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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]
Perspective Therapeutics to Provide Business Highlights and Report Second Quarter 2025 Financial Results
Globenewswire· 2025-07-15 11:00
Company Overview - 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 [2][3] - The company is also developing complementary imaging diagnostics that utilize the same targeting moieties, allowing for personalized treatment and optimized patient outcomes through a "theranostic" approach [2] Clinical Development - The company's melanoma (VMT01), neuroendocrine tumor (VMT-α-NET), and solid tumor (PSV359) programs are currently 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] Upcoming Financial Reporting - The company will report its second quarter 2025 financial results and provide a business update on August 13, 2025, before the market opens [1]
Perspective Therapeutics Presents at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2025 Annual Meeting
Globenewswire· 2025-06-21 12:00
Core Viewpoint - Perspective Therapeutics, Inc. is advancing its radiopharmaceutical treatments for cancer, with significant presentations at the SNMMI 2025 Annual Meeting highlighting its clinical trials and novel imaging agents [1][2][3][4]. Group 1: Clinical Trials and Presentations - The company is presenting findings on [Pb]VMT-α-NET, an imaging agent in a Phase 1/2a clinical trial for patients with unresectable or metastatic SSTR2-positive neuroendocrine tumors, indicating it was well-tolerated among patients [3][5]. - A second presentation focuses on [Ga]PSV377, a novel PET imaging agent targeting fibroblast activation protein, which showed strong affinity and tumor retention in preclinical models, with promising first-in-human imaging results [4][8]. - Both presentations are scheduled for the SNMMI 2025 Annual Meeting, with poster sessions on June 21 and oral sessions on June 23 [2]. Group 2: Product Development and Technology - Perspective Therapeutics is utilizing a proprietary technology that employs the alpha-emitting isotope Pb to deliver targeted radiation to cancer cells, enhancing treatment efficacy while minimizing toxicity [9][10]. - The company is conducting multi-center, open-label studies for its products, including [Pb]VMT-α-NET and PSV359, aimed at improving patient outcomes through personalized treatment approaches [5][8][10]. - The company is expanding its regional network of drug product candidate finishing facilities to support clinical trials and commercial operations [10].
Perspective Therapeutics Commences Recruitment for [212Pb]VMT-α-NET in the Third Dose Escalation Cohort of its Ongoing Phase 1/2a Clinical Trial
Globenewswire· 2025-06-21 12:00
Core Viewpoint - Perspective Therapeutics, Inc. has reached an agreement with the FDA to open the third dosing cohort of its Phase 1/2a clinical trial for [Pb]VMT-α-NET, targeting patients with unresectable or metastatic SSTR2-positive neuroendocrine tumors who have not previously received radiopharmaceutical therapies [1][2] Group 1: Clinical Trial Details - Cohort 3 will administer up to four fixed doses of [Pb]VMT-α-NET at 6 mCi every eight weeks for patients over 60 kg, or 100 μCi/kg for those 60 kg or under [2] - The trial will assess dose limiting toxicities (DLTs) in up to eight patients within 42 days of the first treatment cycle to determine maximum tolerated dose (MTD) or maximum feasible dose (MFD) [2] - Recruitment for Cohort 3 is now open, and patients currently evaluated for entry will enroll if they qualify [3] Group 2: Product and Technology Overview - [Pb]VMT-α-NET is designed to target and deliver lead (Pb) to tumor sites expressing SSTR2, with a multi-center, open-label, dose-escalation study ongoing [4] - The company employs a "theranostic" approach, utilizing alpha-emitting isotopes to deliver radiation specifically to cancer cells while also developing complementary imaging diagnostics [5] - The ongoing programs for melanoma (VMT01), neuroendocrine tumor (VMT-α-NET), and solid tumor (PSV359) are in Phase 1/2a trials in the U.S. [6] Group 3: Future Plans and Updates - The company plans to submit further clinical updates to scientific congresses in the second half of 2025, including safety follow-up data and anti-tumor activity results [6] - A dosimetry sub-study analysis is scheduled to be presented at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2025 Annual Meeting [6]
Perspective Therapeutics Highlights Updated Interim Data from its Ongoing Phase 1/2a Clinical Trial of [212Pb]VMT-α-NET at the 2025 ASCO Annual Meeting
Globenewswire· 2025-05-30 21:21
Core Viewpoint - Perspective Therapeutics, Inc. announced updated interim results from its ongoing Phase 1/2a clinical trial of [Pb]VMT-α-NET, presented at the 2025 ASCO Annual Meeting, indicating a favorable safety profile and promising anti-tumor activity in patients with neuroendocrine tumors [1][5][11]. Clinical Trial Overview - The Phase 1/2a clinical trial is a multi-center, open-label study focusing on patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2) expressing neuroendocrine tumors who have not received prior radiopharmaceutical therapy [2][12]. - Cohort 2 was reopened for enrollment in August 2024, with a total of 33 additional patients enrolled by April 30, 2025 [4][12]. Efficacy and Safety Data - Updated interim efficacy data were presented for two patients in Cohort 1 and seven patients in Cohort 2, with a data cut-off date of April 30, 2025 [3][5]. - Among 42 patients who received at least one treatment, there were no dose-limiting toxicities (DLTs) or treatment discontinuations due to adverse events reported [4][5]. - Ten patients experienced at least one Grade 3 treatment emergent adverse event (TEAE), with the majority deemed unrelated to [Pb]VMT-α-NET [4][5]. Anti-Tumor Activity - Four of seven patients in Cohort 2 experienced investigator-assessed objective responses, with three confirmed responses [5][11]. - Seven out of nine patients in Cohorts 1 and 2 remained free from disease progression after more than one year of follow-up [5][11]. Future Plans and Regulatory Engagement - The company plans to submit longer safety follow-up data and preliminary efficacy data for a subgroup for presentation at a scientific congress in the second half of 2025 [11][12]. - The company is engaging with the FDA to continue pursuing dose finding for [Pb]VMT-α-NET [10][11]. Company Background - Perspective Therapeutics, Inc. specializes in developing advanced radiopharmaceutical treatments for cancers, utilizing proprietary technology to deliver targeted radiation to cancer cells [14][15]. - The company is also developing complementary imaging diagnostics to personalize treatment and optimize patient outcomes [14].
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
Financial Performance - Grant revenue for Q1 2025 was $342,000, up from $325,000 in Q1 2024, representing a 5.23% increase[14] - Research and development expenses increased to $14,332,000 in Q1 2025, compared to $7,452,000 in Q1 2024, reflecting a 92.5% rise[14] - Total operating expenses for Q1 2025 were $22,174,000, up from $13,330,000 in Q1 2024, marking a 66.5% increase[14] - Net loss from continuing operations for Q1 2025 was $18,177,000, compared to $11,825,000 in Q1 2024, indicating a 53.5% increase in losses[14] - Basic and diluted loss per share remained at $0.25 for Q1 2025, unchanged from Q1 2024[14] - The company reported a comprehensive loss of $18,107,000 for Q1 2025, compared to $12,284,000 in Q1 2024, an increase of 47.5%[14] - The weighted average shares used in computing net loss per share increased to 72,357,000 in Q1 2025 from 49,510,000 in Q1 2024, a growth of 46.1%[14] Cash and Liquidity - Cash, cash equivalents, and restricted cash at the end of Q1 2025 totaled $44,406,000, down from $142,299,000 at the end of Q1 2024, a decrease of 68.8%[17] - Net cash used in operating activities for Q1 2025 was $21,582,000, compared to a net cash provided of $13,848,000 in Q1 2024[17] - As of March 31, 2025, the company reported cash, cash equivalents, and short-term investments of $211.7 million, with a total accumulated deficit of $249.9 million[29] - The company believes its current cash position will fund operations into late 2026, but may seek additional capital through various means[30] - Total cash equivalents decreased from $59,720,000 on December 31, 2024, to $41,112,000 on March 31, 2025, representing a decline of approximately 31%[75] - Total available-for-sale securities increased slightly from $165,336,000 on December 31, 2024, to $167,296,000 on March 31, 2025, reflecting a growth of about 1.2%[76] - The fair value of total cash equivalents and available-for-sale securities combined was $208,408,000 as of March 31, 2025, down from $225,056,000 at the end of 2024, indicating a decrease of approximately 7.4%[78] Stock and Financing Activities - The company issued 3,379,377 shares of common stock under the 2024 At-the-Market Agreement, generating gross proceeds of approximately $10.2 million at an average price of $3.02 per share[42] - The Company raised approximately $80.0 million from the May 2024 Registered Offering, before underwriting discounts and commissions[44] - The Company completed a private placement on March 4, 2024, raising approximately $87.4 million by issuing 9,200,998 shares at $9.50 per share[47] - The gross proceeds from the January 2024 Public Offering were approximately $69.0 million, with 13,207,521 shares sold at $3.70 per share[60] - Under the 2023 ATM Agreement, the Company sold 3,535,246 shares at an average price of approximately $14.00 per share, resulting in gross proceeds of approximately $49.5 million[64] - The company executed a 1-for-10 reverse stock split on June 14, 2024, affecting all stockholders uniformly[27] - The company has a 2024 At-the-Market Agreement allowing for the sale of up to $250 million in common stock, with a commission of up to 3.0% on gross proceeds from sales[38][39] Discontinued Operations - The company completed the sale of its Cesium-131 brachytherapy business on April 12, 2024, presenting the financial information of this segment as discontinued operations[26] - The Company reported a total loss from discontinued operations of $459,000 for the three months ended March 31, 2024[68] Assets and Liabilities - As of March 31, 2025, the Company's property and equipment net value was $61.247 million, an increase from $57.321 million as of December 31, 2024[72] - The Company has indefinite-lived intangible assets valued at $50 million related to in-process research and development[73] - The Company has accrued an estimated liability of $200,000 related to settlement negotiations with stockholder plaintiff firms as of March 31, 2025[82] - The Company maintains an estimated liability of $0.5 million related to hazardous waste removal in its financial statements as of March 31, 2025[96] - A promissory note of $1.7 million was obtained on December 29, 2022, for purchasing land and a building in Coralville, IA, with a balloon payment of approximately $1.5 million due on December 29, 2027[97] Research and Development - The company is focused on obtaining regulatory approvals for its future program candidates, including Fast Track designation for PSV359[6] - The company reported a net loss in its radiopharmaceutical development segment, with no revenue generated from commercial products[28] - The Company is committed to purchasing approximately $8.4 million of thorium-228 from the U.S. Department of Energy during 2025 and 2026[83] Lease Agreements - The Company recognized a right-of-use asset and lease liability of approximately $1.1 million upon entering into a lease for lab and office space effective April 1, 2024[89] - The total lease liability as of March 31, 2025, is $2,154,000, with a current portion of $980,000[95] - The weighted average remaining term for the Company's operating leases as of March 31, 2025, was 2.9 years with a discount rate of 8%[94] - Future operating lease payments total $2.419 million, with a total lease liability of $2.154 million after accounting for imputed interest[95]