Perspective Therapeutics(CATX) - 2025 Q4 - Annual Results

Recent Business Highlights and 2Q 2025 Results This section covers the company's overview, key business achievements including clinical trial progress and financial position, and the CEO's strategic commentary Company Overview Perspective Therapeutics is a radiopharmaceutical company focused on pioneering advanced treatments for cancers throughout the body, utilizing proprietary technology - Perspective Therapeutics, Inc. is a radiopharmaceutical company that is pioneering advanced treatments for cancers throughout the body[2] Key Business Highlights The company reported positive interim results from its Phase 1/2a [212Pb]VMT-α-NET study in neuroendocrine tumors, including objective responses and a favorable safety profile. FDA alignment was reached for Cohort 3, and two patients have been dosed. Upcoming data presentations are planned, and current cash is expected to fund operations into late 2026 - [212Pb]VMT-α-NET study showed objective responses in 4 of 7 patients in Cohort 2, with 3 confirmed and remaining in response. Favorable safety profile with no dose-limiting toxicities or discontinuations due to adverse events observed among 42 patients[3] - FDA alignment reached in June to open Cohort 3 (6.0 mCi) of the [212Pb]VMT-α-NET study; two patients dosed as of July 31, 2025[3] - 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] CEO Commentary CEO Thijs Spoor highlighted the company's commitment to cancer patients, attributing recent and upcoming scientific data presentations to strong clinical trial participation and stable supply of proprietary radiopharmaceutical medicines. The company plans further updates through mid-2026 and beyond - CEO emphasizes company-wide commitment to helping cancer patients with limited treatment options, supported by strong clinical trial participation and stable supply of three clinical-stage, proprietary new medicines[4] Clinical Program Updates This section details the progress of the company's key clinical programs, including VMT-α-NET for neuroendocrine tumors, VMT01 for melanoma, and PSV359 for solid tumors, highlighting study designs, enrollment, dosing, and upcoming data presentations VMT-α-NET (Neuroendocrine Tumors) VMT-α-NET targets SSTR2-expressing tumors. The Phase 1/2a study has progressed, with Cohort 2 enrollment closed and Cohort 3 (6.0 mCi) opened in June 2025 following FDA alignment. Two patients have been dosed in Cohort 3. Data from the study were presented at ASCO and SNMMI 2025, and an update is accepted for ESMO Congress 2025 Program Description and Study Design VMT-α-NET is designed to target and deliver 212Pb to SSTR2-expressing tumor sites. It is being evaluated in a multi-center, open-label, dose-finding, dose-expansion Phase 1/2a study (NCT05636618) for unresectable or metastatic SSTR2-positive neuroendocrine tumors in patients without prior radiopharmaceutical therapies - VMT-α-NET targets SSTR2-expressing tumor sites with 212Pb for patients with unresectable or metastatic SSTR2-positive neuroendocrine tumors[5] - Study is a multi-center, open-label, dose finding, dose expansion Phase 1/2a (NCT05636618) for patients without prior radiopharmaceutical therapies[5] Enrollment and Dosing Progress Cohort 2 enrollment closed in 2Q 2025 with 46 patients treated. Cohort 3 (6.0 mCi) opened in June 2025 after FDA alignment, with two patients dosed by July 31, 2025. The study has progressed through dose escalations from 2.5 mCi (Cohort 1) to 5.0 mCi (Cohort 2) based on Safety Monitoring Committee recommendations - Cohort 2 enrollment closed in 2Q 2025 with an additional 39 patients, totaling 46 patients[6] - Cohort 3 (6.0 mCi) opened in June 2025 after FDA alignment; two patients dosed as of July 31, 2025[7][9] - Dose escalation progressed from Cohort 1 (2.5 mCi) to Cohort 2 (5.0 mCi) based on Safety Monitoring Committee recommendations after DLT review[8] Key Data and Upcoming Presentations Updated interim results from the Phase 1/2a study were presented at the 2025 ASCO Annual Meeting, showing objective responses in Cohort 2 and a favorable safety profile. An update has been accepted for a Mini Oral presentation at the ESMO Congress 2025 in October. Further updates on dosed patients are planned for scientific congresses in the next twelve months - Updated interim results from Phase 1/2a study presented at 2025 ASCO Annual Meeting, showing objective responses and favorable safety profile[3] - Data on [212Pb]VMT-α-NET accepted for Mini Oral presentation at ESMO Congress 2025 on October 20, 2025[3][11] - Plans to submit relevant updates on dosed patients to scientific congresses for presentation in the next twelve months[12] VMT01 (Melanoma) VMT01 is an MC1R-targeted RPT for melanoma, radiolabeled with 203Pb for imaging or 212Pb for therapy. The Phase 1/2a study has progressed through dose escalations, and the Safety Monitoring Committee recommended exploring a lower dose (1.5 mCi) both as monotherapy and in combination with nivolumab, with initial patients treated in March and April 2025 Program Description and Study Design VMT01 is an MC1R-targeted radiopharmaceutical therapy (RPT) that can be radiolabeled with 203Pb for patient selection/dosimetry or 212Pb for alpha particle therapy. It is being studied in a multi-center, open-label, dose-finding, dose-expansion study (NCT05655312) for previously treated patients with histologically confirmed melanoma and MC1R-positive imaging scans - VMT01 is an MC1R-targeted RPT, using 203Pb for imaging/dosimetry and 212Pb for alpha particle therapy[13] - Study (NCT05655312) is a multi-center, open-label, dose finding, dose expansion for previously treated melanoma patients with MC1R-positive imaging[13] Dosing and Cohort Updates The study initially dosed patients in Cohort 1 (3.0 mCi) and Cohort 2 (5.0 mCi). The Safety Monitoring Committee later recommended exploring a lower dose of 1.5 mCi, both as monotherapy and in combination with nivolumab, allowing concurrent progression. As of July 31, 2025, five patients received monotherapy and two received combination treatment - SMC recommended exploring a lower dose level of 1.5 mCi for VMT01, both as monotherapy and in combination with 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[14] PSV359 (Solid Tumors) PSV359 is designed to deliver 212Pb to FAP-α expressing tumor sites in multiple solid tumors. Its targeting ligand shows improved target engagement and reduced retention in healthy tissues in preclinical and human imaging. As of July 31, 2025, two patients have been treated, and additional site activations are in progress Program Description and Status PSV359 targets fibroblast activation protein-α (FAP-α) in solid tumors with 212Pb. The targeting moiety can also be radiolabeled with 203Pb or 68Ga (PSV377) for FAP-α detection. Preclinical and human imaging suggest improved target engagement and reduced healthy tissue retention. Two patients treated as of July 31, 2025, with additional site activations underway - PSV359 targets FAP-α expressing tumor sites with 212Pb for multiple highly prevalent solid tumors; can also use 203Pb or 68Ga (PSV377) for detection[16] - Proprietary targeting ligand shows improved levels of target engagement and uptake in tumors, as well as reduced retention in healthy tissues[16] - Two patients treated with [212Pb]PSV359 as of July 31, 2025; additional site activation activities are underway[17] Second Quarter 2025 Financial Summary This section provides a detailed overview of the company's financial performance and position for the second quarter of 2025, including cash flow, operating expenses, net loss, and balance sheet highlights Financial Position and Outlook Cash, cash equivalents, and short-term investments decreased to $192 million as of June 30, 2025, from $227 million at December 31, 2024. This funding is projected to be sufficient into late 2026, supporting clinical programs, pre-IND assets, and manufacturing site development. The company had 74.3 million common shares and 10.6 million warrants/options outstanding, with all pre-funded warrants exercised in 2Q 2025 Cash, Cash Equivalents, and Short-Term Investments (in millions) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :-------------- | :---------------- | | Cash, cash equivalents, and short-term investments | $192 million | $227 million | - Current funding expected to be sufficient into late 2026, supporting clinical programs, pre-IND assets, and regional manufacturing sites[18] - As of June 30, 2025, approximately 74.3 million shares of common stock and 10.6 million warrants/options outstanding. All outstanding pre-funded warrants exercised in 2Q 2025[19] Segment Reporting Changes Following the divestiture of the brachytherapy segment in April 2024, its operations are now classified as discontinued operations in the financial statements. Financial discussions primarily pertain to continuing operations - Brachytherapy segment divested in April 2024; operations classified as discontinued in financial statements[20] Condensed Consolidated Statements of Operations The company reported a net loss of $21.5 million for 2Q 2025, up from $11.7 million in 2Q 2024, driven by significant increases in R&D and G&A expenses. Grant revenue decreased, while interest income provided a net benefit Grant Revenue Grant revenue decreased to $0.3 million for 2Q 2025 from $0.5 million in 2Q 2024, and to $0.6 million for the six months ended June 30, 2025, from $0.9 million in the prior year, primarily from NIH work Grant Revenue (in millions) | Period | 2Q 2025 | 2Q 2024 | YoY Change | 6M 2025 | 6M 2024 | YoY Change | | :---------------- | :------ | :------ | :--------- | :------ | :------ | :--------- | | Grant Revenue | $0.3 | $0.5 | -40% | $0.6 | $0.9 | -33.3% | Operating Expenses Total operating expenses increased by 65% to $24.3 million for 2Q 2025 and $46.5 million for the six months ended June 30, 2025. This was primarily due to a 79% increase in R&D expenses (to $16.6 million) and a 40% increase in G&A expenses (to $7.7 million) for 2Q 2025, driven by increased clinical activities, drug product costs, and higher personnel costs Operating Expenses (in millions) | Expense Category | 2Q 2025 | 2Q 2024 | YoY Change | 6M 2025 | 6M 2024 | YoY Change | | :----------------------- | :------ | :------ | :--------- | :------ | :------ | :--------- | | Research and development | $16.6 | $9.3 | +79% | $31.0 | $16.7 | +85% | | General and administrative | $7.7 | $5.5 | +40% | $15.6 | $11.4 | +37% | | Total operating expenses | $24.3 | $14.8 | +65% | $46.5 | $28.1 | +65% | - Increase in R&D expenses primarily related to increased clinical site activities, drug product costs, delivery costs, and higher personnel costs (including share-based compensation)[22] - Increase in G&A expenses primarily due to increased personnel costs, including share-based compensation[23] Net Loss and EPS Net loss for 2Q 2025 was $21.5 million ($0.29 per share), compared to $11.7 million ($0.18 per share) in 2Q 2024. For the six months, net loss was $39.7 million ($0.54 per share) versus $24.0 million ($0.41 per share) in the prior year. Net interest income and other expense provided a benefit of $2.0 million and $4.3 million for the three and six months ended 2025, respectively Net Loss and EPS (in millions, except per share) | Metric | 2Q 2025 | 2Q 2024 | YoY Change | 6M 2025 | 6M 2024 | YoY Change | | :-------------------------------- | :------ | :------ | :--------- | :------ | :------ | :--------- | | Net loss | $(21.5) | $(11.7) | +83.8% | $(39.7) | $(24.0) | +65.4% | | Basic and diluted loss per share | $(0.29) | $(0.18) | +61.1% | $(0.54) | $(0.41) | +31.7% | | Net benefit from interest income and other expense | $2.0 | $3.0 | -33.3% | $5.7 | $4.2 | +35.7% | Condensed Consolidated Balance Sheets Total assets decreased to $310.7 million as of June 30, 2025, from $341.1 million at December 31, 2024. This was primarily driven by a decrease in cash and cash equivalents. Total liabilities also decreased to $45.0 million from $50.4 million, while total stockholders' equity decreased to $265.7 million from $290.7 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change | | :-------------------------------- | :-------------- | :---------------- | :----- | | Total assets | $310,725 | $341,101 | $(30,376) | | Cash and cash equivalents | $28,849 | $61,580 | $(32,731) | | Short-term investments | $162,729 | $165,336 | $(2,607) | | Total current assets | $195,958 | $231,160 | $(35,202) | | Total liabilities | $45,033 | $50,433 | $(5,400) | | Total stockholders' equity | $265,692 | $290,668 | $(24,976) | About Perspective Therapeutics, Inc. This section outlines Perspective Therapeutics' mission to develop advanced cancer treatments using alpha-emitting isotopes and a theranostic approach, detailing its clinical programs and manufacturing strategy Company Mission and Technology Perspective Therapeutics is a radiopharmaceutical company developing advanced cancer treatments using the alpha-emitting isotope 212Pb with specialized targeting moieties. They employ a 'theranostic' approach, combining imaging diagnostics (using the same targeting moieties) with therapy to personalize treatment and optimize outcomes. Their clinical programs include VMT-α-NET (neuroendocrine tumors), VMT01 (melanoma), and PSV359 (solid tumors), all in Phase 1/2a trials. The company is also expanding its regional manufacturing network for product candidates - Perspective Therapeutics pioneers advanced cancer treatments using the alpha-emitting isotope 212Pb delivered via specialized targeting moieties[26] - Employs a 'theranostic' approach, combining complementary imaging diagnostics with therapy to personalize treatment and optimize patient outcomes[26] - Clinical programs in Phase 1/2a trials include VMT-α-NET (neuroendocrine tumors), VMT01 (melanoma), and PSV359 (solid tumors)[27] Safe Harbor Statement This section outlines the company's forward-looking statements, highlighting potential risks and uncertainties that could cause actual results to differ materially, and disclaims any obligation to update these statements Forward-Looking Statements and Risks This section contains forward-looking statements regarding the company's expected cash runway, clinical development plans, timing of data release, market opportunities, product candidate capabilities, and future strategies. It cautions that actual results may differ materially due to various risks and uncertainties, including clinical trial delays, regulatory approvals, manufacturing issues, funding sufficiency, intellectual property, and changes in laws. The company disclaims any obligation to update these statements - Press release contains forward-looking statements regarding cash runway, clinical development plans, data timing, market opportunities, and product capabilities[28] - Actual results may differ materially due to risks and uncertainties, including clinical trial delays, regulatory issues, manufacturing, funding, intellectual property, and legal changes[29] - Company undertakes no obligation to publicly update or revise any forward-looking statements unless required by law[30] Media and Investor Relations Contacts This section provides essential contact information for media and investor relations inquiries Contact Information Provides contact information for media and investor relations inquiries, including email addresses for Perspective Therapeutics IR and Russo Partners, LLC - Contact information provided for Media and Investor Relations: Annie J. Cheng, CFA (ir@perspectivetherapeutics.com) and Nic Johnson of Russo Partners, LLC (PerspectiveIR@russopr.com)[31]