Core Insights - Telix Pharmaceuticals reported a significant increase in Q2 2025 revenue, reaching approximately $204 million, a 63% increase year-over-year, and reaffirmed its FY 2025 revenue guidance of $770 million to $800 million [3][6][22]. Financial Performance - Group revenue for Q2 2025 was $204 million, compared to $125 million in Q2 2024, marking a 63% increase. Revenue for Q1 2025 was $186 million, showing a 10% increase quarter-over-quarter [3][6]. - Global Illuccix® revenue was $154 million in Q2 2025, up 25% from $123 million in Q2 2024, and slightly increased by 2% from $151 million in Q1 2025 [3]. - RLS revenue reached $46 million in Q2 2025, with no revenue reported in Q2 2024, and a 39% increase from $33 million in Q1 2025 [3]. Business Highlights - Dose volumes for Illuccix rose 7% quarter-on-quarter in the U.S., indicating strong market demand despite competitive pricing pressures [4]. - The launch of Gozellix in the U.S. has commenced, with the product assigned a Level II HCPCS code, a key step towards reimbursement [6]. - The ProstACT Global Phase 3 trial achieved a milestone with all 30 patients consented for Part 1, and the trial is expanding into China, Japan, and Canada [7]. Therapeutics Development - TLX591 (Lu-rosopatamab tetraxetan) is progressing in its Phase 3 trial, with dosing completed for patients in two of the three arms [7]. - TLX592 (Ac-PSMA-RADmAb) has submitted an application for a Phase 1 study in Australia [7]. - TLX101 (I-iodofalan) received HREC approval in Australia for an international pivotal trial [7]. - TLX250 (¹⁷⁷Lu-DOTA-girentuximab) is enrolling patients in a Phase 1b/2 clinical trial for clear cell renal cell carcinoma [7]. Regulatory and Corporate Updates - Telix is cooperating with the U.S. SEC regarding a subpoena for documents related to its prostate cancer therapeutic candidates [11][12]. - The company has received country-level approvals for Illuccix in multiple European countries and is launching on a market-by-market basis [13]. - Telix has completed enrollment for the Illuccix China Phase 3 study, aiming for marketing authorization in Q4 2025 [13]. Manufacturing and R&D - Telix announced a GMP manufacturing facility in Yokohama, Japan, enhancing its global manufacturing strategy [14]. - The TMS facility in Brussels South, Belgium, has produced its first GMP commercial radiopharmaceutical doses [14]. - The company expects a 20% to 25% increase in R&D expenditure for FY 2025 compared to FY 2024 [22].

Zelenectide Pevedotin (Nectin-4 Targeting Bicycle Drug Conjugate) - Zelenectide pevedotin targets Nectin-4, which is highly expressed in many tumors, and is being studied as a potential treatment for multiple solid tumors including mUC, TNBC, and NSCLC[19, 20] - In the Duravelo-1 Ph1 study, zelenectide has shown a promising response and differentiated safety profile in 2L+ EV-naïve mUC, with an ORR of 45% (17/38 patients)[22, 26] - In the Duravelo-1 Ph1 study, zelenectide + pembrolizumab has shown an encouraging response in 1L cisplatin-ineligible mUC, with an ORR of 65% (13/20 patients) including a Complete Response of 25% (5/20 patients)[36, 38] - Patients with NECTIN4 gene amplification show an enhanced response to zelenectide in 2L+ TNBC and NSCLC, with ORRs of 57% (4/7) and 40% (2/5) respectively in NECTIN4-amplified patients[49, 55] - The company initiated the Duravelo-3 trial in March 2025 in NECTIN4-amplified breast cancer and plans to initiate Duravelo-4 and Duravelo-5 trials in 2H 2025 in NECTIN4-amplified NSCLC and multi-tumor respectively[60, 62] Bicycle Radioconjugates (BRC) - BRC molecules show selective tumor uptake and ideal PK across a range of targets and tumor models, including MT1-MMP, EphA2, and CD38[71, 72] - Early MT1-MMP-targeting BRC molecules show high tumor enrichment in PET imaging studies, with first human MT1-MMP imaging representative of data seen in 12 patients with various solid tumors[80, 83] - EphA2 is a tumor antigen that is widely expressed in many cancers, with 60% of pancreatic cancer and 58% of bladder cancer cases testing positive[101, 93] BT5528 (EphA2 Targeting BDC Molecule) - BT5528 demonstrated anti-tumor activity in patients with advanced solid tumors, particularly in mUC, with an ORR of 34% (10/29 patients) in all monotherapy dose escalation and expansion[119] - BT5528 delivers 10x more drug to the tumor compared to plasma in patients, demonstrating efficient and durable tumor MMAE delivery[112, 113] - In clinical trials, treatment-related adverse events of interest were of low frequency and severity, with peripheral neuropathy occurring in 20% (26/128) of patients and neutropenia in 10% (13/128) of patients[131] BT7480 (Bicycle TICA Molecule) - BT7480 was generally well-tolerated, with any grade treatment-related AEs occurring in 49% (19/39) of patients, the most common being fatigue (23%)[157, 159] - BT7480 showed preliminary antitumor activity in patients with advanced Nectin-4–associated solid tumors, with a clinical benefit rate of 38% (15/40 patients)[160, 161]

Financial Performance & Guidance - Lantheus' Q1 2025 revenues reached $372.8 million, reflecting a 0.8% increase[9] - The company's updated full-year 2025 revenue guidance is $1.55 billion to $1.585 billion[17] - The updated adjusted fully diluted EPS guidance for 2025 is $6.60 to $6.70[17] - As of March 31, 2025, Lantheus had $938.5 million in cash on hand and $750 million available in revolving credit[17, 18] Acquisitions & Divestments - Lantheus closed the acquisition of Evergreen Theragnostics in April 2025[9] - The company anticipates closing the acquisition of Life Molecular Imaging in Q2 2025[9] - Lantheus plans to finalize the divestment of its SPECT business by the end of 2025[9] Key Products & Market - PYLARIFY net sales were $257.7 million in Q1 2025, and it is the 1 utilized PSMA PET imaging agent[26, 24] - 99% of enrolled patients in the CONDOR study experienced a change in intended patient management based on PYLARIFY results[29] - The PSMA PET market may exceed $3.5 billion by the end of the decade[38] - DEFINITY net sales were $79.2 million in Q1 2025, with a 3.5% year-over-year growth, remaining the 1 utilized ultrasound enhancing agent[61] - The U S Ultrasound Enhancing Agent TAM is $600M+[68] Pipeline & Development - Lantheus is advancing a diversified radiotherapeutic and radiodiagnostic pipeline, including MK-6240 for Tau imaging and NAV-4694 for β amyloid imaging in Alzheimer's disease[71, 74] - PNT2003, a somatostatin receptor (SSTR)-targeted radiotherapeutic, has a potential launch in 2026[75] - LNTH-2401/2402 (GRPR-targeted) are in development for metastatic prostate cancer, with an IND filing for LNTH-2401 expected in Q4 2025 and Phase 1 initiation for LNTH-2402 planned for 2026[141]

Core Insights - Radiopharm Theranostics has completed the preclinical data package for RAD 402, an anti-Kallikrein Related Peptidase 3 (KLK3) monoclonal antibody radiotherapeutic, and is preparing to initiate a Phase 1 clinical trial for prostate cancer in the second half of 2025 [1][2][3] 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 three Phase 1 trials targeting various solid tumors, including lung, breast, and brain cancers [5] Partnership and Development - A supply agreement has been signed with Cyclotek to radiolabel RAD 402 with Terbium-161 (Tb), which is crucial for the upcoming Phase 1 clinical trial [1][3] - Cyclotek, a leading radiopharmaceutical manufacturer in Australia and New Zealand, will produce and provide doses of Tb-labeled RAD 402 [6][4] Therapeutic Focus - RAD 402 is designed to target KLK3, which is highly expressed in prostate tissue, potentially leading to improved therapeutic efficacy due to the unique properties of Tb compared to other radionuclides [2][4] - The partnership aims to enhance patient outcomes by improving the accessibility of radiopharmaceuticals [7][8]

Commercial Portfolio Performance - PYLARIFY achieved blockbuster status in 2024 with over $1 billion in sales[154], and Q1 2025 net sales reached $257.7 million[13] - DEFINITY remains the 1 utilized ultrasound enhancing agent, with Q1 2025 net sales of $79.2 million, a 3.5% year-over-year growth[24] Market Opportunities - The U S PSMA PET imaging market has a potential of over $3.5 billion by 2030, driven by expansion of radiotherapeutics and increasing clinical utility in BCR population[19, 20] - The U S ultrasound enhancing agent total addressable market is over $600 million[35] Pipeline Development - Lantheus is advancing an innovative pipeline of radiopharmaceuticals, including diagnostic and therapeutic candidates for prostate cancer, neuroendocrine tumors, and Alzheimer's disease[38, 40] - LNTH-2402, a GRPR-targeted radiotherapeutic, is expected to have an IND filing in Q4 2025, with Phase 1 initiation planned for 2026[109] Financial Highlights - As of March 31, 2025, Lantheus had $938.5 million in cash on hand and $98.8 million in free cash flow in Q1 2025[10] - The updated interim corporate financial guidance for the full year 2025 projects revenue between $1.550 billion and $1.585 billion, and adjusted fully diluted EPS between $6.60 and $6.70[142] Strategic Transactions - The acquisition of Evergreen Theragnostics closed in April 2025, strengthening radiodiagnostic and therapeutic capabilities[10, 165] - The acquisition of Life Molecular Imaging is expected to close by 2Q 2025, expanding the commercial portfolio and pipeline in Alzheimer's disease[10, 144]

Core Insights - Lantheus Holdings, Inc. is set to present new data on two oncology radiodiagnostic agents at the 2025 Society of Nuclear Medicine and Molecular Imaging Annual Meeting, highlighting its commitment to improving patient outcomes through advanced radiopharmaceuticals [1][12]. Presentation Details - Oral presentations will include the optimized production and quality control of the FAP imaging agent [64Cu]LNTH-1363S, presented by Gengyang Yuan on June 24, 2025 [2]. - Poster presentations will cover topics such as the positive predictive value of 18F-Piflufolastat PET/CT in recurrent prostate cancer and the first clinical evaluation of 68Ga-LNTH-1363S for PET imaging [2]. Product Information - PYLARIFY® (piflufolastat F 18) is a PSMA-targeted PET imaging agent that allows visualization of metastatic prostate cancer, with a recommended dose of 333 MBq (9 mCi) [3][4]. - PYLARIFY has been utilized in over 500,000 scans across the U.S., making it the most ordered PSMA PET imaging agent [3]. Company Overview - Lantheus is a leading company in the radiopharmaceutical sector, with nearly 70 years of experience in providing solutions that enhance disease detection and treatment [12].

Core Insights - Radiopharm Theranostics is advancing its RV01 program towards a first-in-human therapeutic basket study targeting solid tumor cancers, with an Investigational New Drug submission planned for mid-2025 and Phase 1 study initiation expected in Q4 2025 [1][7] Group 1: RV01 Program Development - The RV01 therapy is a B7-H3-targeted radiopharmaceutical designed to target solid tumors expressing the B7-H3 protein, which is associated with poor prognosis in various cancers [2] - Preclinical data indicates that RV01 demonstrates favorable biodistribution and high tumor uptake, with modifications in the Fc region leading to a shorter half-life compared to traditional monoclonal antibodies [1][3] - The antibody's faster liver excretion allows for effective tumor targeting while potentially reducing associated toxicities, offering advantages over traditional excretion methods [4] Group 2: Preclinical Data and Efficacy - New preclinical data supports earlier findings of RV01's strong affinity for the cancer-specific 4Ig isoform of the B7-H3 receptor, showing complete regression of established solid tumors and evidence of immune system stimulation [6] - The biodistribution study is the final preclinical work required for the IND application with the U.S. FDA, confirming the timeline for submission and study initiation [7] Group 3: Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals, with a diverse pipeline including peptides, small molecules, and monoclonal antibodies for cancer treatment [9]

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 ...

Core Insights - Perspective Therapeutics, Inc. is advancing its clinical-stage radiopharmaceuticals targeting various cancers, with a focus on expanding manufacturing capabilities and patient recruitment for ongoing trials [2][38]. Clinical Development - The company is conducting a Phase 1/2a trial of [Pb]VMT-α-NET for patients with unresectable or metastatic somatostatin receptor type 2-positive neuroendocrine tumors, having received Fast Track Designation from the FDA [3][4]. - As of April 2025, 40 patients have been enrolled in Cohort 2 of the VMT-α-NET trial, with no dose-limiting toxicities observed [6][12]. - The VMT01 program, targeting MC1R in melanoma, has also progressed, with initial dosing completed and ongoing patient recruitment [10][12]. - PSV359, targeting FAP-α in solid tumors, has achieved first-in-human dosing, indicating progress in the company's clinical pipeline [17][18]. Financial Overview - As of March 31, 2025, the company reported cash, cash equivalents, and short-term investments of approximately $212 million, expected to fund operations into late 2026 [6][28]. - Research and development expenses increased to $14.3 million for Q1 2025, up from $7.5 million in Q1 2024, reflecting the company's commitment to advancing its clinical programs [34]. - General and administrative expenses rose to $7.8 million in Q1 2025, compared to $5.9 million in the same period of 2024, primarily due to increased personnel costs [35]. Manufacturing and Supply Chain - The company is expanding its U.S. manufacturing capabilities, with two existing sites and plans for three additional facilities to meet growing clinical and commercial demands [20][21]. - A purchase order with the U.S. Department of Energy for thorium (Th) procurement has been established, ensuring a sufficient supply for clinical trials through 2026 [25][26]. Patent and Intellectual Property - The patent portfolio has been strengthened with the allowance of two key patent applications related to the generation of Pb and the VMT-α-NET compound, with expiration dates extending to 2044 and 2041, respectively [27].

Financial Performance - Lantheus reported first quarter 2025 revenues of $3728 million, a 08% increase compared to $369975 million in the first quarter of 2024[62, 78] - Adjusted EPS for the first quarter of 2025 was $153, a 95% decrease compared to $169 in the first quarter of 2024[17, 79] - The company's net income for 1Q 2025 was $72945 million, a 443% decrease compared to $131066 million for 1Q 2024[78] Strategic Initiatives - Lantheus is integrating Evergreen Theragnostics Inc and planning to acquire Life Molecular Imaging Ltd to strengthen radiodiagnostic and therapeutic capabilities[17, 24] - The company is divesting its SPECT business to SHINE Technologies, LLC, with the transaction expected to close by the end of 2025[17, 24] - Lantheus has a strong cash position with $9385 million in cash on hand and $750 million available in revolving credit[17, 66] Product Performance and Market Outlook - PYLARIFY net sales were $2577 million in 1Q 2025, representing a 05% decrease compared to 1Q 2024[37, 62] - DEFINITY net sales were $792 million in 1Q 2025, a 35% increase year-over-year[47, 62] - The PSMA PET market may exceed $35 billion by the end of the decade, with an annual scan potential of approximately 750,000[40, 41]