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Perspective Therapeutics Provides Recent Business Highlights and Reports 1Q 2025 Results
Globenewswire· 2025-05-12 20:36
Core Insights - Perspective Therapeutics, Inc. is advancing its clinical-stage radiopharmaceuticals targeting various cancers, with a focus on expanding manufacturing capabilities and patient recruitment for ongoing trials [2][38]. Clinical Development - The company is conducting a Phase 1/2a trial of [Pb]VMT-α-NET for patients with unresectable or metastatic somatostatin receptor type 2-positive neuroendocrine tumors, having received Fast Track Designation from the FDA [3][4]. - As of April 2025, 40 patients have been enrolled in Cohort 2 of the VMT-α-NET trial, with no dose-limiting toxicities observed [6][12]. - The VMT01 program, targeting MC1R in melanoma, has also progressed, with initial dosing completed and ongoing patient recruitment [10][12]. - PSV359, targeting FAP-α in solid tumors, has achieved first-in-human dosing, indicating progress in the company's clinical pipeline [17][18]. Financial Overview - As of March 31, 2025, the company reported cash, cash equivalents, and short-term investments of approximately $212 million, expected to fund operations into late 2026 [6][28]. - Research and development expenses increased to $14.3 million for Q1 2025, up from $7.5 million in Q1 2024, reflecting the company's commitment to advancing its clinical programs [34]. - General and administrative expenses rose to $7.8 million in Q1 2025, compared to $5.9 million in the same period of 2024, primarily due to increased personnel costs [35]. Manufacturing and Supply Chain - The company is expanding its U.S. manufacturing capabilities, with two existing sites and plans for three additional facilities to meet growing clinical and commercial demands [20][21]. - A purchase order with the U.S. Department of Energy for thorium (Th) procurement has been established, ensuring a sufficient supply for clinical trials through 2026 [25][26]. Patent and Intellectual Property - The patent portfolio has been strengthened with the allowance of two key patent applications related to the generation of Pb and the VMT-α-NET compound, with expiration dates extending to 2044 and 2041, respectively [27].
Perspective Therapeutics(CATX) - 2025 Q3 - Quarterly Report
2025-05-12 20:34
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to ____________ Commission File Number: 001-33407 PERSPECTIVE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) | De ...
Perspective Therapeutics(CATX) - 2025 Q3 - Quarterly Results
2025-05-12 20:30
[Business Highlights and Q1 2025 Results](index=1&type=section&id=Perspective%20Therapeutics%20Provides%20Recent%20Business%20Highlights%20and%20Reports%201Q%202025%20Results) [Recent Business Highlights](index=1&type=section&id=Recent%20Business%20Highlights) The company advanced its clinical trials and U.S. manufacturing, supported by a strong cash position of $212 million - Enrollment is ongoing for the VMT-α-NET Phase 1/2a trial in neuroendocrine tumors, with **40 patients enrolled** in Cohort 2 as of the end of April 2025[3](index=3&type=chunk) - The VMT01 trial for melanoma saw the first patient treated at a new monotherapy dose level in April 2025 and the first patient treated in combination with nivolumab in March 2025[3](index=3&type=chunk) - Achieved **first-in-human dosing of PSV359**, a therapy targeting FAP-α, which is associated with multiple prevalent solid tumors[3](index=3&type=chunk) - The company is expanding U.S. manufacturing to meet clinical and future commercial demand for its radiopharmaceutical products[3](index=3&type=chunk) - As of March 31, 2025, cash, cash equivalents, and short-term investments were approximately **$212 million**, providing a cash runway into late 2026[3](index=3&type=chunk) [Program Highlights](index=2&type=section&id=Program%20Highlights) [VMT-α-NET for Neuroendocrine Tumors (NETs)](index=2&type=section&id=VMT-%CE%B1-NET) The VMT-α-NET trial shows promising anti-tumor activity and a favorable safety profile in NET patients - The trial is a multi-center, open-label study (NCT05636618) for patients with unresectable or metastatic SSTR2-positive NETs who have not received prior radiopharmaceutical therapies, and the program has received **FDA Fast Track Designation**[5](index=5&type=chunk) - As of April 30, 2025, a total of **40 patients** have begun treatment in Cohort 2 (5.0 mCi dose)[10](index=10&type=chunk) - Safety findings as of January 10, 2025, showed **no dose-limiting toxicities (DLTs)**, no grade 4 or 5 treatment-emergent adverse events (TEAEs), and no treatment discontinuations due to AEs[10](index=10&type=chunk) - As of January 10, 2025, anti-tumor activity in Cohort 2 (7 patients) included **one confirmed response and two unconfirmed responses**, while eight of nine total patients remained on study without progressive disease[10](index=10&type=chunk) - Updated data on [212Pb]VMT-α-NET has been accepted for an oral presentation at the **2025 ASCO Annual Meeting** on May 30, 2025[10](index=10&type=chunk) [VMT01 for Melanoma](index=3&type=section&id=VMT01) The VMT01 program is exploring a lower dose level for melanoma following favorable initial safety data - The trial (NCT05655312) is evaluating VMT01 in previously treated patients with **MC1R-positive melanoma**[11](index=11&type=chunk) - The Safety Monitoring Committee (SMC) recommended exploring a **lower dose of 1.5 mCi**, both as monotherapy and in combination with nivolumab, with the first patients in these new cohorts treated in March and April 2025[13](index=13&type=chunk) - As of September 4, 2024, data from higher dose cohorts (3.0 mCi and 5.0 mCi) showed **no DLTs** or treatment-related discontinuations, with TEAEs being mostly Grade 1 and 2[14](index=14&type=chunk) - In the higher dose cohorts, one patient experienced an **unconfirmed objective response**, and two had stable disease, supporting the exploration of lower radiation doses[14](index=14&type=chunk) [PSV359 for Solid Tumors](index=5&type=section&id=PSV359) The novel radiopharmaceutical PSV359 entered clinical-stage development with the first patient dosed in April 2025 - PSV359 targets **FAP-α**, which is expressed in multiple highly prevalent solid tumors with unmet medical needs[16](index=16&type=chunk) - The **first patient was treated** with [212Pb]PSV359 in April 2025, and activation activities are underway for additional clinical sites[17](index=17&type=chunk) [Manufacturing, Supply Chain, and IP](index=5&type=section&id=Other%20Business%20Highlights) [Manufacturing and Supply Chain](index=5&type=section&id=Manufacturing%20and%20Supply%20Chain) The company is expanding its U.S. manufacturing network and has secured its key isotope supply through 2026 - The company has two operational U.S. manufacturing sites and is building out **three additional facilities** in the Houston, Chicago, and Los Angeles metropolitan areas[20](index=20&type=chunk)[25](index=25&type=chunk) - The company is expanding capacity at its Somerset, NJ facility, which began shipping 212Pb-labeled radiopharmaceuticals in **Q4 2024**[25](index=25&type=chunk) - The company procures the key starting material, 228Th, from the U.S. Department of Energy (DOE) and entered a new purchase order in May 2025 to **secure supply for 2025 and 2026**[22](index=22&type=chunk)[23](index=23&type=chunk) - Based on an initial analysis of recently announced tariffs, the company **does not expect any material cost impacts** in 2025[20](index=20&type=chunk) [Patent Portfolio](index=6&type=section&id=Patent%20portfolio) The company strengthened its IP by securing two key U.S. patents for its 212Pb generation and VMT-α-NET compound - A U.S. patent was allowed for the company's proprietary technology for generating 212Pb, with a term expiring in **August 2044**[24](index=24&type=chunk) - A U.S. patent was allowed for the VMT-α-NET compound, with a term expiring in **January 2041**[24](index=24&type=chunk) [First Quarter 2025 Financials](index=7&type=section&id=First%20Quarter%202025%20Financial%20Summary) [Financial Performance](index=7&type=section&id=Financial%20Performance) Q1 2025 net loss increased to $18.2 million, driven by higher R&D expenses, with a cash runway into late 2026 - Cash, cash equivalents, and short-term investments were approximately **$212 million** as of March 31, 2025, down from $227 million at year-end 2024[26](index=26&type=chunk) - In February 2025, the company sold 3,379,377 shares under its ATM agreement, raising gross proceeds of approximately **$10.2 million**[27](index=27&type=chunk) - The company's financial reporting now classifies the divested brachytherapy segment as **discontinued operations**[29](index=29&type=chunk) Q1 2025 vs. Q1 2024 Financial Results (Continuing Operations) | Financial Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Grant Revenue | $0.3M | $0.3M | 0% | | R&D Expenses | $14.3M | $7.5M | +92% | | G&A Expenses | $7.8M | $5.9M | +33% | | Total Operating Expenses | $22.2M | $13.3M | +66% | | Net Loss | ($18.2M) | ($12.3M) | +48% | | Loss Per Share | ($0.25) | ($0.25) | 0% | [Financial Statements](index=12&type=section&id=Financial%20Statements) [Condensed Consolidated Balance Sheets](index=12&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $329.3 million as of March 31, 2025, primarily due to a reduction in cash Key Balance Sheet Items (in thousands) | Balance Sheet Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $44,406 | $61,580 | | Short-term investments | $167,296 | $165,336 | | **Total Assets** | **$329,349** | **$341,101** | | Total current liabilities | $12,679 | $18,230 | | **Total Liabilities** | **$44,704** | **$50,433** | | **Total Stockholders' Equity** | **$284,645** | **$290,668** | [Condensed Consolidated Statements of Operations](index=13&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Operating loss widened to $21.8 million for the quarter, driven by higher R&D expenses Consolidated Statement of Operations (in thousands) | Line Item | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Grant revenue | $342 | $325 | | Research and development | $14,332 | $7,452 | | General and administrative | $7,842 | $5,878 | | **Operating loss** | **($21,832)** | **($13,005)** | | Total non-operating income, net | $3,655 | $1,180 | | **Net loss from continuing operations** | **($18,177)** | **($11,825)** | | **Net loss** | **($18,177)** | **($12,284)** | | **Basic and diluted loss per share** | **($0.25)** | **($0.25)** |
Perspective Therapeutics to Participate in Upcoming May Investor Conferences
Globenewswire· 2025-05-01 11:00
Core Insights - Perspective Therapeutics, Inc. is a radiopharmaceutical company focused on advanced cancer treatments using proprietary technology that employs the alpha-emitting isotope Pb to target cancer cells specifically [1][2][3] - The company is participating in upcoming investor conferences, including the Bank of America Global Healthcare Conference and the RBC Capital Markets Global Healthcare Conference, to engage with investors [2] Company Overview - Perspective Therapeutics specializes in developing advanced treatments for various cancers and is advancing its proprietary technology for targeted radiation therapy [1][2] - The company is also working on complementary imaging diagnostics that utilize the same targeting moieties, enhancing the personalization of treatment and optimizing patient outcomes through a "theranostic" approach [2][3] Clinical Development - The company's current clinical programs include melanoma (VMT01), neuroendocrine tumor (VMT-α-NET), and solid tumor (PSV359), which are in Phase 1/2a imaging and therapy trials in the U.S. [3] - Perspective Therapeutics is expanding its regional network of drug product finishing facilities, supported by its proprietary Pb generator, to provide patient-ready products for clinical trials and commercial operations [3]
Perspective Therapeutics Announces First Patient Dosed with PSV359 in a Phase 1/2a Study in Patients with FAP-α Positive Solid Tumors
Globenewswire· 2025-04-29 11:00
Core Insights - Perspective Therapeutics, Inc. has initiated a Phase 1/2a dose-finding trial for its radiopharmaceutical [Pb]PSV359, targeting solid tumors expressing fibroblast activation protein alpha (FAP-α) [1][4] - The trial aims to assess the safety and preliminary anti-tumor activity of [Pb]PSV359, with patient selection based on SPECT imaging [1][4] - The company emphasizes the innovative design of [Pb]PSV359, which is optimized for preferential uptake in tumors and rapid clearance from healthy tissues [2][3] Company Overview - Perspective Therapeutics is focused on developing advanced radiopharmaceutical treatments for various cancers, utilizing alpha-emitting isotopes to deliver targeted radiation to cancer cells [6] - The company is also working on complementary imaging diagnostics to personalize treatment and improve patient outcomes through a "theranostic" approach [6] - Current clinical programs include treatments for melanoma, neuroendocrine tumors, and solid tumors, all in Phase 1/2a trials [7] FAP-α Significance - FAP-α is a protein commonly expressed in the tumor microenvironment of many epithelial cancers, and its higher expression is associated with poor prognosis in several solid tumors [5] - The targeting of FAP-α by [Pb]PSV359 aims to provide new treatment options for patients with advanced solid tumors [3][5]
Perspective Therapeutics Announces Acceptance of VMT-α-NET and VMT01 Data for Presentation at the 2025 ASCO Annual Meeting
Globenewswire· 2025-04-23 16:25
Core Insights - Perspective Therapeutics, Inc. announced that data on its [Pb]VMT-α-NET and [Pb]VMT01 programs have been accepted for presentation at the 2025 ASCO Annual Meeting, highlighting the company's ongoing commitment to advancing cancer treatments [1][2] Group 1: Company Overview - Perspective Therapeutics is a radiopharmaceutical development company focused on pioneering advanced treatments for various cancers using alpha-emitting isotopes [5] - The company employs a "theranostic" approach, combining targeted radiation therapy with imaging diagnostics to personalize treatment and optimize patient outcomes [5] Group 2: Clinical Programs - The [Pb]VMT-α-NET program targets SSTR2-positive neuroendocrine tumors and is currently in a multi-center, open-label dose escalation study [3] - The [Pb]VMT01 program is designed for MC1R-positive metastatic melanoma and is also undergoing a multi-center, open-label dose finding study [4] - Initial results from both programs have been presented at various oncology conferences, indicating ongoing research and development efforts [3][4] Group 3: Upcoming Presentations - The presentation of [Pb]VMT-α-NET will include data on dose-limiting toxicity and a one-year follow-up of participants, scheduled for May 30, 2025 [2] - The interim safety and efficacy data for [Pb]VMT01 in melanoma will be presented as a poster on June 2, 2025 [2]
Perspective Therapeutics to Provide Business Highlights and Report First Quarter 2025 Financial Results
Newsfilter· 2025-04-17 11:00
Company Overview - Perspective Therapeutics, Inc. is a radiopharmaceutical company focused on pioneering advanced treatments for cancers throughout the body using proprietary technology that utilizes the alpha-emitting isotope 212Pb [2] - The company is developing complementary imaging diagnostics that incorporate the same targeting moieties, allowing for personalized treatment and optimized patient outcomes through a "theranostic" approach [2] Current Developments - The company's melanoma (VMT01) and neuroendocrine tumor (VMT-α-NET) programs are currently in Phase 1/2a imaging and therapy trials in the U.S. for treating metastatic melanoma and neuroendocrine tumors [3] - Perspective Therapeutics is expanding its regional network of drug product finishing facilities, supported by its proprietary 212Pb generator, to deliver patient-ready products for clinical trials and commercial operations [3] Upcoming Events - The company will report its first quarter 2025 financial results and provide a business update on May 12, 2025, after the market closes [1]
Perspective Therapeutics Announces First Patient Dosed with [212Pb]VMT01 Monotherapy at 1.5 mCi in a Phase 1/2a Study of MC1R-Positive Metastatic Melanoma
Newsfilter· 2025-04-11 11:00
Core Insights - Perspective Therapeutics, Inc. has initiated dosing for the first patient in a new cohort of a Phase 1/2a trial for [212Pb]VMT01, a targeted alpha-particle therapy for melanoma patients with positive MC1R imaging scans [1][2] Company Overview - Perspective Therapeutics is focused on developing advanced radiopharmaceutical treatments for cancer, utilizing the alpha-emitting isotope 212Pb to target cancer cells specifically [6] - The company is also working on complementary imaging diagnostics to personalize treatment and optimize patient outcomes through a "theranostic" approach [6] Clinical Development - The current trial involves administering [212Pb]VMT01 at a dose of 1.5 mCi as monotherapy, with earlier cohorts showing promising initial results [2][3] - The FDA granted Fast Track Designation for [212Pb]VMT01 for treating unresectable or metastatic melanoma with MC1R tumor expression, aimed at expediting its development [4] Melanoma Context - Melanoma is a serious skin cancer with approximately 100,000 new diagnoses and 8,300 deaths annually in the U.S. Metastatic melanoma has a poor prognosis, with a 50% survival rate at one year and 29%-35% at five years [5] - There is a significant unmet need for effective treatments, especially for patients who are refractory to existing therapies, as current second-line therapies offer limited progression-free survival of 2-5 months [5]
Down -16.6% in 4 Weeks, Here's Why Perspective Therapeutics (CATX) Looks Ripe for a Turnaround
ZACKS· 2025-04-02 14:35
Perspective Therapeutics (CATX) has been on a downward spiral lately with significant selling pressure. After declining 16.6% over the past four weeks, the stock looks well positioned for a trend reversal as it is now in oversold territory and there is strong agreement among Wall Street analysts that the company will report better earnings than they predicted earlier.Guide to Identifying Oversold StocksWe use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whe ...
Perspective Therapeutics to Participate in Upcoming April Investor Conferences
Newsfilter· 2025-03-31 11:00
Stifel Virtual Targeted Conference Forum – Company Presentation Date: Tuesday, April 8, 2025 Time: 3:30-3:55 p.m. ET Location: Virtual About Perspective Therapeutics, Inc. Perspective Therapeutics, Inc. is a radiopharmaceutical development company that is pioneering advanced treatment applications for cancers throughout the body. The Company has proprietary technology that utilizes the alpha-emitting isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting moieties. ...