On March 16, 2026 Perspective Therapeutics, Inc. ("Perspective," the "Company," "we," "us," and "our") (NYSE AMERICAN: CATX), a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body, reported a business update and announced full year results for the year ended December 31, 2025.
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"The rich flow of data readouts in 2026 reflects years of dedication by our team to develop transformational new treatment options for patients in need of more choices," said Thijs Spoor, Perspective’s CEO. "We look forward to evaluating how these results will inform next steps for advancing our lead program VMT-α-NET and contribute to our understanding of the broader potential of our proprietary next-generation targeted radiopharmaceutical technology."
Advancing the current clinical pipeline
VMT-α-NET
We are conducting a multi-center, open-label, dose-finding study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2)-positive neuroendocrine tumors (NETs) who have not received prior radiopharmaceutical therapies (RPT).
Updated interim data from the study, as of a data-cut off (DCO) date of December 10, 2025, were presented at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium ("ASCO-GI 2026"). Highlights from the updated analysis included the following:
Safety findings based on 56 patients who received at least one treatment:
The 56 patients in this safety analysis comprised 2 patients in Cohort 1 (2.5 mCi), 46 patients in Cohort 2 (5.0 mCi), and 8 patients in Cohort 3 (6.0 mCi).
There were no reports of dose limiting toxicities (DLTs), treatment-related discontinuations, serious renal complications, dysphagia, or clinically significant treatment-related myelosuppression.
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 5 patients, with none deemed related to the study medication.
Anti-tumor activity reported at ASCO (Free ASCO Whitepaper)-GI in January 2026, based on both patients in Cohort 1 and 23 (half) of the patients enrolled in Cohort 2:
Updated efficacy analysis in the same 25 patients from ESMO (Free ESMO Whitepaper) Congress 2025 ("ESMO 2025") in October 2025 was presented with an additional ~13 weeks of follow-up since the previous presentation at ESMO (Free ESMO Whitepaper) 2025.
19 of the 25 patients (76%) were without progression and remained alive, including both 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 (Free ESMO Whitepaper) 2025. One additional patient experienced an initial response in their most recent tumor assessment after the prior update at ESMO (Free ESMO Whitepaper) 2025. As the patient remains on 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. 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.
Cohort 3 opened in June 2025 after alignment was reached with the FDA, as previously agreed prior to the initiation of this study in 2023. Patients in Cohort 3 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 60kg (133lb), or 100μCi/kg of body weight if they weigh less than or equal to 60kg.
After the opening of Cohort 3 was announced in June 2025, eight Cohort 3 patients commenced treatment and contributed to dose-limiting toxicity (DLT) assessment by a safety monitoring committee (SMC). The DLT assessment is now complete, and we are cleared to treat more patients at this dose, with an additional eight patients already treated as of February 28, 2026, for a total of 16 patients in Cohort 3.
By mid-2026, the eight DLT patients in Cohort 3 would have had the opportunity for at least 32 weeks of follow-up since beginning treatment, sufficient time to have completed at least one scan following the full course of 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
VMT01 is a MC1R-targeted RPT that can be radiolabeled with either 203Pb for patient selection and dosimetry assessments, or 212Pb for alpha particle therapy.
We are conducting a multi-center, open-label, dose-finding study (clinicaltrials.gov identifier NCT05655312) in heavily pre-treated patients with histologically confirmed melanoma and MC1R-positive imaging scans.
Most recently, patients have received treatments at 3.0 mCi, either as monotherapy or in combination with nivolumab, a PD-1 blocking antibody developed and marketed by Bristol Myers Squibb as Opdivo.
Since dosing re-opened for 3.0 mCi of VMT01 as monotherapy, and was initiated for 3.0 mCi of VMT01 in combination with nivolumab in September 2025, 10 patients had received VMT01 3.0 mCi treatment as of February 28, 2026; six patients had received VMT01 at 3.0 mCi in combination with nivolumab, and four patients had received 3.0 mCi of VMT01 as monotherapy, in addition to the three patients who received this monotherapy dose in late 2023. Both cohorts are now closed for enrollment.
By late 2026, the 10 patients who had received VMT01 3.0 mCi treatment since the initiation or re-opening of these cohorts in September 2025 would have had the opportunity for at least 24 weeks of follow-up after their initial doses, sufficient time to have completed at least one scan after the full course of treatment (up to three doses every eight weeks).
PSV359
We designed PSV359 to target and deliver 212Pb to tumor sites expressing fibroblast activation protein-α, or FAP-α, associated with multiple highly prevalent solid tumors, with patients in need of additional treatment options. The targeting moiety may also be radiolabeled with 203Pb or 68Ga and 64Cu to detect FAP-α expression in individual patients. Preclinical imaging and therapy as well as human imaging results suggest our proprietary targeting ligand has improved levels of target engagement and uptake in tumors, as well as reduced retention in healthy tissues, which may result in a desirable therapeutic index.
As of February 28, 2026, two patients in Cohort 1 had been treated with [212Pb]PSV359 at 2.5 mCi, and six patients in Cohort 2 had been treated at 5.0 mCi, for a total of eight patients. By late 2026, these patients would have had the opportunity for at least 32 weeks of follow-up after their initial doses, sufficient time to have completed at least one scan after the full course of treatment (up to four doses every eight weeks). Activation activities are underway for additional sites.
Updates to the preclinical pipeline
Our discovery team is preparing additional novel constructs for potential first-in-human (FIH) imaging. If and when those constructs meet our criteria for further development, we plan to proceed with pre-IND filing activities. During the fourth quarter of 2025, we decided not to pursue further development of one early-stage preclinical asset, while activities continue on multiple other preclinical assets.
Updates on manufacturing infrastructure
We continue to make progress on expanding our manufacturing capabilities by increasing and enhancing capacity at existing facilities and building out recently acquired sites.
Full Year 2025 Financial Summary
Cash, cash equivalents, and short-term investments as of December 31, 2025 were approximately $145 million as compared to $227 million as of December 31, 2024. In February 2026, we announced the closing of an underwritten offering of securities with net proceeds of approximately $164 million after deducting underwriting discounts and commissions and other offering-related expenses. We believe our cash, cash equivalents and short-term investments as of December 31, 2025, together with the net proceeds from the February 2026 offering, will be sufficient to fund our current clinical milestones and operational investments into late 2027.
As of December 31, 2025, we had approximately 74.3 million shares of common stock and approximately 10.9 million warrants and options to purchase shares of common stock outstanding. In connection with the February 2026 underwritten offering of securities noted above, we issued 39.6 million shares of common stock along with pre-funded warrants to purchase 6.6 million shares of common stock.
Grant revenue was $0.9 million for the year ended December 31, 2025, compared to approximately $1.5 million for the year ended December 31, 2024. Grant revenue is derived from our work with the National Institutes of Health.
Research and development expenses were $84.2 million for the year ended December 31, 2025, compared to $41.6 million for the year ended December 31, 2024, an increase of approximately 102%. The increase in research and development expenses was primarily related to increased clinical site activities, drug program costs and delivery costs along with higher personnel costs, including share-based compensation.
Research and development expenses additionally included a $10.0 million non-cash impairment loss for the three months ended December 31, 2025, in connection with our decision to deprioritize an early-stage preclinical asset within our in-process research and development portfolio. This early-stage preclinical asset was acquired as part of the merger between Viewpoint Molecular Targeting, Inc. and Isoray, Inc. in February 2023.
General and administrative expenses were $30.2 million for the year ended December 31, 2025, compared to $26.6 million for the year ended December 31, 2024, an increase of approximately 14%. The increase in general and administrative expenses for the year ended December 31, 2025 was primarily due to increased personnel costs, partially offset by decreased fees for professional services.
Total operating expenses for the year ended December 31, 2025 were $114.4 million (including a non-cash, one-time impairment loss for a preclinical asset of $10.0 million), compared to $92.3 million for the same period in 2024 (including a non-cash, one-time goodwill impairment charge of $24.1 million), an increase of approximately 24%.
Net loss for the year ended December 31, 2025 was $103.1 million, or $1.40 per basic and diluted share, compared to a net loss of $79.3 million, or $1.23 per basic and diluted share, for the same period in 2024. During the year ended December 31, 2025, there was a net benefit of $7.7 million in net interest income and other expense, compared to a net benefit of $10.5 million in net interest income and other expense during the year ended December 31, 2024.
(Press release, Perspective Therapeutics, MAR 16, 2026, View Source [SID1234663587])