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 mile ...

Core Insights - Radiopharm Theranostics has increased its ownership stake in Radiopharm Ventures, LLC from 75% to 87.5% as the joint venture progresses in its cancer therapeutic pipeline [1][2] Group 1: Joint Venture and Ownership - The increase in ownership percentage reflects the promising progress of the joint venture, particularly with the B7H3 candidate and other preclinical assets [2] - Radiopharm Ventures, LLC was launched in September 2022 in collaboration with The University of Texas MD Anderson Cancer Center to develop novel radiopharmaceutical products for cancer treatment [5] Group 2: Product Development and Clinical Trials - The lead candidate, Betabart (RV01), is a monoclonal antibody targeting B7H3, which has received Investigational New Drug clearance from the U.S. FDA and is expected to begin dosing the first patient in Q1 2026 [3][7] - Two additional preclinical candidates have shown early positive results and are moving towards final candidate selection, with applications across multiple solid tumor types [4][7] Group 3: Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs, with a pipeline that includes one Phase 2 and four Phase 1 trials in various solid tumor cancers [6]

Core Insights - The interim analysis of RAD 101 shows that 92% of evaluable patients achieved concordance with MRI imaging, indicating significant tumor uptake in brain metastases [1][2] - The company plans to initiate a pivotal study by the end of 2026, bolstered by the positive interim data from the Phase 2b trial [3] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs [1][10] - The company is listed on ASX (RAD) and NASDAQ (RADX) and has a pipeline that includes one Phase 2 and four Phase 1 trials targeting various solid tumors [10] Clinical Trial Details - The Phase 2b clinical trial is evaluating the diagnostic performance of RAD 101 in 30 individuals with confirmed recurrent brain metastases from solid tumors [8] - The primary objective is to assess concordance between RAD 101 positive lesions and those seen in conventional MRI imaging [8] Market Opportunity - The U.S. market opportunity for RAD 101 is estimated to exceed $500 million annually, positioning it among the top three imaging agents in the market [3] - Over 300,000 patients are diagnosed with brain metastases annually in the U.S., highlighting a significant patient population for RAD 101 [4][3] Technology and Innovation - RAD 101 is a novel imaging agent targeting fatty acid synthase (FASN), which is overexpressed in many solid tumors, including brain metastases [9] - The integration of RAD 101 PET with standard MRI could enhance patient management and treatment decisions for brain metastases [3]

Core Insights - Radiopharm Theranostics has received approval from the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate a First-In-Human (FIH) Phase 1 clinical trial for RAD 402, a radiotherapeutic targeting KLK3 for metastatic or locally advanced prostate cancer [1][4] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs, listed on ASX (RAD) and NASDAQ (RADX) [5] - The company has a diverse pipeline that includes one Phase 2 and four Phase 1 trials targeting various solid tumors, including lung, breast, and brain metastases [5] Product Details - RAD 402 is an anti-KLK3 monoclonal antibody radiolabelled with the radionuclide 161Tb, designed for the treatment of prostate cancer, with KLK3 being a key biomarker for the disease [2] - Preclinical studies have demonstrated strong tumor targeting and a favorable excretion profile for RAD 402, supporting its potential effectiveness [3] Clinical Development - The initiation of the Phase 1 trial for RAD 402 is significant as it is reportedly the first company-sponsored therapeutic trial utilizing 161Tb, highlighting the innovative approach of targeting KLK3 in advanced prostate cancer [4]

Core Insights - The Phase 2b clinical trial for RAD101 has reached a 50% patient enrollment milestone, indicating progress towards demonstrating its clinical benefits in differentiating tumor recurrence from radiation necrosis in brain metastasis patients [2][6] - Early patient data shows significant and selective tumor uptake in brain metastases, aligning with previous Phase 2a results, which may lead to a global Phase 3 registrational trial if confirmed [3][7] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs [1][9] - The company is listed on ASX (RAD) and NASDAQ (RADX), with a pipeline that includes one Phase 2 and four Phase 1 trials targeting various solid tumor cancers, including lung, breast, and brain metastases [9] Clinical Trial Details - The Phase 2b trial is a multicenter, open-label study evaluating the diagnostic performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain metastases from solid tumors [6] - The primary objective is to assess the concordance between 18F-RAD101 positive lesions and those identified through conventional imaging methods [6] Product Information - RAD101 is a novel imaging small molecule targeting fatty acid synthase (FASN), which is overexpressed in many solid tumors, including brain metastases [2][7] - The product has received FDA Fast Track Designation to help distinguish between recurrent disease and treatment effects in brain metastases [5]

Core Insights - Radiopharm Theranostics has completed enrollment for the second cohort in the Phase 1 trial of 177Lu-RAD204, which targets PD-L1 positive advanced cancers, marking a significant milestone for the company [1][2] - The Data and Safety Monitoring Committee has approved advancing to a higher dose of 90mCi for the third cohort of patients [2] - The trial aims to evaluate the safety, tolerability, biodistribution, radiation dosimetry, and preliminary anti-tumor activities of 177Lu-RAD204 in patients with metastatic solid tumors [2][3] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs [1][5] - The company is listed on both ASX (RAD) and NASDAQ (RADX) and has a diverse pipeline that includes one Phase 2 and four Phase 1 trials targeting various solid tumors [5] - The company’s technology platform spans peptides, small molecules, and monoclonal antibodies for cancer treatment [5] Product Details - 177Lu-RAD204 is a single-domain monoclonal antibody that targets PD-L1, which is overexpressed in many solid tumors, making it a promising therapeutic target [3][4] - Previous Phase 1 imaging data indicated that the diagnostic compound is safe and has acceptable dosimetry in NSCLC patients [3]

Core Insights - Radiopharm Theranostics is advancing its clinical programs with promising early data from multiple trials, indicating strong potential for its radiopharmaceutical pipeline [1][2][3] Clinical Trials and Data - Preliminary data from the Phase 2b trial of RAD 101 shows uptake in brain metastases from solid tumors, with topline results expected by H1 2026 [1][6] - The Phase 1 trial of RAD 202 (HER2) has shown higher than expected tumor uptake, with data from the second cohort anticipated by year-end 2025 [1][10] - RAD 204 (PD-L1) has demonstrated promising tumor uptake and stable disease in two out of three patients at the first dose level [5][11] - RAD 301 is being evaluated in a Phase 1 imaging trial for pancreatic cancer, with initial data supporting a move to a Phase 2 trial [8][12] Regulatory and Designation Updates - RAD 101 has received FDA Fast Track Designation to expedite its review process for patients with cerebral metastases [3] - RAD 301 has received Orphan Drug Designation from the FDA, highlighting its potential in treating pancreatic ductal adenocarcinoma [8] Company Strategy and Future Plans - The company plans to initiate Phase 1 trials for RV01 and RAD402 by year-end 2025, expanding its clinical portfolio to include four therapeutic candidates and two imaging agents [2] - The strategic execution of the company remains strong, with a focus on advancing multiple trials and achieving significant milestones [2][9]

Core Points - Radiopharm Theranostics Limited has successfully raised approximately A$35 million through a private placement of new shares at A$0.03 per share, with significant participation from institutional investors including Lantheus Holdings, Inc. [1][5][6] - The company will also conduct a Share Purchase Plan (SPP) to raise an additional A$5 million for existing eligible shareholders, maintaining the same terms as the placement [3][6]. Placement Details - The placement involves the issuance of approximately 1,167 million new fully paid ordinary shares, with Lantheus investing A$7.6 million, increasing its shareholding to 14.5% [5][6]. - Each placement subscriber will receive one free attaching option for every share subscribed, with an exercise price of A$0.039 and an expiration date of October 31, 2027 [2][10]. Use of Funds - The funds raised will be allocated as follows: A$6 million for drug manufacturing, A$34 million for clinical trials, and A$19 million for administration and working capital, extending the funding runway into 2027 [4][7][6]. Shareholder Approval - The second tranche of the placement, amounting to A$22.5 million, will require shareholder approval at an upcoming Extraordinary General Meeting (EGM) anticipated in early December 2025 [9][10].

Core Insights - CVS Pharmacy has successfully acquired select assets from Rite Aid, now serving over 9 million former Rite Aid and Bartell Drugs patients [1][2] - The acquisition includes 63 former Rite Aid and Bartell Drugs stores and the prescription files of 626 pharmacies across 15 states [2][4] - CVS Health has completed the conversion of these stores and is actively operating them [3] CVS Pharmacy's Strategy - The company aims to expand access to pharmacy care and enhance its retail presence in local communities [4] - CVS has distributed prescription files to nearby CVS locations, hired over 3,500 former Rite Aid employees, and invested in existing CVS locations for better service [4] Market Context - Rite Aid filed for Chapter 11 bankruptcy in May, following a previous restructuring that closed around 850 stores [5] - The company is in the process of selling its assets, with CVS, Walgreens, Albertsons, Kroger, and Giant Eagle among the bidders for its prescription files [5] Financial Performance - In the second quarter, CVS reported an 18% increase in same-store pharmacy sales, with prescription volumes up by 6% and retail script share reaching 27.8%, partly due to the closure of Rite Aid stores [6]

Core Insights - CVS Pharmacy has completed the acquisition of select Rite Aid and Bartell Drugs assets, enhancing its pharmacy services in the Pacific Northwest and serving millions of customers [1][2]. Expansion across the Pacific Northwest - CVS now operates 63 former Rite Aid and Bartell Drugs stores in Idaho, Oregon, and Washington [2]. - The company has acquired prescription files from 626 former Rite Aid and Bartell Drugs pharmacies across 15 states, allowing CVS to serve over nine million patients [2]. Recruitment and Investment to Support Pharmacy Operations - CVS has hired more than 3,500 former employees from Rite Aid and Bartell Drugs to maintain service standards and ensure timely prescription support [4]. - Targeted investments have been made in existing pharmacy locations to improve staff scheduling, recruitment, and training [4]. Transaction Finalised Following Bankruptcy Court Approval - The acquisition was approved by the US Bankruptcy Court for the District of New Jersey in May 2025, and the entire transaction was completed in under four months [6]. - The final store acquisitions were concluded on September 30, with locations in Bend, Oregon, and Bainbridge Island, Washington [6]. Key Factors in Acquisition Decisions - CVS prioritized convenience and access to essential prescriptions when selecting Rite Aid locations and prescription files for acquisition [7]. - Most CVS stores receiving transferred prescription files are within three miles of existing Rite Aid branches, with nearly half within one mile, minimizing disruption for affected patients and communities [7].