Question: Competitive Landscape in Alzheimer's Imaging - MK-6240 is positioned as a second-generation tau agent with significant competitive advantages, although the market remains immature [31][32] Question: Pricing Stabilization Factors - Management highlighted disciplined pricing strategies and superior service as key factors in achieving market stabilization [34] Question: Future Market Dynamics - The company is monitoring the development of new competitors but remains confident in its sensitivity and specificity advantages [36]

Summary of Radiopharm Theranostics Conference Call Company Overview - **Company Name**: Radiopharm Theranostics - **Ticker Symbols**: ASX (Australia), NASDAQ: RADX - **Founded**: 2021 in Australia - **Core Business**: Radiopharmaceutical imaging and therapies - **Management Team**: Primarily U.S.-based, located on the East Coast - **Public Listing**: Dual-listed on ASX and NASDAQ since December 2024 [2][4] Key Business Strategies - **Differentiation**: Focus on unique mechanisms of action in radiopharmaceuticals, avoiding common targets like PSMA, SSTR2, and FAP [3] - **Clinical Development**: Four therapeutic molecules and one imaging molecule currently in clinical stages [2][5] - **Supply Chain**: Established a secure and redundant supply chain, with strategic partnerships [4] Strategic Partnerships - **Lantheus**: Co-development agreement and largest shareholder (12% stake) [4] - **MD Anderson Cancer Center**: Joint venture for developing new radiopharmaceuticals [4][21] Product Pipeline - **RAD101**: Imaging agent for brain metastasis, currently in Phase IIB trials with 12 out of 30 patients enrolled. Expected completion by Q1 2026 [5][6][10] - **RAD204**: Therapeutic targeting PD-L1, in dose escalation trials, with promising early results [6][15] - **RAD202**: Therapeutic targeting HER2, also in dose escalation trials, showing significant tumor uptake [18][19] - **B7-H3**: Emerging mechanism for multiple solid tumors, IND approval received, expected to start Phase I soon [8][9] - **KLK3**: Prostate cancer drug using Tb-161 isotope, expected to start Phase I soon [9] Market Potential - **RAD101 Market Assessment**: Estimated total addressable market of $500 million to $700 million in the U.S. alone, with a projected market share of 94% due to lack of competition in brain metastasis imaging [26][27] - **Patient Population**: 300,000 new patients diagnosed annually with brain metastasis [10] Financials and Capital Raise - **Recent Capital Raise**: Conducted to extend cash runway into Q1 2027, following a previous raise in June 2024 [5][20] - **Cash Position**: Current cash runway is eight months, prompting the recent capital raise [20][27] Clinical Trial Updates - **RAD101**: Primary endpoint focuses on concordance with MRI, with secondary endpoints assessing additional lesion detection [23] - **RAD204 and RAD202**: Expected readouts in mid-2026 and end of 2026, respectively [25] Conclusion - **Outlook**: Positive early signals from clinical trials, with a strong focus on expanding the use of radiopharmaceuticals in oncology [25]

Core Insights - Telix Pharmaceuticals has initiated a Phase 1 clinical trial for TLX090, a therapeutic radiopharmaceutical aimed at treating pain from bone metastasis in cancer patients [1][2]. Company Overview - Telix Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic radiopharmaceuticals [7][8]. - The company is headquartered in Melbourne, Australia, with operations in multiple countries including the United States, United Kingdom, and Japan [7]. Clinical Trial Details - The SOLACE trial will enroll up to 33 patients with advanced cancer that has metastasized to the bony skeleton, evaluating pharmacokinetics, dosimetry, safety, and pain relief [2][3]. - TLX090 aims to provide a non-opioid solution for patients suffering from bone pain, addressing a significant unmet medical need [2][4]. Market Need and Treatment Comparison - Pain from osteoblastic bone metastases affects approximately 400,000 new cases annually, with up to 90% of metastatic prostate cancer patients experiencing this pain [3][4]. - Current treatments, including opioids and external beam radiation therapy, often provide only partial relief and come with significant drawbacks [4][5]. - TLX090 is positioned as a cost-effective, systemic, and targeted alternative that may offer up to 3-4 months of pain relief with the potential for repeat doses [5][6]. Expert Commentary - Medical professionals involved in the SOLACE trial express optimism about TLX090's potential to improve pain management and quality of life for patients with metastatic bone pain [6].

NASDAQ: RADX / ASX: RAD CLINICAL UPDATE AND CAPITAL RAISING OCTOBER 20th , 2025 For personal use only Notice & Disclaimer The information in this presentation does not constitute personal investment advice. The presentation is not intended to be comprehensive or provide all information required by investors to make an informed decision on any investment in Radiopharm Theranostics Ltd ACN 647 877 889 (Company). In preparing this presentation, the Company did not take into account the investment objectives, f ...

Core Insights - Telix Pharmaceuticals reported a significant increase in Q3 2025 revenue, reaching approximately $206 million, which is a 53% increase year-over-year [3][6] - The company has raised its full-year 2025 revenue guidance to between $800 million and $820 million, reflecting strong performance in its PSMA imaging products [6][16] - Gozellix has received full reimbursement from the Centers for Medicare and Medicaid Services (CMS) in the U.S., effective October 1, 2025, enhancing its market position [6][15] Financial Performance - Q3 2025 group revenue was $206 million, compared to $135 million in Q3 2024, marking a 53% increase [3] - PSMA imaging revenue for Q3 2025 was $155 million, up 17% from $132 million in Q3 2024 [3] - RLS third-party revenue reached $47 million, with a notable increase from zero in Q3 2024 [3] Business Highlights - The company has two FDA-approved PSMA imaging agents, which are expected to enhance market share across various customer segments [4] - Gozellix's reimbursement status is expected to improve production flexibility and customer choice [4] - Telix has commenced commercial launches of Illuccix in multiple European markets, including the UK, Germany, and France [6][15] Clinical Development - The first patients have been dosed in the BiPASS™ trial, which aims to evaluate MRI combined with PSMA-PET imaging for prostate cancer diagnosis [6][15] - The ProstACT Global Phase 3 trial has opened for enrollment in several countries, including Australia, New Zealand, and Canada [7] - TLX250 has received ethics approval to commence a pivotal trial in advanced metastatic clear cell renal cell carcinoma [7] Regulatory and Corporate Updates - Telix has received radiation licenses for its manufacturing facilities in North Melbourne and Yokohama, preparing for operational readiness [12] - The company successfully executed a buy-out of remaining variable payments related to the acquisition of Advanced Nuclear Medicine Ingredients (ANMI) due to strong sales performance [13] - Telix plans to resubmit the New Drug Application for its brain cancer imaging candidate, Pixclara, during Q4 2025 [10]

Core Viewpoint - Perspective Therapeutics, Inc. has initiated the treatment of the first patient in the second cohort of its Phase 1/2a trial for the radiopharmaceutical [Pb]PSV359, targeting solid tumors expressing fibroblast activation protein alpha (FAP-α) [1][3] Group 1: Clinical Trial Details - The second cohort of the trial involves patients receiving [Pb]PSV359 at a dose of 5.0 mCi for up to four doses every eight weeks, with a recommendation from the Safety Monitoring Committee to evaluate higher doses based on initial patient responses [2][5] - The primary objective of the trial is to assess the safety and tolerability of various doses of [Pb]PSV359, aiming to determine the recommended Phase 2 dose for further study [5] Group 2: Mechanism and Targeting - [Pb]PSV359 is designed to target tumor sites expressing FAP-α, which is associated with several prevalent solid tumors, providing a potential treatment option for patients with limited alternatives [4][6] - FAP-α is predominantly expressed on cancer-associated fibroblasts in the tumor microenvironment and is linked to poor prognosis in various solid tumors, including pancreatic and colorectal cancers [6] Group 3: Company Overview - Perspective Therapeutics, Inc. specializes in developing radiopharmaceuticals that utilize alpha-emitting isotopes to deliver targeted radiation to cancer cells, enhancing treatment efficacy while minimizing toxicity [7] - The company is also advancing complementary imaging diagnostics that utilize the same targeting moieties, facilitating personalized treatment approaches [7][8]

Core Insights - Monopar Therapeutics Inc. announced the publication of a peer-reviewed Letter to the Editor in the Journal of Hepatology, discussing the effects of ALXN1840 on copper balance in patients with Wilson disease [1][2] Group 1: Study Findings - The earlier conclusion from the Phase 2 ALXN1840-WD-204 study indicated that ALXN1840 did not promote copper excretion due to methodological limitations in the copper balance equation [2] - By comparing pre- and post-treatment data, the analysis showed that ALXN1840 statistically significantly improved copper balance, leading to increased copper excretion [2] - Key findings from the study include: - For the 15 mg/day treatment period, the mean daily difference in copper balance was -0.367 mg (p=0.005) - For the overall treatment period, including dose changes, the mean daily difference was -0.289 mg (p=0.023) - The cumulative mean change from baseline was -6.08 mg (95% CI: -10.18 mg to -1.98 mg) [5] Group 2: Company Overview - Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for unmet medical needs, including late-stage ALXN1840 for Wilson disease and various radiopharmaceutical programs [8]