Perspective Therapeutics(CATX) - 2025 Q3 - Quarterly Results

Business Highlights and Q1 2025 Results Recent Business Highlights The company advanced its clinical trials and U.S. manufacturing, supported by a strong cash position of $212 million - Enrollment is ongoing for the VMT-α-NET Phase 1/2a trial in neuroendocrine tumors, with 40 patients enrolled in Cohort 2 as of the end of April 2025[3] - The VMT01 trial for melanoma saw the first patient treated at a new monotherapy dose level in April 2025 and the first patient treated in combination with nivolumab in March 2025[3] - Achieved first-in-human dosing of PSV359, a therapy targeting FAP-α, which is associated with multiple prevalent solid tumors[3] - The company is expanding U.S. manufacturing to meet clinical and future commercial demand for its radiopharmaceutical products[3] - As of March 31, 2025, cash, cash equivalents, and short-term investments were approximately $212 million, providing a cash runway into late 2026[3] Program Highlights VMT-α-NET for Neuroendocrine Tumors (NETs) The VMT-α-NET trial shows promising anti-tumor activity and a favorable safety profile in NET patients - The trial is a multi-center, open-label study (NCT05636618) for patients with unresectable or metastatic SSTR2-positive NETs who have not received prior radiopharmaceutical therapies, and the program has received FDA Fast Track Designation[5] - As of April 30, 2025, a total of 40 patients have begun treatment in Cohort 2 (5.0 mCi dose)[10] - Safety findings as of January 10, 2025, showed no dose-limiting toxicities (DLTs), no grade 4 or 5 treatment-emergent adverse events (TEAEs), and no treatment discontinuations due to AEs[10] - As of January 10, 2025, anti-tumor activity in Cohort 2 (7 patients) included one confirmed response and two unconfirmed responses, while eight of nine total patients remained on study without progressive disease[10] - Updated data on [212Pb]VMT-α-NET has been accepted for an oral presentation at the 2025 ASCO Annual Meeting on May 30, 2025[10] VMT01 for Melanoma The VMT01 program is exploring a lower dose level for melanoma following favorable initial safety data - The trial (NCT05655312) is evaluating VMT01 in previously treated patients with MC1R-positive melanoma[11] - The Safety Monitoring Committee (SMC) recommended exploring a lower dose of 1.5 mCi, both as monotherapy and in combination with nivolumab, with the first patients in these new cohorts treated in March and April 2025[13] - As of September 4, 2024, data from higher dose cohorts (3.0 mCi and 5.0 mCi) showed no DLTs or treatment-related discontinuations, with TEAEs being mostly Grade 1 and 2[14] - In the higher dose cohorts, one patient experienced an unconfirmed objective response, and two had stable disease, supporting the exploration of lower radiation doses[14] PSV359 for Solid Tumors The novel radiopharmaceutical PSV359 entered clinical-stage development with the first patient dosed in April 2025 - PSV359 targets FAP-α, which is expressed in multiple highly prevalent solid tumors with unmet medical needs[16] - The first patient was treated with [212Pb]PSV359 in April 2025, and activation activities are underway for additional clinical sites[17] Manufacturing, Supply Chain, and IP Manufacturing and Supply Chain The company is expanding its U.S. manufacturing network and has secured its key isotope supply through 2026 - The company has two operational U.S. manufacturing sites and is building out three additional facilities in the Houston, Chicago, and Los Angeles metropolitan areas[20][25] - The company is expanding capacity at its Somerset, NJ facility, which began shipping 212Pb-labeled radiopharmaceuticals in Q4 2024[25] - The company procures the key starting material, 228Th, from the U.S. Department of Energy (DOE) and entered a new purchase order in May 2025 to secure supply for 2025 and 2026[22][23] - Based on an initial analysis of recently announced tariffs, the company does not expect any material cost impacts in 2025[20] Patent Portfolio The company strengthened its IP by securing two key U.S. patents for its 212Pb generation and VMT-α-NET compound - A U.S. patent was allowed for the company's proprietary technology for generating 212Pb, with a term expiring in August 2044[24] - A U.S. patent was allowed for the VMT-α-NET compound, with a term expiring in January 2041[24] First Quarter 2025 Financials Financial Performance Q1 2025 net loss increased to $18.2 million, driven by higher R&D expenses, with a cash runway into late 2026 - Cash, cash equivalents, and short-term investments were approximately $212 million as of March 31, 2025, down from $227 million at year-end 2024[26] - In February 2025, the company sold 3,379,377 shares under its ATM agreement, raising gross proceeds of approximately $10.2 million[27] - The company's financial reporting now classifies the divested brachytherapy segment as discontinued operations[29] Q1 2025 vs. Q1 2024 Financial Results (Continuing Operations) | Financial Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Grant Revenue | $0.3M | $0.3M | 0% | | R&D Expenses | $14.3M | $7.5M | +92% | | G&A Expenses | $7.8M | $5.9M | +33% | | Total Operating Expenses | $22.2M | $13.3M | +66% | | Net Loss | ($18.2M) | ($12.3M) | +48% | | Loss Per Share | ($0.25) | ($0.25) | 0% | Financial Statements Condensed Consolidated Balance Sheets Total assets decreased to $329.3 million as of March 31, 2025, primarily due to a reduction in cash Key Balance Sheet Items (in thousands) | Balance Sheet Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $44,406 | $61,580 | | Short-term investments | $167,296 | $165,336 | | Total Assets | $329,349 | $341,101 | | Total current liabilities | $12,679 | $18,230 | | Total Liabilities | $44,704 | $50,433 | | Total Stockholders' Equity | $284,645 | $290,668 | Condensed Consolidated Statements of Operations Operating loss widened to $21.8 million for the quarter, driven by higher R&D expenses Consolidated Statement of Operations (in thousands) | Line Item | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Grant revenue | $342 | $325 | | Research and development | $14,332 | $7,452 | | General and administrative | $7,842 | $5,878 | | Operating loss | ($21,832) | ($13,005) | | Total non-operating income, net | $3,655 | $1,180 | | Net loss from continuing operations | ($18,177) | ($11,825) | | Net loss | ($18,177) | ($12,284) | | Basic and diluted loss per share | ($0.25) | ($0.25) |