-- Updated interim results from the Company's [212Pb]VMT-<ALPHA>-NET Phase
1/2a study supporting the therapy's compelling overall clinical profile
at the 5 mCi dose were presented at the ESMO Congress 2025, NANETS and
Triple meetings
-- Enrolled eight patients into Cohort 3 (6.0 mCi) of the
[212Pb]VMT-<ALPHA>-NET study within three months of opening the cohort
-- Visibility on updates for all three of the Company's clinical-stage
potential new medicines expected throughout 2026 based on strong
recruitment of patients and clinical sites
-- Cash, cash equivalents and short-term investments of approximately $174M
as of September 30, 2025 expected to be sufficient to fund current
planned clinical milestones and operational investments into late 2026
SEATTLE, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. ("Perspective," the "Company," "we," "us," and "our") (NYSE AMERICAN: CATX), a radiopharmaceutical development company that is pioneering advanced treatments for cancers throughout the body, today provided a business update and announced results for the quarter ended September 30, 2025.
"The strength of our clinical data continues to validate our technology and reinforce our mission to redefine cancer treatment," said Thijs Spoor, Perspective's CEO. "With several important milestones ahead, we look forward to sharing new data and strategic updates as we close out the year and head into 2026 and beyond."
Clinical Highlights
VMT-<ALPHA>-NET
We designed [(212) Pb]VMT-<ALPHA>-NET to target and deliver (212) Pb to tumor sites expressing SSTR2.
We are conducting a multi-center, open-label, dose finding, dose expansion study (clinicaltrials.gov identifier NCT05636618) of [(212) Pb]VMT-<ALPHA>-NET in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2)-positive neuroendocrine tumors (NETs) who have not received prior radiopharmaceutical therapies $(RPT)$.
During October 2025, updated interim data from the study, as of a data-cut off $(DCO)$ date of September 12, 2025, were presented at the European Society of 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. Highlights from the new data included the following:
Safety findings based on 55 patients who received at least one treatment:
-- [(2)(1)(2)Pb]VMT-<ALPHA>-NET continued to demonstrate a favorable safety
profile, with no dose-limiting toxicities (DLTs), treatment-related
discontinuations, or Grade 4 or 5 treatment-emergent adverse events
(TEAEs) reported.
-- Grade 3 TEAEs have occurred in 16 patients (30%).
-- No serious renal complications, and no clinically significant
treatment-related myelosuppression.
-- No dysphagia of any grade observed.
Anti-tumor activity based on all patients in Cohort 1 and half of the patients enrolled in Cohort 2:
-- Of these 25 patients, 20 (80%) remained progression-free. Eight patients
achieved confirmed responses per investigator-assessed RECIST v1.1, all
of which occurred in Cohort 2.
-- All 23 patients in Cohort 2 had at least one tumor expressing SSTR2, and
16 showed SSTR2 expression in all of their tumors.
-- Among the 16 patients with SSTR2 expression in all of their tumors, seven
(44%) achieved confirmed responses, and 14 (87.5%) remained
progression-free and on study, with a median follow-up of 41 weeks.
-- Initial anti-tumor activity data for an additional 23 patients in Cohort
2 and eight patients in Cohort 3 are expected to be submitted for
presentation at a future medical conference in 2026.
Enrollment for Cohort 2 closed in 2Q 2025 with a total of 46 patients, including the seven who were enrolled for DLT observation prior to May 2024.
-- As of October 31, 2025, a total of 35 patients in Cohort 2 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.
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. The alignment was based on clinical and dosimetry results, including public presentations at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in May 2025 and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2025 Annual Meeting in June 2025, respectively. Patients in Cohort 3 are receiving up to four fixed administered doses of [(212) Pb]VMT-<ALPHA>-NET at 6.0 mCi every eight weeks if they weigh more than 60kg (133lb), or 100<MU>Ci/kg of body weight if they weigh less than or equal to 60kg.
Since the opening of Cohort 3 was announced on June 21, 2025, eight Cohort 3 patients have commenced treatment with VMT-<ALPHA>-NET as of September 30, 2025 and will contribute to DLT observation for this dose level. We are evaluating whether to add additional patients to this cohort or explore alternative dose regimens before nominating a dose for a registration enabling study.
We plan to submit to medical conferences relevant updates on patients dosed to date who have had the opportunity to receive at least one scan after their full treatment (up to four doses every eight weeks), for presentation in the next 12 months.
VMT01
VMT01 is a melanocortin 1 receptor (MC1R)-targeted RPT that can be radiolabeled with either (203) Pb for patient selection and dosimetry assessments, or (212) Pb for alpha particle therapy.
We are conducting a multi-center, open-label, dose finding, dose expansion study (clinicaltrials.gov identifier NCT05655312) in heavily pre-treated patients with histologically confirmed melanoma and MC1R-positive imaging scans.
-- Currently, patients are receiving 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$(R)$.
-- 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, five patients had received VMT01 treatment as of October 31, 2025.
Three patients had received VMT01 at 3.0 mCi in combination with
nivolumab. Two patients had received 3.0 mCi of VMT01 as monotherapy, in
addition to the three patients who received this monotherapy dose in late
2023.
We plan to submit to medical conferences data on each cohort after all patients in the cohort have had the opportunity for at least 24 weeks of follow-up after their initial doses, sufficient time to receive at least one scan after their full treatment (up to three doses every eight weeks), if they receive all three doses of treatment per protocol.
PSV359
We designed PSV359 to target and deliver (212) Pb to tumor sites expressing fibroblast activation protein-<ALPHA>, or FAP-<ALPHA>, associated with multiple highly prevalent solid tumors, with patients in need of additional treatment options. The targeting moiety may also be radiolabeled with (203) Pb, (68) Ga or (64) Cu to detect FAP-<ALPHA> 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.
Two patients in Cohort 1 had been treated with [(212) Pb]PSV359 at 2.5mCi and one patient in Cohort 2 had been treated at 5.0mCi, for a total of three patients as of October 31, 2025. Activation activities are underway for additional sites.
Third Quarter 2025 Financial Summary
Cash, cash equivalents, and short-term investments as of September 30, 2025 were approximately $174 million as compared to $227 million as of December 31, 2024. Based on our current plans, which include advancing current clinical programs, progressing multiple pre-IND assets towards clinical trials, as well as building out regional manufacturing sites, we expect to have sufficient funding into late 2026.
As of September 30, 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.
We previously presented our results in two segments: Drug Operations and Brachytherapy. Due to the divestiture of our entire brachytherapy segment to GT Medical in April 2024, the operations of the brachytherapy segment have been classified as discontinued operations in our financial statements. The discussion below pertains to continuing operations unless otherwise noted.
Grant revenue was $0.2 million for the three months ended September 30, 2025, compared to $0.4 million for the three months ended September 30, 2024. Grant revenue was $0.8 million for the nine months ended September 30, 2025, compared to $1.2 million for the nine months ended September 30, 2024. Grant revenue is derived from our work with the National Institutes of Health.
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