IsoRay, Inc.(ISR) - 2025 Q4 - Annual Results

Executive Summary & Recent Highlights Company Overview & Key Updates Perspective Therapeutics, a radiopharmaceutical company, provided a business update and reported Q2 2025 results, highlighting positive interim results for [212Pb]VMT-α-NET, FDA alignment for Cohort 3, upcoming scientific presentations, and a cash runway expected into late 2026 - Perspective Therapeutics is pioneering advanced treatments for cancers using radiopharmaceuticals, specifically the alpha-emitting isotope 212Pb[2][26] - Interim results from the Phase 1/2a study of [212Pb]VMT-α-NET in neuroendocrine tumors showed objective responses in 4 of 7 patients in Cohort 2, with 3 confirmed responses, maintaining a favorable safety profile with no dose-limiting toxicities[3] - The company reached alignment with the FDA in June 2025 to open Cohort 3 (6.0 mCi) of the [212Pb]VMT-α-NET study, with two patients dosed as of July 31, 2025[3][7][9] - An update on the [212Pb]VMT-α-NET study has been accepted for presentation at the European Society of Medical Oncology Congress 2025 on October 20, 2025[3][11] - Cash, cash equivalents, and short-term investments of approximately $192 million as of June 30, 2025, are expected to fund current planned clinical milestones and operational investments into late 2026[3][18] Clinical Program Updates VMT-α-NET (Neuroendocrine Tumors) VMT-α-NET, designed to target SSTR2-expressing tumors, is undergoing a Phase 1/2a study, with Cohort 2 enrollment closed, Cohort 3 (6.0 mCi) opened in June 2025 following FDA alignment, and data to be presented at ESMO 2025 - VMT-α-NET is designed to target and deliver 212Pb to SSTR2-expressing tumor sites in patients with unresectable or metastatic neuroendocrine tumors[5] - Enrollment for Cohort 2 closed in 2Q 2025, with a total of 46 patients having received at least one treatment[6] - Cohort 3 opened in June 2025 after FDA alignment, with patients receiving up to four fixed administered doses of [212Pb]VMT-α-NET at 6.0 mCi every eight weeks (or 100μCi/kg for patients ≤ 60kg), and two patients commenced treatment as of July 31, 2025[7][9] - Data on [212Pb]VMT-α-NET have been accepted for a Mini Oral presentation at the European Society of Medical Oncology (ESMO) Congress 2025 on October 20, 2025[11] VMT01 (Melanoma) VMT01, an MC1R-targeted RPT, is in a Phase 1/2a study for melanoma, with the SMC recommending exploration of a lower dose of 1.5 mCi as monotherapy and in combination with nivolumab, both cohorts currently open for enrollment - VMT01 is an MC1R-targeted Radiopharmaceutical Therapy (RPT) that can be radiolabeled with 203Pb for patient selection/dosimetry or 212Pb for alpha particle therapy[13] - The Safety Monitoring Committee (SMC) recommended exploring a lower dose level of 1.5 mCi per dose for VMT01, both as monotherapy and in combination with the anti-PD-1 antibody nivolumab[13] - As of July 31, 2025, five patients received initial monotherapy treatments of VMT01 at 1.5 mCi, and two patients received treatment in the VMT01 1.5 mCi plus nivolumab cohort, with both cohorts open for enrollment[14] PSV359 (Solid Tumors) PSV359 is designed to target FAP-α expressing solid tumors with 212Pb for therapy, offering a theranostic approach with 203Pb or 68Ga (PSV377) for imaging, with two patients treated and additional site activations in progress - PSV359 targets fibroblast activation protein-α (FAP-α) expressing tumor sites with 212Pb for therapy, and its targeting moiety can also be radiolabeled with 203Pb or 68Ga (PSV377) for diagnostic imaging[16] - Preclinical and human imaging results suggest the proprietary targeting ligand has improved target engagement and tumor uptake, with reduced retention in healthy tissues[16] - Two patients had been treated with [212Pb]PSV359 as of July 31, 2025, with activation activities underway for additional sites[17] Financial Summary Cash Position & Capital Structure Perspective Therapeutics reported approximately $192 million in cash, cash equivalents, and short-term investments as of June 30, 2025, a decrease from $227 million at December 31, 2024, with its capital structure including 74.3 million common shares and 10.6 million warrants/options outstanding Cash, cash equivalents, and short-term investments (in USD) | Metric | June 30, 2025 (USD) | December 31, 2024 (USD) | | :-------------------------------- | :-------------- | :---------------- | | Cash, cash equivalents, and short-term investments | $191,578,000 | $226,916,000 | - The company expects current funding to be sufficient into late 2026, supporting clinical programs, pre-IND assets, and regional manufacturing site build-out[18] - As of June 30, 2025, there were approximately 74.3 million shares of common stock and 10.6 million warrants and options outstanding, with all outstanding pre-funded warrants exercised during Q2 2025[19] Operating Results (Continuing Operations) For Q2 2025, grant revenue decreased to $0.3 million from $0.5 million YoY, while R&D expenses significantly increased by 79% to $16.6 million and G&A expenses rose by 40% to $7.7 million, leading to a net loss of $21.5 million, or $0.29 per share - The brachytherapy segment was divested in April 2024 and is classified as discontinued operations[20] Grant Revenue (Continuing Operations) | Period | 2025 (Millions) | 2024 (Millions) | Change (YoY) | | :-------------------- | :-------------- | :-------------- | :----------- | | Three Months Ended June 30 | $0.3 | $0.5 | -40% | | Six Months Ended June 30 | $0.6 | $0.9 | -33.3% | Research and Development Expenses (Continuing Operations) | Period | 2025 (Millions) | 2024 (Millions) | Change (YoY) | | :-------------------- | :-------------- | :-------------- | :----------- | | Three Months Ended June 30 | $16.6 | $9.3 | +79% | | Six Months Ended June 30 | $31.0 | $16.7 | +85% | - Increase in R&D expenses was primarily due to increased clinical site activities, drug product and delivery costs, and higher personnel costs, including share-based compensation[22] General and Administrative Expenses (Continuing Operations) | Period | 2025 (Millions) | 2024 (Millions) | Change (YoY) | | :-------------------- | :-------------- | :-------------- | :----------- | | Three Months Ended June 30 | $7.7 | $5.5 | +40% | | Six Months Ended June 30 | $15.6 | $11.4 | +37% | - Increase in G&A expenses was primarily due to increased personnel costs, including share-based compensation[23] Net Loss and EPS (Continuing Operations) | Period | Net Loss 2025 (Millions) | Net Loss 2024 (Millions) | Loss Per Share 2025 (USD) | Loss Per Share 2024 (USD) | | :-------------------- | :----------------------- | :----------------------- | :------------------------ | :------------------------ | | Three Months Ended June 30 | $(21.5) | $(11.7) | $(0.29) | $(0.18) | | Six Months Ended June 30 | $(39.7) | $(24.0) | $(0.54) | $(0.41) | About Perspective Therapeutics Perspective Therapeutics is a radiopharmaceutical development company focused on pioneering advanced cancer treatments using its proprietary technology, which utilizes the alpha-emitting isotope 212Pb with specialized targeting moieties, employing a 'theranostic' approach to personalize treatment - Perspective Therapeutics utilizes proprietary technology with the alpha-emitting isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting moieties[26] - The company is developing complementary imaging diagnostics that incorporate the same targeting moieties, enabling a 'theranostic' approach to personalize treatment and optimize patient outcomes[26] - Current clinical programs in Phase 1/2a imaging and therapy trials in the U.S. include VMT-α-NET (neuroendocrine tumor), VMT01 (melanoma), and PSV359 (solid tumor)[27] - The company is expanding its regional network of drug product candidate finishing facilities, supported by its proprietary 212Pb generator, for clinical trials and commercial operations[27] Forward-Looking Statements & Risks This section outlines forward-looking statements regarding the company's expected cash runway, clinical development plans, timing of data release, market opportunities, and product candidate capabilities, while highlighting significant risks and uncertainties that could cause actual results to differ materially - The press release contains forward-looking statements concerning expected cash runway, preclinical and clinical development plans, timing of clinical data, market opportunities, and product candidate functionality[28] - Key risks and uncertainties include delays in clinical trials, unanticipated costs, potential impact of FDA changes, early clinical trial results not being indicative of later trials, regulatory approval challenges, manufacturing and supply disruptions, and the sufficiency of cash and cash equivalents[29] - Investors should not place undue reliance on forward-looking statements, as actual results may differ materially due to various risks detailed in the company's SEC filings[29][30] Investor Information This section provides contact information for media and investor relations inquiries for Perspective Therapeutics, including email addresses for direct contact and through Russo Partners, LLC - Contact information for Media and Investor Relations is provided, including Annie J. Cheng, CFA (ir@perspectivetherapeutics.com) and Nic Johnson of Russo Partners, LLC (PerspectiveIR@russopr.com)[31] Financial Statements Condensed Consolidated Balance Sheets The condensed consolidated balance sheets show a decrease in total assets from $341.1 million at December 31, 2024, to $310.7 million at June 30, 2025, driven by a reduction in current assets, while total liabilities also decreased from $50.4 million to $45.0 million Condensed Consolidated Balance Sheets (Selected Items, in thousands USD) | ASSETS | June 30, 2025 (unaudited, thousands USD) | December 31, 2024 (thousands USD) | | :---------------------------------- | :--------------------------------------- | :-------------------------------- | | Cash and cash equivalents | $28,849 | $61,580 | | Short-term investments | $162,729 | $165,336 | | Total current assets | $195,958 | $231,160 | | Property and equipment, net | $62,599 | $57,321 | | Total assets | $310,725 | $341,101 | | LIABILITIES AND STOCKHOLDERS' EQUITY | | | | Total current liabilities | $12,986 | $18,230 | | Total liabilities | $45,033 | $50,433 | | Total stockholders' equity | $265,692 | $290,668 | | Total liabilities and stockholders' equity | $310,725 | $341,101 | Condensed Consolidated Statements of Operations and Comprehensive Loss The condensed consolidated statements of operations show a net loss of $21.5 million for the three months ended June 30, 2025, an increase from $11.7 million in the prior year, driven by significantly higher operating expenses, resulting in a basic and diluted loss per share of $0.29 Condensed Consolidated Statements of Operations (Selected Items, in thousands USD, except per-share amounts) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Grant revenue | $290 | $526 | $632 | $851 | | Research and development | $16,620 | $9,275 | $30,952 | $16,727 | | General and administrative | $7,709 | $5,514 | $15,551 | $11,392 | | Total operating expenses | $24,329 | $14,789 | $46,503 | $28,119 | | Operating loss | $(24,039) | $(14,263) | $(45,871) | $(27,268) | | Net loss from continuing operations | $(21,999) | $(11,214) | $(40,176) | $(23,039) | | Net gain (loss) from discontinued operations | $514 | $(490) | $514 | $(949) | | Net loss | $(21,485) | $(11,704) | $(39,662) | $(23,988) | | Basic and diluted loss per share | $(0.29) | $(0.18) | $(0.54) | $(0.41) |