Perspective Therapeutics: VMT01 partial responses in 2/8
At the 3.0 mCi dose, six of eight patients achieved disease control; across 20 patients, no treatment-related serious treatment-emergent adverse events were reported.
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Rhea-AI Filing Summary
Perspective Therapeutics, Inc. reported updated interim monotherapy results from its ongoing Phase 1/2a trial of investigational [212Pb]lapemelanotide zapixetar (VMT01) in previously treated patients with unresectable or metastatic melanoma whose tumors express MC1R. The update covers 20 patients who had received at least one monotherapy treatment by September 18, 2026. At the 3.0 mCi dose, 2 of 8 patients had objective partial responses, and 6 of 8 (75%) achieved disease control, including 2 with long-lasting disease stabilization. One responder remained in partial response and on study approximately 40 weeks after the first treatment.
Across all 20 patients, no dose-limiting toxicities, treatment-related serious treatment-emergent adverse events, or adverse-event-related treatment discontinuations were reported. Grade 3 or higher treatment-emergent adverse events occurred in 5 patients (25%), none considered treatment-related. The eighth patient in the 3.0 mCi cohort had recently been treated and was not yet eligible for a first tumor assessment as of the data cutoff. Perspective said continued evaluation and dose optimization will inform future clinical development.
Filing Explained
The attached poster also lists nivolumab-combination cohorts 1B and 2B as recruitment complete, while cohort 3B’s dose remains to be determined; the reported 20-patient results are monotherapy-only, and no combination outcomes are disclosed.
8-K Event Classification
Key Figures
Key Terms
dose-limiting toxicities medical
disease control rate medical
treatment-emergent adverse events medical
MC1R-positive imaging medical
theranostic approach medical
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events.
On November 6, 2026, Perspective Therapeutics, Inc. (the “Company”) issued a press release and posted to its website a poster presentation announcing updated interim results from the Company’s Phase 1/2a clinical trial of [212Pb]lapemelanotide zapixetar (VMT01) for the diagnosis and treatment of patients with unresectable or metastatic melanoma who have demonstrated melanocortin 1 receptor tumor expression that are being presented at the 41st Annual Meeting of the Society for Immunotherapy of Cancer taking place November 4-8, 2026 in Phoenix, Arizona. A copy of the press release is filed herewith as Exhibit 99.1, and a copy of the poster presentation is filed herewith as Exhibit 99.2, and each is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Press Release dated November 6, 2026. |
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Poster Presentation. |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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PERSPECTIVE THERAPEUTICS, INC. |
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November 6, 2026 |
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/s/ Johan (Thijs) Spoor |
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Johan (Thijs) Spoor |
Perspective Therapeutics Presents Promising [212Pb]Lapemelanotide Zapixetar (VMT01) Monotherapy Data from a Phase 1/2a Study in
Heavily Pretreated Advanced Melanoma Patients at SITC 2026
SEATTLE, November 6, 2026 -- Perspective Therapeutics, Inc. (“Perspective,” the “Company,” “we,” “us,” and “our”) (NYSE AMERICAN: CATX), a radiopharmaceutical development company pioneering advanced systemic treatments for cancers, today announced updated interim monotherapy results from its ongoing Phase 1/2a clinical trial of [212Pb]lapemelanotide zapixetar (VMT01), an investigational targeted alpha therapy. The Company presented the data as a poster at the Society for Immunotherapy of Cancer (SITC) 41st Annual Meeting, being held November 4 to 8, 2026, in Phoenix, Arizona.
The update covered 20 patients who received at least one monotherapy treatment of lapemelanotide as of September 18, 2026 (DCO date), across three dose cohorts of up to cumulative 4.5 mCi, 9 mCi, and 15 mCi, administered in three treatments of 1.5 mCi, 3.0 mCi, and 5.0 mCi, respectively, every eight weeks.
At the program’s focus dose of 3.0 mCi, two out of the eight patients enrolled in the monotherapy cohort had objective partial responses, one of whom remained in partial response and in study approximately 40 weeks after their first treatment. The disease control rate (DCR) was 75%, including two patients with long-lasting disease stabilization. As of the DCO date, eight patients had received at least one treatment in this dose cohort, with the eighth patient recently treated and not yet eligible for their first tumor assessment.
Across all 20 monotherapy patients, no dose-limiting toxicities (DLTs), treatment-related serious treatment-emergent adverse events (TEAEs), or adverse event-related treatment discontinuations were reported. Grade 3 or higher TEAEs occurred in five patients (25%), with none considered treatment-related.
“Despite significant advances in immunotherapy, many patients with advanced melanoma do not respond to checkpoint inhibitors, or they experience disease progression following treatment,” said Markus Puhlmann, MD, Perspective’s Chief Medical Officer. “The clinical activity observed with lapemelanotide, together with its safety profile to date, supports further investigation of targeted alpha therapy as a potential treatment option for patients with limited alternatives.”
“With lapemelanotide, we’re seeing responses and meaningful periods of disease stabilization in heavily pretreated patients,” said Thijs Spoor, Perspective’s Chief Executive Officer. “We believe there is an opportunity to make a difference for these patients. We’re continuing to learn from the data as we determine the best way to move the program forward.”
About [212Pb]Lapemelanotide Zapixetar
Perspective designed lapemelanotide to target and deliver 212Pb to metastatic melanoma tumor sites expressing MC1R, a protein that can be overexpressed in metastatic melanoma tumors. The Company is 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 obtained with the companion investigational imaging agent [203Pb]VMT01.
About Perspective Therapeutics, Inc.
Perspective Therapeutics, Inc. is a radiopharmaceutical development company pioneering advanced systemic treatments for cancers. The Company has proprietary technology that utilizes the alpha-generating isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting moieties. The Company is also developing complementary imaging techniques that incorporate the same targeting moieties, creating an 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.
The Company is advancing a portfolio of clinical-stage programs in the U.S., including bamzireotide navoxetan (VMT-α-NET, neuroendocrine tumors), lapemelanotide zapixetar (VMT01, melanoma), and PSV359 (solid tumors).
The Company is expanding its regional finished drug product candidate supply network, enabled by its proprietary 224Ra/212Pb generator platform used to manufacture clinical drug product candidates, to support the delivery of patient-ready drug product candidates for clinical trials and, if approved, commercial operations.
For more information, please visit the Company's website at www.perspectivetherapeutics.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Words such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "estimate," "believe," "predict," "potential," or "continue," or the negative of these terms or other similar expressions are intended to identify forward-looking statements, though not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements concerning, among other things, the Company’s proprietary technology, imaging techniques and product candidates, including VMT-α-NET, PSV359, and VMT01, and related treatment opportunities in connection therewith; the Company’s understanding regarding the clinical profiles of its product candidates, including VMT-α-NET, PSV359, and VMT01; the Company’s preclinical and clinical development plans and the expected timing for the release of additional data from its clinical programs; the anticipated clinical benefits of the Company’s product candidates relative to existing therapies; the Company’s expectations regarding regulatory engagement and pathways for its product candidates; the Company’s expectations regarding its interactions with regulatory agencies, including the FDA, and the expected timing thereof; the Company’s regional distribution and manufacturing capabilities; and other statements that are not historical fact.
The Company may not actually achieve the plans, intentions, or expectations disclosed in the forward-looking statements, and you should not place undue reliance on the forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the Company's actual results to differ materially from the results described in or implied by the forward-looking statements. Known risk factors include (without limitation) that the Company’s clinical trials may be more costly or take longer to complete than anticipated, or may never be completed, or may not generate results that warrant future development of the tested product candidate; regulatory authorities may not grant or may delay approval for our product candidates; the Company may elect to change its strategy regarding its product candidates and clinical development and manufacturing activities; economic and market conditions may worsen; the Company’s ability to establish, maintain and expand its regional distribution and manufacturing capabilities; and risks related to the sufficiency of the Company’s cash resources for its future operating expenses and capital expenditures. A more complete discussion of the risks and uncertainties facing the Company appears under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”), in the Company’s other filings with the SEC, and in the Company’s future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this news release are made as of this date. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Media and Investor Relations Contacts:
Perspective Therapeutics IR:
Annie J. Cheng, CFA
ir@perspectivetherapeutics.com
ENTENTE Network of Companies
Katie Morris, PhD
katiemorris@ententeinc.com
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1Su DG, Djureinovic D, Schoenfeld D, et al. Melanocortin-1 Receptor Expression as a Marker of Progression in Melanoma. JCO Precis Oncol. 2024;8:e2300702. doi:10.1200/PO.23.00702.
A Phase I/IIa Trial of [212Pb]VMT01 MC1R-targeted Alpha-Particle Mono- and Combination-Therapy with Nivolumab in Participants with Previously Treated Unresectable or Metastatic Melanoma M.S. Block1, Z.S. Morris2, J. Lutzky3, R.L. Wahl4, A.J. Olszanski5, Y. Menda6, S. Mehr7, L. Baratto8, S. Ayuk8, D. Pomponio8, S. Patel8, M. Puhlmann8, R.B. Patel9, and R. Arays10 1Mayo Clinic, Rochester, MN; 2University of Wisconsin, Madison, WI; 3University of Miami, Miami, FL; 4Washington University School of Medicine, St. Louis, MO; 5Fox Chase Cancer Center, Philadelphia, PA; 6University of Iowa, Iowa City, IA; 7Nebraska Cancer Specialists, Omaha, NE; 8Perspective Therapeutics Inc., Seattle, WA; 9University of Pittsburgh Hillman Cancer Center, Pittsburgh, PA; 10University of Kentucky, Lexington, KY #571 Background Immune checkpoint inhibitors (ICIs) have improved outcomes in metastatic melanoma, but many patients experience primary or acquired resistance after ICI-based therapy. Treatment options remain limited for patients who progress after ICI and BRAF/MEK-targeted therapy. Melanocortin-1 receptor (MC1R) is a melanoma-associated target that enables a theranostic approach.1 » VMT01 is an MC1R-targeted radiopharmaceutical that can be labeled with 203Pb for patient selection and dosimetry or with 212Pb for targeted alpha-particle therapy. In preclinical melanoma models, [212Pb]VMT01 demonstrated direct antitumor activity and immune-mediated effects, with enhanced antitumor activity when combined with ICIs.2,3 (Figure 1) Preclinical findings support potential immunomodulatory effects of targeted alpha-particle therapy in the tumor microenvironment (TME); the clinical relevance and dose dependence of these effects remain under investigation.4 (Figure 2) Objective To evaluate the safety, tolerability, dosimetry, pharmacokinetics (PK), and preliminary antitumor activity of [212Pb]VMT01 in participants with previously treated MC1R-positive metastatic melanoma. » Phase I/IIa study: NCT05655312 Study Design Most Common Treatment-Emergent Adverse Events (TEAEs; All Grades; Frequency ≥10%) Monotherapy [212Pb]VMT01 This first-in-human, phase 1/2a dose-finding study evaluates [212Pb]VMT01 in participants with previously treated, unresectable or metastatic melanoma. Tumor Volume (mm3) Recruitment Complete MONO Cohort 3A [212Pb]VMT01 n = 5 / 1.5 mCi × 3 Part 1: Monotherapy MONO Cohort 4A [212Pb]VMT01 n = 2–8 @TBD mCi by SMC × 3 Recommended Phase 2 Dose (RP2D) Part 2: Combination with nivolumab (480 mg every 4 weeks) Recruitment Complete COMBO Cohort 1B [212Pb]VMT01/PD-1 n = 2 / 1.5 mCi × 3 Recruitment Complete COMBO Cohort 2B [212Pb]VMT01/PD-1 n = 6 / 3 mci × 3 COMBO Cohort 3B [212Pb]VMT01/PD-1 n = 2–8 @TBD mCi by SMC × 3 Up to 100 patients may be enrolled in the expansion phase *Additional patients may be enrolled in up to 2 cohorts in Part 1 and up to 2 cohorts in Part 2 Tumor Volume (mm3) DCO 18-SEPT-2026: All clinical data presented on this poster reflects data from the 20 patients enrolled in the [212Pb]VMT01 monotherapy cohorts; TEAE window: monotherapy, starting at first dose until 30 days after last dose No dose-limiting toxicities (DLTs) were observed among the 20 participants treated with [212Pb]VMT01 monotherapy. TEAEs were predominantly Grades 1 and 2. Grade ≥3 TEAEs and serious TEAEs each occurred in 5 of 20 participants (25%) receiving [212Pb]VMT01 monotherapy; none were considered treatment-related. No treatment-related serious TEAEs were reported. Five participants receiving [212Pb]VMT01 monotherapy experienced serious TEAEs, including dehydration, malignant neoplasm progression, hypoglycemia, pleural effusion, and seizure (all n=1). No adverse events led to treatment discontinuation. Cytoreductive — Immediate Local Killing Immunostimulatory — Durable Widespread Response RPT injection Targeting peptide* Binds to receptors on cancer cells and 1. Targeted cell death 212Pb isotope releases α particles that induce dsDNA breaks and membrane disruption. 2. Bystander effect Dying cancer cells release DAMPs, causing nearby cells to die as well. 3. Immune activation Dying cancer cells release neoantigens that are taken up by APCs. APCs activate T cells which further attack cancer cells and drive memory T cells. dsDNA breaks; *RPT not to scale. repair mechanisms overwhelmed Naïve T cell α radiation Memory T cell Neoantigens APC Vaccine-like effect Naïve T cell DAMPs Cytokines Active T cell Tumor Cancer cell Dying cancer cell Figure 2. Proposed multimodal mechanisms of MC1R-targeted α-particle therapy, including direct cytotoxicity and immunomodulatory effects in the TME.5 Phase 1 includes dose-escalation cohorts evaluating [212Pb]VMT01 monotherapy and combination therapy with nivolumab. » In the initial cohorts, [203Pb]VMT01 imaging was used for patient selection and dosimetry before administration of up to 3 cycles of [212Pb]VMT01. Dose-limiting toxicities (DLTs) are evaluated during the first 6 weeks after Cycle 1. Antitumor activity is assessed by investigators (RECIST v1.1). The nivolumab combination cohorts were added by protocol amendment. Trial Parameters Key Eligibility Criteria Key Study Features Study Endpoints Unresectable or metastatic melanoma Progression after at least 1 prior systemic therapy No prior radiopharmaceutical therapy (RPT) MC1R-positive imaging with [203Pb]VMT01 or [68Ga]VMT02 Bayesian Optimal Interval (BOIN)-12 design with iterative assessment of toxicity and efficacy Intermediate doses may be evaluated based on emerging data Dosimetry assessed using [203Pb]VMT01 Preliminary Antitumor Activity — Best Response on Treatment 1000 800 600 400 200 0 0 20 Days Post-Treatment Control (n = 8) 1.9 MBq (n = 6) 3.7 MBq (n = 6) 5.6 MBq (n = 6) 40 Combination Therapy [212Pb]VMT01+ ICIs 1000 800 600 400 200 0 ICIs (n = 7) 1.9 MBq + ICIs (n = 7) 3.7 MBq + ICIs (n = 6) 5.6 MBq + ICIs (n = 7) 0 20 40 Days Post-Treatment Figure 1. [212Pb]VMT01 alone and in combination with anti-CTLA4 and anti–PD-1 demonstrated dose-dependent antitumor activity in female C57Bl6 mice bearing B16-F10 melanoma, with robust activity observed at lower combination doses.4 Demographics and Baseline Characteristics Age, years Median 68.0 Range 49–81 Sex, n (%) Female 9 (45.0) Male 11 (55.0) Race, n (%) White 20 (100) ECOG PS, n (%) 0 11 (55.0) 1 9 (45.0) Time from diagnosis to enrollment, months Median 59.0 Range 9.7–227.2 Data cutoff (DCO) 18-SEPT-2026: All clinical data presented on this poster reflects data from the 20 patients enrolled in the [212Pb]VMT01 monotherapy cohorts Fitzpatrick skin phototype TYPE I 2 (10.0) TYPE II 4 (20.0) TYPE III 5 (25.0) TYPE IV 8 (40.0) TYPE V 1 (5.0) TYPE VI 0 (0.0) Prior systemic therapies Median (range) 4 (1–7) Targeted therapy, n (%) 9 (45.0) Immunotherapy, n (%) 18 (90.0) Chemotherapy, n (%) 5 (25.0) DCO 18-SEPT-2026: All clinical data presented on this poster reflects data from the 20 patients enrolled in the [212Pb]VMT01 monotherapy cohorts Conclusions [212Pb]VMT01 was generally well-tolerated in this preliminary analysis, with no DLTs observed among the 20 participants treated with [212Pb]VMT01 monotherapy. 1 participant in the 1.5 mCi monotherapy cohort experienced SD for more than 34 weeks. 2 of 8 participants (25%) in the 3 mCi monotherapy cohort had objective partial responses; 2 additional participants had long-lasting disease stabilization » The antitumor activity observed at a lower dose level is consistent with preclinical data suggesting that MC1R-targeted alpha-particle therapy may modulate the TME and enhance antitumor immunity. 6 of 8 participants (75%) in the 3 mCi monotherapy cohort achieved disease control (PR or SD), including 1 with ongoing disease control at the DCO. Further evaluation of [²¹²Pb]VMT01 monotherapy is warranted to characterize safety, antitumor activity, and dose optimization, with future combination strategies to be guided by emerging clinical data. Abbreviations: APC, antigen presenting cell; AST, aspartate aminotransferase; BOR, best overall response; CR, complete response; CT, computed tomography; DAMPs, damaged-associated molecular patterns; DCO, data cutoff; DLT, dose-limiting toxicity; DOR, duration of response; dsDNA, double-stranded DNA; ECOG PS, Eastern Cooperative Oncology Group Performance Status; FDA, Food and Drug Administration; FDG-PET, fluorodeoxyglucose positron emission tomography; ICIs, immune checkpoint inhibitors; MC1R, melanocortin-1 receptor; NE, not evaluable; ORR, objective response rate; OS, overall survival; PD, progressive disease; PFS, progression free survival; PK, pharmacokinetics; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; RP2D, recommended phase 2 dosing; RPT, radiopharmaceutical therapy; SD, stable disease; SMC, safety monitoring committee; TBD, to-be-determined; TEAE, treatment-emergent adverse events; TME, tumor microenvironment References: 1) Su DG et al. JCO Precis Oncol. 2024. 2) Li M et al. Cancers 2021. 3) Rodman et al. International Symposium on Radiopharmaceutical Sciences iSRS 2023. 4) Patel et al. Cancer 2021. 5) Adapted from Pouget et al. Trends Cancer 2023. Acknowledgments: We would like to thank all participants, caregivers, investigators, and site personnel. Preclinical data were provided by Sam Rodman. Trial sponsored by Perspective Therapeutics. Medical writing and poster production support was provided by Acumen Medical Communications, funded by Perspective Therapeutics. Copies of this poster obtained through Quick Response (QR) Code are for personal use only and may not be reproduced without permission from the authors of this poster. Dose-finding Phase* Recruitment Complete MONO Cohort 2A [212Pb]VMT01 n = 7 / 5 mCi × 3 Recruitment Ongoing MONO Cohort 1A [212Pb]VMT01 n = 8 / 3 mCi × 3 Expansion Cohort [212Pb]VMT01 RP2D mCi × 3 Expansion Cohort [212Pb]VMT01/PD-1 RP2D mCi × 3 Primary: Safety and tolerability; determination of the RP2D based on the overall assessment of DLT incidence and severity, objective response rate (ORR), and dosimetry, when performed. Secondary: ORR, BOR, DOR, PFS by RECIST v1.1, OS, PK Figure 3. Best overall response on treatment 18F-FDG PET CT 18F-FDG PET/CT Baseline After Cycle 1 Figure 4. Representative CT and PET/CT images from a participant with a confirmed partial response after 2 cycles of [212Pb]VMT01. After Cycle 2 Preferred Term, n (%) Cohort 1A n = 8 (%) Cohort 2A n = 7 (%) Cohort 3A n = 5 (%) Total n = 20 (%) Participants with at least 1 TEAE 6 (75.0 ) 6 (85.7 ) 4 (80.0 ) 16 (80 ) Fatigue 3 ( 37.5 ) 2 ( 28.6 ) 1 ( 20.0 ) 6 (30 ) Nausea 3 ( 37.5 ) 2 ( 28.6 ) - 5 (25 ) Dyspnoea 2 ( 25.0 ) 3 ( 42.9 ) - 5 (25 ) Pain in extremity 3 ( 37.5 ) - - 3 (15 ) Muscular weakness 1 ( 12.5 ) 1 ( 14.3 ) 1 ( 20.0 ) 3 (15 ) Vomiting 1 ( 12.5 ) 1 ( 14.3 ) 1 ( 20.0 ) 3 (15 ) Abdominal pain - 1 ( 14.3 ) 1 ( 20.0 ) 2 (10 ) Cough - 2 ( 28.6 ) - 2 (10 ) Pruritus 2 ( 25.0 ) - - 2 (10 ) COVID-19 2 ( 25.0 ) - - 2 (10 ) Contusion 2 ( 25.0 ) - - 2 (10 ) Proteinuria 1 ( 12.5 ) 1 ( 14.3 ) - 2 (10 ) Urinary tract infection 1 ( 12.5 ) - 1 ( 20.0 ) 2 (10 ) Weight decreased - 1 ( 14.3 ) 1 ( 20.0 ) 2 (10 ) n (%) Cohort 1A n = 8 (%) Cohort 2A n = 7 (%) Cohort 3A n = 5 (%) Total n = 20 (%) ORR (CR + PR) 2 (25.0) 0 0 2 (10 ) Confirmed PR 2 (25.0) 0 0 2 (10 ) SD 4 (50.0) 3 (42.9) 1 (20.0) 8 (40 ) PD 1 (12.5) 4 (57.1) 4 (80.0) 9 (45 ) NE 1 (12.5) 0 0 1 (5 ) Subjects 0 8 16 24 32 40 48 56 64 72 80 Week Cohort 1A: [212Pb]VMT01 3 mCi Cohort 2A: [212Pb]VMT01 5 mCi Cohort 3A: [212Pb]VMT01 1.5 mCi Partial Response Stable Disease PD Ongoing Death Subsequent Cancer Therapy