Perspective Therapeutics, Inc. (CATX)
SIC breadcrumb: Manufacturing > Chemicals And Allied Products > SIC 2834 Pharmaceutical Preparations
SEC company page: https://www.sec.gov/edgar/browse/?CIK=728387. Latest filing source: 0000728387-26-000004.
Informational only. Descriptive public-record data — not a rating, forecast, or investment advice. See Disclaimer.
At a glance
Peer & cluster context
Peer percentile fingerprint
Percentile = share of the N covered peers reporting that ratio whose value is lower (ties counted half); computed among grepcent-covered companies in SIC industry 2834 Pharmaceutical Preparations, not the whole market. A higher percentile means a higher value of the ratio, not a better company. Ratios with fewer than 8 reporting peers are omitted. Latest reported values per company; fiscal periods may differ. Descriptive arithmetic - not a score, rating, or ranking.
Selected Fundamentals
| Metric | Value | Unit | FY | Filed |
|---|---|---|---|---|
| Net income | -103,121,000 | USD | 2025 | 2026-03-16 |
| Assets | 266,972,000 | USD | 2025 | 2026-03-16 |
Financials
Annual standardized facts from SEC companyfacts as of latest extracted filing date 2026-03-16. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0000728387.json. Derived margins, ratios, and free cash flow are computed from the extracted annual SEC facts.
| Metric | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|---|---|---|
| Net income | -4,711,000 | -6,162,000 | -6,700,000 | -5,144,000 | -3,446,000 | -3,387,000 | -10,760,000 | -46,508,000 | -79,279,000 | -103,121,000 |
| Operating income | -5,082,000 | -6,307,000 | -6,729,000 | -5,254,000 | -3,476,000 | -3,446,000 | -8,672,000 | -40,941,000 | -90,886,000 | -113,564,000 |
| Diluted EPS | -1.74 | -1.23 | -1.40 | |||||||
| Operating cash flow | -3,884,000 | -5,712,000 | -5,712,000 | -5,049,000 | -3,641,000 | -2,837,000 | -10,401,000 | -36,913,000 | -18,294,000 | -82,484,000 |
| Capital expenditures | 479,000 | 549,000 | 337,000 | 444,000 | 273,000 | 381,000 | 282,000 | 1,072,000 | 54,414,000 | 12,749,000 |
| Assets | 18,102,000 | 12,269,000 | 7,455,000 | 9,422,000 | 8,699,000 | 70,416,000 | 58,091,000 | 97,891,000 | 341,101,000 | 266,972,000 |
| Liabilities | 1,701,000 | 1,667,000 | 2,425,000 | 1,742,000 | 2,976,000 | 3,010,000 | 3,449,000 | 22,712,000 | 50,433,000 | 59,941,000 |
| Stockholders' equity | 16,401,000 | 10,602,000 | 5,030,000 | 7,680,000 | 5,723,000 | 67,406,000 | 54,642,000 | 75,179,000 | 290,668,000 | 207,031,000 |
| Cash and cash equivalents | 10,139,000 | 5,932,000 | 2,600,000 | 5,326,000 | 2,392,000 | 63,828,000 | 20,993,000 | 9,238,000 | 61,580,000 | 30,629,000 |
| Free cash flow | -4,363,000 | -6,261,000 | -6,049,000 | -5,493,000 | -3,914,000 | -3,218,000 | -10,683,000 | -37,985,000 | -72,708,000 | -95,233,000 |
Ratios
| Metric | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|---|---|---|
| Return on equity | -28.72% | -58.12% | -133.20% | -66.98% | -60.21% | -5.02% | -19.69% | -61.86% | -27.27% | -49.81% |
| Return on assets | -26.02% | -50.22% | -89.87% | -54.60% | -39.61% | -4.81% | -18.52% | -47.51% | -23.24% | -38.63% |
| Liabilities / equity | 0.10 | 0.16 | 0.48 | 0.23 | 0.52 | 0.04 | 0.06 | 0.30 | 0.17 | 0.29 |
| Current ratio | 12.46 | 9.30 | 2.97 | 6.53 | 3.50 | 37.37 | 17.07 | 1.07 | 12.68 | 5.17 |
Industry Peer Context
ROE peer context
ROA peer context
Financial Bridges
Free cash flow = operating cash flow - capital expenditures
Figure provenance: SEC companyfacts FY 2025. Operating cash flow: accession 0000728387-26-000004; concept NetCashProvidedByUsedInOperatingActivities; source concepts us-gaap:NetCashProvidedByUsedInOperatingActivities | Capital expenditures: accession 0000728387-26-000004; concept PaymentsToAcquirePropertyPlantAndEquipment; source concepts us-gaap:PaymentsToAcquirePropertyPlantAndEquipment | Free cash flow: accession 0000728387-26-000004; concept NetCashProvidedByUsedInOperatingActivities - PaymentsToAcquirePropertyPlantAndEquipment; source concepts us-gaap:NetCashProvidedByUsedInOperatingActivities; us-gaap:PaymentsToAcquirePropertyPlantAndEquipment
Financial Charts
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0000728387-26-000004; filed 2026-03-16. Concept: NetIncomeLoss. Source concepts: us-gaap:NetIncomeLoss.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0000728387-26-000004; filed 2026-03-16. Concept: OperatingIncomeLoss. Source concepts: us-gaap:OperatingIncomeLoss.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0000728387-26-000004; filed 2026-03-16. Concept: EarningsPerShareDiluted. Source concepts: us-gaap:EarningsPerShareDiluted.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0000728387-26-000004; filed 2026-03-16. Concept: NetCashProvidedByUsedInOperatingActivities. Source concepts: us-gaap:NetCashProvidedByUsedInOperatingActivities.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0000728387-26-000004; filed 2026-03-16. Concept: PaymentsToAcquirePropertyPlantAndEquipment. Source concepts: us-gaap:PaymentsToAcquirePropertyPlantAndEquipment.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0000728387-26-000004; filed 2026-03-16. Concept: Assets. Source concepts: us-gaap:Assets.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0000728387-26-000004; filed 2026-03-16. Concept: Liabilities. Source concepts: us-gaap:Liabilities.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0000728387-26-000004; filed 2026-03-16. Concept: StockholdersEquity. Source concepts: us-gaap:StockholdersEquity.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0000728387-26-000004; filed 2026-03-16. Concept: CashAndCashEquivalentsAtCarryingValue. Source concepts: us-gaap:CashAndCashEquivalentsAtCarryingValue.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0000728387-26-000004; filed 2026-03-16. Concept: NetCashProvidedByUsedInOperatingActivities - PaymentsToAcquirePropertyPlantAndEquipment. Source concepts: us-gaap:NetCashProvidedByUsedInOperatingActivities; us-gaap:PaymentsToAcquirePropertyPlantAndEquipment.
As-reported value updates
Quarterly
Quarterly standardized facts from SEC companyfacts as of latest extracted filing date 2026-08-10. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0000728387.json.
| Quarter | End Date | Revenue | Net Income | Diluted EPS | Method |
|---|---|---|---|---|---|
| 2020-Q4 | 2020-06-30 | 2,279,000 | derived Q4 = FY annual - nine-month YTD | ||
| 2021-Q1 | 2020-09-30 | 2,384,000 | reported discrete quarter | ||
| 2021-Q2 | 2020-12-31 | 2,359,000 | reported discrete quarter | ||
| 2021-Q3 | 2021-03-31 | 2,600,000 | reported discrete quarter | ||
| 2021-Q4 | 2021-06-30 | 2,710,000 | derived Q4 = FY annual - nine-month YTD | ||
| 2022-Q1 | 2021-09-30 | 2,564,000 | reported discrete quarter | ||
| 2022-Q2 | 2021-12-31 | 2,816,000 | reported discrete quarter | ||
| 2022-Q3 | 2022-03-31 | 2,910,000 | reported discrete quarter | ||
| 2022-Q4 | 2022-06-30 | 2,505,000 | derived Q4 = FY annual - nine-month YTD | ||
| 2023-Q1 | 2023-03-31 | 1,830,000 | reported discrete quarter | ||
| 2023-Q2 | 2023-06-30 | 1,500,000 | reported discrete quarter | ||
| 2023-Q3 | 2023-06-30 | -11,106,000 | reported discrete quarter | ||
| 2023-Q3 | 2023-09-30 | 1,909,000 | reported discrete quarter | ||
| 2023-Q4 | 2023-12-31 | -24,675,000 | derived Q4 = FY annual - nine-month YTD | ||
| 2024-Q1 | 2024-03-31 | -12,284,000 | -0.02 | reported discrete quarter | |
| 2024-Q2 | 2024-03-31 | -12,284,000 | reported discrete quarter | ||
| 2024-Q2 | 2024-06-30 | -0.18 | reported discrete quarter | ||
| 2024-Q3 | 2024-06-30 | -11,704,000 | reported discrete quarter | ||
| 2024-Q3 | 2024-09-30 | -0.21 | reported discrete quarter | ||
| 2024-Q4 | 2024-12-31 | -40,169,000 | derived Q4 = FY annual - nine-month YTD | ||
| 2025-Q1 | 2025-03-31 | -18,177,000 | -0.25 | reported discrete quarter | |
| 2025-Q2 | 2025-03-31 | -18,177,000 | reported discrete quarter | ||
| 2025-Q2 | 2025-06-30 | -0.29 | reported discrete quarter | ||
| 2025-Q3 | 2025-06-30 | -21,485,000 | reported discrete quarter | ||
| 2025-Q3 | 2025-09-30 | -0.35 | reported discrete quarter | ||
| 2025-Q4 | 2025-12-31 | -37,490,000 | derived Q4 = FY annual - nine-month YTD | ||
| 2026-Q1 | 2026-03-31 | -26,189,000 | -0.25 | reported discrete quarter | |
| 2026-Q2 | 2026-03-31 | -26,189,000 | reported discrete quarter | ||
| 2026-Q2 | 2026-06-30 | -0.22 | reported discrete quarter |
Quarterly Charts
Figure provenance: SEC companyfacts. Latest point: FY 2023 ended 2023-09-30; accession 0001437749-23-032036; filed 2023-11-14. Concept: RevenueFromContractWithCustomerIncludingAssessedTax. Source concepts: us-gaap:RevenueFromContractWithCustomerIncludingAssessedTax.
Figure provenance: SEC companyfacts. Latest point: FY 2026 ended 2026-03-31; accession 0001193125-26-216790; filed 2026-05-11. Concept: NetIncomeLoss. Source concepts: us-gaap:NetIncomeLoss.
Figure provenance: SEC companyfacts. Latest point: FY 2026 ended 2026-06-30; accession 0001193125-26-342512; filed 2026-08-10. Concept: EarningsPerShareDiluted. Source concepts: us-gaap:EarningsPerShareDiluted.
Business
Read CATX's verbatim Item 1 Business section from its latest 10-K: Business.
Risk Factors
Read CATX's verbatim Item 1A Risk Factors from its latest 10-K: Risk Factors.
Latest quarter (10-Q)
Latest 10-Q source: 0001193125-26-342512.
ITEM 2 – MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations together with (i) the unaudited condensed consolidated financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 (Form 10-Q), (ii) our audited consolidated financial statements and notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission (SEC) on March 16, 2026 (2025 Form 10-K) and (iii) other filings we have made with the SEC. As discussed under the heading “Cautionary Note Regarding Forward-Looking Statements,” this discussion contains forward-looking statements that reflect our plans, estimates and beliefs, and involves numerous risks and uncertainties, including but not limited to those described under the heading “Risk Factors” in the 2025 Form 10-K that may cause actual results to differ materially from those described in or implied by any forward-looking statements. Unless the context otherwise requires, references in this section to the “Company,” “Perspective,” “we,” “us” and “our” refer to Perspective Therapeutics, Inc. and its subsidiaries.
Overview
We are a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body. We have proprietary technology that utilizes the alpha-emitting isotope Lead-212 (212Pb) to deliver powerful radiation specifically to cancer cells via specialized targeting moieties. We are also developing complementary imaging techniques that incorporate the same targeting moieties, which provides the opportunity to personalize treatment and optimize patient outcomes. This theranostic approach enables visualization of the specific tumor and subsequent treatment, potentially improving efficacy and minimizing toxicity.
We are advancing a portfolio of clinical-stage programs in the U.S., including VMT-α-NET (neuroendocrine tumors), VMT01 (melanoma) and PSV359 (solid tumors). We are expanding our regional finished drug product candidate supply network, enabled by our proprietary 224Ra/212Pb generator platform used to manufacture clinical drug product candidates, to supply the delivery of patient-ready drug product candidates for clinical trials and, if approved, commercial operations.
Bamzireotide Navoxetan (VMT-α-NET)
We designed VMT-α-NET to target somatostatin receptor type 2 (SSTR2), a protein that is overexpressed in neuroendocrine tumors (NETs) and other cancers, and to deliver the alpha-emitting radioisotope 212Pb to tumor sites expressing SSTR2. We are conducting a multi-center, open-label, dose-escalation and dose-expansion study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-positive tumors who have not received prior radiopharmaceutical therapies.
We initially dosed two patients in Cohort 1 (treated with four doses at 2.5 mCi per dose) and seven patients in Cohort 2 (treated with four doses at 5.0 mCi per dose) of the study, regardless of body weight. Subsequent review for dose-limiting toxicity (DLT) during the safety observation period in the seven patients enrolled in Cohort 2 by the Safety Monitoring Committee (SMC) led the SMC to recommend escalating further in a third cohort and enrolling additional patients at 5.0 mCi to better understand efficacy and safety. During the second quarter of 2025, enrollment for Cohort 2 closed with an additional 39 patients having received at least one treatment, for a total of 46 patients including the seven who were enrolled for DLT observation. By late 2026, all 46 patients in Cohort 2 will have had the opportunity for at least 60 weeks of follow-up, which is expected to inform the Phase 3 study design.
In late June 2025, we announced the opening of Cohort 3 in which patients are receiving up to four fixed administered doses of [212Pb]VMT-α-NET at 6.0 mCi every eight weeks if they weigh more than 60 kg (133 lb), or 100μCi/kg of body weight if they weigh less than or equal to 60 kg. Eight Cohort 3 patients then commenced treatment with VMT-α-NET and contributed to the DLT assessment by the SMC. The DLT assessment is now complete, and we are cleared to treat more patients at this dose. As of April 30, 2026, a total of 20 patients had been treated in Cohort 3. This cohort was fully enrolled.
In May 2026, we announced that the first patient was treated with [212Pb]VMT-α-NET in a fourth cohort. This cohort explores optimizing a 20 mCi cumulative dose by front-loading, with 6.0 mCi in the first dose, 5.0 mCi in the second dose, 5.0 mCi in the third dose, and 4.0 mCi in the fourth dose. The purpose of this dosing regimen is to determine whether front-loading could improve response rate at lower cumulative doses.
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We have an allowance for enrollment of patients with NETs whose disease originated in the lung (of which small cell lung cancer is a subset), pheochromocytoma and paraganglioma NETs, and SSTR2+ meningioma. In June 2026, we announced the initiation of, and the first patient dosed in, a new cohort intended to evaluate the safety, dosimetry and preliminary anti-tumor activity of [212Pb]VMT-α-NET in patients with meningioma (LEMONαDE). The initiation of the meningioma cohort reflects our broader strategy to evaluate [212Pb]VMT-α-NET across SSTR2-expressing tumor types beyond neuroendocrine tumors.
Updated interim data from the study, as of a data cut-off (DCO) date of March 4, 2026, were presented at the American Association for Cancer Research Annual Meeting 2026 (AACR 2026). The safety findings based on 64 patients (two patients in Cohort 1 (2.5 mCi), 46 patients in Cohort 2 (5.0 mCi) and 16 patients in Cohort 3 (6.0 mCi)) showed no reports of DLTs, serious renal complications, treatment-related discontinuations, dysphagia or clinically significant treatment-related myelosuppression. Grade 3 or higher treatment-emergent adverse events were reported in 23 patients (36%). One of these patients, who was enrolled in Cohort 3, experienced a transient decrease in lymphocyte count on the cusp between Grades 3 and 4. The site subsequently determined this event to be a Grade 3 event. This event was transient and resolved without medical intervention. The patient completed the full course of [212Pb]VMT-α-NET treatment, consisting of four treatments without interruption, and remains on study. There were no Grade 4 or 5 events. No additional patients experienced serious adverse events (SAEs) since the most recent update at the 2026 ASCO Gastrointestinal Cancers Symposium (ASCO-GI 2026), with none of the five SAEs deemed related to the study medication.
Updated efficacy analysis in the same 25 patients from ASCO-GI 2026 and the European Society for Medical Oncology (ESMO) Congress 2025 in October 2025 (consisting of both patients in Cohort 1 and 23 patients in Cohort 2) were presented at AACR 2026 with an additional 12 weeks and 25 weeks of follow-up, respectively. Eighteen of the 25 patients (72%) were without progression and remained alive, including both patients in Cohort 1. Ten patients were observed to have a response according to investigator-assessed RECIST v1.1. Nine of those responses were previously reported at ASCO-GI 2026, including one initial response that has since been confirmed. Since then, one more patient experienced an initial response in their most recent tumor assessment. The patient remains in the study and thus is expected to receive a subsequent tumor assessment. Ten of the 23 patients (43%) in Cohort 2 were observed to have a response according to investigator-assessed RECIST v1.1. Eight of the 16 patients (50%) in Cohort 2 whose tumors all express SSTR2 were observed to have a response according to investigator-assessed RECIST v1.1. Nine patients were observed to have deepening of best response since initial tumor assessments on these patients were reported at ESMO.
Updated data was presented at the 2026 American Society of Clinical Oncology Annual Meeting (ASCO), which took place from May 29 through June 2, 2026. The presentation highlighted that the deepening of response continued to be observed following the AACR 2026 and ESMO presentations. The ASCO DCO date of April 17, 2026 represented an additional six weeks of follow-up after the prior update at AACR 2026 in April 2026 and approximately 31 weeks after ESMO 2025 in October 2025.
As of July 31, 2026, a total of 76 NETs patients across four cohorts and one meningioma patient had been treated with [212Pb]VMT-α-NET. Updated data on NETs patients enrolled in the trial will be presented at the ESMO 2026 conference on October 23, 2026.
In July 2026, we announced that the European Commission has granted orphan medicinal product designation for [212Pb]VMT-α-NET for the treatment of gastroenteropancreatic NETs. The designation follows a positive opinion from the Committee of Orphan Medicinal Products of the European Medicines Agency.
We continue to advance [212Pb]VMT-α-NET toward a Phase 3 study in NETs, with regulatory engagement ongoing and clinical site activation targeted around year-end 2026, subject to regulatory feedback and finalization of the study protocol.
Lapemelanotide Zapixetar (VMT01)
We are also leveraging our TAT platform with our product candidate, VMT01, which is currently in Phase 1/2a clinical trials. We designed VMT01 to target and deliver 212Pb to tumor sites expressing melanocortin 1 receptor (MC1R), a protein that can be overexpressed in metastatic melanoma cancers. We are conducting a multi-center, open-label dose escalation, dose expansion study (clinicaltrials.gov identifier NCT05655312) in patients with histologically confirmed melanoma and MC1R-positive imaging scans.
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In preclinical experiments [212Pb]VMT01 demonstrated efficacy via two distinct mechanisms of action: direct cell killing at high radiation doses and through immunostimulatory low-dose induction of immune-mediated cell death. Efficacy was augmented by immune checkpoint inhibitors. In September 2024, we announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for the development of [212Pb]VMT01 for the diagnosis and treatment of patients with unresectable or metastatic melanoma and who have demonstrated MC1R tumor expression.
In March 2024, we entered into a clinical trial collaboration with Bristol Myers Squibb to evaluate the safety and tolerability of [212Pb]VMT01 in combination with Bristol Myers Squibb’s checkpoint inhibitor nivolumab in patients with histologically confirmed melanoma and positive MC1R imaging scans. A protocol amendment was submitted in July 2024 to explore the combination of nivolumab with [212Pb]VMT01 in patients with histologically confirmed melanoma and positive MC1R imaging scans in our ongoing Phase 1/2a clinical study of [212Pb]VMT01.
In October 2024, we announced initial results from the first two dosing cohorts. Three patients were enrolled in Cohort 1 and received 3 mCi of [212Pb]VMT01, while seven patients were enrolled in Cohort 2 and received 5 mCi of [212Pb]VMT01. Patients in each cohort received a median of five prior lines of systematic therapy, including a median of three prior lines of immunotherapy. No DLTs were observed among any patients, and no adverse events (AEs) led to treatment discontinuation. Treatment emergent AEs were mostly grades 1 and 2. None of the four cases of grade 3 treatment emergent AEs were deemed to be treatment related. There were no grade 4 or 5 treatment emergent AEs. No renal toxicities had been reported as of October 11, 2024 (there were no clinically significant changes in blood urea nitrogen or serum creatinine) in spite of dosimetry estimated renal radiation that approached the higher end of conventional d
[Excerpt truncated for page length; source filing is linked above.]
Latest 10-K MD&A (excerpt)
Latest 10-K Item 7 source: 0000728387-26-000004. The complete FY 2025 MD&A is published at /company/CATX/mda/fy2025/.
ITEM 7 – MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations together with our audited consolidated financial statements and the related notes appearing at the end of this Annual Report on Form 10-K (“Annual Report” or “Form 10-K”). Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. You should read “Cautionary Note Regarding Forward-Looking Statements” and Item 1A. Risk Factors of this Annual Report for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. Unless the context otherwise requires, references in this Annual Report to the “Company,” “Perspective,” “we,” “us” and “our,” except where the context requires otherwise, refer to Perspective Therapeutics, Inc. and its subsidiaries. References to “Viewpoint” refer to Viewpoint Molecular Targeting, Inc., a wholly owned subsidiary, and references to “Isoray” refer to Isoray Medical, Inc., a wholly owned subsidiary.
Overview
We are a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body. We have proprietary technology that utilizes the alpha-emitting isotope Lead-212 (212Pb) to deliver powerful radiation specifically to cancer cells via specialized targeting moieties. We are also developing complementary imaging diagnostics that incorporate the same targeting moieties, which provides the opportunity to personalize treatment and optimize patient outcomes. This theranostic approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity.
Our neuroendocrine tumor (VMT-α-NET), melanoma (VMT01) and solid tumor (PSV359) programs are in Phase 1/2a imaging and therapy trials in the U.S. We are growing our regional network of drug product finishing facilities, enabled by our proprietary 212Pb generator, to deliver patient-ready products for clinical trials and commercial operations.
VMT-α-NET
We designed VMT-α-NET to target and deliver 212Pb to target cancer-specific receptors on tumor cells expressing somatostatin receptor type 2 (SSTR2), a protein that is overexpressed in neuroendocrine tumors (NETs) and other cancers. [212Pb]VMT-α-NET is a targeted alpha therapy (TAT) in development for patients with unresectable or metastatic SSTR2-expressing tumors who have not previously received peptide-targeted radiopharmaceutical therapy, such as Lutathera. NETs are a group of rare, heterogeneous tumors that develop in different organs of the body and arise from specialized cells in the neuroendocrine system.
We initially dosed two patients in Cohort 1 (treated at 2.5 mCi per dose) and seven patients in Cohort 2 (treated at 5.0 mCi per dose) of our Phase 1/2a study of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-expressing NETs, regardless of body weight. Subsequent review for dose-limiting toxicity (DLT) during the safety observation period in the seven patients enrolled in Cohort 2 by the Safety Monitoring Committee (SMC) led the SMC to recommend escalating further in a third cohort and enrolling additional patients at 5.0 mCi to better understand efficacy and safety. During the second quarter of 2025, enrollment for Cohort 2 closed with an additional 39 patients having received at least one treatment, for a total of 46 patients including the seven who were enrolled for DLT observation.
In late June 2025, we announced the opening of Cohort 3 in which patients will receive up to four fixed administered doses of [212Pb]VMT-α-NET at 6.0 mCi every eight weeks if they weigh more than 60 kg (133 lb), or 100μCi/kg of body weight if they weigh less than or equal to 60 kg. Eight Cohort 3 patients then commenced treatment with VMT-α-NET and contributed to the DLT assessment by the SMC. The DLT assessment is now complete, and we are cleared to treat more patients at this dose, with eight additional patients already treated as of February 28, 2026, for a total of 16 patients. By mid-2026, the eight DLT patients would have had the opportunity for at least 32 weeks of follow up since beginning treatment, which is sufficient time to have completed at least one scan following the full course of treatment.
During October 2025, updated interim results from our ongoing Phase 1/2a clinical trial (NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-expressing NETs with a data cut-off date of September 12, 2025, were presented at the European Society for Medical Oncology (ESMO) Congress 2025, the 2025 North American Neuroendocrine Tumor Society (NANETS) Multidisciplinary NET Medical Symposium, and the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. In this analysis, 55 patients across three dose cohorts received at least one treatment of VMT-α-NET. Two patients in Cohort 1 and 23 patients in Cohort 2 had at least nine months of follow up since their initial treatment.
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During January 2026, updated interim results with a data cut-off date of December 10, 2025, were presented at the 2026 ASCO Gastrointestinal Cancers Symposium (ASCO-GI 2026). The 56 patients in the safety analysis comprised two patients in Cohort 1 (2.5 mCi), 46 patients in Cohort 2 (5.0 mCi) and eight patients in Cohort 3 (6.0 mCi), each of whom had received at least one treatment. There were no DLTs, no treatment-related discontinuations, and no serious renal complications, dysphagia or clinically significant treatment-related myelosuppression reported. Grade 3 or higher treatment-emergent adverse events were reported in 21 patients (37.5%). One of these patients, who was enrolled in Cohort 3, experienced a transient Grade 4 event (lymphocyte count decrease). This event was transient and resolved without medical intervention. The patient continues to receive [212Pb]VMT-α-NET treatment. There were no Grade 5 events. Serious adverse events were reported in five patients, with none deemed related to the study medication.
In October 2025 at ESMO, we reported interim efficacy data for two patients in Cohort 1 and 23 patients in Cohort 2. At ASCO-GI 2026, we presented updated efficacy analysis for the same 25 patients from ESMO with an additional 13 weeks of follow up since the presentation at ESMO. Of the 25 patients, 19 (76%) were without progression and remained alive, including both of the patients in Cohort 1. Nine (39%) patients in Cohort 2 were observed to have response according to investigator-assessed RECIST v1.1. Eight (35%) of those responses were confirmed and previously reported at ESMO; one additional patient experienced an initial response in their most recent tumor assessment after the prior update at ESMO. As the patient remains on the study, the patient is expected to receive a subsequent tumor assessment. Seven patients were observed to have deepening of best response, including one patient with stable disease.
As of February 28, 2026, the first 23 patients in Cohort 2 would have had the opportunity for at least 48 weeks of follow up since beginning treatment, and by mid-2026, we expect all 46 patients in Cohort 2 would have had the opportunity for at least 48 weeks of follow up since beginning treatment.
We believe our clinical data package positions us for meaningful regulatory engagement in 2026 to align on the path forward.
During the dose finding phase of the study, we enrolled primarily NETs patients whose disease originated in the pancreas or the digestive track. We have allowance for enrollment of NETs patients whose disease originated in the lung (of which small cell lung cancer is a subset), and pheochromocytoma/paraganglioma NETs, as well as SSTR2+ meningioma.
VMT01
We are also leveraging our TAT platform with our product candidate, VMT01, which is currently in Phase 1/2a clinical trials. We designed VMT01 to target and deliver 212Pb to tumor sites expressing melanocortin 1 receptor (MC1R), a protein that is overexpressed in melanoma cancers. [212Pb]VMT01 is a TAT in development for second-line or later treatment of patients with progressive MC1R-positive metastatic melanoma.
In preclinical experiments [212Pb]VMT01 demonstrated efficacy via two distinct mechanisms of action: direct cell killing at high radiation doses and through immunostimulatory low-dose induction of immune-mediated cell death. Efficacy was augmented by immune checkpoint inhibitors. In September 2024, we announced that on the basis of these results, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for the clinical development of [212Pb]VMT01. This study is a multi-center, open-label dose escalation, dose expansion study (clinicaltrials.gov identifier NCT05655312) in patients with histologically confirmed melanoma and MC1R-positive imaging scans. Patients were required to have already received standard of care. Eligible patients may receive up to three treatments with [212Pb]VMT01, eight weeks apart.
In March 2024, we entered into a clinical trial collaboration with Bristol Myers Squibb to evaluate the safety and tolerability of [212Pb]VMT01 in combination with Bristol Myers Squibb’s checkpoint inhibitor nivolumab in patients with histologically confirmed melanoma and positive MC1R imaging scans. A protocol amendment was submitted in July 2024 to explore the combination of nivolumab with [212Pb]VMT01 in patients with histologically confirmed melanoma and positive MC1R imaging scans in our ongoing Phase 1/2a clinical study of [212Pb]VMT01.
In October 2024, we announced initial results from the first two dosing cohorts. Three patients were enrolled in Cohort 1 and received 3 mCi of [212Pb]VMT01, while seven patients were enrolled in Cohort 2 and received 5 mCi of [212Pb]VMT01. Patients in each cohort received a median of five prior lines of systematic therapy, including a median of three prior lines of immunotherapy. No DLTs were observed among any patients, and no adverse events (AEs) led to treatment discontinuation. Treatment emergent AEs were mostly grades 1 and 2. None of the four cases of grade 3 treatment emergent AEs were deemed to be treatment related. There were no grade 4 or 5 treatment emergent AEs. No renal toxicities had been reported as of October 11, 2024 (there were no clinically significant changes in blood urea nitrogen or serum creatinine) in spite of dosimetry estimated renal radiation that approached the higher end of conventional dosing.
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All patients in Cohort 1 completed three treatments, with one patient experiencing an unconfirmed RECIST version 1.1 objective response after completion of treatment, and two patients experiencing stable disease at 9 and 11 months from the start of treatment, respectively, as reported on October 11, 2024. In Cohort 2, patients progressed after either the first cycle (three patients) or the second cycle (four patients). These findings are consistent with published and ongoing preclinical studies showing immunostimulatory effects at lower radiation doses.
The SMC reviewed these findings and recommended exploring a lower dose level of 1.5 mCi per dose, both as a single agent and in combination with the anti-PD-1 antibody, nivolumab. The SMC’s recommendation would allow for the monotherapy and combination cohorts to proceed concurrently. An amendment to further explore lower dose levels for monotherapy was approved, and Cohort 3 at 1.5 mCi per dose was opened for enrollment. The combination cohort at 1.5 mCi per dose with nivolumab
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FDA-approved drug applications
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