Perspective Therapeutics(CATX)

Search documents
Perspective Therapeutics Announces First Patient Dosed with PSV359 in the Second Cohort of a Phase 1/2a Study in Patients with FAP-α Positive Solid Tumors
Globenewswire· 2025-10-02 11:00
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 ...
Perspective Therapeutics Progresses Dose Finding for [212Pb]VMT01 in Combination with Nivolumab in its Ongoing Phase 1/2a Study of MC1R-Positive Metastatic Melanoma
Globenewswire· 2025-09-15 11:00
First patient dosed with [212Pb]VMT01 3.0 mCi in combination with nivolumab[212Pb]VMT01 3.0 mCi single agent dose Cohort re-opened SEATTLE, Sept. 15, 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, announced today that the first patient was dosed in a new cohort of a Phase 1/2a trial evaluating the safety of [212Pb]VMT01, a targeted alpha-parti ...
Perspective Therapeutics Appoints Biotech Veteran Joel Sendek as Chief Financial Officer
Globenewswire· 2025-09-04 11:00
Core Insights - Perspective Therapeutics, Inc. has appointed Joel Sendek as the new Chief Financial Officer, effective immediately, bringing extensive experience in biotech finance and equity research [1][2][3] - Sendek has a proven track record, having raised over $2.5 billion in corporate finance transactions and recognized as an All-Star Analyst by The Wall Street Journal [2] - The company is advancing its clinical programs in the targeted alpha radiopharmaceutical field, with ongoing trials for neuroendocrine tumors, melanoma, and solid tumors [3][5] Company Overview - Perspective Therapeutics is focused on developing advanced radiopharmaceutical treatments for various cancers, utilizing proprietary technology that employs the alpha-emitting isotope Pb for targeted radiation delivery [4] - The company is also working on complementary imaging diagnostics to personalize treatment and optimize patient outcomes through a "theranostic" approach [4] Clinical Programs - The company's clinical programs include VMT-α-NET for neuroendocrine tumors, VMT01 for melanoma, and PSV359 for solid tumors, all currently in Phase 1/2a trials in the U.S. [5] - Perspective is expanding its regional network of drug product candidate finishing facilities to support clinical trials and commercial operations [5]
Perspective Therapeutics Appoints Maya Martinez-Davis to Board of Directors
Globenewswire· 2025-09-03 11:00
Core Insights - Perspective Therapeutics, Inc. has appointed Maya Martinez-Davis as an independent director to its Board of Directors, effective immediately [1][3] - Ms. Martinez-Davis brings extensive experience in the pharmaceutical industry, having held leadership roles at GSK, Merck KGaA, and Pfizer, particularly in oncology and specialty products [2][3] - The company is focused on pioneering advanced radiopharmaceutical treatments for cancer, utilizing proprietary technology that employs alpha-emitting isotopes for targeted therapy [4][5] Company Overview - Perspective Therapeutics specializes in radiopharmaceuticals aimed at treating various cancers, leveraging alpha-emitting isotopes to deliver radiation directly to cancer cells [4] - The company is developing complementary imaging diagnostics to personalize treatment and optimize patient outcomes through a "theranostic" approach [4] - Current clinical-stage programs include treatments for neuroendocrine tumors (VMT-α-NET), melanoma (VMT01), and solid tumors (PSV359), which are in Phase 1/2a trials in the U.S. [5] Leadership and Strategic Direction - Lori Woods, Chairperson of Perspective, expressed enthusiasm about Ms. Martinez-Davis joining the board, highlighting her complementary experience to existing directors and management [3] - Ms. Martinez-Davis aims to contribute insights to advance the company's clinical programs and enhance shareholder value [3] - CEO Thijs Spoor emphasized the potential of the company's innovative science to develop new medicines that could significantly improve patient lives [3]
Perspective Therapeutics to Participate in Upcoming September Conferences
Globenewswire· 2025-08-26 11:00
SEATTLE, Aug. 26, 2025 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. ("Perspective" or the "Company") (NYSE AMERICAN: CATX), a radiopharmaceutical company pioneering advanced treatments for cancers throughout the body, today announced that members of its senior leadership team will participate in and be available for one-on-one meetings with investors at the following upcoming conferences. Cantor Global Healthcare Conference – Fireside ChatDate: Thursday, September 4, 2025Time: 1:00 p.m. - 1:30 p.m. ET ...
Perspective Therapeutics(CATX) - 2025 Q4 - Annual Report
2025-08-13 11:05
[FORM 10-Q Filing Information](index=1&type=section&id=FORM%2010-Q) [Registrant Information](index=1&type=section&id=Registrant%20Information) This report is a quarterly filing by Perspective Therapeutics, Inc. for the period ended June 30, 2025, registered in Delaware, listed on NYSE American LLC as CATX, and classified as a non-accelerated filer and smaller reporting company - Company Name: PERSPECTIVE THERAPEUTICS, INC[1](index=1&type=chunk) - Reporting Period: Quarter ended June 30, 2025[1](index=1&type=chunk) Company Registration Information | Metric | Details | | :--- | :--- | | Registered State | Delaware | | Stock Symbol | CATX | | Registered Exchange | NYSE American LLC | | Filing Status | Non-accelerated filer, Smaller reporting company | | Common Stock Par Value | $0.001 | | Common Stock Outstanding (as of August 11, 2025) | 74,262,990 | [CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS](index=3&type=section&id=CAUTIONARY%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This report contains forward-looking statements under the Private Securities Litigation Reform Act of 1995, covering future financial conditions, operations, strategies, and industry trends - Forward-looking statements in this report are intended to qualify for the safe harbor provisions of the Private Securities Litigation Reform Act of 1995[5](index=5&type=chunk) - Forward-looking statements cover the company's future financial condition, operating results, business strategy, management objectives, industry trends, and future events[6](index=6&type=chunk) - Actual results may differ materially from expectations due to risks and uncertainties described in the "Risk Factors" section[7](index=7&type=chunk) [AVAILABLE INFORMATION](index=4&type=section&id=AVAILABLE%20INFORMATION) [Company Website and SEC Filings](index=4&type=section&id=Company%20Website%20and%20SEC%20Filings) The company provides free access to its annual, quarterly, and current reports, and other SEC filings on its website after electronic submission - The company's annual, quarterly, current reports, and other SEC filings and amendments are available for free on its website, www.perspectivetherapeutics.com, after filing with the SEC[9](index=9&type=chunk) [PART I FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Item 1 Financial Statements](index=5&type=section&id=Item%201%20Financial%20Statements) This section presents the company's unaudited condensed consolidated financial statements for the period ended June 30, 2025, including balance sheets, statements of operations and comprehensive loss, cash flows, and changes in stockholders' equity [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Presents the company's financial position, including assets, liabilities, and equity, as of June 30, 2025, and December 31, 2024 Condensed Consolidated Balance Sheets Key Data (in thousands of US dollars) | Metric | June 30, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | 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 | | Intangible assets, IPR&D | $50,000 | $50,000 | | Total assets | $310,725 | $341,101 | | Total current liabilities | $12,986 | $18,230 | | Total liabilities | $45,033 | $50,433 | | Total stockholders' equity | $265,692 | $290,668 | | Accumulated deficit | $(271,381) | $(231,719) | - As of June 30, 2025, the company's cash and cash equivalents decreased by **53.15%** year-over-year, total assets decreased by **8.89%**, total liabilities decreased by **10.71%**, total stockholders' equity decreased by **8.59%**, and accumulated deficit increased by **17.16%**[13](index=13&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Details the company's revenues, expenses, and net loss for the three and six months ended June 30, 2025, and 2024 Condensed Consolidated Statements of Operations and Comprehensive Loss Key Data (in thousands of US dollars, 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 expenses | $16,620 | $9,275 | $30,952 | $16,727 | | General and administrative expenses | $7,709 | $5,514 | $15,551 | $11,392 | | Operating loss | $(24,039) | $(14,263) | $(45,871) | $(27,268) | | Net loss | $(21,485) | $(11,704) | $(39,662) | $(23,988) | | Basic and diluted loss per share | $(0.29) | $(0.18) | $(0.54) | $(0.41) | - For the three months ended June 30, 2025, grant revenue decreased by **44.9%** year-over-year, research and development expenses increased by **79.2%**, operating loss expanded by **68.5%**, net loss expanded by **83.6%**, and loss per share expanded by **61.1%**[14](index=14&type=chunk) - For the six months ended June 30, 2025, grant revenue decreased by **25.7%** year-over-year, research and development expenses increased by **85.0%**, operating loss expanded by **68.2%**, net loss expanded by **65.3%**, and loss per share expanded by **31.7%**[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Summarizes the cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2025, and 2024 Condensed Consolidated Statements of Cash Flows Key Data (in thousands of US dollars) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | $(41,535) | $4,946 | | Net cash (used in) provided by investing activities | $(1,301) | $(50,592) | | Net cash provided by financing activities | $10,105 | $288,412 | | Net (decrease) increase in cash and cash equivalents | $(32,731) | $242,766 | | Cash and cash equivalents at end of period | $28,849 | $252,186 | - For the six months ended June 30, 2025, cash flow from operating activities shifted from a net inflow to a net outflow, cash outflow from investing activities significantly decreased, and cash inflow from financing activities substantially declined, leading to a significant reduction in cash and cash equivalents at period-end[16](index=16&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) Details the changes in the company's common stock, additional paid-in capital, accumulated other comprehensive income (loss), and accumulated deficit for the periods presented Condensed Consolidated Statements of Changes in Stockholders' Equity Key Data (in thousands of US dollars, except shares) | Metric | Balance as of December 31, 2024 | Balance as of March 31, 2025 | Balance as of June 30, 2025 | | :--- | :--- | :--- | :--- | | Common stock shares | 70,671,464 | 74,050,841 | 74,262,990 | | Common stock amount | $70 | $73 | $74 | | Additional paid-in capital | $522,368 | $534,449 | $536,996 | | Accumulated other comprehensive income (loss) | $(51) | $19 | $3 | | Accumulated deficit | $(231,719) | $(249,896) | $(271,381) | | Total stockholders' equity | $290,668 | $284,645 | $265,692 | - As of June 30, 2025, total stockholders' equity decreased by approximately **8.6%** compared to December 31, 2024, primarily due to an increase in net loss, despite an increase in additional paid-in capital from common stock issuance through the ATM agreement[18](index=18&type=chunk) [Notes to the Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations and additional information supporting the unaudited condensed consolidated financial statements [1. Basis of Presentation and Summary of Significant Accounting Policies](index=10&type=section&id=1.%20Basis%20of%20Presentation%20and%20Summary%20of%20Significant%20Accounting%20Policies) Outlines the basis of financial statement presentation and summarizes the company's significant accounting policies, including its business nature and recent corporate actions - The company is a radiopharmaceutical development company focused on advanced therapeutic applications for systemic cancer[22](index=22&type=chunk) - On April 12, 2024, the company completed the sale of its Cesium-131 brachytherapy business, with related financial information presented as discontinued operations[24](index=24&type=chunk) - On June 14, 2024, the company effected a 1-for-10 reverse stock split, and all historical per share data has been retroactively adjusted[25](index=25&type=chunk) - The company currently operates in a single operating and reporting segment: radiopharmaceutical development[26](index=26&type=chunk) Liquidity Position (in thousands of US dollars) | Metric | June 30, 2025 | | :--- | :--- | | Cash, cash equivalents, and short-term investments | $191,600 | | Accumulated deficit | $(271,400) | - The company expects its cash resources as of June 30, 2025, to be sufficient to support its currently planned clinical milestones and operating investments through the end of 2026[28](index=28&type=chunk) [2. Loss per Share](index=12&type=section&id=2.%20Loss%20per%20Share) Explains the calculation of loss per share, including the treatment of potentially dilutive securities - Due to the company's net loss position, common stock warrants and options are considered anti-dilutive in the calculation of diluted loss per share[32](index=32&type=chunk) Potentially Dilutive Securities (in shares) | Security Type | June 30, 2025 | June 30, 2024 | | :--- | :--- | :--- | | Common stock warrants | 415,779 | 416,164 | | Common stock options | 10,185,506 | 6,934,022 | | Total potentially dilutive securities | 10,601,285 | 7,350,186 | [3. Investments and Agreements](index=14&type=section&id=3.%20Investments%20and%20Agreements) Details various investment and financing agreements, including ATM agreements, public offerings, and strategic partnerships - 2024 ATM Agreement: On February 18, 2025, the company sold **3,379,377** shares of common stock through this agreement, generating gross proceeds of approximately **$10.2 million**[36](index=36&type=chunk)[40](index=40&type=chunk) - May 2024 Registered Offering: Completed on May 29, 2024, generating gross proceeds of approximately **$80 million**, involving the issuance of common stock and pre-funded warrants, with all pre-funded warrants exercised in the second quarter of 2025[41](index=41&type=chunk)[42](index=42&type=chunk)[43](index=43&type=chunk) - March 2024 Institutional Investor Private Placement: Completed on March 6, 2024, generating gross proceeds of approximately **$87.4 million**, involving the issuance of **9,200,998** shares of common stock[44](index=44&type=chunk)[45](index=45&type=chunk) - Lantheus Agreements: Include an investment agreement with Lantheus on January 8, 2024 (sale of **5,634,235** shares of common stock), an asset purchase agreement (acquisition of Progenics' radiopharmaceutical manufacturing facility for **$8 million** cash), and an option agreement (Lantheus paid **$28 million** for exclusive negotiation rights for [212Pb]VMT-α-NET license)[47](index=47&type=chunk)[48](index=48&type=chunk)[52](index=52&type=chunk)[53](index=53&type=chunk) - January 2024 Public Offering: Completed on January 22, 2024, generating gross proceeds of approximately **$69 million**, involving the issuance of common stock and pre-funded warrants, with all pre-funded warrants exercised in the fourth quarter of 2024[57](index=57&type=chunk)[58](index=58&type=chunk)[59](index=59&type=chunk) - 2023 ATM Agreement: On April 11, 2024, **3,535,246** shares of common stock were sold, generating gross proceeds of approximately **$49.5 million**, and this agreement was terminated on August 12, 2024[60](index=60&type=chunk)[62](index=62&type=chunk)[63](index=63&type=chunk) [4. Discontinued Operations](index=17&type=section&id=4.%20Discontinued%20Operations) Reports on the financial impact and details of the company's divested Cesium-131 brachytherapy business - The company completed the sale of its Cesium-131 brachytherapy business on April 12, 2024, receiving common stock of GT Medical and cash royalties on future sales[64](index=64&type=chunk)[65](index=65&type=chunk) Discontinued Operations Income (Loss) (in thousands of US dollars) | 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 | | :--- | :--- | :--- | :--- | :--- | | Net sales | $0 | $205 | $0 | $2,178 | | Total gain (loss) from discontinued operations | $514 | $(490) | $514 | $(949) | - In the second quarter of 2025, the company recognized **$0.2 million** in royalty revenue and reduced its environmental waste remediation reserve by **$0.3 million** based on estimates from a hazardous waste disposal vendor[67](index=67&type=chunk) [5. Property and Equipment](index=18&type=section&id=5.%20Property%20and%20Equipment) Provides details on the company's property and equipment, including recent acquisitions and commitments for manufacturing facilities - In 2024, the company purchased buildings in Houston, Chicago, and Los Angeles, planned for the production of its product candidates[70](index=70&type=chunk) - The company entered into equipment and services agreements with Comecer SpA totaling approximately **€49 million** for the procurement of radiopharmaceutical manufacturing equipment[70](index=70&type=chunk) Property and Equipment, Net (in thousands of US dollars) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Property and equipment, net | $62,599 | $57,321 | | Construction in progress | $47,991 | $42,601 | [6. Other Intangible Assets](index=19&type=section&id=6.%20Other%20Intangible%20Assets) Discusses the company's intangible assets, specifically in-process research and development (IPR&D) - The company's in-process research and development (IPR&D) asset remained unchanged at **$50 million** as of June 30, 2025, and December 31, 2024[72](index=72&type=chunk) - No impairment testing of intangible assets was conducted in the second quarter of 2025[72](index=72&type=chunk) [7. Available-for-Sale Securities](index=19&type=section&id=7.%20Available-for-Sale%20Securities) Details the company's available-for-sale securities, their fair value, and management's assessment of unrealized losses Fair Value of Available-for-Sale Securities (in thousands of US dollars) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total available-for-sale securities | $162,729 | $165,336 | - The company classifies available-for-sale securities as current assets to meet working capital needs[75](index=75&type=chunk) - As of June 30, 2025, **71** available-for-sale securities were in an unrealized loss position, but the company does not believe a sale of these securities will be required[75](index=75&type=chunk) [8. Fair Value Measurements](index=20&type=section&id=8.%20Fair%20Value%20Measurements) Explains the fair value measurement of the company's financial instruments, primarily cash equivalents and available-for-sale securities Fair Value of Cash Equivalents and Available-for-Sale Securities (in thousands of US dollars) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total cash equivalents | $25,095 | $59,720 | | Total available-for-sale securities | $162,729 | $165,336 | | Total cash equivalents and available-for-sale securities | $187,824 | $225,056 | - The company's cash equivalents and available-for-sale securities are primarily measured at fair value using quoted prices in active markets (Level 1) or observable market data (Level 2), with no Level 3 financial instruments[76](index=76&type=chunk)[77](index=77&type=chunk) [9. Share-Based Compensation](index=21&type=section&id=9.%20Share-Based%20Compensation) Provides information on the company's share-based compensation plans and related expenses - On May 31, 2024, shareholders approved the amended 2020 Equity Incentive Plan, increasing the total authorized common stock by **4,870,092** shares to **12,500,000** shares and adjusting the "evergreen" provision[79](index=79&type=chunk) Share-Based Compensation Expense (in thousands of US dollars) | 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 | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $958 | $259 | $1,855 | $522 | | General and administrative expenses | $1,445 | $328 | $2,646 | $687 | | Total share-based compensation expense | $2,403 | $587 | $4,501 | $1,209 | - For the six months ended June 30, 2025, total share-based compensation expense increased by **272.3%** year-over-year[80](index=80&type=chunk) [10. Commitments and Contingencies](index=22&type=section&id=10.%20Commitments%20and%20Contingencies) Details the company's commitments and contingent liabilities, including legal settlements and purchase obligations - The company expects to resolve a shareholder lawsuit for a total amount not exceeding **$0.2 million** and has accrued a corresponding liability[81](index=81&type=chunk) - In May 2025, the company entered into a purchase order with the U.S. Department of Energy (DOE), committing to purchase approximately **$8.4 million** of Thorium-228 between 2025 and 2026[82](index=82&type=chunk) [11. Related Parties](index=22&type=section&id=11.%20Related%20Parties) Discloses transactions and relationships with related parties, specifically Lantheus - Lantheus is a significant shareholder, holding **19.99%** of common stock as of January 8, 2024, and increasing to approximately **19.9%** after the March 2024 private placement[83](index=83&type=chunk)[86](index=86&type=chunk) - On January 8, 2024, the company entered into an asset purchase agreement with Progenics, an affiliate of Lantheus, to acquire its manufacturing facility for **$8 million**[84](index=84&type=chunk) - Lantheus paid **$28 million** for exclusive negotiation rights for [212Pb]VMT-α-NET, of which **$1.4 million** was recognized as "other income from related parties" after the right of first refusal and last look expired on January 8, 2025[85](index=85&type=chunk)[86](index=86&type=chunk) [12. Leases](index=24&type=section&id=12.%20Leases) Provides information on the company's operating leases, including lease expenses, remaining terms, and future payment obligations - The company entered into several new operating lease agreements in 2024 and 2023, including laboratory and office spaces in Iowa, New Jersey, and Washington[88](index=88&type=chunk)[89](index=89&type=chunk)[90](index=90&type=chunk)[92](index=92&type=chunk) Operating Lease Expense (in thousands of US dollars) | 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 | | :--- | :--- | :--- | :--- | :--- | | Operating lease expense | $300 | $200 | $600 | $300 | - As of June 30, 2025, the company's operating leases had a weighted-average remaining term of **2.8 years** and a discount rate of **8%**[93](index=93&type=chunk) Future Operating Lease Payments and Lease Liabilities (in thousands of US dollars) | Year | Amount | | :--- | :--- | | 2025 (remaining six months) | $559 | | 2026 | $647 | | 2027 | $493 | | 2028 | $443 | | Total | $2,142 | | Less: Estimated interest | $(224) | | Total lease liabilities | $1,918 | | Less: Current portion | $(847) | | Non-current lease liabilities | $1,071 | - Asset retirement obligations related to the Richland facility were transferred to GT Medical, but the company retains an estimated **$0.2 million** liability for hazardous waste removal[95](index=95&type=chunk) [13. Note Payable](index=25&type=section&id=13.%20Note%20Payable) Details the company's note payable, including its purpose, interest rate, and maturity - On December 29, 2022, the company obtained a **$1.7 million** promissory note for the purchase of land and buildings in Coralville, Iowa, with an annual interest rate of **6.15%**[96](index=96&type=chunk) Note Payable (in thousands of US dollars) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total note payable | $1,651 | $1,677 | | Less: Current portion | $(54) | $(52) | | Note payable, long-term portion | $1,597 | $1,625 | - The remaining balance of approximately **$1.5 million** on this note is due on December 29, 2027[96](index=96&type=chunk) [Item 2 Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and operating results for the period ended June 30, 2025, covering business overview, clinical programs, funding, manufacturing, and capital activities [Overview](index=26&type=section&id=Overview) Provides a high-level summary of the company's business as a radiopharmaceutical developer and its focus on targeted cancer therapies - The company is a radiopharmaceutical development company utilizing proprietary Lead-212 (212Pb) alpha-emitting isotope technology to develop targeted therapies and complementary imaging diagnostics (theranostics) for cancer[99](index=99&type=chunk) - The company's VMT-α-NET (neuroendocrine tumors), VMT01 (melanoma), and PSV359 (solid tumors) programs are all in Phase 1/2a imaging and therapeutic clinical trials[100](index=100&type=chunk) [Program Candidates](index=26&type=section&id=Program%20Candidates) Details the progress and key findings of the company's various radiopharmaceutical program candidates in clinical development [VMT-α-NET](index=26&type=section&id=VMT-%CE%B1-NET) Focuses on the development and clinical trial progress of VMT-α-NET for treating SSTR2-expressing neuroendocrine tumors - VMT-α-NET is designed to target tumor cells expressing somatostatin receptor type 2 (SSTR2) for the treatment of unresectable or metastatic SSTR2-expressing neuroendocrine tumors (NETs)[101](index=101&type=chunk) - Phase 1/2a study progress: Cohort 2 completed enrollment of **46** patients, Cohort 3 opened in late June 2025, with **2** patients treated as of July 31, 2025[102](index=102&type=chunk) - Safety data presented at the 2025 ASCO meeting showed no dose-limiting toxicities (DLTs), discontinuations due to adverse events (AEs), or Grade 4/5 treatment-related AEs observed in **42** patients[104](index=104&type=chunk) - Preliminary efficacy data showed **3** confirmed responses and **1** unconfirmed response, with **7** patients achieving disease control in the first **9** patients[105](index=105&type=chunk) [VMT01](index=28&type=section&id=VMT01) Provides an update on the VMT01 program, targeting MC1R-expressing melanoma, including its fast track designation and combination therapy studies - VMT01 targets melanoma expressing melanocortin 1 receptor (MC1R) for the treatment of second-line or later MC1R-positive metastatic melanoma[111](index=111&type=chunk) - In September 2024, the FDA granted Fast Track designation to [212Pb]VMT01[112](index=112&type=chunk) - The company is collaborating with Bristol Myers Squibb to evaluate the safety and tolerability of [212Pb]VMT01 in combination with nivolumab[113](index=113&type=chunk) - Preliminary results showed no DLTs in Cohort 1 and Cohort 2, with AEs mostly Grade 1/2 and no reports of nephrotoxicity[114](index=114&type=chunk)[115](index=115&type=chunk) - The Safety Monitoring Committee (SMC) recommended exploring a lower dose level of **1.5 mCi**, with enrollment open for both monotherapy and combination with nivolumab[117](index=117&type=chunk) [PSV359](index=30&type=section&id=PSV359) Details the development of PSV359, a novel cyclic peptide targeting FAP-α for pan-cancer potential, and its clinical trial initiation - PSV359 is a novel cyclic peptide targeting FAP-α (fibroblast activation protein alpha) expressed on tumor stromal cells and some cancer cells, with pan-cancer target potential[118](index=118&type=chunk) - First-in-human SPECT/CT imaging showed [203Pb]PSV359 had good tumor targeting and retention, with rapid clearance from normal organs[118](index=118&type=chunk)[119](index=119&type=chunk) - An IND application was submitted in December 2024, approved by the FDA in the first quarter of 2025, and the first patient received [212Pb]PSV359 treatment on April 29, 2025[121](index=121&type=chunk) [Discovery Program](index=30&type=section&id=Discovery%20Program) Describes the company's discovery efforts to develop new constructs for potential first-in-human imaging and therapeutic benefits - The company's discovery team is preparing several new constructs for potential first-in-human imaging as a de-risking step for potential therapeutic benefit, including a pre-targeting platform licensed from Stony Brook University[122](index=122&type=chunk) [Intellectual Property](index=30&type=section&id=Intellectual%20Property) Highlights recent patent grants covering the company's 212Pb production technology, VMT-α-NET compound, and lead-specific chelator - The company recently obtained two U.S. patents and one European patent covering its 212Pb scalable production technology, VMT-α-NET compound, and lead-specific chelator[123](index=123&type=chunk) - The 212Pb generation technology patent is valid until **August 2044**, the VMT-α-NET compound patent until **January 2041**, and the lead-specific chelator European patent until **April 2039**[123](index=123&type=chunk) [Funding Requirements](index=30&type=section&id=Funding%20Requirements) Discusses the company's anticipated funding needs to advance its clinical programs and expand operations, and its current liquidity position - The company expects expenses to continue increasing as preclinical activities, clinical trials, and commercialization of product candidates progress[124](index=124&type=chunk) - As of June 30, 2025, the company had **$191.6 million** in cash, cash equivalents, and short-term investments, expected to be sufficient to support its currently planned clinical milestones and operating investments through the end of 2026[126](index=126&type=chunk) - Management anticipates a significant increase in research and development and general and administrative expenses to advance clinical and preclinical assets[126](index=126&type=chunk) [Manufacturing and Supply](index=32&type=section&id=Manufacturing%20and%20Supply) Outlines the company's strategy for manufacturing and supplying its radiopharmaceutical candidates, including partnerships and facility plans - The company assembles and manufactures its radiopharmaceutical product candidates by chelating 212Pb with targeting peptides[127](index=127&type=chunk) - The company plans to utilize a combination of third-party contract manufacturing organizations (CMOs) and its own FDA CGMP-compliant manufacturing sites to produce and distribute doses[127](index=127&type=chunk) - The company entered into a purchase order with the U.S. Department of Energy (DOE), committing to purchase approximately **$8.4 million** of Thorium-228 between 2025 and 2026[128](index=128&type=chunk) - In 2024, the company entered into equipment and services agreements with Comecer SpA totaling approximately **€49 million** for the procurement of radiopharmaceutical manufacturing equipment[129](index=129&type=chunk) [Facility Acquisitions](index=32&type=section&id=Facility%20Acquisitions) Details the company's recent acquisitions of buildings and a manufacturing facility to support its production capabilities - In 2024, the company acquired buildings in Houston, Chicago, and Los Angeles, planned for the manufacturing of its product candidates[130](index=130&type=chunk) - The company also acquired assets and related leases for Lantheus' radiopharmaceutical manufacturing facility in Somerset, New Jersey, achieving its first shipment and patient dosing in October 2024[131](index=131&type=chunk) [Capital Market Activities](index=33&type=section&id=Capital%20Market%20Activities) Reports on the company's recent capital market activities, including its ATM agreement for common stock sales - On August 13, 2024, the company entered into the 2024 ATM Agreement, allowing for the sale of up to **$250 million** of common stock; as of February 18, 2025, **3,379,377** shares of common stock were sold, generating gross proceeds of approximately **$10.2 million**[134](index=134&type=chunk)[138](index=138&type=chunk) [Brachytherapy Divestiture](index=33&type=section&id=Brachytherapy%20Divestiture) Provides an update on the completed divestiture of the Cesium-131 brachytherapy business and related financial impacts - The company completed the sale of its Cesium-131 brachytherapy business to GT Medical Technologies, Inc. on April 12, 2024[139](index=139&type=chunk) - As part of the transaction, the company received common stock of GT Medical and cash royalties on future sales for four years, with royalty rates dependent on sales and product type[140](index=140&type=chunk)[143](index=143&type=chunk) - In the second quarter of 2025, the company recognized **$0.2 million** in royalty revenue and reduced its environmental waste remediation reserve by **$0.3 million**[140](index=140&type=chunk) [Legislative Update](index=33&type=section&id=Legislative%20Update) Informs about recent tax legislation and its anticipated impact on the company's financial performance - On July 4, 2025, the President signed the "One Big Beautiful Bill Act" (OBBBA) tax legislation, which the company does not expect to have a material impact on its 2025 financial results[142](index=142&type=chunk) [Critical Accounting Policies and Estimates](index=35&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) States that there have been no significant changes to the company's critical accounting policies and estimates - There have been no significant changes to the company's critical accounting policies and estimates as of June 30, 2025[145](index=145&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) Analyzes the company's operating performance, focusing on changes in grant revenue and operating expenses [Grant Revenue](index=35&type=section&id=Grant%20Revenue) Discusses the trends and sources of the company's grant revenue Grant Revenue (in thousands of US dollars) | 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 | - Grant revenue decreased year-over-year, primarily from work with the National Institutes of Health, as the company currently generates no sales revenue from its alpha-therapeutic product candidates[148](index=148&type=chunk) [Operating Expenses](index=35&type=section&id=Operating%20Expenses) Examines the changes and drivers behind the company's operating expenses, including research and development and general and administrative costs [Research and Development](index=35&type=section&id=Research%20and%20Development) Analyzes the increase in research and development expenses, attributing it to clinical activities, drug costs, and personnel Research and Development Expenses (in thousands of US dollars) | 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 | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $16,620 | $9,275 | $30,952 | $16,727 | - Research and development expenses increased by **$7.3 million** and **$14.2 million** for the three and six-month periods, respectively, primarily due to increased clinical site activities, drug and delivery costs, and higher personnel costs, including share-based compensation[149](index=149&type=chunk) - Management expects research and development expenses to continue increasing to invest in new radiopharmaceutical development and expand manufacturing capabilities, while also evaluating the potential impact of trade policies on raw material costs[150](index=150&type=chunk)[151](index=151&type=chunk) [General and Administrative](index=36&type=section&id=General%20and%20Administrative) Discusses the increase in general and administrative expenses, mainly driven by higher personnel costs General and Administrative Expenses (in thousands of US dollars) | 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 | | :--- | :--- | :--- | :--- | :--- | | General and administrative expenses | $7,709 | $5,514 | $15,551 | $11,392 | - General and administrative expenses increased by **$2.2 million** and **$4.2 million** for the three and six-month periods, respectively, primarily due to increased personnel costs, including share-based compensation[153](index=153&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's liquidity position, cash flow trends, and future capital requirements [Cash Flow Summary](index=36&type=section&id=Cash%20Flow%20Summary) Provides a summary of cash flows from operating, investing, and financing activities and their impact on cash and cash equivalents Cash Flow Summary (in thousands of US dollars) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :--- | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | $(41,535) | $4,946 | $(46,481) | | Net cash (used in) provided by investing activities | $(1,301) | $(50,592) | $49,291 | | Net cash provided by financing activities | $10,105 | $288,412 | $(278,307) | | Net (decrease) increase in cash and cash equivalents | $(32,731) | $242,766 | $(275,497) | - Cash outflow from operating activities increased by **$46.5 million**, primarily due to changes in operating assets and liabilities and an increased net loss[154](index=154&type=chunk) - Cash outflow from investing activities decreased by **$49.3 million**, mainly due to increased maturities of short-term investments, decreased purchases of short-term investments, and reduced increases in property and equipment[155](index=155&type=chunk) - Cash inflow from financing activities decreased by **$278.3 million**, primarily due to reduced proceeds from capital market transactions compared to the prior year[156](index=156&type=chunk) [Sources of Liquidity](index=38&type=section&id=Sources%20of%20Liquidity) Details the various capital market transactions and agreements that have provided liquidity to the company - 2024 ATM Agreement: On February 18, 2025, the company sold **3,379,377** shares of common stock through this agreement, generating gross proceeds of approximately **$10.2 million**[162](index=162&type=chunk) - May 2024 Registered Offering: Generated gross proceeds of approximately **$80 million**, involving the issuance of common stock and pre-funded warrants, with all pre-funded warrants exercised in the second quarter of 2025[163](index=163&type=chunk)[164](index=164&type=chunk)[165](index=165&type=chunk) - March 2024 Institutional Investor Private Placement: Generated gross proceeds of approximately **$87.4 million**, involving the issuance of **9,200,998** shares of common stock[166](index=166&type=chunk) - Lantheus Investment Agreement: The company sold **5,634,235** shares of common stock to Lantheus, representing **19.99%** of its outstanding common stock as of January 8, 2024[167](index=167&type=chunk) - January 2024 Public Offering: Generated gross proceeds of approximately **$69 million**, involving the issuance of common stock and pre-funded warrants, with all pre-funded warrants exercised in the fourth quarter of 2024[168](index=168&type=chunk)[169](index=169&type=chunk)[170](index=170&type=chunk) - 2023 ATM Agreement: On April 11, 2024, common stock was sold, generating gross proceeds of approximately **$49.5 million**[171](index=171&type=chunk) [Funding Requirements](index=42&type=section&id=Funding%20Requirements) Discusses the company's future capital needs, potential financing methods, and factors influencing these requirements - The company expects its cash, cash equivalents, and short-term investments (totaling **$191.6 million** as of June 30, 2025) to be sufficient to support its currently planned clinical milestones and operating investments through the end of 2026[172](index=172&type=chunk) - The company anticipates needing to raise additional capital before achieving profitability, potentially through equity financing, debt financing, strategic collaborations, or licensing agreements[173](index=173&type=chunk)[177](index=177&type=chunk) - Future funding requirements will depend on various factors, including the scope of research and development, regulatory approvals, employee recruitment, intellectual property maintenance, acquisition or licensing of other product candidates, and trade policies[175](index=175&type=chunk)[176](index=176&type=chunk) [Capital expenditures](index=44&type=section&id=Capital%20expenditures) Explains management's approach to capital allocation for research and development, general and administrative functions, clinical trials, and product supply - Management regularly reviews research and development and general and administrative functions to effectively allocate capital in support of clinical trials, preclinical activities, and product supply[178](index=178&type=chunk) [Financing activities](index=44&type=section&id=Financing%20activities) Outlines the expected sources for financing future capital needs, including equity sales, strategic collaborations, and debt financing - Future capital needs are expected to be financed through equity sales, strategic collaborations, debt financing, or other sources that may dilute existing stockholders' equity[179](index=179&type=chunk) [Other Commitments and Contingencies](index=44&type=section&id=Other%20Commitments%20and%20Contingencies) States that there have been no significant changes to other commitments and contingencies beyond those disclosed in the financial statements - Except as disclosed in Note 10 to the financial statements, there have been no significant changes to other commitments and contingencies as of June 30, 2025[180](index=180&type=chunk) [Off-Balance Sheet Arrangements](index=44&type=section&id=Off-Balance%20Sheet%20Arrangements) Confirms that the company has no off-balance sheet arrangements - The company has no off-balance sheet arrangements[181](index=181&type=chunk) [Item 3 Quantitative and Qualitative Disclosures About Market Risk](index=45&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Perspective Therapeutics, Inc. is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk[182](index=182&type=chunk) [Item 4 Controls and Procedures](index=45&type=section&id=Item%204%20Controls%20and%20Procedures) Management assessed the effectiveness of the company's disclosure controls and procedures as of June 30, 2025, concluding they are effective, with no material changes to internal controls during the quarter - As of June 30, 2025, the company's disclosure controls and procedures were determined to be effective in design and operation[183](index=183&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected or are reasonably likely to materially affect internal control[184](index=184&type=chunk) [PART II OTHER INFORMATION](index=46&type=section&id=PART%20II%20OTHER%20INFORMATION) This section provides additional information not covered in Part I, including legal proceedings, risk factors, equity sales, defaults, and exhibits [Item 1 Legal Proceedings](index=46&type=section&id=Item%201%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings and has no pending or threatened litigation that would significantly impact its business or financial condition - The company is not currently involved in any material legal proceedings[185](index=185&type=chunk) [Item 1A Risk Factors](index=46&type=section&id=Item%201A%20Risk%20Factors) There have been no material changes to the risk factors disclosed in the company's 2024 Form 10-K annual report, which investors should carefully consider - There have been no material changes to the risk factors disclosed in the 2024 Form 10-K annual report[186](index=186&type=chunk) [Item 2 Unregistered Sales of Equity Securities and Use of Proceeds](index=46&type=section&id=Item%202%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds during this quarter - No unregistered sales of equity securities and use of proceeds[187](index=187&type=chunk) [Item 3 Defaults Upon Senior Securities](index=46&type=section&id=Item%203%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during this quarter - No defaults upon senior securities[188](index=188&type=chunk) [Item 4 Mine Safety Disclosures](index=46&type=section&id=Item%204%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine safety disclosures are not applicable[189](index=189&type=chunk) [Item 5 Other Information](index=46&type=section&id=Item%205%20Other%20Information) No Rule 10b5-1 trading arrangements were adopted, modified, or terminated by the company's directors or officers during this quarter - No "Rule 10b5-1 trading arrangements" or "non-Rule 10b5-1 trading arrangements" were adopted, modified, or terminated by the company's directors or officers during this quarter[190](index=190&type=chunk) [Item 6 Exhibits](index=47&type=section&id=Item%206%20Exhibits) This section lists all exhibits filed with this report, including corporate charters, certification documents, and XBRL data files - Exhibits include corporate charters, certification documents (e.g., CEO and CFO certifications), and Inline XBRL files[192](index=192&type=chunk) [Signatures](index=48&type=section&id=Signatures) This section contains the official signatures of the company's authorized officers, certifying the accuracy and completeness of the report [Report Signatures](index=48&type=section&id=Report%20Signatures) This report was officially signed by Perspective Therapeutics, Inc.'s CEO, Johan (Thijs) Spoor, and CFO, Juan Graham, on August 13, 2025 - The report was signed on August 13, 2025[194](index=194&type=chunk) - Signatories include CEO Johan (Thijs) Spoor and CFO Juan Graham[194](index=194&type=chunk)
Perspective Therapeutics(CATX) - 2025 Q4 - Annual Results
2025-08-13 10:45
[Recent Business Highlights and 2Q 2025 Results](index=1&type=section&id=Recent%20Business%20Highlights%20and%202Q%202025%20Results) 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](index=1&type=section&id=Company%20Overview) 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](index=2&type=chunk) [Key Business Highlights](index=1&type=section&id=Key%20Business%20Highlights) 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](index=3&type=chunk) - 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](index=3&type=chunk) - 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](index=3&type=chunk) [CEO Commentary](index=2&type=section&id=CEO%20Commentary) 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](index=4&type=chunk) [Clinical Program Updates](index=2&type=section&id=Clinical%20Program%20Updates) 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)](index=2&type=section&id=VMT-%CE%B1-NET%20(Neuroendocrine%20Tumors)) 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](index=2&type=section&id=VMT-%CE%B1-NET_Program%20Description%20and%20Study%20Design) 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](index=5&type=chunk) - Study is a multi-center, open-label, dose finding, dose expansion Phase 1/2a (NCT05636618) for patients without prior radiopharmaceutical therapies[5](index=5&type=chunk) [Enrollment and Dosing Progress](index=2&type=section&id=VMT-%CE%B1-NET_Enrollment%20and%20Dosing%20Progress) 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](index=6&type=chunk) - Cohort 3 (**6.0 mCi**) opened in June 2025 after FDA alignment; **two patients** dosed as of July 31, 2025[7](index=7&type=chunk)[9](index=9&type=chunk) - 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](index=8&type=chunk) [Key Data and Upcoming Presentations](index=1&type=section&id=VMT-%CE%B1-NET_Key%20Data%20and%20Upcoming%20Presentations) 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](index=3&type=chunk) - Data on [212Pb]VMT-α-NET accepted for Mini Oral presentation at ESMO Congress 2025 on October 20, 2025[3](index=3&type=chunk)[11](index=11&type=chunk) - Plans to submit relevant updates on dosed patients to scientific congresses for presentation in the next twelve months[12](index=12&type=chunk) [VMT01 (Melanoma)](index=3&type=section&id=VMT01%20(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](index=3&type=section&id=VMT01_Program%20Description%20and%20Study%20Design) 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](index=13&type=chunk) - Study (NCT05655312) is a multi-center, open-label, dose finding, dose expansion for previously treated melanoma patients with MC1R-positive imaging[13](index=13&type=chunk) [Dosing and Cohort Updates](index=3&type=section&id=VMT01_Dosing%20and%20Cohort%20Updates) 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](index=13&type=chunk) - 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](index=14&type=chunk) [PSV359 (Solid Tumors)](index=4&type=section&id=PSV359%20(Solid%20Tumors)) 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](index=4&type=section&id=PSV359_Program%20Description%20and%20Status) 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](index=16&type=chunk) - Proprietary targeting ligand shows improved levels of target engagement and uptake in tumors, as well as reduced retention in healthy tissues[16](index=16&type=chunk) - **Two patients** treated with [212Pb]PSV359 as of July 31, 2025; additional site activation activities are underway[17](index=17&type=chunk) [Second Quarter 2025 Financial Summary](index=4&type=section&id=Second%20Quarter%202025%20Financial%20Summary) 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](index=4&type=section&id=Financial%20Position%20and%20Outlook) 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](index=18&type=chunk) - 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](index=19&type=chunk) [Segment Reporting Changes](index=4&type=section&id=Segment%20Reporting%20Changes) 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](index=20&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=5&type=section&id=Grant%20Revenue) 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](index=5&type=section&id=Operating%20Expenses) 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](index=22&type=chunk) - Increase in G&A expenses primarily due to increased personnel costs, including share-based compensation[23](index=23&type=chunk) [Net Loss and EPS](index=5&type=section&id=Net%20Loss%20and%20EPS) 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](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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.](index=5&type=section&id=About%20Perspective%20Therapeutics%2C%20Inc.) 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](index=5&type=section&id=Company%20Mission%20and%20Technology) 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](index=26&type=chunk) - Employs a 'theranostic' approach, combining complementary imaging diagnostics with therapy to personalize treatment and optimize patient outcomes[26](index=26&type=chunk) - Clinical programs in Phase 1/2a trials include VMT-α-NET (neuroendocrine tumors), VMT01 (melanoma), and PSV359 (solid tumors)[27](index=27&type=chunk) [Safe Harbor Statement](index=6&type=section&id=Safe%20Harbor%20Statement) 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](index=6&type=section&id=Forward-Looking%20Statements%20and%20Risks) 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](index=28&type=chunk) - Actual results may differ materially due to risks and uncertainties, including clinical trial delays, regulatory issues, manufacturing, funding, intellectual property, and legal changes[29](index=29&type=chunk) - Company undertakes no obligation to publicly update or revise any forward-looking statements unless required by law[30](index=30&type=chunk) [Media and Investor Relations Contacts](index=7&type=section&id=Media%20and%20Investor%20Relations%20Contacts) This section provides essential contact information for media and investor relations inquiries [Contact Information](index=7&type=section&id=Contact%20Information) 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](index=31&type=chunk)
Perspective Therapeutics Provides Recent Business Highlights and Reports 2Q 2025 Results
Globenewswire· 2025-08-13 10:45
Core Viewpoint - Perspective Therapeutics, Inc. is advancing its clinical programs in radiopharmaceuticals aimed at treating various cancers, with significant updates on their ongoing studies and financial performance for the second quarter of 2025 [1][2][17]. Clinical Highlights - The company is conducting a multi-center, open-label study of [Pb]VMT-α-NET targeting SSTR2-positive neuroendocrine tumors, with 46 patients treated in Cohort 2 and Cohort 3 opened in June 2025 [3][4]. - As of April 30, 2025, four out of seven patients in Cohort 2 showed objective responses, and seven out of nine patients in Cohorts 1 and 2 remained free from disease progression after over one year [4]. - The safety profile of [Pb]VMT-α-NET remains favorable, with no dose-limiting toxicities reported among 42 patients [4]. - The company plans to present updates on its clinical programs at upcoming scientific congresses, including the European Society of Medical Oncology Congress in October 2025 [9][10]. Financial Summary - As of June 30, 2025, the company reported cash, cash equivalents, and short-term investments of approximately $192 million, down from $227 million at the end of 2024, which is expected to fund operations into late 2026 [17]. - Research and development expenses increased by approximately 79% year-over-year for Q2 2025, totaling $16.6 million, primarily due to heightened clinical activities and personnel costs [21]. - General and administrative expenses rose by approximately 40% year-over-year for Q2 2025, amounting to $7.7 million, driven by increased personnel costs [22]. - The total operating expenses for Q2 2025 were $24.3 million, a 65% increase compared to the same period in 2024 [23]. - The net loss for Q2 2025 was $21.5 million, or $0.29 per share, compared to a net loss of $11.7 million, or $0.18 per share, for Q2 2024 [24]. Company Overview - Perspective Therapeutics, Inc. specializes in developing advanced radiopharmaceutical treatments for cancer, utilizing proprietary technology that targets cancer cells with alpha-emitting isotopes [25][26]. - The company is focused on three main clinical programs: VMT-α-NET for neuroendocrine tumors, VMT01 for melanoma, and PSV359 for solid tumors, all currently in Phase 1/2a trials [26].
Perspective Therapeutics: Giving Us Some Valuable Perspective On Alpha Emitter Therapy
Seeking Alpha· 2025-08-02 12:53
Group 1 - The company's valuation had decreased due to a market perception of underwhelming data readout from previous clinical trials [1] - The author has a PhD in biochemistry and extensive experience in analyzing clinical trials and biotech companies, emphasizing the importance of understanding the science behind investments [1] Group 2 - No stock or derivative positions are held by the author in the companies mentioned, indicating an unbiased perspective [2] - The article expresses the author's personal opinions and is not influenced by any business relationships with the companies discussed [2]
Perspective Therapeutics Announces Acceptance of VMT-α-NET Data for Presentation at the ESMO Congress 2025
Globenewswire· 2025-07-24 16:45
Core Insights - Perspective Therapeutics, Inc. announced that updated data on its [Pb]VMT-α-NET program will be presented at the ESMO Congress 2025 in Berlin, Germany from October 17 to 21, 2025 [1] - The presentation will include mature safety and preliminary efficacy data for advanced somatostatin receptor 2 positive neuroendocrine tumors [2] Company Overview - Perspective Therapeutics is a radiopharmaceutical company focused on developing advanced cancer treatments using alpha-emitting isotopes to target cancer cells [4] - The company is also developing imaging diagnostics that complement its therapeutic approaches, enhancing treatment personalization and patient outcomes through a "theranostic" strategy [4] Clinical Programs - The [Pb]VMT-α-NET program is currently in a multi-center, open-label, dose-escalation study for patients with unresectable or metastatic SSTR2-positive neuroendocrine tumors [3] - The study has reported interim updates, with a data cut-off date of April 30, 2025, and additional patients enrolled after reopening Cohort 2 in August 2024 [3] Future Developments - The company is expanding its regional network of drug product candidate finishing facilities, supported by its proprietary Pb generator, to facilitate clinical trials and commercial operations [5]