Supports plans to advance the RV01 program to first-in-human therapeutic basket study in solid tumour cancers Data completes preclinical package for Investigational New Drug submission in mid-2025 with Phase 1 therapeutic study initiation expected in 4Q25 SYDNEY, Australia, June 02, 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 hig ...

Radiopharmaceutical R&D Update May 28, 2025 Mike Rossi President and Chief Executive Officer Natalie Tucker SVP, Radiopharmaceutical Business Unit Head Norman LaFrance, MD Chief Medical and Development Officer Additional Team Members Available During Q&A Disclaimer Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the US Private Securities Litigation Reform Act of 1995. The forward-looking statements involve substantial risks and uncertainties. All statem ...

Molecular Partners (MOLN) FY 2025 Conference May 20, 2025 03:30 PM ET Speaker0 Good afternoon, and thanks for tuning into the HCW, BioConnect conference. I'm Robert Burns, the managing director and senior biotech analyst at HC Wainwright. And I'm joined by Seth Lewis, head of IR for MyPlay Partners. Seth, thank you for joining us today. Speaker1 Really appreciate the invite. Glad to be here. Awesome. So for Speaker0 those who might be unfamiliar with the company, its pipeline, as well as the Platts thing? S ...

Core Insights - Cellectar Biosciences is seeking conditional marketing approval from the European Medicines Agency (EMA) for its product Iopofosine I 131 based on the promising results from the CLOVER WaM Phase 2 study, which showed a major response rate of 59.0% for BTKi-treated patients [1][2] - The company has a pipeline of radiotherapeutic candidates, including alpha- and Auger-emitting radioconjugates, and is exploring various funding pathways to advance its assets [2][5] Corporate Update - Cellectar plans to present the Phase 2 CLOVER WaM clinical trial data to the EMA in Q2 2025 and expects a response regarding the regulatory pathway by the end of Q3 2025 [2] - The company is evaluating strategic alternatives, including mergers, acquisitions, and partnerships, with Oppenheimer & Co. Inc. serving as the exclusive financial advisor [5] Financial Highlights - As of March 31, 2025, Cellectar had cash and cash equivalents of $13.9 million, down from $23.3 million as of December 31, 2024 [5][14] - Research and Development (R&D) expenses for Q1 2025 were approximately $3.4 million, a decrease from $7.1 million in Q1 2024, primarily due to reduced patient follow-up activities [5][15] - General and Administrative (G&A) expenses for Q1 2025 were approximately $3.0 million, down from $4.9 million in the same period of 2024 [5][15] - The net loss for Q1 2025 was $6.6 million, or $0.14 per share, compared to a net loss of $26.6 million, or $0.91 per share, in Q1 2024 [5][16] Product Pipeline - The company's lead assets include Iopofosine I 131, CLR 121225 (an actinium-225 based program for solid tumors), and CLR 121125 (an iodine-125 Auger-emitting program) [8][9] - Iopofosine I 131 has received multiple designations from the FDA, including six Orphan Drug and two Fast Track Designations for various cancer indications [9]

Core Insights - IBA has launched CASSY, a compact synthesizer aimed at revolutionizing radiopharmaceutical production processes, particularly for radiometals and radiotracers [1][5]. Group 1: Product Features - CASSY enhances efficiency in radiopharmaceutical production through seamless integration into laboratory workflows, user-friendly interfaces, and versatility for purification and radiolabelling [2]. - The compact design allows stacking of up to six units in a single standard hot cell, optimizing space and increasing production potential, making it suitable for laboratories with limited space [3]. - CASSY is adaptable for a wide range of radioisotopes, catering to diverse research and clinical needs, and is positioned for future innovations like radiotheranostics [3]. Group 2: Components and Technology - CASSY utilizes specific cassettes developed by Fluidomica, which include all necessary components for radioisotope and radiopharmaceutical manufacturing processes [4]. - The cassettes are designed for single use, ensuring efficiency and reliability in production [4]. Group 3: Company Commitment and Leadership - Charles Kumps, President of IBA RadioPharma Solutions, emphasized that CASSY represents a significant advancement in theranostic innovation, enhancing the quality and reliability of radiopharmaceutical manufacturing [5]. - IBA continues to lead the radiopharmaceutical industry through its commitment to innovation and improving healthcare outcomes globally [5]. Group 4: Company Overview - IBA is recognized as the world leader in particle accelerator technology and is a major supplier in proton therapy, industrial sterilization, and dosimetry, employing approximately 2,100 people worldwide [7]. - The company is listed on the EURONEXT stock exchange and is a certified B Corporation, meeting high standards of social and environmental performance [8].

First of several clinical updates through mid-2026 accepted for presentation at the 2025 American Society of Clinical Oncology Annual Meeting, with recruitment progressing for all three of our clinical stage potential new medicines based on our next generation targeted radiopharmaceutical technology platformEnrollment ongoing for VMT-α-NET, a next generation SSTR2-targeting potential new medicine, with 40 patients enrolled through end of April 2025 in Cohort 2 of the Phase 1/2a trial in neuroendocrine tumor ...

Lantheus (LNTH) Q1 2025 Earnings Call May 07, 2025 08:00 AM ET Speaker0 Good morning. Welcome to Lantheus First Quarter twenty twenty five Conference Call. All lines have been placed on mute. This call is being recorded and a replay will be available in the Investors section of the company's website approximately two hours after the completion of the call and will be archived for at least thirty days. I'll now turn the call over to Mark Kanarney, Vice President of Investor Relations. Mark? Speaker1 Thank yo ...

For more information: Investors: Riccardo Canevari CEO & Managing Director P: +1 862 309 0293 E: rc@radiopharmtheranostics.com 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 pepti ...

Core Insights - Lantheus Holdings, Inc. reported a slight increase in worldwide revenue for Q1 2025, totaling $372.8 million, compared to $370.0 million in Q1 2024, reflecting a 0.8% growth [3][5] - The company experienced a significant decline in GAAP net income, which fell to $72.9 million from $131.1 million year-over-year, representing a 44.3% decrease [3][5] - Adjusted net income also decreased by 7.5% to $109.5 million, with adjusted fully diluted earnings per share dropping to $1.53 from $1.69, a 9.5% decline [3][5] Financial Performance - GAAP fully diluted earnings per share for Q1 2025 were $1.02, down from $1.87 in Q1 2024, marking a 45.5% decrease [3][5] - Free cash flow for the first quarter was reported at $98.8 million [5] - Operating income decreased by 4.3% to $102.1 million, while adjusted operating income fell by 7.1% to $144.3 million [6][27] Business Development - The company completed the acquisition of Evergreen Theragnostics and is in the process of acquiring Life Molecular Imaging, which is expected to close soon [2][10] - Lantheus announced a planned divestiture of its SPECT business to focus on PET radiodiagnostics and microbubbles [10] - Positive data from two pivotal studies of MK-6240 were reported, with plans to file a New Drug Application (NDA) in Q3 2025 [10] Revenue Breakdown - Sales of PYLARIFY were $257.7 million, a slight decrease of 0.5% from the previous year [6][24] - DEFINITY sales increased by 3.5% to $79.2 million [6][24] - Total revenues from strategic partnerships and other sources rose significantly by 65.1% to $10.7 million [24] Guidance and Outlook - The company provided updated guidance for FY 2025, projecting revenue between $1.550 billion and $1.585 billion, and adjusted fully diluted EPS between $6.60 and $6.70 [11]

Enables Lantheus to focus on innovative radiopharmaceuticals, while maximizing the value of its SPECT business "This transaction enables Lantheus to concentrate our efforts on enhancing our radiopharmaceutical leadership focused on innovative diagnostics and therapeutics," said Brian Markison, CEO of Lantheus. "While the SPECT business has been a foundational part of Lantheus' nearly 70-year history, we believe it is the right time for this business and its outstanding employees to continue driving success ...