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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. ...
Perspective Therapeutics(CATX) - 2024 Q4 - Annual Report
2025-03-26 20:14
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 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 No. 001-33407 PERSPECTIVE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) | Delaware | 41-1458152 | | --- | --- ...
Perspective Therapeutics(CATX) - 2025 Q2 - Quarterly Results
2025-03-26 20:11
Clinical Development and Pipeline - The company has three clinical-stage programs with multiple read-outs and milestones expected in the next 12-18 months[9]. - The proprietary pipeline includes VMT01/02 targeting melanoma, with the next cohort open for enrollment, and PSV359 for multiple solid tumors, with IND filed in late 2024 and dosing to initiate in mid-2025[10]. - The ongoing clinical trial for [212Pb]VMT-α-NET is designed to measure the incidence of dose-limiting toxicities (DLTs) and determine the maximum tolerated dose (MTD) in patients with advanced neuroendocrine tumors[45]. - The company is currently recruiting for a therapeutic dose-finding trial in a PRRT-naïve setting throughout the US, indicating strong progress in clinical development[39]. - Recruitment is ongoing for the combination cohort with nivolumab, with an estimated time to primary completion of approximately 18 months[68]. - The first-in-human therapeutic studies for PSV359 are anticipated by mid-2025[94]. Safety and Efficacy - Preliminary results show that [212Pb]VMT-α-NET was well tolerated, with treatment-emergent adverse events occurring in 44% of patients treated[48]. - No decline in renal function has been observed in patients treated with [212Pb]VMT-α-NET, suggesting a favorable safety profile[49]. - [212Pb]VMT-α-NET was well tolerated, supporting rationale for dose escalation, with no dose-limiting toxicities (DLTs) reported[52]. - An objective response and prolonged progression-free survival (PFS) were observed at the 3 mCi activity level[73]. - 89% of patients (8 out of 9) achieved durable disease control, with 67% showing molecular imaging decline in SUVs[52]. - The combination of [212Pb]VMT01 with immune checkpoint inhibitors showed superior efficacy in preclinical studies[58]. Manufacturing and Supply Chain - The company has developed a robust manufacturing infrastructure to ensure patient coverage via distributed manufacturing, providing ready-to-administer products on the day of scheduled treatment[8]. - The company has established a long-term supply contract with the Department of Energy (DoE) to ensure a reliable supply of radioisotopes for therapeutic products[34]. - The regional manufacturing strategy aims to cover over 90% of the US population within an 11-hour delivery radius, enhancing the commercialization of 212Pb-labeled finished products[36]. - The company is advancing multiple pre-IND assets towards clinical trials and developing regional manufacturing sites[99]. Intellectual Property and Regulatory - The company emphasizes the importance of maintaining and enforcing its intellectual property rights to support its innovative therapies[4]. - The company has a robust intellectual property portfolio with 7 issued patents and 54 pending applications, covering various aspects of radiopharmaceuticals[97][98]. - The expected cash runway and market opportunities for the company's product candidates are under evaluation, with a focus on maintaining regulatory approvals[4]. Research and Development - The ideal isotope used is 212Pb, which provides potent tumor cell killing with reduced off-target effects, enhancing safety and efficacy[21]. - The proprietary chelator has been optimized for lead-based RPTs, improving radiolabeling and reducing off-target toxicity[24]. - The platform's theranostics approach allows for imaging pre-treatment, which de-risks clinical trials and optimizes patient selection[14]. - Imaging studies indicate strong tumor retention and low accumulation in normal organs, enhancing the therapeutic profile of FAP-targeted agents[91]. - Preclinical data supports the potential of the optimized peptide developed by the in-house discovery team as a best-in-class candidate[93]. - PSV359 shows anti-tumor activity in mice with U87MG xenografts, achieving a 50% complete response rate[82]. - Imaging with [68Ga]PSV377 demonstrates excellent tumor uptake and fast clearance, indicating favorable characteristics for diagnostic applications[86]. Market and Unmet Needs - The overall response rate (ORR) for existing treatments like LUTATHERA is only 13-17%, highlighting the unmet need for more effective targeted alpha therapies[39]. - The company aims to expand the breadth of tumors addressed by RPT, with a focus on SSTR2+ tumors and potential first-in-class therapies[11]. - The melanoma program targets high melanocortin 1 receptor (MC1R) expression, with approximately 100,000 new diagnoses and 8,000 deaths annually in the US[57]. - The company is evaluating expansion into other SSTR2+ tumor types, including breast cancer and small cell lung cancer (SCLC)[52].
Perspective Therapeutics Provides Recent Business Highlights and Reports Full Year 2024 Results
Newsfilter· 2025-03-26 20:10
Core Insights - Perspective Therapeutics, Inc. is advancing its clinical-stage proprietary medicines based on a next-generation targeted radiopharmaceutical technology platform, with multiple clinical updates expected through mid-2026 [2][6][41] Clinical Programs - The company is conducting a Phase 1/2a trial of [212Pb]VMT-α-NET for patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2)-positive neuroendocrine tumors, having received Fast Track Designation from the FDA [3][4][6] - As of February 2025, 30 patients have been enrolled in Cohort 2 of the trial, with no dose-limiting toxicities observed [6][14] - The company has achieved first-in-human combination dosing of a PD-1 inhibitor with its potential new medicine, VMT01, and has cleared an IND for PSV359, targeting FAP-α in solid tumors, with first patient dosing expected in mid-2025 [6][18][19] Financial Performance - For the year ended December 31, 2024, the company reported a net loss of $79.3 million, or $1.23 per share, compared to a net loss of $46.5 million, or $1.74 per share, for 2023 [40][49] - Research and development expenses increased by approximately 95% to $41.6 million in 2024, reflecting ongoing investments in clinical trials and manufacturing capabilities [36] - Cash, cash equivalents, and short-term investments totaled approximately $227 million as of December 31, 2024, expected to fund operations into late 2026 [31][32] Manufacturing and Operations - The company is expanding its manufacturing capabilities by establishing a regional network of drug-product finishing facilities, with a second facility in Somerset, New Jersey, commencing shipments in Q4 2024 [21][23] - The company has procured three buildings for manufacturing program candidates, with ongoing modifications and equipment installations [30] Strategic Developments - The company divested its brachytherapy business in Q2 2024, which included radioactive Cesium-131 seed assets, to focus on its core radiopharmaceutical development [28] - The patent portfolio was strengthened in 2024 with the issuance of two patents related to key assets, expiring in 2037 and 2039 [27]
Perspective Therapeutics Announces First Patient Dosed with [212Pb]VMT01 in Combination with Nivolumab in a Phase 1/2a Study of MC1R-Positive Metastatic Melanoma
Newsfilter· 2025-03-17 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] - The trial is evaluating the safety of [212Pb]VMT01 in combination with nivolumab, a PD-1 blocking antibody, following encouraging initial results from earlier cohorts [2][3] - The FDA has granted Fast Track Designation for [212Pb]VMT01, which aims to expedite its development for patients with unresectable or metastatic melanoma [4] Company Overview - Perspective Therapeutics is focused on developing radiopharmaceuticals, 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] - The company is expanding its regional network of drug product finishing facilities to support clinical trials and commercial operations [7] Industry Context - Melanoma is a serious skin cancer with approximately 100,000 new diagnoses and 8,300 deaths annually in the U.S. [5] - Metastatic melanoma has a poor prognosis, with a one-year survival rate of 50% and a five-year survival rate of 29%-35% [5] - Current second-line therapies have limited median progression-free survival (mPFS) of 2-5 months, indicating a high unmet need for effective treatments [5]
Perspective Therapeutics to Present at Upcoming March Investor Conferences
Globenewswire· 2025-02-26 12:00
Core Insights - Perspective Therapeutics, Inc. is a radiopharmaceutical development company focused on advanced cancer treatment applications [3][4] - The company utilizes proprietary technology with the alpha-emitting isotope Pb to target cancer cells specifically [3][4] - Perspective is developing a "theranostic" approach that combines imaging diagnostics with treatment to enhance patient outcomes [3][4] Company Events - The company will present at the TD Cowen 45th Annual Health Care Conference on March 3, 2025, from 11:10 a.m. to 11:40 a.m. ET in Boston, MA [2] - A fireside chat is scheduled at the Barclays 27th Annual Global Healthcare Conference on March 11, 2025, from 3:30 p.m. to 3:55 p.m. ET in Miami, FL [2] - Webcast events will be available live and archived for 90 days on the company's investor page [2] Product Development - The company's melanoma (VMT01) and neuroendocrine tumor (VMT-α-NET) programs are currently in Phase 1/2a trials in the U.S. [4] - Perspective is expanding its network of drug product finishing facilities using its proprietary Pb generator to support clinical trials and commercial operations [4]
Perspective Therapeutics to Provide Business Highlights and Report Full Year 2024 Financial Results
Globenewswire· 2025-02-21 12:00
Company Overview - Perspective Therapeutics, Inc. is a radiopharmaceutical development company focused on advanced treatment applications for cancers throughout the body [2] - The company utilizes proprietary technology with the alpha-emitting isotope Pb to deliver targeted radiation specifically to cancer cells [2] - Perspective is also developing complementary imaging diagnostics that enhance treatment personalization and optimize 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. [3] - Perspective 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] Upcoming Events - The company will report its full year 2024 financial results and provide a business update on March 26, 2025, after market close [1]
Perspective Therapeutics to Participate in Upcoming February Investor Conferences
Globenewswire· 2025-02-05 12:00
Company Overview - Perspective Therapeutics, Inc. is a radiopharmaceutical development company focused on advanced treatment applications for cancers throughout the body [3] - The company utilizes proprietary technology with the alpha-emitting isotope Pb to deliver targeted radiation specifically to cancer cells [3] - Perspective is developing complementary imaging diagnostics that enhance the personalization of treatment and optimize patient outcomes through a "theranostic" approach [3] Clinical Development - The company's melanoma program (VMT01) and neuroendocrine tumor program (VMT-α-NET) are currently in Phase 1/2a imaging and therapy trials for metastatic melanoma and neuroendocrine tumors at leading academic institutions [4] - Perspective has developed a proprietary Pb generator to secure key isotopes necessary for clinical trials and commercial operations [4] Investor Engagement - Members of the senior leadership team will participate in upcoming investor conferences, including Oppenheimer's 35th Annual Healthcare Life Sciences Conference on February 12, 2025, and B. Riley Securities Precision Oncology & Radiopharma Investor Conference on February 28, 2025 [2]