IsoRay, Inc.(ISR) - 2025 Q3 - Quarterly Results

Executive Summary & Recent Highlights Perspective Therapeutics reported Q1 2025 results, highlighting clinical trial advancements, U.S. manufacturing expansion, and a strong cash position expected to fund operations into late 2026 Recent Business Highlights Perspective Therapeutics announced its Q1 2025 results and provided key business updates, including progress in clinical trials for its next-generation targeted radiopharmaceutical platform, expansion of U.S. manufacturing, and a strong cash position expected to fund operations into late 2026 - First of several clinical updates through mid-2026 accepted for presentation at the 2025 American Society of Clinical Oncology Annual Meeting[3] - Enrollment ongoing for VMT-α-NET (40 patients in Cohort 2 by April 2025) and VMT01 (first patient treated at new monotherapy dose in April 2025, combination in March 2025)[3] - Achieved first-in-human dosing of PSV359, which targets FAP-α associated with multiple highly prevalent solid tumors[3] - Advancing U.S. manufacturing capabilities to enable delivery of finished product for growing clinical trial and future commercial demands[3] Cash, Cash Equivalents and Short-Term Investments | As of Date | Amount (Millions) | | :---------- | :--------------- | | March 31, 2025 | $212 | | Expected Sufficiency | Into late 2026 | CEO Statement CEO Thijs Spoor emphasized the company's commitment to developing novel radiopharmaceuticals for cancer patients, highlighting continued patient recruitment and expansion of U.S. manufacturing capabilities, with further clinical and operational updates expected through mid-2026 - Demonstrating commitment to bringing novel new medicines to patients through continued patient recruitment into trials and expansion of U.S. based manufacturing capabilities[4] - Focus on three clinical-stage, proprietary potential new medicines based on the next-generation targeted radiopharmaceutical technology platform[4] - On track to provide updates on more clinical and operational progress through mid-2026 and beyond[4] Program Highlights This section details the progress and updates on the company's clinical-stage radiopharmaceutical programs, including VMT-α-NET, VMT01, PSV359, and pipeline development VMT-α-NET The Phase 1/2a trial for [212Pb]VMT-α-NET in SSTR2-positive neuroendocrine tumors is progressing, with 40 patients enrolled in Cohort 2 by April 2025. The study received Fast Track Designation, and initial safety data showed no DLTs or severe adverse events, with some anti-tumor activity observed - Company-sponsored Phase 1/2a trial (NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-positive neuroendocrine tumors[5] - Received Fast Track Designation from the U.S. Food and Drug Administration (FDA)[5] - Cohort 2 reopened for enrollment in August 2024, with a total of 40 patients having begun treatment as of April 30, 2025[7][10] - Safety findings (as of Jan 10, 2025): No DLTs, Grade 4 or 5 treatment emergent adverse events (TEAEs), or serious adverse events (SAEs) reported. Hematologic AEs were Grades 1 and 2. No treatment discontinuations due to AEs[10] - Anti-tumor activity (as of Jan 10, 2025): One confirmed response and two unconfirmed responses (RECIST v1.1) in Cohort 2. Eight of nine patients in Cohorts 1 and 2 remained on study without progressive disease[10] - Data on [212Pb]VMT-α-NET accepted for an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on May 30, 2025[10] VMT01 VMT01, an MC1R-targeted RPT for melanoma, is undergoing a Phase 1/2a study. Following initial dosing, the SMC recommended exploring a lower dose (1.5 mCi) as monotherapy and in combination with nivolumab, with first patients treated in March/April 2025. Initial safety data showed no DLTs or severe adverse events, and some patients achieved objective response or stable disease - VMT01 is an MC1R-targeted RPT that can be radiolabeled with either 203Pb for patient selection/dosimetry or 212Pb for alpha particle therapy[9] - Multi-center, open-label dose finding, dose expansion study (NCT05655312) in previously treated patients with histologically confirmed melanoma and MC1R-positive imaging scans[11] - SMC recommended exploring a lower dose level of 1.5 mCi per dose, both as monotherapy and in combination with the anti-PD-1 antibody nivolumab[13] - First patients in the combination and monotherapy cohorts received their initial treatments in March and April 2025, respectively[13] - Safety findings (as of Sep 4, 2024): No DLTs observed, no adverse events led to treatment discontinuation, TEAEs were mostly Grades 1 and 2, and no renal toxicities reported[14] - Anti-tumor activity (as of Sep 4, 2024): One patient in Cohort 1 (3.0 mCi) experienced an unconfirmed RECIST v1.1 objective response, and two patients experienced stable disease. Cohort 2 (5.0 mCi) patients progressed[14] - Data on [212Pb]VMT01 accepted as a poster presentation at the 2025 ASCO Annual Meeting on June 2, 2025[15] PSV359 PSV359 is designed to target FAP-α expressing solid tumors with the alpha-emitting isotope 212Pb. The first patient has been treated with [212Pb]PSV359, and preclinical/human imaging data suggest improved target engagement and reduced retention in healthy tissues - PSV359 is designed to target and deliver 212Pb to tumor sites expressing fibroblast activation protein-α (FAP-α), associated with multiple highly prevalent solid tumors[16] - The targeting moiety can also be radiolabeled with 203Pb or 68Ga (PSV377) to detect FAP-α expression in individual patients[16] - First patient treated with [212Pb]PSV359 disclosed on April 29, 2025, with activation activities underway for additional sites[17] Clinical Pipeline Expansion Perspective Therapeutics' discovery team is actively preparing multiple novel constructs for potential first-in-human imaging, serving as a de-risking step for future therapeutic development, with plans for pre-IND filing activities once criteria are met - Discovery team is preparing multiple additional novel constructs for potential first-in-human imaging as a de-risking step for potential therapeutic benefit[18] - Plans to proceed with pre-IND filing activities if and when those constructs meet criteria for further development[18] Other Business Developments This section provides updates on the company's operational infrastructure, including manufacturing expansion, isotope procurement, and intellectual property protection Manufacturing Capabilities Perspective Therapeutics is expanding its U.S. manufacturing network to support clinical trials and future commercial operations, utilizing proprietary generator technology for 212Pb and third-party sources for 203Pb. The company has two operational sites and is building three more, with no material tariff impacts expected in 2025 - Establishing a regional network of drug-product finishing facilities to support current clinical activities and prepare for future commercial operations[19] - Utilizes both 203Pb (sourced from third-party cyclotron production) and 212Pb (produced in-house using proprietary generator technology) to manufacture ready-to-administer radiopharmaceuticals[19] - Currently has two U.S. manufacturing sites and is building out three additional U.S. sites in Houston, Chicago, and Los Angeles metropolitan areas to support growing clinical trial and future commercial demands[20][25] - No material incremental tariff-related cost impacts expected in 2025 based on initial analysis of recently announced tariffs[20] - Ordered manufacturing equipment in 3Q 2024, including isotope processing hot cells and production suites, with production commenced[21] - Working towards expanding capacity in the second manufacturing facility in Somerset, New Jersey, acquired in 1Q 2024, to meet demand in the Northeastern U.S.[25] Isotope Supply Chain The company's therapeutic isotope, 212Pb, is derived from 228Th, which is procured from the U.S. Department of Energy (DOE). A new purchase order was entered in May 2025 for additional 228Th for 2025 and 2026, ensuring sufficient supply for clinical trials - Therapeutic isotope 212Pb naturally decays from 224Ra, which in turn naturally decays from 228Th[22] - Procures 228Th from the U.S. Department of Energy (DOE)[22] - Entered into a purchase order with the DOE in May 2025 to purchase additional 228Th during 2025 and 2026, expected to be sufficient to support clinical trials[22][23] Patent Portfolio Perspective Therapeutics strengthened its patent portfolio in Q1 2025 with the allowance of two key patent applications by the USPTO: one for its proprietary 212Pb generation technology (expiring August 2044) and another for the VMT-α-NET compound (expiring January 2041) - Patent portfolio further strengthened in 1Q 2025 by the allowance of two patent applications on key assets by the U.S. Patent and Trademark Office (USPTO)[24] - First patent application pertains to wholly owned, proprietary technology for generation of 212Pb at scale, expiring in August 2044[24] - Second patent application pertains to the VMT-α-NET compound (exclusive license from the University of Iowa), expiring in January 2041[24] Financial Performance (Q1 2025) This section provides a detailed overview of Perspective Therapeutics' financial results for Q1 2025, including cash position, equity, revenue, expenses, net loss, and key balance sheet and income statement figures Cash Position & Funding The company's cash, cash equivalents, and short-term investments decreased to $212 million as of March 31, 2025, from $227 million at December 31, 2024. This funding is expected to be sufficient into late 2026, supporting clinical programs and manufacturing expansion Cash, Cash Equivalents, and Short-Term Investments | Metric | March 31, 2025 (Millions) | December 31, 2024 (Millions) | | :-------------------------------- | :------------------------ | :------------------------- | | Cash, cash equivalents, and short-term investments | ~$212 | ~$227 | - Expected to have sufficient funding into late 2026 to advance current clinical programs, progress multiple pre-IND assets, and build out regional manufacturing sites[26] Equity and Capital Structure In Q1 2025, the company sold 3.38 million common shares under its 2024 ATM Agreement, generating $10.2 million in gross proceeds. As of March 31, 2025, the company had approximately 74.1 million common shares outstanding, along with warrants and pre-funded warrants - Sold 3,379,377 shares of common stock under the 2024 ATM Agreement in February 2025[27] 2024 ATM Agreement Share Sales | Metric | Value | | :---------------- | :------------ | | Average Price per Share | ~$3.02 | | Gross Proceeds | ~$10.2 million | Outstanding Equity as of March 31, 2025 | Instrument | Quantity (Shares) | | :----------------------- | :---------------- | | Common Stock | 74.1 million | | Warrants and Options | 10.6 million | | Pre-funded Warrants | 146,425 | Segment Reporting Change Following the divestiture of its brachytherapy segment in April 2024, Perspective Therapeutics has reclassified these operations as discontinued in its financial statements, with subsequent discussions pertaining to continuing operations - Divestiture of the entire brachytherapy segment to GT Medical in April 2024[29] - Operations of the brachytherapy segment have been classified as discontinued operations in financial statements[29] Grant Revenue Grant revenue for Q1 2025 remained stable at approximately $0.3 million, primarily derived from work with the National Institutes of Health Grant Revenue (Q1 2025 vs Q1 2024) | Period | Grant Revenue (Millions) | | :------------------- | :---------------------- | | Q1 2025 | $0.3 | | Q1 2024 | $0.3 | - Grant revenue is derived from work with the National Institutes of Health[30] Operating Expenses Total operating expenses increased by 66% year-over-year to $22.2 million in Q1 2025, driven by a 92% increase in R&D expenses to $14.3 million (supporting clinical trials and manufacturing expansion) and a 33% increase in G&A expenses to $7.8 million (due to higher personnel costs) Operating Expenses (Q1 2025 vs Q1 2024) | Expense Category | Q1 2025 (Millions) | Q1 2024 (Millions) | YoY Change | | :------------------------ | :----------------- | :----------------- | :--------- | | Research and development | $14.3 | $7.5 | +92% | | General and administrative | $7.8 | $5.9 | +33% | | Total Operating Expenses | $22.2 | $13.3 | +66% | - Increase in R&D expenses supports clinical trials for clinical development assets, manufacturing and CMC activities, and discovery efforts[31] - Increase in general and administrative expenses primarily due to increased personnel costs, partially offset by decreased fees for professional services[32] Net Loss and EPS The net loss for Q1 2025 increased to $18.2 million, or $0.25 loss per basic and diluted share, compared to a net loss of $12.3 million, or $0.25 per share, in Q1 2024 (adjusted for reverse stock split). The period included a $2.3 million net benefit from interest income and other expense, and $1.4 million in deferred income Net Loss and EPS (Q1 2025 vs Q1 2024) | Metric | Q1 2025 (Millions) | Q1 2024 (Millions) | | :-------------------------------- | :----------------- | :----------------- | | Net Loss | $18.2 | $12.3 | | Basic and Diluted Loss per Share | $0.25 | $0.25 | - Net benefit of $2.3 million in net interest income and other expense during the quarter[34] - Recognized $1.4 million of Deferred Income, which was received in 2024[34] Condensed Consolidated Balance Sheets The condensed consolidated balance sheet shows total assets decreased from $341.1 million at December 31, 2024, to $329.3 million at March 31, 2025. Current assets saw a decrease, primarily in cash and cash equivalents, while property and equipment, net, increased. Total liabilities also decreased from $50.4 million to $44.7 million Key Balance Sheet Data (March 31, 2025 vs. December 31, 2024) | Metric | March 31, 2025 (Thousands) | December 31, 2024 (Thousands) | | :-------------------------------- | :------------------------- | :-------------------------- | | Cash and cash equivalents | $44,406 | $61,580 | | Short-term investments | $167,296 | $165,336 | | Total current assets | $215,742 | $231,160 | | Property and equipment, net | $61,247 | $57,321 | | 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 and Comprehensive Loss The condensed consolidated statements of operations show a net loss of $18.2 million for Q1 2025, an increase from $12.3 million in Q1 2024. This was primarily driven by higher R&D and G&A expenses, partially offset by increased interest income and other non-operating income Key Income Statement Data (Three Months Ended March 31, 2025 vs. 2024) | Metric | 2025 (Thousands) | 2024 (Thousands) | | :-------------------------------- | :--------------- | :--------------- | | Grant revenue | $342 | $325 | | Research and development | $14,332 | $7,452 | | General and administrative | $7,842 | $5,878 | | Total operating expenses | $22,174 | $13,330 | | 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 from discontinued operations | $- | $(459) | | Net loss | $(18,177) | $(12,284) | | Basic and diluted loss per share | $(0.25) | $(0.25) | Company Overview & Forward-Looking Statements This section provides an introduction to Perspective Therapeutics' mission and technology, along with a cautionary statement regarding forward-looking information and associated risks About Perspective Therapeutics, Inc. Perspective Therapeutics is a radiopharmaceutical development company focused on pioneering advanced cancer treatments using its proprietary technology, which delivers the alpha-emitting isotope 212Pb to cancer cells. The company employs a 'theranostic' approach, combining imaging diagnostics with targeted therapy to personalize treatment and optimize patient outcomes - Radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body[35] - Proprietary technology utilizes the alpha-emitting isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting moieties[35] - Developing complementary imaging diagnostics that incorporate the same targeting moieties, enabling a 'theranostic' approach to personalize treatment and optimize patient outcomes[35] - Melanoma (VMT01), neuroendocrine tumor (VMT-α-NET), and solid tumor (PSV359) programs are in Phase 1/2a imaging and therapy trials in the U.S.[36] Safe Harbor Statement This section contains forward-looking statements regarding the company's plans, intentions, and expectations, including clinical trial progress, manufacturing expansion, and financial outlook. It also outlines significant risks and uncertainties that could cause actual results to differ materially from these statements, such as regulatory delays, clinical trial outcomes, manufacturing issues, and funding needs - Contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, covering plans, intentions, and expectations[37][38][39] - Highlights risks and uncertainties that could cause actual results to differ materially, including regulatory approval delays, clinical trial outcomes, manufacturing and supply chain disruptions, and the need for additional financing[40] - The Company undertakes no obligation to publicly update or revise any forward-looking statements unless required by law[41]