SEATTLE, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. ("Perspective" or the "Company") (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatments for cancers throughout the body, today announced that the first patient was treated with [212Pb]PSV359 in a second cohort of the Company’s Phase 1/2a dose-finding trial to determine safety and preliminary anti-tumor activity of the radiopharmaceutical [212Pb]PSV359 in patients with solid tumors that express fibr ...

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]

Summary of Radiopharm Theranostics (RADX) Update / Briefing Company and Industry Overview - **Company**: Radiopharm Theranostics (RADX) - **Industry**: Prostate cancer treatment and radiopharmaceuticals Key Points and Arguments 1. **Prostate Cancer Treatment Landscape**: - Significant advancements in prostate cancer treatments, particularly with radiotherapy options like radium-223 combined with enzalutamide and targeted therapies such as PSMA radiotherapeutics like Pluvicto [3][4] - Pluvicto has shown efficacy in prostate cancer patients both before and after chemotherapy, as evidenced by the PSMA-4 and VISION trials [3] 2. **Unmet Medical Needs**: - Despite advancements, there remains a substantial medical need for new therapies, especially targeted radiotherapy, as all patients receiving PSMA-targeting treatments will eventually relapse [4] 3. **Introduction of Betabart**: - Betabart, a monoclonal antibody targeting B7-H3, is being developed as a new treatment option. It has a modified half-life to reduce side effects while maintaining strong target affinity [4][5] - The upcoming study will enroll patients with various tumors, including those with prostate cancer who have previously received Pluvicto [5] 4. **KLK3 Targeting**: - KLK3 (PSA) is identified as a promising new target for prostate cancer therapy, with a focus on its specific expression in prostate tissues compared to PSMA, which is expressed in multiple organs [7][8] - The KLK3-targeted study is set to begin in Australia early next year [8] 5. **Preclinical Data**: - Preclinical studies show that KLK2 and KLK3 are highly specific to prostate tissues, with KLK3 exhibiting higher expression levels than KLK2 [9][19] - The therapeutic efficacy of KLK2-targeted therapies has been demonstrated in advanced mouse models, showing significant tumor reduction [13][14] 6. **Mechanism of Action**: - The therapeutic approach exploits the upregulation of androgen receptors (AR) in response to DNA damage, which increases the expression of KLK2 and KLK3, enhancing the targeting efficacy over time [16][29] 7. **Comparison with Other Therapies**: - KLK3-targeted therapies are positioned as a more advanced approach compared to KLK2, with a higher expression level and a more extensive research background [20][29] - The antibody developed for KLK3 is designed to avoid targeting PSA in circulation, focusing instead on the free form of PSA in tissues [28] 8. **Clinical Development Plans**: - RAD402 (KLK3 targeting molecule) is expected to enter clinical studies in Australia before the end of the year, alongside RV-01 (B7-H3 targeting molecule) in the U.S. [48] Additional Important Content - **Market Potential**: - The arrival of radiopharmaceuticals has significantly changed the metastatic prostate cancer treatment landscape, with improved patient survival rates [45] - There is a recognition that existing treatments like Pluvicto are not perfect, indicating a need for further scientific advancements [46] - **Future Directions**: - The company is exploring new targets and approaches to enhance treatment efficacy and patient outcomes in metastatic prostate cancer [46][47] - **Community Engagement**: - The webinars have attracted significant interest, indicating a strong community engagement and support for ongoing research and development in prostate cancer therapies [45]

Financial Data and Key Metrics Changes - Group revenues increased by 63% year on year, reaching $390 million, driven by growth in Elucix and the addition of third-party revenue from RLS [9][10] - Precision medicine revenues rose by 30% year on year, with EBITDA improving by 24% [9] - Gross margins in the precision medicine business remained stable at 64%, while the group's overall gross margin was 53% [9][10] Business Line Data and Key Metrics Changes - The precision medicine business saw a revenue increase of 29%, with EBITDA improving by $20 million year on year [14] - RLS contributed $79 million in third-party sales, with a gross margin of 7% [10][16] - Selling and marketing expenses increased to 13% of revenue from 10% last year, reflecting preparations for product and geographic expansion [12] Market Data and Key Metrics Changes - Elucix continues to deliver strong growth, with revenues up 25% year on year and dose volumes up 7% [43] - The global rollout of Elucix is progressing well, with marketing authorizations secured in over 23 countries [45] - The company is focusing on expanding into key markets such as France, Germany, Italy, Spain, China, and Japan [45] Company Strategy and Development Direction - The company is transitioning from a single product to a multi-product, multi-region organization, with a focus on long-term growth rather than short-term EPS optimization [21][25] - Strategic investments have been made in R&D, commercial performance, M&A opportunities, and supply chain resilience [19] - The acquisition of RLS is seen as a critical move to enhance U.S. presence and improve distribution capabilities [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate the current operating environment and emphasized the importance of strategic investments for long-term growth [21][39] - The company is focused on building long-term asset value and is committed to delivering value for shareholders and patients [75] - Management acknowledged the SEC inquiry but clarified that it has no impact on the commercial portfolio or pipeline development [39] Other Important Information - The company has made significant investments in its global manufacturing infrastructure, with cash on hand at $27 million [10][18] - R&D investments increased by 47% year on year, reflecting a commitment to advancing the therapeutic pipeline [10][12] Q&A Session Summary Question: Outlook for gross margins and impact of PSMA pricing changes - Management noted that Elucix's gross margin remained consistent at 64% and that RLS's gross margin is expected to improve as more Elucix products are integrated [80][81] Question: Guidance and growth of Elucix moving forward - Management confirmed that July 1 marked the end of pass-through status for one product, but they reported 7% growth quarter on quarter, indicating strong performance despite market challenges [86][87] Question: Launch readiness for Zurkayx - Management indicated that specific details about the launch readiness for Zurkayx could not be disclosed at this time [95]

Financial Performance - Group revenue increased by 63% year-over-year to $390.4 million [26] - Precision Medicine revenue increased by approximately 30% year-over-year [26] - R&D investment increased by 47% year-over-year [26] - The company maintained positive operating cash flow of $17.7 million [26] - The company invested $241.8 million in strategic M&A [26] Business Segments - RLS revenue was $79.0 million, including third-party sales of PET and SPECT products [28, 29] - Precision Medicine gross margins remained stable at 64% [26, 36] - TMS (excluding RLS) experienced operating expenses that support expansion of global facilities and start-up and integration activities [38] Guidance and Future Outlook - The company reaffirmed FY 2025 revenue guidance of $770 million - $800 million [26, 48] - Research & Development (R&D) expenditure is expected to increase 20% - 25% compared to FY 2024 [49] Strategic Initiatives - The company completed target enrollment of 30 patients for ProstACT Global Phase 3 Part 1 [21, 109, 126] - The company received approval to commence IPAX-BrIGHT pivotal trial in glioblastoma (ex-U S) [21, 126] - The company is planning NDA resubmission for Pixclara® in approximately three months [21, 99]

Financial Data and Key Metrics Changes - The company ended the quarter with cash and cash equivalents of $11 million, down from $23.3 million as of December 31, 2024, indicating a significant decrease in liquidity [11] - Research and development expenses for the quarter were approximately $2.4 million, a decrease from $7.3 million in the same period last year, reflecting a conclusion of patient enrollment and follow-up for a significant clinical study [12] - General and administrative expenses decreased to $3.6 million from $6.4 million year-over-year, primarily due to reduced pre-commercialization efforts [12] - The net loss for the quarter was $5.4 million, or $3.39 per share, compared to a net loss of $900,000, or $0.77 per share, in the same period last year [13] Business Line Data and Key Metrics Changes - The lead asset, iapofacine I-131, is positioned for accelerated approval with the FDA, reflecting a strategic shift in regulatory approach [5][6] - The company is advancing its next-generation radiopharmaceutical pipeline, with CLR125 and CLR225 expected to enter clinical trials in late 2025 or early 2026 [9][10] Market Data and Key Metrics Changes - The company anticipates a response from the EMA regarding conditional marketing authorization for iapofacine I-131 late in Q3 or early Q4 2025, indicating ongoing engagement with European regulatory bodies [7] - The market potential for iapofacine I-131 is considered compelling, supported by robust clinical data and a well-understood safety profile [9] Company Strategy and Development Direction - The company is focused on delivering innovative, life-extending therapies for cancer patients, with a clear regulatory strategy for accelerated approval in the US and conditional marketing authorization in Europe [21][22] - Active discussions with potential partners are underway to secure non-dilutive capital and expertise, which will support the company's strategic initiatives [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the new regulatory strategy for iapofacine I-131, highlighting the importance of the twelve-month follow-up data and the shift to earlier lines of therapy [29] - The company remains committed to advancing its clinical programs and regulatory milestones, with a focus on expanding its impact into solid tumors [21][22] Other Important Information - The company raised nearly $10 million in recent financings to support clinical programs and regulatory milestones [10] - The anticipated costs for the confirmatory study related to iapofacine I-131 are estimated to be between $40 million and $45 million [40] Q&A Session Summary Question: Status of the WM program and EU approval path - Management is finalizing the protocol for an accelerated approval confirmatory study and expects to submit the NDA later this year or early next year, pending sufficient capital [27][29] Question: Concerns regarding preclinical biodistribution data - The biodistribution data indicates approximately 25% to 30% of the infused drug reaches the tumor, with off-target activity generally below 5% in other tissues, primarily the liver [32] Question: Timing and costs associated with NDA submission - The estimated cost for the confirmatory study is approximately $40 million to $45 million, with $20 million to $25 million needed for full enrollment and necessary data [40][41]

Financial Data and Key Metrics Changes - Consolidated net revenue for Q2 2025 was $378 million, a decrease of 4.1% year over year [20] - Adjusted net income for Q2 was $110.6 million, a decrease of 12.8% [24] - GAAP fully diluted earnings per share for Q2 were $1.12, with adjusted earnings per share at $1.57, both down 12.8% [24] Business Line Data and Key Metrics Changes - Sales of Polarify were $251 million, down 8.3% year over year, with U.S. volumes up 2% year over year and over 4% sequentially [12][21] - Precision Diagnostics revenue was $115.8 million, up 3.3%, with DEFINITY sales at $83.9 million, up 7.5% [21] - Strategic partnerships and other revenue increased by 32.8% to $11.6 million, driven by contributions from MK6240 and the newly acquired Evergreen CDMO business [22] Market Data and Key Metrics Changes - The PSMA PET market faced competitive pricing pressures, particularly from an F-eighteen competitor, leading to account losses and renegotiations [13][14] - The broader market for PSMA PET is expected to grow in the mid to high teens, while Polarify is anticipated to grow in the low single digits [39] Company Strategy and Development Direction - The company is focused on diversifying its portfolio and enhancing its capabilities in the radiopharmaceutical value chain through acquisitions [9] - A new $400 million stock repurchase program was authorized, reflecting confidence in the business's intrinsic value and future growth potential [11] - The FDA has accepted the NDA for a new formulation of Polarify, expected to increase batch size by approximately 50%, enhancing production efficiency and patient access [6][17] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that Q2 results were below expectations and lowered the financial outlook for the remainder of 2025 [4] - The company is taking a disciplined approach to pricing to preserve the long-term value of its PSMA PET franchise [7][16] - Management expressed confidence in the long-term strategy and the ability to execute, despite current market dynamics [11][28] Other Important Information - The company expects full-year revenue to be in the range of $1.475 to $1.51 billion, down from the previous range of $1.55 to $1.585 billion [27] - The anticipated launch of four additional radiopharmaceutical products is expected to diversify revenue streams [10] Q&A Session Summary Question: Thoughts on achieving double-digit growth in 2026 - Management believes it is achievable through a combination of organic and inorganic growth, with key factors including the performance of DEFINITY and the impact of recent acquisitions [30][31] Question: Guidance for LMI's contribution to revenue - The forecast for LMI's contribution is $40 million to $45 million in net revenue with an EPS accretion of $0.04 [37] Question: Impact of new formulation on long-term contracts - The new formulation will be an add-on to existing contracts, potentially allowing for a 340B price reset [49] Question: Commercial opportunity for tau imaging - The company sees significant potential in the tau imaging market, which could be similar in size to Polarify [52] Question: Market share and contracted business for Polarify - The majority of the business is under contract, and management has made strategic decisions to walk away from certain accounts to protect long-term value [56][61]

Financial Performance - Lantheus' Q2 2025 revenues were $378 million, a decrease of 4.1% compared to Q2 2024[15, 52] - Adjusted EPS for Q2 2025 was $1.57, a decrease of 12.8% year-over-year[15, 52] - Radiopharmaceutical Oncology sales were $250.6 million, down 8.3% year-over-year, but with a 4% sequential volume increase[52] - Precision Diagnostics sales were $115.8 million, up 3.3% year-over-year, driven by DEFINITY sales growth of 7.5%[52] - Strategic Partnerships sales were $11.6 million, up 32.8% year-over-year[52] Financial Position - Cash provided by operations increased to $87.1 million in Q2 2025 from $84.7 million in Q2 2024[55] - Free cash flow for Q2 2025 was $79.1 million[58] - Lantheus has $695.6 million in cash on hand and $750 million available in revolving credit[58] Guidance - Updated FY 2025 revenue guidance is $1.475 billion - $1.51 billion[61] - Updated FY 2025 adjusted fully diluted EPS guidance is $5.50 - $5.70[61] Strategic Initiatives - Lantheus anticipates four key product launches in the next 18 months: MK-6240, OCTEVY, PNT2003, and a new PSMA PET formulation[20] - The company has a board authorization for a new $400 million stock repurchase program[59]

IsoBio's Vision and Strategy - IsoBio seeks to develop antibody-isotope conjugates (AICs) using ASP Isotopes (ASPI) manufactured isotopes, targeting well-known targets to minimize off-target toxicities[12] - IsoBio plans to leverage ASPI's technology to reduce isotope supply chain uncertainty and develop novel isotopes for radiotherapeutics and diagnostics[11] - IsoBio intends to develop monoclonal antibody-isotope conjugates (AICs) against derisked targets with proven antibodies for solid tumors and hematologic malignancies[11] - IsoBio may partner with large cap pharma companies to advance their antibody candidates with reliable access to isotopes and in-house CMC expertise[11] ASP Isotopes' Capabilities and Advantages - ASP Isotopes has the ability to make stable isotopes using its proprietary technologies: Aerodynamic Separation Process and Quantum Enrichment[16, 24] - PET Labs, a subsidiary of ASP Isotopes, supplies approximately 85% of PET Radioisotopes in Sub Saharan Africa[19] - ASP Isotopes' enrichment plants are designed to harvest and enrich a natural mix of isotopes, producing zero waste[26] Market Opportunity and Investment - The radiopharmaceutical market is expected to grow from $67 billion in 2024 to more than $13 billion by 2033[40] - Recent acquisitions suggest large cap pharma players have confidence in the future of RLTs, such as Eli Lilly acquiring Point Biopharma for $14 billion[40]

Core Insights - Radiopharm Theranostics is advancing its clinical pipeline with significant milestones, including FDA Fast Track Designation for RAD101 and clearance for higher dosing of RAD204 [3][5][6] - The company confirmed a cash runway extending through mid-2026, with a year-end cash balance of $29.12 million, up from $18.58 million the previous year [10][12] Program and Business Updates - RAD204, a nanobody targeting PD-L1, is on track for higher dosing at 60mCi of Lu177, with enrollment for the second cohort expected to complete soon [6] - RAD202, targeting HER2, has initiated its Phase 1 HEAT trial, with preliminary data anticipated by the end of 2025 [6] - The company has established supply agreements for key radioisotopes, enhancing its clinical trial capabilities [3][12] Financial Update - For the fiscal year ending June 30, 2025, net cash outflows from operating activities totaled $36.67 million, primarily due to research and development expenditures [10][12] - The company received $4.58 million for research and development tax incentives for the 2024 financial year [12]